DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is in response to the amendment and RCE filed on 12/24/2025. Claims 1-20 are pending. Claims 1 and 18 are independent. Claims 18-20 are newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/24/2025 has been entered.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelissier et al. (US 2006/0064175) in view of Chin (US 5,922,026).
Regarding claim 1, Pelissier discloses an implantable prosthesis (fig. 1) for repairing a tissue or muscle wall defect, the implantable prosthesis comprising: a patch of repair fabric including a body portion 40 that is constructed and arranged to cover the tissue or muscle wall defect, the patch having an oval shape with a major axis 60 and a minor axis 62, the patch including an obtuse end portion 66 and an acute end portion 64, the obtuse end portion being wider than the acute end portion (Fig. 1).
Pelissier discloses the invention essentially as claimed except for one or more accessible pockets provided on the patch to facilitate deployment and/or placement of the prosthesis at the tissue or muscle wall defect, all of the accessible pockets provided on the patch to facilitate deployment and/or placement of the prosthesis being located only at the obtuse end portion of the patch.
Chin teaches placing pockets on opposite sides of the repair fabric (fig. 1; col. 4, ll. 3-5). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Pelissier with pockets on opposite sides of the fabric as taught by Chin, in order to aid in positioning and attaching the prosthesis. Furthermore, Chin discloses varying the number and locations of the pockets (col. 4, ll. 3-5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Pelissier so that all of the pockets are on the obtuse side of the minor axis in view of Chin, in order to accommodate use scenarios where only one end, such as the obtuse end, of the prosthetic needs to be precisely manipulated. Examiner notes that references such as US 2004/0215219 teach implantable prostheses for the same purpose as applicant’s device, wherein all of the pockets are located on one side of the minor axis (paragraph 0033).
Regarding claim 2, the patch includes a first (Pelissier; fig. 2, element 40) and second (forming the first pocket; see Chin fig. 1, the layer forming the left pocket 110) layers attached together to create the at least one pocket / one or more accessible pockets therebetween.
Regarding claim 3, the second layer includes an edge (an edge adjacent the opening of the pocket in the modified device) extending across the portion of the first surface of the first layer.
Regarding claim 4, the patch includes a first opening (the opening in the first pocket of the modified device) to provide access to the at least one pocket / one or more accessible pocket.
Regarding claim 5, the first opening is located along the edge of the second layer (see Chin; fig. 1).
Regarding claim 6, Pelissier discloses a member (fig. 1, element 24) to help deploy and/or hold the body portion in a spread out configuration (paragraph 0027).
Regarding claim 7, the member (Pelissier; fig. 1, element 24) surrounds the body portion of the patch.
Regarding claim 8, the member includes an indentation (Pelissier; fig. 1, element 34) that is adapted to be positioned adjacent a body structure (paragraph 0030), the indentation formed by a portion of the member deviating inwardly toward the body portion.
Regarding claim 9, the indentation (Pelissier; fig. 1, element 34) has a curved shape.
Regarding claim 10, the member (Pelissier; fig. 1, element 24) has a convex shape along a substantial portion thereof and the indentation has a concave shape.
Regarding claim 11, the indentation (Pelissier; fig. 1, element 34) is offset from the minor axis of the patch toward the acute end portion.
Regarding claim 12, the member has a resiliency that allows the member to deform from an initial shape and then return to the initial shape to return the body portion of the patch to the spread out configuration (Pelissier; paragraph 0027).
Regarding claim 13, the repair fabric is susceptible to the formation of adhesions with tissue and organs (Pelissier; paragraph 0065).
Regarding claim 14, the repair fabric has a plurality of interstices that are constructed and arranged to allow tissue ingrowth (Pelissier; paragraph 0065).
