DETAILED OFFICIAL ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2024/0342345, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Information Disclosure Statement
The information disclosure statements filed 23 August 2024, 08 October 2024, 16 October 2024, 26 December 2025, and 23 February 2026 are in compliance with 37 CFR 1.97 and 1.98 and have been considered.
Claim Objections
Claim 26 is objected to for inconsistent claim language/terminology, as indicated below.
“…wherein the non-derivatized polyvinylpyrrolidone comprises PVP-K90.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-25 and 31-36 are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the Applicant regards as the invention.
Regarding claim 23, which is directly dependent upon claim 21, the phrase/limitation “the polymer comprising polyacrylamide, 2-acrylamido-2-methylpropanesulfonate (AMPS), and polyethylene glycol subunits” lacks sufficient antecedent basis, as there is no recitation in claim 21 of a polymer comprising the foregoing. As such, it is unclear what element/component of the coating for a medical device defined by claim 21 is intended to be limited by claim 23.
Given that claim 22 does introduce a polymer comprising polyacrylamide, 2-acrylamido-2-methylpropanesulfonate (AMPS), and polyethylene glycol subunits, claim 23 is interpreted for examination on the merits as being dependent upon claim 22 rather than claim 21, i.e., “The coating for a medical device of claim [[21]]22, wherein the polymer comprising polyacrylamide, 2-acrylamido-2-methylpropanesulfonate (AMPS), and polyethylene glycol subunits further comprises a photoreactive group.” The aforesaid is respectfully suggested as an amendment to overcome the indefiniteness issue.
Regarding claim 24, which is directly dependent upon claim 22, the limitation “the photoreactive group comprising a benzophenone group” renders the claim indefinite, as it is unclear which photoreactive group is being limited – the photoreactive group of the derivatized polyvinylpyrrolidone; one of, the other of, both of, or all of, the at least two photoreactive groups of the cross-linking agent; or if Applicant intended for claim 24 to be dependent upon claim 23 which further limits the polymer to comprising a photoreactive group.
Given that claim 30 limits the polyvinylpyrrolidone derivatized with a photoreactive group to being derivatized with a benzophenone group, claim 24 is interpreted for examination on the merits as (1) limiting any one or more of the at least two photoreactive groups of the cross-linking agent, or (2) as being dependent upon claim 23, i.e., as limiting the photoreactive group of the polymer. If Applicant intended to limit the photoreactive group of the polymer in accordance with aforesaid interpretation (2), it is respectfully suggested to amend claim 24 as follows: “The coating for a medical device of claim [[22]]23, the photoreactive group of the polymer comprising a benzophenone group.”
Claim 25 is indefinite for the same reasons set forth above in the rejection of claim 23. For examination on the merits, claim 25 is interpreted as being dependent upon claim 22 rather than claim 21.
Claims 31-32 are indefinite, as each claim does not define multiple elements and/or measurement conditions which have a direct effect on the reported amount of particulates released from the coating, such that one of ordinary skill in the art would not be apprised of, and could not readily determine, the metes and bounds of the scope of each claim (MPEP 2173). Claims 31 and 32 do not define an exposure duration (e.g., 1 second, 10 seconds, 10 minutes, 150 hours), the temperature at which the coating is exposed to the aqueous environment (i.e., the temperature of the aqueous environment, e.g., 15° C, 23° C, 90° C), the composition of the aqueous environment (e.g., 100 wt.% water; 50 wt.% water, 50 wt.% organic solvent; 1 wt.% water, 99 wt.% organic solvent), the method of determination of the number of particles greater than 10 µm in size (e.g., filtration, laser diffraction), or the coating thickness; claim 31 does not define the surface area of the coating exposed to the aqueous environment.
Claims 31-32 are interpreted for examination on the merits where the foregoing elements and measurement conditions may be any value/composition/method. In order to overcome the indefiniteness issue, it is respectfully suggested to amend the claims to define each of the foregoing.
Claims 33-35 are indefinite, as it is unclear how, and under what conditions, the lubricity (when wetted) is measured, and unclear what property the range/unit of “between 0 and 30 grams of force” corresponds to (e.g., static frictional force, dynamic frictional force), wherein neither of the foregoing are explicitly defined in the specification [spec, 0031], and wherein one of ordinary skill in the art understands that the reported lubricity value is directly dependent upon the measurement conditions/parameters and method thereof. As such, the metes and bounds of the scope of each claim cannot be readily envisaged or determined by one of ordinary skill in the art, and the public would not be clearly informed of the bounds of what constitutes infringement thereupon (MPEP 2111.01(II), MPEP 2173).
