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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/11/26 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 2/11/26 are acknowledged. Any objection or rejection from the 9/11/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species of SEQ ID NO:1 and vitamin E were elected.
Claims 39, 41, 43 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/3/25.
Claim 24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/3/25.
Claims 2-3, 7-23, 25, 27-38, 40, 42, 44-45 and 47-50 have been canceled.
Claims 1, 4-6, 26 and 51-52 are being examined.
Priority
The priority information is found in the filing receipt dated 4/20/22.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended and new claims added the rejection is updated to correspond to the instant 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.
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.
Claim(s) 1, 4-6, 26 and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rochkind et al. (US 2011/0104225; as cited with IDS 2/9/22; ‘Rochkind’) in view of Eisenbach-Schwartz et al. (WO 2006/057003 as cited with IDS 2/9/22; ‘Eisenbach-Schwartz’).
Rochkind teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract). Rochkind teach matrices and hydrogels thereof (abstract). Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087). Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104). Rochkind teach hyaluronic acid for nerve regeneration (section 0002). Rochkind teach hyaluronic acid and laminin to promote neurite extension (section 0003). Rochkind teach hydrogels to support neuronal cells (section 0147). Rochkind teach that the hyaluronic acid based hydrogel comprising laminin and an antioxidant induced neuronal cell differentiation (section 0046). Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
Rochkind does not recite copolymer 1.
Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18). Eisenbach-Schwartz teach known properties and uses of copolymer 1 (pages 7-9) and specifically recites ‘protect CNS cells from glutamate toxicity and prevent or inhibit neuronal degeneration or promote nerve regeneration in the CNS and in the PNS’ (page 8 lines 10-13). Eisenbach-Schwartz teach copolymer 1 as neuroprotective (page 9 last paragraph). Eisenbach-Schwartz teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14). Eisenbach-Schwartz teach that the terms Cop 1, Copolymer 1, glatiramer acetate and GA are used interchangeably (page 40 lines 12-13). Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Rochkind based on the specific teachings and suggestions of Rochkind. Since Rochkind teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract) one would have been motivated to make such compositions. Since Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045) one would have been motivated to use such polypeptide. Since Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069) one would have been motivated to use such antioxidant. Since Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) one would have been motivated to use such range. Since Rochkind teach matrices and hydrogels thereof (abstract) one would have been motivated to make such forms. Since Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104) and teach for nerve regeneration (section 0002), to promote neurite extension (section 0003) and to support neuronal cells (section 0147) one would have been motivated to combine with known agents for such purpose. Since Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18) and teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14) one would have been motivated to include copolymer 1 in the composition based on the advantageous effects. Since Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) one would have been motivated to optimize the amount. Since Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163) one would have been motivated to prepare the compositions in a tube. One would have had a reasonable expectation of success since the claimed components and their functions were known and one skilled in the art could have combined the elements as claimed by known methods.
In relation to the hydrogel of claims 1 and 52, Rochkind teach matrices and hydrogels thereof (abstract).
In relation to the hyaluronic acid of claims 1 and 52, Rochkind teach compositions comprising hyaluronic acid (abstract).
In relation to the laminin polypeptide of claims 1, 26 and 52, Rochkind teach compositions comprising a laminin polypeptide (abstract) and teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is interpreted as meeting the limitation of instant SEQ ID NO:1.
In relation to the antioxidant vitamin E of claims 1 and 52, Rochkind teach compositions comprising an antioxidant (abstract). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069).
In relation to the tube of claims 1 and 52, Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
In relation to the concentrations of claims 51-52, Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) (compare MPEP 2144.05).
In relation to the Copolymer of claims 1 and 52, Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract).
In relation to the concentrations of claims 1, 4-6 and 52, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II).
Response to Arguments - 103
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants refer to previous responses, the previous responses have been addressed and remain of record.
Although applicants argue about the teachings of Rochkind alone and the claimed four component mixture, 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 also noted that claim 1 recites ‘hydrogel comprising’ and it thus can include more than 4 components.
