Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This action is in response to papers filed 1/07/2026.
Applicant’s election of Group I and CD19, MS4A1, CR2 in the reply filed on 9/15/2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). However, based upon the amendments to the claims which require each of the genes, the election of species has been withdrawn.
CLiams 1,4-7, 9-10,21, 24-32,40, 42-43,45,57-58,60 are pending. Claims 2-3,8, 11-20,22-23, 33-39,41, 44, 46-56, 59 are cancelled.
The following rejections are maintained. Response to arguments follows.
This action is FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1,4-7, 9-10,21, 24-32,40, 42-43,45,57-58,60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of identifying a gastric cancer tumor microenvironment type for a subject comprising obtaining RNA expression data from the combination of genes and generating a GC TME signature and identifying a human subject as “GC TME type B”.
The claims requires a determining of GC TME types. The instant specification states that GC TME types encompass types A-E (p. 13). The specification does not specifically teach the critical guidance to determine each of these types. The specification provide figures that provide techniques for identifying GC TME signatures (p. 14 and figures 4-5). However, these descriptors do not prove which expression data is associated with any of these types. Although expression can be determined the specification has not provided guidance as to how this expression data functionally predicts type. The specification provides that certain expression data relative to other date can provide GC types (p. 46-47). However, the specification has not provide which gene expressions have the critical data for identification of each type. For GC TME type B is considered a “immune enriched none fibrotic” type (p. 67-68). The specification describes type B as highest tumor mutation burden (p. 67). Table 4 discloses gene group score in the GC TME type B with percental values, however, it is not clear based upon this guidance if the gene expression needs to have a particular minimum or maximum based upon the table provided. In particular which expression determinations would provide a type B versus any other type?
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: Federal Register: December 21, 1999 (Volume 64, Number 244), revised guidelines for written description.) In the instant case, the specification fails to teach the necessary common attributes or features of the genus of encompassed scores in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of the genus of determination of GC TME type.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude, "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
An adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the '525 patent, "requires a precise definition, such as by structure, formula, chemical name, or physical properties," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel , 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). Accordingly, "an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." Id. at 1170, 25 USPQ2d at 1606.
The claims do not meet the written description provision of 35 USC 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.)
Response to Arguments
The reply traverses the rejection. A summary of the arguments is set forth below with response to arguments following. The reply asserts that the specification does not need to prove a genus of encompassed scores (p. 11). The reply asserts that the specification describes obtaining expression data for the genes recited in the pending claims, normalizing the RNA expression data to TPM, generating gene group expression scores using ssGSE to produce GC TME signatures (p. 12). The reply asserts that example 1 provides unsupervised clustering the 5 GC TME types (p. 12). The reply asserts in example 4 the specification describes that patients from type B and E had a higher disease control rate when administered immunotherapy (p. 12).
These arguments have been fully reviewed but have not been found persuasive.
The issue is not the ability to measure different scores in different statistical methods, the issue is how to apply these and functionally determine type B is provided below. The reply does provide specific expression scores and generating signatures, the issue is how to take the expression data of claim 1 and apply to determining type B.
The tables disclose gene group score in the GC TME type B with percental values, however, it is not clear based upon this guidance if the gene expression needs to have a particular minimum or maximum based upon the table provided. In particular which expression determinations would provide a type B versus any other type? The tables appears to disclose that the median signature values are different in the different TME types, however, the claims are not drawn to identifying TME type based upon the median signature values of each group. The claims are drawn to identifying the human subject as having GC TME type B wherein it clusters with that signature, however, the specification has not provided which expressions are encompassed by type B. Therefore the specification has not described how to functionally define the patient as being type B versus the other types.. In other words, the claims are drawn to determining these scores but it is not clear which scores are type B as the specification has not described which of these scores would be associated with GC TME type B.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682