For examination on the merits, claims 33-35 are interpreted as encompassing any lubricity (wetted) property determined by any measurement method, e.g., static friction or dynamic friction measured under any conditions, against any corresponding test surface, under any amount of applied force, of which constitutes the broadest reasonable interpretation thereof, in view of the specification, without improperly importing limitations from the specification into the claims (see MPEP 2111, MPEP 2111.01(II)). In order to overcome the indefiniteness issue, it is respectfully suggested to amend claims 33-35
Regarding claim 36, the limitation “wherein the coating is between about 100 and 3000 nm when dry” renders the claim indefinite, as the dimension or property corresponding to the range is not stated. That is, it is unclear whether the range corresponds to a dimension such as, e.g., coating thickness or coating length/width, or if the range corresponds to a non-dimensional property.
For examination on the merits, claim 36 is interpreted as being the thickness of the coating when dry, in accordance with, and explicitly supported by, the specification [spec, 0024]. In order to overcome the indefiniteness issue, the following amendment is respectfully suggested: “wherein the coating thickness is between about 100 and 3000 nm when dry.”
Appropriate action is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 26-27, 30, and 36-37 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chappa et al. (US 2003/0165613; “Chappa”). Guire et al. (US 2003/0073086; “Guire”) is relied upon as an evidentiary reference in support of the rejection.
Regarding claim 21, Chappa discloses coating compositions for medical devices and devices coated therewith [Abstract; 0001-0002, 0129]. Specifically, Chappa discloses a coating referred to as “a ‘PhotoLink’ cocktail” [0129, Example 11] which consists of:
(i) photopolyvinylpyrrolidone (SurModics Product PV05) – see [Guire, 0163] (polyvinylpyrrolidone derivatized with a photoreactive group),
(ii) polyvinylpyrrolidone (Kollidon® 90F, BASF) (non-derivatized polyvinylpyrrolidone),
(iii) photopolyacrylamide (SurModics Product PA05), and
(iv) ethylenebis (4-benzoylbenzyldimethylammonium)dibromide (cross-linking agent comprising at least two photoreactive groups) [0089, 0129].
The PhotoLink cocktail coating of Chappa anticipates the coating for a medical device defined by each and every limitation of claim 21.
Regarding claim 26, the rejection of claim 21 above reads on the coating defined by claim 26 – component (ii) of the PhotoLink cocktail is Kollidon® 90F, of which is a commercialized/branded name for PVP-K90, i.e., Povidone K90.
Regarding claim 27, the rejection of claim 21 above reads on the coating defined by claim 27 – component (iv) of the PhotoLink cocktail comprises two bromine counter-ions, i.e., two bromine anions [Chappa, 0089].
Regarding claim 30, the rejection of claim 21 above reads on the coating defined by claim 30 – component (i) of the PhotoLink cocktail is SurModics PV05, of which is a copolymer of vinylpyrrolidone (VP) and N-[3-(4-Benzoylbenzamido)propyl] methacrylamide (BBA-APMA) [Guire, 0163] (wherein the polyvinylpyrrolidone derivatized with a photoreactive group is derivatized with a benzophenone group).
Regarding claim 36, in view of the rejection of claim 21 above, Chappa discloses that the PhotoLink coating exhibits a thickness of about 500 nm [0131], of which is within the claimed range of about 100 and 3000 nm (dry) (MPEP 2131.03).
Regarding claim 37, the rejection of claim 21 above is incorporated herein by reference (not repeated for sake of brevity) and reads on the medical device defined by claim 37.
Claims 21-27, 30, and 37-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chappa et al. (US 2010/0272774; “Chappa ‘774”).
