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 .
Claim Rejections - 35 USC § 112
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 3, 4, 7, 8 and 11-13 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. This is a NEW MATTER rejection.
The claims were filed in a preliminary amendment after the filing date. Claims 3, 7 and 11 recite “wherein the first tag is linked to a peptide of the known microbe through a secondary recognition element”.1 Claims 2, 6 and 10, from which claims 3, 7 and 11 respectively depend, refer to “one or more nucleic acid primers labeled with the first tag that binds to one or more nucleic acid primers of a known microbe”. Therefore, claims 3, 7 and 11 establish a nexus between tags on primers and tags that bind to peptides of the microbes. Such a nexus does not exist in the disclosure as filed.
The disclosure as filed discusses two separate embodiments. In one embodiment, primers labeled with tags are used to amplify nucleic acids of the microbe. In another embodiment, tags are used to bind to peptides of the microbe via a secondary recognition element, such as an antibody or a nano-particle.
However, in no case was there a disclosure of primers labeled with tags that bind to peptides. Therefore, claims 3, 7 and 11 conflate what were originally disclosed as two different techniques (one based on microbial nucleic acids, the other based on microbial peptides). As claims 4, 8 and 12-13 depend directly or indirectly from claims 3, 7 or 11, they are rejected for the same reason.
Claims 5, 9 and 13 recite “the sample further includes a known quantity of synthesized peptides of the known microbe labeled with a second tag” and “comparing the intensity of the first tag and the intensity of the second tag”.
Claims 2, 6 and 10, from which claims 5, 9 and 13 respectively depend, refer to “one or more nucleic acid primers labeled with the first tag that binds to one or more nucleic acid primers of a known microbe”. Therefore, claims 5, 9 and 13 establish a nexus between comparing “first” tags on primers and “second” tags that bind to peptides of the microbes. Such a nexus does not exist in the disclosure as filed. The idea of “comparing” first and second tags appears four times in the disclosure as filed.
At paragraph [0047], the specification reads: “The microbe is further quantified by comparing the intensities of the one or more detected tags with the intensities of one or more tags from the second set of tags that identify the same microbe.” This is fully within an embodiment in which “peptides are tagged with a first set of tags that bind to one or more peptides of one or more known microbes” (paragraph [0045]).
At paragraph [0054], the specification reads: “The microbe is further quantified by comparing the intensities of the one or more detected tags with the intensities of one or more tags from the second set of primer tags that identify the same microbe.” This is fully within an embodiment in which “nucleic acid is tagged with a first set of primer tags that bind to one or more target sequences of one or more known microbes” (paragraph [0050]).
At paragraph [0075], the specification reads: “Processor 830 calculates a quantity of the known microbe in the sample by comparing the measured intensity of the first tag and the measured intensity of the second tag.” This is fully within an embodiment in which “the first tag is linked to a peptide of the known microbe through a secondary recognition element” (paragraph [0074]) and “the sample further includes a known quantity of synthesized peptides of the known microbe labeled with a second tag” (paragraph [0075]).
At paragraph [0088], the specification reads: “Processor 830 calculates a quantity of the known microbe in the sample by comparing the intensity of the first tag and the intensity of the second tag.” This is fully within an embodiment in which “the first tag is linked to a nucleic acid of the known microbe” (paragraph [0087]) and “the sample further includes a known quantity of one or more synthesized nucleic acid primers of the known microbe labeled with a second tag” (paragraph [0088]).
Therefore, claims 5, 9 and 13 conflate what were originally disclosed as two different techniques (one based on microbial nucleic acids, the other based on microbial peptides).
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 6-9 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.
Claim 6 recites “the mass spectrometer” in line 6 and “the labeled peptide” in line 9. Neither of these limitations has antecedent basis in the claim. This renders the claim incomprehensible. As claims 7-9 depend from claim 6, they are rejected for the same reason.
Claims 10-13 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.
Claim 10 recites “the mass spectrometer” in line 10 and “the labeled peptide” in lines 13-14. Neither of these limitations has antecedent basis in the claim. This renders the claim incomprehensible. As claims 11-13 depend from claim 10, they are rejected for the same reason.
Double Patenting
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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,549,944. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘944 claims disclose a system comprising a processor configured to “monitor for an intensity of the first tag in the MS method, and if the intensity of the first tag received from the mass spectrometer exceeds a threshold value, identifies the known microbe in the sample”. The ‘944 claims further disclose “wherein the first tag includes two or more copies of a mass spectrometry enhancing group that increase the intensity of the mass spectrometry enhancing group two or more times when the labeled nucleic acid primer is fragmented to increase a signal intensity and lower a detection limit of the known microbe”. The ‘944 claims further disclose “wherein the intensity of the first tag is an intensity of the mass spectrometry enhancing group”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
1 Claims 7 and 11 contain a typographical error in that the words “to a” have been inadvertently omitted.