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 .
This action is in response to the amendment filed on 2/25/2026. Claims 1, 2, and 8-15 are pending. Claim 1 is independent. Claims 3-7 are canceled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 2, and 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Pub. No.: 2010/0145286) in view of Darois et al. (US Pub. No.: 2005/0085924) and Lecuivre et al. (US Pub. No.: 2015/0080918).
Regarding claims 1, 2, and 8-15, Zhang discloses (claim 1) a biodegradable synthetic surgical mesh (hernia repair mesh, Paras. [0066]-[0072]. poly(orthoesters) and polyolefins are biodegradable. Paras. [0010] and [0091] also describe that the non-fouling coating can be biodegradable) comprising a polymeric material (Paras. [0066]-[0075] and [0100]-[0109], a polymeric medical device which can be hernia repair mesh formed of poly(orthoesters), polyolefins and/or polypropylene and coated with zwitterionic groups) and an antimicrobial (Paras. [0061], [0137], [0138], and [0161]), wherein the surface of one side of said mesh is functionalized with a zwitterionic functional group (Paras. [0015], [0021], [0066]-[0075], and [0100]-[0109], non-fouling material, such as zwitterionic functional group) comprising at least one of a polybetaine, sulfobetaine methacrylate (SBMA), carboxybetaine methacrylate (CBMA), or a polyampholyte (Paras. [0015] and [0021]); (claim 2) wherein the polymer material comprises polypropylene (Para. [0070]); (claim 8) wherein said mesh is non-woven (Paras. [0066] and [0076] and claim 2, hernia repair mesh with non-woven fibers); (claim 9) a kit for use in performing a surgical procedure, comprising the synthetic surgical mesh of claim 1 (Paras. [0066]-[0076] and [0100]-[0109], hernia repair mesh, the polymeric medical device can be hernia repair mesh formed of poly(orthoesters), polyolefins and/or polypropylene and coated with zwitterionic groups); (claim 10) a method of performing a surgical procedure comprising implantation of the synthetic surgical mesh of claim 1 (Para. [0072], hernia repair); and (claim 11) wherein said surgical procedure comprises a hernia repair procedure (Para. [0072], hernia repair); (claim 12) wherein said zwitterionic functional group comprises a polybetaine (Para. [0021]); (claim 13) wherein said zwitterionic functional group comprises sulfobetaine methacrylate (SBMA) (Para. [0015]); (claim 14) wherein said zwitterionic functional group comprises carboxybetaine methacrylate (CBMA) (Para. [0015]); (claim 15) wherein said zwitterionic functional group comprises a polyampholyte (Para. [0021]). However, Zhang does not disclose that the antimicrobial comprises biguanides, and the surface of another side of said mesh consists of an anti-adhesive polymer.
Darois teaches, in the same field of endeavor (hernia mesh), a mesh (10, Fig. 1 and Paras. [0016] and [0042]) comprising an antimicrobial (Para. [0016]); wherein the antimicrobial comprises biguanides (Para. [0026]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the antimicrobial of Zhang to be biguanides as taught by Darois, 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. See MPEP 2144.07.
Lecuivre teaches, in the same field of endeavor (hernia mesh), another side of a surgical mesh (bottom side of mesh 1, Fig. 7) consisting of an anti-adhesive polymer (anti-adhesive polymer layer 201, Fig. 7 and Paras. [0089] and [0096]); wherein the anti-adhesive polymer comprises polyguluronic acid (Para. [0091]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the other side / another side of the surgical mesh of Zhang to consist of an anti-adhesive polymer serving as barrier, wherein the anti-adhesive polymer comprises polyguluronic acid as taught by Lecuivre in order to obtain the advantage of avoiding formation of serious and undesirable post-surgical fibrous adhesion (Lecuivre, Para. [0089]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, and 8-15 have been considered but are moot in view of new ground(s) of rejection.
In response to the arguments on pages 4-6 of the remarks, the newly applied teaching reference, Lecuivre et al. (US Pub. No.: 2015/0080918), teaches another side of a surgical mesh (bottom side of mesh 1, Fig. 7) consisting of an anti-adhesive polymer (anti-adhesive polymer layer 201, Fig. 7 and Paras. [0089] and [0096]); wherein the anti-adhesive polymer comprises polyguluronic acid (Para. [0091]). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the other side / another side of the surgical mesh of Zhang to consist of an anti-adhesive polymer serving as barrier, wherein the anti-adhesive polymer comprises polyguluronic acid as taught by Lecuivre in order to obtain the advantage of avoiding formation of serious and undesirable post-surgical fibrous adhesion (Lecuivre, Para. [0089]).
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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