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 .
Election/Restrictions
To summarize the current election, the applicant elected group I, without traverse.
The requirement is deemed proper and is therefore made FINAL.
Claims 27-32 and 35-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Handa et al. (previously cited) in view of Chug et al. (previously cited) and Yuan et al. (ACS Applied Materials and Interfaces 2016 8:21214−21220).
Handa et al. teach a polysiloxane polymer to which a plurality of nitric oxide releasing moieties is bound for providing a surface on an article that reduces biofilm formation and blood clotting or adhesion to the article (see paragraphs 7 and 9-12; instant claim 1). The nitric oxide releasing moiety is exemplified as S-nitroso-N-acetyl-penicillamine (see paragraphs 7 and 58; instant claims 2-3). They envision the polysiloxane as a polydimethylsiloxane, a polydiethylsiloxane, a polydipropylsiloxane, or a polydiphenylsiloxane as well as to have a kinematic viscosity of 2000 to 4000 cSt when not crosslinked (see paragraph 61; instant claims 5-6). They further exemplify a 2550-3570 cSt polydimethylsiloxane with a covalently bound thiolactone modified to have a nitric oxide releasing moiety, where the polysiloxane is crosslinked by an amine containing crosslinker (see example 1 and paragraph 72-74; instant claims 5-7). They teach applying the polymer as a coating on the surface of silicone extracorporeal tubing and assess its ability to release nitric oxide as well as assess a film form as an antibacterial material (see paragraph 83). Handa et al. show that the nitric oxide is released for over four months at 37⁰C and effectively reduces thrombus formation (blood clotting) and bacterial adhesion (see paragraphs 88-89 and 102). The presence of a silicone oil in the nitric oxide releasing polysiloxane is not detailed.
Chug et al. teach improved medical implant surface functionality by combining the antibacterial properties of nitric oxide releasing surfaces with the adhesion inhibition properties of slippery liquid infused porous surfaces (SLIPS) that provide ultralow fouling surfaces due to infusion with silicone oil (see abstract page 5966 second column first full paragraph-page 5967 first column first partial paragraph). Here the nitric oxide releasing compound is S-nitroso-N-acetyl-penicillamine loaded into/onto silicone tubing that is then infused with 10 cSt silicone oil (see page 5967 first column last paragraph-second column third paragraph). The silicone oil infusion significantly reduced fibrinogen adhesion to the tubing and lubricates the surface, which are both desired outcomes (see figure 6 page 5971 first column last partial paragraph).
Yuan et al. also teach medical implant surfaces that repel bacterial attachment and thrombus formation due to a SLIPS approach that provides surface infusion with a silicone oil (see abstract and page 21214 second column last partial paragraph and figures 4 and 6). Here the silicone oil is a 100 cSt medical grade silicone oil that is applied on a surface previously coated with a polymer (see page 21215 first column second-third full paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to infuse the nitric oxide releasing polysiloxane coated surface of Handa et al. with 100 cSt silicone oil. This modification would have been obvious in light of Chug et al. and Yuan et al. to yield a similar improvement in reduced blood component adhesion and increasing lubricity. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and as the simple substitution of one known element for another in order to yield a predictable outcome. Chug et al. suggest the applicability of the SLIPS coating approach for S-nitroso-N-acetyl-penicillamine coated tubing and Yuan et al. teach a particular variety of silicone oil known for its utility as a SLIPS infusion oil. Given that Handa et al. detail that S-nitroso-N-acetyl-penicillamine conjugated polysiloxane coating providing release of nitric oxide for a duration in excess of 30 days and Handa et al. in view of Chug et al. and Yuan et al. render obvious the claimed components arranged in the claimed configuration, the claimed functionality linked to their presence in combination would be expected to follow, absent evidence to the contrary (see instant claim 24). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1-7 and 24 are obvious over Handa et al. in view of Chug et al. and Yuan et al.
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.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-7 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/485737 (reference application) in view of Chug et al. and Yuan et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a composition comprising 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. The copending claims recite the same nitric oxide donating moieties, polysiloxanes, polysiloxane viscosities, and an amine crosslinker. The composition of the copending claims is additionally recited as a coating on an article that includes catheters and recites a silicone oil as a component of the nitric oxide releasing material. Fibrinogen and biofilm formation both are recited as being reduced on the article. A viscosity is not recited for the silicone oil.
Chug et al. teach improved medical implant surface functionality by combining the antibacterial properties of nitric oxide releasing surfaces with the adhesion inhibition properties of slippery liquid infused porous surfaces (SLIPS) that provide ultralow fouling surfaces due to infusion with silicone oil (see abstract page 5966 second column first full paragraph-page 5967 first column first partial paragraph). Here the nitric oxide releasing compound is S-nitroso-N-acetyl-penicillamine loaded into/onto silicone tubing that is then infused with 10 cSt silicone oil (see page 5967 first column last paragraph-second column third paragraph). The silicone oil infusion significantly reduced fibrinogen adhesion to the tubing and lubricates the surface, which are both desired outcomes (see figure 6 page 5971 first column last partial paragraph).
Yuan et al. also teach medical implant surfaces that repel bacterial attachment and thrombus formation due to a SLIPS approach that provides surface infusion with a silicone oil (see abstract and page 21214 second column last partial paragraph and figures 4 and 6). Here the silicone oil is a 100 cSt medical grade silicone oil that is applied on a surface previously coated with a polymer (see page 21215 first column second-third full paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a 100 cSt silicone oil for the silicone oil of the copending claims. This modification would have been obvious in light of Chug et al. and Yuan et al. to yield a similar improvement in reduced blood component adhesion and increasing lubricity. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and as the simple substitution of one known element for another in order to yield a predictable outcome. Chug et al. suggest the applicability of the SLIPS coating approach for S-nitroso-N-acetyl-penicillamine coated tubing and Yuan et al. teach a particular variety of silicone oil known for its utility as a SLIPS infusion oil. Given that the copending claims in view of Chug et al. and Yuan et al. render obvious the claimed components arranged in the claimed configuration, the claimed functionality linked to their presence in combination would be expected to follow, absent evidence to the contrary (see instant claim 24). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1-7 and 24 are obvious over claims 1-20 of copending Application No. 18/485737.
