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PTO’s final blow to the continuation & claim limit rules.

As previously posted on the pto’s website, the new director killed the rules to limit continuations and the number of claims.  You could read (yawnnnnnn) the announcement at this link:

http://edocket.access.gpo.gov/2009/pdf/E9-24667.pdf

We’ll see what new ways the pto will try to move its backlog along or around.

CAFC reasoning would find that “Humans” resulting from the process of manufacture are eligible subject matter for patenting!

Humans moved one step closer to becoming eligible subject matter for patenting after today’s decision in Prometheus Labs. v. Mayo Collab. Serv. Slip op. 2008-1403 (Fed. Cir. Sep. 16, 2009).  Two active judges of the CAFC applied Bilski’s transformation test and held that the district court erred when it found claims to a method of optimizing therapeutic efficacy were ineligible subject matter.  In the opinion, the judges equated “humans” to “articles,” a term used in the definition of “manufacture” per § 101.  Thus Prometheus provides authority to urge that a human, or a part thereof, resulting from a process of manufacture is eligible subject matter for patenting.

Below, a district court found the following claim ineligible subject matter for patenting:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing [6-TG] to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of [6-TG] in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of [6-TG] less than [a recited concentration range] indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of [6-TG] greater than [a recited concentration range] indicates a need to decrease the amount of said drug subsequently administered to said subject.

(For more details, see my blog from July 6, 2009, regarding Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 04-CV-1200, 2008 WL 878910 (S.D. Cal. Mar. 28, 2008) (“Invalidity Opinion”)).

On appeal, the CAFC applied Bilski’s transformation test: “A claimed process is surely patent-eligible under § 101 if: … it transforms a particular article into a different state or thing.”  Regarding the disputed claims, the panel reversed the holding of ineligibility, reasoning that “[t]he transformation is of the human body following administration of a drug.”   Clearly, and unequivocally, the CAFC equated a “human” with an “article.”  

The term “article” is part of the definition of the term “manufacture” per 35 U.S.C. § 101, meaning “‘articles’ resulting from the process of manufacture.”  See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007).   Because Prometheus equated an article to a human, it seem logical to conclude that a human resulting from a process of manufacture is a “manufacture” per § 101. 

And with that folks, authority exists to urge that a human is eligible subject matter for patenting, a hot-potato issue. 

For an even hotter issue, argue that if the whole human is eligible subject matter, then parts of the human are too.  And with this argument, stem cells, organs, etc. resulting from a process of manufacture would be eligible subject matter for patenting.

For more on this topic, see my earlier blogs, including the one on Jul. 4, 2009.

Update your allowance checklists: CAFC says to rethink about divisional applications.

If you receive a notice of allowance in an application containing a restriction requirement, make sure you file one or more divisional applications containing the non-elected subject matter before the patent issues.  And for crying out loud, check the right boxes during prosecution.  Otherwise, your child, grandchild, etc. applications might not be able hide behind § 121’s safe harbor.  See, Amgen Inc. v. F. Hoffmann-La Roche Ltd, Slip ops. 2009-1020, -1096 (Fed. Cir. Sep 15, 2009).

Amgen filed a base application, which was restricted in multiple ways.  The non-elected subject matter was canceled and not immediately pursued in the next generation of “continuation” child applications. After the application containing the restriction issued, the restricted subject matter was pursued in “continuing” grandchild & great-grandchild applications.  In litigation, a dispute developed about whether or not the earlier issued patent’s claims can be used against the claims in the grandchildren & great-grandchildren patents under a theory of obviousness-type double patenting (ODP). On one hand, Amgen urged that these claims were shielded by the protections afforded by § 121’s safe harbor.  HLR, on the other hand, urged that Amgen waived its protections by failing to comply with the required procedure to invoke the § 121’s safe harbor.  The majority agreed with HLR.

In one simple aspect, claims of a Parent were applied against the claims in a Great-grandchild application. Between the Parent and the Great-grandchild are two serial generations of continuation applications. 