Although applicants argue that Eisenbach-Schwartz is drawn to neurodegenerative disease and vaccination and the examples concern the treatment of nerve injury, it is first noted that the instant claims are composition claims and do not require any administration. MPEP 2123 II expressly recognizes that disclosed examples do not teach away from a broader disclosure. Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18). Eisenbach-Schwartz teach known properties and uses of copolymer 1 (pages 7-9) and specifically recites ‘protect CNS cells from glutamate toxicity and prevent or inhibit neuronal degeneration or promote nerve regeneration in the CNS and in the PNS’ (page 8 lines 10-13). Eisenbach-Schwartz teach copolymer 1 as neuroprotective (page 9 last paragraph). Eisenbach-Schwartz teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14). Thus, Eisenbach-Schwartz teach a wide range of beneficial effects.
Although applicants argue about the teachings of Eisenbach-Schwartz alone, 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). The teachings of Rochkind are discussed in detail above.
Although applicants argue that Eisenbach-Schwartz concerns subcutaneous injection so one would not find any incentive, it is first noted that the instant claims are product claims and do not require any administration. MPEP 2143.01 recites “A "motivation to combine may be found explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill." “ Since Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104) and teach for nerve regeneration (section 0002), to promote neurite extension (section 0003) and to support neuronal cells (section 0147) one would have been motivated to combine with known agents for such purpose. Since Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18) and teach copolymer 1 to boost endogenous neurogenesis and support the survival or new neurons (page 36 lines 9-14) one would have been motivated to include copolymer 1 in the composition.
Double Patenting
Claims were previously rejected based on the applications/patents and references cited below. Since the claims have been amended, the rejections are updated to correspond to the instant claims.
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, 4-6, 26 and 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8,242,076 (‘076’) in view of Rochkind et al. (US 2011/0104225; as cited with IDS 2/9/22) in view of Eisenbach-Schwartz et al. (WO 2006/057003 as cited with IDS 2/9/22).
076 recites a composition comprising hyaluronic acid, a laminin polypeptide of SEQ ID NO:3 and an anti-oxidant (claim 5). 076 recites a matrix and hydrogel (claims 10-11). 076 recites for treating neural tissue (claim 18).
076 does not recite vitamin E or copolymer 1 in the claims.
Rochkind teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract). Rochkind teach matrices and hydrogels thereof (abstract). Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087). Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104). Rochkind teach hyaluronic acid for nerve regeneration (section 0002). Rochkind teach hyaluronic acid and laminin to promote neurite extension (section 0003). Rochkind teach hydrogels to support neuronal cells (section 0147). Rochkind teach that the hyaluronic acid based hydrogel comprising laminin and an antioxidant induced neuronal cell differentiation (section 0046). Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18). Eisenbach-Schwartz teach known properties and uses of copolymer 1 (pages 7-9) and specifically recites ‘protect CNS cells from glutamate toxicity and prevent or inhibit neuronal degeneration or promote nerve regeneration in the CNS and in the PNS’ (page 8 lines 10-13). Eisenbach-Schwartz teach copolymer 1 as neuroprotective (page 9 last paragraph). Eisenbach-Schwartz teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14). Eisenbach-Schwartz teach that the terms Cop 1, Copolymer 1, glatiramer acetate and GA are used interchangeably (page 40 lines 12-13). Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 076 based on the specific teachings and suggestions of 076. Since Rochkind also teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract) one would have been motivated to incorporate such teachings and make such compositions. Since Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045) one would have been motivated to use such polypeptide. Since Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069) one would have been motivated to use such antioxidant. Since Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) one would have been motivated to use such range. Since Rochkind teach matrices and hydrogels thereof (abstract) one would have been motivated to make such forms. Since Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104) and teach for nerve regeneration (section 0002), to promote neurite extension (section 0003) and to support neuronal cells (section 0147) one would have been motivated to combine with known agents for such purpose. Since Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18) and teach copolymer 1 to boost endogenous neurogenesis and support the survival or new neurons (page 36 lines 9-14) one would have been motivated to include copolymer 1 in the composition. Since Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) one would have been motivated to optimize the amount. Since Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163) one would have been motivated to prepare the compositions in a tube. One would have had a reasonable expectation of success since the claimed components and their functions were known and one skilled in the art could have combined the elements as claimed by known methods.
