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 .
CLAIMS UNDER EXAMINATION
Claims 1-3, 7 and 17 have been examined on their merits.
PRIORITY
Foreign document JP2021-023164 filed on 17 February 2021 is acknowledged. A foreign translation has not been provided.
CLAIMS UNDER EXAMINATION
Claims 1-3, 7 and 17 have been examined on their merits.
PRIORITY
Foreign document JP2021-023164 filed on 17 February 2021 is acknowledged. A foreign translation has not been provided.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
NEW REJECTIONS
New rejections have been necessitated by claim amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Braccini et al. (Adhesion of fibroblast cells on thin films representing surfaces of polymeric scaffolds of human urethra rationalized by molecular models of integrin binding: cell adhesion on polymeric scaffolds for regenerative medicine. Journal of Biotechnology. 20 December 2020. Pages 233-238 Volume 324) in view of Armbruster et al. (Film and Methods of Manufacture. US2013/0171410 2013).
Braccini et al. analyze cell adhesion to thin polymer films produced by solvent casting (Abstract). A film has a sheet shape. The art teaches the following films 1) polydioxanone (PDO)/ polyglycolic acid (PGA) and 2) PDO/polylactic acid (PLA) (see Figure 4). A polymer made of PDO/PGA or PDO/PLA reads on the “consisting of” language recited in claim 1.
Braccini is silent regarding the thickness of the thin film.
Armbruster et al. teach a polymer film (Abstract). The film is “thin” ([0047]). The film can comprise one or more bioresorbable polymers, including PLA, PGA and polydioxanone ([0050]). The film is solvent cast ([0073]). The art teaches a thickness of 0.1 mm (hence, 100 micron)([0054]). Armbruster teaches the film can be implanted in a patient ([0004] [0047]).
It would have been obvious to make a thin polymer film of 100 µm. Braccini teaches a solvent case thin polymer film and Armbruster teaches solvent cast polymer films that are 100 µm thick. One would have been motivated to make a film of the claimed size since Armbruster teaches films of this size are used for implantation. One would have had a reasonable expectation of success since Armbruster teaches solvent casting can be used to make films with the claimed thickness containing the claimed polymers. One would have expected similar results since both references are directed to thin films comprising polymers made by the same process. Therefore claim 1 is rendered obvious.
Braccini teaches PLA/PGA copolymers can be used for synthetic biomaterials (see page 234, left column, first paragraph). Therefore claim 2 is rendered obvious.
Braccini teaches the mixtures are in 1 1:1 ratio (Abstract see page 234, right column, first paragraph of section 2.2). This reads on claim 3.
Braccini teaches cells are incubated on the polymer films and allowed to adhere (Abstract; see page 235, first paragraph; see Table1). Armbruster teaches thin films can be implanted into the soft tissue of an animal ([0096] –[0090]). The laminate recited in claim 7 is rendered obvious.
Braccini and Armbruster teach a solvent casting method. Claim 17 is a product by process limitation which does not distinguish the claimed product from the thin film rendered obvious by the teachings of the prior art. Therefore claim 17 is included in this rejection.
Therefore Applicant’s invention is rendered obvious as claimed.
Claims 1-2, 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Armbruster et al. (Film and Methods of Manufacture. US2013/0171410 2013) in view of Fontana et al. (Primary Stability of a PGLA/Polydioxanone Membrane for Potential Autologous Chondrocyte Implantation in the Hip Joint. a Cadaveric Study. HIP International. 2013;23(3):337-342).
Armbruster et al. teach a polymer film (a support; Abstract). The film can be a thin sheet (a support) [0047]). The film can comprise one or more bioresorbable polymers, including PLA, PGA and polydioxanone ([0050]). The art teaches a thickness of 0.1 mm (hence, 100 micron) ([0054]). Armbruster also teaches the film can be implanted in living tissue for soft tissue augmentation ([0058] [0095]).
Armbruster does not teach a support consisting of polydioxanone and a copolymer of polylactic acid and polyglycolic acid with sufficient specificity to anticipate the claim.
Fontana teaches a resorbable polyglactin-910/poly-p-dioxanone membrane for autologous chondrocyte implantation (Abstract). The art teaches polygalactin is a polyglycolic-polylactic acid polymer (see page 338, left column, “Membrane”). A membrane containing polyglactin-910/poly-p-dioxanone reads on the “consisting of” language recited in claim 1. The membrane is used to treat a cartilage (soft tissue) defect in a joint (Abstract). The membrane is prepared to match the size cartilage defect (page right column, last paragraph).
It would have been obvious to prepare a film consisting of polydioxanone and a copolymer of polylactic acid and polyglycolic acid. Armbruster teaches a support comprising polymers for sofit tissue repair and Fontana explicitly teaches polytrioxane and a polylactic acid-polyglycolic acid copolymer to repair a soft tissue. One would use the specific combination taught by Fontana to repair cartilage. One would have had a reasonable expectation of success since Armbruster teaches polydioxanone, polylactic acid and polyglycolic acid can be used to prepare a film. One would have expected similar results since both references are directed to polymer supports for tissue repair. Therefore claim 1 is rendered obvious. Polyglactin-910 reads on claim 2. Armbruster teaches the film can be placed adjacent to living tissue ([0058]). This is broadly interpreted to read on a cell sheet on the support. Therefore claim 7 is rendered obvious.
Armbruster teaches the film is made by adding polymer solution in a mold from which a solution is removed ([0082]). Even arguendo it did not, claim 17 is a product by process limitation which does not distinguish the claimed product from the film rendered obvious by the teachings of the prior art. Therefore claim 17 is included in this rejection.
Therefore Applicant’s invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 26 May 2026 are acknowledged. The Applicant argues the previously recited references do not teach the limitations recited in the amended claims. New grounds of rejection have been made to address the amended claims.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the APIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights