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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on December 31, 2025 is acknowledged.
Claims 1-15 and 18-26 are pending in this application.
Claims 2-7, 11-15, 19-21, and 23 have been amended.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on December 31, 2025 is acknowledged.
Claims 18-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claims 1-15 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on November 15, 2023 is acknowledged. A signed copy is attached to this office action.
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)(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.
Claims 1-12 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akman et al. (Development of Photo crosslinked Poly(glycerol dodecanedioate)-A biodegradable shape memory polymer for 3D-printed tissue engineering applications, Advanced Engineering Materials, Vol 23, Issue 10, April 24, 2021).
Akman discloses poly(glycerol-dodecanedioate) (PGD), a biodegradable shape memory thermosetting polymer with melt transition of ≥ 37 ± 1.1 ˚C. A UV-curable polymer developed via acrylation of PGD (APGD), which removes the need for thermal curing while retaining its shape memory properties (abstract) is taught.
Acrylation was chosen because it is known to induce photocurable behavior (page 2, right column).
2,2-dimethoxy-2-phenylacetophenone (DMPA) is disclosed as a photo-initiator
Regarding claim 2, Photocured APGD samples show clear shape memory behavior, wherein the same is deformed into a programmed shape and upon heating returns to its permanent shape (page 3, left column).
Regarding claim 3, as noted above, the polymers are UV-curable.
Regarding claim 4, as noted above, the polymer is formed via acrylation of PGD.
Regarding claim 5, as noted above, DMPA is disclosed as the photo initiator.
Regarding claim 6, Figure 2 discloses transition temperatures of APGD between 26.7-36.2 ± 0.3.
Regarding claim 7, below APGD network Tm, the material presents as a stiff thermoplastic material exhibiting elastic behavior with opaque white coloration. Upon heating above Tm, the polymer transitions to an elastomer with translucent morphology (page 3, left column).
Regarding claim 8, Figure 9 shows polymer structure having pores of about 1 mm in diameter.
Regarding claim 9, the polymer is disclosed to be a novel material for the development of patient specific devices for the structural repair of soft tissue via minimally invasive procedures such as removing the need for a permanent implant for device delivery through small incisions and access ports (page 1, right column).
Regarding claim 10, the APGD network showed reduced cross link density, suggesting an increased availability of carboxylic acid groups on the surface of the material. It is the Examiner’s position that said carboxylic acid groups are functionalized (page 8, right column).
Regarding claim 11, it is noted the instant claim is a combination of claims 1, 2, 4-6, 8, and 10, which are discussed above.
Regarding claim 12, the increased carboxylic acid groups on the surface result in a material which is very hydrophilic (page 8, right column).
Regarding claim 14, the polymer was synthesized via a condensation reaction between equimolar parts of glycerol and dodecanedioic acid.
Regarding claim 15, the APGD shows approximately 15-20% degradation over a 1 month time period. It is believed the APGD is suitable for applications requiring device survival for approximately 5-6 months (page 11, right column).
Akman, therefore, anticipates the rejected claims.
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.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Akman et al. (Development of Photo crosslinked Poly(glycerol dodecanedioate)-A biodegradable shape memory polymer for 3D-printed tissue engineering applications, Advanced Engineering Materials, Vol 23, Issue 10, April 24, 2021) in view of Biggs (US 20110091518).
The teachings of Akman are discussed above.
Akman does not disclose the use of a bioactive agent as a functionalized group.
Biggs discloses functional groups comprising bioactive agents on the surface of the implant materials coated on one or more of the proximal or distal end surfaces (paragraph 0020).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have incorporated a bioactive agent on the surface of the implant of Akman depending on its desired application and needs of the patient/implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615