DETAILED ACTION
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05-06-2025 has been entered.
Applicant’s amendment filed on 05-06-2025 has been entered. Claim 1 has been amended. Claims 5, 8-9, 12-17, 19-20, 26, 28-30, 33 have been canceled. Claims 1-4, 6-7, 10-11, 18, 21-25, 27, 31-32, 34 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4 drawn to a recombinant melanin producing cell comprising a non-endogenous expression vector comprising a Gαq mutant gene in the reply filed on 04-22-2024 is acknowledged.
Applicant’s election without traverse of species GNAQR183Q as a species of GαQ mutation in claim 1 in the reply filed on 04-22-2024 is acknowledged. However, applicant has amended to delete GNAQR183Q from the claims. Thus, all species are rejoined for examination.
Claims 6-7, 10-11, 18, 21-25, 27, 31-32, 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04-22-2024.
Claims 1-4 are under consideration.
Priority
This application is a 371 of PCT/US19/59788 filed on 11/05/2019 that claim priority from US provisional application 62/756,435 filed on 11/06/2018.
Withdrawn- Claim Rejections - 35 USC § 112
Claims 1-4 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In view of Applicants' amendment of base claim 1, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections necessitated by amendments, as set forth below.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 1-4 were rejected under 35 U.S.C. 103 as being unpatentable over Sondek et al (Pub. No.: US 2015/0218538A1, Pub. Date: Aug. 6, 2015) in view of Griewank et al (Pub. No.: US 2013/0102653 A1, Pub. Date: Apr. 25, 2013). . In view of Applicants' amendment of base claim 1, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections over the prior art of record, as set forth below.
New-Claim Rejections - 35 USC § 112 - necessitated by amendments
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the human Gaq mutant gene” that comprise amino acid mutations such as “GNAQ G48L, GNAQ G48V, GNAQ Q209L, GNAQ Q209P, and GNAQ Q209R” etc. It is unclear how a gene with nucleotides sequence can comprise amino acid mutations.
Additionally, in claim 1, it appears that the phrases such as “human GNAQ has the amino acid sequence …. (SEQ ID NO: 27)” are wildtype amino acid sequence. It is unclear how this wildtype amino acid sequence related to “the human Gαq mutant gene” recited previously in the claim 1. It is unclear how a mutant gene is related a wildtype amino acid sequence or they are two separate entities.
Claims 2-4 are included in the rejection because they directly or indirectly depend from the rejected base claim. Appropriate correction is required.
New-Claim Rejections - 35 USC § 112 - necessitated by amendments
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 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.
In the instant case, in claim 1, the recitation of " MTLESIM …… LQLNLKEYNLV (SEQ ID NO: 27)”; “MTLESMMACC ……. LNLKEYNLV (SEQ ID NO: 28)”; “MERKFMSLQ …... WLRKETRV (SEQ ID NO:29) are considered new matter. Applicants do not explicitly point for the specific support of the claimed amendment. Upon further review of the instant specification, examiner could not find support for the recited limitations. There is no explicit or implicit support for the above limitations. In the remarks, applicant points to “the reference amino acid sequences for human GNAQ (UniProtKB: P50148), human GNAJ1 (UniProtKB: P29992) and human CYSLTR2 (UniProtKB: Q9NS75)” (remarks, page 10). However, there is no support for any UniProtKB accession number in the instant disclosure. Thus, before the effective filing date of the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was not in possession of the SEQ ID NO: 27, 28, and 29. MPEP 2163 .06 notes "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement". In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)". Claims 2-4, directly or indirectly depends from the rejected base claim. This is a new matter rejection.
Claims 1-4 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 because claims are directed to a recombinant melanin producing cell comprising any human Gαq mutant gene comprising mutation(s) from GNAQ, GNA11, and CYSLTR2 genes exhibits increased sensitivity to YM-254890 cyclic depsipeptide relative to a recombinant non-melanin producing cell as recited in the claim.
In analyzing whether the written description requirement is met for the genus claim, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics, specific features and functional attributes that would distinguish different members of the claimed genus. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B. V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43). USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991).
The claims encompass a genus of any human Gαq mutant gene that can exhibit increased sensitivity to YM-254890. However, Nishimura et al (PNAS ∣ August 3, 2010 ∣ vol. 107 ∣ no. 31, Doi: 10.1073/pnas.1003553107) teach that mutation of Arg60 with a lysine residue of Gαq resulted in approximately 620-fold less sensitivity to YM-254890 (Fig. 4B) (Page 13668, right column, 2nd para.), and Switch I mutations, I190N and P193C, which replace each Gαq residue with the corresponding residue in Gα15 and Gα16, respectively, reduce inhibitor sensitivity (Fig. 4B) (Page 13668, right column, last para. to page 13669, left column). Additionally, the specification of the claimed invention also teaches that GNAQR133Q was ~20-fold less sensitive to YM-254890 (YM) compared to CYSLTR2L129Qand GNAQG48V; GNAQQ209L was the most resistant to YM and its signaling was incompletely/poorly inhibited within 24-hour YM treatment ([00133], page 42).
