Inherency as an Element of Obviousness

Hospira v. Fresenius (Fed. Cir. 2020)

Hospira lost at the district court on obviousness — with the court finding its asserted Claim 6 of US8648106 invalid as obvious. On appeal, the Federal Circuit affirmed and now Hospira has petitioned for en banc rehearing — focusing in on the role of inherency in combining prior art.

[Fed. Cir. Decision][Hospira Petition]

The claim is directed to the sedative dexmedetomidine in a “ready use liquid pharmaceutical composition” in a glass container and a shelf-life of 5-months with “no more than about 2% decrease” in the concentration of the active drug.

The “no more than about 2%” loss claim appears functionally described result — if you build the vial and fill it in the way described by the inventor then you’ll presumably get the shelf life.

Here, all of the limitations found in the claim are found within the prior art and the district court held that it would have been obvious for PHOSITA to combine the references as such. The one lacking element was the <2% loss limitation — that one was not expressed in the prior art.  However, the district court concluded that the functional limitation is an inherent result of the combination — and thus the whole claim is obvious.

Petition question:

Whether a party seeking to show that a property is inherent in a combination of prior art disclosures must affirmatively prove that the property is necessarily present in that combination, regardless of how that combination is prepared.

Hospira’s basic arguments here are (1) that inherency for obviousness must be proven with clear and convincing evidence and (2) that inherency for obviousness only ‘counts’ if necessarily present in the proposed combination, not merely likely or possibly present.

In their 2005 paper on Inherency, Professors Dan Burk and Mark Lemely took the position that inherency should have almost no role in the obviousness analysis because of its hindsight approach.

Hindsight reconstruction of the invention, looking back at the prior art to second-guess the inventor once the invention is available, is anathema to an obviousness assessment. But inherency is all about hindsight—a recognition today that an invention was present in the prior art, even though it was not understood to be there at the time.

Given the hindsight limitations on obviousness, we expect the role of inherency under § 103 to be extremely limited, if not altogether nonexistent.

Dan Burk, Mark Lemley, Inherency, 47 William & Mary Law Review 371 (2005).

104 thoughts on “Inherency as an Element of Obviousness

  1. 9

    This concerns an inherency-based obviousness rejection against a claim that includes a functional element. (Please note that I have published more on the topic of patent prosecution than any person in the United States – – – 18 law review articles, most between 80-120 pages long, including articles that are in press.) Inherency-based rejections are not logical, because it impossible for a function to be inherently disclosed by structures picked and chosen from two different prior art references, where the structures are assembled in the examiner’s mind to create a device that possesses the claimed function. This basis for rejection is not reasonable, because it is never the case that two separate prior art references are inherently combined with each other (this combination occurs only in the Examiner’s mind, where the Examiner uses the Doctrine of Obviousness as a basis for combining the references). Using Inherency Doctrine as part of the basis for an obviousness rejection has repeatedly been questioned and criticized, as revealed in the cited references.
    Ex parte Penner, Appeal No. 2015-008273 (August 23, 2017) Ser. No. 13/772,007.

    O’Brien, D. and Spruill, W. (2013) Does Inherency Have a Place in Determinations of Obviousness. Biotechnology Law Report. 32:3-16.

    Browning, P., Raich, W, and Townsend, P (April 13, 2018) Inherency in Obviousness A Worrying Trend. BNA’s Patent, Trademark & Copyright Journal.

    Mahanta, S. (August 1, 2017) Inherency in Obviousness What is the Correct Standard? www dot IPWatchdog dot com

  2. 8

    The thread at #7 reminds me of the hoary old example claim used by retired eminent UK patents judge Robin Jacob, for exploring how obviousness is argued, jurisdiction by jurisdiction.

    The technical field is dinner plates. The hypothetical is that plates that are 5 inches in diameter are known and plates that are 6 inches in diameter are known. The claim is directed to a “Five and a half inch plate”. Basta!

    Different jurisdictions approach the issue differently. For example, under the EPO’s Problem-Solution Approach to obviousness, the claim might or might not be allowable, depending on what the specification as originally filed discloses about any technical problem which the claimed plate plausibly solves. After all, patentable subject matter ought to correspond to a non-obvious solution to an objective technical problem, right?

    But in jurisdictions other than the EPO, the approach varies. And that’s the interesting bit.

    1. 8.1

      Different jurisdictions approach the issue differently

      So very true.

      The US Sovereign has NOT chosen the ‘technical solution to a technical problem’ approach.

      As you are aware, we do not have a “Technical Arts” test.

      What the US Sovereign instead has chosen is a general sense of utility and coverage of this aspect is NOT handled at all by our obviousness doctrine.

      I recently noted this in reply to what appeared to be a denigrating comment from Prof. Crouch in regards to how very low the US bar IS to utility.

      For whatever sets of reasons (and I certainly grant that there may be more than one set), certain individuals simply bristle at some of the low bars that the US Sovereign has chosen.

    2. 8.2

      As to plate sizes, one may consider whether the difference is one of degree or of kind.

      That ties to utility when the difference is a difference of kind (for example, there may be different physics or other constraints invoked across different sets of sizes. For another example, there may be a ‘surprising effect’ with a sub-range within a first given range.

      This MAY be highlighted by an application pointing this out, but — importantly — need not have that explicitly noted as a particular problem being solved. That is to say, the innovators solution remains a solution even if not all of the problems that such a solution may avail itself of are even recognized at the time of filing.

      Quite in fact, OFTEN actual inventors simply are not aware of the depth of their own innovation, and it is a critical role of us ‘mere scriveners’ to write specifications that afford a sense of protection that extends forward in time for twenty years. If, as a scriviner, one blandly accepts some type of ‘picture claim,’ one has NOT (typically – I grant that there may be exceptions) fulfilled one’s duty to one’s client.

      1. 8.2.1

        I do not understand the “need not” observation about drafting style (but I agree that one should draft for optimal enforceability, through the courts, 15 or 20 years later). If your client wants an enforceable patent somewhere in the world in addition to the USA, and what client today doesn’t, would you draft the specification any different from the one that is, in your mind, optimal for your client to assert today in the courts of the home jurisdiction?