In relation to the hydrogel of claims 1 and 52, Rochkind teach matrices and hydrogels thereof (abstract). 076 recites a matrix and hydrogel (claims 10-11).
In relation to the hyaluronic acid of claims 1 and 52, Rochkind teach compositions comprising hyaluronic acid (abstract). 076 recites a composition comprising hyaluronic acid (claim 5).
In relation to the laminin polypeptide of claims 1, 26 and 52, Rochkind teach compositions comprising a laminin polypeptide (abstract) and teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is interpreted as meeting the limitation of instant SEQ ID NO:1. 076 recites a composition comprising a laminin polypeptide of SEQ ID NO:3 (claim 5).
In relation to the antioxidant vitamin E of claims 1 and 52, Rochkind teach compositions comprising an antioxidant (abstract). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069).
In relation to the concentrations of claims 51-52, Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) (compare MPEP 2144.05).
In relation to the tube of claims 1 and 52, Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
In relation to the Copolymer of claims 1 and 52, Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract).
In relation to the concentrations of claims 1, 4-6 and 52, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II).
Claims 1, 4-6, 26 and 51-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,729,815 (‘815’) in view of Rochkind et al. (US 2011/0104225; as cited with IDS 2/9/22) in view of Eisenbach-Schwartz et al. (WO 2006/057003 as cited with IDS 2/9/22).
815 recites a composition comprising hyaluronic acid (claim 1), a laminin polypeptide of SEQ ID NO:1 (claim 4) and an anti-oxidant that is vitamin E (claim 11) and Copaxone (Copolymer 1) (claim 1). 815 recites a matrix and hydrogel (claims 7-8). 815 recites for treating neuronal tissue (claim 12). 815 recites amounts of the antioxidant and Copaxone (claim 9).
815 does not recite the concentration as in claim 6
Rochkind teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract). Rochkind teach matrices and hydrogels thereof (abstract). Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087). Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104). Rochkind teach hyaluronic acid for nerve regeneration (section 0002). Rochkind teach hyaluronic acid and laminin to promote neurite extension (section 0003). Rochkind teach hydrogels to support neuronal cells (section 0147). Rochkind teach that the hyaluronic acid based hydrogel comprising laminin and an antioxidant induced neuronal cell differentiation (section 0046). Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18). Eisenbach-Schwartz teach known properties and uses of copolymer 1 (pages 7-9) and specifically recites ‘protect CNS cells from glutamate toxicity and prevent or inhibit neuronal degeneration or promote nerve regeneration in the CNS and in the PNS’ (page 8 lines 10-13). Eisenbach-Schwartz teach copolymer 1 as neuroprotective (page 9 last paragraph). Eisenbach-Schwartz teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14). Eisenbach-Schwartz teach that the terms Cop 1, Copolymer 1, glatiramer acetate and GA are used interchangeably (page 40 lines 12-13). Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 815 based on the specific teachings and suggestions of 815. Since Rochkind also teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract) one would have been motivated to incorporate such teachings and make such compositions. Since Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045) one would have been motivated to use such polypeptide. Since Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069) one would have been motivated to use such antioxidant. Since Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) one would have been motivated to use such range. Since Rochkind teach matrices and hydrogels thereof (abstract) one would have been motivated to make such forms. Since Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104) and teach for nerve regeneration (section 0002), to promote neurite extension (section 0003) and to support neuronal cells (section 0147) one would have been motivated to combine with known agents for such purpose. Since Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18) and teach copolymer 1 to boost endogenous neurogenesis and support the survival or new neurons (page 36 lines 9-14) one would have been motivated to include copolymer 1 in the composition. Since Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) one would have been motivated to optimize the amount. Since Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163) one would have been motivated to prepare the compositions in a tube. One would have had a reasonable expectation of success since the claimed components and their functions were known and one skilled in the art could have combined the elements as claimed by known methods.
