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 .
Claims 1-50 have been canceled. Claims 51-67 have been added and are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 54, 55, 57 and 66 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 57 states that in the method of claim 51, the evolving step comprises substitution, insertion, deletion or combinations thereof. Claim 51 requires that the evolution is by mutating at least one amino acid. Mutations of one or more amino acids result in substitutions, rather than insertions of amino acids or deletions of amino acids. Thus, claim 57 fails to include all the limitations of claim 51 on which it depends.
Claim 54 states that the evolving step comprises replacing the Fc region with a variable region of another antibody to form a bispecific antibody. Claim 55 states that the evolving step comprises of replacing the Fc region with a variable region of a separate antibody to form a single chain antibody. Claim 51 requires that the evolution is by mutating at least one amino acid. Mutations of at least one amino acid are not commensurate with replacement of the Fc region with a variable region of a separate antibody. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 66 states that the antibody, SCA or antibody fragment is a non-naturally occurring mutant antibody, SCA or antibody fragment evolved from a parent antibody, SCA or antibody fragment. Claim 51 requires that the parent antibody, SCA or antibody fragment is evolved by mutation of at least one amino acid. The resulting antibody, SCA or antibody fragments are non-naturally occurring mutant antibodies. Thus, claim 66 fails to further limit claim 51.
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 51, 57-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,472,876 in view of Shamsuddin and Quinton (American Journal of Respiratory Cell and Molecular Biology, 2014, Vol. 50, pp. 796-804), Han et al (Cellular and Molecular Neurobiology, 2006, Vol. 26, pp. 101-107) and ben-David et al (U.S. 6.573,050).
Claim 2 of the patent teaches the limitations of instant claims 51, 57-59, 62, and 65-67 wherein the small molecule or ion is at or near physiological concentration. Claim 3 of the patent teaches that the molecule or ion is selected from bicarbonate, acetate, hydrogen sulfide and sodium sulfide which fulfills that limitation in instant claims 51, 60 and 61. Claims 4 and 5 of the patent teaches the limitations of instant claims 63 and 64, respectively. Claim 62 teaches the limitations of claim 62. The claims of the patent do not teach that the physiological concentration of bicarbonate ion is 25mM to 100 mM, and the physiological concentration of hydrogen sulfide is from 100uM to 100Mm. The claims of the patent do not teach that the assays fir binding are ELISA assays.
Ben-David et al teach that the ELISA assay is a conventional evaluation method (column 8, lines 24-29).
Thus, it would have been prima facie obvious to use the ELISA assay as the specific method for the binding assay in claim 1 of the patent.
Shamsuddin and Quinton teach the physiological concentration of bicarbonate is 25mM (page 799, third column, lines 7-10).
Han et al teach that the physiological concentration of hydrogen sulfide is 274.35 uM (Table 1, first entry).
It would have been prima facie obvious to use 25mM bicarbonate as the physiological concentration of bicarbonate, and 274uM as the physiological concentration of hydrogen sulfide in the method of claim 1 of the patent. One of skill in the art would have been motivated to do so by the teachings of Shamsuddin and Quinton and Han et al of the specific values for the physiological concentration of bicarbonate and hydrogen sulfide.
Allowable Subject Matter
Claims 52, 53 and 56 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643