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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/19/2025 has been entered.
Claim Objections
Claim 22 is objected to because of the following informalities: the claim appears to introduce a new element “tether member” without an appropriate indefinite article and read awkwardly as currently constituted as “wherein tether member”. It is suggested to amend to “wherein a tether member”. Further, it appears that prior to the element “a suture lock cam”, the term “and” is misspelled as “an”. Appropriate correction is required.
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: an adjustment member (a rewritten form of “a member for adjustment” in claims 1, 23, and 24. The corresponding structure for performing the claimed function is a suture tension lead screw (see [0070]-[0071] of the spec. as filed).
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.
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.
Claim 22 is 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 22 appears to recite that the tether member is wedged between the tether member and a suture lock cam. It is unclear how a structure/component can be wedged between itself and a different structure/component, therefore rendering the claim indefinite. Based on [0070] of the spec., it appears that the claim intends to recite that the tether member is wedged between the suture tension lead screw and a suture lock cam, and will be examined as such.
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) 1-5, 8-15, 21-22, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0049875 A1 to Iflah et al. (hereinafter “Iflah”) in view of US 2022/0296365 A1 to Huddelston et al. (hereinafter “Huddleston”) and US 2015/0250471 A1 to Nason et al. (hereinafter “Nason”) (Iflah and Huddelston are previously of record)
Regarding claims 1, 22, and 23, Iflah discloses (see abstract; Figs. 1-31C; and [0394]-[0632]) a delivery and deployment system (as shown in Fig. 2) for delivering and/or deploying an implantable device (222 and/or 32) to an anatomical site, said delivery and deployment system comprising: a flexible elongate member (12); an implantable device delivery device (14) deliverable at a distal end of the flexible elongate member to an anatomical site (see Fig. 6B); an implantable device (32) deliverable by said implantable device delivery device; and a control handle (101 - see [0415] and Fig. 2) comprising one or more of the following: a steering system (210 + 29a/b) operably coupled with said flexible elongate member to control movement of said flexible elongate member to deliver said implantable device to the anatomical site (see [0400]/[0402]/[0416]); an implantable device deployment system (28) operably coupled with said implantable device to deploy said implantable device at the anatomical site (see [0414]-[0415]); or a tensioning and locking system operably engageable with the implantable device to adjust a configuration of a tensioning and locking device operably associated with said implantable device (444, see [0468] & [0507]-[0510] & [0517]-[0526]); wherein the control handle comprises a tether adjustment system (40) operably engageable with a tether element (86) engageable with said implantable device (see Figs. 3D-F) (see [0398], [0437]-[0438]; [0467]; [0499]-[0504]); wherein the control handle comprises a tether adjustment system (40) operably engageable with a tether element that is engageable with said implantable device (see Figs. 3D-F) (see [0398], [0437]-[0438]; [0467]; [0499]-[0504]); wherein the tether element extends with respect to said implantable device to a location spaced from said implantable device (see Figs. 3D-F) (see [0398], [0437]-[0438]; [0467]; [0499]-[0504]); wherein the tether adjustment system is configured to adjust the tension on and/or length of said tether element between said implantable device and the location spaced from said implantable device (see Figs. 3D-F) (see [0398], [0437]-[0438]; [0467]; [0499]-[0504]).
Iflah further discloses, with respect to claims 1, 22, and 23, and wherein said tether adjustment system comprises a tuning mechanism engageable with said tether element and rotatable about the longitudinal axis of said control handle to adjust the tension on and/or length of said tether element between said implantable device and the location spaced from said implantable device (see [0467]), but fails to specifically disclose that the tuning mechanism is a fine-tuning knob, or that the tether adjustment system comprises an adjustment member secured to the tether element such that adjusting the tension and/or length of the tether element is caused by the adjustment member translating. Further, Iflah fails to specifically disclose (claim 21) wherein the adjustment member includes a suture tension lead screw, and (claim 22) wherein the tether member is wedged between the suture tension lead screw and a suture lock cam disposed adjacent to the suture tension lead screw.
Nason discloses, in the same field of endeavor of tension-based surgical delivery devices, a delivery and deployment system for delivering and/or deploying an implantable device (10) to an anatomical site, said delivery and deployment system comprising: an implantable device (10) deliverable by an implantable device delivery device; and a control handle (44) comprising a tensioning and locking system operably engageable with the implantable device to adjust a configuration of a tensioning and locking device operably associated with said implantable device (see Figs. 19-23 and [0046]-[0056]); wherein the control handle comprises a tether adjustment system (50 + 38 + 46) operably engageable with a tether element (12) that is engageable with said implantable device; wherein the tether element extends with respect to said implantable device to a location spaced from said implantable device (see Fig. 23); wherein the tether adjustment system is configured to adjust the tension on and/or length of said tether element between said implantable device and the location spaced from said implantable device (see Figs. 19-23 and [0046]-[0056]); and wherein said tether adjustment system comprises a knob (50) engageable with said tether element with an adjustment member (38 + 51a + 46, corresponding to a suture tension lead screw under 112f and as per claim 21 since it is a screw that is rotated to cause translation to induce tension on a suture) secured to the tether element (see Figs. 22-23 and [0051]), the knob being rotatable about the longitudinal axis of said control handle to adjust the tension on and/or length of said tether element between said implantable device and the location spaced from said implantable device by causing the adjustment member to translate (see Figs. 22-23 and [0051]-[0053]), wherein the tether member is wedged between the suture tension lead screw and a suture lock cam (48) disposed adjacent to the suture tension lead screw (see Fig. 23 and [0051]-[0053]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of combining prior art elements according to known methods to yield predictable results (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have modified Iflah’s device with the tension locking mechanism including the adjust member (suture tension lead screw) taught by Nason because Nason teaches a suitable mechanism for adjusting and locking the tension in a tether member and one of ordinary skill would have understood that Iflah’s tension mechanism would be well suited to have several types of tension locking systems, and that Nason’s tension locking mechanism would be compatible with Iflah’s device and that the combination would have been predictable to one of ordinary skill in that it provides a known, suitable, and appropriate mechanism for locking the tension of Iflah’s device.
