The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The disclosure is objected to because of the following informalities: the status of the parent application needs to be updated.
Appropriate correction is required.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-10, 15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chandrapati (US 2011/0182770). With respect to claim 9, Chandrapati teaches a biological indicator (BI) having a BI housing (housing 110) with a first surface (front wall 114) and second surface (rear wall 116) substantially opposite the first surface; the BI housing defining an opening at the second surface (slots 158); the biological indicator further comprising a sterilant opening, the sterilant opening being distinct from said opening (a first inlet 134 defined by an aperture 136 in the rear wall 116 of the housing 110, a second inlet 135 defined by an aperture 137 in the right side wall 120); a germinant container inside the BI housing and housing a germinant composition (second reservoir 128 that contains a liquid 130 and paragraph [0061], liquid 130 can include a nutrient medium for the spores, such as a germination medium that will promote germination of surviving spores); a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores (a locus 124 of spores positioned in a spore reservoir 126); and an imaging window at a first surface of the BI housing (detection window 150). With respect to claim 10, Chandrapati teaches the biological indicator of claim 9 in which the opening is located at a first end of the BI housing (near bottom wall 121) and the sterilant opening is located at a second end of the BI housing (near top wall 112), the second end being opposite to the first end. With respect to claim 15, Chandrapati teaches a biological indicator (BI) having a BI housing (housing 110) with a germinant container inside the BI housing and housing a germinant composition (second reservoir 128 that contains a liquid 130 and paragraph [0061], liquid 130 can include a nutrient medium for the spores, such as a germination medium that will promote germination of surviving spores); a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores (a locus 124 of spores positioned in a spore reservoir 126); and an imaging window at a first surface of the BI housing (detection window 150), the BI housing comprising a grip portion (handle 140 including one or more depressions 142 to facilitate manual and/or robotic handling) and a protrusion portion (the section including detection window 150), the grip portion and protrusion portion being lateral to each other along a length dimension of the biological indicator, the protrusion portion containing at least a portion of the germinant container and the first spore carrier. With respect to claim 17, Chandrapati teaches the biological indicator of claim 15, having an opening in the protrusion portion of the BI housing (slots 158); and a sterilant entry port in the grip portion of the BI housing (a first inlet 134 defined by an aperture 136 in the rear wall 116 of the housing 110, a second inlet 135 defined by an aperture 137 in the right side wall 120).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
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, 5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-12 of U.S. Patent No. 11,603,551. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are of a scope that totally encompasses the patented claims such that one cannot practice the patented claims without practicing the instant claims.
Claims 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of U.S. Patent No. 11,603,551. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are of a scope that totally encompasses the patented claims such that one cannot practice the patented claims without practicing the instant claims.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of U.S. Patent No. 11,603,551. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is of a scope that totally encompasses the patented claims such that one cannot practice the patented claims without practicing the instant claim.
Claims 2-4, 6-7, 11-14, 16 and 18-20 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.
The following is a statement of reasons for the indication of allowable subject matter: the combination of elements is not taught or fairly suggested by the art of record.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art is directed toward biological indicators and/or covers that would seal an opening used during activation of a device to release a germinant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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, Lyle Alexander can be reached at (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARLEN SODERQUIST/Primary Examiner, Art Unit 1797