The majority held that the Great-grandchild patent does not receive the protections afforded by § 121’s safe harbor. The majority reasoned that § 121’s plain meaning says that the safe harbor shall shield a divisional from the effects of an earlier issued patent, “if the divisional application is filed before the issuance of the patent on the other application.”  Add a logical connector, not mentioned in the opinion, called the cannon of expressio unius est exclusio alterius (i.e., expressly mentioning one thing excludes others), and you reach the conclusion that the Great-grandchild cannot hide behind § 121’s safe harbor, unless, as relevant here, it was “filed before the issuance of the patent on the [parent] application” containing the restriction requirement.

After interpreting the statute, the majority refused to find broad exceptions in cited precedent.  To the contrary, it narrowly interpreted cited precedent as merely standing for the proposition that an “intervening continuation applications do not render a patent ineligible for § 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement.”  Slip op. at p. 17.

Parent [restriction] – Child [divisional] – Grandchild [continuation] – Great-grandchild [divisional]

The majority contrasted this situation with Amgen’s family, because during prosecution Amgen identified the child application as a “continuation” rather than a divisional. Thus, the dispositive issue was whether or not the Great-grandchild was filed before the Parent issued. It was not, and thus, the Parent’s claims are ODP prior-art against the claims of the Great grandchild.

Reexam, another bite at the litigation apple?

In a surprising separate opinion, aka. dictum, Judge Dyk noted that a district court could stay a proceeding filed in 2003, tried & decided, and appealed & remanded for reconsideration of the remedy because of a pending reexamination in the PTO (control no. 90/007,751).  FRESENIUS USA, INC. v. BAXTER INTERNATIONAL, INC., slip ops. 2008-1306, -1331 (Fed. Cir. Sep. 10, 2009).  Again, no issues of validity remained on remand. And the main opinion never mentioned a reexamination.

The disputed technology was claimed in US Pat. Nos. 5,247,434, 5,744,027, & 6,284,131 and was described as a prior art dialysis machine coupled to a touch screen display. For procedural reasons, the accused infringer failed to prove to the district court the invalidity of some asserted claims of the ’434 patent, but Judge Dyk’s dictum noted that “those claims on their face are of dubious validity” due to a holding that certain claims in the ’131 and ’027 patents are invalid.  Judge Newman objected to the dictum, urging that a stay would add more delay, including the times for the reexamination and for the patentee to appeal to the CAFC of the PTO’s adverse decision after reexamination.

Clearly, this case illustrates the advantages of filing a parallel reexamination to supplement a defense in litigation.

Obvious to try and rigid too.

BAYER SCHERING PHARMA AG v. BARR LAB., INC., Civ. No. 2008-1282 (Fed. Cir. Aug. 5, 2009) shows the post- KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) reality of what could happen when a court ignores secondary considerations while trying to make a point about KSR.

U.S. Patent No. 6,787,531 covers the contractive known as Yasmin®, which is said to be 99+% effective in women.  The differences between the claims and the prior art include the form of the active ingredient (AI).  While the prior art used the normal form of AI, the claims recited the micronized form of AI (i.e., smaller).  Bayer urged that it proceeded against conventional wisdom, because AI isomerizes in acid to an inactive ingredient, and micronized AI would most likely more efficiently isomerize.  Bayer also noted using enteric coatings to combat acid-isomerization would decrease bioavailability of the AI.  Bayer’s formulation unexpectedly does not require an enteric coating, and it is said to be 99+% effective in women.

The panel majority thought this invention was obvious to try, i.e., obvious.  Without boring you with the details, the majority noted the consistency between In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988) and KSR.  Then it concluded that one of ordinary skill in the art would have either micronized AI or used a straw man option.  Having only identified two options, the majority concluded that the invention fits cleanly into the finite-options obviousness of KSR and O’Farrell.  “This is a finite number of identified, predictable solutions.” Slip op. p. 14. 

Whoa!  What “predictable solution” is the majority referring to?  Just making the forms for the sake of doing it? 

The “predictable solution” is certainly not achieving the 99+% effectiveness that Bayer targeted and acheived.  That secondary consideration appears in Judge Newman’s strong dissent. 

So, I ask you, did the majority apply a rigid obviousness test, notwithstanding KSR’s warnings about rigid tests?

