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 Election/Restriction response filed on 03/13/2026. Claims 1-20 are pending. Claims 1 and 16 are independent. Claims 6, 7, 10, and 16-20 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 03/13/2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/13/2026.
Applicant’s election without traverse of Species B (Figures 5-6), Subspecies SA (mesh material defining openings); Species FB (non-bioresorbable), and Subspecies SA (hydrophobic) in the reply filed on 03/16/2026 is acknowledged.
Claims 6, 7, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and subspecies, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/13/2026.
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 § 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 12-14 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 12 recites the limitation “the outer surface” in line 6 of the claim. Lines 1-2 recites “a first outer surface” and “a second outer surface.” It is unclear which of the outer surface that “the outer surface” in line 6 is referring to. For the purpose of examination, “the outer surface” ion line 6 of the claim is interpreted to be –the second outer surface--.
Claim 13 recites the limitation “the outer surface” in line 6 of the claim. Lines 1-2 recites “a first outer surface” and “a second outer surface.” It is unclear which of the outer surface that “the outer surface” in line 6 is referring to. For the purpose of examination, “the outer surface” ion line 6 of the claim is interpreted to be –the second outer surface--.
Claim 14 recites the limitation “the outer surface” in line 6 of the claim. Lines 1-2 recites “a first outer surface” and “a second outer surface.” It is unclear which of the outer surface that “the outer surface” in line 6 is referring to. For the purpose of examination, “the outer surface” ion line 6 of the claim is interpreted to be –the second outer surface--.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112(b) issue(s) state above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 9, and 11-14 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Greenhalgh et al. (US Pub. No.: 2017/0020646).
Regarding claims 1-5, 8, 9, and 11-14, Greenhalgh discloses [claim 1] an implant (the whole implant shown in Figs. 6A and 6B), comprising: a substrate (the middle mesh layer of the implant, Figs. 6A and 6B) having an outer surface (the outer surface facing the first layer, see Figure below); a first layer (see Figure below) disposed on the outer surface of the substrate, the first layer including a polymeric material (e.g. polypropylene, Para. [0009]); and a second layer (see Figure below) disposed on the outer surface of the substrate; [claim 2] wherein the substrate includes a mesh material (Para. [0008]); [claim 3] wherein the substrate includes a polypropylene mesh material (Para. [0009]); [claim 4] wherein the substrate defines openings (Para. [0008], the mesh material is porous and defines openings); [claim 5] wherein the substrate includes a hydrocarbon polymer (Para. [0009] polypropylene is a hydrocarbon polymer); [claim 8] wherein the first layer is formed of a material that is non-bioresorbable (Para. [0009], polypropylene is non-bioresorbable); [claim 9] wherein the second layer is a hydrophobic layer (Para. [0009], layer formed of polypropylene is hydrophobic); [claim 11] wherein the outer surface is a first outer surface, the substrate having a second outer surface (the outer surface facing the third layer, see Figure below); [claim 12] wherein the outer surface is a first outer surface, the substrate having a second outer surface (the outer surface facing the third layer, see Figure below), the second outer surface being spaced from the first outer surface (Figs. 6A and 6B), further comprising, a third layer (see Figure below) disposed on the second outer surface of the substrate, the first layer including a polymeric material (Para. [0009]); and a fourth layer (see Figure below) disposed on the second outer surface of the substrate, the third layer being disposed between the fourth layer and the second outer surface of the substrate (see Figure below); [claim 13] wherein the outer surface is a first outer surface, the substrate having a second outer surface (the outer surface facing the third layer, see Figure below), the second outer surface being disposed opposite the first outer surface, further comprising, a third layer (see Figure below) disposed on the second outer surface of the substrate, the first layer including a polymeric material (Para. [0009]); and a fourth layer (see Figure below) disposed on the second outer surface of the substrate, the third layer being disposed between the fourth layer and the second outer surface of the substrate (see Figure below); [claim 14] wherein substrate includes a mesh material (Para. [0008], the outer surface is a first outer surface, the substrate having a second outer surface (see Figure below), the second outer surface being disposed opposite the first outer surface (see Figure below), further comprising, a third layer (see Figure below) disposed on the second outer surface of the substrate, the first layer including a polymeric material (Para. [0009]); and a fourth layer (see Figure below) disposed on the second outer surface of the substrate, the third layer being disposed between the fourth layer and the second outer surface of the substrate (see Figure below).
PNG
media_image1.png
613
607
media_image1.png
Greyscale
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 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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US Pub. No.: 2017/0020646) as applied to claim 1 above, and further in view of Thierfelder et al. (US Pub. No.: 2003/0195386)
Regarding claim 15, Greenhalgh discloses substantially all the limitations of the claim but fails to disclose that the substrate includes a first portion, a second portion, and a third portion, the first portion, the second portion, and the third portion forming a Y-shaped substrate.
Thierfelder teaches, in the same field of endeavor (surgical implant), a surgical implant comprising a substrate (10, Fig. 1) including a first portion (18, Fig. 1), a second portion (14, Fig. 1), and a third portion (16, Fig. 1), the first portion, the second portion, and the third portion forming a Y-shaped substrate (Fig. 1).
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 substrate of Greenhalgh to include a first portion, a second portion, and a third portion, the first portion, the second portion, and the third portion forming a Y-shaped substrate as taught by Thierfelder in order to obtain the advantage of obtain the appropriate shape for addressing urological disorders, such as pelvic floor disorders (Thierfelder, Paras. [0051] and [0074]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20060195010 A1 Arnal; Kevin R. et al. discloses a multiple-layer mesh implant.
US 20220296351 A1 Patel; Umesh H. et al. discloses a multiple-layer implant.
US 7070558 B2 Gellman; Barry et al. discloses a multiple-layer implant.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JING RUI OU/ Primary Examiner, Art Unit 3771
Prosecution Insights