        1. 8.2.1.1

          That you claim not to understand the “need not” comment is clear in your proclivity of offering solutions for other Sovereigns based merely on the spectacles that you were within the ‘Sovereign’ of your own lack experience.

          You seem to recognize the concept that different Sovereigns may choose to implement legal concepts differently, but you routinely FA1L to grasp the particulars.

          I can only lead you to the well. You just choose to drink once you are there.

          1. 8.2.1.1.1

            ‘Sovereign’ of your own lack experience. ==>
            ‘Sovereign’ of your own experience.

            You just choose to drink once you are there. ==>
            You must choose to drink once you are there.

          2. 8.2.1.1.2

            I was just wondering, when was the last time a client entrusted you with the task of drafting a specification for an application at a Patent Office to protect a patentable invention over the 21 years to come. You only get one shot, you see, to do an adequate job.

            1. 8.2.1.1.2.1

              Oh please — you want to implicate other writing because of typos on a blog…? Have you looked at the content of your own blog posts (much more critical errors than mere typos). Do you want a reminder message from the author of this blog vis a vis typos?

              Put your energy where it matters my friend.

            2. 8.2.1.1.2.2

              I’ll try again. Patent drafting is an exercise in anticipating what will pass muster in the courts for the next 21 years. There is one drafting style, these days, for the USA and a different one for the First to File Rest of the World. How long will it be before the courts of the USA start taking notice of how courts in the First to File world resolve issues of priority between Applicants, novelty over the prior art, and whether amendments made after filing are acceptable? How long will it be, before US drafting style gives way to RoW style? Those law firms drafting patent applications in the USA should mull this over, if they want to achieve the scope of protection which their clients are paying them to achieve. In house, at Google, J&J, Pfizer and other large international corporations, they are there already, of course. How about you, anon? That was my question.

              1. 8.2.1.1.2.2.1

                Max, that requires U.S. companies and their patent attorneys to realize that the U.S. market is now a rapidly shrinking percentage of the total world market and total affluent world population which U.S.-only patent protection does not adequately protect.

                1. As you say Paul. But with so much reaction against globalisation, gradual return of manufacturing from offshore to the USA, perhaps, in time, a US patent will again be the only patent one will ever need? Who knows.

              2. 8.2.1.1.2.2.2

                My clients are heavy US Centric, and aim the principal writing for this Sovereign. ANY trade-offs are geared to US law.

                Be that as it may, Dave Boundy (as I recall), quite disagreed with you the last time you wanted to play “comparative law.”

                We do have counsel that directly handles the (loosely) parallel European matters (just as we have Asian and Indian counsel for those markets).

                ALL of this however is nothing more than dust kicking from you in response to the points of my post at 8.2.1.1, of which the key factor under discussion is the FACT that differences amongst the Sovereigns remain.

                1. David Boundy and I understand each other very well, thank you. At least he understands that if you want effective patents outside the USA you have to take that into account during the original drafting.

                  As the US courts gradually come to terms with the inevitabilities of any First to File patent system, in particular how to adjudicate between rival Applicants who filed at the PTO on much the same subject matter at much the same date, the obviousness of drafting patent applications the way the rest of the world has been doing, these past 40 years, will be more and more apparent to US patent attorneys. Let’s see what happens in the CRISPR litigation, shall we?

                2. Note that I did NOT indicate that you two do not misunderstand each other.

                  I ‘get’ that you both understand the point of your disagreement.

                  MY point is that you two DO disagree.

                  Yet again, MaxDrei, your reply is nothing but dust-kicking.

                  As to your continued “One World Order” advocating…

                  in particular how to adjudicate between rival Applicants who filed at the PTO on much the same subject matter at much the same date, the obviousness

                  Full Stop.

                  The court (here) is NOT at liberty to adjudicate based on some other Sovereign’s choice of the legal principles under obviousness.

                  Further, you insert the notion “between rival Applicants” as if PHOSITA somehow ‘becomes’ a real world person in a legal test.

                  YOUR Sovereign may well have chosen that path. Our Sovereign has not. Our Sovereign has maintained a consistent “Legal Person” approach to PHOSTIA for each of the different tests for novelty and non-obviousness.

                  US Patent Attorneys would be wise to note the continued differences in Sovereign laws.

                  However they may choose to address those differences is of far lesser import to the necessary action of recognizing that such differences exist.

                  Do you disagree?
                  Do you understand?

                  Do you understand the difference between understanding and disagreeing?

                3. I’m not saying that the US courts must copy into US law the jurisprudence of Europe. What I’m saying is that as a consequence of moving to a First to File patent law, the courts of the USA will find themselves inevitably adjudicating priority contests by reference to what is disclosed to the PTO on the PTO filing date ascribed to the claim in suit in the specification that fixes the disclosure made to the PTO on the date of that claim.

                  I imagine that you will reply that they do that already. But wait and see, how the upcoming priority contests under FtF will test the jurisprudence up to now. Already the WD requirement is ratcheting up, but mark my words, you ain’t seen nothing yet.

    3. 8.3

      Dinner plates is definitely a superior example because no one will misunderstand you and then pretend like they had a high school junior’s understanding of chemistry all along.

      However the fact that an ostensibly educated engineer can misunderstand such an elementary fact shows how effective functional claiming can be to hide the ball. Sure an actual examiner would be somewhat trained in the art, but the functional parameters could be vastly more complex and obscure. One shouldn’t be receive a patent for applying someone else’s measurement technique to someone else’s product and reporting the results.

      1. 8.3.1

        Your desire to paint someone else’s view as a misunderstanding (it never was) while YOUR OWN VIEW was plain error, AND then still try to blow this out of proportion and try to make this an attack on ‘functional claiming’ only shows that YOU lack an understanding of the actual legal issues at play here Ben.

        One shouldn’t be receive a patent for applying someone else’s measurement technique to someone else’s product and reporting the result

        Absolutely. But that is NOT what you have shown is going on. ALL that you have shown is that you are a big whiner and do not understand that something that is a 102 type WILL have an inherent property, while a 103 attempt CANNOT have that same inherent property. You then muddle up the discussion of inherency with your ‘pet peeve’ of ‘functional claiming,” and you have shown NO correlation or legal connection.