After 8 ½ years, Yellow beans are obvious…. Eligibility not mentioned

In 1994, Patentee purchased a mixed bag of beans containing, among others, yellow beans (P).  Patentee planted and harvested the beans and their producing plants. After three annual planting-harvesting cycles (P–>F1–>F2–>F3), Patentee applied for and was issued U.S. Pat. no. 5,894,079 (“the ‘079 patent”), the infamous yellow-bean patent, containing claims covering, among other things, F3’s yellow “Enola” beans and claims covering non-Enola yellow-beans.

After a reexamination was filed in 2000 (a reissue application was subsequently filed), the PTO examined the claims with its version of “special dispatch.”  After 8 ½ years, each claim was held obvious in a CAFC’s nonprecedential, per curium split-opinion in which one judge, believe it or not, merely concurred in the result without comment.  In re Pod-ners, Slip op. 2008-1492 (July 10, 2009, Fed. Cir.). The opinion’s reasoning, I forgot, because I became distracted.  

Why is a purchased bean’s great-grandchild not a product of nature and thus eligible for patenting?  Well, here, the theory is that the beans were not products of Darwin’s natural selection but were man-made through selective cultivation and/or breeding.  More specifically, the ‘079 patent stated that the yellow beans were “cultivars,” a group of cultivated plants the members of which have been selected for desirable, reproducible characteristics which differentiate it from otherwise similar groups of plants of the same species. In this case, the ‘079 specification states that the reproducible characteristic that differentiates the “Enola” beans from other beans is its particular yellow color.

Yet quite a few claims embraced non-Enola beans that produce seeds having a “seed coat that is yellow in color….”  These claims embraced more subject matter than the Enola cultivar members and seemingly would embrace natural products that just happened, through random genetics and/or epigenetics, to possess the recited phenotype.  Of course claims embracing natural products are ineligible subject matter for patenting.

And even the Enola bean claims, whose parent’s origin was practically unknown or undisclosed, present a difficult question of eligibility.  More specifically, a cultivar could be discovered in the wild, i.e., a cultivar could be a product of nature.  So, in a situation where one purchased or otherwise comes into possession of parent seeds (P) that have an unknown origin, one might want to test whether or not the parent seeds (P) represent a natural cultivar.  After several planting-harvesting cycles (P–>F1–>F2–>F3 …–>Fx), there should be a distinguishable, reproducible difference between the phenotype of P and Fx to show that the phenotype is not the product of nature.  Otherwise Fx is merely a product of nature and ineligible subject matter for patenting.

At this point you should also test your assumptions, which I suspect might include that your parent seeds (P) from the previous paragraph represent members of one and only one cultivar or of a random variety.  Let’s assume there’s a mixture of both.  More specifically, assume that you bought a mixed bag of seeds of unknown origin and only God knows that the mixed seeds include members of a first parent cultivar (Pyellow) and members of random varieties (Pj, Pk, etc.).  Importantly, you merely self-pollinate each seed and after three cycles of self-pollination and harvesting, voila, you have your “new cultivar.”  Yet how do you know that your cultivar is not a product of nature distinguishable from Pyellow, a product of nature?  How will you convince someone that your self-pollination did more than selectively weed out the varieties Pj, Pk,etc. in favor of Pyellow, a product of nature?  You merely self-pollinated a mixed bag of seeds and selected plants from your cultivation. 

After these points sink in, read the ‘079 patent’s description.

Special thanks to –<E for all her comments and discussions.

Fixing the Funk-y Bilski test.

This piece builds on earlier pieces starting June 25, 2009, related to Bilski’s machine or transformation test. Ask yourself the following: does Bilski’s test capture all natural phenonema?

Azotobacter is a genus of bacteria capable of fixing nitrogen, i.e., turning nitrogen into ammonium.

                       N2 + 8H+ –> 2NH4 (details omitted)                                                                   (A)

What would Bilski’s machine or transformation test predict about the following claim?

                    1. A method of fixing nitrogen, comprising introducing Azotobacteraceae azotobacter to air under conditions sufficient to fix nitrogen in the introduced air. 

Claim 1 recites transforming a composition known as air by taking a fraction of its nitrogen and converting it to ammonium per reaction (A).  So, Bilski’s test would declare this claim eligible, because claim 1 does not recite a Bilski’s natural principle. 