Regarding claim 21, Chappa ‘774 discloses a coating for medical devices, and medical devices coated therewith [Abstract; 0055-0065, Example 1]. Specifically, Chappa ‘774 discloses the first basecoat coating of Example 1 [0062, 0065] comprising:
(i) poly[vinylpyrrolidone-co-N-3-(4-benzoylbenzamido)propyl) methacrylamide] [0058, 0062] (polyvinylpyrrolidone derivatized with a photoreactive group),
(ii) polyvinylpyrrolidone (PVP-K90) [0062] (non-derivatized polyvinylpyrrolidone),
(iii) N-Acetylated poly[acrylamide-co-sodium-2-acrylamido-2-methylpropanesulfonate-co-N-3-(4-benzoylbenzamido)propyl) methacrylamide]-co-methoxy poly(ethylene glycol) monomethacrylate [0059, 0062], and
(iv) disodium 4,5-bis[(4-benzoylbenzyl)oxy]-1,3-benzenedisulfonate (DBDS) [0060, 0062] (cross-linking agent comprising at least two photoreactive groups).
The coating of Chappa ‘774 anticipates the coating for a medical device defined by each and every limitation of claim 21.
Regarding claims 22-25, the rejection of claim 21 above reads on each coating defined by claims 22-25. That is, component (iii) of the coating of Chappa ‘774 reads on the polymer defined by claim 22; the polymer defined by claim 23; the coating defined by claim 24 in accordance with interpretation (2) set forth above (¶10-11) in the rejection of claim 24 under 35 U.S.C. 112 (pre-AIA ), second paragraph; and the polymer defined by claim 25. Specifically, the polymer (component (iii)) disclosed by Chappa ‘774 [0059, 0062] is identical to the polymer defined by claim 25 and disclosed in Applicant’s specification [spec, 0089].
Regarding claim 26, the rejection of claim 21 above reads on the coating defined by claim 26 – component (ii) of the coating of Chappa ‘774 is PVP-K90.
Regarding claim 27, the rejection of claim 21 above reads on the coating defined by claim 27 – component (iv) of the coating of Chappa ‘774, i.e., DBDS includes two sulfonate groups (the cross-linking agent comprising an anionic group) each having a sodium counter-cation.
Regarding claim 30, the rejection of claim 21 above reads on the coating defined by claim 30 – the photoreactive group of component (i) of the coating of Chappa ’774 is benzophenone group (wherein the polyvinylpyrrolidone derivatized with a photoreactive group is derivatized with a benzophenone group).
Regarding claim 37, the rejection of claim 21 above is incorporated herein by reference and reads on the medical device defined by claim 37. Specifically, Chappa ‘774 discloses a medical device coated with the first basecoat coating of Example 1 [0062, 0065].
Regarding claims 38-40, in view of the rejection of claim 37 above, the rejection of claims 22-25 above (¶32) is incorporated herein by reference and reads on each medical device defined by claims 38-40.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 27-29 and 31-35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chappa ‘774 as applied to claim 21 under pre-AIA 35 U.S.C. 102(b) above, further in view of Kurdyumov et al. (US 2011/0245367; “Kurdyumov”).
Regarding claims 28-29, as set forth above in the rejection of claim 21, the cross-linking agent of the coating of Chappa ‘774 is disodium 4,5-bis[(4-benzoylbenzyl)oxy]-1,3-benzenedisulfonate (DBDS) [0060, 0062], of which includes two photoreactive benzophenone groups. Though the coating (first basecoat) of Example 1 of Chappa ‘774 utilizes DBDS as the cross-linking agent, the broad/general disclosure of Chappa ‘774 does not limit the cross-liker to the aforesaid species [0029-0033]. That is, Chappa ‘774 reasonably suggests to one of ordinary skill in the art that the cross-linker is required to be photoreactive, and in some embodiments (e.g., as exemplified in Example 1) the photoreactive groups of the cross-linker are benzophenone groups [0029, 0032-0033].
Chappa ‘774 is silent regarding the cross-linking agent comprising a phosphate group (claim 28), and in particular, is silent regarding the cross-linking agent comprising sodium bis(4-benzoylphenyl) phosphate (claim 29).
Kurdyumov is directed to cross-linking agents having two benzophenone photoreactive groups, and coatings including said cross-linking agents formed on medical devices [Abstract; 0002-0005, 0007-0008, 0020, 0024-0025, 0044-0045, 0073-0074]. Kurdyumov teaches that, inter alia sodium bis(4-benzoylphenyl) phosphate [0046, 0048] is a cross-linking agent having two benzophenone photoreactive groups, suitable for said intended use [0074], and capable of providing the increased coating efficiency recognized/desired by Chappa ‘774 [Chappa ‘774, 0033]. See MPEP 2144.06, MPEP 2144.07.