        All that you have done is toot the horn of your feelings.

        It’s just not an impressive sound.

        1. 8.3.1.1

          YOU are the one who asserted that “a water ethanol mixture” inherently has a specified boiling point.

          “I’d agree that a water-ethanol mixture cannot reasonably be said to inherently have an 85.2789345 C boiling point.”

          You would be wrong.

          YOU were the one effectively positing that a 103 reference for a mixture inherently included a property of a specific undisclosed mixture.

          That is not, and has NEVER been my position. It was YOUR position until I provided you with the high school chemistry background that anyone with an engineering degree should know. I understand that you’re now inclined to flee from that position because of it’s implications, but it a craven thing to act like that wasn’t what you were saying.

          1. 8.3.1.1.1

            Wrong Ben — my position all along has been that inherency requires a 102 situation and NOT a 103 situation.

            You still lose this argument— you would simply do better figuring out why.

            Here’s a hint: your so-called “high school additional change takes it out of 103 and makes it a 102 situation.

            As I have said all along (but you were too busy being upset that I corrected you and called it hand waving).

  3. 7

    Claim 1: A mixture comprising: water; and ethanol; wherein the mixture has a boiling point at 85.2789345 C.

    I’d agree that a water-ethanol mixture cannot reasonably be said to inherently have an 85.2789345 C boiling point. But this claim shouldn’t be non-obvious either.

    I think the disagreement here shows why functional claiming is so pernicious. When you allow people to claim results rather than what they did, it obscures their contribution. It makes it difficult, if not impossible, for the agency to discern an improvement from an inherent feature.

    Of course, my claim 1 and the “no more than about 2% decrease” should probably be tanked under 112(a). But like patent practitioners, the office misunderstands 112 to keep the income flowing.

    1. 7.1

      I’d agree that a water-ethanol mixture cannot reasonably be said to inherently have an 85.2789345 C boiling point.

      You would be wrong. Any actual liquid has an inherent boiling point. Such is simply a factual matter.

      But this claim shouldn’t be non-obvious either

      Shouldn’t? Do you have anything other than your feelings on that? Your feelings are noted.

      the disagreement here shows why functional claiming is so pernicious.

      Again, your feelings are noted.

      Also noted is the fact that your feelings simply do NOT reflect actual controlling law.

      I would posit that you rambling on as if it did is even more pernicious. especially as an examiner, you have a duty to apply the law and NOT apply your feelings.

      makes it difficult, if not impossible, for the agency to discern an improvement from an inherent feature.

      Your job may be difficult, but your ignorance of factual matters and your insistence on treating your feelings as if they control, are probably why YOU may be having an especially difficult time.

      1. 7.1.1

        anon–posters are allowed to express opinions on a board.

        Also you are wrong as the law says inherency in obviousness is proper as has been held in several CAFC cases including the case you are posting about…

        1. 7.1.1.1

          Read my post again. Note just where the draw the legal point at (hint: functional as opposed to inherency).

          Yes, anyone can have — and express an opinion. I never said otherwise.

          In fact, YOU are the one that appears to be the one who does not want to allow MY opinion about Ben’s inane opinion.

          And in your hurry to try to squelch my better view, you just did not pay enough attention to what I wrote.

          1. 7.1.1.2.1

            Ben,

            Maybe you ought to get out of the mud if you are going to whine about slinging it.

      2. 7.1.2

        “I’d agree that a water-ethanol mixture cannot reasonably be said to inherently have an 85.2789345 C boiling point.”

        You would be wrong. Any actual liquid has an inherent boiling point. Such is simply a factual matter.

        Ok, I’m curious. What made you mentally erase that “85.2789345 C” bit, and act like I don’t know that liquids inherently have a boiling point? Is it a deliberate discussion tactic to misrepresent what others say, or do you just instinctively gloss over other people’s points when they don’t make sense to you?

        1. 7.1.2.1

          and act like I don’t know that liquids inherently have a boiling point?

          Hmm, maybe: “ I’d agree that a water-ethanol mixture cannot reasonably be said to inherently have an 85.2789345 C boiling point.

          Yep. That’s it.

          1. 7.1.2.1.2

            The boiling point of a mixture is a function of the mixture’s composition. A 90-10 (mole fraction) water-ethanol mixture has a B.P. of ~86 C and a 50-50 water-ethanol mixture has a B.P. of ~79 C.

            So while ‘a water-ethanol mixture’ has ‘a boiling point’, it does not necessarily have a particular boiling point.

            So, when you ignored that I specified the boiling point of the mixture, was it a deliberate mischaracterization or did you not understand the significance of the temperature?

            1. 7.1.2.1.2.1

              Neither — as is clear I just took your statement as the asinine statement that it was.

              I gave it back to you.

              Twice now.

              (it’s still asinine)

              But yet, for some reason, you don’t want to accept your own statement and you want to accuse me of mischaracterizing your own words.

            2. 7.1.2.1.2.2

              Ben’s inanity is made explicit as he attempts to walk back his own post (which was what I made fun of. Twice.)

              At 7.1.2.1.2, he attempts to augment his first post with additional details.

              But these additional details merely point out that my post below at 3. is more on point.

              To explore:

              Water (100%) certainly has an inherent boiling point; as does ethanol all on its own. Ben proposes that two other explicit (i.e., 102 type) combinations also have explicit boiling points.

              Great. Fine. Dandy even.

              But (as Ben unartfully FINALLY comes around to stating), merely the concept of mixing some (unknown) amount of water with some (unknown) amount of ethanol , does NOT have a particular boiling point that can be said to be inherent.

              This IS the 103 type – BUT this is necessarily different than Ben’s 102 type.

              JUST as I indicated, a particular ratio DOES have an inherent boiling point.

              But this is NO LONGER a 103 type of item.

              To BE that particular item with that particular inherent value, you now must have the actual item, and that actual item would necessarily be a 102 item.

              This is exactly what the Venn diagram of post 3 indicates. In other words, when Ben finally gets out of his own way, and supplements his early (and inane) post with enough details, he actually moves off his original point and moves over to MY point that has already been put on the table for discussion.

