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 .
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 12 August 2025 are acknowledged. Claims 1-20, 22, 24, and 32-36 are cancelled. Claims 21, 23, and 25-31 are currently pending. Claims 21, 28, and 31 are currently amended. Claims 21, 23, and 25-31 are examined on the merits within.
Withdrawn Rejections
2. Applicants’ arguments, filed 12 August 2025, with respect to the 35 U.S.C. 112(b) Rejection have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejection of claim 28 has been withdrawn. The 35 U.S.C. 103 Rejection of Wang et al. (Biofabrication, 2015) in view of Hutson et al. (Tissue Engineering, 2011) has been withdrawn in view of applicants’ arguments and amendments.
Claim Rejections – 35 U.S.C. 102
3. 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.
4. Claim(s) 21, 23, and 25-31 is/are again rejected under 35 U.S.C. 102(a)(2) as being anticipated by Khanh et al. (WO2019/198086).
Regarding instant claims 21, 23, 25-26, and 29, Khanh et al. disclose compositions comprising PEGDA in a concentration of 1-40% w/v, a gelatin in a concentration of 1-50% w/v and a collagen in amounts of 0.03-15% w/v. Gelatins include crosslinked gelatin methacrylate. See paragraph [0092]. The composition additionally comprises a photoinitiator. See paragraph [0095]. In some embodiments, crosslinking occurs by irradiating in vivo. See paragraph [0149].
Regarding instant claims 27-28, Khanh et al. disclose the same combination of ingredients and thus would have been expected to have the same properties, i.e., burst pressure of at least 25 kPa, adhesion strength that is at least two-fold greater than GelMA not crosslinked to the PEGDA, compression modulus that is at least two fold greater than the GelMA not crosslinked to PEGDA, tensile modulus of 150 kPa to 350 kPa, compression modulus of 150 kPa to 350 kPa, and storage modulus of 5 kPa to 10 kPa. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claims 30-31, the crosslinking agent is Eosin Y, triethanolamine or l-vinyl-2-pyrrolidinone. See paragraph [0095].
Thus the instant claims are anticipated by Khanh et al.
Response to Arguments
Applicants’ arguments filed 12 August 2025 have been fully considered but they are not persuasive.
5. Applicants argued, “Khanh teaches a gelatin concentration of 1-50% but does not teach GelMA in amounts from 10-30% in combination with a crosslinkable synthetic polymer polyethylene glycol diacrylate in amounts from 0.5 to 3%. Khanh does not teach this 0.5% to 3% crucial range for the PEGDA concentration. Instead, those of skill in the art would have expected the synthesis process to operate when using PEGDA concentration beyond 3% and would not have expected decreased sealing capability beyond 3%. Limiting the PEGDA amounts as recited in claim 21 allows for the formation of hybrid hydrogels having optimized burst pressures.”
In response to applicants’ arguments, Kahn specifically recites “The polymers are present in concentrations (w/v) of 1 - 40% for solutions comprising PEGDA; 1 - 50%, preferably 10 - 35% for solutions comprising GELMA; and 0.1 - 20%, preferably 0.2 - 2%, for solutions comprising COLMA. When the material comprises more than one polymer, the concentration range of each individual polymer within the mixture is the same range of that polymer when it is the only component of the solution. As a non-limiting example, a polymer material based on PEGDA and COLMA is prepared from a solution comprising between 1 and 40% PEGDA and between 0.1 and 20% COLMA. See paragraph [0132]. Thus Kahn teaches 1-40% PEGDA which overlaps the claimed 0.5 to 3%, and 10-35% GELMA, which overlaps the claimed 10-30%. Since the prior art teaches the same combination of ingredients in the same amounts, one would expect it to have the same properties. Thus the resultant product should have a burst pressure of at least 25 kPA.
Thus this rejection is maintained.
Conclusion
6. 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.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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