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 .
Claims 36-56 are pending in the application. Claims 36-38 and 41 have been amended. Claims 44-56 are newly added.
Election/Restrictions
Applicant’s election without traverse Group IV, claims 36-43 and photoinitiator as the further compound in the reply filed on May 29, 2026 is acknowledged. With the choice of Group IV, the photoinitiator is already a part of the composition used in the method. As such, Applicant elected the transforming growth factor beta-1 (TGFβ-1) as the further compound per the interview conducted July 2, 2026 and July 8, 2026. See the Interview Summary.
Claims 50, 52, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 29, 2026 and July 8, 2026.
Claims 36-56 are pending in the application. Claims 50, 52, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 36-49, 51, and 54-56 will presently be examined to the extent they read on the elected subject matter of record.
Priority
This application is a National Stage Entry of PCT/US2021/051096 filed September 20, 2021, which claims benefit to U.S. Provisional Application No. 63/080,890 filed September 21, 2020.
Information Disclosure Statement
Receipt of Information Statements filed March 21, 2023, April 25, 2023, May 19, 2023, June 22, 2023, July 17, 2023, December 14, 2023, January 3, 2024, June 25, 2024, October 3, 2024, and January 14, 2025 is acknowledged.
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 43, 45 and 48 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 43, the phrase "such that" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the phrase “the implanted material travels with the physis as the bone grows over time” is a part of the claimed invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 45 recites the broad recitation 16% to 30% and the claim also recites at least 16% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 45 recites the broad recitation 30%, and the claim also recites at least 16% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 48 recites the broad recitation 6% to 10%, and the claim also recites 8% to 10% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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 36 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Toboas et al. (WO 2017/152112, Toboas et al. 1). Toboas et al. 1 cited by Applicant on the IDS filed 3/21/2023.
Toboas et al. 1 disclose methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures (Abstract). Toboas et al. 1 teach bovine type B gelatin (gelatin), PEG (polyethylene glycol), and intestinal mucosa sodium heparin (heparin) were methacrylated, purified and characterized in-house. The hydrogels were prepared by dissolving polymers in HBSS (Hanks’ Balanced Salt Solution, saline liquid), adding 0.005% w/v initiator lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP) (photoinitiator), and photopolymerizing with 2.5 J/cm2/mm UV-A (light) (page 11, lines 28-32).
Toboas et al. 1 meet all the limitations of the claim and thereby anticipate the claim.
Claim 36 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Toboas et al. (WO 2019/241577, Toboas et al. 2). Toboas et al. 2 cited by Applicant on the IDS filed 3/21/2023.
Regarding claim 36, Toboas et al. 2 disclose methacrylated PEG, gelatin and sodium heparin were used. Hydrogel blends were formed by dissolving polymers in PBS, which is phosphate buffered saline, mixing at the indicated mass ratio of (6.3% P, 2.1% G, 1.6% H w/v). For the implantable hydrogel infused device, the photocrosslinking initiator is added during the mixing step of the hydrogel precursor. 0.005% w/v LAP initiator (lithium phenyl-2,4,6-trimethylbenzoyl phosphinate) (photoinitiator) and photopolymerizing with 2.5 J/cm2/mm UV-A (salt) (page 21, lines 19-32).
Toboas et al. 2 meet all the limitations of the claim and thereby anticipate 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36-41, 43-49, 51, and 54-56 are rejected under 35 U.S.C. 103 as being unpatentable over Toboas et al. (WO 2017/152112, Toboas et al. 1) in view of Toboas et al. (WO 2019/241577, Toboas et al. 2). Toboas et al. 1 and Toboas et al. 2 cited by Applicant on the IDS dated 3/21/2023.