              By the way, the added constraint (claim element) of the particular number ( the very item that ‘upsets’ Ben) is easily seen to be equivalent to very specific ACTUAL concentration – How Ben wants to ‘de facto’ jump to such a thing as necessarily obvious – in and of itself — has no legal tie whatsoever to any notion of obviousness. This is simply NOT any effort of mine to ‘twist’ or ‘misconstrue’ what Ben has posited. This is simply Ben’s inanity.

              1. 7.1.2.1.2.2.1

                Lots of hand waving to distract from how you thought that that a water-ethanol mixture inherently has a boiling point of 85.2789345 C.

                If you’re trying to save face, you’d be better off supporting that position.

                1. I am not the one doing the hand-waving Ben.

                  Your initial post was inane. You took issue, and I pointed out that it was still inane. You THEN changed the post by adding more to it — and I have merely now pointed out how your NEW position reflects a position already up on the board.

                  Bottom line is that your initial position was at fault.

                  Bottom line is that your changed position merely reflects something other than your initial position.

                  It only does YOU more harm in trying to make this out as if I am ‘saving face’ as I completely stand by ALL of my posts on this thread.

                2. “Bottom line is that your changed position”

                  My position remains that a water-ethanol mixture does not inherently have a 85.2789345 C boiling point.

                  YOU declared that I was wrong.

                  Do you still believe that a water ethanol mixture inherently has a 85.2789345 C boiling point?

                  I think not. And so YOU have changed your position, while accusing me of the same.

                  You have no honor. Enjoy the last word.

                3. I have changed no position, Ben.

                  Your first post — in its entirety is inane.

                  Your second post DOES change what you are saying — and does so as I pointed out — and falls directly to my EARLIER post with Venn diagrams (as I patiently explained, only to have you refuse to follow and call the explanation something that it is not).

                  So no, Ben, YOU are the one with no honor.

        2. 7.1.2.2

          The way that anon understood your comment is clearly the one and only way that anyone could have possibly understood your statement. The fact that you (and I) understood your comment differently is completely irrelevant.

          1. 7.1.2.2.1

            The “well, I know what you really meant, even though that’s not what you said” is NOT a ‘cover’ when the person that points out “what was really said” IS inane, just happens to be the person that YOU don’t like because he also happens to point out how often you bark up the wrong tree.

              1. 7.1.2.2.1.1.1

                LOL — just not how you think it to be (naturally, with your proclivity for barking up the wrong tree).

          2. 7.1.2.2.2

            It’d be one this if he was merely unhesitatingly certain of his position. What makes him so repellent is his habit of refusing to take a position, in conjunction with those delusions of grandeur. Note how he’s never actually said what’s wrong with my statement. The better to get an allowance win an argument! I would guess that this is simply how a career in patent prosecution warps a human being, but there are too many examples of prosecutors who haven’t been reduced to empty contradiction and deception.

            1. 7.1.2.2.2.1

              Translation: Wah, anon DOES win the argument, so like the empty Malcolm that Ben upvoted every chance back in the DISQUS days, he will simply lob empty ad hominem….

              Ben, maybe figure out WHY I win the argument. That way, instead of whining, you might actually learn something.

            2. 7.1.2.2.2.2

              Anon’s comprehension skills are beside the point because they simply confirm that anon lacks the ability to use critical thinking. The concept of a hypothetical is beyond anon’s capabilities. For example, an ordinary person can comprehend F = m * a, whereas anon can at most comprehend 1 N = 1 kg * m/s^2. However, anon doesn’t realize this limitaion and simply denies that anyone is capable of doing this.

              1. 7.1.2.2.2.2.1

                Yet again, an amazingly incorrect and totally tangential assertion of yours NS II.

                Why in the world would you posit that I do not understand hypotheticals? How in the world do you fold scientific equations into your (attempted) point on hypotheticals?

                Nothing more than a tail-chasing, bark-up-the-wring-tree, “anon-has-offended-me-too” crock of sh 1t.

    2. 7.2

      “It makes it difficult, if not impossible, for the agency to discern an improvement from an inherent feature.”

      For the life of me I still don’t know why the office/the gubmit doesn’t treat such situations under a similar procedure to the procedure used for a product by process claim.

      “Your job may be difficult, but your ignorance of factual matters and your insistence on treating your feelings as if they control, are probably why YOU may be having an especially difficult time.”

      Anon he’s not btching about the difficulty of the job, he’s saying that the current system makes no sense because institutionally/gubmentally it makes no sense to have the gubmit operate in such a manner (setting forth a herculeanly difficult and/or impossible task for the gubmit to perform and then just granting an entitlement if that task is not completed). Although yes, I’m sure he probably does have an especially difficult time accepting the current “gotta have evidence for the feature being inherent or we just let it slide if we can’t tell if it is inherent or not” paradigm as it is nonsensical or because his signatory puts pressure on him, likely to bs limitations that appear inherent. Though once you explain the current “just let it slide” paradigm/situation to the individual, and to their signatory examiner, and if the signatory examiner still doesn’t try to make them bs the rejections then sure, individual examiners have it much easier than they would when any of that doesn’t go correctly.

      1. 7.2.1

        Yes, the issues raised by the claiming of results/properties are similar to those raised by product-by-process claiming. And the validity issues should be resolved similarly, i.e., by forcing applicants to claim the novel and non-obvious structure of the thing they invented, or by forcing applicants to recite the novel non-obvious physically transformative steps in their inventive method.

        Attempts to run an end around these basic propositions should be dealt with reasonably, which means harshly for those applicants who can’t distinguish what they invented from the prior art except by some non-eligible “property” or “function”.

        Now cue up the whining from the usual suspects who will claim that this comment is “anti-patent” or that adhering to these principles will prevent some unknown but super important invention from ever being invented because [hand waving].

        1. 7.2.1.2

          “And the validity issues should be resolved similarly, i.e., by forcing applicants to claim the novel and non-obvious structure of the thing they invented, or by forcing applicants to recite the novel non-obvious physically transformative steps in their inventive method.”

