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 51, 57, and 62 have been amended. Claims 51-67 are pending and under consideration.
The rejection of claims 54, 55, 57 and 66 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s arguments regarding claims 54, 55 and 66, and applicant’s amendment and argument regarding claim 57.
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 51-64, 66 and 67 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.
(A)Claim 51 is vague and indefinite in the recitation of “first pH” in the presence of 25mM to 100mM bicarbonate or 100uM to 100mM hydrogen sulfide, wherein the pH is up to 4 pH units away from the pKa of the bicarbonate or hydrogen sulfide because both of bicarbonate and hydrogen sulfide have two pKa values 6.4 and 10.3 for bicarbonate and 6.9 to 7.04 or 12-14 for hydrogen sulfide. Thus, it is unclear if the claim encompasses a first pH based on the lower pKa value, a first pH based on the higher pKa value or both.
(B)Claim 51 is vague and indefinite in the recitation of the “second pH” without defining the metes and bound of the second pH. It is noted that dependent claim 63 specifies that the second pH is, in effect, greater than the pKa and thus the pKa is flanked by the first pH and the second pH. However, this is also vague and indefinite due to the undefined pKa as stated in point A above. Also, if claim 63 is assumed to be further limiting claim 51, then claim 51 is not bound by this relative statement about the first pH, the pKa and the second pH in claim 63 and must encompass second pH values which are not greater than the pKa.
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 6[2] teaches that limitation of claim 62. The claims of the patent do not teach that (i)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 (ii)the assays for 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.
Applicant argues that the rejection is improper because Han is non-analogous art. This has been considered but not found persuasive. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case the disclosure of Han et al regarding that the physiological concentration of hydrogen sulfide being 274.35 uM is pertinent to the particular problem of obtaining an antibody for which the binding activity is pH dependent in the presence of hydrogen sulfide but not pH dependent in the absence of hydrogen sulfide in order to obtain the conditionally active antibody which was active under physiological conditions because claim 1 of the patent requires that the concentration of the molecule or ion be at or near physiological concentration.
Applicant argues that the cited references fail to teach the claimed ranges, but instead teach a point value which falls within the claimed ranges. Applicant argues that there was no reasoning provided to indicate why one of ordinary skill in the art would extend the point values to the specific ranges claimed. This has been considered but not found persuasive. The instant claims are obvious over the patented claims for the reasons set forth above, to the extent that the concentration of bicarbonate ion is 25mM and the concentration of hydrogen sulfide is 100mM.
All claims are rejected.
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
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