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 of group 1 – claims 1-18 in the reply filed on 10/28/2025 is acknowledged. Because applicant did not distinctly and specifically point out if the election was with or without traverse in the restriction response, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
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 1-18 are 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 1 recites the limitation “mesh-like” in line 2. It is unclear to the examiner the scope of a structure that would be considered as “mesh-like” to meet the claim language. Under broadest reasonable interpretation, “like” is defined as “the same or nearly the same (as in appearance, character, or quantity) (see attached Merriam-Webster Dictionary of the definition of “like”). For examination purposes, the limitation will be interpreted as any structure that is nearly the same as a mesh structure.
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) 1-6 and 10-16 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 mesh-like main body 60 that has a plurality of through-holes (as the buttresses 60 are porous; para. 0037), the mesh-like 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).
Kollar further discloses a breakable portion 64 of the mesh-like main body 60 (Figs. 3A-B, para. 0039).
However, Kollar fails to disclose wherein the main body includes, when 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 (1) to (4):
Y ≤ 244734(X - Z)-1.665 (1)
0 ≤ Z < 408.216 (2)
X - Z > 0 (3)
39 ≤ X (4).
There is no evidence of record that establishes that changing the breaking strength and the compression elongation percentage would result in a difference in function of the breakable portion of the mesh-like main body of Kollar. Further, a person having ordinary skill in the art, being faced with modifying the breakable portion of the mesh-like main body of Kollar such that it has a breaking strength between 0.2 N – 16N, a compression elongation percentage between 39%-1414%, and a Z range between 0 – 408.216 (see para. 0090-0091 and 0093 of the instant application which states that these ranges would satisfy the claimed formulas), would have a reasonable expectation of success in making such a modification and it appears the breakable portion of the mesh-like main body of Kollar would function as intended being given the claimed ranges (the breakable portion of the mesh-like main body of Kollar is intended to separate from the mesh-like 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). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the breakable portion 110A preferably satisfies 0 ≤ Z ≤ 351.466, and more preferably satisfies Z = 0” (para. 0090), “The breaking strength of the breakable portion 110A can be, for example, 16 N (Newtons) or less….Note that 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).
Hence, 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 Kollar to have the breaking strength between 0.2 N – 16N and the compression elongation percentage between 39%-1414% in order to satisfy the claimed formulas as an obvious matter of design choice within the skill of the art.
Regarding claim 2, modified Kollar discloses wherein 0 ≤ Z ≤ 351.466 is satisfied in the formula (2) (see rejection of claim 1 above in regards to the modification above in which this limitation is met).
Regarding claim 3, modified Kollar discloses wherein Z = 0 is satisfied in the formula (2) (see rejection of claim 1 above in regards to the modification above in which this limitation is met).
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 5, modified Kollar discloses wherein the compression elongation percentage is 1414% 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 (Figs. 3A-B, para. 0039).
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 (1) to (4):
Y ≤ 244734(X - Z)-1.665 (1)
0 ≤ Z < 408.216 (2)
X - Z > 0 (3)
39 ≤ X (4).
There is no evidence of record that establishes that changing the breaking strength and the compression elongation percentage would result in a difference in function of the breakable portion of the mesh-like main body of Kollar. Further, a person having ordinary skill in the art, being faced with modifying the breakable portion of the mesh-like main body of Kollar such that it has a breaking strength between 0.2 N – 16N, a compression elongation percentage between 39%-1414%, and a Z range between 0 – 408.216 (see para. 0090-0091 and 0093 of the instant application which states that these ranges would satisfy the claimed formulas), would have a reasonable expectation of success in making such a modification and it appears the breakable portion of the mesh-like main body of Kollar would function as intended being given the claimed ranges (the breakable portion of the mesh-like main body of Kollar is intended to separate from the mesh-like 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). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “the breakable portion 110A preferably satisfies 0 ≤ Z ≤ 351.466, and more preferably satisfies Z = 0” (para. 0090), “The breaking strength of the breakable portion 110A can be, for example, 16 N (Newtons) or less….Note that 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).
Hence, 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 Kollar to have the breaking strength between 0.2 N – 16N and the compression elongation percentage between 39%-1414% in order to satisfy the claimed formulas as an obvious matter of design choice within the skill of the art.
Regarding claim 11, modified Kollar discloses wherein 0 ≤ Z ≤ 351.466 is satisfied in the formula (2) (see rejection of claim 10 above in regards to the modification above in which this limitation is met).
Regarding claim 12, modified Kollar discloses wherein Z = 0 is satisfied in the formula (2) (see rejection of claim 10 above in regards to the modification above in which this limitation is met).
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 14, modified Kollar discloses wherein the compression elongation percentage is 39% to 1312% (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 and 17-19 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 mesh-like 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 mesh-like 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 mesh-like 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
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
/SARAH A LONG/Primary Examiner, Art Unit 3771