Huddleston discloses (see abstract; Figs. 1 and 6A-C; and [0078]-[0081]), in the same field of endeavor of cardiac devices, the known use of a fine tuning knob (480) engageable with a tether (“T”, Fig. 1) and rotatable about a longitudinal axis of a control handle to adjust the tension and/or length of a tether element between an implantable device (“PMV”, Fig. 1) and a location spaced from said implantable device for the purpose of allowing a user to fine tune the tension on the tether (see [0078]/[0081]). It would have been obvious to one having ordinary skill in the art to have modified Iflah’s device (as modified by Nason above) with the fine-tuning knob taught by Huddleston in order to allow the user to fine tune the tension on the tether.
The combination of Iflah, Nason, and Huddleston, as set forth above for the reasons set forth above, would further disclose (as per Iflah) (claim 2) wherein: said flexible elongate member includes a pull element (29a/b) operatively associated therewith; and said control handle comprises at least a steering system (210 + 29a/b), said steering system comprising a steering control knob (210) rotatable about the longitudinal axis of said control handle to pull said pull element axially to steer said flexible elongate member (see [0400]/[0402]/[0416]); (claim 3) wherein said implantable device is a tissue anchor (32) (see [0405]); (claim 4) wherein said flexible elongate member is tubular (see Fig. 2 and [0399]), said delivery and deployment system further comprising a stylet (14) operably coupled with said implantable device and extending through said tubular flexible elongate member (see Figs. 2/6B and [0399]); (claim 5) wherein said control handle comprises at least an implantable device deployment system operably coupled with said stylet to axially translate said stylet along the longitudinal axis of said control handle to advance and to deploy the implantable device from the implantable device delivery device (see [0403], [0414]-[0415]); (claim 8) further comprising a tensioning and locking device operably associated with said tether element and shiftable from a tension- adjusting configuration, in which tension on and/or the length of said tether element is adjustable, to a tension-setting configuration, in which tension on and/or the length of said tether element is fixed with respect to said implantable device see ([0468] & [0507]-[0510] & [0521]); (claim 9) wherein said control handle further comprises a tensioning and locking system operably associated with said tensioning and locking device to shift said tensioning and locking device between the tension-adjusting configuration and the tension-setting configuration (444, see [0468] & [0507]-[0510] & [0517]-[0526]); (claim 10) wherein said tensioning and locking system includes a tensioning and locking knob rotatable about the longitudinal axis of said control handle to shift said tensioning and locking device between the tension-adjusting configuration and the tension-setting configuration (see Figs. 16A-18J and [0468] & [0507]-[0510] & [0517]-[0526]); (claim 11) wherein said tensioning and locking system further comprises an anchor state indicator operably associated with said tensioning and locking knob to indicate the configuration of said tensioning and locking device (see [0524]); (claim 12) further comprising a stylet (14 or 460) operably coupled with said implantable device (see Figs. 2/6B and [0399]; or [0518]-[0525]); (claim 13) wherein said control handle comprises at least an implantable device deployment system operably coupled with said stylet to axially translate said stylet along the longitudinal axis of said control handle to advance and to deploy the implantable device from the implantable device delivery device (see [0403], [0414]-[0415]); or [0518]-[0525]); (claim 14) wherein said stylet is operably coupled with said tensioning and locking device and said tensioning and locking system such that rotation of said tensioning and locking knob rotates said stylet, and rotation of stylet shifts said tensioning and locking device between the tension-adjusting configuration and the tension-setting configuration (see [0518]-[0525] and Figs. 16A-18J); and (claim 15) further comprising a tether element (86) and a tensioning and locking device (444, see [0468] & [0507]-[0510] & [0517]-[0526]) operably associated with said tether element, wherein: said tether element extends from said implantable device to a location spaced from said implantable device; said tensioning and locking device is shiftable from a tension-adjusting configuration, in which tension on and/or the length of said tether element is adjustable, to a tension-setting configuration, in which tension on and/or the length of said tether element is fixed with respect to said implantable device; and said control handle comprises at least said tensioning and locking device to shift said tensioning and locking device between the tension-adjusting configuration and the tension-setting configuration (see [0468] & [0507]-[0510] & [0517]-[0526]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 8-15, and 21-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771