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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 4/29/2026 has been entered.
Claims cancelled 1-18
Claims pending 19,22-24,26-31
Claims currently under consideration 19,22-24,26-31
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
Withdrawn Rejection(s)
All rejections from the previous action are hereby withdrawn in view of Applicant’s amendments
New Claim Rejection(s) – 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 19,22-24,26-31 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection concerns new matter.
As now presented, claim 19 adds step (d) drawn to “comparing [] expression levels of the one or more genes [recited in step (c)] to a control sample” and new claim 31 is drawn to “administering a therapeutic intervention to [a] subject for a premalignant lesion, wherein the sample [set forth in claim 19] confirms the presence [set forth in claim 19] of a premalignant bronchial lesion” with the current remarks urging support therefor may be found at paragraphs [0042], [0046], [0047] and [0054] (of the present published application). In reviewing such passages, however, at best, the examiner only finds description regarding claim 19 for all the genes set forth in table 3 (208) as opposed to the 256 claimed; and regarding claim 31 for chemotherapeutic agents as opposed to any therapeutic agent, whereas the remarks do not point to narrowing or broadening language elsewhere in the present published application, much less in the priority documents.
As such, because the originally filed disclosure provides no implicit or explicit support therefor such amendments, they are deemed new matter.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I.
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).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.
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 19,22-24,26-31 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 pre-AIA the applicant regards as the invention.
Claim 19d recites the limitation "the one or more genes" in line 1. There is insufficient antecedent basis for this limitation in the claim, rendering the metes and bounds uncertain.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 19 are rejected as being indefinite as well.
New 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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 19,22-24,27-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al (US PG-Pub 20090061454; IDS entry 2/6/2023; of record) in view of Zhukov et al (US 8198019) or Ellis et al (2002 Current Opinion in Pulmonary Medicine 8:270-4) each taken separately.
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: provide 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 measure 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 19b line 2, at paragraph 0213, Brody et al incorporates by reference the entirety of Thibervile et al (1995 Cancer Research 55: 5133-9; of record) 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 19b,c,d; 22;23;24;27 and 29. Furthermore in paragraph 0091, Brody et al teach subjects over 40 years old, overlapping with claims 28 and 30.
Nevertheless, Brody et al do not expressly teach: a subject suspected of having a premalignant bronchial lesion seen in a CT (computed tomography) scan and confirming thus with a sample thereof as recited in claim 19a & e; nor administering a therapeutic intervention to a subject so confirmed to have a premalignant bronchial lesion of claim 31.
Zhukov et al suggest throughout the document and especially column 3 lines 2-3; 27-34 and/or figure 12, a subject suspected of having a premalignant bronchial lesion from a CT scan of claim 19a and confirming thus with a protein profile from a sample thereof, as recited in claim 19a & e; as well as administering chemoprotective agents if a subject indeed has a premalignant bronchial lesion of claim 31. Alternatively concerning claim 19b line 2, Zhukov et al teach laser capture microdissection of suspected premalignant bronchial lesions (AAH) in figures 1 & 8.
In the abstract Ellis et al likewise suggest in occult lung cancer (a patient suspected of having a premalignant bronchial lesion) from a CT scan of claim 19a and confirming a sample as having a premalignant lesion by molecular medicine techniques as recited in claim 19a & e; as well as administering a therapeutic intervention preinvasive (premalignant) disease of claim 31.
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 employed a CT scan and/or applied a therapeutic regimen as advocated by Zhukov et al or Ellis et al in treating and/or prognosing patients exhibiting bronchial neoplasia as in Brody et al.
One of ordinary skill in the art would have been motivated to have employed a CT scan and/or applied a therapeutic regimen as advocated by Zhukov et al or Ellis et al in treating and/or prognosing patients exhibiting bronchial neoplasia as in Brody et al because Brody et al expressly suggest the methods chest X-ray analysis and CT analysis of the chest do not provide a combination of both sensitivity and specificity needed for an optimal diagnostic test (see paragraph 0008).
One of ordinary skill in the art would have had a reasonable expectation of success using a CT scan to decide whether to initiate treatment of premetastatic bronchial lesions as in Ellis based upon confirmation with modern molecular medicine techniques in view of the impressive experimental results reported in both Brody or Zhukov.
Claims 19,22-24,27-31 and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brody et al (US PG-Pub 20090061454; IDS entry 2/6/2023; of record) in view of Zhukov et al (US 8198019) or Ellis et al (2002 Current Opinion in Pulmonary Medicine 8:270-4) each taken separately and further in view of Chatterjee et al (2011 Cancer Prev Res 4:638-54; of record) as evidenced by Dasgupta et al (2010 Cancer Prevention Research 3:1205-11; referred to as Dasgupta 2010) if necessary.
Brody et al in view of Zhukov et al or Ellis et al is relied on as above.
Brody et al in view of Zhukov et al or Ellis et al not explicitly teach a subject previously diagnosed with head/neck cancer of claim 26.
Chatterjee et al teaches throughout the document and especially figures 1,3 and tables 1-2 at least, ten human mitochondrial gene mutations (mtDNA) as markers for cancer. 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 38, Dasgupta 2010), testing mtDNA for mutations as indicative of cancer recurrence at surgical margins of head and neck cancer (e.g. HNCC) patients, that is a subject that had been previously been diagnosed with head/neck cancer but has no current evidence of the cancer (following surgery) like claim 26.
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 considered mitochondrial markers as advocated by Chatterjee et al together with a transcriptomic and/or protein profile of Brody et al in view of Zhukov et al or Ellis et al.
One of ordinary skill in the art would have been motivated to have considered mitochondrial markers as advocated by Chatterjee et al together with a transcriptomic and/or protein profile of Brody et al in view of Zhukov et al or Ellis 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 other markers suggested by Brody et al in view of Zhukov et al or Ellis et al due to the advent of the Mitochip array expressly therefor that has been commercially available since the turn of the millennium.
Moreover, akin to In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) as interpreted in MPEP 2144.06, it is prima facie obvious to combine compositions (e.g. mtDNA, proteins, mRNA/cDNA) each of which is taught by the prior art to be useful for the same purpose of characterizing premalignant lesions.
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.
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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
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