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 .
Response to Arguments
The amendment to claim 1 is acknowledged, and the previous 112(b) rejection is withdrawn.
Applicant's arguments filed 07/14/2026 have been fully considered but they are not persuasive.
Applicant argues that modifying the breakable portion of the mesh member of Kollar to have a breaking strength between 0.2 N -16N and a compression elongation percentage between 39% - 1,414% as a result of the claimed formulas is not a mere design choice. Applicant explains that Kollar discloses a mesh buttress that can be punched by a stapler but does not disclose or suggest the relationship between the breaking strength of the main body and the compression elongation percentage. However, the relationship between the breaking strength and the compression elongation percentage of a material is inherent, in that all materials have a breaking strength to compression elongation percentage relationship. Furthermore, the examiner modified the mesh to have a breaking strength to be within the claimed range, and with a breaking strength of the prior art being within the claimed range, the compression elongation percentage range is met.
Therefore, the examiner respectfully disagrees with Applicant’s arguments. Moreover, the Examiner notes that Applicant’s arguments cannot take place of evidence. MPEP 716.01(c), section II, states “The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)”. Applicant explains that the formulas result in improved breaking processability of the medical member to prevent punching failure in which fraying occurs (see pages 3-4 of the remarks). However, applicant only provided a description of the unexpected results and fails to provide evidence as to why the medical member of Kollar would not operate in the same way with the formulas that result in breaking strength and compression elongation percentage ranges.
Kollar discloses a mesh medical member 60 comprising a breakable portion 64 that is intended to separate from the main body of the mesh medical member when performing a punching operation for anastomosis (Fig. 3A, para. 0046 of Kollar: “In some embodiments, perforations 65 are disposed between the inner edges 62b of the body segments 62 and the outer edge 64a of the ring segment 64, and in alignment with the knife 58, to aid in the separation of the ring segment 64 from the body segments 62 during actuation of the surgical stapling apparatus 10”). Therefore, the intended use of Kollar’s breakable portion is analogous to applicants. Since Kollar discloses the structure required to meet the formula (i.e., a mesh buttress comprising a breakable portion that undergoes some form of break strength and compression elongation in order for the breakable portion to break away from the rest of the device during a punching procedure), one of ordinary skill in the art would expect the mesh medical member of Kollar to operate the same way given the claimed ranges.
Furthermore, the instant application states "The breaking strength of the breakable portion 110A can be, for example, 16 N (Newtons) or less… the breakable portion 110A more preferably has a breaking strength of 0.2 N or more and 16 N or less" (see para. 0092 of the instant application) and "The compression elongation percentage of the breakable portion 110A can be, for example, 1414% or less…the breakable portion 110A, for example, more preferably has a compression elongation percentage of 39% or more and 1312% or less" (para. 0093 of the instant application). The claimed formulas result in ranges that are described preferentially and are very large such that the application would need more of an explanation as to why those specific ranges are critical. Therefore, the rejections of claims 1 and 10 over Kollar is maintained.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
Claim 1, line 10: “the plane direction” should recite “a plane direction”.
Claim 10, line 5: “the plane direction” should recite “a plane direction”.
Appropriate correction is required.
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, 4, 6 and 10, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kollar et al. (US 20190175172) [hereinafter Kollar].
Regarding claim 1, Kollar discloses a medical member (see Figs. 3A-B, para. 0034) comprising:
a main body 60 having a mesh structure that has a plurality of through-holes (as the buttresses 60 are porous; para. 0037), the main body 60 configured to induce expression of a biological component by being applied to anastomotic portions of a biological organ (Fig. 2, para. 0004-0005, 0034-0036) and to promote adhesion of the anastomotic portions by the induced biological component passing through the through-holes and being accumulated (para. 0036, 0038).
However, Kollar fails to disclose wherein the main body includes a breaking strength of the main body in a direction intersecting with a plane direction is represented by Y, a compression elongation percentage of the main body in the plane direction is represented by X, and the breakable portion having a relationship between the breaking strength and the compression elongation percentage, represented by the following formulas:
Y ≤ 244734(X)-1.665
39 ≤ X 1312.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the breakable portion of the main body of Kollar such that it has a breaking strength between 0.2 N – 16N and a compression elongation percentage between 39%-1414% (see para. 0091 and 0093 of the instant application which states that these ranges would satisfy the claimed formulas) since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the breakable portion of the main body of Kollar would not operate differently with the claimed breaking strength and compression elongation percentage ranges and since the breakable portion of the main body of Kollar is intended to separate from the main body 60 when performing a breaking operation for anastomosis (para. 0046 of Kollar) which is analogous to the intended use of applicant’s breakable portion. Therefore, the breakable portion of the main body of Kollar would function appropriately having the claimed breaking strength and a compression elongation percentage.
