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 .
Specification
The disclosure is objected to because of the following informalities: The continuation data listed in Paragraph 1 of the specification for Application No. 17/165,485, filed February 2, 2021, should be updated, as Application No. 17/165,485 is now U.S. Patent No. 12,016,969. Appropriate correction is required.
Claim Objections
Claims 2-4 and 7-8 are objected to because of the following informalities: “in vivo” is not italicized, which is inconsistent with in vivo as recited in claim 1. Appropriate correction is required.
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.
Claim 18-19 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.
Claim 18 recites the limitation "the injectable in vivo crosslinking material" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "injectable in vivo crosslinking material" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "a healthcare" in line 1. It is unclear what a healthcare corresponds to, therefore claim 20 is indefinite. Claim 20 will be interpreted as a healthcare provider.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennett et al. (EP 2 389 925) [IDS 8/6/24].
Regarding claims 1-7: Bennett et al. (EP ‘925) discloses crosslinking hydrogel compositions [abstract], wherein the hydrogel precursor is polymeric core such as polyethylene glycol (PEG), poly(amino acids) or poly(saccharides) [0035-0036]. Bennett et al. (EP ‘925) discloses Example 1 [Ex. 1; 0137-0147] prepares a first reactive precursor containing an 80% solution of PEG-diacrylate and PEG-NHS (N-hydroxysuccinimide [0037]) [0137-0138]. Bennett et al. (EP ‘925) additionally discloses an embodiment containing poly(saccharide)-diacrylate and poly(saccharide)-NHS (i.e. poly(saccharide) exchanged for PEG as the polymeric core [0035-0036]; see MPEP 2131.02). A second reactive precursor of lysine was prepared [0139]. 4,4’-bis(diethylamino)benzophenone was added to the first reactive precursor [0140-0141], and equal volumes of the first and second reactive precursors were loaded into syringes, mixed, crosslinked, and exposed to UV light to afford a hydrogel [0142-0147]. Bennett et al. (EP ‘925) discloses formation of the hydrogel in situ (ex. disc implant, wound closure, soft tissue augmentation, vascular grafts, sutures, dermal filler, etc.) [0090-0091, 0096, 0098; Fig. 1A].
Note lysine:
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[0139].
Regarding claim 9: Bennett et al. (EP ‘925) discloses formation of the hydrogel in situ (ex. disc implant, wound closure, soft tissue augmentation, vascular grafts, sutures, dermal filler, etc.) [0090-0091, 0096, 0098; 0107-0109; Fig. 1A].
Claim(s) 10 and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennett et al. (EP 2 389 925) [IDS 8/6/24].
Regarding claims 10, 12 and 16: Bennett et al. (EP ‘925) discloses crosslinking hydrogel compositions [abstract], wherein the hydrogel precursor is polymeric core such as polyethylene glycol (PEG), poly(amino acids) or poly(saccharides) [0035-0036]. Bennett et al. (EP ‘925) discloses Example 1 [Ex. 1; 0137-0147] prepares a first reactive precursor containing an 80% solution of PEG-diacrylate and PEG-NHS (N-hydroxysuccinimide [0037]) [0137-0138]. Bennett et al. (EP ‘925) additionally discloses an embodiment containing poly(saccharide)-diacrylate and poly(saccharide)-NHS (i.e. poly(saccharide) exchanged for PEG as the polymeric core [0035-0036]; see MPEP 2131.02). A second reactive precursor of lysine was prepared [0139]. 4,4’-bis(diethylamino)benzophenone was added to the first reactive precursor [0140-0141], and equal volumes of the first and second reactive precursors were loaded into syringes, mixed, crosslinked, and exposed to UV light to afford a hydrogel [0142-0147]. Bennett et al. (EP ‘925) discloses formation of the hydrogel in situ (ex. disc implant, wound closure, soft tissue augmentation, vascular grafts, sutures, dermal filler, etc.) [0090-0091, 0096, 0098; 0107-0109; Fig. 1A].
Note lysine:
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[0139].
Regarding claims 13-15: Bennett et al. (EP ‘925) discloses formation of the hydrogel in situ (ex. disc implant, wound closure, soft tissue augmentation, vascular grafts, sutures, dermal filler, etc.) [0090-0091, 0096, 0098; 0107-0109; Fig. 1A].
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennett et al. (EP 2 389 925) [IDS 8/6/24].
Regarding claims 17-20: Bennett et al. (EP ‘925) discloses methods of using crosslinking hydrogel compositions [abstract], wherein the hydrogel precursors can be injected underneath the tissue surface [0107-0109]. Bennett et al. (EP ‘925) disclose the hydrogel precursor is polymeric core such as polyethylene glycol (PEG), poly(amino acids) or poly(saccharides) [0035-0036]. Bennett et al. (EP ‘925) discloses Example 1 [Ex. 1; 0137-0147] prepares a first reactive precursor containing an 80% solution of PEG-diacrylate and PEG-NHS (N-hydroxysuccinimide [0037]) [0137-0138]. Bennett et al. (EP ‘925) additionally discloses an embodiment containing poly(saccharide)-diacrylate and poly(saccharide)-NHS (i.e. poly(saccharide) exchanged for PEG as the polymeric core [0035-0036]; see MPEP 2131.02). A second reactive precursor of lysine was prepared [0139]. 4,4’-bis(diethylamino)benzophenone was added to the first reactive precursor [0140-0141], and equal volumes of the first and second reactive precursors were loaded into syringes, mixed, crosslinked, and exposed to UV light to afford a hydrogel [0142-0147]. Bennett et al. (EP ‘925) discloses formation of the hydrogel in situ (ex. disc implant, wound closure, soft tissue augmentation, vascular grafts, sutures, dermal filler, etc.) [0090-0091, 0096, 0098; 0107-0109; Fig. 1A].
Note lysine:
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[0139].
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bennett et al. (EP 2 389 925) as applied to claim 7 above.
Regarding claim 8: Bennett et al. (EP ‘925) discloses the basic claimed material [as set forth above with respect to claim 7], wherein Bennett et al. (EP ‘925) discloses carbodiimide crosslinking [0054].
Bennett et al. (EP ‘925) does not specifically disclose Ex. 1 containing a carbodiimide crosslinking agent. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a carbodiimide crosslinking agent based on the invention of Bennett et al. (EP ‘925), and would have been motivated to do so since Bennett et al. (EP ‘925) suggests carbodiimide crosslinking [0054]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bennett et al. (EP 2 389 925) as applied to claim 10 above.
Regarding claim 11: Bennett et al. (EP ‘925) discloses the basic claimed system [as set forth above with respect to claim 10], wherein Bennett et al. (EP ‘925) discloses the composition can contain visualization agents [0110-0012], as well as bioactive agents such as tetracycline [0115, 0117-0120].
Bennett et al. (EP ‘925) does not specifically disclose Ex. 1 containing visualization agents and/or bioactive agents. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included visualization agents and/or bioactive agents based on the invention of Bennett et al. (EP ‘925), and would have been motivated to do so since Bennett et al. (EP ‘925) suggests the composition can contain visualization agents [0110-0012], as well as bioactive agents such as tetracycline [0115, 0117-0120]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,016,969 in view of Sawhney (US 6,818,018) [IDS 8/6/24]. The injectable in vivo crosslinking material, system of forming injectable in vivo crosslinking material and method of U.S. Patent No. 12,016,969 substantially overlaps in scope with the instant claimed injectable in vivo crosslinking material, instant claimed system of forming injectable in vivo crosslinking material and instant claimed method.
U.S. Patent No. 12,016,969 does not claim a reactive multi-arm polymer comprising a plurality of hydrophilic polymer arms selected from poly(amino acid) and poly(saccharide). However, Sawhney (US 6,818,018) discloses crosslinking hydrogel compositions [abstract], wherein the hydrogel precursor can be poly(ethyloxazoline), poly(amino acids) or poly(saccharides) [4:66-5:6; 9:45-59]. U.S. Patent No. 12,016,969 and Sawhney (US 6,818,018) are analogous art because they are concerned with a similar technical difficulty, namely the preparation of crosslinking hydrogel compositions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined poly(amino acids) or poly(saccharides), as taught by Sawhney (US 6,818,018) in the invention of U.S. Patent No. 12,016,969, and would have been motivated to do so since Sawhney (US 6,818,018) discloses the hydrogel precursor can be poly(amino acids) or poly(saccharides) [4:66-5:6; 9:45-59].
See attached form PTO-892.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached on 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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