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 Claim 9 and 11-17 in the reply filed on 09/03/2026 is acknowledged.
Claims 1-8 and 10 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method for determining whether a subject with cancer is likely to benefit from treatment with a BRAF inhibitor, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/03/2026.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term "Thermo Fisher" (pg 4, line 30), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 17 is objected to because of the following informalities:
The claim recite “consisting ofBMS-908662”, however it should recite “consisting of BMS-908662”.
Appropriate correction is required.
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.
Claim 9 is 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.
The term “effe” in claim 9 is a relative term which renders the claim indefinite. The term “effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP 2173.05(c).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9, 11, 12, 13, 14, 15, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Biechele et al. (US 20120059021 A1), and further in view of non-patent literature “Sperm-Specific Glyceraldehyde-3-Phosphate Dehydrogenase - An Evolutionary Acquisition of Mammals” by Muronetz et al.
Regarding claim 9, Biechele teaches a method for treating a subject with cancer (para 0008), the method comprising administering to the subject a therapeutically effective amount of a BRAF inhibitor (para 0083-0084).
Regarding claim 11, Biechele teaches a method for treating a subject who has cancer (para 0008), the method comprising: providing a sample comprising cancer cells from a subject (para 0166); evaluating presence and/or level of a protein in the sample (para 0014), comparing the presence and/or level of protein with a reference level (0014), identifying a subject who has a level of protein that is greater than or equal to the reference level of protein (para 0014), and administering to the subject a treatment comprising administration of a BRAF inhibitor (para 0083-0084).
Biechele does not teach evaluation, comparing and identifying levels of the GAPDHS protein.
Muronetz teaches the role of sperm specific glyceraldehyde-3-phosphate dehydrogenase (GAPDS) in energy production, and it has role in the development of certain pathologies such as cancer (Abstract). Muronetz further teaches how GAPDHS protein level and mRNA levels are studied in melanoma cells (pg 1683-1684). Muronetz further teaches GAPDHS being expressed in certain cancer cells should be studied as it is likely to affect energy metabolism and induction to apoptosis (pg 1675, left column). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Biechele with evaluation, comparing and identifying levels of the GAPDHS protein for the benefit of analyzing a protein that is likely to affect energy metabolism and induction to apoptosis of cancer cells (pg 1675, left column).
Regarding claim 12, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches the sample comprising cancer cells is obtained by punch biopsy and needle biopsy (para 0166).
Regarding claim 13, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches determining a level of AXIN1 mRNA in the sample (para 0033).
Biechele does not teach determining a level of GAPDHS mRNA in the sample.
Muronetz teaches determining a level of GAPDHS mRNA in the sample for the benefit of using the sperm-specific protein as marker of certain oncological disorders (pg 1682, Section: Expression of GAPDHS in Melanoma Cells). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Biechele with determining a level of GAPDHS mRNA in the sample as taught by Muronetz for the benefit of using the sperm-specific protein as marker of certain oncological disorders (pg 1682, Section: Expression of GAPDHS in Melanoma Cells).
Regarding claim 14, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches determining a level of AXIN1 protein in the sample (para 0035).
Biechele does not teach determining a level of GAPDHS protein in the sample.
Muronetz teaches determining a level of GAPDHS protein in the sample for the benefit of quantifying the amount of GAPDHS in a sample (pg 1683, Section: Expression of GAPDHS in Melanoma Cells). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Biechele with determining a level of GAPDHS protein in the sample as taught by Muronetz for the benefit of quantifying the amount of GAPDHS in a cell (pg 1683, Section: Expression of GAPDHS in Melanoma Cells).
Regarding claim 15, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches the subject has melanoma (para 0008).
Regarding claim 16, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches the subject has melanoma (para 0008).
Regarding claim 17, Biechele in view of Muronetz teaches the invention of claim 11. Biechele further teaches the BRAF inhibitor is GSK2118436 and vemurafenib (para 0011).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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