In view of the aforecited disclosures/teachings, Chappa ‘774 and Kurdyumov each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have modified the coating (first basecoat) of Example 1 of Chappa ‘774 by having utilized sodium bis(4-benzoylphenyl) phosphate as the cross-linking agent (component (iv)) in place of DBDS, as sodium bis(4-benzoylphenyl) phosphate would have been readily recognized as a photoreactive cross-linking agent exhibiting the necessary (two) photoreactive benzophenone groups and (thereby) capable of providing the increased coating efficiency recognized/desired by Chappa ‘774, and as a suitable photocrosslinker for use in medical device coatings. See MPEP 2144.06 and MPEP 2144.07.
In accordance with the foregoing modification, component (iv) of the coating of Chappa ‘774 (see ¶30 above) (hereinafter “modified Chappa ‘774”) would have been sodium bis(4-benzoylphenyl) phosphate, thereby reading on the coating defined by claim 28 (the cross-linking agent comprising a phosphate group) and claim 29 (the cross-linking agent comprising sodium bis(4-benzoylphenyl) phosphate) as dependent upon claim 21.
Regarding claim 27, the rejection of claims 28-29 above reads on the coating defined by claim 27.
Regarding claims 31-35, in view of the rejection of claim 21 above, the rejection of claims 28-29 above is incorporated herein by reference (not repeated). In accordance therewith, the coating of modified Chappa ‘774 includes components (i), (ii), (iii), and (iv), wherein component (iv) is sodium bis(4-benzoylphenyl) phosphate as the cross-linking agent, and wherein component (iii) is, specifically, N-Acetylated poly[acrylamide93.6%-co-sodium-2-acrylamido-2-methylpropanesulfonate4.9%-co-N-3-(4-benzoylbenzamido)propyl) methacrylamide0.9%]-co-methoxy poly(ethylene glycol)1000 monomethacrylate0.6% [0059, 0062] (percentages are mol%).
Chappa ‘774 (as modified) does not explicitly disclose that the coating releases less than 10,000 particles greater than 10 µm in size (per square centimeter of coating surface) when exposed to an aqueous environment (claims 31-32), does not explicitly disclose the coating exhibiting a lubricity when wetted of between 0-30 grams of force (claim 33) for at least 10 consecutive testing cycle (claim 34), and does not explicitly disclose the coating exhibiting a durability of lubricity of less than 30% increase in measured friction (claim 35), as claimed.
However, given that the coating of modified Chappa ‘774 is substantially identical or identical to the claimed/disclosed coating in terms of the species of photo-PVP [spec, 0091], species of non-derivatized PVP (PVP-K90) [spec, 0093], species of polymer (component (iii)) [spec, 0089, 0096, 0142; Table 2] including monomeric mol% thereof, and species of cross-linking agent [spec, 0096]; in terms of the coating being a solvent-borne coating composition [Chappa ‘774, 0062] [spec, 0071-0073]; and in terms of the method of forming the coating (immersion dip-coating, extraction rate), and given the indefinite nature of each of claims 31-35 as indicated/interpreted in the rejection of claims 31-35 under 35 U.S.C. 112 (pre-AIA ), second paragraph above, it stands to reason that the coating of modified Chappa ‘774 would have necessarily exhibited the claimed particle release, lubricity, and lubricity durability properties (claims 31-35), absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(V), MPEP 2112.01(I) and (II), MPEP 2145, and MPEP 2145(I).
The coating of modified Chappa ‘774, set forth above, reads on each coating defined by claims 31-35 as dependent upon claim 21.
Claim 36 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chappa ‘774 as applied to claim 21 under pre-AIA 35 U.S.C. 102(b) above, further in view of Chappa.
Regarding claim 36, in view of the rejection of claim 21 above, Chappa ‘774 is silent regarding the thickness of the coating (dry) ranging from between about 100 and 3000 nm, as claimed.
Chappa – set forth/cited above (see ¶22-28) – teaches that the thickness of medical device coatings formed from photo-PVP, PVP (specifically PVP-K90), photo-derivatized polyacrylamide, and a photoreactive (two benzophenone groups) cross-linking agent, suitably/typically exhibit a thickness ranging from 0.2 to 1 µm (200 to 1000 nm) [0129, 0131].