Regarding claim 15, the obtuse end portion of the modified prothesis of Pelissier in view of Chin is fully capable to overlie and cover the tissue or muscle wall defect and the acute end portion the modified prothesis of Pelissier in view of Chin is fully capable to be positioned away from the tissue or muscle wall defect because the obtuse end portion of the prothesis of Pelissier is fully capable to overlie and cover the tissue or muscle wall defect and the acute end portion of the prothesis of Pelissier is fully capable to be positioned away from the tissue or muscle wall defect (Pelissier, Fig. 1).
Claims 16 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelissier et al. (US 2006/0064175) in view of Chin (US 5,922,026) as applied to claim 1 above, and further in view of Rousseau (US Pub. No.: 2002/0133236).
Regarding claims 16 and 17, Pelissier in view of Chin renders obvious all the limitations of claim 1 but fails to disclose that the one or more accessible pockets are positioned and oriented substantially symmetrically about the major axis; wherein the one or more accessible pockets consist of a single accessible pocket. Chin further discloses the number and location of pockets can be varied (col. 4, ll. 3-5).
Rousseau teaches, in the same field of endeavor (implantable prosthesis), an implantable prosthesis consisting a single accessible pocket (pocket 15, Figs. 1 and 1 or the pocket shown in Fig. 3) positioned and oriented substantially symmetrically about the major axis.
Before the invention was made, it would have been obvious to one of ordinary skill in the art to modify the implantable prosthesis of Pelissier in view of Chin to include only a single accessible pocket which is positioned and oriented substantially symmetrically about the major axis as taught by Rousseau in order to allow the surgeon’s finger(s) or a surgical instrument to be received in the pocket (Paras. [0016], [0004], [0024] and Fig. 9) to precisely manipulate the prosthesis.
Claims 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pelissier et al. (US 2006/0064175) in view of Rousseau (US Pub. No.: 2002/0133236) and Chin (US 5,922,026).
Regarding claim 18, Pelissier discloses an implantable prosthesis (fig. 1) for repairing a tissue or muscle wall defect, the implantable prosthesis comprising: a patch of repair fabric including a body portion 40 that is constructed and arranged to cover the tissue or muscle wall defect, the patch having an oval shape with a major axis 60 and a minor axis 62, the patch including an obtuse end portion 66 and an acute end portion 64, the obtuse end portion being wider than the acute end portion (Fig. 1); wherein the body portion includes: a first layer of repair fabric (40, Fig. 2); and a second layer (42, Fig. 2) of repair fabric attached to the first layer of repair fabric (Figs. 2-4); a support member (24, Figs. 2-4) positioned between the first layer of repair fabric and the second layer of repair fabric and extending around the body portion. However, Pelissier does not specifically disclose that the second layer of repair fabric includes one or more unattached segments extending across the first layer of repair fabric to form one or more accessible pockets located only on the first side of the minor axis and at the obtuse end portion of the patch.
Rousseau teaches, in the same field of endeavor (implantable prosthesis), a body portion of a patch repair fabric (10, Figs. 1 and 2) comprising a first layer (12, Figs. 1 and 2) and a second layer (14, Figs. 1 and 2); wherein the second layer of repair fabric includes an unattached segment extending across the first layer of repair fabric to form an accessible pocket (pocket 15, Figs. 1 and 2 and Paras. [0016]-[0018]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the second layer of the repair fabric of the prosthesis of Pelissier to include an unattached segment extending across the first layer of repair fabric to form an accessible pockets located only on the first side of the minor axis as taught by Rousseau in order to facilitate the deployment of the implantable prosthesis enabling an object, such as a surgical instrument or surgeon’s finger, to be placed into the pocket (Rousseau, Para. [0004]).
Furthermore, Chin teaches placing pockets on opposite sides of the repair fabric (fig. 1; col. 4, ll. 3-5). Furthermore, Chin discloses varying the number and locations of the pockets (col. 4, ll. 3-5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Pelissier in view of Rousseau so that all of the pockets are on the obtuse side of the minor axis in view of Chin, in order to accommodate use scenarios where only one end of the prosthetic, such as the obtuse end, needs to be precisely manipulated.
