Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group I in the reply filed on 12/16/25 is acknowledged.
3. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
NON-PRIOR ART REJECTIONS
4. 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 1-18 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. These claims are indefinite because it cannot be determined what is encompassed by the language ‘primers are selected without consideration of genotype information from said subject’. This language is not defined in the specification, and the skilled artisan would not be apprised of its meaning. This language is passive as opposed to active, and it cannot be determined what positive, active step(s) is (are) required to satisfy ‘selecting’ primers ‘without consideration of genotype information from said subject’. Such ‘selection’ can reasonably be interpreted as being a mental step carried out by a person, in which case selection ‘without consideration of genotype information from said subject’ cannot be tested or verified, as it depends on what someone is thinking or considering. This language can also be reasonably interpreted as being a programmed step in a computer, in which case testing or verification cannot take place without knowing the programming. Thus, clarification is required. It is noted that in related patent 12,404,547 and related application 19/281,431, patentability over the prior art relies on the language ‘wherein genotyping of said subject is not performed’, which although stated in a negative manor, can be tested or verified.
5. 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.
6. Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,404,547. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims and the pending claims are related as species-genus. That is, ‘wherein genotyping of said subject is not performed’ in the patented claims is a species within the broader language ‘selected without consideration of genotype information’ in the pending claims. One of ordinary skill in the art considering the patented claims would have been motivated merely by straightforward logical scientific reasoning to modify the claims by selecting primers without consideration of genotype information, as the patented claims require that genotyping is not performed. It would have been prima facie obvious to one of ordinary skill in the art considering the patented claims to carry out the method of the pending claims.
7. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/281,431 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims and the pending claims are related as species-genus. That is, ‘wherein genotyping of said subject is not performed’ in the copending claims is a species within the broader language ‘selected without consideration of genotype information’ in the pending claims. One of ordinary skill in the art considering the copending claims would have been motivated merely by straightforward logical scientific reasoning to modify the claims by selecting primers without consideration of genotype information, as the copending claims require that genotyping is not performed. It would have been prima facie obvious to one of ordinary skill in the art considering the copending claims to carry out the method of the pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
ALLOWABLE SUBJECT MATTER
8. Claims 1-18 are free of the prior art, but they are rejected for other reasons. Similar to what was determined during prosecution of related application 18/936,839, now US 12,404,547, the closest prior art is Schutz et al. (US 2016/0115541), in which SNP analysis of recipients of an allograft does take into consideration genotype information. No prior art has been found teaching or suggesting modifying the method of Schutz such that the primers used to amplify polymorphisms in allograft recipients do not take into account genotype information.
CONCLUSION
9. No claims are allowable.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
01/06/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681