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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/16/2026 has been entered. Claims 1 and 15 have been amended. Claims 16-19 have been canceled. Claims 1-15 and 20-30 are pending.
Declaration under 37 CFR 1.130(a)
Applicant submission of a Declaration under 37 CFR 1.130(a) establishing co-ownership and evidence that the secondary citing of Reggiardo reference was published less than one year from the filing of the of the instant invention is acknowledged. Accordingly, the teachings of Reggiardo et al is withdrawn.
New Ground(s) of rejections
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 and 20-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalluri et al {Kalluri, used interchangeably herein} (US 10598665, March 24, 2020) and Nagy et al (Int. J. Cancer, vol. 140, p.930-937, 2017).
Regarding claims 1, 4-7, Kallluri teaches a method for detecting a RAS pathway mutation in a subject, the method comprising: identifying a cancer biomarker in a subject, wherein the cancer biomarker may a KRAS mutation (col. 3, lines 7-8; col. 4, lines 1-4), the method comprising obtaining a biological sample from the sample (col. 2, lines 44); isolating nucleic acids from the biological sample (col. 4, lines 39-41; col. 9-12); and analyzing the expression level of extracellular RNAs in the nucleic acids, wherein a differential expression level of the extracellular RNAs compared to a control sample indicates that the subject has a RAS pathway mutations (col. 2-7, 12-15, col. 45, lines 12-15; col. 46, lines 4-17; col. 47, lines 25-27, 40-41, Table 2; Figures 1, 2, 5, 11, 13, 19; see also Examples 2 and 3). Kalluri teaches wherein non-coding RNAs are analyzed (col. 40, lines 21-38). Kalluri further teaches wherein cancer is a RAS mutant cancer and wherein the RAS mutant cancer is a lung, cancer, pancreatic cancer, colorectal cancer, or melanoma (col. 2 line 2 to col. 3, line 25).
Regarding claim 2, Kalluri teaches where the RAS pathway mutation is in KRAS (Fig 2A-E, Fig. 11F, Fig. 12A-F, Fig. 19), EGFR (col. 12, line 21).
Regarding claim 3, Kalluri teaches wherein the biological sample comprises extracellular vesicles isolated from biofluids from the subject (abstract, col., 1, line 60 to col. 2, first full paragraph).
Regarding claim 8, Kalluri teaches wherein the method further comprises analyzing the expression level of a gene involved in the interferon IFN gamma or Zn Finger response (col. 21, lines 45 – 49, Table 1).
Regarding claims 20-23, Kalluri teaches wherein the biological sample is a blood sample, a urine sample, a saliva sample or a tissue sample and wherein the subject is a human (col. 2, lines 49 to col. 3, lines 42; col. 13 first full paragraph).
Regarding claim 24-26, Kalluri teaches further comprising administering to the subject one or more anticancer agents, wherein the anticancer agent is an inhibitor of a RAS pathway gene (col. 3-7, col. 12).
Regarding claims 27-30, Kalluri teaches further comprising isolating extracellular vesicles from the sample on the basis of size wherein the size is from about 40 – 150 nm (col. 11 line 64; col. 13, line 64 to col. 14, 11). Kalluri does not teach wherein the vesicles are from about 150 nm or about 213 nm in diameter. However, MPEP states "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
While, Kalluri teaches number aspects of the claimed invention including analyzing differential expression levels of RNA, analyzing increase, decrease or lack of change in cancer derived exosomes to detect cancer in a sample and response to therapy, the reference does not teach in the sequencing step, aligning the one or more sequencing reads of the noncoding RNA to repetitive sequences in a human genome, analyzing expression level of noncoding RNA transcribed from transposable elements.
Regarding claims 1-8 and 23-30, Nagy et al. teach a method for detecting Kras mutations in a sample, wherein the method comprises exome RNA sequencing and aligning sequence data with repetitive sequences in human genome (page 931-935, paragraphs under ‘methods’ section).
It would have been prima facie obvious to one skilled in the art before the effective filing date of the invention to modify the KRAS detection method of Kalluri et al. to encompass aligning sequencing reads as taught by Nagy et al and comparing to a control. The ordinary person skilled in the art would have motivated to do so for the combined benefit of improving the sensitivity of detecting Kras mutation in a sample because Nagy et al. explicitly taught the analyzing sequencing data in comparison to human genome SNP reference accurately detect the sequence variations per gene (page 932, paragraphs under the section ‘statistical analysis pipeline’). Such modification of the method is considered obvious over the cited prior art.
Double Patenting
8. 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.
9. Claims 1-15 and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No.18/706,482 {Application ‘482}.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims 1-23 of the instant invention and the claims 1-22 of copending application ‘482 are drawn to a method for detecting RAS pathway mutations in a subject, the method comprising: obtaining a biological sample from the subject; isolating nucleic acids from the biological sample and analyzing the expression level of the RNA compared to a control sample indicates that the subject has a RAS pathway mutation (claim 1 of instant invention and claim 1 of copending application ‘482). The claims 2-22 of copending application ‘482 embodies the limitations of the claims 2-23 of the instant invention.
The claims of copending application ‘482 differs from the claims 1-15 and 20-23 of the instant invention in that they are broader in scope and comprise of overlapping subject matter. The claims of the copending application and the instant application clearly comprise of a species/genus relationship.
As the court stated in In re Goodman, 29 USPQ2d 2010 (CAFC 1993), “a second application-- "containing a broader claim, more generical in its character than the specific claim in the prior patent"--typically cannot support an independent valid patent. Miller, 151, U.S. at 198; See Stanley, 214 F.2d at 153. Thus, the generic invention, as noted above is "anticipated" by the species of the patented invention. Cf., Titanium metal corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that an earlier species disclosure in the prior art defeats any generic claims). This court's predecessor has held that, without a terminal disclaimer, the species claims preclude issuance of the generical application. "In re Van Ornum, 686 F.2d 937, 944, 214 USPQ 761, 767 (CCPA 1982); Schneller, 397 F.2d at 354".
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
10. Applicant traverses the rejections on the following grounds: Applicant states that the present application has the earlier patent term filing date and therefore and therefore request the rejection be withdrawn.
11. All of the arguments have been thoroughly reviewed and considered but are not found persuasive because it cannot be determined which of the application may be patented and published first. The examiner further notes under under 37 CFR 1.111(b), applicants may request that certain objections or requirements “as to form” be held in abeyance until allowable subject matter in indicated. However, MPEP 804.02 clarifies that a non-statutory double patenting rejection is not “as to form” – it is a substantive rejection based on the doctrine of obviousness-type double patenting. To overcome the double patenting rejection, a proper terminal disclaimer under 37 CFR 1.321 is required.
Conclusion
12. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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