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 .
Priority
The application claims priority to provisional application 63/453,575, with a filing date of 3/21/2023. The instant claims are examined with an effective filing date of 3/21/2023.
Status of the Claims
Claims 1-10, 12-16, and 18-22 are pending and under current examination.
Claim Objections
Claims 5-8 and 19 are objected to because of the following informalities:
Claims 5-8 and 19 contain the abbreviation “PVP”. The clarity of the record would be improved if the full term was provided followed by the abbreviation in parentheses at the first use of the term in the claim 5, as in “polyvinylpyrrolidone (PVP)”.
Appropriate correction is required.
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.
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 1-10, 12-16, and 18-22 are rejected under 35 U.S.C. 112(b) or 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 inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “a bound portion” and “an unbound portion”. This renders the claim indefinite because it is not clear to what the polyzwitterion should be bound to.
Claim 8 recites the limitation “the PVP polymer or copolymer comprising a photoreactive PVP polymer or copolymer and a non-photoreactive PVP polymer or copolymer”. This renders the claim indefinite because it is not clear if PVP polymer of copolymer of claim 5 is a mixture of two separate PVP polymers (a photoreactive species and a non-photoreactive species) or if the PVP polymer is a single polymer that contains photoreactive monomers and non-photoreactive monomers.
Claim 20 contains the trademark/trade name “Pluronic”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific polymer species and, accordingly, the identification/description is indefinite.
Claim 21 recites the limitation “II(Original) A platelet inhibitor”. This renders the claim indefinite because it is not clear if the “(Original)” limitation is a typographical error or if it is describing the anti-platelet agent.
Regarding claims 2-7, 9-10, 12-16, 18-19, and 22, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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.
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.
Claims 1-7, 10, 12, 14, 18-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair (U.S. Patent Application Publication No. 2021/0301108, publication year: 2021, cited in the IDS filed 9/23/2025).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Sinclair teaches a hydrogel composition comprising both polysaccharide-based and polyzwitterionic components, which are crosslinked or intermingled together in a way such that this combined network exhibits material characteristics or clinical utility desirable for biomedical applications [0010]. The hydrogel composition may be used to provide antifouling materials or surface coatings to prevent nonspecific protein or other biomolecule adsorption for drug delivery platforms, biosensors and other medical devices, vascular grafts, intravascular stents, cardiac valves, joint replacements, and other materials and devices that come into contact with physiological environments [0184]. The polysaccharide component may be based on heparin sulfate [0111]. Constitutional unit(s) of each component are covalently bonded to at least one, and potentially many, constitutional units of the other component through crosslinking junctions [0071]. The Examiner considers the crosslinked and un-crosslinked united of the polyzwitterion to read on the “bound portion” and “unbound portion” limitations of the instant claim. The compositions may also include polyzwitterionic and/or polysaccharide components that are not crosslinked or otherwise chemically bonded to the crosslinked bulk of the network, for purposes including viscosity modulation or promoting local anesthetic delivery [0027].
Regarding claims 2 and 3, Sinclair teaches that the constitutional unit(s) of each component are covalently bonded to at least one, and potentially many, constitutional units of the other component through crosslinking junctions [0071]. The Examiner considers the crosslinked and un-crosslinked united of the polyzwitterion to read on the “bound portion” and “unbound portion” limitations of the instant claims.
Regarding claim 4, Sinclair teaches that the post-reaction hydrogel product is equilibrated or dialyzed in aqueous solution [0043]. Sinclair does not disclose the aqueous properties as recited in claim 4. However, the invention as claimed is not structurally distinguishable from the disclosure of Sinclair and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 5, Sinclair teaches that the polyzwitterionic component can comprise a copolymer or a combination of two mixed polymers containing zwitterionic repeat units in addition to hydrophilic repeat units such as polyvinylpyrrolidone (PVP) (Claim 7).
