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 without traverse of Group I, claims 1-10, in the reply filed on 04/132026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/13/2026.
Information Disclosure Statement
An information disclosure statements were filed on 03/01/2024 and 05/06/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification broadly sets out a composition of a) a first hydrophilic polymer functionalized with a plurality of functional groups, and b a second hydrophilic group functionalized with a plurality of second functional groups , wherein the first and second functional groups which are induced to form covalent bonds and crosslink the composition through a change in conditions. This broadly encompasses a wide range of polymers, none of which is listed in the specification. Broad claims require a specification which is at least as broad in its description. Clarification is requested.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a first and second hydrophilic polymer which crosslink through changes in temperature, and pH, does not reasonably provide enablement for all condition changes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The claims broadly claim that all conditions will cause the hydrophilic polymers to crosslink. However, there is no support except for changes in temperature or pH. Correction is requested.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for succinimidyl groups on the first hydrophilic polymer, and amine groups on the second hydrophilic polymer , does not reasonably provide enablement for all functional groups. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The only functional groups enabled are succinimidyl and amine groups. The specification fails to list any other groups which would work as claimed. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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) 1-5, and 7-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 00/12018 A1 (Cruise et al).
Cruise et al claims a composition applied to a tissue defect (medical procedure) hydrogel comprising a mixture of a protein solution and a polymer solution of at least three 4-PEG-SG. The protein solution may be a chitosan. The mixture is a non-liquid. The rate of gelation is controlled by buffers which shows that the condition changed is pH. Physiological pH is a range between 7.35 to 7.45 and meets the limitation of claim 3. The bonds formed between an amine and hydroxyl groups are able to be hydrolyzed. These procedures can be done on blood vessels during angioplasty, vascular punctures, live, lungs and bowels ( see page 33, line 5; page 74 and Example 5; page 75; and page 76, line 16). The claims are anticipated by Cruise et al (see Abstract; Page 1, lines 5-8; page 4, line 26 to page 6, line 8; page 20, lines 26 to page 21, line 9; page 26, line 29 to page 27, line 7; and Example 2).
(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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 656 215 A1 (collagen Corp).
Collagen Corp discloses an injectable (medical procedure) hydrogel comprising one or more glycosaminoglycans or derivatives thereof and a synthetic hydrophilic polymer. The preferred hydrophilic polymers include activated PEG. The glycosaminoglycans provide free amine groups which covalently crosslink with PEG. For example, chitin can be deacylated to form chitosan. The bonds formed between an amine and hydroxyl groups are able to be hydrolyzed. The claims are anticipated by Collagen Corp (see Page 2, lines 3-6; page 13, lines 51 to page 15, line 15; page 21, line 29 to page 24, line 31; page 28, lines 47-51; and claim 18.)
Conclusion
No claims are allowed.
The article by Tanuma et al is cited as background art in its disclosure of PEG crosslinked chitosan films.
Correspondence
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/CARLOS A AZPURU/ Primary Examiner, Art Unit 1617 caz
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