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 .
Information Disclosure Statement
Examiner refers to MPEP 609.02 and reminds Applicant that references that were considered in the parent application will be considered in this continuation application. However, if Applicant desires the information regarding the references to be printed on any patent that might issue from this application, an IDS meeting the requirements of 37 CFR 1.97 and 1.98 must be submitted.
Claim Objections
Claim 1 is objected to because of the following informalities: the semicolon (after “product”) in the middle of line 14 should be removed for added clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9 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. The phrase “the ingestible device”
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.
Claims 1 - 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 24, and 32 of U.S. Patent No. 11,547,301. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are generally consistent with those of the patent except for indicating that the dye is fluorogenic in nature. However, one of ordinary skill in the art would recognize that the dye needed in the invention of the patent claims could be selected from known types available at the time of the invention, including fluorogenic-type. As such, absent a showing of criticality or unexpected results, it would have been within the skill level of the art before the effective filing date of the claimed invention, to have implemented the invention of the patent claims with a known dye, including to select a fluorogenic dye, since it has generally been held to be within the skill of the art to use known compounds in their intended manner.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Lipshutz et al. (USPN 6,043,080) teach a miniaturized sample analysis device comprising a housing with chambers therein (Figures 3, 5A-B, 8 and the descriptions thereof with particular attention to column 17, line 55 - column 18, line 44; see also, column 3, line 66 - column 4, line 41), the chambers including lysing agents (column 5, lines 33 - 44) and fluorescent labels (column 8, lines 47 - 54; column 12, line 59 - column 13, line 18). Additionally, optical elements (emitter and detector in a variety of configurations - confocal; epifluorescence; etc. which necessarily include optical elements for directing light to and receiving light from the sample to be measured; CCD array detectors) are provided for performing measurements of the labeled sample (column 11, lines 40 - 47) and Lipshutz et al. indicate that the detecting elements may be incorporated in the miniature device. Rabinowitz et al. (USPGPub 2008/0146896) teach an ingestible capsule (Figure 7) that may include sample collection, fluorescent labels, and optical analysis components (Figures 4 – 5) for analyzing analytes in body fluids. However, the prior art does not teach or suggest a method particular to assessment or monitoring of a subject suffering from or at risk of overgrowth of bacterial cells in the GI tract that includes disposing a sample in a composition comprising a dye (capable of binding to or reacting with a target component of a viable cell; fluorescent; fluorogenic when metabolized by the viable cell) and a reagent capable of lysing eukaryotic cells; and correlating a measured fluorescence response parameter to a number of viable bacterial cells in the sample, in combination with the other claimed steps.
Claims 10 – 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chuck Marmor, II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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