Chappa ‘774 and Chappa each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to have modified the coating of Chappa ‘774 to have exhibited a dry thickness within the range of 0.2 to 1 µm, in order to have imparted smoothness to the surface of a medical device coated therewith and/or to have achieved the predictable result of coating thickness uniformity [Chappa, 0083, 0129-0133].
In accordance therewith, the coating of Chappa ‘774 would have exhibited a dry thickness ranging from about 200 nm to about 1000 nm, of which is within the claimed range of between about 100 and 3000 nm (dry) (see MPEP 2131.03, MPEP 2144.05(I)). The coating of Chappa ‘774, as modified hereinabove, reads on the coating defined by claim 36.
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 21 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 9,375,517 (hereinafter “the ‘517 Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 21 is anticipated by, and claim 37 is obvious over, claim 9 of the ‘517 Patent.
Regarding claim 21, claim 9, which is directly dependent on claim 1, of the ‘517 patent, claims a coating for a medical device comprising a first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group, a first cross-linking agent comprising at least two photoreactive groups, and a non-derivatized polyvinylpyrrolidone, thereby anticipating the coating for a medical device of claim 21.
Regarding claim 37, the rejection of claim 21 above is incorporated herein, wherein it would have been prima facie obvious to have applied the coating for a medical device of claim 9 of the ‘517 patent to a medical device, thereby rendering obvious the medical device of claim 37.
Claims 21 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10,905,802 (hereinafter “the ‘802 Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 21 is anticipated by, and claim 37 is obvious over, claim 11 of the ‘802 Patent.
Regarding claim 21, claim 11, which is directly dependent on claim 1, of the ‘802 patent, claims a coating for a medical device comprising a first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group, a first ionic cross-linking agent comprising at least two photoreactive groups, and a non-derivatized polyvinylpyrrolidone, thereby anticipating the coating for a medical device of claim 21.
Regarding claim 37, the rejection of claim 21 above is incorporated herein, wherein it would have been prima facie obvious to have applied the coating for a medical device of claim 11 of the ‘802 patent to a medical device, thereby rendering obvious the medical device of claim 37.
Claims 21-25, 27-29, and 37-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of US Patent No. 11,872,325 (hereinafter “the ‘325 Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by claim 5 of the ‘325 Patent.
Regarding claim 21, claim 5, which is directly dependent upon claim 1, of the ‘325 Patent, claims a medical device comprising a substrate and a first layer (i.e., coating) disposed thereon comprising polyvinylpyrrolidone derivatized with a photoreactive group, sodium bis(4-benzoylphenyl) phosphate (cross-linking agent comprising at least two photoreactive groups), a non-derivatized polyvinylpyrrolidone, and at least one acrylamide copolymer selected from, inter alia N-Acetylated poly[acrylamide-co-sodium-2-acrylamido-2-methylpropanesulfonate-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide]-co-methoxy poly(ethylene glycol) monomethacrylate, thereby anticipating the coating for a medical device of claim 21.
Regarding claims 22-25, the rejection of claim 21 above over claim 5 of the ‘325 Patent is incorporated herein and reads on each coating defined by claims 22-25.
Regarding claims 27-29, the rejection of claim 21 above over claim 5 of the ‘325 Patent is incorporated herein and reads on each coating defined by claims 27-29.
Regarding claims 37-40, the rejection of claim 21 above over claim 5 of the ‘325 Patent is incorporated herein and reads on each medical device by claims 37-40.
Pertinent Prior Art
The following constitutes a list of prior art which are not relied upon herein, but are considered pertinent to the claimed invention and/or written description thereof. The prior art are purposely made of record hereinafter to facilitate compact/expedient prosecution, and consideration thereof is respectfully suggested.
WO 96/03164 to Michal (copy provided herewith) – discloses flexible hydrophilic coatings for medical devices, said coatings including a copolymer of a hydrophilic monomer, e.g., acrylamide, and a plasticizing monomer, e.g., methoxy (polyethylene glycol) monomethacrylate where the polyethylene glycol moiety has a molecular weight of about 1,000 [Abstract]
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782
Prosecution Insights