          I will again ask you, how does one do that? If I combine X-Y% of compound A and M-N% of compound B, which is novel and has never been done before, and I find that the coefficient of thermal expansion C for a representative number of examples that I make is in a range of P-V, how do I claim the “novel and non-obvious structure” of that?

          It seems to me that you have no idea how to do that. Yet you keep pounding the table insisting that applicants be forced to do it.

          1. 7.2.1.2.1

            “It seems to me that you have no idea how to do that. Yet you keep pounding the table insisting that applicants be forced to do it.”

            I don’t think he’s looking for more than the x-y% and m-n%’s be included in the claim brosefus. Unless those percents are already in the prior art. If they are novel, then I doubt that he has a problem unless there is a 103 potential issue. In which case, he would say you’re getting a 103 you can’t get over unless there is some way for you to show that in the obvious combo it would be a different coefficient of thermal expansion/range thereo (I presume at least for one emb within the obvious combo). Neither he, nor me, have any problem with people getting a patent for things that are verified to be not anticipated and non-obvious under 103. The issue we see is one in general of procedure. Personally I am more concerned with instances of anticipation (or at least of outright disclosure of the small feature at issue in the inherency issue at hand, even if the whole claim is not outright anticipated) than I am with huge problems of results of obvious combos that would be difficult to experimentally make a showing of by the applicant.

            1. 7.2.1.2.1.1

              Or in the alternative, I should add, he might would say you just get a claim to “representative number of examples that I make” instead of the generic shebang. At least presuming those have no 102/103 issues for themselves.

              If any of that makes sense.

              1. 7.2.1.2.1.1.1

                None of that makes any sense, but thanks for trying.

                Going back to the Stepan case, the court had no issue with the applicant reciting a “functional” limitation or a “result” (what I would call a characteristic) to distinguish the claim over the prior art.

                The point I’m trying to make is that we have one poster constantly posting that applicants are required to recite “objective technical structure” to distinguish their claims over the prior art. That is not the law. Functional recitations and “results” and “product by process” claim features have all been found by the courts to be acceptable in distinguishing from the prior art.

                BTW, where’s the examiner peanut gallery claiming that this constant misstatement of the law is going to cause younger/newer practitioners who read the comments to be Rule 36’d and cert denied and slapped down by the courts?

                1. “None of that makes any sense, but thanks for trying.”

                  Oh bs, you understood all of it.

                  “The point I’m trying to make is that we have one poster constantly posting that applicants are required to recite “objective technical structure” to distinguish their claims over the prior art.”

                  That’s because he thinks all arts should be regulated just like his is. He sees other arts as getting away with what his art was prevented from getting away with long ago.

                2. “That’s because he thinks all arts should be regulated just like his is. He sees other arts as getting away with what his art was prevented from getting away with long ago.”

                  His art isn’t regulated any differently than any other art. Functional limitations and results and characteristics and product by process features are permissible in ALL arts. The courts have said so over and over. He is alleging that they are not. Or should not be. Yet he can’t explain how his proposed change in the law would even be possible to claim.

                3. I don’t see anyone but MM pushing the “objective technical structure” nonsense. Let’s not tar every member of the opposition with the excrement of their worst.

                4. “Functional limitations and results and characteristics and product by process features are permissible in ALL arts. ”

                  But I bet the nature of his art ends up forcing him to do it the way I described above. In general. And more or less. Which is why he goes on and on about it. He’s the only bio regular poster that I know of.

                  “He is alleging that they are not. Or should not be. Yet he can’t explain how his proposed change in the law would even be possible to claim.”

                  I think it’s the “or should not be”. And I just told you how to do it above. Initially claiming it is easy, as you’re aware.
                  And the possible ways to amend the claim are also easy to see. The only thing that is at all hard is determining what would ultimately pop out allowable. Instead of getting the generic claim, as you would normally under office policy based on court holdings currently, you just get the few embs ultimately or you get nothing ultimately. Presuming those few embs don’t have any art that would get them rejected then you get them np. Otherwise you end up with no valid claim because what you’re claiming is deemed obvious.

                  You appear to be equating inventions being “possible to claim” with being “assured to be ultimately allowed” through this sub-discussion on claiming. The thing you noted up above is easy to claim at time of drafting and requires no explanation. Though you may want to provide in depth details as to your sub-embodiments. Thus only thing that I can see that requires explanation is what would happen under MM’s plan when those claims meet hypothetical prior art rejections they would face.

                5. Ben,

                  That’s funny coming from you (the company you keep AND the fact that in the DISQUS days, you upvoted nearly every comment by Malcolm).

                  There is no getting that excrement out of you.

                6. 6: “Oh bs, you understood all of it.

                  Well, I understood what you were trying to say, but NONE of that fits with what Malcolm actually peddles.

                  (I had another reply – but it was nabbed in the Count Filter, and those do not always shake loose).

                  Your attempts here 6 are NOT to “objective physical structure” because the moment you climb up a rung on the Ladders of Abstraction (you know, to actually avoid an all-too-easy-to-get-around picture claim), you are no longer tied directly to that SINGULAR physical structure OF the picture claim.

                  As I noted in my other comment, even the word “comprising” makes a claim not possible to be presented in a singular objective physical structure because of the “other stuff” is necessarily part of any REAL objective physical structure, and one is turning a blind eye to that stuff.

                  My nabbed comment has other examples, so I am hoping that it finds its way to print.

  4. 6

    Its amusing to see here a Prof. Lemely position – a PRO-patentee position – that inherency should have almost no role in the obviousness analysis because of its hindsight approach – devoid of the usual ineffective conspiracy theories and personal attacks here. So I feel almost obligated to argue the other side. Here it is, for argument sake:
    I think an inherency argument is not really “hindsight.” Especially as to the 103 teaching of a single chemical reference. If a property or characteristic of the cited reference was inherent it means it was pre-existing in nature. That is consistent with Sup. Ct. decisions holding that to be unpatentable subject matter.

    1. 6.1

      Not sure that “Especially as to the 103 teaching of a single chemical reference” applied for the “inherency” factor.

      That’s more of the 102 approach.

    2. 6.2

      … as to Lemley, you clearly do not understand the nature of his being denigrated for his anti-patent activities.