Claims 1-3, 7, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 of copending Application No. 18/693198 (reference application) in view of Chug et al. and Yuan et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a composition comprising a nitric oxide releasing material comprising (i) a polysiloxane network and (ii) a plurality of nitric oxide-donating moieties covalently bonded to the polysiloxane network. The copending claims recite the same nitric oxide donating moieties such as S-nitroso-N-acetyl-penicillamine and some of the same polysiloxanes. The composition additionally composes a layer in the surface of an article. Biofilm formation is recited as being reduced on the article. The presence of a silicone oil in the nitric oxide releasing polysiloxane is not detailed.
Chug et al. teach improved medical implant surface functionality by combining the antibacterial properties of nitric oxide releasing surfaces with the adhesion inhibition properties of slippery liquid infused porous surfaces (SLIPS) that provide ultralow fouling surfaces due to infusion with silicone oil (see abstract page 5966 second column first full paragraph-page 5967 first column first partial paragraph). Here the nitric oxide releasing compound is S-nitroso-N-acetyl-penicillamine loaded into/onto silicone tubing that is then infused with 10 cSt silicone oil (see page 5967 first column last paragraph-second column third paragraph). The silicone oil infusion significantly reduced fibrinogen adhesion to the tubing and lubricates the surface, which are both desired outcomes (see figure 6 page 5971 first column last partial paragraph).
Yuan et al. also teach medical implant surfaces that repel bacterial attachment and thrombus formation due to a SLIPS approach that provides surface infusion with a silicone oil (see abstract and page 21214 second column last partial paragraph and figures 4 and 6). Here the silicone oil is a 100 cSt medical grade silicone oil that is applied on a surface previously coated with a polymer (see page 21215 first column second-third full paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to infuse the nitric oxide releasing polysiloxane coated surface of the copending claims with 100 cSt silicone oil. This modification would have been obvious in light of Chug et al. and Yuan et al. to yield a similar improvement in reduced blood component adhesion and increasing lubricity. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and as the simple substitution of one known element for another in order to yield a predictable outcome. Chug et al. suggest the applicability of the SLIPS coating approach for S-nitroso-N-acetyl-penicillamine coated tubing and Yuan et al. teach a particular variety of silicone oil known for its utility as a SLIPS infusion oil. Given that the copending claims in view of Chug et al. and Yuan et al. render obvious the claimed components arranged in the claimed configuration, the claimed functionality linked to their presence in combination would be expected to follow, absent evidence to the contrary (see instant claim 24). According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore claims 1-3, 7, and 24 are obvious over claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 of copending Application No. 18/693198 in view of Chug et al. and Yuan et al.
Claims 1-7 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 of copending Application No. 18/693198 (reference application) in view of Chug et al. and Yuan et al. as applied to claims 1-3, 7, and 24 above, and further in view of Handa et al.
Claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 of copending Application No. 18/693198 in view of Chug et al. and Yuan et al. render the limitations of instant claims 1-3, 7, and 24 obvious. A crosslinker is not detailed by the modified claims.
Handa et al teach a polysiloxane polymer to which a plurality of nitric oxide releasing moieties is bound for providing a surface on an article that reduces biofilm formation and blood clotting or adhesion to the article (see paragraphs 7 and 9-12). The nitric oxide releasing moiety is exemplified as S-nitroso-N-acetyl-penicillamine (see paragraphs 7 and 58). They envision the polysiloxane as a polydimethylsiloxane, a polydiethylsiloxane, a polydipropylsiloxane, or a polydiphenylsiloxane as well as to have a kinematic viscosity of 2000 to 4000 cSt when not crosslinked (see paragraph 61; instant claims 5-6). They further exemplify a 2550-3570 cSt polydimethylsiloxane with a covalently bound thiolactone modified to have a nitric oxide releasing moiety, where the polysiloxane is crosslinked by an amine containing crosslinker (see example 1 and paragraph 72-74). They teach applying the polymer as a coating on the surface of silicone extracorporeal tubing and assess its ability to release nitric oxide as well as assess a film form as an antibacterial material (see paragraph 83). Handa et al. show that the nitric oxide is released for over four months at 37⁰C and effectively reduces thrombus formation (blood clotting) and bacterial adhesion (see paragraphs 88-89 and 102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the crosslinked nitric oxide releasing polysiloxane of Handa et al. as the nitric oxide releasing polysiloxane of the modified copending claims because they both teach the same nitric oxide releasing moiety attached to similar polysiloxanes to achieve the same goal. In addition, the crosslinking of Handa et al. achieves multiple months of nitric oxide release which is beneficial for a prolonged and desirable antibacterial effect. The modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome and the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-7 and 24 are obvious over claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 of copending Application No. 18/693198 in view of Chug et al., Yuan et al., and Handa et al.
Response to Arguments
Applicant's arguments filed December 8, 2025 have been fully considered. In light of the amendment to the claims, the objections and rejections under 35 US 102 are hereby withdrawn. New grounds of rejection under 35 USC 103 and new double patenting rejections are detailed with additional art to address the new scope of claim limitations.
Conclusion
No claim is allowed.
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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615