Yet claim 1 merely recites what Azotobacteraceae azotobacter colonies do naturally.  Although both azotobacter and air are articles or compositions, they are not a the modified nouns used in 35 U.S.C. § 101—new and useful … manufacture, or composition—Diamond v. Charkrabarty, 477 US 303 (1980), because they are nature’s handiwork and not made by man.  Cf. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (concerning ineligibility of combinations of naturally occurring bacteria colonies).  Furthermore, the fixed air also embraces natural products, especially since the percent ammonium enrichment and nitrogen depletion are not recited in claim 1. 

So, does the Funk-y (yes a pun is intended) Bilski test open the door for patent practitioners to file claims covering what natural product do, even if the natural products themselves are ineligible subject matter?  Does Bilski’s test need fixing (yes a second pun is intended)?

Tafas IV, coming this Fall to consider limits on contuations, etc.

On July 6, 2009, the Court of Appeals for the Federal Circuit (CAFC) vacated a panel’s March 20, 2009, decision upholding the part of a permanent injunction stopping the United States Patent and Trademark Office (PTO) from enforcing a regulation limiting the number of continuing applications per patent family but reversing the part of the injunction concerning regulations limiting the number of both Requests for Continued Examination (RCEs) per family and claims.  Tafas v. Doll, 559 F.3d 1343 (Fed. Cir. 2009) (“Tafas III”); Tafas v. Doll, No. 2008-1352 (Fed. Cir. Jul. 6, 2009).  The appeal will be heard en banc, and briefing should be completed around September 1, 2009.

Most of us recall that settled practice has been in limbo since January 2006, when the PTO initiated two related rulemaking proceedings proposing, among other things, to effectively limit the number of continuing applications, the number of RCEs, and the number of claims that may be filed without a showing of cause or additional requirements.  70 Fed. Reg. 48 (Jan. 3, 2006); 70 Fed. Reg. 61 (Jan. 3, 2006).  After comment periods, the PTO published new rules effective on November 1, 2007. 72 Fed. Reg. 46,716 (Aug. 21, 2007). These rules were challenged under the administrative procedures act.  On October 31, 2007, the eve of the effective date, the district court preliminarily enjoined enforcement of the Final Rules, Tafas v. Dudas, 511 F. Supp. 2d 652 (E.D. Va. 2007) (“Tafas I”), and, on April 1, 2008, it permanently enjoined enforcement after granting a motion for summary judgment that the Final Rules are invalid as impermissibly substantive. Tafas v. Dudas, 541 F. Supp. 2d 805, 814 (E.D. Va. 2008) (“Tafas II”).

The en banc rehearing will consider on the entire appeal, as opposed to a particular issue.  So, the decision will most certainly address the PTO’s argument that it has substantive rule making authority from 35 U.S.C. § 2(b)(2) and that each of the Final Rules are not substantive but procedural and entitled to Chevron deference.  The former argument was rejected by all panel members, while the latter argument was accepted by two judges for two of the three sets of rules, but failed to provide a bright-line test for determining whether or not a rule is substantive or procedural. 

Keep this decision on your radar.

Another test for Bilski’s machine or transformation.

This piece builds on earlier pieces starting June 25, 2009, related to Bilski’s machine or transformation test. Ask yourself the following: would a machine make a difference in the reasoning for declaring this patent’s claim invalid for embracing ineligible suject matter for patenting? 

Take a look at Prometheus Labs. v. Mayo Collab. Serv., Order Civil No. 04cv1200 JAH (RBB) (S.D. Cal. Mar. 8, 2008).  On a motion for summary judgment, the court found the following claim ineligible subject matter for patenting:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing [6-TG] to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of [6-TG] in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of [6-TG] less than [a recited concentration range] indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of [6-TG] greater than [a recited concentration range] indicates a need to decrease the amount of said drug subsequently administered to said subject.

Steps (a) and (b) are in the prior art.  More specifically, the inventors never claimed to have invented administering 6-TG or determining its level.  Regarding step (a), a drug called 6-MP was known to be administered to treat diseases like Crohn’s disease (CD) and ulcerative colitis (UC).  The prior art taught that 6-MP metabolizes to a second product 6-TG.  Regarding step (b), measuring the level of 6-TG is in the prior art, as the patent admits as much (“6-MP metabolites such as 6-TG can also be measured …. (cited prior art reference omitted).”).  Thus, because the combination of steps (a)-(b) are conventional, the last steps represent what the inventor’s discovered, namely, a correlation between the metabolite and treating CD or UC.   

