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
This application is a 371 of PCT/US2020/054838 filed 10/08/2020.
PCT/US2020/054838 has PRO of 62912617 filed 10/08/2019.
However, the subject matter of the therapeutic agent being “a cell” or “a protein” as recited in claim 15 is not disclosed in PCT/US2020/054838 or the provisional application of 62912617. Thus, claim 15 will not receive filing date benefit of the PCT/US2020/054838 application or the provisional application of 62912617.
Accordingly, claims 1, 4-11, 13-14, 16-20, 22-23, and 25-37 are afforded the effective filing date of 10/08/2019; and claim 15 is afforded the effective filing date of 04/04/2022 (actual filing date).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/07/2022, 10/19/2023, 11/13/2023, 04/19/2024, 06/21/2024, 08/06/2024, 10/17/2024, 12/06/2024, 03/12/2025, 08/20/2025, and 02/26/2026 have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 4-11, 13-20, 22, and 31-35, in the reply filed on 02/26/2026 is acknowledged.
Claims 23, 25-30, 36 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/26/2026.
Status of the Claims
This action is in response to preliminary papers filed 06/07/2024 in which claims 2, 3, 12, 21, and 24 were canceled; claims 1, 4-11, 13-20, 22-23, and 25-30 were amended; and claims 31-37 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4-11, 13-20, 22-23, 25-37 are pending in this instant application, of which claims 23, 25-30, 36 and 37 are withdrawn at this time as being drawn to non-elected group/invention.
Claims 1, 4-11, 13-20, 22, and 31-35 are examined herein on the merits for patentability.
Claim Objections
Claim 4 is objected to because of the following informalities: triethanolamine is recited twice in the claim. See lines 2 and 4 of claim 4. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: please remove the “or” before “Eosin Y,” as said “or” is not needed due to latter recitation “or a mixture thereof.” Appropriate correction is required.
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 introduces new matter as the claim recites the limitation: “a cell” and “a protein.” This is no support or disclosure in the specification for the generic (genus) recitation of “a cell” and “a protein” as they pertain to therapeutic agent.
While the specification from the published application (US 20240050621) discloses at paragraphs [0007], [0015], [0059]-[0061] and claims 14-16 that the therapeutic agent comprises an antibiotic, an anti-inflammatory drug, a growth factor, or any combination thereof, there is no disclosure of generically claimed genus of “a cell” or “a protein” as the therapeutic agent. Thus, Applicant does not have possession of the broad genus of “a cell” or “a protein” as generically recited in claim 15.
MPEP §2163.06 states: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments.
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendments at the time of filing of the instant application.
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 4 and 11 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.
Regarding claim 4, the parenthetical recitation “(50/50 blend)” in claim 4 is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 11, the claim recites the limitation "the sealant composition". There is insufficient antecedent basis for this limitation claim 11, claim 33, or claim 1 to which claim 11 depends from indirectly or directly from, respectively. It is noted that the preamble of claim 1 recites “a composition” and the preamble of claims 11 and 33 recites “the composition” and thus, it is unclear what “the sealant composition” in the body of claim 11 is referencing to, as there is no “sealant composition” in claim 1.
As a result, claims 4 and 11 do not clearly set forth the metes and bounds of patent protection desired.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 14-16, 17-20, and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Bharti et al (WO 2018/089515 A1).
Regarding claims 1 and 33-35, Bharti teaches a hydrogel formed photocrosslinking with visible light of a composition containing methacrylated gelatin, methacrylated hyaluronan, and a photoinitiator (pages 27, 29-30).
Regarding claims 14-16, Bharti teaches the hydrogel further contains a therapeutic agent such as a growth factor including epithelial growth factor (page 48).
Regarding claims 17-20, as discussed above, Bharti teaches structurally the same hydrogel as recited in claim 35. Thus, the properties of swelling ratio, viscosity, burst strength, and degradation rate as recited in claims 17-20, respectively, are inherent to the structurally same hydrogel of Bharti because "[p]roducts 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. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP §2112.01 (I)-(II).
As a result, the aforementioned teachings from Bharti are anticipatory to claims 1, 14-16, 17-20, and 33-35 of the instant invention.