Applicant’s Invention
Applicant claims a method comprising: combining a composition comprising poly(ethylene glycol) (“PEG”), gelatin (“GEL”), and heparin (“HEP”) with a saline liquid and a photoinitiator or other catalyst to form an implantable material. Applicant claims a method comprising implanting an implantable material, formed by combining a composition comprising poly(ethylene glycol) (“PEG”), gelatin (“GEL”), and heparin (“HEP”) with a saline liquid and a photoinitiator or other catalyst, at a site of a growth plate injury in a patient.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Regarding claim 36, 41, and 49, Toboas et al. 1 teach methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures (Abstract). Toboas et al. 1 teach bovine type B gelatin, PEG, and intestinal mucosa sodium heparin were methacrylated, purified and characterized in-house. The hydrogels were prepared by dissolving polymers in HBSS, adding 0.005% w/v initiator lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP), and photopolymerizing with 2.5 J/cm2/mm UV-A (page 11, lines 28-32).
Toboas et al. 1 teach hydrogel compositions, such as those containing poly(ethylene glycol), gelatin, and heparin (page 5, lines 13-15).
Regarding claims 37, 38, 43, and 44, Toboas et al. 1 teach a method of forming a layered biomaterial implant in an epiphyseal growth plate, injecting the biomaterial of claim 1 into a defect in the growth plate; allowing the biomaterial to self-segregate based on gravitation interaction with the particles; and causing the biomaterial to solidify in a desired configuration that establishes native structure of the growth plate (page 24, claim 15). Toboas et al. 1 teach the hydrogel comprises PEG, gelatin, and heparin (page 23, claim 2).
Regarding claim 39, Toboas et al. 1 teach a method of forming a layered biomaterial implant in an epiphyseal growth plate, comprising: injecting the biomaterial of claim 1, which comprises PEG, gelatin, and heparin, into the growth plate; allowing the biomaterial to self-segregate based on gravitation interaction with the particles, and causing the biomaterial to solidify in a desired segregated configuration that established native structure of the growth plate (page 24, lines 24-30).
Regarding claims 40 and 44, Toboas et al. 1 teach the biological compositions can be applied via various different modalities depending on the nature of the physeal injury. Toboas et al. 1 teach an injectable hydrogel can be used to treat physeal fractures and small deficits after boney tether removal, for example, the implantable hydrogel infused scaffold can be used to treat large deficits such as those resulting from osteosarcoma resection (page 3, lines 30-32; page 8, lines 29-34-page 9, line 1).
Toboas et al. 1 teach biomaterial, systems, and methods for guiding regeneration of a growth plate or similar interfacial tissue structures (page 3, lines 19-20).
Toboas et al. 1 teach implantable constructs can be fabricated where cell, materials and/or growth factors are patterned into spatial regions using layered assembly (page 4, line 34-page 5, lines 1-2).
Toboas et al. 1 teach physeal regeneration in a second round of the goat model. This model test re-formation of the gradient tissue architecture using the PGH hydrogel and spatially discrete deliver of growth factors with the self-segregating microparticles (page 18, lines 29-31).
Toboas et al. 1 teach the injectable hydrogels can be readily translated to surgical use in patients. They can be more readily infused into difficult-to-operate sites and can fill defects of variable sizes. They also accommodate the surrounding healthy tissue and induce less damage than pre-shaped scaffolds that can require resection (page 10, lines 20-26).
Regarding claim 47, Toboas et al. 1 teach the hydrogel polymers can be made photochemically crosslinkable (page 11, lines 20-21).
Regarding claim 48, Toboas et al. 1 teach the hydrogels have a density of 10% w/v (page 14, lines 31-33; page 15, line 6).
Regarding claim 51, Toboas et al. 1 teach TGF-β-1 was used to promote chondrogenesis (page 19, 1-2).
Regarding claim 54, Toboas et al. 1 teach alternatives to heparin include chondroitin sulphate (page 11, lines 8-13).
Regarding claim 55, Toboas et al. 1 teach alternatives to gelatin include collagens (page 11, lines 1-7).
