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 .
The examiner acknowledges receipt of amendment and remarks filed 02/17/2026.
Claims 1 and 21 are amended.
Claim 3 is canceled.
Claims 1-2, 4-5, 8-10, 12, 14, 18-19 and 21 are pending.
The status identifier for claims 18-19 and 21 should be withdrawn (claims 18-19) and withdrawn, currently amended (claim 21). Applicant is respectfully requested to use proper status identifiers for all claims in all future filings.
Election/Restrictions
Applicant's election of Group I, claims 1-5, 8-10, 12 and 14-15 in the reply filed on 10/30/2024 has been acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.0l(a)).
Claims 18-19 and 21 stand withdrawn from further consideration pursuant to 37 CPR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2024.
Claims 1-2, 4-5, 8-10, 12 and 14 are under consideration.
Priority
This application is a 371 of PCT/IL2020/050879 filed 08/12/2020 which claim benefit of 63/003,319 filed 04/01/2020 and which claims benefit of 62/885,345 filed 08/12/2019.
Response to Arguments
Based on the cancelation of claim 3, the rejection of claim 3 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn.
For the rejection under 35 USC 103, i) applicant argues that the examiner appears to read the claims as comprising nondegradable nature of he patch to include patch or sheet of film made of metals and that metals are not suggested anywhere in the claims or description of the instant application, and that synthetic gingival patch graft cannot include metals but that the body of the synthetic gingival patch graft is a porous polymeric structure. ii) Applicant argues that the scaffold of SOO-HONG KIM is formed by biodegradable polymer and does not use non-biodegradable polymer, it is the use of degradable polymer that assists regeneration of periodontal tissue after which the scaffold is degraded; iii) the shielding membranes of SOO-HONG KIM is used to regenerate normal tissues while the instant patch is the tissue replacement itself. Therefore, applicant argues, the scaffold of SOO-HONG KIM cannot be seen as teaching a skilled person to use the scaffold of SOO-HONG KIM for permanent tissue replacement patch. iii) Applicant argues that shielding film in SOO-HONG KIM is synthetic degradable polymer such as PCL, PLA, PLGA, PGA or natural absorbent polymer such as alginic acid, chitosan, collagen, hyaluronic acid, cellulose or mixture, such that the shielding membrane in SOO-HONG KIM is not capable to replace tissue permanently. iv) Regarding the rejection of claim 10 over SOO-HONG KIM in view of Aleksandra Porjazoska Kujundziski and ZASTITA MATERIJALA, applicant argues that Aleksandra Porjazoska Kujundziski acknowledges disadvantages of using permanent implants and the reference to non-degradable polymers relates to controlled drug delivery systems, as micro or nano carriers of drugs. Therefore, applicant asserts that none of the prior art cited by the examiner, taken together or taken separately teaches or suggests the claimed invention.
Response: i) Regarding metals, the question is not that the claims or the instant description teaches metals. In the office action mailed 11/17/2025, the examiner was responding to applicant’s arguments. Specifically, SOO-HONG KIM teaches a shielding film used to keep externally attached gingiva or muscle tissue from penetrating into the space to be regenerated with a new periodontal tissue (page 3 of the translation at lines 11 and 12 from the bottom) and the material for the shielding is polyethylene or polyvinylidene fluoride or polytetrafluoroethylene or polymethyl methacrylate or polyhydroxyethyl methacrylate or poly N-isopropylacrylamide or polypyrrole or polyethylene terephthalate or polyethylene-co-vinyl acetate; and the shield can also be of thin film of titanium or stainless steel (page 3 of the translation at lines 4-9 from the bottom and fifth full paragraph of page 5 of the translation) and these polymers are non-degradable. Thus, it is non-degradable polymer or titanium or stainless steel. SOO-HONG KIM teaches non-degradable polymer. ii) SOO-HONG KIM teaches shield comprised polymers such as polyethylene-co-vinyl acetate is non-degradable. Therefore, the effect of the non-degradable polymer would be the same as what applicant is arguing for. iii) Tissue replacement is the intended use of the product and the prior art scaffold/shielding film comprised of non-degradable polymer would also be capable of the intended use. iv) Aleksandra Porjazoska Kujundziski was relied upon for teaching porous matrices are prepared by electrospinning (page 335, right column, last full paragraph) and not for possible advantages or disadvantages of using permanent implants.