Claim(s) 1, 7-8, 11, 17-20, and 32-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kessler et al (Journal of Tissue Engineering, 2017, 8: 1-14; cited ISR 04/04/2022).
Regarding claims 1 and 33-35, Kessler teaches a methacrylated gelatin/hyaluronan hydrogel that is photocrosslinked with a photoinitiator such as lithium phenyl-2,4,6-trimethylbenzoylphosphinate or Eosin (Abstract; pages 2-3).
Regarding claim 7, Kessler teaches the methacrylated hyaluronic acid is a glycidyl methacrylated hyaluronic acid (page 3, left column).
Regarding claim 8, Kessler teaches the methacrylated hyaluronic acid is present in the hydrogel at a concentration of 1% w/v (page 3, right column), which reads on the claimed between about 0.5% and 3% weight per volume (w/v).
Regarding claims 11 and 32 Kessler teaches the methacrylated gelatin is present in the hydrogel at a concentration of 4% w/v (page 3, right column), which reads on the claimed between about 0.5% and 4% weight per volume (w/v).
Regarding claims 17-20, as discussed above, Kessler teaches structurally the same hydrogel as recited in claim 35. Thus, the properties of swelling ratio, viscosity, burst strength, and degradation rate as recited in claims 17-20, respectively, are inherent to the structurally same hydrogel of Kessler because "[p]roducts 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. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP §2112.01 (I)-(II).
As a result, the aforementioned teachings from Kessler are anticipatory to claims 1, 7-8, 11, 17-20, and 32-35 of the instant invention.
Claim(s) 1, 8, 17-20, 31, and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (US 2017/0281828 A1).
Regarding claims 1, 31, and 33-35, Zhang teaches a hydrogel formed photocrosslinking of a composition containing gelatin methacrylate, methacrylate-hyaluronic acid, polyethylene glycol diacrylate, and a photoinitiator such as lithium phenyl-2,3,6-trimethylbenzoylphosphinate ([0046]-[0048]).
Regarding claim 8, Zhang teaches the methacrylate-hyaluronic acid is present in the composition at a concentration of 1% or 2.5% w/v ([0046]-[0047]), which reads on the claimed range of “between about 0.5% and 3% weight per volume (w/v).
Regarding claims 17-20, as discussed above, Zhang teaches structurally the same hydrogel as recited in claim 35. Thus, the properties of swelling ratio, viscosity, burst strength, and degradation rate as recited in claims 17-20, respectively, are inherent to the structurally same hydrogel of Zhang because "[p]roducts 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. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP §2112.01 (I)-(II).
As a result, the aforementioned teachings from Kessler are anticipatory to claims 1, 8, 17-20, 31, and 33-35 of the instant invention.
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.
Claim(s) 1, 4-6, 8-10, 13-20, 31, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2017/0281828 A1), and further in view of Khademhosseini et al (WO 2017/139318 A1).
The composition and hydrogel of claims 1, 8, 17-20, 31, and 33-35, respectively, are discussed above, said discussion being incorporated herein in its entirety.
However, Zhang does expressly teach the limitations of claims 4-6, 9-11, 13-16, and 32.
Regarding claims 4-6, Khademhosseini teaches a hydrogel formed from photocrosslinking with visible light of a composition containing methacrylated gelatin and a photoinitiator, wherein the photoinitiator is selected from the group consisting of: Eosin Y, triethanolamine, vinyl caprolactam, dl-2,3-diketo- 1,7,7- trimethylnorcamphane (CQ), 1 -phenyl- 1 ,2-propadione (PPD), 2,4,6-trimethylbenzoyl- diphenylphosphine oxide (TPO), bis(2,6-dichlorobenzoyl)-(4-propylphenyl)phosphine oxide (Ir819), 4,4'-bis(dimethylamino)benzophenone, 4,4'-bis(diethylamino)benzophenone, 2- chlorothioxanthen-9-one, 4-(dimethylamino)benzophenone, phenanthrenequinone, ferrocene, diphenyl(2,4,6 trimethylbenzoyl)phosphine oxide / 2-hydroxy-2-methylpropiophenone (50/50 blend), dibenzosuberenone, (benzene) tricarbonylchromium, resazurin, resorufin, benzoyltrimethylgermane, derivatives thereof, and any combination thereof ([0008]-[0034], [0060]-[0076] and [0085]-[0086]; claims 1-36). Khademhosseini further teaches the composition is exposed to visible light with a wavelength in the range of 450 to 550 nm ([0033], [0064], [0076]).
