DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 10, 2025 has been entered.
Status of the Claims
Claims 1-52 were originally filed August 23, 2021.
The amendment received October 29, 2021 canceled claims 1-29 and 37-52, amended claim 36, and added new claims 53-65.
The amendment received December 15, 2022 changed the status identifiers only.
The amendment received April 10, 2023 amended claims 30 and 54-57 and canceled claim 53.
The amendment filed December 5, 2023 amended claim 30. Please note: claim 57 is indicated as “(Withdrawn-Currently Amended)”, but no amendments are present.
The amendment received December 9, 2024 amended claim 30 and canceled claim 56.
The amendment received September 10, 2025 canceled claim 55.
Claims 30-36, 54, and 57-65 are currently pending.
Claims 30, 35, 36, and 54 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, an at least partially denatured gelatin, a scaffold, and a bioactive agent as the species in the reply filed on December 15, 2022. Claims 31-34 and 57-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Priority
The present application is a CON of 14/941,814 filed November 16, 2015 (now U.S. Patent 11,097,033) which is a CON of 12/673,400 filed February 12, 2010 (now U.S. Patent 9,216,235) which is a 371 (National Stage) of PCT/AU2008/001178 and claims foreign priority to AU 2008901531 filed March 31, 2008, AU 2007904381 filed August 14, 2007, and AU 2007904359 filed August 14, 2007.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Product-by-Process Claims
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
Please note: the new limitation of “and wherein said cross-linked 3-dimensional matrix comprises bonds formed by said irradiation between individual molecules of the at least partially denatured protein” does not appear to add any additional structure to the claims (wherein the biomaterial is already cross-linked through irradiation – e.g. bonds formed). If additional structure is added, applicants are respectfully requested to specifically point out support in the originally filed specification for the new structure.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 30, 35, and 54 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Fassihi et al., 1988, Influence of Gamma Radiation on the Gel Rigidity Index and Binding Capability of Gelatin, Journal of Pharmaceutical Sciences, 77(10): 876-879.
For present claims 30, 35, and 54, Fassihi et al. teach biomaterials comprising gelatin gels wherein the gelatin was obtained by alkali treatment and the gel was formed by irradiation in conjunction with cobalt (please refer to the entire reference particularly the abstract; Experimental Section).
Therefore, the teachings of Fassihi et al. anticipate the claims.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (b) as being anticipated by Fassihi et al. for claims 30, 35, and 54 were considered but are not persuasive for the following reasons.
Applicants contend that Fassihi et al. do not teach a cross-linked 3D matrix of a protein or peptide cross-linked through irradiation of a photoactivatable metal-ligand complex and an electron acceptor. Applicants appear to argue unexpected results.
Applicants’ arguments are not convincing since the teachings of Fassihi et al. anticipate the biomaterial of the instant claims. It is respectfully noted that the biomaterial of the present claims is drawn to a cross-linked 3D matrix of a protein or peptide wherein partially denatured gelatin is utilized as a starting material. The majority of the claim limitations are product-by-process limitations. Only the structure of the presently claimed biomaterial is provided patentable weight. Fassihi et al. teach alkali-treated gelatin which is irradiated to form bonds (please refer to the entire specification particularly the Experimental section). Furthermore, the present claims do not require the photoactivatable metal-ligand complex in the biomaterial. However, Fassihi et al. teach rods of cobalt labeled pellets wherein gelatin samples are surrounding the cobalt. Applicants should provide structural information in the claims as to why an electron acceptor would alter the biomaterial.
Examples 4 and 5 show that different electron acceptors have different crosslinking ability. However, the electron acceptor is not defined in the present claims.
It is respectfully noted that unexpected results must be commensurate in scope with the present claims. The present claims are much broader in scope than the Examples and the Figures in the originally filed specification.
Claims 30, 35, 36, and 54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fassihi et al., 1988, Influence of Gamma Radiation on the Gel Rigidity Index and Binding Capability of Gelatin, Journal of Pharmaceutical Sciences, 77(10): 876-879 and Nakayama et al., 2001, Development of high-performance stent: gelatinous photo-gel-coated stent that permits drug delivery and gene transfer, J Biomed Mater Res, 57: 559-566.
For present claims 30, 35, 36, and 54, Fassihi et al. teach biomaterials comprising gelatin gels wherein the gelatin was obtained by alkali treatment and the gel was formed by irradiation in conjunction with cobalt (please refer to the entire reference particularly the abstract; Experimental Section).
