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
The information disclosure statement (IDS) submitted on 4/15/2025 was considered by the examiner.
Allowable Subject Matter
Claims 6, 7 and 9 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chae et al. (KR 20100019051; translation provided).
Chae describes a polymer film having anti-fouling properties, the polymer comprising a zwitterionic monomer having a phosphorylcholine group, e.g. 2-methacryloyloxyethyl phosphorylcholine (see claim 2), a photopolymerization initiation, e.g. benzophenone (an aryl ketone) (see claim 5) and a water-soluble monomer such as 2-hydroxyethyl methacrylate (a substituted alkyl methacrylate) (see claim 4).
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.
Claims 10 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weaver et al. (US 8574660).
Weaver describes medical devices (e.g. stents, catheters, etc.; see column 27, lines 35-50; see instant claims 17 and 18) having a drug-containing/releasing substrate possessing a low-fouling polymeric surface coating (see abstract) wherein the coating is attached via one or more covalent bonds (see column 42, lines 16-55). The substrate may be comprised of a material such as polyurethane and/or siloxane (i.e. silicone oil) (see column 25, lines 30-45) (see instant claims 10, 15, 16 and 19) wherein the drug agent contained within the substrate may be those that prevent restenosis such as nitric oxide and analogs/derivatives thereof (see column 78, lines 22-24) (see instant claim 10).
The low-fouling coating polymer is to be a hydrophilic material so as to mitigate protein adsorption onto the substrate surface (see column 18, lines 7-8). Exemplified hydrophilic polymers are those that contain a zwitterionic moiety (e.g. phosphorylcholine moiety) (see column 42, lines 54-67) (see instant claim 10). The substrate coating is to be crosslinked/polymerized via a UV initiator (i.e. photo crosslinking agent) such as benzophenone (i.e. an aryl ketone) and its analogs (see column 42, lines 20-30 and column 66, lines 15-35) (see instant claim 10).
Methods of preparing the coated substrate are contemplated wherein a therapeutic substrate according to that described above is coated with the surface polymer and polymerized via application of UV irradiation (i.e. light energy) (see column 20, lines 20-30) (see instant claim 20).
The only difference between Weaver and the instant claims is that Weaver does not teach the specific combination of components as claimed with sufficient specificity to be anticipatory. The specific combination of features claimed is described within the reference, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation. However, when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected the claimed combinations from the various disclosed ingredients from within Weaver to arrive at a composition such as that presently claimed with a reasonable expectation for success.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Weaver et al. (US 8574660) as applied to claims 10 and 15-20 above, and further in view of Pacetti et al. (US 2006/0111546).
Weaver fails to teach the nitric oxide donor as being provided by a nitric oxide donor, such as an S-nitrosothiol, in an amount of between 6-11wt% based upon total weigh of the substrate.
Pacetti, like Weaver, is directed to medical devices, such as stents, having the property of releasing therapeutic substances therefrom. An exemplified therapeutic substance is nitric oxide which is provided via nitric oxide donor like S-nitrosothiols (see [0048] and claim 10) (see instant claims 11 and 13). The nitric oxide donor is present in the substrate in an amount of 2-20% (see [0067]) (see instant claim 12). See MPEP 2144.05 regarding obviousness of ranges and their optimization.
It would have been obvious to modify Weaver’s medical substrate such that it comprised a nitric oxide donor, rather than nitric oxide itself, as the end effect would be the same; a substrate capable of releasing nitric oxide to a biological environment so as to prevent restenosis. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Weaver et al. (US 8574660) in view of Pacetti et al. (US 2006/0111546) as applied to claims 10-13 and 15-20 above, and further in view of Fronabarger et al. (US 7375221).
Weaver and Panacetti fail to teach the nitric oxide donor as being S-nitroso-N-acetylpenacillamine.
Fronabarger is directed to compositions for providing nitric oxide with utility in biomedical and pharmaceutical applications (see abstract). It is taught that S-nitroso-N-acetylpenacillamine is a nitric oxide donor capable of undergoing denitrosation in the body thereby releasing nitric oxide (see column 1, line 56 – column 2, line 5). It would have been obvious to identify and select S-nitroso-N-acetylpenacillamine as a nitric oxide donor in the medical device of Weaver with a reasonable expectation for success in providing nitric oxide to a target tissue. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 8, 15 and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8, dependent from claim 1, recites, “…wherein 0.3 ≤ a ≤ 0.9.” However, claim 1 does not recite an “a” variable and thus this limitation lacks antecedent basis.
Claim 15, dependent from claim 10, recites, “… wherein the second polymer is selected from…” Claim 10, however, does not recite a ‘second polymer’ and so this limitation lacks antecedent basis.
Claim 16, dependent from claim 10, recites, “… wherein the second polymer comprises…” Claim 10, however, does not recite a ‘second polymer’ and so this limitation lacks antecedent basis.
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 1-14 of U.S. Patent No. 11370934.
Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims in the instant and reference patent are drawn to a nitric-oxide releasing substrate having a surface the surface having a coating comprising as zwitterionic polymer of structure:
PNG
media_image1.png
127
178
media_image1.png
Greyscale
. The polymer is overlapping with the instant invention as the presently claimed polymers of claim 6-9 overlap with the polymer of the patent. Moreover, the reference patent and instant claims requires a nitric oxide donor, such as S-nitroso-N-acetylpenicillamine, be present in a substrate material. The scope of the claims in the application and patent are overlapping and not patentably distinct over the instantly claimed subject matter.
Claims 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12319828.
Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims in the instant and reference patent are drawn to methods of coating a nitric-oxide releasing substrate having a surface coating comprising as zwitterionic polymer of structure:
PNG
media_image1.png
127
178
media_image1.png
Greyscale
and then exposing the polymer to UV light energy. The patented claims are overlapping with the instant invention.
Potentially Relevant Prior Art
Huang et al. (US 2006/0183863).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
Prosecution Insights