It would have been obvious to one of ordinary skill in the art to incorporate the photoinitiator as taught by Khademhosseini as the photoinitiator used in photocrosslinking of the hydrogel of Zhang, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Khademhosseini provided the guidance to do so by teaching that photoinitiators such as Eosin Y, triethanolamine, vinyl caprolactam, dl-2,3-diketo- 1,7,7- trimethylnorcamphane (CQ), 1 -phenyl- 1 ,2-propadione (PPD), 2,4,6-trimethylbenzoyl- diphenylphosphine oxide (TPO), bis(2,6-dichlorobenzoyl)-(4-propylphenyl)phosphine oxide (Ir819), 4,4'-bis(dimethylamino)benzophenone, 4,4'-bis(diethylamino)benzophenone, 2- chlorothioxanthen-9-one, 4-(dimethylamino)benzophenone, phenanthrenequinone, ferrocene, diphenyl(2,4,6 trimethylbenzoyl)phosphine oxide / 2-hydroxy-2-methylpropiophenone (50/50 blend), dibenzosuberenone, (benzene) tricarbonylchromium, resazurin, resorufin, and benzoyltrimethylgermane, are nontoxic and suitable photoinitiators used in photocrosslinking of hydrogel, especially for hydrogel used in corneal repair (Khademhosseini: [0008]-[0034], [0060]-[0076] and [0085]-[0086], [0129]; claims 1-36), which is the application to which the hydrogel of Zhang is used for (Zhang: [0045]-[0048]). Thus, an ordinary artisan seeking to produce a hydrogel that is non-toxic for corneal repair would have looked using the photoinitiator as taught by Khademhosseini as the photoinitiator used in photocrosslinking of the hydrogel of Zhang, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 9-10 and 13, Khademhosseini teaches the methacrylated gelatin is a methacryloyl-substituted gelatin comprising methacrylamide substitution and methacrylate substitution, and the ratio of methacrylamide substitution to methacrylate substitution is between 80:20 and 99: 1 ([0009], [0029], [0066]; claim 3). Khademhosseini further teaches the methacryloyl-substituted gelatin has a degree of methacryloyl substitution between 30% and 85% ([0066]-[0067], [0072]; claim 2).
It would have been obvious to one of ordinary skill in the art to incorporate the methacryloyl-substituted gelatin of Khademhosseini as the methacrylated gelatin of Zhang, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Khademhosseini provided the guidance to do so by teaching that the methacryloyl-substituted gelatin having the degree of substitution and substitution ratio as recited in claims 9-10 and 13 are especially suitable for use in forming hydrogel for corneal repair, as said methacryloyl-substituted gelatin has improved bioadhesive and mechanical properties (Khademhosseini: [0006], [0073], [0075], [0086], [0096]). It is noted that Zhang is also drawn to using the hydrogel for in corneal repair (Zhang: [0045]-[0048]). Thus, an ordinary artisan seeking to provide a hydrogel that have improved bioadhesive and mechanical properties for repair and reconstruction of defects and injuries to the cornea, would have looked to incorporating the methacryloyl-substituted gelatin of Khademhosseini as the methacrylated gelatin of Zhang, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 14-16, Khademhosseini teaches the composition further contains a therapeutic agent including an antibacterial, an anti-fungal, an anti-viral, an anti-acanthamoebal, an anti-inflammatory, an immunosuppressive, an anti-glaucoma, an anti-VEGF, a growth factor, or any combination thereof ([0015], [0024], [0034], [0071]). Khademhosseini teaches growth factors include: epidermal growth factor, platelet-derived growth factor, vitamin A, fibronectin, annexin a5, albumin, alpha-2 macroglobulin, fibroblast growth factor b, insulin-like growth factor-I, nerve growth factor, and hepatocyte growth factor ([0071]).
