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
1. The Applicant’s response to the office action filed on November 12, 2025 is acknowledged.
Status of the Application
2. Claims 1-23 are pending under examination. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-Withdrawn
3. The objection to the specification has been withdrawn in view of the amendment.
4. The objection to the claims has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112-Maintained
5. 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.
Claim 21 is 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. Claim 21 recites
‘disease progression’. The metes and bounds of the claim 21 are unclear and indefinite
because it is not clear what disease progression, the claimed limitations refer to. Claim
1 upon which do not require any detection of a disease and it is unclear what the
limitation in claim 21 is referring to.
Response to Arguments:
With reference to the rejection of claims under 35 USC 112(b), the Applicant’s arguments and the amendment have been fully considered and found persuasive in-part. The rejection of claims 10-13 has been withdrawn in view of the amendment. With reference to the rejection of claim 21, the arguments haven been fully considered and found unpersuasive because the claim 1 upon which claim 21 only requires detection of pathogen as opposed to the Applicant’s arguments drawn to disease. For all the above the rejection of claim 21 has been maintained.
Claim Rejections - 35 USC § 102-Maintained
6. 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.
Claims 1-12, 14-15 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krolov et al. (WO 2017/103269).
Krolov et al. teach a method of claim 1, 14, for extraction-free analysis of nucleic acid comprising: obtaining a sample comprising a bodily fluid or swab sample; contacting the sample with a buffer composition comprising nuclease free water, an antifungal, antibiotic (antimicrobial peptides) and a ribonuclease inhibitor (EDTA) (page 6, line 6-34 to line 29 on page 9, page 17, line 15 to line 29 on page 21); directly amplifying nucleic acid from the sample in said buffer with primers specific to one or more nucleic acids of one or more sexually transmitted (ST) pathogens without prior extraction of said nucleic acid (page 6, line 6-34 to line 29 on page 9, page 22, line 23 to line 35 on page 26);
analyzing amplicons produced in said amplifying step to detect one or more said pathogens in the subject (page 6, line 6-34 to line 29 on page 9, page 30, line 18-30).
With reference to claims 2-8, Krolov et al. teach mucosal membrane swab comprises one or more one or more vaginal, buccal or nasal swab and bodily fluid comprises saliva, urine, blood plasma or serum (page 6, line 6-34 to line 29 on page 9, page 13, line 20 to line 18 on page 14).
With reference to claims 9-12, Krolov et al. teach that the ST pathogen is a virus or bacterium, wherein the pathogens comprise at least one chlamydia trachomatis,
Neisseria gonorrhoeae, HIV, HPV or herpes (page 10, line 4-33, page 12, line 1-14, page 6, line 6-34 to line 29 on page 9).
With reference to claims 15, Krolov et al. teach that the nucleic acid is RNA or DNA (page 6, line 6-34 to line 29 on page 9, page 41 to 55, example 1).
With reference to claim 20, Krolov et al. teach that buffer composition stabilizes the nucleic acids from the sample (page 41 to 55, example 1).
With reference to claims 21, Krolov et al. teach that the method further comprises comparing the target nucleic acid quantities in a plurality of samples obtained from the subject at successive time points and determining disease progression based on increases or decreases in the nucleic acid quantities over time (page 32, line 5 to line 35 on page 36, page 41 to 55, example 1).
With reference to claims 22-23, Krolov et al. teach that the amplicons are derived from an oncogenic virus and the nucleic acid comprises a portion of oncogene (page 35, line 26-35). For all the above, the claims are anticipated.
Response to Arguments:
With reference to the rejection of claims 1-12, 14-15 and 20-23 under 35 USC 102(a)(1) as being anticipated by Krolov et al, the Applicant’s arguments were fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to antibiotic, the arguments were found unpersuasive because the antimicrobial peptides as taught by Krolov et al. encompass, antifungal and antibacterial activity and anticipate the claims as presented. The examiner cited portions of Krolov et al. teach antimicrobial peptides comprising antibacterial and antifungal peptides (page 19, line 1 to line 30 on page 21). The claims as presented recite a buffer composition comprising… , wherein ‘comprising do not exclude any additional components that are within the scope of the buffer composition, as stated in MPEP 2111.03. Thus, the additional components EDTA, Triton-X surfactant are within the scope of the claims, Further, with reference to no teaching of nuclease-free water as a base medium, the arguments were found unpersuasive., the sample is diluted with a buffer to which the antimicrobial compounds are added, which is within the scope of the water based medium or buffered sample (page 13, line 20-25, page 15, lie 16-20). With reference to the Applicant’s arguments drawn to ribonuclease inhibitor, the arguments were found unpersuasive the broader scope of a ribonuclease inhibitor do not exclude EDTA- as ribonuclease inhibitor as taught by Krolov et al. With reference to Applicant’s cited portion of specification to support a ribonuclease inhibitor as RNase inhibitor, human placenta, the arguments were found unpersuasive because Krolov et al. on page 21, line 24) teach EDTA as an inhibitor of endonucleases and is within the scope of ribonuclease inhibitor. For all the above the rejection has been maintained.
Claim Rejections - 35 USC § 103-Maintained
7. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 1-12, 14-15 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Krolov et al. (WO 2017/103269) in view of Mielke et al. ((US 2015/0353919).
Krolov et al. teach a method for extraction-free analysis of nucleic acid as discussed above. However, Krolov et al. did not specifically teach buffer composition comprising reducing agent, TCEP and amphotericin and penicillin or streptomycin.
