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 .
Election/Restrictions
Applicant’s election without traverse of Group III and MTAP and FGFR3 in the reply filed on 2/3/2026 is acknowledged.
Claims 13,37-38,99,106,471-482 are pending. Claims 1-12,14-36,39-98,100-105,107-470 have been cancelled.
An action on the merits is set forth below.
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 13,37-38,99,106,471-482 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 encompass treating or delaying progression of a UCB by detecting any deletion of the MTAP gene or portion thereof and any mutation of FGFR3. Therefore
The rejected claims detection of any deletion of a portion of MTAP and any mutation of FGFR3 from any individual and correlation to treatment. Therefore the claims encompass any deletion including one nucleotide deletions of MTAP. The claims further include any fusion, inversion, variant, SNP, insertion or deletion at any position of FGFR3. The claims also encompass detecting these in any individual which would encompass any species.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
In the present situation, the claims only provide description in humans, however, the claims encompass any species. As mutations differ between species the specification has not provided which mutations are predictive of treatment in any species. Table 3 shows measurement of MTAP deleted and MTAP intact data. However, the specification does not provide the critical guidance for other deletions (including one nucleotide) as claims and treatment. The specification does not provide which nucleotides are required to be deleted to provide the functionality to treatment.
The specification states that the FGFR3 gene can comprise one or more of an insertion, deletion or substitution of one or more nucleotides, genomic rearrangement, alteration in a promoter, a gene fusion or a copy number alteration (para 48). The specification discloses treatment with a FGFR3 inhibitor (para 363), however, the specification does not provide that any of these mutations would provide for a determination of administration of the inhibitor. Rather, the specification has not provided guidance as to which are theses mutations provide a functionality of treating with a therapy.
It is noted that the specification teaches the general methodology for detecting mutations. However, possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (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 Vas-Cath at page 1116.)
The skilled artisan cannot envision the detailed chemical structure of the encompassed mutations that are associated with detecting increased risk of cancer. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993), and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The current situation is a definition of the compound solely based on its functional utility, as a gene or genomic region, without any definition of the particular regions claimed.
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 that "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.
In conclusion, the limited information provided regarding mutations which are functionally associated with treatment is not deemed sufficient to reasonably convey to one skilled in the art nucleic acid molecules encompassed by the claims.
Thus, having considered the breadth of the claims and the provisions of the specification, it is concluded that the specification does not provide adequate written description for the claims.
Claim Rejections - 35 USC § 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.
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 13,37-38,99,106,471-482 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.
Claims 13,37-38,99,106,471-482 are indefinite over the phrase “based on the detection” in claim 13. The claim is unclear as it is not clear if the claim intends the presence or absence of or some other undefined relationship to the detection to administer.
Claim 38 and 480 are indefinite. The claim contains the trademark/trade names of the inhibitors. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the inhibitors and, accordingly, the identification/description is indefinite.
Claim 106 Is indefinite over the “and/or” statements. In particular it is not clear if the sample intends to be multiple samples or how in particular one sample can comprise fluid and FFPE.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 13,37,38,99,106,471-477,481-482 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes et al. (US Patent Application Publication 2015/0315657 November 5, 2015).
With regard to claim 13, Rhodes et al. suggests that one can treat UCB (paragraph 201 and table 9). Rhodes et al. teaches detection of a deletion of MTAP gene (para 201). Rhodes teaches a mutations in FGFR3 (including fusion) (Table 23). The term “based on the detection” is indefinite. Rhodes et al. teaches screening for these detections and treating with a FGFR target therapy (table 8 and para 172) and as such teaches the breath of the limitation of treating based on detection.
Therefore it would be prima facie obvious at the time of the effective filing date to screen for both MTAP gene deletion and mutations of FGFR3 in UCB individual and treat with a known treatment. The ordinary artisan would have a reasonable expectation of success as Rhodes suggests measuring these regions and treatment.
With regard to claims 37-38, Rhodes et al. teaches treatments with combinations including ponatinb and dovitinib (table 8 and para 172).
With regard to claim 99, Rhoades et al. suggests that metastic bladder cancer can a sample (table 15 and table 17). Although Rhodes et al. does not specifically teach metastic bladder cancer, Rhodes teaches that bladder urothelial can be used and that metastic cancer types can be used in the screening.
With regard to claim 106, Rhodes et al. teaches using fluid , FFPE samples (para 54).
With regard to claim 471, Rhodes et al. teaches selectively enriching the regions of interest (para 224 and 265).
With regard to claim 472-473, Rhodes et al. teaches enrichment using a capture (bait) (para 280 and 292).
With regard to claim 474, Rhodes et al. teaches enriching by using a PCR method (para 275,289,295).
With regard to claim 475, Rhodes et al. teaches sequencing (para 298).
With regard to claim 476, Rhodes teaches a mutations in FGFR3 (including fusion) (Table 23).
With regard to claim 477, Rhodes et al. teaches detection using hybridization assays, RT-PCR (para 56-57).
With regard to claim 481, Rhodes teaches a sample comprising mRNA (para 56-57).
With regard to claim 482, Rhodes et al. teaches a human sample (para 54 and 73).
Claim(s) 478-480 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes et al. (US Patent Application Publication 2015/0315657 November 5, 2015) as applied to Claims 13,37,38,99,106,471-477,481-482 in view of Fedoriw et al. (US Patent Application 20190365710 December 5, 2019). .
Rhodes et al. suggests that one can treat UCB (paragraph 201 and table 9). Rhodes et al. teaches detection of a deletion of MTAP gene (para 201). Rhodes teaches a mutations in FGFR3 (including fusion) (Table 23). The term “based on the detection” is indefinite. Rhodes et al. teaches screening for these detections and treating with a FGFR target therapy (table 8 and para 172) and as such teaches the breath of the limitation of treating based on detection.
However, Rhodes et al. does not teach PRMT5 targeted therapy.
With regard to claims 478-480, Fedoriw et al. teaches that the loss of MTAP gene can inhibit PRMT5 in tumor cells including UBC (para 146 and 298). Fedoriw et al.suggests that a treatment with targeted therapy can be performed in patients with deleted MTAP (para 275-298).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to use known treatments as taught by Fedoriw et al. on a known sample (UBC). The ordinary artisan would have a reasonable expectation of success as Fedoriw et al. teaches that there is an association of MTAP deletion and inhibition of PRMT5.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
Prosecution Insights