In relation to the hydrogel of claims 1 and 52, Rochkind teach matrices and hydrogels thereof (abstract). 815 recites a matrix and hydrogel (claims 7-8).
In relation to the hyaluronic acid of claims 1 and 52, Rochkind teach compositions comprising hyaluronic acid (abstract). 815 recites a composition comprising hyaluronic acid (claim 1).
In relation to the laminin polypeptide of claims 1, 26 and 52, Rochkind teach compositions comprising a laminin polypeptide (abstract) and teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is interpreted as meeting the limitation of instant SEQ ID NO:1. 815 recites a composition comprising a laminin polypeptide of SEQ ID NO:1 (claim 4).
In relation to the antioxidant vitamin E of claims 1 and 52, Rochkind teach compositions comprising an antioxidant (abstract). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). 815 recites vitamin E (claim 11).
In relation to the tube of claims 1 and 52, Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
In relation to the concentrations of claims 51-52, Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) (compare MPEP 2144.05).
In relation to the Copolymer of claims 1 and 52, Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract). 815 recites Copaxone (claim 1).
In relation to the concentrations of claims 1, 4-6 and 52, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II).
Claims 1, 4-6, 26 and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-19, 24, 26-27 and 29-30 of copending Application No. 17/617,043 (‘043’) in view of Rochkind et al. (US 2011/0104225; as cited with IDS 2/9/22) in view of Eisenbach-Schwartz et al. (WO 2006/057003 as cited with IDS 2/9/22).
This is a provisional nonstatutory double patenting rejection.
043 recites a composition comprising hyaluronic acid (claim 1), a laminin polypeptide that is SEQ ID NO:1 (claim 17) and an anti-oxidant (claim 1) that is vitamin E (claim 18). 043 recites a matrix and hydrogel (claims 29-30). 043 recites for treating nerve injury (claim 1). 043 recites Copolymer 1 (claim 26).
043 does not recite the concentration as in claim 6
Rochkind teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract). Rochkind teach matrices and hydrogels thereof (abstract). Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087). Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104). Rochkind teach hyaluronic acid for nerve regeneration (section 0002). Rochkind teach hyaluronic acid and laminin to promote neurite extension (section 0003). Rochkind teach hydrogels to support neuronal cells (section 0147). Rochkind teach that the hyaluronic acid based hydrogel comprising laminin and an antioxidant induced neuronal cell differentiation (section 0046). Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18). Eisenbach-Schwartz teach known properties and uses of copolymer 1 (pages 7-9) and specifically recites ‘protect CNS cells from glutamate toxicity and prevent or inhibit neuronal degeneration or promote nerve regeneration in the CNS and in the PNS’ (page 8 lines 10-13). Eisenbach-Schwartz teach copolymer 1 as neuroprotective (page 9 last paragraph). Eisenbach-Schwartz teach copolymer 1 to boost endogenous neurogenesis and support the survival of new neurons (page 36 lines 9-14). Eisenbach-Schwartz teach that the terms Cop 1, Copolymer 1, glatiramer acetate and GA are used interchangeably (page 40 lines 12-13). Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 043 based on the specific teachings and suggestions of 043. Since Rochkind also teach compositions comprising hyaluronic acid, a laminin polypeptide and an antioxidant (abstract) one would have been motivated to incorporate such teachings and make such compositions. Since Rochkind teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is described as capable of supporting neuronal cells (section 0045) one would have been motivated to use such polypeptide. Since Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069) one would have been motivated to use such antioxidant. Since Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) one would have been motivated to use such range. Since Rochkind teach matrices and hydrogels thereof (abstract) one would have been motivated to make such forms. Since Rochkind teach for treatment of diseased or damaged tissue (abstract) specifically the brain (section 0104) and teach for nerve regeneration (section 0002), to promote neurite extension (section 0003) and to support neuronal cells (section 0147) one would have been motivated to combine with known agents for such purpose. Since Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract) specifically for damaged or injured brain regions (claim 18) and teach copolymer 1 to boost endogenous neurogenesis and support the survival or new neurons (page 36 lines 9-14) one would have been motivated to include copolymer 1 in the composition. Since Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) one would have been motivated to optimize the amount. Since Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163) one would have been motivated to prepare the compositions in a tube. One would have had a reasonable expectation of success since the claimed components and their functions were known and one skilled in the art could have combined the elements as claimed by known methods.
