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 .
Response to Amendment
The amendment filed 8/26/2026 has been entered. Claims 1, 4, 8-10, 13, 25-33, 35, 39, 40, 51, and 52 remain pending in the application. Claims 2 and 3 have been canceled.
Any rejections and/or objections made in the previous Office Action and not repeated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1, 4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 are rejected under 35 U.S.C. 103 as obvious over Handa et al (US 20210268156 A1).
Regarding claim 1, Handa discloses a nitric oxide-releasing material including a polymer matrix, which includes a plurality of nitric oxide-donating crosslinking moieties that covalently crosslink polysiloxanes in the plurality of polysiloxanes [0007]. Handa discloses moieties of the formula shown below (page 8 [0008]), wherein
R1 is a substituted or unsubstituted C1-C20 alkyl, a substituted or unsubstituted C1-C20 heteroalkyl, a substituted or unsubstituted C2-C20 alkenyl, a substituted or unsubstituted C2-C20 herteroalkenyl, a substituted or unsubstituted C1-C20 alkoxy, or a substituted or unsubstituted C1-C20 heteroalkoxy; and
where each occurrence of R2 is independently a substituted or unsubstituted C1-C20 alkyl, a substituted or unsubstituted C1-C20 heteroalkyl, a substituted or unsubstituted C2-C20 alkenyl, a substituted or unsubstituted C2-C20 herteroalkenyl, a substituted or unsubstituted C1-C20 alkoxy, or a substituted or unsubstituted C1-C20 heteroalkoxy, or a bond to a polysiloxane in the plurality of polysiloxanes when at least two occurrences of R2 are a bond to a polysiloxane in the plurality of polysiloxanes; and
where A is a nitric oxide donor [0009].
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A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I). Applicant's own specification defines "alkyl" [0049], when "substituted" [0067], to include such substituents as amido groups. As a result, Handa's structure and definition of R1 reads on applicant's claimed substituted alkyl variants of R1.
While the instant application does not disclose a crosslinked network, Handa particularly discloses that leaching of SNAP (S-nitroso-N-acetyl-penicillamine) is significantly reduced by covalently attaching SNAP to the polysiloxane [0107]. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the crosslinked polysiloxane with a linear, non-crosslinked polysiloxane, motivated by a desire to reduce leaching of a nitric oxide-donating moiety, with a reasonable expectation of success. From the short list of polymer architectures, it would be obvious to try a linear polysiloxane. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” (325 U.S. at 335, 65 USPQ at 301.). See MPEP 2144.07.
In the alternative, "a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). See MPEP 2131.02. In the instant case, the species of a plurality of nitric oxide-donating moieties that covalently crosslink polysiloxanes anticipates the genus of a polysiloxane backbone covalently bonded to one or more nitric oxide releasing moieties.
Regarding claims 8 and 9, Handa discloses that the nitric oxide donor is particularly an S-nitrosothiol which may be S-nitroso-N-acetyl-penicillamine, S-nitroso-N-acetyl cysteine, S-nitroso-N-acetyl cysteamine, S-nitrosoglutathione, methyl S-nitrosothioglycolate, and a derivative thereof [0059-0060].
Regarding claim 10, Handa particularly discloses a plurality of polysiloxanes [0007], which reads on applicant’s claimed copolymer. The limitations of Handa’s disclosed R1 and R2 are set forth above with respect to claims 1 and 4. Handa discloses both polysiloxanes and nitric oxide-releasing polysiloxanes [0007], which read on applicant’s structure II. Moreover, applicant’s own disclosure dictates that the term “alkyl”, as applied to instant R3, encompasses “both "unsubstituted alkyls" and "substituted alkyls", the latter of which refers to alkyl moieties having one or more substituents replacing a hydrogen on one or more carbons of the hydrocarbon backbone. Such substituents include, but are not limited to, halogen, hydroxyl, carbonyl (such as a carboxyl, alkoxycarbonyl, formyl, or an acyl), thiocarbonyl (such as a thioester, a thioacetate, or a thioformate), alkoxyl, phosphoryl, phosphate, phosphonate, a phosphinate, amino, amido, amidine, imine, cyano, nitro, azido, sulfhydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido, sulfonyl, heterocyclyl, aralkyl, or an aromatic or heteroaromatic moiety” [0049]. In this way, Handa’s disclosed structure (page 8, [0008]) reads on structure II.
Regarding claim 13, Handa further discloses a method of making a nitric oxide-releasing material prepared by reacting thiolactone with an amine pendant on a polysiloxane backbone to produce a thiol-functionalized polymer matrix, followed by nitrosating a thiol on the thiol-functionalized polymer matrix to produce the nitric oxide-releasing material [0069].
Regarding claims 25, 26, and 28, Handa particularly disclose S-nitrosothiols as nitric oxide donors as set forth with respect to claims 8 and 9 above. The limitations of Handa’s disclosed R1 and R2 are set forth above with respect to claims 1 and 4. A S-nitrosothiol-based nitric oxide-donating moiety coupled with an amide-terminated heteroalkyl group for R1 reads on applicant’s structure IV.
