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 .
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.
Status of Claims
In response to the correspondence received 10/29/25:
Claims 1 – 20 are pending in the application.
Claims 16 - 20 are withdrawn as directed to non-elected inventions.
Claims 1 - 15 are currently under examination.
The rejection under 35 U.S.C. 103 (a) is upheld.
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.
Claim(s) 1 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013014278 A1 to Langer et al. hereinafter “Langer” in further in view of US 20140216649 A1 to Woods et al. hereinafter “Woods”.
Langer is directed to hydrogels for treatment of peripheral nerve injury [0002].
Regarding claims 1 – 9, Langer teaches a composition at Example 1 which is directed to a polyethylene glycol (PEG) based hydrogel with an overall polymer weight fraction at curing of 15% for the controlled delivery of anti-inflammatory drugs and surgical analgesia in peripheral nerve injury applications [0138]. The PEG based hydrogel comprises ethoxylated trimethylolpropane tri-3 mercaptopropionate (ETTMP) and polyethylene glycol diacrylate (PEGDA) in an aqueous buffer (physiological buffer) [0138]. Both of these materials have a polyethylene glycol structure. The two constituents are prepared and then mixed at stoichiometric ratios (1:1) [0138]. The stoichiometry of the acrylate and thiol groups is equal. Once the two materials are mixed the time to gelation is approximately 8 – 10 minutes [0141]. This is a thiol-ene system.
As ETTMP is used at 40% of the total, there is approximately 6% ETTMP (0.4* 15%) and 9% PEGDA (0.6* 15%) [0139].
The composition of Example 1 can be used for the controlled delivery of anti-inflammatory drugs and surgical analgesia in peripheral nerve injury applications [0138] therefore, barring any information to the contrary, it could be applied to the tissues of the gastrointestinal tract also to deliver the same compounds.
Langer is silent as to the use of a photoinitiator hence attention is directed to Woods. Woods is directed to thiol-ene systems curable by UV and / heat [0002].
Woods teaches at Example 6 that thiol-ene compositions of Tables 1 – 2 incorporate 1% of a photoinitiator and are cured upon exposure to UV light for 60 seconds [0105].
Therefore, it would have been obvious to the skilled artisan to add a photoinitiator as used in Woods to the composition of Langer and cure the composition by exposure to a UV light for 60 seconds. This would enable the composition of Langer to be cured much more quickly.
As to claims 10 – 12, the photoinitiator in Woods was used at 1 wt. % and has a MW of 490.53 g/mol (BAPO) therefore approximately 2.03 mMol of photoinitiator was used. This is within the claimed ranges. The compositions of Woods at Example 6 were cured by exposure to a 160 mW/cm2 UV light for 60 seconds total. This is the time to full cure for the materials. Woods is silent as to the gel times; however it would be obvious to one of ordinary skill in the art that the gel times of the system of Langer would fall within the ranges claimed as exposure to high intensity UV light to generate radicals would accelerate the gel formation of the materials over mixture at room temperature. UV light sources also emit large amounts of visible light and the initiator of Woods (bis(2,6-dimethoxybenzoyl-2,4,4-trimethyl pentyl) phosphine oxide) is known to exhibit some absorbance in the visual range.
Allowable Subject Matter
Claims 13 – 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 10/29/25 have been fully considered but they are not persuasive. First, applicant argues that one skilled in the art of Langer’s hydrogels would not have sought guidance in Wood’s photocurable adhesive. This is not persuasive as one skilled in the art would also look to method of polymerizing the thiol / ene system, common both to Langer and Woods, in addition to its intended use. The cure chemistry of both Lange and Woods uses a thiol / ene system and this would motivate one of ordinary skill to include the photoinitiator of Wood into the hydrogel of Langer.
Second, applicant argues that Langer already teaches that increasing the pH of the system decreases the gelation time and one of ordinary skill would have increased the pH from 7.0 to 10.0 to achieve time. This is also non-persuasive as, a pH of 10 is highly caustic and will possibly damage live tissue as Langer’s intended use is for the controlled delivery of anti-inflammatory drugs and surgical analgesia in peripheral nerve injury applications [0138]. One of ordinary skill would recognize the danger in applying a system with a pH of 10 to live tissue and would have been motivated to use another way to increase the cure speed of Langer such as by adding a photoinitiator a photocuring the system.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER A. SALAMON whose telephone number is 571-270-3018. The examiner can normally be reached M-F: 9AM - 6PM.
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PAS 1/8/26
/PETER A SALAMON/Primary Examiner, Art Unit 1759