For present claim 36, Nakayama et al. teach gelatin coated stents wherein the gelatin was irradiated comprising a drug, bioactive agent, and/or therapeutic agent.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
The claims would have been obvious because the substitution of one known element (i.e. gelatin gel) for another (i.e. gelatin gel with drug, bioactive agent, and/or therapeutic agent) would have yielded predictable results (e.g. utilization of the gelatin gel to hold and/or deliver drug, bioactive agent, and/or therapeutic agent) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. adding drug, bioactive agent, and/or therapeutic agent to irradiated gelatin) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Fassihi et al. and Nakayama et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants contend that Example 11 shows that the present method of making a biomaterial with gelatin had increased tensile strength compared to commercial fibrin glue. Applicants argue the references separately. Applicants contend that one of skill in the art would not combine the references.
Applicants’ arguments are not convincing since the teachings of Fassihi et al. and Nakayama et al. render the biomaterial of the instant claims prima facie obvious. A proper control for Example 11 would be a gelatin crosslinked via a different method. It is also respectfully noted that the examples in Table 1/Example 11 have a much narrower method than as presently claimed (i.e. not commensurate in scope with the present claims).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Nakayama et al. is utilized to teach the limitations of present claim 36 (i.e. gelatin coated stents wherein the gelatin was irradiated comprising a drug, bioactive agent, and/or therapeutic agent).
It is respectfully noted that the biomaterial of the present claims is drawn to a cross-linked 3D matrix of a protein or peptide wherein partially denatured gelatin is utilized as a starting material. The majority of the claim limitations are product-by-process limitations. Only the structure of the presently claimed biomaterial is provided patentable weight. Fassihi et al. teach alkali-treated gelatin which is irradiated to form bonds (please refer to the entire specification particularly the Experimental section). Furthermore, the present claims do not require the photoactivatable metal-ligand complex in the biomaterial. However, Fassihi et al. teach rods of cobalt labeled pellets wherein gelatin samples are surrounding the cobalt. Applicants should provide structural information in the claims as to why an electron acceptor would alter the biomaterial.
Examples 4 and 5 show that different electron acceptors have different crosslinking ability. However, the electron acceptor is not defined in the present claims.
In response to applicant's argument that Fassihi et al. and Nakayama et al. are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Fassihi et al. and Nakayama et al. are drawn to crosslinked gelatin.
Claims 30, 35, 36, and 54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kodadek et al. U.S. Patent 6,613,582 published September 2, 2003; Fassihi et al., 1988, Influence of Gamma Radiation on the Gel Rigidity Index and Binding Capability of Gelatin, Journal of Pharmaceutical Sciences, 77(10): 876-879; and Nakayama et al., 2001, Development of high-performance stent: gelatinous photo-gel-coated stent that permits drug delivery and gene transfer, J Biomed Mater Res, 57: 559-566.
For present claims 30, 35, and 36, Kodadek et al. teach 3D crosslinked matrix/scaffold comprising peptides, proteins, antibodies, drugs, growth hormone, fibronectin, and/or compounds produced via irradiation of a photoactivatable metal-ligand complex and an electron acceptor (please refer to the entire specification particularly the abstract; columns 2, 4-16; Table 1; claims).
For present claims 30, 35, 36, and 54, Fassihi et al. teach biomaterials comprising gelatin gels wherein the gelatin was obtained by alkali treatment and the gel was formed by irradiation in conjunction with cobalt (please refer to the entire reference particularly the abstract; Experimental Section).
For present claim 36, Nakayama et al. teach gelatin coated stents wherein the gelatin was irradiated comprising a drug, bioactive agent, and/or therapeutic agent.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
The claims would have been obvious because the substitution of one known element (i.e. undenatured polypeptides; gelatin gel) for another (i.e. partially denatured polypeptides including gelatin; gelatin gel with drug, bioactive agent, and/or therapeutic agent) would have yielded predictable results (e.g. forming a crosslinked gelatin gel; utilization of the gelatin gel to hold and/or deliver drug, bioactive agent, and/or therapeutic agent) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. forming a crosslinked gelatin gel; adding drug, bioactive agent, and/or therapeutic agent to irradiated gelatin) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Kodadek et al.; Fassihi et al.; and Nakayama et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants contend that Example 11 shows unexpected results because a gelatin biomaterial has increased tensile strength compared to a commercial fibrin glue and that the references do not teach gamma irradiation. Applicants argue the references individually. Applicants appear to argue unexpected results. Applicants argue that one of skill in the art would not have combined references due to the differences in the references.
