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 Amendment
This action is in response to the preliminary amendment filed on 5/7/2025. In the amendment, claims 1-20 were cancelled and claims 21-40 were added.
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 21-23 & 25-29 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 21 recites the limitation "anchor cap swivel" in line 5. There is insufficient antecedent basis for this limitation in the claim. Since the ‘anchor cap swivel’ is positively recited in claim 24, examiner considers the recitation in claim 21 of the anchor cap swivel to be a typographical error and will be read for the purposes of examination as ‘anchor cap’
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: ‘tension component’ in claims 21, 24-31, 34-37, & 40.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 21, 24-31, 34-37, & 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9, 11, & 12 of U.S. Patent No. 12,268,595 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
19/169282
21, 24, 30
25
26
27, 35, 36
28
29
30, 31, 34
27, 30, 35, 36, 40
37
12,268,595
1
4
5
6
7
8
9
11
12
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.
Claims 21-23, 25-27, and 30-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gregoire et al. (US Pub. No. 2013/0197578 A1).
Regarding claim 21, Gregoire et al. disclose a surgical anchor (Fig. 2A), comprising: a distal end 30 (Fig. 2A) and a proximal end 42 (Fig. 2A), wherein the distal end 30 comprises an anchor head 32 (Fig. 2A) that is tapered to a distal tip to pierce and anchor into tissue; an anchor cap 42 (Fig. 2A) provided at the proximal end; and a tension component 48 (Fig. 2A) connecting the anchor head 32 and the anchor cap 42 swivel (see 35 USC 112, 2nd paragraph, above - ‘swivel’ will not be read as part of the anchor cap since the insertion of ‘swivel’ is considered to be a typographical error as explained in the 35 USC 112, 2nd paragraph section), wherein the tension component 48 exerts a proximal force on the anchor cap 42 when the surgical anchor is deployed into the tissue.
Regarding claim 22, Gregoire et al. further disclose wherein the tension component 48 comprises an elastomer (paragraph [0057]).
Regarding claim 23, Gregoire et al. further disclose wherein the tension component includes an elastomer (paragraph [0057]). The limitation 'overmolded to the distal end and the proximal head' is being treated as a product by process limitation; that is the product of a tension component integrally connected to the distal and proximal portions of the device is achieved by the process of overmolding. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 25, Gregoire et al. further disclose wherein the anchor cap 42 includes a non-deforming material (paragraph [0054] - may be formed of metal; additional elements may be incorporated but not required in the formation of the element 42, so it is considered to meet the 'includes a non-deforming material' limitation).
Regarding claim 26, the surgical anchor of Fig. 2A is considered to be capable of being received in an anchor receptacle of a prosthetic valve (as described in the claim) since it meets all structural requirements of claim 1. Regarding the language ‘a prosthetic valve comprising: a plurality of inflow cells situated in the proximal direction of the prosthetic valve, wherein the inflow cells are malleable; a plurality of annular cells situated medially in the prosthetic valve, forming a circular outflow track, wherein the annular cells are more rigid than the inflow cells; and a plurality of leaflet posts integral to, and extending distally beyond, the annular cells in the outflow direction of the prosthetic valve, wherein the leaflet posts are more rigid than the annular cells’, these limitations do not further limit the surgical anchor since the prosthetic valve is not positively recited as part of the surgical anchor and, therefore, are not required to be disclosed by the prior art for the purposes of anticipation.
Regarding claim 27, Gregoire et al. further disclose a plurality of barbs extending proximally from the anchor head 30 (paragraph [0075] and claim 14 discuss the addition of barbs to the anchor body to add bone fixation structure to the anchor when utilized for bone suture anchoring; the anchor head is integral to the body so it is considered to be encompassed by the anchor body).
Regarding claim 30, Gregoire et al. disclose a surgical device (Fig. 2A), comprising: an anchor (Fig. 2A), wherein the anchor includes: a distal end 30 (Fig. 2A) and a proximal end 42 (Fig. 2A), wherein the distal end 30 comprises an anchor head 32 (Fig. 2A) that is tapered to a distal tip configured to pierce and anchor into tissue; an anchor cap 42 (Fig. 2A) provided at the proximal end that has a width greater than a width of a corresponding anchor receptacle of a prosthetic valve (this dimension is based on the size of the unclaimed prosthetic valve anchor receptacle, since there is no dimension associated therewith, the proximal end of the prior art’s anchor cap is considered to be wider than any anchor receptacle having a smaller width; this limitation is dependent on the prosthetic valve which could be chosen to have a smaller anchor receptacle width than the disclosed prior art anchor cap proximal end); and a tension component 48 (Fig. 2A) connected with the anchor head 32 and the anchor cap 42, wherein the distal end of the anchor is configured to be driven by a deployment device through the corresponding anchor receptacle of the prosthetic valve into the tissue adjacent to the prosthetic valve, wherein a proximal end of the anchor is configured to be brought into apposition with the corresponding anchor receptacle, and wherein the tension component exerts a proximal force on the anchor cap when the anchor is deployed by the deployment device (the above italicized limitations are dependent on a theoretical prosthetic valve that has not been positively recited, the anchor of the prior art merely needs to be capable of being delivered in such a manner, and since the prior art’s anchor has all of the structural requirements of the claim that are claimed to be capable of performing this function, the prior art’s anchor is considered to be capable of these functional/intended use limitations).