Mielke et al. teach method for sample collection, processing and amplification of nucleic acids in the sample, wherein sample buffer comprises reducing agent TCEP and
microbial growth inhibiting agents comprising amphotericin and penicillin (para 0010, 0066-0067, 105-108).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method as taught by Krolov
et al. with a buffer comprising reducing agent, amphotericin and penicillin as taught by
Mieke et al. to develop a sensitive method for detecting target nucleic acids in a sample.
The ordinary person skilled in the art would have motivated to combine the references
to develop a sensitive method for detecting a target nucleic acid because the ordinary
person skilled in the art would have a reasonable expectation of success that the combination of references would result in enhancing the sensitivity of the method because Mieke et al. explicitly taught use of a sample buffer comprising TCEP, amphotericin and penicillin or streptomycin for amplification, which would stabilize the nucleic acids in a sample (para 0010, 0066-0067, 105-108) and such a modification of the method is considered obvious over the cited prior art.
B. Claims 1-15 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Krolov et al. (WO 2017/103269) in view of Savelkoul et al. (US 2011/0020796).
Krolov et al. teach a method for extraction-free analysis of nucleic acid as discussed above. However, Krolov et al. did not specifically teach a primer for amplification.
Savelkoul et al. teach a primer pair for amplifying Chlamydia trachomatis in a sample, wherein a primer of the primer pair comprises a sequence of SEQ ID NO: 4 as claimed (para 0033-0036).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method as taught by Krolov et al. with a primer for amplifying Chlamydia pathogen as taught by Savelkoul et al. to develop a sensitive method for detecting target nucleic acids in a sample. The ordinary
person skilled in the art would have motivated to combine the references to develop a
sensitive method for detecting a target nucleic acid because the ordinary person skilled in the art would have a reasonable expectation of success that the combination of references would result in enhancing the specificity of the method because Savelkoul
et al. explicitly taught use of a primer for amplifying and detecting chlamydia trachomatis (para 0033-0036) and such a modification of the method is considered obvious over the cited prior art.
C. Claims 1-12, 14-16, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Krolov et al. (WO 2017/103269) in view of Robinson et al. (US 2018/0100181).
Krolov et al. teach a method for extraction-free analysis of nucleic acid as discussed above. However, Krolov et al. did not specifically teach sequencing amplicons.
Robinson et al. teach a method for detecting HIV pathogen, wherein the method
comprises amplifying the target nucleic acids in the sample and sequencing the amplicons for quantitation of the target nucleic acids (para 0121-0123).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method as taught by Krolov et al. with sequencing amplicons as taught by Robinson et al. to develop a sensitive method for detecting target nucleic acids in a sample. The ordinary person skilled in the art would have motivated to combine the references to develop a sensitive method for detecting a target nucleic acid because the ordinary person skilled in the art would have a reasonable expectation of success that the combination of references would result in
enhancing the sensitivity of the method because Robinson et al. explicitly taught
sequencing the amplicons for quantitation of target nucleic acids in the sample (para
0123) and such a modification of the method is considered obvious over the cited prior art.
Response to Arguments:
With reference to the rejection of claims 1-12, 14-15, 17-23 under 35 USC 103 over Krolov et al in view of Mielke et al.; the rejection of claims 1-15, 20-23 under 35 USC 103 over Krolov et al. in view of Savekoul; and the rejection of claims 1-12, 14-26, 20-23 under 35 USC 103 over Krolov et al. in view of Robison et al., the Applicant’s arguments were found unpersuasive. As discussed above, Krolov et al teach buffered urine sample or diluted urine with a buffer, which is a water base medium as required by the claims. As discussed in the rejection, it would be obvious to modify the method of Krolov et al. with adding TCEP as reducing agent, amphotericin, penicillin as taught by Meilke et al. further with reference to the Applicant’s arguments drawn to Svekoul et al. and Robison et al. use zero buffer composition, the arguments were found unpersuasive. As discussed above, Krolov et al. teach buffered sample comprising water base medium and it would be obvious to modify the method with the teaching of Savekoul et al. and Robinson as discussed in the rejection. For all the above the rejection has been maintained.
Double Patenting-Maintained
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.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,344,889 (hereafter the ‘889) in view of Savelkoul et al. (US 2011/0020796).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 1-23 are entirely within the scope of the claims 1-17 of the patent ‘889, specifically the method steps for detecting one or more target nucleic acids in an extraction-free sample amplification analysis of the claims 1-23 are within the scope of the claims 1-17 in the patent ‘889. The claims in the patent ‘889 do not teach detecting one or more ST pathogens.
Savelkoul et al. teach a method for detecting Chlamydia trachomatis (ST pathogen) using a primer pair for amplifying Chlamydia trachomatis in a sample and detecting said pathogen, wherein a primer of the primer pair comprises a sequence of SEQ ID NO: 4 as claimed (para 0033-0036).
It would have been prime facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of the claims in the patent ‘889 with detection of ST pathogens as taught by Savelkoul et al. to develop a sensitive method for detecting target nucleic acids in a sample. The ordinary person skilled in the art would have motivated to combine the references to develop a sensitive method for detecting target nucleic acids because the ordinary person skilled in the art would have a reasonable expectation of success that the combination of references would result in enhancing the sensitivity of the method because Savelkoul et al. explicitly taught detecting one or more ST pathogens (0033-0036) and such a modification of the method is considered obvious over the cited prior art.
Response to Arguments:
With reference to the rejection of claims under nonstatutory double patenting over US patent 12,344,889 in view of Savekoul et al., the Applicant’s arguments have been fully considered. The rejection has been maintained because the claims are within the scope of the claims in patent and no terminal disclaimer has been submitted.
Conclusion
No claims are allowable.
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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681