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 .
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on June 7, 2024 is acknowledged. A signed copy is attached to this office action.
Claim Objections
Claim 15 is objected to because of the following informalities: the claim does not end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-9, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Handa et al. (CN 112689518).
Handa discloses a method for preparing nitric oxide release material, and a device comprising nitric oxide release material.
The nitric oxide release material comprises a polymer matrix containing a plurality of polysiloxane and nitric oxide donor cross-linked portion, the cross-linked portion covalently crosslinked the polysiloxane (abstract).
The mechanism of releasing NO from the RSNOs is accomplished by cleavage of the sulfur-nitrogen bonds, and is promoted by thermal degradation, metal ion catalysis and/or light (discussion).
Regarding claim 2, the RSNO is exposed to UV-Vis spectrophotometer. The characteristic S-nitroso bond in the RSNO is displayed at the maximum absorbance of 340 nm and 590 nm (SNAP leaching test).
Regarding claim 5, the recitation of the wherein clause is a necessary result of the application of light to the polymer matrix.
Regarding claims 6-7, nitric oxide donor crosslinking moieties may have an S-nitroso-N-acetyl-penicillamine group covalently attached thereto (Contents of the Invention).
Regarding claim 8, The method may include cross-linking a plurality of polysiloxanes with a plurality of amine-functionalized cross-linking moieties, producing a cross-linked polymer matrix (contents of the Invention).
Regarding claim 9, the polysiloxane of the plurality of polysiloxane is selected from polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane and polydiphenylsiloxane (Discussion).
Regarding claims 15-19, the nitric oxide release material can be present on the surface of a device and is applied to the surface of the substrate. The substrate is selected from polymer, metal and glass. Examples include catheters, artificial heart valves, vascular catheters, grafts and stents (discussion).
Regarding claim 20, the nitric oxide release material prevents bacterial adhesion (bacterial adhesion test).
Handa, therefore, anticipates the rejected claims.
Claims 1-10 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frost et al. (WO 2014/046671).
Frost discloses stable, photosensitive polymers that release NO response to intensity and wavelength of light, methods of making such polymers and methods using such polymers (abstract).
Figure 1 discloses the synthesis of S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (paragraph 0010).
Using light as an external trigger to release NO allowed precise control of turning NO on and off as well as increasing or decreasing NO flux as desired (paragraph 0083).
Regarding claim 2, photoinitiation of NO release was performed utilizing an LED light source at 470 nm (paragraph 0079).
Regarding claim 3, it is noted that 470 nm LED is equivalent to 470 lumens.
Regarding claim 4, Figure 14 discloses the light exposure (at specific discrete wavelengths) at multiple intervals.
Regarding claim 5, the recitation of the wherein clause is a necessary result of the application of light to the polymer matrix.
Regarding claim 6, S-nitrosothiols (RSNOs) are disclosed as a class of nitric oxide (NO) donors that thought to serve as a reservoir and transporter of NO within biological systems (paragraph 0026).
Regarding claim 7, as noted above, S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (SNAP-PDMS) is disclosed.
Regarding claims 8-9, various polysiloxanes may be used. For example, the silicone rubber may be a polydimethylsiloxane or a polydiethylsiloxane (paragraph 0050).
Regarding claim 10, In addition, various molecular weights are suitable for use according to Frost. For example, a higher weight polymer chains (152 x 106 Daltons or 10,000 cSt) creates a compound that is more viscous due to greater chain entanglement and tend to lead to harder cured polymers, while lower molecular weight polymers (1.6-1.7 x 106 Daltons or 700-800 cSt) tend to create compounds that are less viscous and cure to softer materials (paragraph 0050). Example 1 discloses Silanol-terminated polydimethylsiloxane (viscosity 2,000 cSt), which the Examiner has interpreted to be “about” 2500.
Regarding claims 15-20, SNAP-PDMS is used to coat a medical device such as a pacemaker or implantable glucose monitor (paragraph 0107), incorporated into medical dressings used to cover and protect wounds and catheter sites (paragraph 0105), and used to prepare medical tubing used in intravenous tubes and catheters (paragraph 0106). Coating the device with polymers described into the medical dressing renders the dressing biocompatible. The polymer releases NO, thereby decreasing fibrous encapsulation, enhancing wound healing, and improving tissue response.
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 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over Handa et al. (WO 2020/018488) in view of Chug et al. (ACS Applied Biomaterials 2019 2:5965-5975).
Handa discloses 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). S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (SNAP-PDMS) is exemplified.
The release mechanism of NO from RSNOs is done by the cleavage of the sulfur-nitrogen bond and is facilitated by either thermal degradation, metal ion catalysis, and/or light (paragraph 0053).
Regarding claims 6-7, The nitric oxide releasing moiety is exemplified as S-nitroso-N-acetyl- penicillamine (see paragraphs 7 and 58; instant claims 2-3).
Regarding claims 8-10, the polysiloxane as a polydimethylsiloxane, a polydiethyIsiloxane, 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).
Regarding claims 15-19, a device is disclosed having at least one surface, wherein the surface comprises a nitric oxide-releasing material described (paragraph 0063). The device can also be a urinary catheter, artificial heart valve, a vascular catheter, a graft, or a stent. In some embodiments, the device is intended to contact human blood or tissue or a hemodialysis device or a component thereof. The device can also an implantable medical device or a device having anti-biofilm invoking surface.
Regarding claim 20, SNAP-PDMS is disclosed to prevent bacterial binding and growth on the polymeric surface .
Handa does not disclose the use of a silicone oil in the nitric oxide releasing polysiloxane.
Chug discloses antibacterial properties and improved antifouling characteristics provided to silicone rubber medical tubing by releasing nitric oxide and silicone oil infusion (see abstract). Here the nitric oxide releasing compound is S- nitroso-N-acetyl-penicillamine loaded into the silicone tubing that is 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). Such silicone oil infusion in polydimethylsiloxane tubing has been seen to produce a swelling of about 2 at equilibrium in 5 cSt silicone oil (see MacCallum et al. page 44 second column second paragraph and page 46).
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 coating and the underlying silicone tubing of Handa with 10 cSt silicone oil. This modification would have been obvious in light of Chug 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.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/264,094 (reference application) in view of Frost et al. (WO 2014/046671).
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 swelling ratio as well as an amine crosslinker. The composition of the copending claims is additionally recited as a coating on an article that includes catheters. Fibrinogen and biofilm formation both are recited as being reduced on the article.
Frost discloses stable, photosensitive polymers that release NO response to intensity and wavelength of light, methods of making such polymers and methods using such polymers (abstract).
Figure 1 discloses the synthesis of S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (paragraph 0010).
Using light as an external trigger to release NO allowed precise control of turning NO on and off as well as increasing or decreasing NO flux as desired (paragraph 0083).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used light, as discussed by Frost to release the NO of the polymers recited in the copending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/693198 (reference application) in view of Frost et al. (WO 2014/046671).
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 swelling ratio as well as an amine crosslinker. The composition of the copending claims is additionally recited as a coating on an article that includes catheters. Fibrinogen and biofilm formation both are recited as being reduced on the article.
Frost discloses stable, photosensitive polymers that release NO response to intensity and wavelength of light, methods of making such polymers and methods using such polymers (abstract).
Figure 1 discloses the synthesis of S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (paragraph 0010).
Using light as an external trigger to release NO allowed precise control of turning NO on and off as well as increasing or decreasing NO flux as desired (paragraph 0083).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used light, as discussed by Frost to release the NO of the polymers recited in the copending claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615