Regarding claim 56, Toboas et al. 1 teach alternatives to PEG include poly(vinyl alcohol).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Toboas et al. 1 does not specifically disclose the HEP comprises at least 16%, at least 30%, or from 16% to 30%, of a total mass of the PEG, the GEL, and the HEP combined, as claimed in claim 45, or the mass ratio of PEG:GEL:HEP is about 3:3:4 or
about 63:21:16, as claimed in claim 46. It is for this reason Toboas et al. 2 is added as the secondary reference.
Toboas et al. 2 teach biomaterials that comprise a hydrogel comprising PEG, gelatin, and a glycosaminoglycan with sulfated moiety; and cytokines (Abstract),
Toboas et al. 2 teach that the glycosaminoglycan with sulfated moiety is heparin.
Regarding claim 46, Toboas et al. 2 teach the hydrogel comprises PEG, gelatin, and heparin in a 3:4:3 proportion by mass (page 2, lines 19-20).
Regarding claim 45, Toboas et al. 2 teach the hydrogel comprising from 7.5% to 8.5% by mass of PEG, gelatin and a glycosaminoglycan with sulfated moiety (page 2, lines 23-24).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Toboas et al. 1 and Toboas et al. 2 and use experimentation and optimization to use at least 16%, at least 30%, or from 16% to 30%, of HEP based on the total mass of the PEG, the GEL, and the HEP combined, as claimed in claim 45. Toboas et al. 1 teach a method of forming a layered biomaterial implant in an epiphyseal growth plate, injecting the biomaterial of claim 1 into a defect in the growth plate; allowing the biomaterial to self-segregate based on gravitation interaction with the particles; and causing the biomaterial to solidify in a desired configuration that establishes native structure of the growth plate. Toboas et al. 1 teach the hydrogel comprises PEG, gelatin, and heparin. Toboas et al. 2 teach biomaterials that comprise a hydrogel comprising PEG, gelatin, and a glycosaminoglycan with sulfated moiety; wherein the glycosaminoglycan with sulfated moiety is heparin and cytokines. Toboas et al. 1 and Toboas et al. 2 teach the same implantable hydrogels. Toboas et al. 2 teach the hydrogel comprising from 7.5% to 8.5% by mass of PEG, gelatin and a glycosaminoglycan with sulfated moiety. Toboas et al. 2 teach when forming the hydrogel PEG, gelatin, and heparin are mixed at the indicated mass ratio of (6.3% P, 2.1% G, 1.6% H w/v). One of ordinary skill in the art would have been motivated to use the teachings of Toboas et al. 2 as a guide in Toboas et al. 1 to determine the amount of heparin to use in the compositions, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007). In addition, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Toboas et al. 1 and Toboas et al. 2 and use experimentation and optimization to determine the mass ratio of PEG:GEL:HEP. Toboas et al. 1 teach a method of forming a layered biomaterial implant in an epiphyseal growth plate, injecting the biomaterial of claim 1 into a defect in the growth plate; allowing the biomaterial to self-segregate based on gravitation interaction with the particles; and causing the biomaterial to solidify in a desired configuration that establishes native structure of the growth plate. Toboas et al. 1 teach the hydrogel comprises PEG, gelatin, and heparin. Toboas et al. 2 teach biomaterials that comprise a hydrogel comprising PEG, gelatin, and a glycosaminoglycan with sulfated moiety; wherein the glycosaminoglycan with sulfated moiety is heparin and cytokines. Toboas et al. 1 and Toboas et al. 2 teach the same implantable hydrogels. Toboas et al. 2 teach the hydrogel comprises PEG, gelatin, and heparin in a 3:4:3 proportion by mass. One of ordinary skill in the art would have been motivated to use the teachings of Toboas et al. 2 as a guide in Toboas et al. 1 to determine the amount of heparin to use in the compositions, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007). In addition, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Toboas et al. (WO 2017/152112, Toboas et al. 1) in view of Toboas et al. (WO 2019/241577, Toboas et al. 2) as applied to claims 36-41, 43-49, 51, and 54-56 above, and further in view of the Temenoff Publication (2000, Temenoff et al.). Toboas et al. 1 and Toboas et al. 2 cited by Applicant on the IDS dated 3/21/2023.