Regarding claims 6 and 7, Sinclair teaches that the compositions may include polyzwitterionic and/or polysaccharide components that are not crosslinked or otherwise chemically bonded to the crosslinked bulk of the network, for purposes including viscosity modulation or promoting local anesthetic delivery [0027]. With regards to the “configured to elute off the coating after implant in a patient” limitations of instant claim 7, the prior art teaches the same unbound polyzwitterion as claimed and therefore, the elution properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 10, Sinclair teaches that constitutional unit(s) of each component are covalently bonded to at least one, and potentially many, constitutional units of the other component through crosslinking junctions [0071].
Regarding claim 12, Sinclair teaches that the composition is formed through a two-stage crosslinking reaction, in which part or all of the polysaccharide components are first modified, functionalized, and/or crosslinked, after which the polyzwitterionic components are grafted, combined, or attached in a second synthesis step [0041]. The pre-reaction solution may include a photo-active free radical initiator that initiates a reaction that forms the desired composition when exposed to ultraviolet or visible light radiation [0131]. The Examiner considers the phrase “photo-active free radical initiator” to read on the “photoactivatable group” limitation of the instant claim 12.
Regarding claim 14, Sinclair teaches that the polyzwitterionic component may be based on poly(carboxybetaine), poly(sulfobetaine), or poly(phosphobetaine), including functionalized derivatives, copolymers, or pharmaceutically accepted salts [0022].
Regarding claims 18-20, Sinclair teaches that the polyzwitterionic component can comprise a copolymer or a combination of two mixed polymers containing zwitterionic repeat units in addition to hydrophilic repeat units such as polyvinylpyrrolidone (PVP) (Claim 7). With regards to the “anti-platelet” limitations of instant claims 18-20, the prior art teaches the same polyvinylpyrrolidone as claimed and therefore, the anti-platelet properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 22, Sinclair teaches that the polyzwitterionic component comprises a copolymer or combination of two mixed polymers containing zwitterionic repeat units in addition to hydrophilic repeat units of polyacrylic acid (Claim 7).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1-7, 10, 14, 18-20, and 22, Sinclair does not teach a single embodiment or example meeting all limitation of the invention of claims 1-7, 10, 14, 18-20, and 22.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1-7, 10, 14, 18-20, and 22, within the broader scope of Sinclair, all of the limitations of the invention of claims 1-7, 10, 14, 18-20, and 22 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Sinclair and arrive at this conclusion because such was contemplated by Sinclair.
Claims 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair (U.S. Patent Application Publication No. 2021/0301108, publication year: 2021, cited in the IDS filed 9/23/2025), as applied to claims 1-7, 10, 12, 14, 18-20, and 22 above, and further in view of Guire (U.S. Patent No. 5,741,551, issue date: 4/21/1998, cited in the IDS filed 5/21/2026).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 8-9 and 13, Sinclair teaches that the polyzwitterionic component can comprise a copolymer or a combination of two mixed polymers containing zwitterionic repeat units in addition to hydrophilic repeat units such as polyvinylpyrrolidone (PVP) (Claim 7). The polysaccharide component may be based on heparin sulfate [0111].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 8-9 and 13, Sinclair does not teach the inclusion of a photoreactive PVP polymer or copolymer or a photo-heparin. However, this deficiency is cured by Guire.
