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 .
Summary
Receipt of Applicant’s disclosures filed on 05/28/2024 is acknowledged.
Claims 1-20 are pending.
Claims 1-20 are pending and under examination in this application.
Priority
The current application filed on 05/28/2024 is a Continuation of 17/405,866 filed 08/18/2021, which in turn is a Continuation of 16/867,319 filed 05/05/2020, which in is a Continuation of parent application 14/588,811 filed 01/02/2015
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/2024 is in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 recites “a polymers”, the term should be “a polymer” in singular form and not plural form. Appropriate correction is required.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. (US 11,103,450 B2), hereinafter the reference is referred as Millis in view of Kelly et al. (US 20050182060 A1) hereinafter the reference is referred as Kelly.
Although the claims at issue are not identical, they are not patentably distinct from each other because the inventive entity of the instant application and Millis are drawn to a method of applying the polyfunctional free radical scavenger hydrogel composition to a human tissue. The claims of Millis are directed to a method of treating a wound comprising the step of contacting a polyfunctional free radical scavenger hydrogel composition with a wounded tissue, wherein the first and second free radical scavenger comprises the identical general formulas and their substitutes to those at are recited in claims 1, 10, 16, 19 and 20 of instant application. The polyfunctional free radical scavenger hydrogel composition of claims 1-18 of Millis clearly encompass the instantly claims 1, 10, 16, 19 and 20 embodiments wherein the first free radical scavenger slows the degradation of the second free radical scavenger when a condition of all or a portion of the first and second free radical scavenger is incorporated into the hydrogel formulation and wherein both first and second free radical scavengers are suspended or dissolved within the hydrogel. It would have been obvious to one of ordinary skill in the art, before the effective filing date of instant application, to have reasonable expectation of the feature of slow degradation of the second free radical scavenger when these two free radical scavengers are incorporated into a hydrogel formulation, whether all or portion of the first free radical are totally incorporated in the hydrogel formulation. The Millis reference of the claimed composition, method and intended use render obvious to instant composition and methods of treating wound site of instant claims.
Claims 1-18 of Millis encompass the instantly claimed 1-20, wherein the claims in Millis are directed to a composition and method of treating a wounded tissue that occurs as a result of tissue repairs, transplantations or implantations, comprising step of applying the hydrogel composition comprising hydroxylamine and a sterically hindered nitrone wherein 1) coating the hydrogel composition on a surface of a medical device or a dental device or 2) an ointment applied directly to the wounded site, wherein the medical device is selected from a group consisting of a catheter, a stent, and artificial valve, an organ, an organ parts, a pulmonary filter, and an atrial appendage occlusion device, and the step of applying the hydrogel composition to tissues during surgical procedures and visceral soft tissue repairs. The composition and method claims 1-18 of Millis anticipates the composition of instant claims 1, 10, 16, 19 and 20, wherein instant claims 1, 10, 16, 19 and 20 recites a polyfunctional free radical scavenger hydrogel composition comprising a first free radical scavenger; a second free radical scavenger; wherein the first free radical scavenger comprises a sterically hindered amine of the general formula
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and wherein the second free radical scavenger comprises a sterically hindered nitrone of the general formula
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and wherein the aromatic moiety Y is a methyl phenyl aromatic moiety such that the sterically hindered nitrone is of the general formula
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treating a wound site with hydrogel composition comprises hydroxylamine and a sterically hindered nitrone, and coating the hydrogel to the surface of a medical device chosen from the group consisting of a catheter, a stent, and artificial valve, an organ, an organ parts, a pulmonary filter, and an atrial appendage occlusion device, wherein the hydrogel composition is an ointment applying to wounded tissue during surgical procedures and visceral soft tissue repairs as recited in instant claims 1, 10, 16, 19 and 20. Millis differs from instant claims without the recitation of the aromatic moiety Y comprises a halide containing substituent.
However, in view of Kelly, aromatic nitrone compounds exhibits improved antioxidant activity compared to C-(phenyl)N-(tert-butyl)nitrone (PEN) and derivatives thereof (¶ 0005), and that the need for new classes of aromatic nitrones derivatives that have improved properties for example, low toxicity, increased solubility, improved cellular and blood brain-barrier permeability, and improved oral bioavailability (¶ 0006), Kelly teaches 2-substituted and 4-substituted aryl nitrones display surprisingly high oral bioavailability and surprisingly low toxicity (¶ 0007), wherein the compounds comprise an aryl group or heteroaryl group bonded to carbon atom of the nitrone group and can be any aryl or heteroaryl known to those skilled in the art (¶ 0008), for example, a halogen (¶ 0014). Kelly discloses "Halo" or "halogen" refers to fluoro, chloro, bromo and iodo, and the preferred halo groups are either fluoro or chloro (¶ 0090). Therefore, the limitation of attaching a halide to aromatic nitrone compounds is explicitly taught by Kelly.
It would have been obvious to one of ordinary skill in the art to incorporate an aromatic halide substituent into aryl nitrone compounds of the awarded Millis patent, in order to achieve increased lipid solubility and benefits thereof as taught by Kelly (¶ 0304-0320 and 0512-0518). One of ordinary skill in the art would have been motivated to do this because Millis teaches all the features and limitations of aromatic nitrones and Kelly teaches a halogen substituent (halide) in free radical scavenging antioxidant nitrone compounds (¶ 0512) and benefits thereof as claimed. It would have been obvious to a person having skill in the art to incorporated the halide substituent to achieve the improved properties of low toxicity, increased solubility, improved cellular and blood brain barrier permeability, and improved bioavailability as taught by Kelly (¶ 0005-¶ 0014). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615