Applicant’s Invention
Applicant claims a method comprising: combining a composition comprising poly(ethylene glycol) (“PEG”), gelatin (“GEL”), and heparin (“HEP”) with a saline liquid and a photoinitiator or other catalyst to form an implantable material. Applicant claims a method comprising implanting an implantable material, formed by combining a composition comprising poly(ethylene glycol) (“PEG”), gelatin (“GEL”), and heparin (“HEP”) with a saline liquid and a photoinitiator or other catalyst, at a site of a growth plate injury in a patient. Applicant claims the application of light occurs while the implantable material is within a patient.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Toboas et al. 1 and Toboas et al. 2 with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Toboas et al. 1 and Toboas et al. 2 do not specifically disclose the application of light occurs while the implantable material is within a patient. It is for this reason the Temenoff Publication (Temenoff et al.) is added as a secondary reference.
Temenoff et al. teach that both polymeric materials and ceramics have been studied as a means to repair defects in bone. Temenoff et al. teach polymers offer some distinct advantages over ceramic materials (page 2406, col. 1, 2. Bone tissue engineering, paragraph 1). Like ceramics, they are injectable and harden in situ, but the mechanical properties and degradation times can be more easily tailored with polymers than with calcium phosphate materials (page 2407, col. 2, 2.2 Polymeric materials, paragraph 1). Temenoff et al. teach that to provide the necessary mechanical strength for use in orthopedics, injectable polymers must be polymerized or cross-linked in situ. This curing is usually initiated via the use of light (page 2407, 2.2 Polymeric materials, paragraph 2). Temenoff et al. teach that while transdermal photopolymerization may not be possible for many orthopedic applications, a light source may be provided arthroscopically for some procedures, as in the case of bone (page 2410, col. 1, first full paragraph).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Toboas et al. 1, Toboas et al. 2, and Temenoff et al. and apply light while the implantable material is within a patient. Toboas et al. 1 teach a method of forming a layered biomaterial implant in an epiphyseal growth plate, injecting the biomaterial of claim 1 into a defect in the growth plate; allowing the biomaterial to self-segregate based on gravitation interaction with the particles; and causing the biomaterial to solidify in a desired configuration that establishes native structure of the growth plate. Toboas et al. 1 teach the hydrogel comprises PEG, gelatin, and heparin. Toboas et al. 2 teach biomaterials that comprise a hydrogel comprising PEG, gelatin, and a glycosaminoglycan with sulfated moiety; wherein the glycosaminoglycan with sulfated moiety is heparin and cytokines. Toboas et al. 1 and Toboas et al. 2 teach the same implantable hydrogels. Toboas et al. 1 teach methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures. Toboas et al. 1 teach bovine type B gelatin, PEG, and intestinal mucosa sodium heparin were methacrylated, purified and characterized in-house. The hydrogels were prepared by dissolving polymers in HBSS, adding 0.005% w/v initiator lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP), and photopolymerizing with 2.5 J/cm2/mm UV-A. Toboas et al. 1 and Toboas et al. 2 provide methods of guiding regeneration of an epiphyseal growth plate. One of ordinary skill in the art would have been motivated to use light while the implantable material is within a patient because Temenoff et al. teach that to provide the necessary mechanical strength for use in orthopedics, injectable polymers must be polymerized or cross-linked in situ. This curing is usually initiated via the use of light. In situ indicates that the curing with light is done inside a patient. Temenoff et al. teach that polymeric materials have been studied as a means to repair defects in bone. Temenoff et al. further teach polymers are injectable and harden in situ, but the mechanical properties and degradation times can be more easily tailored with polymers than with calcium phosphate materials. As such, one of ordinary skill in the art would have been motivated to use the light that is used in the methods taught by Toboas et al. 1 and Toboas et al. 2 to form the hydrogels inside a patient since it is known in the art based on the teachings of Temenoff et al.