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 Group I (claims 17-31, 34-35) in the reply filed on 1/22/26 is acknowledged. Claims 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invetion, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
3. 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.
4. Claim(s) 17-19, 24-25, 34 are rejected under 35 U.S.C. 103 as being unpatentable over Chhaya et al. 2021/0267742.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
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Regarding claim 17-18, 24-25, 28 and noting figures 1 and 2, Chhaya et al. discloses a three-dimensional implant [0014-0015] for tissue reconstruction or tissue augmentation for insertion into a patient, the implant comprising a planar layers (see strands 22) forming a three-dimensional structure, wherein the three- dimensional structure comprises a plurality of hollow channels (22), wherein each hollow channel comprises a plurality of sidewalls (see figure 2), wherein a sidewall comprises a plurality of strand segments and a plurality of gaps arranged alternatingly (for instance along the arrow 23) so that a gap is formed between adjacent strand segments of the sidewall ([0071-0072]), wherein the gap comprises a gap length (gl) and a resting gap height (gh), wherein the plurality of gaps are reversibly expandable gaps, wherein the height of a reversibly expandable gap increases due to an object being received by the gap and wherein the height of the gap decreases due to the object being removed from the gap (this is intended use/functional. See MPEP 2114). Because the implant as described by Chhaya et al. has the same three-dimensional structure also described in the present application, and even the material of the strands is the same, the plurality of gaps of the three-dimensional structure of the implant of Chhaya et al. would be reversibly expandable gaps as well.
Chhaya et al. describes a non-exhaustive list of some of the same materials (see [0014] e.g. polycaprolactone, polygycolide, polylactide and/or a (co)-polymer ) as described in the current application (see [0090]). It would be obvious to one having ordinary skill in the art that the equivalent material may be used to in the manufacturing as recited in claims 17 and 18:
"wherein the plurality of strands are formed from a material having an a yield strength (ayield) and elastic modulus (E), and wherein a radius (R) of the plurality of strands and a gap length (gl) of a reversibly expandable gap is based on a yield strength (<ryield)), the elastic modulus (E) of the material and a deflection capability of the adjacent strand segments forming the reversibly expandable gap".
It is noted that the materials used in Chhaya et al. have some kind of yield strength (a yield and elastic modulus (E). Any property of the implant is dependent on its yield strength (a yield and elastic modulus (E).
With regards to requirements of testing against the specific standards of B-15, the claimed resultant properties as desired in the aforesaid claims would be inherent in, if not obvious to, the composite of Chhaya et al. (as discussed above) It is reasonable to presume so as support for said presumption is found in the use of like materials (i.e. a material having an a yield strength (σyield) and elastic modulus (E), wherein each strand (101) has a length and a cross-sectional diameter, wherein a ratio of the radius (R) of the strand segments (101) to a square of the gap length (gl) of a reversibly expandable gap (this is interpreted because the implant is capable of being contracted and then expanded thus making it reversibly expandable) is based on the yield strength (σyield) of the material, the elastic modulus (E) of the material and a deflection capability (δ) of a strand segment (105) of the gap (106), wherein the deflection capability (δ) is the deflection of the adjacent strand segments caused by the insertion of the object into the gap; wherein a ratio of the radius (R) of the plurality of strands (101) to a square of the gap length (gl) of a reversibly expandable gap (106) is expressed by the expression wherein δ represents a deflection capability of a strand segment of the gap.)
8. Regarding claim 19 “The implant of claim 17, wherein the deflection capability (δ) of the strand segments of the reversibly expandable gap (106) lies between 0.05 times and 0.75 times the gap height (gh) of the gap” is considered to be functional language and depends upon the act of deflection. See MPEP 2114.
9. Regarding claim 20, wherein a reversibly expandable gap (106) is expandable with respect to the resting gap height, wherein the resting gap height is the minimal or smallest height between the adjacent strand segments when the implant is at rest” is considered to be functional language and depends upon the act of deflection. See MPEP 2114.
10. Regarding claims 22-23, e.g. “wherein more than 80% of all the sidewalls (104) of the plurality of sidewalls comprise the reversibly expandable gaps (106)” it is obvious that because the entire is compactable and expandable that it is reversibly expandable and would include 80% of the sidewalls.
11. Regarding claims 28-30, Chhaya et al. discloses that the implant is a soft-tissue implant and a breast implant see [0052].
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Product by Process 103
12. Products by Process claims are NOT limited to the manipulations of the recited steps only to the structure implied by the steps.
Claim 31 is rejected under 103 as being anticipated by over Chhaya et al. 2021/0267742 (as discussed supra).
Chhaya et al. has been disclosed supra does not disclose “a method of using an implant according to claim 17 during surgery, comprising the step of guiding a needle through the implant for implant surgery”.
Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. A statement or argument by the attorney is not factual evidence. See MPEP 716.01
Thus, even though Chhaya et al. are silent s to the process using an implant according to claim 17 during surgery, comprising the step of guiding a needle through the implant for implant surgery”, it appears that the product in reference would be the same or similar as that claimed.
Allowable Subject Matter
13. Claims 26-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
14. The bold and italicized below indicate novel features. The following is a statement of reasons for the indication of allowable subject matter: The closes prior art of Chhyar et al. has been disclosed supra however does not teach or disclose: that the implant of claim 17, further comprising one or more contouring strands arranged at an outer surface region of the implant, and wherein the plurality of contouring strands are arranged such that a plurality of reversibly expandable contouring gaps are formed between adjacent strand segments of the plurality of contouring strands” or “ that implant of claim 17, wherein the plurality of hollow channels comprise at least one of a sinusoidal channel and zig-zag channel”.
15. Claims 34-35 are allowed
16. The bold and italicized below indicate novel features. The following is an examiner’s statement of reasons for allowance: The closest prior art of Chhyar et al. has been disclosed supra. The prior art fails to teach or disclose:
A three-dimensional implant for tissue reconstruction or tissue augmentation for insertion into a patient, the implant comprising: a plurality of planar layers, wherein a first group of sublayers comprises a plurality of strands oriented in first direction, wherein a second group of sublayers comprises a plurality of strands oriented in a second direction, the sublayers of the first group of sublayers and the sublayers of the second group of sublayers are arranged alternatingly in a third direction, the plurality of layers forming a three-dimensional structure comprising a plurality of hollow channels extending in the third direction, wherein the implant is compressible at least along the third direction; wherein each hollow channel comprises a first sidewall extending in the third direction and comprises a plurality of strand segments oriented in a first direction and a plurality of gaps arranged alternatingly, and a second sidewall extending in the third direction and comprising a plurality of strand segments oriented in the second direction and a plurality of gaps arranged alternatingly, wherein at least one of the first sidewall and the second sidewall of the hollow channel is an undulating sidewall, wherein the plurality of strand segments of the undulating sidewall belong to different layers of the implant, wherein adjacent strand segments of the undulating sidewall are separated by a gap, wherein the adjacent strand segments have a lateral offset with respect to each other to create a pattern of a plurality of peaks and a plurality of troughs of the undulating sidewall.
Conclusion
17. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cesarano, III et al. 6,993,406; Stuecker et al. 7,527,671.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 April 22, 2026
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