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 § 102
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.
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.
Claim(s) 1-2 and 4-7 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US PGPUB 2004/0235193.
Regarding claim 1, ‘193 discloses a method of determining analytes in a sample by mass spectrometry comprising:
Purifying a sample by liquid chromatography
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Ionizing the sample to produce ions detectable by mass spectrometry for DHEA, cortisol, and androstenedione
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Determining by tandem mass spectrometry an amount of the ions for each analyte
Using the determined amount to determine the amount of the analyte in the sample
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Regarding claim 2, incorporated reference [4] to Lai et al. discloses the use of high performance liquid chromatography to purify analytes prior to tandem mass spectrometry analysis in a CAH methodology.
Regarding claims 4-5, an internal standard including an isotopically labeled, or deuterated standard, is used for determining amounts of analytes in samples:
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Regarding claim 6-7, the sample comprises biological samples including plasma or serum:
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Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 12-14 of prior U.S. Patent No. 8,674,291. This is a statutory double patenting rejection.
Claims 1 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 24 of prior U.S. Patent No 9,057,732 This is a statutory double patenting rejection.
Claims 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 25 of prior U.S. Patent No 9,057,732 This is a statutory double patenting rejection.
Claims 3 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 26 of prior U.S. Patent No 9,057,732 This is a statutory double patenting rejection.
Claims 1 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 31 of prior U.S. Patent No 9,541,562 This is a statutory double patenting rejection.
Claims 2 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 32 of prior U.S. Patent No 9,541,562 This is a statutory double patenting rejection.
Claims 3 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 33 of prior U.S. Patent No 9,541,562 This is a statutory double patenting rejection.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 8,153,962. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipates the pending claim.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 8,153,962. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipates the pending claim.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 8,153,962. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipates the pending claim.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 23 of U.S. Patent No. 9,921,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 24 of U.S. Patent No. 9,921,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 25 of U.S. Patent No. 9,921,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 26 of U.S. Patent No. 9,921,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22 and 27 of U.S. Patent No. 9,921,231. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the pending claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A VANORE whose telephone number is (571)272-2483. The examiner can normally be reached Monday to Friday 7AM to 6 PM.
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DAVID A. VANORE
Primary Examiner
Art Unit 2881
/DAVID A VANORE/Primary Examiner, Art Unit 2878
