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
Responsive to claim set of 4/14/2026
Claims pending 1-20
Claims withdrawn 20
Claims currently under consideration 1-19
Priority
This application has a filing date of 12/26/2023 and is a CON of
17/065,889 10/08/2020 PAT 11898209
17/065,889 is a CON of 15/560,324 09/21/2017 ABN
15/560,324 is a 371 of PCT/US2016/024367 03/25/2016
PCT/US2016/024367 has PRO 62/253,619 11/10/2015
PCT/US2016/024367 has PRO 62/219,339 09/16/2015
PCT/US2016/024367 has PRO 62/137,891 03/25/2015
Double Patenting (maintained)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of U.S. Patent No. 11898209 (IDS entry 9/16/2024; referred to hereafter as ‘209.) in view of Mitas (US AppPub 20070231822).
Although the claims at issue are not identical, they are not patently distinct from each other because, for example, said present claims represent patentably indistinct methodological variants of all that is recited in the conflicting claims of ‘209 or, alternatively the subject matter claimed overlaps in scope to a large extent and, as a result, are rendered obvious.
The following is illustrative.
For claim(s) 2, ‘209 is drawn to reducing volume before isolating RNA as in claim 2.
For claim(s) 8, ‘209 is drawn to comprising removing contaminants from the (recited) solution containing the cDNA molecules before encapsulating cDNA molecules as in claim 3.
For claim(s) 4, ‘209 is drawn to wherein generating cDNA molecules from isolated RNA comprises conducting RT-PCR of the (recited) isolated RNA.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify embodiments of ‘209 that fall outside the scope of the present application to select a specifically disclosed embodiment that falls within the scope of the present application because each set of claims concern reagents similar if not the same physiochemical properties in that they all possess a common core structure and accordingly biological activities (e.g. FAT1 and AGR2 PCR amplicons from SEQ IDs 22 & 23 and SEQ IDs 1 & 2, respectively). Furthermore, one of ordinary skill in the art would have been motivated to make such a modification because they are disclosed as “preferred” since the dependent claims of ‘209 “teach toward” Applicant’s presently claimed physical steps of analyzing tumor cells circulating in blood, especially in view of Mitas, who teaches, for instance, AGR2 as associated with lung cancer as currently claimed as well as pancreatic and breast cancers of ‘209 (cf abstract).
Response to Arguments
In the pertinent section, at pp 9-10, Applicant asserts that it is factually incorrect that the present application and ‘209 claims share any common core structure, urging AGR2 expression was discovered as suitable toward diagnosing lung cancer, not liver or pancreatic cancer, nor melanoma; unlike ‘209 where AGR2 is used in pancreatic and/or breast cancer diagnosis; and the FAT1 PCR product is presently applied toward lung or pancreatic cancers, unlike ‘209 where it is used in prostate cancer diagnosis.
Applicant’s arguments have been fully considered but they are not deemed persuasive.
The examiner disagrees for the following reasons.
First it is not clear how using precisely the same experiment (PCR) with precisely the same primers for amplifying DNA from precisely the same sample (circulating tumor cells) will not generate precisely the same amplicons with precisely the same (core) sequences from AGR2 and FAT1, as in both ‘209 and the present application: Second, that such ARG2 amplicon common between the present application and ‘209 is not used for liver or pancreatic cancer, nor melanoma diagnosis is immaterial to the conflicting claims. Third, as mentioned in the rejection above from the previous action, well before the present invention was filed Mitas plainly teaches AGR2 as associated with lung cancer like the present claims as well as prostate and breast cancer of ‘209.
Finally, regarding FAT1, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Moreover concerning AGR2,, a recitation of intended use (e.g. of diagnosing lung vs. prostate vs. breast cancers) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention, in so far as a structure is capable of performing the intended use, then it meets the claim.
Maintained 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 1-19 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 pre-AIA the applicant regards as the invention, as evidenced by ‘209 claim 1 and/or Mitas (US AppPub 20070231822)
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). FAT1 being a “lung cancer-selective” in claim 1 is contradicted by FAT1 being pancreatic-cancer selective also in claim 1. Similarly, again amplified with the same primers, AGR2 being lung cancer-selective contradicted by ‘209 patented claim 1, being in both pancreatic and breast cancers. Moreover, beyond the presently claimed lung cancer selectivity, Mitas like ‘209 indicates AGR2 is a genetic marker for prostate and breast cancers as well as pancreatic cancer. The term “cancer-selective” as recited in claim 1 is deemed indefinite because the specification does not clearly redefine the term.
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 1 are rejected as being indefinite as well.
Response to Arguments
In the pertinent section, pp 10-11 the remarks accompanying the present response argue claim 1 is not indefinite because the cancer selective genes recited in claim 1 may be selective for more than one cancer like p53 that is related to breast, lung, colorectal, ovarian and other cancers, a meaning consistent with table 1 and paragraphs 0015-0016 of the present published application.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
The examiner does not disagree that p53 is associated with many cancers and because of this, the skilled artisan cannot diagnose a particular cancer based on p53 mutations alone. Likewise here, in accordance with table 1 of the present published application, expression of FAT1 occurs in lung, breast, liver, melanoma, prostate and pancreatic circulating tumor cells, and as such, paragraphs 0015-0016 of the application taken in context therewith table 1, isuggests with 2 or more genes in order to resolve such ambiguities.
On the other hand, present 1 is drawn to a “lung cancer-selective gene including one or more of AQP4...FAT1...ARG2 and FAT2” (emphasis added) and a “pancreatic cancer-selective genes include one or more of ALDH1A3, ...FAT1...and STEAP2” (emphasis added), thus it is ambiguous if circulating tumor cell positive for FAT1 RNA would have originated from lung or pancreatic cancer. It bears mentioning such present ambiguity is not reflected in issued patent ‘209 (the present application being a continuation application thereof ‘209) wherein ‘209 claim 1 is drawn 8 or 12 gene for prostate cancer and breast cancer respectively (2 or more genes).
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 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.
THIS ACTION IS MADE FINAL. 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
Prosecution Insights