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 .
Response to Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on 3/2/26 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Applicant’s election without traverse of hydrated porcine mucin glycoprotein for species A, and 4-arm PEG thiol for species B, in the reply filed on 3/2/26 is also acknowledged.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yom-Tov et al (European Polymer Journal, Vol 74, 2016, Pgs 1-12) in view of Leitner et al (European Journal of Pharmaceutics and Biopharmaceutics 56 (2003) 207–214)
Yom-Tov et al teaches it was well known to use PEG-thiol cores to make hydrogels with controllable properties (abstract). The PEG was mw 10kDa (Sec 2.1).
Yom-Tov et al does not teach the attachment of mucin glycoproteins for the hydrogel.
Leitner et al teaches it was known to use mucus glycoproteins in thiolated polymer systems to enhance the mucoadhesive properties of the thiomers in porcine mucosa (abstract). When forming polymers, the viscoelastic properties are checked to compare to control hydrogels and include measuring G’ and G” (Sec 3.3).
It would have been obvious to one of ordinary skill in the art to modify the PEG-thiol cored hydrogels of Yom-Tov by attaching mucus glycoproteins via the disulfide bonds to create a mucoadhesive hydrogel with controllable properties.
With regards to claims 8 and 9, where the primary reference teaches varying the properties of the hydrogels by varying the components, it would have been obvious to optimize the hydrogel to be consistent with natural mucin, given the purpose is to create a synthetic version of the natural product.
Conclusion
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612