      One should NOT be looking for ‘conspiracy’ for PRO-patent statements or views. The reason WHY the patent power is allocated in the Constitution (even before consideration of the Bill of Rights) is that it was pretty much a GIVEN that having a patent system was aligned with betterment for the Sovereign.

      Some have either forgotten that notion, or never properly understood that notion (likely competing with an anti-personal property proclivity as may occur with several Left leaning philosophies).

    3. 6.3

      I agree somewhat. If it is obvious to combine references A and B to get X structure; and if Y property is a necessary consequence of X structure, then saying that Y is inherent is proper.

      However, the analysis should not end there, due to the doctrine of “reasonable expectation of success” which has become more robust recently.

      If there would not be a reasonable expectation that Y property could result from X structure if A and B were combined, then the obviousness rejection should not be made, unless there is a strong alternative motivation (i.e., other than the motivation to obtain property Y) to combine A and B.

      To say inherency should never be involved in obviousness is problematic to me because applicants would otherwise be able to obtain patents over trivial properties that stem from trivial combinations.

      Here is a stupid example to illustrate what I am saying.

      Ref A–teaches peanut butter sandwiches
      Ref B–teaches that jelly enhances the flavor of peanut butter.

      Claim:

      1. A sandwich comprising:
      a first bread slice;
      a second bread slice;
      a composite layer between the first and second bread slides, where the composite layer comprises a peanut butter layer and a jelly layer;
      where a coefficient of adhesion between the peanut butter layer and the jelly layer is ________ to ________.

      Of course, the references do not teach the coefficient of adhesion, which is a ridiculous parameter that I just made up. However, the references do make it obvious to make a peanut butter/jelly sandwich, the motivation being to enhance flavor. Here, it is acceptable to say the adhesion is inherent from the combination and the claim is therefore obvious.

      Now, changing the hypothetical, let’s say reference B also teaches that while jelly enhances the flavor of peanut butter, jelly adheres very poorly to the peanut butter detriment of the flavor profile. This looks like a non-obvious claim now, even if the adhesion is a necessary result of combining peanut butter and jelly (and therefore inherent). Now instead, one would not have been motivated to combine the references to begin with because there would have been no reasonable expectation that a tasty sandwich would have resulted due to poor adhesion (even if inherent) between the layers, which reference B teaches would destroy the flavor profile.

      As an applicant, if you try to rely on inherency alone, you will lose as you should. Once the combination of references is air-tight, there is little you can do, other than making up implicit properties to try to trick the Examiner, which will not work.

      1. 6.3.1

        A flaw in your logic is that you indicate that the combination is already shown to be obvious, thus there is no need for the inherency doctrine.

        The other problem is that you jump to an actual item in order to discuss the necessity of that actual item to have the inherent item.

        That is no longer the domain of 103, but is instead the domain of 102.

  5. 4

    I’ve noticed a trend where applicants take an obvious combination or modification, then throw in any data they can that sets apart the combination from the prior art, even if it is irrelevant to the intended use of the combination, or make up an arbitrary threshold that sets the invention apart from the prior art (greater than threshold? better for one reason! lower than threshold? better for different reason!).

    Applicants put the inherent result in the combination, then argue unexpected results and/or inherency. Most examiners don’t even bother to determine whether or not it’s actually unexpected, and allow because it takes too much time to consider, and/or they never knew the art to begin with.

    If inherency should have no role in the obvious analysis, then you just incentive generating whatever new data about a combination or modification that isn’t explicitly in the prior art, and/or make up arbitrary thresholds to exclude the prior art. It turns “inventing” into a game of measurements designed to exclude prior art, and that doesn’t promote progress.

    1. 4.1

      I think that you have your nose too close to the grindstone of examination there patentcat.

      Refuting the allegation of ‘it’s obvious’ is part and parcel of the examination.

      You appear to be ‘upset’ that any such refuting works (for what you deem — and assert in conclusory manner), and thus any such ‘gains’ are ill-founded.

      If You (the Royal You) cannot support the initial assertion, then why are You (again, the Royal You) making that assertion in the first place? It seems that you are placing your feelings at the wrong doorstep.

      1. 4.1.1

        I think quite simply that you know what games applicants are playing, but it’s in your financial interest to pretend otherwise.

        Applicants are basically taking combinations, like lemon juice plus tea (assuming there is no 102 art, but ample prior art suggesting obviousness of the combination) then adding in “wherein the freezing point of the resulting mixture is X.”

        1. 4.1.1.1

          Again – if you cannot sustain your rejection, why are you making it in the first place?

          AND again – you appear to want to put YOUR troubles on the wrong doorstep.

    2. 4.2

      Excellent point, patentcat. This has been going on for years, by the way.

      As Dennis suggests upthread, this really isn’t about “Inherency”. It’s about functional/result claiming which is a much bigger problem.

      If the structurally claimed “invention” is prima facie obvious, then the allegedly unexpected result which overcomes the prima facie obviousness should be cited as a result. That result HAS to be inherent to the claimed invention to be relied upon for that purpose otherwise the claims are too broad and need to be amended to restore additional structure (ie the structure necessary to obtain the unexpected result).

      1. 4.2.1

        Oops, I meant to say “recite additional structure” instead of “restore additional structure”.

        In other words, to rely on an unexpected result to prove non-obviousness after a prima facie case has been made, the claims can’t broadly cover embodiments that don’t necessarily lead to the result.

        The generic non-legal concept of “Inherency” is certainly important and necessary for this analysis. But note that it’s not the same legal issue as relying on an inherent (non-disclosed) STRUCTURAL feature in one of the prior art references cited in a 103 rejection, or an inherent STRUCTURAL feature that would result from a prima obvious combination of prior art teachings. Those issues are related but it’s not helpful to lump them together and the unvarnished idea that”Inherency has no place in a 103 analysis” is a silly absolutist proposition that doesn’t make much sense.

        1. 4.2.1.1

          nothing to see here but Malcolm’s perpetual quest to somehow turn one optional claim format into a non-optional format.

