Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
OBJECTIONS
2. The specification is objected to because of the following informality: the continuation information must be updated to indicate the issue of the parent ‘696 application as US 11,879,162.
3. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
4. Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
NON-PRIOR ART REJECTIONS
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.
Claims 1-2 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.
A) These claims are indefinite because it cannot be determined what is encompassed by a ‘quenchiplexing’ kit. This language is not defined in the specification, and one of ordinary skill in the art would not be apprised of its meaning. Clarification is required.
B) Claim 2 is further indefinite because it is drawn to a method, but no active step(s) is recited such that it can be understood what actions are actually required. While minute details are not required in method claims, at least the basic steps must be recited in a positive, active fashion. See Ex parte Erlich, 3 USPQ2d, p. 1011 (Bd. Pat. App. Int. 1986). Although the language ‘using the quenchiplexing kit of claim 1’ is recited in the preamble, no active step is recited in the claim body in such a way as to indicate what action(s) is required. Clarification is required.
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite the language ‘quenchiplexing kit’ and ‘distance up to four times the Forster distance one with respect to the other and separated by 15-250 bp along the target polynucleotides’, but no support for this language has been found in the specification or that of the listed parent applications. If this rejection is traversed, it is requested that support be pointed to with particularity, as in page, paragraph, or line numbers.
7. 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.
8. Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,571,048 in view of Sorge (US 2006/0110748). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented kit and the pending kit are related as genus-obvious species. That is, the patented kit recites ‘forward FRET chromophore’ and ‘reverse FRET chromophore’, which is a genus, and the pending claims recite ‘first fluorophore’ and ‘first quencher’, which is a species within that genus, according to the specification. Sorge disclosed that along with chromophores, fluorophores and quenchers were known to be useful in detection of nucleic acids based on FRET (see paragraphs 0551-0558). One of ordinary skill in the art would have been motivated to use a fluorophore and a quencher as the FRET chromophore pair in the patented kit because Sorge disclosed that fluorophore/quencher pairs were useful in FRET detection. It would have been prima facie obvious to one of ordinary skill in the art considering the patented kit to make and use the pending kit.
9. Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 38 of U.S. Patent No. 10,889,863 in view of Sorge (US 2006/0110748). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented kit and the pending kit are related as genus-obvious species. That is, the patented kit recites ‘forward FRET chromophore’ and ‘reverse FRET chromophore’, which is a genus, and the pending claims recite ‘first fluorophore’ and ‘first quencher’, which is a species within that genus, according to the specification. Sorge disclosed that along with chromophores, fluorophores and quenchers were known to be useful in detection of nucleic acids based on FRET (see paragraphs 0551-0558). One of ordinary skill in the art would have been motivated to use a fluorophore and a quencher as the FRET chromophore pair in the patented kit because Sorge disclosed that fluorophore/quencher pairs were useful in FRET detection. It would have been prima facie obvious to one of ordinary skill in the art considering the patented kit to make and use the pending kit.
10. Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 38 of U.S. Patent No. 10,077,475 in view of Sorge (US 2006/0110748). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented kit and the pending kit are related as genus-obvious species. That is, the patented kit recites ‘forward FRET chromophore’ and ‘reverse FRET chromophore’, which is a genus, and the pending claims recite ‘first fluorophore’ and ‘first quencher’, which is a species within that genus, according to the specification. Sorge disclosed that along with chromophores, fluorophores and quenchers were known to be useful in detection of nucleic acids based on FRET (see paragraphs 0551-0558). One of ordinary skill in the art would have been motivated to use a fluorophore and a quencher as the FRET chromophore pair in the patented kit because Sorge disclosed that fluorophore/quencher pairs were useful in FRET detection. It would have been prima facie obvious to one of ordinary skill in the art considering the patented kit to make and use the pending kit.
CONCLUSION
11. For the reasons established during prosecution of related applications 18/128,764, 16/102,583, and 14/633,094, claims 1-2 are free of the prior art, but they are rejected for other reasons. No claims are allowable.
12. 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.
08/06/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
Prosecution Insights