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 .
New Examiner
This application has bee reassigned to Robert A. Wax, Supervisory Patent Examiner, Art Unit 1615.
Status of the Claims
Claims 1-11 are pending in this application. Claims 1-11 are under examination.
Withdrawn Objection/Rejection
The objection to the drawings is withdrawn in view of the filing of new figures.
The rejection of claim 1 under 35 USC 102(a)(1) over Burnett et al. is withdrawn. Burnett et al. only teach PVA and PVP, which are now excluded from claim 1.
Maintained and Modified Rejections
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 and 8 contain the trademark/trade name Matrigel. 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 soluble preparation from Engelbreth-Holm-Swarm (EHS) mouse sarcoma cells and, accordingly, the identification/description is indefinite.
The presence of the parentheses is another factor showing indefiniteness because it is unclear whether the parenthetical information is intended to be part of the claim or not.
Deletion of “(Matrigel) from the claims would overcome this rejection.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al.
A “self-healing nerve suture patch” is interpreted as intended use and does not constitute functional limitations. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02 II. Here, the recitation of “self-healing nerve suture patch” is interpreted merely as intended use for the instantly claimed “patch”. The instant specification does not provide a definition for “patch.” Under broadest reasonable interpretation, a patch does not add structure to a product beyond just being material that is capable of “patching up” something. That said, Chen et al. teach “a novel double-network hydrogel based on dopamine-grafted oxidized sodium alginate (OSA-DA) and polyacrylamide (PAM)” which has “self-healing ability and exceptional tissue adhesiveness . . . suitable for repairing wound tissue” (page 33528 right column). Since, Chen’s invention has self-healing capability, Chen’s PAM teaching is interpreted as a self-healing polymer, and Chen’s teaching of sodium alginate meets the instantly claimed alginate limitation for the hydrogel patch. Therefore, Chen is anticipatory over the instant claim.
Chen et al. teach alginate which is one of the list from which to select at least one. Removing polyacrylamide from the list only means that the "one" cannot be polyacrylamide but does not forbid its presence as an additional ingredient. Plus, claim 1 does not require two separate layers of polymer and hydrogel so that their combination of polymer and hydrogel reads on the 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.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. in view of Burnett et al.
Chen et al. teach “a novel double-network hydrogel based on dopamine-grafted oxidized sodium alginate (OSA-DA) and polyacrylamide (PAM)” which has “self-healing ability and exceptional tissue adhesiveness . . . suitable for repairing wound tissue” (page 33528 right column). Since, Chen’s invention has self-healing capability, Chen’s PAM teaching is interpreted as a self-healing polymer, and Chen’s teaching of sodium alginate meets the instantly claimed alginate limitation for the hydrogel patch. Chen et al. do not teach inclusion of a nerve growth factor.
Burnett et al. teach a “self-adhesive, biocompatible and hydratable polymeric matrix in the form of a sheet, patch or film . . . the matrix comprising a naturally occurring or synthetic polymerisable and/or cross-linkable material that supports wound healing, and a synthetic polymer having bioadhesive properties, such properties enabling the matrix to adhere to underlying tissue by means of ionic and/or hydrogen bonding.” Burnett et al. also teach “nerve repair” (para 93) use and also teaches “growth factors” “may be added to the solution used to form the patch product, or covalently linked to components prior to their use in patch formation” (para 99).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to add the nerve growth factor of Burnett et al. to the patch of Chen et al. with the expectation that the patch would be useful in nerve repair. This expectation is taught by Burnett et al. teaching nerve repair and also teaching growth factors may be added, a person of ordinary skill in the art would use a nerve growth factor in a composition prepared for nerve repair.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. in view of Pettignano et al.
The teachings of Chen et al. are outlined above.
Pettignano et al. teach biocompatible hydrogels comprising a “conjugate” of “Alg–B(OH)2” (alginate and boronic acid conjugate) (page 3351 right column).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date to have used the alginate-boronic acid conjugate of Pettignano et al. as the self-healing hydrogel of Chen et al. with the expectation of beneficial results. This expectation is provided by the statement in Pettignano et al. that their hydrogel possesses “Extraordinary elasticity, self-healing, injectability and multi-stimuli responsive properties . . . rapid self-healing of a damaged gel . . . good biocompatibility” (page 3353 left column) wherein the results “indicate that the material could be useful for different biomedical applications.” (page 3353 right column).
Claims 1, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable Chen et al. in view of Kang et al.
The teachings of Chen et al. are outlined above.
Regarding claim 5, Kang et al. teach a “supramolecular network in polymer film realizes exceptional mechanical properties such as notch-insensitive high stretchability (1200%), high toughness of 12 000 J m−2, and autonomous self-healing” (abstract) comprising “PDMS–MPUx–IU1−x” (figure 1) which meets the instantly claimed first moiety of polymethylsiloxane (PDMS) and second moiety including isophrone bisurea (IU) (evidenced in left column of page 2).
Regarding claim 6, Kang et al. teach “Young’s modulus” (page 4 left column) which is provided in figures 2b, and c, demonstrating a range from 0.5 to 1.5 MPa which is 500 to 1500 kPa. This range is within the instantly claimed 1 to 3000 kPa. In Fig 2a, Kang et al. disclose stretching (interpreted as elongation) of 3000% which is within the instantly claimed 1200-3000%.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to substitute the PDMS and isophorone bisurea of Kang et al. as the polymer of Chen et al. with the expectation of creating a viable self-healing hydrogel patch. This expectation is provided by Kang et al.’s teaching that “since most self-healing polymers are based on weak dynamic bonds, they easily break along locations where damage is incurred due to their low fracture energies typically at ≈100 J m−2 or less. Furthermore, most self-healing polymers are highly viscoelastic with weak mechanical toughness and are susceptible to fatigue under large deformation” (page 1 left column) and provides “tough, self-healable, and stretchable materials” (page 1 left column).