Therefore, the references, taken together or taken separately suggests the claimed invention. The rejection will be maintained below.
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.
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.
Claim(s) 1-2, 4-5, 8-9, 12 and 14 remain rejected under 35 U.S.C. 103 as being unpatentable over SOO-HONG KIM (WO 2013094992, Eng. Trans Description) for reasons of record.
The amendment to claim 1 does not change the scope of claim 1
The recitation that the patch is a tissue replacement patch is the intended use of the gingival patch. The body of claim 1 fully and intrinsically sets forth the limitations of the gingival patch.
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed
invention, and merely states the purpose or intended use of the invention, rather than any distinct
definition of any of the claimed invention's limitations, then the intended use or purpose of the invention does not limit structure of the gingival patch. See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
For claims 1-2 and 8, SOO-HONG KIM teaches a shielding film used to keep externally attached gingiva or muscle tissue from penetrating into the space to be regenerated with a new periodontal tissue (page 3 of the translation at lines 11 and 12 from the bottom) and the material for the shielding is polyethylene or polyvinylidene fluoride or polytetrafluoroethylene or polymethyl methacrylate or polyhydroxyethyl methacrylate or poly N-isopropylacrylamide or polypyrrole or polyethylene terephthalate or polyethylene-co-vinyl acetate; and the shield can also be of thin film of titanium or stainless steel (page 3 of the translation at lines 4-9 from the bottom and fifth full paragraph of page 5 of the translation) and these polymers are non-degradable. The shielding film has pore size of 0.01 to 30 micron (fourth paragraph from the bottom of page 5 of the translation) and a thickness of 0.01-0.5 mm (third paragraph from the bottom of page 5 of the translation). The shielding film comprising non-degradable polymer applied in the gingival area meets the limitation of gingival patch graft and the polymer meets claim 8. SOO-HONG KIM does not specifically say that the shielding film replaces tissue. Because the recitation that the patch is a tissue replacement patch is the intended use of the gingival patch, before the effective date of the invention the ordinary skilled artisan will reasonably expect that the shielding film would be capable of predictably replace tissue at site of application. The pore size of 0.01 to 30 micron overlaps the claimed range of less than 5 micron of claim 1 and 0.01 to 5 micron of claim 2 and 5-20 micron and because 0.01 to 30 micron allows for ranges of less than 5 microns, 0.01 to 5 micron, and 5 to 20 microns.
For claim 4, the shielding film comprising the non-degradable polymer is biocompatible.
For claim 5, the thickness of the shielding film at 0.01 (10 micron)-0.5 mm (500 micron) encompasses the claimed range as the disclosed range allows for 10 to 100 micron.
For claim 9, the shielding film is formed by nanofibers having pores having [pore size of 0.01 to 30 micron (last paragraph on page 5 of the translation).
For claim 12, growth factor is an active agent (line 25 of page 3 of the translation).
For claim 14, the shielding film/membrane comprises nonporous sheet/layer (last paragraph of page 5 of the translation).
Therefore, SOO-HONG KIM renders claims 1-2, 4-5, 8-9, 12 and 14 prima facie obvious.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over SOO-HONG KIM (WO 2013094992, Eng. Trans Description), as applied to claim 1, in view of Aleksandra Porjazoska Kujundziski et al., "Biodegradable polymers suitable for tissue engineering and drug delivery systems" in ZASTITA MATERIJALA 58 (2017) 333-348.
Claim 10 depends on claim 1.
SOO-HONG KIM has been described above to render claim 1 prima facie obvious.
SOO-HONG KIM does not teach that its polymer is electrospun as required by claim 10. However, Aleksandra Porjazoska Kujundziski teaches that porous matrices are prepared by electrospinning (page 335, right column, last full paragraph). Therefore, before the effective date of the invention, one having ordinary skill in the art would reasonably expect that the porous shield film of SOO-HONG KIM is predictably electrospun as taught by Aleksandra Porjazoska Kujundziski.
Therefore, SOO-HONG KIM in view of Aleksandra Porjazoska Kujundziski renders claim 10 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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