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 .
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 ‘000 application as US 11,834,708.
3. 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
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 7 and 9 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) Claim 7 is indefinite because ‘the plateau’ lacks proper antecedent basis. Correction is required.
B) Claim 9 is indefinite because ‘the Mg++ concentration’ lacks proper antecedent basis. Correction is required.
5. 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 4 and 14 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 claim(s) contains 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. Claim 4 recites ‘no more than 0.73 seconds’. Claim 14 recites ‘no more than 56 seconds’. No support has been found for this language in the specification, so these claims comprise new matter. Regarding claim 4, page 30 of the specification refers to an example of 0.73 second cycles, but there is no support for a cycle of ‘no more than’ 0.73 seconds, which includes less than 0.73 seconds. Regarding claim 14, page 28 of the specification recites an example in which ‘fifty cycles were complete in 56 seconds’, which does not support any number of amplification cycles being performed in ‘no more than’ 56 seconds, which includes less than 56 seconds. If this rejection is traversed, it is requested that support be pointed to in the specification with particularity, as in page, line, or paragraph numbers.
6. 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.
7. Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,932,634 in view of Wittwer et al. (US 2002/0058258).
Claim 5 differs from patented claims 1 and 2 in that it requires an additional step of generating an amplification curve.
Wittwer discloses the benefit of generating an amplification curve. See paragraphs 0312-0320.
One of ordinary skill in the art considering the patented claims would have been motivated to add an additional step of generating an amplification curve because Wittwer disclosed the benefit of generating an amplification curve in analyzing amplification data. It would have been prima facie obvious to one of ordinary skill in the art considering the patented claims to carry out the pending claim.
8. Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 18 of U.S. Patent No. 9,932,634 in view of Wittwer et al. (US 2002/0058258).
Claim 6 differs from patented claims 17 and 18 in that it requires an additional step of generating an amplification curve.
Wittwer discloses the benefit of generating an amplification curve. See paragraphs 0312-0320.
One of ordinary skill in the art considering the patented claims would have been motivated to add an additional step of generating an amplification curve because Wittwer disclosed the benefit of generating an amplification curve in analyzing amplification data. It would have been prima facie obvious to one of ordinary skill in the art considering the patented claims to carry out the pending claim.
PRIOR ART REJECTIONS
9. 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.
10. 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.
Claims 1-4 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over either of Termaat et al. (US 2011/0039305) or Maltezos et al. (US 8,003,370) in view of Wittwer et al. (US 2002/0058258).
Regarding independent claim 1, both Termaat and Maltezos disclose a method comprising adding a thermostable polymerase and primers to a sample, and amplifying a target nucleic acid, wherein each cycle of amplification is completed in less than 10 seconds. In Termaat, see paragraphs 0043, 0060, and 0062-0066. In Maltezos, see column 41, lines 20-55.
Neither Termaat nor Maltezos disclose generating an amplification curve.
Wittwer discloses the benefit of generating an amplification curve. See paragraphs 0312-0320.
One of ordinary skill in the art would have been motivated to modify the method of either of Termaat or Maltezos by adding an additional step of generating an amplification curve because Wittwer disclosed the benefit of generating an amplification curve in analyzing amplification data. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
Regarding dependent claims 2-4 and 7-14, exact cycle time, amplification plateau details, primer concentration, magnesium concentration, type of target nucleic acid including genomic, polymerase type and concentration, total primer concentration, and total time of completion of all amplification cycles would have merely involved routine optimization of known-important reaction parameters, which as well settled in U.S. patent practice does not support unobviousness (M.P.E.P. 2144.05).
ALLOWABLE SUBJECT MATTER
11. For the reasons determined during prosecution of the parent ‘369 application, claims 5 and 6 are free of the prior art, but they are rejected for another reason.
CONCLUSION
12. No claims are allowable.
13. 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.
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02/05/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681