      2. 4.2.2

        “That result HAS to be inherent to the claimed invention to be relied upon for that purpose otherwise the claims are too broad and need to be amended to recite additional structure (ie the structure necessary to obtain the unexpected result).”

        Can you tell me what STRUCTURAL feature of this claim obtains or produces the result of the concentrate having a cloud point above at least 70°C. or no cloud point when the concentrate is heated to its boiling point? If it’s not recited in the claim already, what “additional structure” would have be to included?

        Thanks.

        1. An ultra-high load, aqueous glyphosate salt-containing concentrate comprising:
        a. water;
        b. glyphosate salt in solution in the water in an amount greater than about 39 weight percent of acid equivalent, based on the weight of the concentrate, said glyphosate salt being selected from the group consisting of the isopropylamine salt of glyphosate, the potassium salt of glyphosate, mixtures of the isopropylamine salt and the potassium salt of glyphosate and mixtures of the potassium salt and the ammonium salt of glyphosate;
        c. a surfactant system in an amount ranging from about 1 to about 20 weight percent, based on the weight of the concentrate, comprising:
        i. from about 10 to about 60 weight percent, based on the weight of the surfactant system, of one or more dialkoxylated alkylamines;
        ii. from about 5 to about 30 weight percent, based on the weight of the surfactant system, of one or more water miscible solubilizers; and
        iii. from about 30 to about 75 weight percent, based on the weight of the surfactant system, of one or more amine oxides;
        said concentrate having a cloud point above at least 70°C. or no cloud point when the concentrate is heated to its boiling point.

        1. 4.2.2.1

          Off the top of my head, no, I can’t. But I’m not sure what your point is, at least with respect to rebutting or commenting on my assertion which you quoted.

          If this cloud point is an important but unexpected feature of the otherwise novel structure described in the claim, and the prima facie obviousness case against the claim isn’t particularly strong, then it doesn’t matter much whether the functional limitation appears in the claim or not.

          Note that these facts will pretty much never apply to “carry out logic with a computer” type claims.

          1. 4.2.2.1.1

            You said:

            “That result HAS to be inherent to the claimed invention to be relied upon for that purpose otherwise the claims are too broad and need to be amended to restore additional structure (ie the structure necessary to obtain the unexpected result).”

            In case you didn’t recognize it, the claim I posted is from In re Stepan Co., 868 F.3d 1342. In that case, the claim was rejected under a single prior art reference (Pallas) along with the usual “routine experimentation/optimization” that is routinely misapplied by the examining corps.

            The court reversed and stated, “Stepan’s ‘567 application does not merely claim a range of surfactants that is within or overlaps with the range of surfactant systems taught by Pallas. The claimed surfactant system contains four elements. The first three elements describe the surfactants, and their respective ranges, that comprise the surfactant system. The fourth element limits the combination of those surfactants to only those combinations that produce a cloud point above at least 70°C or no cloud point at all. The cloud point thus limits and defines the scope of what surfactant combinations satisfy the claimed composition. It therefore may be that not all compositions that contain the claimed combination and range of surfactants fall within the claims. As an element of the composition claims, it was the PTO’s — not Stepan’s — burden to show that achieving a cloud point above 70°C would have been obvious to a person of ordinary skill in the art.”

            So the cloud point feature of the claim is not an inherent result of the composition. Some compositions that fall within the claimed ranges would not produce the cloud point features of the claim. But according to the court, the recitation of the cloud point above 70F or no cloud point at the boiling point is sufficient to distinguish the claim from the prior art. The cloud point temperature is a result, or characteristic, of the claimed composition. It is not a STRUCTURAL feature as you claim must be included.

            So what STRUCTURAL feature do you think needs to/could be added to the claim?

            And no, applicants are not “just combining tea and lemon juice and claiming the freezing temperature just to get a patent” as some ridiculous examiner is asserting. Applicants disclose, and claim, the characteristics of their inventions because they can/may serve to distinguish the claimed invention(s) from the prior art (which they don’t have a perfect knowledge of, despite what even more ridiculous examiners and others think.)

            1. 4.2.2.1.1.1

              Yes, they are; the fact pattern very similar to the Imatinib patent (US6894051B1): Novartis took a known pharmaceutically acceptable salt (mesylate) of a known compound (admitted in the background as prior art), recrystallized it with one of the most common and most economical solvents for recrystallization (methanol, although the spec of the patent suggests any alcohol is suitable), which yielded a specific polymorph (beta polymorph). Applicant claimed the specific hygrospecificity (see claim 1), which was the factor that led to the allowance of that patent.

              The specific crystal form does not contribute to the efficacy of the drug (link to en.wikipedia.org). Yes, hygroscopicity makes a difference in manufacture, as do a million other factors, such as melting point. These outcomes suggest to applicants “hey, just stage the right test, and you can have a patent.”

              If the recrystallized form from the common, economic solvent (methanol/alcohols) had a higher melting point compared to the “comparative” example, you could be darn well sure that the applicant would have argued that the increased melting point leads to better processability.

              This is the kind of crap I see once a week during examination: there exists great prior art that does not anticipate the claimed invention, and great motivation to arrive at the claimed invention via a known modification.

              Applicant attempts to preempt the modification by staging a test in which the prior art performs poorly/has a poor inherent characteristic, but the prior art + known modification performs well/has an arguably better characteristic.

              It’s not that the prior art is universally poor, it’s that they have devised a test which is a round hole, the prior art is a square peg, and the prior art + known modification is the round peg. Had they devised a test which was a square hole, the prior art would outperform the prior art + known modification.

              It’s simple gaming of the system, and unless the examiner has had research and industry experience in the area they are examining, they will most likely be persuaded by either the allegation of unexpected results, or by applicant putting some “inherent characteristic” of the prior art + known modification that distinguishes it from the prior art.

              1. 4.2.2.1.1.1.1

                “..there exists great prior art that does not anticipate the claimed invention, and great motivation to arrive at the claimed invention via a known modification.”

                What is the great motivation to arrive at the claimed invention? What is the evidence of such great motivation?

              2. 4.2.2.1.1.1.2

                I see that the Novartis patent was litigated, but I haven’t been able to find if it was invalidated? Do you know?

