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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 19-23, 25-26, 32-35, and 37-38 have an effective filing date of 03 MAR 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/25/2025 & 09/02/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 11/03/2023 Applicant elected, without traverse:
Species
SAMD9, IFI35, IFIT3, OAS2, OASL, and RTP4
Type I interferon
Status of Claims
Claims 19-23, 25-26, 32-35, and 37-38 are currently pending and presented for examination on the merits.
Claims 1-18, 24, 27-31, and 36 are canceled.
Claims 19, 25, 32, and 37 are amended.
Claims 20-21, 34-35 are withdrawn from further consideration under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 19, 22-23, 25-26, 32-33, and 37-38 are currently under review.
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 19, 22-23, 25-26, 32-33, and 37-38 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 19 recites a method of treating breast cancer, comprising obtaining combined expression levels of various interferon pathway-related genes and using these combined expression levels to obtain a critical value; however the claim provides no information for how critical value may be obtained by using said combined expression levels. Essential steps for obtaining a critical value are absent from the claim.
Applicant is informed that this rejection may be overcome by amending claim 19 to clearly delineate a means of obtaining a critical value.
Claim Rejections - 35 USC § 103
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.
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 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 19 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Judde et al (WO 2017178509, IDS 9/2/2022), and further in view of Laurin et al (Rac-specific guanine nucleotide exchange factor DOCK1 is a critical regulator of HER2-mediated breast cancer metastasis, PNAS, vol. 110, no. 18, 2013).
In regards to claims 19 and 32, Judde et al teaches a method of treating breast cancer patients [Abstract]. Judde et al further teaches detecting and measuring genes from a biological sample [Abstract]. Judde et al further teaches the cancer is breast cancer [Line 8, pg. 6]. Judde et al further teaches treating the patient by expression level of gene, combining the expression level into an index, and predicting responsiveness to treatment based off of the index [Lines 24-30, pg. 3]. Judde et al further teaches treating with PARP inhibitor [Line 30, pg. 3]. Judde et al further teaches measuring the expression profile of SAMD9, IFI35, IFIT3, OAS2, and OASL [Lines 1-7, pg. 17].
Judde et al does not specifically teach RTP4. However, this deficiency is made up in the teachings of Laurin et al.
Laurin et al teaches a method of predicting HER2+ breast cancer patient outcome based on the expression level of RTP4 [Abstract]. Laurin et al further teaches the expression level of RTP4 predict disease-free survival in HER2+ cancer patients [Fig. 4, pg. 7438].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combines Judde’s method of treating the patient by expression level of genes SAMD9, IFI35, IFIT3, OAS2, and OASL, combining the expression level into an index, and predicting responsiveness to treatment based off of the index, with Laurin’s method of predicting HER2+ breast cancer patient treatment outcome base on RTP4 expression levels. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Judde and Laurin’s methods for a method of treating HER2+ breast cancer comprising a test sample, determining the expression levels of genes SAMD9, IFI35, IFIT3, OAS2, OASL, and RTP4, obtaining a critical value by combined expression levels, diagnosing the subject if the critical value is below a reference value, and treating the diagnosed subject, because Judde and Laurin both teach measuring the expression level of these genes in breast cancer treatments and adapting the treatments.
Claims 19, 22-23, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Judde et al (WO 2017178509, IDS 9/2/2022), Laurin et al (Rac-specific guanine nucleotide exchange factor DOCK1 is a critical regulator of HER2-mediated breast cancer metastasis, PNAS, vol. 110, no. 18, 2013) as applied to claims 19 and 32 above, and further in view of Kozera et al (Reference genes in real-time PCR, J Appl Genetics, 54:391-406, 2013), and Ferrell et al (The New Favorite Reference Gene:36B4, a.k.a. RPLP0, Biosearch Technologies, https://blog.biosearchtech.com/thebiosearchtechblog/bid/27718/the-new-favorite-reference-gene-36b4-a-k-a-rplp0, 2009).
The teachings of Judde et al and Laurin et al are discussed above.
Judde et al does not specifically teach reference genes ACTB and GAPDH. However, this deficiency is made up in the teachings of Kozera et al.
In regards to claims 22, 23, and 33, Kozera et al teaches commonly used reference genes ACTB and GAPDH to validating PCR results [Left column, 1st Paragraph, pg. 394].
Judde et al does not specifically teach reference gene RPLP0. However, this deficiency is made up in the teachings of Ferrell et al.
Ferrell et al teaches the gene RPLP0 as a reference gene for PCR [1st Paragraph, pg. 1]. Ferrell et al further teaches the reference gene beta-action (ACTB) [2nd Paragraph, pg. 1].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combines Judde’s method of treating the patient by expression level of genes SAMD9, IFI35, IFIT3, OAS2, and OASL, combining the expression level into an index, and predicting responsiveness to treatment based off of the index and Laurin’s method of predicting HER2+ breast cancer patient treatment outcome base on RTP4 expression levels, with Kozera’a method of using ACTB and GAPDH as reference genes in PCR, with Ferrell’s method of using RPLP0 and ACTB to normalize the reference gene in PCR. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Judde, Laurin, Gozera, and Ferrell’s methods for a method of treating HER2+ breast cancer comprising a test sample, determining the expression levels of genes SAMD9, IFI35, IFIT3, OAS2, OASL, and RTP4, obtaining a critical value by combined expression levels and using reference genes ACTB, GAPDH, and RPLP0, diagnosing the subject if the critical value is below a normalized reference value, and treating the diagnosed subject, because Judde and Laurin both teach measuring the expression level of these genes in breast cancer treatments and adapting the treatments.
Claims 19, 25-26, 32, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Judde et al (WO 2017178509, IDS 9/2/2022), Laurin et al (Rac-specific guanine nucleotide exchange factor DOCK1 is a critical regulator of HER2-mediated breast cancer metastasis, PNAS, vol. 110, no. 18, 2013) as applied to claims 19, and 32 above, and further in view of Slaney et al (The role of Type I interferons in immunoregulation of breast cancer metastasis to the bone, Onco Immunology 2:1, e22339; January 2013).
The teachings of Judde et al and Laurin et al are discussed above.
Judde et al does not specifically teach administering interferon. However, this deficiency is made up in the teachings of Slaney et al.
In regards to claims 25-26 and 37-38, Slaney et al teaches the treatment of breast cancer cells by administering Type I interferon [Right column, pg. 2].
One of ordinary skill in the art, before the effective filing date, would have been motivated to combines Judde’s method of treating the patient by expression level of genes SAMD9, IFI35, IFIT3, OAS2, and OASL, combining the expression level into an index, and predicting responsiveness to treatment based off of the index and Laurin’s method of predicting HER2+ breast cancer patient treatment outcome base on RTP4 expression levels, with Slaney’s method of treating breast cancer by administering Type I interferon. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Judde, Laurin, and Slaney’s methods for a method of treating HER2+ breast cancer comprising a test sample, determining the expression levels of genes SAMD9, IFI35, IFIT3, OAS2, OASL, and RTP4, obtaining a critical value by combined expression levels, diagnosing the subject if the critical value is below a reference value, and treating the diagnosed subject with Type I interferon, because Judde and Laurin both teach measuring the expression level of these genes in breast cancer treatments and adapting the treatments, and Slaney teaches type I interferon as a treatment for breast cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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, Samira Jean-Louis can be reached at (571) 270-3503. 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.
/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642