Applicants’ arguments are not convincing since the teachings of Kodadek et al.; Fassihi et al.; and Nakayama et al. render the biomaterial of the instant claims prima facie obvious.
A proper control for Example 11 would be a gelatin crosslinked via a different method. It is also respectfully noted that the examples in Table 1/Example 11 have a much narrower method than as presently claimed (i.e. not commensurate in scope with the present claims).
It is respectfully noted that the biomaterial of the present claims is drawn to a cross-linked 3D matrix of a protein or peptide wherein partially denatured gelatin is utilized as a starting material. The majority of the claim limitations are product-by-process limitations. Only the structure of the presently claimed biomaterial is provided patentable weight. Fassihi et al. teach alkali-treated gelatin which is irradiated to form bonds (please refer to the entire specification particularly the Experimental section). Furthermore, the present claims do not require the photoactivatable metal-ligand complex in the biomaterial. However, Fassihi et al. teach rods of cobalt labeled pellets wherein gelatin samples are surrounding the cobalt. Applicants should provide structural information in the claims as to why an electron acceptor would alter the biomaterial.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examples 4 and 5 show that different electron acceptors have different crosslinking ability. However, the electron acceptor is not defined in the present claims.
It is respectfully noted that unexpected results must be commensurate in scope with the present claims. The present claims are much broader in scope than the Examples and the Figures in the originally filed specification.
In response to applicant's argument that Kodadek et al.; Fassihi et al.; and Nakayama et al. are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Fassihi et al. and Nakayama et al. are drawn to crosslinked gelatin.
Claims 30, 35, 36, and 54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kodadek et al. U.S. Patent 6,613,582 published September 2, 2003 and Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003.
For present claims 30, 35, and 36, Kodadek et al. teach 3D crosslinked matrix/scaffold comprising peptides, proteins, antibodies, drugs, growth hormone, fibronectin, and/or compounds produced via irradiation of a photoactivatable metal-ligand complex and an electron acceptor (please refer to the entire specification particularly the abstract; columns 2, 4-16; Table 1; claims).
However, Kodadel et al. do not teach partially denatured polypeptides including gelatin.
For present claims 30, 35, 36, and 54, Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. genus of proteins) for another (i.e. species of partially denatured gelatin) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. photoactivated crosslinking of denatured gelatin and photoactivated crosslinking of a protein, a metal-ligand complex, and an electron acceptor) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Kodadek et al. and Lamberti et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants argue unexpected results and argues the references individually.
Applicants’ arguments are not convincing since the teachings of Kodadek et al. and Lamberti et al. render the biomaterial of the instant claims prima facie obvious. Arguments of unexpected results must be commensurate in scope with the present claims. See MPEP § 716.02(d). The specific examples in the specification have a much narrower scope than the present claims. Example 11 refers to specific metal-ligand complex and a specific electron acceptor.
Examples 4 and 5 show that different electron acceptors have different crosslinking ability. However, the electron acceptor is not defined in the present claims.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is respectfully noted that unexpected results must be commensurate in scope with the present claims. The present claims are much broader in scope than the Examples and the Figures in the originally filed specification.
In response to applicant's argument that Kodadek et al. and Lamberti et al. are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Fassihi et al. and Nakayama et al. are drawn to crosslinked gelatin.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 30, 35, and 54 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-21 of prior U.S. Patent No. 11,097,033. This is a statutory double patenting rejection.
U.S. Patent No. 11,097,033 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; and a protein including gelatin.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of statutory double patenting as being unpatentable over U.S. Patent No. 11,097,033 for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants contend that U.S. Patent No. 11,097,033 the claims require features as cited above and are further patentably distinct.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,097,033 results in the same structure of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
Claims 30, 35, and 54 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-14 of prior U.S. Patent No. 9,216,325. This is a statutory double patenting rejection.
U.S. Patent No. 9,216,325 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; and a protein including gelatin.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of statutory double patenting as being unpatentable over U.S. Patent No. 9,216,325 for claims 30, 35, and 54 were considered but are not persuasive for the following reasons.
Applicants contend that U.S. Patent No. 9,216,325 requires features as cited above and are further patentably distinct.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,216,325 results in the same structure of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). See MPEP § 2113.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 30, 35, 36, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,441,675 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 10,441,675 claims a crosslinked protein matrix/light activated tissue adhesive wound dressing comprising a photoactivatable metal-ligand complex; an electron acceptor; a protein including fibrinogen, fibrin, collagen, fibronectin, keratin, or laminin; and a drug or therapeutic.
Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. crosslinked collagen matrix/scaffold) for another (i.e. crosslinked gelatin matrix/scaffold wherein the starting material is partially denatured gelatin and/or collagen) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,441,675 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003 for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants “would like to come to agreement on allowable claims prior to deciding on the filing of a terminal disclaimer”.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,441,675 renders obvious the biomaterial of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 30, 35, 36, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,669,132 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003.
U.S. Patent No. 9,669,132 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; and a protein including fibrinogen, fibrin, collagen, fibronectin, keratin, or laminin.
However, U.S. Patent No. 9,669,132 does not teach the addition of cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients.
For present claims 30, 35, 36, and 54, Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. crosslinked gelatin matrix/scaffold) for another (i.e. crosslinked gelatin matrix/scaffold comprising cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin with the ability to be utilized as a cell scaffold, drug delivery system, etc.) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,669,132 in view of Lamberti et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants “would like to come to agreement on allowable claims prior to deciding on the filing of a terminal disclaimer”.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,669,132 in view of Lamberti et al. renders obvious the biomaterial of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 30, 35, 36, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,579,415 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,579,415 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; a protein including fibrinogen, fibrin, collagen, fibronectin, keratin, or laminin; and a drug.
Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. crosslinked collagen matrix/scaffold) for another (i.e. crosslinked gelatin matrix/scaffold wherein the starting material is partially denatured gelatin and/or collagen) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,579,415 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003 for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants “would like to come to agreement on allowable claims prior to deciding on the filing of a terminal disclaimer”.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,579,415 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003 renders obvious the biomaterial of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 30, 35, 36, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,097,033 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003.
U.S. Patent No. 11,097,033 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; and a protein including gelatin.
However, U.S. Patent No. 11,097,033 does not teach the addition of cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients.
For present claims 30, 35, 36, and 54, Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. crosslinked gelatin matrix/scaffold) for another (i.e. crosslinked gelatin matrix/scaffold comprising cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin with the ability to be utilized as a cell scaffold, drug delivery system, etc.) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,097,033 in view of Lamberti et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants “would like to come to agreement on allowable claims prior to deciding on the filing of a terminal disclaimer”.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,097,033 in view of Lamberti et al. renders obvious the biomaterial of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Claims 30, 35, 36, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,216,235 in view of Lamberti et al. U.S. Patent Application Publication 2003/0232198 published December 18, 2003.
U.S. Patent No. 9,216,235 claims a crosslinked protein matrix comprising a photoactivatable metal-ligand complex; an electron acceptor; and a protein including gelatin.
However, U.S. Patent No. 9,216,235 does not teach the addition of cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients.
For present claims 30, 35, 36, and 54, Lamberti et al. teach a 3D matrix/scaffold/hydrogel comprising polypeptides including partially denatured gelatin and/or collagen or laminin and cells, nutrients, drugs, growth factors, etc. produced via photoactivated cross-linking and wherein the denaturation is via chemical treatment, thermal treatment, acid treatment, alkali treatment, etc. (please refer to the entire specification particularly the abstract; paragraphs 2, 8-10, 25-27, 32, 35, 39-42, 50, 51, 55, 61, 68, 74, 75, 79, 80, 83-86; Table 1).
The claims would have been obvious because the substitution of one known element (i.e. crosslinked gelatin matrix/scaffold) for another (i.e. crosslinked gelatin matrix/scaffold comprising cells, growth factors, bioactive agents, drugs, therapeutic agents, or nutrients) would have yielded predictable results (i.e. 3D matrix comprising crosslinked gelatin with the ability to be utilized as a cell scaffold, drug delivery system, etc.) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 9,216,235 in view of Lamberti et al. for claims 30, 35, 36, and 54 were considered but are not persuasive for the following reasons.
Applicants “would like to come to agreement on allowable claims prior to deciding on the filing of a terminal disclaimer”.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,216,235 in view of Lamberti et al. renders obvious the biomaterial of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fancy et al., 2000, Scope, limitations and mechanistic aspects of the photo-induced cross-linking of proteins by water-soluble metal complexes, Chemistry & Biology, 7: 697-708.
Brown et al., 2001, Protein Cross-Linking Mediated by Metal Ion Complexes, Met Ions Biol Syst, 38: 351-384.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/AMBER D STEELE/ Primary Examiner, Art Unit 1658