              3. 4.2.2.1.1.1.3

                Patentcat,

                Do you think efficacy is the only permissible advance that may be covered by a patent?

                Why would you think that?

                Real world advances may occur across a whole spectrum of features, of which efficacy is but one.

                And that’s not even recognizing that the word ‘promote’ is NOT limited to ‘advances’ per se and includes the advertising notion of the word (as in ‘promotion’).

                Need I remind you of the nature of innovation as NOT being linear, and that OFTEN (and historically some of the greatest innovation) have occurred merely because of cross-fertilization and ‘promotion’ in the advertising sense…?

              4. 4.2.2.1.1.1.4

                patentcat, as a prosecutor in this area for many years I am here to say that you have hit the nail squarely on the head. Some examiners (experienced ones) are very much on top of this game and others are not.

                As I noted upthread, one correct response during exam if there is a good prima facie case against the structural combo and some minor “new property” is recited in the claim is to force the applicant to limit the claim to the specific formulation (“consisting of”) which was demonstrated to yield that “unexpected” result. Typically this will be one example in the application. It’s odd that anyone would object to this but maybe some patent attorneys and “small inventors” (and professors?) just like paying high prices for old or obvious drug formulations.

              5. 4.2.2.1.1.1.5

                This also leads to those pharma specs that recite “wherein the substance has a boiling point of 1-2C, 2-3C, 3-4C, 4-5C…” ad nauseum for a page, just so that they can eventually cherry pick something outside of the prior art and call it unpredictable.

                1. Do you have an actual legal argument here, or are you just venting your feelings on “cherry-picking”…?

            2. 4.2.2.1.1.2

              I also think it’s particularly interesting that in this case regarding a chemical composition, the only person on the panel with a chemical background dissented.

              1. 4.2.2.1.1.2.1

                Well, J. Lourie may be a good chemist, but he’s a lousy judge, as evidenced by the fact that he’s not sure a reasonable expectation of success is a requirement of obviousness, and his befuddlement at why an application with a large portfolio of patents and applications would file an IDS with 1,500 references.

          2. 4.2.2.1.2

            “If this cloud point is an important but unexpected feature of the otherwise novel structure described in the claim, and the prima facie obviousness case against the claim isn’t particularly strong, then it doesn’t matter much whether the functional limitation appears in the claim or not.”

            This is incorrect. It does matter much whether the “functional limitation” appears in the claim or not. Without it the court would not have reversed the rejection. Features that you dismiss as “results” or “functional” are limitations of the claim that can distinguish the claim from the prior art, your incessant drum beating of “only STRUCTURAL features can distinguish the claim” notwithstanding.

    3. 4.3

      Well said, patentcat. But the “trend” you have noticed is, as MM observes, nothing new.

      It’s only human, to ask for more than you deserve. In a properly functioning patent system, one in which the PTO is adequately financed, and supported by sensible case law from the courts, this Applicant behaviour is well-understood and fully taken into account. Hence the “trend” you observe.

    4. 4.4

      Re: “It turns “inventing” into a game of measurements designed to exclude prior art, and that doesn’t promote progress.”
      That triggered something I was shown by a PTO mentor many years ago. Years ago one denizen of the old PTO D.C. public search room bet another one that he could get a patent on sh it. He did, with such claim measurement numbers. [PTO fees were a lot lower then.] I obtained a copy of the issued patent. It claimed a novel wallpaper paste comprising, as I recall, approximately X% sheep manure, Y% cow manure and Z% horse manure. [Sorry, I didn’t save it.]

      1. 4.4.1

        “[in an] old PTO D.C. public search room”

        If that’s true, you win. The PTO moved from non-air conditioned offices in DC to Arlington, VA (Crystal City) pretty much overnight (to the surprise of the employees) in 1960 something. Abe Fortas was behind the move, I heard. But, I did have a collection of patents like that back when there was paper.

        1. 4.4.1.1

          My favorite in the collection was the one where the inventor got stuck on how to invent his orbiting space platform and his cat spoke human language to him spelling out the details. I think that was a UK patent.

          1. 4.4.1.1.1

            For oldsters in the UK, the name “Pedrick” is associated with numerous amusing patents mostly involving the inventor/Applicant’s pet cat. Pedrick was a Patent Office Examiner. Back in those days, the Office examined novelty and clarity with strictness but not for obviousness. Too difficult, ex Parte, it was thought, back then. Here Wikipedia:

            link to en.wikipedia.org

        2. 4.4.1.2

          …so from the info you share, you were an examiner some 50 years ago or so.

          Then what is your line of work now?

  6. 3

    Technically speaking, I would suppose that a Venn diagram of what the legal concepts of obviousness and inherency would provide a set of two non-intersecting spheres.

    Inherency — and the notion of ‘necessarily present’ — only makes sense for what would be necessarily present in an ACTUAL thing.

    Any such actual thing would present in the patent evaluation sense strictly in 35 USC 102 — not 35 USC 103.

    Obviousness is about things that are NOT ACTUAL things. Anything that is ‘not actual,’ cannot have the physical qualities of ‘necessarily present,’ as there is NO “physical” there.

    Perhaps an aim of the ‘inherency’ thrust is better re-stated as the proposed items of a combination HAVING the attribute in one of the references singularly. In other words, any sense of ‘necessarily present’ may be satisfied by a showing of IS PRESENT. In that manner, normal obviousness analysis would be already adequate without resorting to any notion of ‘inherency.’

      1. 3.1.1

        But much better ‘gobbledygook’ than your very own ‘gobbledygook’ as I don’t pretend that one optional claim format is somehow not an option at all…

        1. 3.1.1.1

          I’m not pretending anything and this has nothing to do with “optional” “claim formats.”

          1. 3.1.1.1.1

            And yet, you ARE pretending (still — see 4.2.1) AND are either dishonest or patentably oblivious as to what you are doing.

            More than likely, it’s you being dishonest, as this is not a new point, and you insist on a position that the law just does not provide.

  7. 2

    This Hospira v. Fresenius (Fed. Cir. 2020) case looks like a good example for the below blog discussion of an article on the word “evergreening”?

  8. 1

    Must have been before Lemley was making the millions burning the patent system down.

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