Regarding claim 30, Handa discloses a method of making a nitric oxide-releasing material prepared by reacting thiolactone with an amine pendant on a polysiloxane backbone to produce a thiol-functionalized polymer matrix, followed by nitrosating a thiol on the thiol-functionalized polymer matrix to produce the nitric oxide-releasing material [0069], as set forth with respect to claim 13 above.
Regarding claim 31, Handa further discloses that the plurality of polysiloxanes may be selected from the group consisting of polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, and polydiphenylsiloxane [0063]. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). See MPEP 2131.02. In the instant case, the species of polydimethylsiloxane and others anticipates the genus of dialkyl polysiloxanes.
Regarding claims 32, 33, and 35, Handa further discloses thiol-functionalized polysiloxane polymer matrices [0009], which read on structure V in combination with the limitations of Handa’s R1 and R2, as set forth in the above rejection with respect to claims 1 and 4.
Regarding claims 39 and 40, Handa further discloses a device having at least one surface wherein the surface comprises said composition [0065] and discloses a device prepared from said composition which is a component of a hemodialysis device [0066].
Regarding claims 51 and 52, Handa further discloses use of their nitric oxide-releasing polymer composition in antibacterial [0115] and anti-biofilm applications [0068].
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, 4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, and 7 of copending Application No. 18/264,094 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application recites a composition comprising a nitric oxide-releasing material comprising (a) a nitric oxide releasing material comprising a (i) a polysiloxane network and (ii) a plurality of nitric oxide-donating moieties covalently bonded to the polysiloxane network; and (b) a silicone oil. Disclosed nitrogen oxide-donating moieties include residues of S-nitroso-N-acetyl-penicillamine, S-nitroso-N-acetyl cysteine, S-nitroso- N-acetyl cysteamine, S-nitrosoglutathione, methyl S-nitrosothioglycolate, and a derivative thereof. While the instant application does not specify inclusion of a silicone oil, the claimed invention requires “comprising” which does not exclude the introduction of a silicone oil. The copending application also recites crosslinked polysiloxanes, which the instant application does not specifically include or teach away. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 8, 9, 13, 30, 31, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 43, 46, 47, and 68 of U.S. Patent No. 12721935. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses a nitric oxide releasing material comprising a polymer matrix, wherein the polymer matrix comprises a plurality of polysiloxanes covalently crosslinked with a plurality of nitric oxide-donating crosslinking moieties, and wherein the polysiloxanes are selected from the group consisting of polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, and polydiphenylsiloxane. The patent also discloses use of the composition to reduce biofilm formation. The patent further discloses a method of crosslinking a plurality of polysiloxanes with a plurality of amine-functionalized crosslinking moieties to produce a crosslinked polymer matrix; covalently attaching a thiolactone to an amine in the amine-functionalized crosslinking moieties to produce a thiol-functionalized crosslinked polymer matrix; and nitrosating the thiol in the thiol-functionalized crosslinked polymer matrix in the presence of an organic acid to produce the nitric oxide-releasing material. While the instant application does not teach the presence of an organic acid, the claimed invention requires “comprising” which does not exclude the introduction of such an organic acid. The patent also recites crosslinked polysiloxanes, which the instant application does not specifically include or teach away. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Response to Arguments
Applicant's arguments filed 8/26/2026 have been fully considered but they are not persuasive.
Applicant argues that Handa does not disclose structure I as recited by amended claim 1. This is not persuasive for the reasons set forth in the above rejection with respect to amended claim 1.
Applicant argues that Handa is directed to a fundamentally different architecture than the instant application. This is not persuasive because although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a superconducting magnet which generates a "uniform magnetic field" were not limited to the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR) imaging. Although the specification disclosed that the claimed magnet may be used in an NMR apparatus, the claims were not so limited.); Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); Ex parte McCullough, 7 USPQ2d 1889, 1891 (Bd. Pat. App. & Inter. 1987) (Claimed electrode was rejected as obvious despite assertions that electrode functions differently than would be expected when used in nonaqueous battery since "although the demonstrated results may be germane to the patentability of a battery containing appellant’s electrode, they are not germane to the patentability of the invention claimed on appeal."). The instant claims do not specify a lack of crosslinking junctions; as such, Handa’s structure reads on applicant’s amended claim 1.
Applicant argues that Handa does not direct the skilled artisan to produce and use nitric oxide releasing materials that do not use crosslinked polysiloxanes. This is not persuasive for the reasons set forth in the above rejection with respect to amended claim 1.
Applicant argues that removing the crosslinks of Handa would change its principle of operation because applicant argues that Handa attributes its non-leaching nitric oxide to the presence of a crosslinker. This is not persuasive because Handa merely discloses that “covalently attaching SNAP directly to the PDMS” significantly reduces the amount of leaching [0107]. Substitution of a crosslinked polysiloxane with a linear analog would thus not change Handa’s principle of operation.
Applicant’s arguments with respect to the non-statutory double patenting rejections over copending Application No. 18/254,094 and 17/259,817 have been considered but are not persuasive for the reasons set forth in the above rejections. Application 17/259,817 has since been patented (US 12721935), and this provisional rejection is now nonprovisional.
Application No. 18/485,737 has been abandoned and is no longer copending. The provisional double patenting rejection over Application No. 18/485,737 is rendered moot and withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
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/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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