DETAILED ACTION
Claims 1-6, 8-13, and 16-20 are pending and under consideration on the merits.
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 .
Notice of Subject Matter Free of the Prior Art
The prior art does not teach or suggest base claim 1 as amended which is drawn to a biological material wherein a first crosslinking agent crosslinks the aldehyde groups of the mucopolysaccharides and a second crosslinking agent crosslinks collagen fibers of the biological material, and specifies that the biological material is prepared by performing oxidation, first crosslinking, and second crosslinking steps in sequence, or by performing second crosslinking, oxidation, and first crosslinking in sequence.
Dove et al. (US 2021/0100931; of record) discloses a process of preparing a biological material comprising the steps of a pretreatment crosslinking step followed by an oxidation step followed by treatment with lysine to cap aldehydes in the biological material. The capping of the aldehydes means that the sequence of steps taught by Dove will not result in crosslinking between the aldehyde groups of the mucopolysaccharides as required by the language of claim 1.
Therefore, claims 1-6, 8-13, and 16-20 are free of the prior art.
Status of the Rejections
The 112(b) rejection is withdrawn in view of the amendment, but a new rejection was necessitated by the amendment.
The 103 rejections are withdrawn in view of the amendment and accompanying arguments.
Status of the Application
Examiner made repeated attempts to contact Applicant’s Representative, Kevin Che, at the phone number of record, to discuss a potential Examiner’s amendment to correct the indefiniteness issue detailed below, but the phone calls were not answered and there was no option available to leave a voicemail message. Therefore, it was necessary to mail the present Final Office Action.
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.
Claims 1-6, 8-13, and 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 1 has been amended to recite “wherein the method is selected from either of two optional sequential process steps,” which is indefinite because on the one hand, the amendment requires that the method is selected from one of the two sequential process routes, but on the other hand, the use of “optional” implies that both options are optional and therefore neither option is required Since the dependent claims do not clarify the point of confusion, they are also rejected. Clarification is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