These correlations, recited in wherein clauses, should be taught in med school text books.  In other words, the court reasoned, claim 1 recites the steps necessary for an ordinary doctor to use her inherent knowledge of a fundamental principle.  Before the discovery of the correlation, claim 1 did not exist and doctors were able to administer 6-TG (e.g., via 6-MP) and to determine its concentration.  After the discovery of the correlation and claim 1’s existence, anytime a doctor ordered “administering” and “determining” procedures, the returned results would allow an ordinary doctor to mentally perform the correlation step; it’s her job.  So, claim 1 effectively took away prior art “administering” and “determining” procedures due to the claim language reciting a doctor’s knowledge of the fundamental principle of “correlating.”  Cf. Flook’s claim 1, without the post calculation step (my weblog of June 26, 2009).  You could also reread Metabolite blog (June 30, 2009).

Assume a dependent claim recited that “(b) determining the level of [6-TG]” were performed by a machine.  Would that make the claim Bilski eligible?

Bilski: patent-eligible humans or patent-ineligible administering active-ingredients?

This piece builds on earlier pieces starting June 25, 2009, related to Bilski’s machine or transformation test.  In these earlier pieces, the main question is whether or not the machine or transformation test stinks for the electronic and other arts, like biotech.  This piece further explains why those in the biotech industry cringed after reading Bilski, how Bilski’s machine or transformation test might lead to a holding making humans eligible subject matter for patenting, and how the active-ingredient/prodrug distinction might influence whether or not administering claims are Bilski eligible.  

Consider claim 1, which differs from the one in Lab Corp. (see my weblog, June 30, 2009), because the assaying step is assumed absent from in the prior art:

        1. A method for detecting a Disease Y comprising:
        assaying a body fluid for a Mutation X; and
        correlating the presence of Mutation X to the presence or absence of Disease Y.

The inventors found a marker.  Mutation X marks Disease Y, because the presence of Mutation X is sufficient to detect Disease Y. Claim 1 respresents those that appear in many patent applications and patents.

For example, if Mutation X is a SEQ ID NO. X, which differs from prior art sequences, then claim 1 would not take away prior art “assaying,” because, although “assaying” in general may be within the level of ordinary skill in the art,  “assaying … for SEQ ID NO. X” is, in view of the prior art, “new.”  Cf. 35 U.S.C. § 101.  So, for claim 1, Lab Corp’s eligibility concerns would not exist.

But thinking about claim 1’s fate after Bilski’s machine or transformation test would cause some to cringe, and I’ll take the 5th before stating why.

And as long as we’re thinking about common claims and cringing, what would Bilski’s machine or transformation test say about a simple a administering claim?

         2.  A method of treating Disease Y, comprising administering an effective amount of compound X to a human.

Is a human Bilski’s machine or an article capable of Bilski’s transformation?  If you answered yes to either question, then you would that hold a human is eligible subject matter for patenting,  cf.  35 U.S.C. § 101, a hot-potato issue.   If you answered no, then you might think that claim 2 is not eligible for patenting or that claim 2’s administering necessarily transforms Compound X.

Stop.  Not all compounds transform when administered.  So, Bilski’s transformation test might lead to different results depending on the properties of Compound X.  For example, if, on one hand, Compound X is an active ingredient that does not transform in the human until after its activity (treating Disease Y) starts, then Bilski’s transformation test might force one to hold that claim 2 is ineligibile for lacking a machine or transformation.  But if, on the other hand, Compound X is a prodrug that transforms to the active ingredient after administering, as opposed to the active-ingredient itself, then Bilski’s transformation test might hold that claim 2 is eligibile.

Thus, Bilski’s transformation test could lead to a crazy result.  While claim 2 might be Bilski eligible if Compound X were a prodrug, claim 2 might be Bilski ineligible if compound X were an active ingredient.  Now really, would a prodrug/active-ingredient distinction be a proper basis for eligibility?  It might be under Bilski’s machine/transformation test, unless humans are eligible subject matter for patenting, because they are Bilski’s machines and/or articles capable of transformation.

Feel any tension in your face?  If so, you’re likely familar with settled expectations of biotech.