In relation to claims 1 and 52, Rochkind teach matrices and hydrogels thereof (abstract). 043 recites a hydrogel (claim 29).
In relation to the hyaluronic acid of claims 1 and 52, Rochkind teach compositions comprising hyaluronic acid (abstract). 043 recites a composition comprising hyaluronic acid (claim 1).
In relation to the laminin polypeptide of claims 1, 26 and 52, Rochkind teach compositions comprising a laminin polypeptide (abstract) and teach that the laminin polypeptide is SEQ ID NO:3 (section 0020) which is KSIKVAVRSYIGSRCV (sequence listing page 13 and figure 3) which is interpreted as meeting the limitation of instant SEQ ID NO:1. 043 recites a composition comprising a laminin polypeptide of SEQ ID NO:1 (claim 17).
In relation to the antioxidant vitamin E of claims 1 and 52, Rochkind teach compositions comprising an antioxidant (abstract). Rochkind teach that antioxidants protect cells or macromolecules from oxidative stress (section 0068) and specifically recites vitamin E as an antioxidant (section 0069). 043 recites vitamin E (claim 26).
In relation to the tube of claims 1 and 52, Rochkind teach implanting the hydrogel (sections 0014-0015, 0110, 0112, 0115-0116 and claims 23-24) and specifically teach the use of tubes filled with the hydrogel for tissue regeneration and repair (section 0163).
In relation to the concentrations of claims 51-52, Rochkind teach that the antioxidant can in some embodiments be provided at a concentration range of about 8 micromolar to 8 millimolar (section 0087) (compare MPEP 2144.05).
In relation to the Copolymer of claims 1 and 52, Eisenbach-Schwartz teach the inclusion of copolymer 1 in compositions (abstract). 043 recites Copolymer 1 (claim 26).
In relation to the concentrations of claims 1, 4-6 and 52, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II).
Response to Arguments – Double Patenting
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants refer to arguments above, such arguments were not found persuasive as discussed above.
Although applicants argue about filing a terminal disclaimer under certain conditions, no terminal disclaimer is of record.
Although applicants argue about 043 referring to methods of use, such methods require a composition. Thus, to carry out the method a composition is required.
Although applicants argue about amounts, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II). It is first noted that a concentration is not the same as an amount so the basis for such assertion is not clear. A 100 ml container of a composition that is 10-150 ug/ml would necessarily contain a mg quantity. Further, Eisenbach-Schwartz teach that any suitable dosage of Cop 1 is encompassed by the invention and the dosage will be determined by the physician according to the age and condition of the patient for example (page 46 last paragraph) (compare MPEP 2144.05 II). Further, a close reading of Eisenbach-Schwartz reveals that it states ‘may be chosen from a range of 1-80 mg’ and ‘although any other suitable dose is encompassed by the invention’ (page 46 last paragraph). Thus, Eisenbach-Schwartz is not limited to mg quantities.
Although applicants argue about case law and situations and a “patent term determining date”, the meaning of this term is unclear. The MPEP does not include such exact phrase and even a google search states ‘no results for “patent term determining date” ‘. U.S. Patent No. 8,242,076 (‘076’) is dated 2012, Rochkind et al. (US 2011/0104225; as cited with IDS 2/9/22) is dated 2011 and Eisenbach-Schwartz et al. (WO 2006/057003 as cited with IDS 2/9/22) is dated 2006. The arguments about “patent term determining date” are not persuasive because there is no standard as to what that is or how to determine it.
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights