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 .
Election/Restrictions
Applicant's election with traverse of claims 1-9 in the reply filed on 6/30/2026 is acknowledged. The traversal is on the ground(s) that the Examiner did not provide a reference demonstrating that the gel can be used in a different process and thus relied upon conclusory assertions. This is not found persuasive because the Examiner need not cite prior art and as stated in the Restriction Requirement, the processes have different modes of operation and effect, i.e. a method of making a gel and a method of activating an enzyme using a caged compound (not requiring a gel), and the product is not claimed to be used in the process of Group III, for example.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 are pending.
Claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/30/2026.
Claims 1-9 have been considered on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The use of the term DM-NITROPHEN™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al, (Bioconj. Chem, vol. 13, p. 640-646, 2002).
Regarding claim 1, Zhang teaches a gel precursor composition comprising a biocompatible polymer, i.e. fibrinogen, a crosslinking agent, i.e. a calcium-dependent transglutaminase, and a photoresponsive compound containing calcium, i.e. phototriggerable liposomes entrapping calcium (abstract, p. 640, intro, 2nd col, p. 642, whole page, results section last 2 parag., p. 643, Discussion section-p. 645). The reference teaches the making of fibrinogen hydrogels for drug delivery and wound healing. (p. 640, Intro., whole page).
Regarding claim 2, the polymer is a human fibrinogen, thus from an organism (p. 642, Light trigg. Gelation section).
Regarding claim 3, the biocompatible polymer is fibrinogen (p. 642, light trigg. Gelation section).
Regarding claims 4 and 5, the crosslinking agent is a calcium-dependent transglutaminase (p. 641, intro, 2nd col, 1st full parag., p. 642, whole page, particularly, results section 2nd and 3rd parag.).
Regarding claims 6 and 7, the photoresponsive compound is a caged calcium (p. 641, prep of liposomes section, light trigg. Ca+ release- light trigg. Gelation section, whole p. 642).
Regarding claim 8, fibrinogen is a biocompatible polymer that undergoes temperature responsive sol-gel transition.
Regarding claim 9, while the reference teaches the development of fibrinogen hydrogels to be used for therapeutic purpose, the intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
Thus, the reference anticipates the claimed subject matter.
Claim(s) 1-3, 6, 8, 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by DeForest et al. (US20240042101 A1, IDS).
DeForest teaches a gel precursor composition comprising a biocompatible polymer, i.e. natural gel precursors collagen and fibrin (0104, Ex. 1), a crosslinking agent to be activated by a substance, i.e. aldehyde functionalized proteins (Ex. 1, (0158), and a photoresponsive compound encompassing the specific substance, i.e. 2-(2-nitrophenyl)propoxycarbonyl(NPPOC) with photocaged alkoxyamine (0105, 0106, 0158, 0159).
Regarding claim 2, the polymers are natural polymers, i.e. found in nature and thus collagen which is found in animals is taken to be from an organism.
Regarding claim 3, the natural gel precursors are collagen, gelatin and fibrin, for example (0104, Ex. 1)
Regarding claim 6, a photoresponsive compound is 2-(2-nitrophenyl)propoxycarbonyl(NPPOC) with photocaged alkoxyamine.
Regarding claim 8, collagen, fibrin and gelatin are polymers which inherently undergo gel-sol transitions.
Regarding claim 9, the gel is used for therapeutic purposes (0144); however, the intended use and function of the claimed product does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
Thus, the reference anticipates the claimed subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chueh teach a gel precursor composition comprising a biocompatible polymer, i.e. alginate, and a photoresponsive compound encompassing a specific substance, i.e. DM-nitrophen (DM-n) which cages calcium. When the DM-n-Ca+ compounds are exposed to light, the Ca+ is released, which cross-links the alginate and generates an alginate hydrogel (p. 4, section 3.1, p. 6, Conclusion section).
Cui teach a gel precursor composition comprising a biocompatible polymer, i.e. alginate, and a photoresponsive compound encompassing a specific substance, i.e. nitr-T which cages calcium. When the nitr-T-Ca+ compounds are exposed to light, the Ca+ is released, which cross-links the alginate and generates an alginate hydrogel (p. p. 1252, 1st parag., Prep. Of hydrogel section, p. 1253, Results section-p. 1255). The references do not teach a separate crosslinking agent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
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