It would have been obvious to one of ordinary skill in the art to include a therapeutic agent including an antibacterial, an anti-fungal, an anti-viral, an anti-acanthamoebal, an anti-inflammatory, an immunosuppressive, an anti-glaucoma, an anti-VEGF, a growth factor, or any combination thereof, in the hydrogel of Zhang, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Khademhosseini provided the guidance to do so by teaching that the hydrogel of Zhang used for corneal repair can include a therapeutical agent including an antibacterial, an anti-fungal, an anti-viral, an anti-acanthamoebal, an anti-inflammatory, an immunosuppressive, an anti-glaucoma, an anti-VEGF, a growth factor, or any combination thereof, so as the hydrogel when delivered to the cornea would promote healing and regrowth of the cornea, prevent or treat infections or immune response, prevent or treat corneal vessel formation, treat increased intraocular pressure, or promote general eye health (Khademhosseini: [0071]). Thus, an ordinary artisan seeking to provide a therapeutically effective hydrogel for promoting healing and regrowth of the cornea, preventing or treating infections or immune response, preventing or treating corneal vessel formation, treating increased intraocular pressure, or promoting general eye health, would have looked to include a therapeutic agent including an antibacterial, an anti-fungal, an anti-viral, an anti-acanthamoebal, an anti-inflammatory, an immunosuppressive, an anti-glaucoma, an anti-VEGF, a growth factor, or any combination thereof, in the hydrogel of Zhang, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1, 8, 11, 17-20, and 31-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2017/0281828 A1), and further in view of Kessler et al (Journal of Tissue Engineering, 2017, 8: 1-14; cited ISR 04/04/2022).
The composition and hydrogel of claims 1, 8, 17-20, 31, and 33-35, respectively, are discussed above, said discussion being incorporated herein in its entirety.
However, Zhang does not expressly teach the concentration of the chemically modified gelatin such as GelMA of claims 11 and 32.
Regarding claims 11 and 32, Kessler teaches a methacrylated gelatin/hyaluronan hydrogel that is photocrosslinked with a photoinitiator such as lithium phenyl-2,4,6-trimethylbenzoylphosphinate or Eosin (Abstract; pages 2-3). Kessler teaches the methacrylated hyaluronic acid is present in the hydrogel at a concentration of 1% w/v and the methacrylated gelatin is present in the hydrogel at a concentration of 4% w/v (Abstract; pages 2-3).
It would have been obvious to one of ordinary skill in the art to optimize the concentration of the methacrylated gelatin in the hydrogel of Zhang to a concentration of 4% w/v, and produce the claimed invention. One of ordinary skill in the art would have been motivated do so because Kessler provided the guidance to so by teaching that for a hydrogel containing 1% w/v methacrylated hyaluronic acid, a 4% w/v of methacrylated gelatin is suitable concentration for use in producing stable composite hydrogel of methacrylated gelatin/hyaluronan (Kessler: Abstract; pages 2-3). Thus, an ordinary artisan would have looked to optimizing the concentration of methacrylated gelatin in the hydrogel of Zhang to a concentration of 4% w/v to achieve a desired stable composite hydrogel of methacrylated gelatin/hyaluronan, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1, 7-8, 17-20, 31, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2017/0281828 A1), and further in view of Kumar et al (US 2009/0118423 A1).
The composition and hydrogel of claims 1, 8, 17-20, 31, and 33-35, respectively, are discussed above, said discussion being incorporated herein in its entirety.
However, Zhang does expressly teach the methacrylated hyaluronic acid comprises glycidyl methacrylate-hyaluronic acid of claim 7
Regarding claim 7, Kumar teaches glycidyl methacrylate-hyaluronic acid is suitable for use in preparing biomimetic hydrogel that is used for promoting tissue repair and wound healing ([0002]-[0005] and [0049]).
It would have been obvious to one of ordinary skill in the art to incorporate glycidyl methacrylate-hyaluronic acid as the methacrylate hyaluronic acid in the hydrogel of Zhang, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Kumar provided the guidance to do so by teaching glycidyl methacrylate-hyaluronic acid is a suitable acrylated hyaluronic acid used for forming biomimetic hydrogel that is used for protein tissue repair, which is the type of hydrogel desired by Zhang ([0042]). Thus, an ordinary artisan would have looked to suitable known acrylated hyaluronic acid including glycidyl methacrylate-hyaluronic acid, and incorporate said glycidyl methacrylate-hyaluronic acid as the methacrylate hyaluronic acid in the hydrogel of Zhang so as to achieve a desired biomimetic hydrogel, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1, 8, 17-20, 22, 31, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 2017/0281828 A1), and further in view of Park et al (Biomaterial, 2003, 24: 893-900).
The composition and hydrogel of claims 1, 8, 17-20, 31, and 33-35, respectively, are discussed above, said discussion being incorporated herein in its entirety.
However, Zhang does expressly teach the concentration PEGDA of claim 22.
Regarding claim 22, Park teaches a photopolymerized hyaluronic acid-based hydrogel comprising a methacrylated hyaluronic acid polymerized with polyethylene glycol diacrylate (PEGDA), wherein the concentration of polyethylene glycol diacrylate used in forming the hydrogel is 2% w/v so as to provide a hydrogel with improved mechanical properties, elastic modulus, and swelling behavior (Abstract; pages 894-899).
It would have been obvious to one of ordinary skill in the art to optimize the concentration of polyethylene glycol diacrylate in the hydrogel of Zhang to a concentration of 2% w/v, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Park provided the guidance to do so by teaching that a hydrogel containing a methacrylated hyaluronic acid can utilize polyethylene glycol diacrylate at a concentration of 2 w/v to provide a resultant hydrogel with improved mechanical properties, elastic modulus, and swelling behavior. Thus, an ordinary artisan looking to provide a hydrogel that have improved mechanical properties, elastic modulus, and swelling behavior would have looked to optimizing the concentration of polyethylene glycol diacrylate in the hydrogel of Zhang to a concentration of 2% w/v, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 4-11, 13-20, 22, and 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11058800 in view of Zhang et al (US 2017/0281828 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘800 significantly overlap with the subject matter of instant claims, i.e., compositions comprising a methacryloyl-substituted gelatin and a visible light activated photoinitiator, wherein the methacryloyl-substituted gelatin comprises methacrylamide substitution and methacrylate substitution, and a ratio of methacrylamide substitution to methacrylate substitution in the methacryloyl-substituted gelatin is between 80:20 and 99:1.
While the claims in the Patent ‘800 do not recite the composition also contains methacrylated hyaluronic acid, it would have been obvious to include methacrylated hyaluronic acid in the composition of Patent ‘800 in view of the guidance Zhang ([0046]-[0048]).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11058800 in view of Zhang.
Claims 1, 4-11, 13-20, 22, and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 9, 13, 15, 20, 24, 39, and 41-48 of copending Application No. 17285743 in view of Zhang et al (US 2017/0281828 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending Application ‘743 significantly overlap with the subject matter of instant claims, i.e., compositions comprising a methacryloyl-substituted gelatin, polyethylene glycol diacrylate (PEGDA), and a visible light activated photoinitiator.
While the claims in the copending Application ‘743 do not recite the composition also contains methacrylated hyaluronic acid, it would have been obvious to include methacrylated hyaluronic acid in the composition of copending Application ‘743 in view of the guidance Zhang ([0046]-[0048]).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 17285743 in view of Zhang.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-11, 13-20, 22, and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37, 39-43, and 46-57 of copending Application No. 18471748 in view of Zhang et al (US 2017/0281828 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in copending application ‘748 significantly overlap with the subject matter of instant claims, i.e., compositions comprising a methacryloyl-substituted gelatin and a visible light activated photoinitiator, wherein the methacryloyl-substituted gelatin comprises methacrylamide substitution and methacrylate substitution, the methacryloyl-substituted gelatin has a degree of methacryloyl substitution between 30% and 85%, and a ratio of methacrylamide substitution to methacrylate substitution in the methacryloyl-substituted gelatin is between 80:20 and 99:1, and wherein the composition also contains a therapeutic agent.
While the claims in the copending application ‘748 do not recite the composition also contains methacrylated hyaluronic acid, it would have been obvious to include methacrylated hyaluronic acid in the composition of copending application ‘748 in view of the guidance Zhang ([0046]-[0048]).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 18471748 in view of Zhang.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613