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 36, 37, 38, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, and 9 of U.S. Patent No. 11,583,613 (‘613) in view of over Toboas et al. (WO 2017/152112, Toboas et al. 1). Although the claims at issue are not identical, they are not patentably distinct from each other because each is drawn to a biomaterial comprising PEG, gelatin, and heparin (claims 36 and 37; claims 1, 2, 8, and 9, U.S. Patent ‘613). Each claims the biomaterial is injectable for regeneration of an epiphyseal growth plant (claim 38, instant invention; claim 1 and 8, U.S. Patent ‘613). U.S. Patent No. ‘613 does not specifically disclose combining PEG, gelatin, and heparin with a saline liquid and a photoinitiator or other catalyst to form an implantable material. It is for this reason Toboas et al. 1 is added as a secondary reference. Toboas et al. 1 teach methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures. Toboas et al. 1 teach bovine type B gelatin, PEG, and intestinal mucosa sodium heparin were methacrylated, purified and characterized in-house. The hydrogels were prepared by dissolving polymers in HBSS, adding 0.005% w/v initiator lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP), and photopolymerizing with 2.5 J/cm2/mm UV-A. HBSS is a saline liquid and lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP) is a photoinitiator. It would have been obvious to one of ordinary skill in the art to use the teachings of Toboas et al. 1 to form the hydrogels and biomaterials that are used to regenerate an epiphyseal growth plate, as one of ordinary skill in the art would have been motivated to use a known technique to form the hydrogels used for the same methods with a reasonable expectation of success. For these reasons, one of ordinary skill in the art would have found the instant invention obvious over the claims of U.S. Patent No. ‘613.
Claims 36, 37, 38, 44, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 9, and 11 of U.S. Patent No. 12,440,604 (‘604) in view of over Toboas et al. (WO 2017/152112, Toboas et al. 1). Although the claims at issue are not identical, they are not patentably distinct from each other because each is drawn to a biomaterial comprising PEG, gelatin, and heparin and a method comprising injecting or implanting the biomaterial (claims 36, 37, and 38; claims 1, 4, and 8, U.S. Patent ‘604). Each claims the biomaterial comprises TGF-β-1 (claim 51, instant invention; claim 1, U.S. Patent No. ‘604). Each claims bone regeneration (claim 38, instant invention; claim 9, U.S. Patent ‘604). Each claims the hydrogel comprises the PEG, the gelatin, and the heparin in about a 3:4:3 proportion mass (claim 46, instant invention, claim 11, U.S. Patent No. ‘604). U.S. Patent No. ‘604 does not specifically disclose combining PEG, gelatin, and heparin with a saline liquid and a photoinitiator or other catalyst to form an implantable material. It is for this reason Toboas et al. 1 is added as a secondary reference. Toboas et al. 1 teach methods for guiding regeneration of an epiphyseal growth plate or similar interfacial tissue structures. Toboas et al. 1 teach bovine type B gelatin, PEG, and intestinal mucosa sodium heparin were methacrylated, purified and characterized in-house. The hydrogels were prepared by dissolving polymers in HBSS, adding 0.005% w/v initiator lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP), and photopolymerizing with 2.5 J/cm2/mm UV-A. HBSS is a saline liquid and lithium phenyl-2,4,6-trimethylbenzoyl phosphinate (LAP) is a photoinitiator. It would have been obvious to one of ordinary skill in the art to use the teachings of Toboas et al. 1 to form the hydrogels and biomaterials that are used to regenerate an epiphyseal growth plate, as one of ordinary skill in the art would have been motivated to use a known technique to form the hydrogels used for the same methods with a reasonable expectation of success. For these reasons, one of ordinary skill in the art would have found the instant invention obvious over the claims of U.S. Patent No. ‘604.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDRIAE M HOLT/ Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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