Further, it appears that applicant places no criticality on the claimed breaking strength and compression elongation percentage, indicating simply that “The breaking strength of the breakable portion 110A can be, for example, 16 N (Newtons) or less…. the breakable portion 110A more preferably has a breaking strength of 0.2 N or more and 16 N or less” (see para. 0092 of the instant application) and “The compression elongation percentage of the breakable portion 110A can be, for example, 1414% or less… Note that the breakable portion 110A, for example, more preferably has a compression elongation percentage of 39% or more and 1312% or less” (para. 0093 of the instant application).
Regarding claim 4, modified Kollar discloses wherein the breaking strength is 16 Newtons (N) or less (see rejection of claim 1 above in regards to the modification above in which this limitation is met).
Regarding claim 6, modified Kollar discloses wherein at least a part of the breakable portion 64 is disposed at a position closer to a center portion 61 of the main body 60 in the plane direction than an outer peripheral portion 62a of the main body 60 (see Fig. 3A, para. 0041).
Regarding claim 10, Kollar discloses a medical member (see Figs. 3A-B, para. 0034) comprising:
a main body 60 having a plurality of through-holes (para. 0037).
Kollar further discloses a breakable portion 64 of the main body 60 that is intended to separate from the main body of the mesh medical member when performing a punching operation for anastomosis (Fig. 3A, para. 0046 of Kollar: “In some embodiments, perforations 65 are disposed between the inner edges 62b of the body segments 62 and the outer edge 64a of the ring segment 64, and in alignment with the knife 58, to aid in the separation of the ring segment 64 from the body segments 62 during actuation of the surgical stapling apparatus 10”).
However, Kollar fails to disclose wherein the main body includes a breaking strength of the main body in a direction intersecting with a plane direction is represented by Y, a compression elongation percentage of the main body in the plane direction is represented by X, and the breakable portion having a relationship between the breaking strength and the compression elongation percentage, represented by the following formulas:
Y ≤ 244734(X)-1.665
39 ≤ X 1312.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the breakable portion of the main body of Kollar such that it has a breaking strength between 0.2 N – 16N and a compression elongation percentage between 39%-1414% (see para. 0091 and 0093 of the instant application which states that these ranges would satisfy the claimed formulas) since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the breakable portion of the main body of Kollar would not operate differently with the claimed breaking strength and compression elongation percentage ranges and since the breakable portion of the main body of Kollar is intended to separate from the main body 60 when performing a breaking operation for anastomosis (para. 0046 of Kollar) which is analogous to the intended use of applicant’s breakable portion. Therefore, the breakable portion of the main body of Kollar would function appropriately having the claimed breaking strength and a compression elongation percentage.
Further, it appears that applicant places no criticality on the breaking strength and compression elongation percentage claimed, indicating simply that “The breaking strength of the breakable portion 110A can be, for example, 16 N (Newtons) or less…. the breakable portion 110A more preferably has a breaking strength of 0.2 N or more and 16 N or less” (see para. 0092 of the instant application) and “The compression elongation percentage of the breakable portion 110A can be, for example, 1414% or less… Note that the breakable portion 110A, for example, more preferably has a compression elongation percentage of 39% or more and 1312% or less” (para. 0093 of the instant application).
Regarding claim 13, modified Kollar discloses wherein the breaking strength is 0.2 Newtons (N) to 16 N (see rejection of claim 10 above in regards to the modification above in which this limitation is met).
Regarding claim 15, modified Kollar discloses wherein the breaking strength is 16 N or less, and the compression elongation percentage is 1414 % or less (see rejection of claim 10 above in regards to the modification above in which this limitation is met).
Regarding claim 16, modified Kollar discloses wherein at least a part of the breakable portion 64 is disposed at a position closer to a center portion 61 of the main body 60 in the plane direction than an outer peripheral portion 62a of the main body 60 (see Fig. 3A, para. 0041).
Claim(s) 7-9, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kollar et al. (US 20190175172) [hereinafter Kollar], as applied to claims 1 and 10 above, and in further in view of D’Agostino et al. (US 20060212050) [hereinafter D’Agostino].
Regarding claims 7 and 17, modified Kollar discloses all of the limitations set forth above in claim 1. Modified Kollar further discloses that the main body may be fabricated from biocompatible materials. However, modified Kollar fails to disclose wherein a constituent material of the breakable portion contains polyglycolic acid.
D’Agostino in the same field of endeavor of surgical buttresses 100 for anastomosis (Fig. 3, para. 0051, 0056) teaches that it is known in the art to fabricate a main body from biocompatible material such as polyglycolic acid for its bioabsorbable properties (para. 0056, 0058).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the main body of Kollar using the polyglycolic acid material as taught by D’Agostino, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding claims 8 and 18, modified Kollar discloses wherein the breakable portion 64 is made of a nonwoven fabric (para. 0037 of Kollar).
Regarding claim 9, modified Kollar discloses wherein the breakable portion 64 is constituted by a heated portion 62b that has been subjected to heat treatment (para. 0041 of Kollar).
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/
Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
