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 request for extension of time, request for continued examination under 37 CFR 1.114, amendment and remarks filed 11/05/2025.
Claims 1 and 21 are amended. While applicant amends claims 1 and 21, it is respectfully brought to applicant’s attention that claims 1 and 21 in the current format after the amendment is the same as the claims filed 04/07/2025.
Claims 1-5, 8-10, 12, 14, 18-19 and 21 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/05/2025 has been entered.
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Claims 18-19 and 21 stand withdrawn from further consideration pursuant to 37 CPR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 1-5, 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
Applicant argues that the claimed invention is patentable over the cited prior art. The examiner has carefully considered applicant’s arguments. i) Applicant argues that SOO-HONG KIM does not use non-biodegradable polymer; ii) the shield in SOO-HONG KIM is shielding membrane that can never function as a tissue replacement because it is used to prevent tissue growth around the implant from interacting with the surrounding tissue and that the shield allows for the process of regeneration to occur by the use of growth factors and that the shield is absorbed and degraded thereafter and that the shield cannot be seen to replace tissue permanently; iii) that in ZEESHAN SHEIKH, any non-degradable shielding membrane has pore sizes that are difference from the pore size of the polymer in the present invention; iv) ALEKSANDRA PORJAZOSK KUJUNDZISKI, teaches advantages of biodegradable polymer, does not teach the claimed pore size of less than 5 microns, is an implant for delivery of active agents and cannot be used as tissue replacement, teaches problems with permanent implants.
Response: Firstly, the examiner upon further review and consideration of the claims and applicant’s arguments, notes that claim 1 teaches that the patch is a nondegradable and nondegradable nature of the patch includes patch or sheet or film made of metals. Claim 1 does not say that the patch is non-degradable polymer. Tissue replacement is intended use and the polymeric shield or thin film of titanium metal would be capable of tissue replacement.
Therefore:
i) & ii) The examiner agrees that the SOO-HONG KIM teaches scaffold that is made of degradable polymer. However, SOO-HONG KIM teaches shield that is reinforced with synthetic polymer mesh for shape maintenance (line 10 of page 3 of the translation) and this shield maintaining the shape in the dental area broadly reads on gingival patch graft and is capable of replacing tissue. The as filed specification does not say that the graft is permanently placed and the claims as presented on 11/05/2025 does not say permanent implanted graft. The comprising language is open and does not exclude the presence of growth factors which are active agents.
iii) ZEESHAN SHEIKH was not relied upon for teaching pore size. ZEESHAN SHEIKH was relied upon for teaching in dental implants, non-degradable membrane films provide more predictably performance (first full paragraph under “Non-degradable barrier membrane” in the left column of page 8 of 20).
iv) ALEKSANDRA PORJAZOSK KUJUNDZISKI was not relied upon for teaching pore sizes and biodegradable polymers, ALEKSANDRA PORJAZOSK KUJUNDZISKI was relied upon for suggesting that in the case for implantation to oral or nasal or buccal areas, non-degradable polymers are preferable (left column of page 40 at the second full paragraph).
The rejections below are made after consideration of applicant’s arguments and further search and consideration of the claims and prior art of record.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The pore size in claim 1 is less than 5 microns. Claim 3 depends on claim 1. In claim 3 the pore size is between 5 and 20 microns so that the pore size is greater than 5. Thus the pore size in claim 3 does not further limit the pore size of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-5, 8-9, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over SOO-HONG KIM (WO 2013094992, Eng. Trans Description).
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 1-3 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 are 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 of claim 3 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 1-5, 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.
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