DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The listing of claims filed 16 April 2024 has been examined.
Claims 1and 2 are pending. Claims 3–5 are canceled.
Priority
The instant application was filed 17 January 2022; is a national stage application of PCT/EP2020/070241, filed 17 January 2020, and claims priority to EP19186941.1, filed 19 July 2019. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 17 June 2024; 7 January 2025; and 20 February 2026 are acknowledged and have been considered.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 and 2 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A claim is indefinite when it contains words or phrases whose meaning is unclear. MPEP § 2173.05(e). In this case, the word “group” in the term “hydrocarbon group” in the definition of variable R renders the scope ambiguous because it is unclear whether R is only a hydrocarbon (e.g., methyl, ethyl, etc.) or a hydrocarbon that also contains atoms other than carbon and hydrogen (e.g., an ether, ester, etc.).
Appropriate correction is required.
If R is only a hydrocarbon (e.g., methyl, ethyl, etc.), then Examiner recommends deleting the word “group” in the term “hydrocarbon group” to remove the ambiguity.
Claim Interpretation
The broadest reasonable interpretation of the term “group” is based on its plain meaning (e.g., an assemblage of elements into a unit). For examination purposes, “group” is understood to modify the term preceding it such that the preceding term is required but not limiting. Thus, “hydrocarbon group” means the hydrocarbon can include or be substituted by atoms other than carbon or hydrogen; “heterocyclic group” means the heterocyclic ring can include substituents or be indirectly bonded to the pyrazole; and “organic group” includes any component with carbon.
To avoid any potential confusion resulting from the term “group,” Examiner recommends amending “hydrocarbon group” to hydrocarbon; amending “heterocyclic group” to heterocycle; and amending “organic group” to specific functional groups.
Variable X is understood to include heterocycles having a halogen, nitrogen, or oxygen ring atom; or, instead of a heterocycle, -OA1 or -NA1A2 as substituents. Examiner recommends separating the options for variable X with a semicolon so they don’t appear to be in a list.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 and 2 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claimed invention in view of the specification: the claimed invention generally relates to the chemical art and more specifically to a pyrazole compound of formula (1) having the structure below, and a process of making the same.
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Variable R is a “hydrocarbon group having 1 to 12 carbon atoms.”
Variable X is a “heterocyclic group containing at least one heteroatom selected from the group consisting of a halogen atom, nitrogen and oxygen as a ring atom, -OA1, and NA1A2.”
The specification discloses the example compounds of formula (1) below. (Spec., p.11).
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As shown above, none of the examples include a halogen as a heterocyclic ring atom. And none of the examples include a -OA1 as variable X.
(B) The extent and content of the prior art: Examiner is not aware of prior art that shows the claimed but not described subject matter would have been known or obvious to one of ordinary skill in the art. Accordingly, Applicant’s disclosure is critical to show possession.
(C) The maturity of the science or technology: the claimed compounds, including compounds having a halogen as a heterocyclic ring atom, as recited in the claim, are not well known. The science is in an infancy stage.
(D) The predictability of the aspect at issue: the chemical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. Here, there is no evidence suggesting the claimed invention is more predictable than the chemical art is generally.
The question of written description
When the above factors and evidence of record are considered as a whole, one of skill in the art would conclude the specification does not adequately describe a representative number of species to support a claim to a compound comprising -OA1 as variable X or a compound with halogen as a heterocyclic ring atom. There are no examples of either subgenus. Accordingly, the specification would not reasonably convey to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.
Conclusion
No claims are allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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