Regarding claim 19, Rousseau discloses an unattached length or segment of the unattached segment extend across a portion of the body portion to form an opening to the accessible pocket (Figs. 1 and 2).
Regarding claim 20, Rousseau discloses that the opening to the accessible pocket is formed through the second layer of repair fabric (Figs. 1 and 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,452,588. Although the claims at issue are not identical, they are not patentably distinct from each other because all the limitations of claims 1-16 of U.S. Patent No. 11,452,588 are contained in claims 1-15 and 18-20 of the instant application.
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Claims 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,452,588 in view of Rousseau (US Pub. No.: 2002/0133236).
Regarding claims 16 and 17, claim 1 of U.S. Patent No. 11,452,588 recites all the limitations of claims 1 of the instant application. However, claim 1 of U.S. Patent No. 11,452,588 does not recite that the one or more accessible pockets are positioned and oriented symmetrically about the major axis, and the major axis is colinear with a central axis of the one or more accessible pockets; wherein the one or more accessible pockets consist of a single accessible pocket.
Rousseau teaches, in the same field of endeavor (implantable prosthesis), an implantable prosthesis consisting a single accessible pocket (pocket 15, Figs. 1 and 1 or the pocket shown in Fig. 3) positioned and oriented symmetrically about the major axis, and the major axis is colinear with a central axis of the one or more accessible pocket.
Before the invention was made, it would have been obvious to one of ordinary skill in the art to modify the invention of claim 1 of U.S. Patent No. 11,452,588 to include only a single accessible pocket which is positioned and oriented symmetrically about the major axis, and the major axis is colinear with a central axis of the one or more accessible pocket as taught by Rousseau in order to allow the surgeon’s finger(s) or a surgical instrument to be received in the pocket (Paras. [0016], [0004], [0024] and Fig. 9).
Response to Arguments
The objection to the drawing and the rejection on claims 16 and 17 under 35 U.S.C. 112 have been withdrawn in light of the amendment
The double patent rejection has been maintained.
Applicant's arguments regarding art rejection(s) on claims 1-17 filed 12/24/2025 have been fully considered but they are not persuasive.
In response to the argument(s) on pages 7-8 of the remarks, Pelissier discloses an implantable prosthesis (fig. 1) for repairing a tissue or muscle wall defect, the implantable prosthesis comprising: a patch of repair fabric including a body portion 40 that is constructed and arranged to cover the tissue or muscle wall defect, the patch having an oval shape with a major axis 60 and a minor axis 62, the patch including an obtuse end portion 66 and an acute end portion 64, the obtuse end portion being wider than the acute end portion (Fig. 1).
Pelissier discloses the invention essentially as claimed except for one or more accessible pockets provided on the patch to facilitate deployment and/or placement of the prosthesis at the tissue or muscle wall defect, all of the accessible pockets provided on the patch to facilitate deployment and/or placement of the prosthesis being located only at the obtuse end portion of the patch.
Chin teaches placing pockets on opposite sides of the repair fabric (fig. 1; col. 4, ll. 3-5). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Pelissier with pockets on opposite sides of the fabric as taught by Chin, in order to aid in positioning and attaching the prosthesis. Furthermore, Chin discloses varying the number and locations of the pockets (col. 4, ll. 3-5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Pelissier so that all of the pockets are on the obtuse side of the minor axis in view of Chin, in order to accommodate use scenarios where only one end, such as the obtuse end, of the prosthetic needs to be precisely manipulated. Examiner notes that references such as US 2004/0215219 teach implantable prostheses for the same purpose as applicant’s device, wherein all of the pockets are located on one side of the minor axis (paragraph 0033). Since Chin discloses that the number and locations of the pockets can be varied (col. 4, ll. 3-5), it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Pelissier so that all of the pockets are on the obtuse side of the minor axis in view of Chin, in order to accommodate use scenarios where only one end, such as the obtuse end, of the prosthetic needs to be precisely manipulated.
Conclusion
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.
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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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