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 .
Election/Restrictions
Applicant’s election without traverse of Claims 7-17 in the reply filed on 12/10/2025 is acknowledged.
Claims 1-6 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 [ 3 ].
Claim Objections
Claim 7-17 objected to because of the following informalities: the phrase "further comprising" should be "comprising". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 – 17 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “the uncovered fascia” and “the repaired hernia site” There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "for the subject". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the nanofibers" in the mesh implant. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 7 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,688,224 hereinafter Altaf in view of US 6,066,776 hereinafter Goodwin in further view of US 2020/0095374 hereinafter Skalla.
In regards to Claim 7: Altaf teaches of a method of using -a mesh implant for hernia repair (Altaf, Column 6 Lines 27-32) wherein the mesh implant includes an original longitudinal tensile strength and an original transverse tensile strength (Altaf, Column 8 Lines 39-47) and wherein the original longitudinal tensile strength ≥16N/cm and the original transverse tensile strength ≥16N/cm (Altaf, Column 9 Lines 1-5). Altaf does not teach placing a mesh implant on the uncovered fascia at the repaired hernia site and preventing hernia recurrence with the mesh implant and the mesh implant losses about 20% of the original longitudinal tensile strength by the 10th day and about 35% of the original transverse tensile strength by the 10th day through biodegradation.
Goodwin teaches placing a mesh implant on the uncovered fascia at the repaired hernia site and preventing hernia recurrence with the mesh implant (Goodwin, Column 4 Lines 66-67; Column 5 Lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the method of placing a prothesis to repair a hernia taught in Goodwin to the prosthetic taught in Altaf, the motivation being to provide a method of repair for hernias utilizing the device to fill the void created by the hernia.
Skalla teaches the mesh implant losses about 20% of the original longitudinal tensile strength by the 10th day and about 35% of the original transverse tensile strength by the 10th day through biodegradation (Skalla, Paragraph 0163; Figure 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the loss in tensile strength taught by Skalla to the prosthetic of Altaf, the motivation being to provide a rate of degradation that allows the body to heal itself to fill the space needed.
In regards to Claim 8: a modified Altaf teaches all of claim 7, and wherein the hernia repair is selected from the group consisting of. inguinal, femoral (Goodwin, Column 4 Line 66-67), umbilical, incisional, epigastric, and hiatal.
Claim(s) 9 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,688,224 hereinafter Altaf in view of US 6,066,776 hereinafter Goodwin in further view of US 2020/0095374 hereinafter Skalla in furthest view of EP 3,705,143 hereinafter Baer.
In regards to Claim 9: A modified Altaf teaches all of claims 7 & 8, but does not teach wherein the mesh implant does not cause connective tissue irritation that leads to mesh rejection and the mesh implant degrades gradually enough to stay in the tissue for at least six months.
Baer teaches wherein the mesh implant does not cause connective tissue irritation that leads to mesh rejection and the mesh implant degrades gradually enough to stay in the tissue for at least six months (Baer, Paragraph 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the degradation rate of the implant of Baer to the prosthetic of Altaf, the motivation being to provide a rate of degradation that does not interfere with the natural healing process facilitated by the presence of the implant.
In Regards to Claim 10: A modified Altaf teaches wherein the mesh implant supports the repaired hernia site until a scar tissue is formed (Baer, Paragraph 0021).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,688,224 hereinafter Altaf in view of US 6,066,776 hereinafter Goodwin in further view of US 2020/0095374 hereinafter Skalla in further view of EP 3,705,143 hereinafter Baer in further view of US 6,425,919 hereinafter Lambrecht in further view of 2018/0303592 hereinafter Taylor in further view of US 2010/0082114 hereinafter Gingras.
In Regards to Claim 11: A modified Altaf teaches all of claims 7, 8, 9 , & 10; Atlaf does suggest that the mesh implants would reduce infection and thus reduce pain and irritation but does not explicitly teach wherein said mesh implant does not cause long term pain, irritation, or restricted mobility for the subject.
Gingas teaches wherein said mesh implant does not cause long term pain (Gingas, Paragraph 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the lack of long-term pain caused by the implant of Gringas to the prosthetic of a modified Altaf, the motivation being to provide a better experience for the end user.
Taylor teaches wherein the implant does not cause irritation (Taylor, Paragraph 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the lack of irritation caused by the prosthetic taught in Taylor to the prosthetic device of a modified Altaf, the motivation being to provide a better experience for the end user.
Lambrecht teaches wherein the mesh implant does not restrict the movement of the user (Lambrecht, Column 12 Lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the mobility allowed by the implant of Lambrecht to the prosthetic device of Altaf, the motivation being to provide a better experience for the end user.
Claim(s) 12 - 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,688,224 hereinafter Altaf in view of US 6,066,776 hereinafter Goodwin in further view of US 2020/0095374 hereinafter Skalla in further view of EP 3,705,143 hereinafter Baer in further view of US 6,425,919 hereinafter Lambrecht in further view of 2018/0303592 hereinafter Taylor in further view of US 2010/0082114 hereinafter Gingras in furthest view of US 2002/0120348 hereinafter Melican.
In Regards to Claim 12: A modified Altaf teaches all of claims 7, 8 , 9, 10 , & 11; but does not teach wherein the mesh implant mimics the structure of the extracellular matrix and facilitates cell attachment, cell infiltration, cell proliferation, and cell differentiation.
Melican teaches wherein the mesh implant mimics the structure of the extracellular matrix and facilitates cell attachment, cell infiltration, cell proliferation, and cell differentiation (Melican, Paragraph 0033 & 0066).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the extracellular matrix and progression taught in Melican to the prosthetic device of Altaf, the motivation being to provide a more comprehensive integration of the device into the body’s natural healing process.
In Regards to Claim 13: A modified Altaf teaches all of claims 7, 8, 9, 10, 11, & 12; and wherein white blood cells and fibroblasts infiltrate, attach to, and grow on the nanofibers of said mesh implant (Melican, Paragraph 0063).
In Regards to Claim 14: A modified Altaf teaches all of the claims 7, 8, 9, 10, 11, 12, & 13; and wherein said mesh implant integrates into the neighboring tissues at the repaired hernia site and the mesh implant facilitates proper wound healing and defect closure (Melican, Paragraph 0023).
In Regards to Claim 15: A modified Altaf teaches all of claims 7, 8, 9, 10, 11, 12, 13, & 14; and further comprising growing isolated differentiable cells on the mesh implant as a scaffold (Melican, Paragraph 0035).
In Regards to Claim 16: A modified Altaf teaches all of claims 7, 8, 9, 10, 11, 12, 13, 14, & 15; and wherein said isolated differentiable cells include, but are not limited to, the stem cells or progenitor cells of the blood, cartilage, bones, skin, and nerves (Melican, Paragraph 0035).
In Regards to Claim 17: A modified Altaf teaches claim 7, 8, 9, 10, 11, 12, 13, 14, 15, & 16; and further comprising using the mesh implant in the repair of tissue injury including wound healing, repair of injuries to the bone, nerves, or skin, and treatment of burn injuries (Melican, Paragraph 0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./ Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791