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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8OCT2025 has been entered.
Claims cancelled 1-18
Claims pending 19,22-30
Claims currently under consideration 19,22-30
Priority
This application has a filing date of 02/22/2021 and is a CON of
15/644,721 07/07/2017 PAT 10927417
15/644,721 has PRO 62/360,218 07/08/2016
Maintained Claim Rejection(s) - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 19,22-24,27,29 are rejected under 35 U.S.C. 102(a)(1 and 2) as being anticipated by Brody et al (US PG-Pub 20090061454; IDS entry 2/6/2023; of record) including Thibervile et al (1995 Cancer Research 55: 5133-9; of record) if necessary.
Brody et al teach throughout the document and especially the title, diagnosis of lung disorders using gene expression profiles derived from nose epithelial cells and more particularly at paragraphs 0134,0183,0913,0090-0091,0170,0197 and in figure 3 tables 5,6 and 13 at least, Brody et al: provides a biological sample from the mouth or nose of subjects such as a smoker, never-smoker or individual with emphysema or else from a brushing of the bronchi walls of said subjects; then measures the expression of the entire human genome with an Affymetrix Human Genome U133 chip that inherently includes probes for at least: CCDC93, BAZ2A, TJAPl, PNN, LY6G5B and SGSH gene transcription in the sample via cDNA generated from RT-PCR. As in claim 1a line 2, at paragraph 0213, Brody et al incorporates by reference the entirety of Thibervile et al, entitled “Evidence of cumulative gene losses with progression of premalignant epithelial lesions to carcinoma of the bronchus” which in turn discloses biological samples from subjects with premalignant bronchial lesions as expounded in the left column of p 5134 at least. The foregoing reads on claims 19,22,23,24,27 and 29.
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Please note that the above rejection has been updated from the original version to more clearly address Applicants’ amended claims.
Response to Arguments
The remarks accompanying the current response argue not all elements are taught.
Applicant’s arguments have been fully considered, but they are not deemed persuasive for the following reasons.
Page 5 of said remarks asserts Brody et al do not disclose: measuring expression of five genes set forth in claim 19; nor diagnosing or monitoring regression or progression into lung cancer from premalignant bronchial lesions.
With regard to the now presented claim 19 genes, applicant’s attention is respectfully invited to the excerpt of probes on the Affymetrix Human Genome U133 (provided with the 3/16/2025 action) chip used by Brody et al, that plainly includes CCDC93, BAZ2A, TJAPl, PNN, LY6G5B and SGSH.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., diagnosis or monitoring regression or progression into lung cancer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With regard to premalignant bronchial lesions per se, as addressed in the previous action, at paragraph 0213, Brody et al incorporates Thibervile et al that indeed provides a biological sample from a subject with a premalignant bronchial lesion such as in left column of the second page or even article title.
Maintained Claim Rejection(s) - 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.
Claims 19,22-24,27,29 and 25-26,28,30 are rejected under 35 U.S.C. 103 as being unpatentable over Brody et al (US PG-Pub 20090061454; IDS entry 2/6/2023) in view of Chatterjee et al (2011 Cancer Prev Res 4:638-54) as evidenced by Dasgupt et al (2009 PLoS ONE 4:e6533 9 pages) if necessary.
Brody et al is relied on as above and further in paragraph 0091, Brody et al teach subjects over 40 years old, overlapping with claims 28 and 30.
Brody et al do not explicitly teach a subject with positive result in an imaging study of a premalignant bronchial lesion; nor a subject previously diagnosed with head/neck or lung cancer of claims 25-26.
Chatterjee et al teaches throughout the document and especially figures 1,3 and at least, ten human mitochondrial genes (mtDNA) as markers for cancer. And like claims 25-26 in the section entitled 'MtDNA Alterations as Markers for Cancer' starting at p 640, Chatterjee et al suggest, referring to previous studies from their laboratory (citation 39), testing mtDNA for mutations as indicative of cancer recurrence in patients exhibiting a positive result in an imaging (histology) study of premalignant bronchial lesions, as evidenced by Dasgupt et al, as well as testing at surgical margins of head and neck cancer patients.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have measured expression of mitochondrial genes as markers for cancer as advocated by Chatterjee et al together with the nuclear genomic markers evaluated by Brody et al.
One of ordinary skill in the art would have been motivated to have measured expression of mitochondrial genes as markers for cancer as advocated by Chatterjee et al together with the nuclear genomic markers evaluated by Brody et al because the role of mtDNA integrity and cancer progression cannot be ignored, as emphasized by Chatterjee et al in the first full paragraph at p 649.
One of ordinary skill in the art would have had a reasonable expectation of success in evaluating mtDNA integrity along with the nuclear markers of Brody et al due to the advent of the now commercially available Mitochip array therefor, as well as compelling results disclosed therewith, such as disclosed by Chatterjee et al in the second paragraph at p 641, table 2 and glossary.
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Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended claims.
Response to Arguments
Applicant does not offer further arguments regarding the above obviousness rejection(s) beyond what was set forth with regard to the 35 U.S.C. § 102 rejection, above. To the extent that Applicant is merely repeating their previous argument, the examiner respectfully submits that those issues were adequately addressed in the above section(s), which is/are incorporated in their entireties herein by reference.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684