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.