DETAILED ACTION
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 .
This action is in response to papers filed 12/05/2025.
Applicant’s election without traverse of (1) differential methylation signatures and (2) cancer driver genes from a target or immune cancer gene in the reply filed on 8/06/2025 is acknowledged.
Claims 43-72 are pending. Claims 1-42 have been cancelled.
The following rejections have been maintained with response to arguments following.
This action is FINAL.
Withdrawn Rejections
The terminal disclaimer for US Patent Number 12297508 have been filed and accepted (12/05/2025). As such this obviousness double patenting rejection is withdrawn.
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 43-72 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.
Claims 43-71 are indefinite over step a-c of claim 43 and 71. In particular steps a to b require the generation and processing from a first sample. However, the steps after do not use the processing of step b. It is not clear how steps a and b limit the steps of informing therapy decision. Therefore the metes and bounds are unclear as it is not clear if the claims are identifying that steps a and b are used in the determination steps.
Claim 72 is indefinite over step a-c of claim 72. In particular steps a to b require the generation and processing from a first sample. However, the steps after do not use the processing of step b. It is not clear how steps a and b limit the steps of informing therapy decision. Therefore the metes and bounds are unclear as it is not clear if the claims are identifying that steps a and b are used in the determination steps.
Response to Arguments
The reply traverses the rejection. A summary of the arguments have been reviewed but have not been found persuasive. The reply asserts that claim 71 is not dependent to claim 43, however, the claim has the same issue as claim 43. The reply asserts that the claims do not recite processing however it is pointed out that the nucleic acid molecules derived from a second biological sample from the subject are enriched or amplified using a probe set configured to selectively enrich or amplify the genetic signature of the subject (p. 9). The reply asserts that therefore the genetic signature that is generated in step b is used in steps c-e. The reply asserts that further claim 72 has the same issue (p. 10).
These arguetmsn have been reviewed but have not been found persuasive.
The reply appears to be asserting the genetic signature generated in step b are used in steps c to e. However, steps c is enriching or amplifying nucleic acids molecules derived from a second on biological samples from the subject using a probe set configures to selectively enrich or amplify the genetic signature of the subject over other sequences. However, this step does not provide that the probe set is the selectively enrichment or amplification of the generated genetic signature of step b. Rather, there is no indication that step c is enriched or amplified using the same genetic signature of step b as it is not clear that the probe set is configured to selectively enrich or amply the genetic signature of step b. The use of “the genetic signature” is not clear as “the genetic signature” of c is described as a signature “over other sequences in the second biological sample” not necessarily the signature in step b (e.g. a first biological sample).
Double Patenting
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer
Claims 43-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10450611. Although the claims at issue are not identical, they are not patentably distinct from each other because each sets of claims require processing nucleic acid samples to generate using probes from a first sample and a second sample to enrich or amplify sequences in a library and subset of genetic variants. The difference is that in the instant claims is informing therapy decision based upon the sequencing, however, the limitation is an intended use of the steps. As such the steps of 611 would provide the same sequencing information as is claimed.
Response to Arguments
The reply traverses the rejection. A summary of the arguments have been reviewed but have not been found persuasive.
The reply asserts that the 611 patent does not tea h “polymorphisms comprising individual instances of the one or more multiple nucleotide polymorphism are out of phrase” as recited in claim 43 (p. 11). With regard to claims 71-72, the arguetmsn have been considered persuasive. With regard to claim 43, it is noted that the patent claim does not require “out of phase” polymorphisms. The instant specificaoin teaches that this term means SBVs that are not on the same strand. The 611 patent indicates that SNVs can encompass non synonymous variants (claim 27) and as such would encompass “out of phase” mutations.
Conclusion
No claims are allowed.
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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached on 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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