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. in view of Park et al. (the Korean Intellectual Property Office English Translation document for KR20190143298A will be used to address the instant claims’ limitations below).
Please note that claim 7 does not limit the composition of the patch and the amendment of claim 1 to eliminate the PVA and PVP of Burnett et al. do not affect this rejection.
Regarding claim 7, Burnett et al. teach forming a first layer by applying A solution, which includes PVA, on a PTFE-coated surface (substrate) and allowed to cool (drying), and forming a second layer formed by applying B solution including PVP, on the first layer, in order to produce a bilayer hydrogel patch (example 1 para 105-108). Thus, while Burnett meets the instantly claimed S1 and S3, Burnett et al. do not teach “treating a surface of the film with plasma” (S2).
Regarding claim 7, Park teaches “3D hydrogel laminate structure including a plurality of lattice type structures, The lattice type structure is, first hydrogel layer; the second hydrogel layer positioned at the upper side of the first hydrogel layer And the fibrous support inserted between the first hydrogel layer and the second hydrogel layer is included. A three-dimensional hydrogel laminated structure in which the plurality of lattice-shaped structures are laminated with each other in a direction in which the first hydrogel layer, the fibrous support, and the second hydrogel layer are laminated.” (claim 1). Park et al. also teach “The fibrous support may be a hydrophilic treatment selected from gas plasma” (para 27, para 94, claim 13).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to treat the laminate of Burnett et al. with plasma because Park et al. teach the advantages of doing so. Motivation is provided by the disclosure in Park et al. of the plasma treatment: “The fibrous support subjected to the hydrophilic treatment as described above may increase the bonding force between the stacking interfaces of the first hydrogel layer and the second hydrogel layer, and the bonding force between the interfaces of the lattice-shaped structures stacked adjacent to each other.” (para 94).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. in view of Park et al. as applied to claims 7 and 10 above, and further in view of Chen et al.
Neither Burnett et al. nor Park et al. teach formulations of hydrogel patch that do not include polyvinyl alcohol or polyvinylpyrrolidone.
Chen et al. teach “a novel double-network hydrogel based on dopamine-grafted oxidized sodium alginate (OSA-DA) and polyacrylamide (PAM)” which has “self-healing ability and exceptional tissue adhesiveness . . . suitable for repairing wound tissue” (page 33528 right column). Since, Chen’s invention has self-healing capability, Chen’s PAM teaching is interpreted as a self-healing polymer, and Chen’s teaching of sodium alginate meets the instantly claimed alginate limitation for the hydrogel patch.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to substitute the materials of Chen et al. for those of Burnett et al. with the expectation of beneficial results. This expectation is provided by Chen et al.’s teaching that their hydrogel has exceptional tissue adhesiveness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. in view of Park et al. as applied to claims 7 and 10 above, and further in view of Pettignano et al.
Neither Burnett et al. nor Park et al. teach the use of boronic acid conjugated to alginate.
Pettignano et al. teach biocompatible hydrogels comprising a “conjugate” of “Alg–B(OH)2” (alginate and boronic acid conjugate) (page 3351 right column).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to have used the alginate-boronic acid conjugate of Pettignano et al. while preparing the self-healing hydrogel of Chen et al. with the expectation of beneficial results. This expectation is provided by the statement in Pettignano et al. that their hydrogel possesses “Extraordinary elasticity, self-healing, injectability and multi-stimuli responsive properties . . . rapid self-healing of a damaged gel . . . good biocompatibility” (page 3353 left column) wherein the results “indicate that the material could be useful for different biomedical applications.” (page 3353 right column).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burnett et al. in view of Park et al. as applied to claims 7 and 10 above, and further in view of Kang et al.
Neither Burnett et al. nor Park et al. teach the combination of siloxane and isophorone bisurea as the self-healing polymer.
Kang et al. teach a “supramolecular network in polymer film realizes exceptional mechanical properties such as notch-insensitive high stretchability (1200%), high toughness of 12 000 J m−2, and autonomous self-healing” (abstract) comprising “PDMS–MPUx–IU1−x” (figure 1) which meets the instantly claimed first moiety of polymethylsiloxane (PDMS) and second moiety including isophrone bisurea (IU) (evidenced in left column of page 2).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to substitute the PDMS and isophorone bisurea of Kang et al. as the polymer of Chen et al. with the expectation of creating a viable self-healing hydrogel patch. This expectation is provided by Kang et al.’s teaching that “since most self-healing polymers are based on weak dynamic bonds, they easily break along locations where damage is incurred due to their low fracture energies typically at ≈100 J m−2 or less.
Response to Arguments
Applicant's arguments filed May 13, 2025 have been fully considered but they are not persuasive.
Applicant argues that the amendment of claim 1 overcomes the rejection under 35 USC 112(b). This is not persuasive because the trademark Matrigel is still present, see maintained rejection above.
Applicant argues that removing polyacrylamide, polyvinyl alcohol and polyvinylpyrrolidone from the Markush group in claims 1 and 8 obviates the art rejections. This was persuasive with regard to the 102 over Burnett et al. since they only disclose PVA and PVP. However, because claims 1 and 8 recite, “at least one selected from the group,” Chen et al. still applies because their alginate qualifies as one of the at least one to be selected.
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.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615