The claims lack written description because there is no disclosure of a correlation using any human Gαq mutant gene that can render the cell to exhibit increased sensitivity to YM-254890. The specification lacks sufficient variety of species to reflect this variance in the genus showing contemplated biological activity of any human Gαq mutant gene to render the cell to exhibit increased sensitivity to YM-254890 . The specification does not provide sufficient descriptive support for the myriad of variant embraced by the claims.
Overall, what these statements indicate is that the Applicant must provide adequate description of such any human Gαq mutant gene to render the cell to exhibit increased sensitivity to YM-254890 such that the Artisan of skill could determine the desired effect. Hence, the analysis above demonstrates that Applicant has not determined any human Gαq mutant gene to render the cell to exhibit increased sensitivity to YM-254890 for full scope of the claimed genus for contemplated any human Gαq mutant gene.
The skilled artisan cannot envision the detailed chemical structure of the encompassed any human Gαq mutant gene other than those described in the specification, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen lnc. v.Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
New-Claim Rejections - 35 USC § 102- necessitated by amendments
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2)as being anticipated by Bastian et al (Pub. No.: US 2011/0070221 A1, Pub. Date: Mar. 24, 2011) as evidence by Invitrogen (User Manual, Catalog nos. 12489-019 and 12489-027, Version E, 27 October 2010, 25-0500).
Regarding to claims 1and 2, Bastian et al teach GNAQ mutations in melanoma (title). FIG. 2a-2b provides exemplary data showing that GNAQQ209L induces MAP kinase activation in human melanocytes. a, hTERT/CDK4R24C/p53DD melanocytes express increased levels of pERK and cyclin D1 after stable transfection with GNAQQ209L compared to GNAQWT or vector only (For the preamble and the claimed : “wherein the human Gaq mutant gene is human GNAQ and further comprises a mutation selected from the group consisting of ….GNAQ Q209L etc.”).
Bastian et al teach SEQ ID No 2 which is guanine nucleotide binding protein (G protein) q polypeptide (Gnaq, GAQ, G-alpha- q, Galphaq) (Page 21-22). SEQ ID No 2 is 100% identical to SEQ ID No 27 of the claimed invention:
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Regarding to claim 1, the claimed: wherein the recombinant melanin producing cell exhibits increased sensitivity to YM-254890 cyclic depsipeptide relative to a recombinant non-melanin producing cell, with the claims as currently written, it is noted that the recombinant human melanocytes as taught by Bastian et al and the recombinant human melanocytes of claimed invention are structurally identical (recombinant human melanocytes comprising GNAQQ209L mutation) as described above. Thus, it is expected they have the same function such as exhibiting increased sensitivity to YM-254890 cyclic depsipeptide relative to a recombinant non-melanin producing cell as required by the claim. It is also noted that Applicant’s own disclosure and claims provide evidence that the recombinant melanin producing cell comprising GNAQQ209L mutant gene exhibit increased sensitivity to YM-254890: in Example 4 of the present application, treatment with YM-254890 completely inhibited IP1 accumulation across all the recited Gaq activating mutants in melan-a cells (melanocytes) after 24 hours, including the resistant GNAQQ209L compared to non-melanin producing HEK293T cells.
As per MPEP 2112 (I): something which is old does not become patentable upon the discovery of a new property: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As per MPEP 2112 (II): inherent feature need not be recognized at the relevant time: There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Regarding to claim 3, Bastian et al teach a plasmid with the entire GNAQ coding region of GNAQQ209L was obtained from UMR cDNA Resource Center ([0156], page 17). Transfections were carried out using Lipofectamine 2000 (Invitrogen) and 2 µg plasmid pcDNA 6.2/V5-DESTR Gateway vector (Invitrogen) alone or containing the complete coding region for either GNAQQ209L or GNAQWT, respectively.
Regarding to claim 4, since Bastian et al teach pcDNA 6.2/V5-DESTR Gateway vector which contain Human cytomegalovirus immediate-early (CMV) promoter which is a constitutive/ heterologous promoter as evidence by Invitrogen.
Thus, claims 1-4 are anticipated by Bastian et al.
Conclusion
No claim is allowed.
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632