DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. The restriction requirement dated April 17, 2026 is withdrawn.
Information Disclosure Statement
3. The information disclosure statements dated July 11, 2015 were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
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.
4. Claims 245-249 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,639,321. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
Determination of Scope and Contents of the Claims of the Patent
The claims are drawn to methods of protecting an organ of a human patient from injury based on a scheduled insult, comprising administering to the organ a therapeutically effective amount of iron or an iron complex and a heme protein degradation inhibitor prior to the scheduled insult. The embodiments include tin protoporphyrin for the inhibitor, surgery for the insult, iron sucrose for the iron complex.
Ascertaining the differences between claims of patent and claims at issue
The embodiments anticipate the present claims.
Resolving the level of ordinary skill in the pertinent art - Prima Facie Case of
Obviousness
MPEP 2144.08.11.A.4(c) states "...consider teachings of a preferred species within the
genus. If such a species is structurally similar to that claimed, its disclosure may
motivate on of ordinary skill in the art to choose the claimed species or subgenus from
the genus, based on the reasonable expectation that structurally similar species usually
have similar properties." This is a "Genus-Species Guidelines” for the examination
based on 35 USC 103. An analogous guideline was followed here for the analysis of
obviousness type double patenting. As such the claims suggest to the skilled artisan to practice the invention.
5. Claims 245-249 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,844,563. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
Determination of Scope and Contents of the Claims of the Patent
The claims are drawn to methods of protecting an organ of a human patient from injury based on a scheduled insult, comprising administering to the organ a therapeutically effective amount of iron sucrose and protoporphyrin prior to the scheduled insult. The embodiments include tin protoporphyrin, surgery for the insult.
Ascertaining the differences between claims of patent and claims at issue
The embodiments anticipate the present claims.
Resolving the level of ordinary skill in the pertinent art - Prima Facie Case of
Obviousness
MPEP 2144.08.11.A.4(c) states "...consider teachings of a preferred species within the
genus. If such a species is structurally similar to that claimed, its disclosure may
motivate on of ordinary skill in the art to choose the claimed species or subgenus from
the genus, based on the reasonable expectation that structurally similar species usually
have similar properties." This is a "Genus-Species Guidelines” for the examination
based on 35 USC 103. An analogous guideline was followed here for the analysis of
obviousness type double patenting. As such the claims suggest to the skilled artisan to practice the invention.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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