Product-by-Process Not Obvious Over a Reference ‘Capable of’ Undergoing the Process
In Ex parte Babcock (Case No. 2011-011726, in Application Serial No. 10/636,834, decision issued May 9, 2012), the Board reversed the Office’s rejections under 35 U.S.C. § 103(a) because the process steps recited in the Applicant’s claims were relevant to patentability and not adequately described in the cited references.
Citing In re Thorpe, the Manual states the general rule that the patentability of product-by-process claims does not depend on the process steps if the product is the same as, or obvious from, a prior art product made by a different process. Section 2113 states:
[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
M.P.E.P. § 2113 (8th ed., Rev. 8, July 2010) (quoting In re Thorpe, 777 F.2d 695, 698, 227 U.S.P.Q. 964, 966 (Fed. Cir. 1985)) (citations omitted).
However, the Manual also provides two exceptions when the process steps of a product-by-process are relevant to patentability. Citing In re Ganero, Section 2113 states that the structure implied by the process steps should be considered when assessing patentability where:
(1) The product can only be defined by the process steps by which the product is made; or
(2) The manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
M.P.E.P § 2113 (citing In re Ganero, 412 F.2d 276, 279, 162 U.S.P.Q. 221, 223 (CCPA 1979)).
In Ex parte Babcock, the Board found that the process steps of the claimed product-by-process imparted distinctive structural characteristics to the final product. While by no means a close case, this decision illustrates how the burden of proving a correlation between the claimed process steps and the distinctive structural characteristics relied upon can be overcome.
The claimed invention was directed to a composition comprising a low-solubility drug at least partially in a semi-ordered state, and a concentration-enhancing polymer, wherein at least a portion of the drug is present in “drug-free regions” which are interspersed throughout “drug-poor, polymer-rich regions.” The specification, claims and prosecution history all indicated that the claimed compositions were formed by controlling the rate at which the drug is converted from a disordered state to a semi-ordered state. Op. at 2. Relevant portions of Claim 1 read:
1. A composition comprising:
(a) a solid comprising a low-solubility drug and a concentration enhancing polymer;
. . .
said composition made by forming a solid amorphous dispersion of said low solubility drug and said concentration-enhancing polymer followed by treating said dispersion by a method selected from the group consisting of (1) heating said dispersion to a temperature T in degrees Kelvin wherein said dispersion has a glass-transition temperature Tg in degrees Kelvin, and wherein said heating satisfies the relationship Tg/T ≤ 1; (2) exposing said dispersion to a mobility enhancing agent; and (3) a combination of (1) and (2);
at least a portion of said drug is present in drug-rich regions and said drug-rich regions are interspersed throughout drug-poor, polymer-rich regions,
at least 60 wt% of said drug is in a non-amorphous semi-ordered state . . . , and
said drug in said non-amorphous semi-ordered state exhibits at least one of:
(i) a powder x-ray diffraction pattern that is different from a powder x-ray diffraction pattern of said first control composition, . . . ;
(ii) a powder x-ray diffraction pattern having at least one peak that has . . . ;
(iii) an onset in the melt endotherm that is . . . ; or
(iv) a maximum in the melt endotherm that is . . . .
Op. at 2-3. It is noteworthy that Claim 1 includes: (i) the components of the composition; (ii) the process applied to the components of the composition; and (iii) the distinctive structural characteristics of the final product.
The Office rejected the relevant claims in two separate rejections under 35 U.S.C. § 103(a) as obvious over two references. Op. at 3. Citing the general rule of In re Thorpe, the Office found that the process steps of Claim 1 did not limit the composition produced therefrom. Op. at 4. As further justification, the Office afforded the process limitations no weight because “[t]he composition of [the prior art reference] has the capacity of being subjected to the treatment recited in [the] claims . . . .” Op. at 4, 5 (emphasis added).
The Applicants responded that the product-by-process claims were not directed to a solid amorphous dispersion per se, but rather to a post-treated solid amorphous dispersion that results in a composition having the claimed characteristics. Op. at 4-5. The Applicants noted that although the prior art compositions could be subjected to the claimed treatments, there was no suggestion or motivation described in the prior art references, or articulated by the Office, to do so. Op. at 5.
The Board flatly rejected the Office’s conclusion that the mere capacity to undergo the claimed process steps was sufficient to meet the claimed characteristics of the final product. Op. at 5. In doing so the Board highlighted an important temporal feature of a successful product-by-process claim:
[T]he claimed composition is defined as it exists after the treatment, or as Appellants call it, a “post-treated” composition (App. Br. 5), not the composition before treatment. Put another way, the rejection failed to account for every limitation claimed because the [prior art] composition is, in Appellants’ terms, a pre-treatment composition, not the post-treatment composition defined in the claims.
Op. at 5-6.
In this case the burden of proving that the process steps imparted distinctive structural characteristics to the final product was satisfied by: (i) claiming both the process steps and the distinctive characteristics; (ii) explaining in the specification that the process steps were responsible for the distinctive characteristics; and (iii) arguing on the record that the process steps were relevant to patentability.