Guire teaches photoactivatable ketones that may be included as latent reactive groups to cause covalent bond formation to the surfaces to which polymer molecules are to be attached (col. 5 lines 32-41). The substrate to which the polymer molecules may be attached include the tangible surface of a contact lens or surgical implant (col. 7 line 43). The polymers that may include the photoactivatable ketones include polyvinyl pyrrolidone (col. 3 line 20) and heparin (col. 3 line 34). This allows the particular advantage of providing means by which non-pretreated definable surfaces may simply and rapidly be provided with covalently bonded-on polymer coatings in a simple, rapid, and hence economical manner (col. 7 lines 51-54).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 8-9 and 13, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a photo-PVP polymer and a photo-heparin in the hydrogel of Sinclair. One of ordinary skill in the art of filing would have understood in view of Guire that heparin or polyvinyl pyrrolidone polymers that contain a photoactivatable ketone are modified in such a way that allowed them to attach to a substrate via covalent bond formation. It would have been obvious to modify the heparin and PVP of Sinclair with such a group. One of ordinary skill in the art of filing would have been motivated to include a photo-PVP or a photo-heparin such as that taught by Guire in order to provide a simple, rapid, and economical means of attaching the hydrogel to the substrate surface. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Guire teaches that the photoactivatable groups may be utilized to coat the polymers onto the tangible surface of a contact lens or surgical implant (col. 7 line 43).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair (U.S. Patent Application Publication No. 2021/0301108, publication year: 2021, cited in the IDS filed 9/23/2025), as applied to claims 1-7, 10, 12, 14, 18-20, and 22 above, and further in view of Lee et. al. (Biomaterials Research, pg. 1-7, publication year: 2018).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 15 and 16, Sinclair teaches that the polyzwitterionic component may be based on poly(carboxybetaine), poly(sulfobetaine), or poly(phosphobetaine), including functionalized derivatives, copolymers, or pharmaceutically accepted salts [0022].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 15 and 16, Sinclair does not teach the inclusion of a sulfobetaine methacrylate or a poly(sulfobetaine methacrylate). However, this deficiency is cured by Lee.
Lee teaches that a sulfobetaine methacrylate hydrogel may be utilized to coat implantable biomedical devices and impart them with anti-fouling properties (pg. 1, Abstract).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 15 and 16, it would have been prima facie obvious to one of ordinary skill in the art of filing to utilize a poly(sulfobetaine methacrylate) as the polyzwitterion present in the hydrogel of Sinclair. One would have understood in view of Lee that a hydrogel comprising sulfobetaine methacrylate may be coated onto an implantable medical device in order to impart anti-fouling properties to the medical device. It would have been obvious to utilize the same sulfobetaine methacrylate as the polyzwitterion present in the hydrogel of Sinclair. One of ordinary skill in the art of filing would have been motivated to utilize sulfobetaine methacrylate in the hydrogel of Sinclair in order to utilize the anti-fouling properties of the polyzwitterion. The artisan of ordinary skill in the art would have had reasonable expectation of success because Sinclair teaches that the polyzwitterion may be based on a poly(sulfobetaine).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Sinclair (U.S. Patent Application Publication No. 2021/0301108, publication year: 2021, cited in the IDS filed 9/23/2025), as applied to claims 1-7, 10, 12, 14, 18-20, and 22 above, and further in view of Sirhan (U.S. Patent No. 11,654,036, filing date: 8/13/2021).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Sinclair teaches the relevant limitations of claims 1 and 19 above. Sinclair also teaches that the hydrogel composition may be supplemented or blended with one or more additives of cosmetic or therapeutic utility, such as a drug or drug precursor [0166].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Sinclair does not teach the inclusion of a non-prodrug anti-platelet agent embraced by the instant claims. However, this deficiency is cured by Sirhan.
Sirhan teaches drug-coated stents, balloons, balloon reservoirs, heart implants, hip implants, knee implants, shoulder implants, and the like (col. 69 lines 48-51). The devices may, at least partially, cause an injury to the tissue which may initiate the coagulation cascade. Coagulation may lead to one or more of inflammation, injury, blockage of a lumen or vessel partially or fully, degradation of the device function, formation of clot, and/or adverse clinical events (col. 69 lines 57-67). The therapeutic composition includes a direct IIa inhibitor (col. 70 line 22). The implant may comprise a carrier such as a hydrogel to control the release of the drugs (Claims 39 and 40).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to include a IIa inhibitor in the hydrogel of Sinclair. One would have understood in view of Sirhan that implantable medical device may cause injury to tissue that initiates a coagulation cascade and that inclusion of IIa inhibitor in a hydrogel carrier that coats such a medical device may help prevent coagulation. One of ordinary skill in the art would have been capable of applying this know technique (incorporation of a IIa inhibitor in a hydrogel coating for a medical device) to a known device (the hydrogel of Sinclair) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art (reduced coagulation rendered by incorporation of the IIa inhibitor). The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Sinclair teaches that the hydrogel may contain a drug and Sirhan teaches that the IIa inhibitor may be incorporated into a hydrogel carrier coated on a medical device. See MPEP 2143 (I)(D).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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