Regarding claim 31, the limitation ‘wherein the prosthetic valve comprises: a plurality of inflow cells situated proximally in the prosthetic valve, wherein the inflow cells are malleable; a plurality of annular cells situated medially in the prosthetic valve, forming a circular outflow track, wherein the annular cells are more rigid than the inflow cells; and a plurality of leaflet posts integral to, and extending distally beyond, the annular cells in the outflow direction of the prosthetic valve, wherein the leaflet posts are more rigid than the annular cells’ fails to further define/limit the claimed surgical anchor since the prosthetic valve is not considered to be part of the surgical anchor as it is never positively recited to be associated therewith, just recited as the surgical anchor is capable of being used with such a prosthetic valve, which Gregoire et al.'s anchor is considered to be as it meets all of the structural limitations of claim 30.
Regarding claim 32, Gregoire et al. further disclose wherein the tension component 48 comprises an elastomer (paragraph [0057]).
Regarding claim 33, Gregoire et al. further disclose wherein the tension component includes an elastomer (paragraph [0057]). The limitation 'overmolded to the distal end and the proximal head' is being treated as a product by process limitation; that is the product of a tension component integrally connected to the distal and proximal portions of the device is achieved by the process of overmolding. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 34, Gregoire et al. further disclose wherein the anchor cap 42 of the anchor is configured to act on the anchor receptable of the prosthetic valve to affix the prosthetic valve to the tissue (as discussed in the above claim rejections, the prosthetic valve is not positively recited as part of the claimed invention - the anchor in the prior art merely needs to be capable of performing the function as claimed - since the anchor of Gregoire et al. comprises all of the structural requirements of claim 30, it is considered to also be capable of performing the claimed function/being used for the intended purpose since no further structural elements have been recited to perform this function in the claim).
Regarding claim 35, Gregoire et al. further disclose wherein the anchor comprises a plurality of barbs extending proximally from the anchor head 30 (paragraph [0075] and claim 14 discuss the addition of barbs to the anchor body to add bone fixation structure to the anchor when utilized for bone suture anchoring; the anchor head is integral to the body so it is considered to be encompassed by the anchor body).
Regarding claim 36, Gregoire et al. disclose a surgical anchor, comprising: a distal end and a proximal end, wherein the distal end comprises an anchor head 30 (Fig. 2A) that is tapered to a distal tip 32 (Fig. 2A) to pierce and anchor into tissue; a plurality of barbs extending proximally from the anchor head 30 (paragraph [0075] and claim 14 discuss the addition of barbs to the anchor body to add bone fixation structure to the anchor when utilized for bone suture anchoring; the anchor head is integral to the body so it is considered to be encompassed by the anchor body); an anchor cap 42 (Fig. 2A) provided at the proximal end; and a tension component 48 (Fig. 2A) connecting the anchor head 30 and the anchor cap 42, wherein the tension component 48 exerts a proximal force on the anchor cap 42 when the surgical anchor is deployed into the tissue.
Regarding claim 37, Gregoire et al. further disclose wherein the barbs resist proximal movement of the surgical anchor when the surgical anchor is engaged with the tissue (as described in paragraph [0075], the barbs are intended to fix the anchor in the bone, which would mean that the barbs are resisting movement all together, including proximal movement which would be the movement that an anchor is intending to resist since this is how it would be removed and the barbs are meant to resist removal).
Regarding claim 38, Gregoire et al. further disclose wherein the tension component 48 comprises an elastomer (paragraph [0057]).
Regarding claim 39, Gregoire et al. further disclose wherein the tension component includes an elastomer (paragraph [0057]). The limitation 'overmolded to the distal end and the proximal head' is being treated as a product by process limitation; that is the product of a tension component integrally connected to the distal and proximal portions of the device is achieved by the process of overmolding. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).40. (New) The surgical anchor of claim 31, wherein the anchor cap comprises an anchor cap swivel.
Allowable Subject Matter
Claims 24, 28, 29, & 40* contain no prior art rejection but are rejected under Double Patenting (see above). The prior art fails to further disclose, teach, or suggest: wherein the anchor cap comprises an anchor cap swivel [claims 24 & 40]; wherein the anchor head comprises a threaded proximal portion and the anchor cap comprises a threaded distal portion and the tension component is connected to the threaded proximal portion of the anchor head and the threaded distal portion of the anchor cap [claim 28]; and wherein the anchor head, anchor cap, and the tension component each comprise a hollow lumen, and the anchor head, the tension component, and the anchor cap are arranged to align the hollow lumens for receiving a pusher wire of an anchor deployment device [claim 29].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 August 7, 2026
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