CTNF 18/151,601 CTNF 85046 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-24-01 AIA Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color and filed on 01/09/2023. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). 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. 07-34-05 AIA Claim 1 recites the limitation " the lock ” in line 6 . There is insufficient antecedent basis for this limitation in the claim. Claims 2-19 are rejected as being dependent from rejected claim. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 2 and 20 are rejected under 35 U.S.C. 102( a)(1) and 102 (a)(2 ) as being anticipated by Rogers et al. (2016/0120647) “Rogers” . Regarding claim 1, as best understood, Rogers discloses an implant 58 (Fig. 9) configured to traverse a passageway defined through tissue about a cardiac chamber of a heart (par. 0073 discloses heart encircling), comprising: a) an elongate flexible tether (suture having ends 64/66; par. 0074 and Fig. 9) having two ends formed into a loop (as shown in Fig. 9, ends 64/66 come together and form a loop 70); b) a lock body 72 disposed over the two ends of the tether (as shown in Fig. 9), the lock body being configurable of releasably engaging the elongate flexible tether (par. 0074 discloses the lock body 72 can be a collar which is fully capable of releasably engaging the suture ends via limbs 60a and 62a); and c) first and second tubular limbs 60a/62a extending outwardly from the lock 72 over the elongate flexible tether along the loop toward each other (par. 0074 and Fig. 9 disclose the limbs extend from the lock towards each other from the loop and are located over the suture with the capability of being pulled off). Regarding claim 2, Rogers discloses wherein the implant is compliant and can change in length in response to movements of the heart (par. 0011 and claim 1 discloses the limbs are flexible which are capable are changing in length in response to movements of the heart and there is a articulation gap 68 which allows for the implant to change length). Regarding claim 20, Rogers discloses an implant 58 (Fig. 9) comprising: a) an elongate inner tether having a proximal end and a distal end (par. 0074 and Fig. 9 disclose an elongate suture having ends 64/66), the proximal end of the elongate inner tether terminating in a loop 70 (Fig. 9); and b) an outer tubular body (limbs 60a-b/62a-b) surrounding the elongate inner tether along at least a portion of the length of the inner tether (as shown in Fig. 9 and disclosed in par. 0074, the suture is surrounded by the limbs), wherein the outer tubular body is shorter in length than the elongate inner tether (the suture is longer length than the limbs since the suture ends 64/66 extend outwardly from the limbs) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (2016/0120647) “Rogers” in view of Mody et al. (2010/0016784) “Mody” . Rogers discloses the claimed invention of claim 1 including an implant having tubular limbs (Fig. 9); except for wherein the first and second tubular limbs are of different diameters and have tapered distal ends and wherein a distal end of the first tubular limb slides within a distal end of the second tubular limb along the loop of the elongate flexible tether such that the first and second tubular limbs overlap. However, Mody teaches a similar implant 100 (Fig. 6C) comprising first and second tubular limbs (150 and 152; Fig. 6C and par. 0080) are of different diameters and have tapered distal ends and wherein a distal end of the first tubular limb slides within a distal end of the second tubular limb along the loop of an elongate flexible tether 158 such that the first and second tubular limbs overlap (Fig. 6C and par. 0080 disclose limb 152 has a hollow mating portion 162 and limb 150 has a tapered region 160 where the hollow region 162 receives the tapered region 160 having the smaller diameter allowing the limbs to overlap). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular limbs in Rogers to include the first and second tubular limbs are of different diameters and have tapered distal ends and wherein a distal end of the first tubular limb slides within a distal end of the second tubular limb along the loop of the elongate flexible tether such that the first and second tubular limbs overlap, as taught and suggested by Mody, for having proper indicia that allows for allowing the device to behave as single unitary device facilitating ease of operability (par. 0080) . 07-21-aia AIA Claim s 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (2016/0120647) “Rogers” in view of Rafiee et al. (2022/0000544) “Rafiee ‘544” . Rogers discloses the claimed invention of claim 1 including an implant having tubular limbs (Fig. 9); except for wherein at least one of the first and second tubular limbs includes a plurality of radiopaque markers along its length and wherein the plurality of radiopaque markers are disposed along the length of said at least one of the first and second tubular limbs in a predetermined pattern in order to facilitate measurement of the implant under visualization. However, Rafiee ‘544 teaches a similar implant 100 (Fig. 1) comprising a plurality of radiopaque markers 110 (Fig. 1) along its length (the radiopaque marker patten 110 is positioned along the length of the implant 100; Fig. 1 and par. 0056) and wherein the plurality of radiopaque markers are disposed along the length of said at least one of the first and second tubular limbs in a predetermined pattern in order to facilitate measurement of the implant under visualization (Fig. 1 and par. 0056 disclose the radiopaque markers have indicia 114 for determining relative distances during conducting a medical procedure). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular limbs in Rogers to include a plurality of radiopaque markers along its length and wherein the plurality of radiopaque markers are disposed along the length of said at least one of the first and second tubular limbs in a predetermined pattern in order to facilitate measurement of the implant under visualization, as taught and suggested by Rafiee ‘544, for having proper indicia that allows for measurement of relative distances when conducting a medical procedure (par. 0056) . 07-21-aia AIA Claim s 7-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (2016/0120647) “Rogers” in view of Rafiee et al. (2021/0045879) “Rafiee ‘879” . Rogers discloses the claimed invention of claim 1 including an implant having tubular limbs (Fig. 9); except for wherein at least one of the first and second tubular limbs includes at least one pacing electrode to stimulate cardiac tissue further comprising a controller coupled to the at least one pacing electrode to provide at least one of pacing, defibrillation, measurement and control and wherein the elongate flexible tether includes an antenna that conducts signals to and from the controller; and wherein an electrical circuit is completed in the process of locking the lock body into place. However, Rafiee ‘879 teaches a similar implant 400 (Fig. 2) including at least one pacing electrode to stimulate cardiac tissue further comprising a controller coupled to the at least one pacing electrode to provide at least one of pacing, defibrillation, measurement and control (pars. 0110 and 0113 discloses a pacemaker electrode lead and a lock including a controller where the lock is threaded over the lead) and wherein the elongate flexible tether includes an antenna that conducts signals to and from the controller (par. 0113 and 0115 discloses a tether functioning as an antenna for sending signals to power the pacemaker using the lock which has the controller); and wherein an electrical circuit is completed in the process of locking the lock body into place (par. 0113 discloses the tether is caused to complete an electrical circuit with the lock). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular limbs in Rogers to include wherein at least one of the first and second tubular limbs includes at least one pacing electrode to stimulate cardiac tissue further comprising a controller coupled to the at least one pacing electrode to provide at least one of pacing, defibrillation, measurement and control and wherein the elongate flexible tether includes an antenna that conducts signals to and from the controller; and wherein an electrical circuit is completed in the process of locking the lock body into place, as taught and suggested by Rafiee ‘879, for providing an implantable pacing system providing improved techniques for cardiac pacing (abstract) . 07-21-aia AIA Claim s 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (2016/0120647) “Rogers” in view of Santini, JR. et al. (2006/0057737) “Santini” . Regarding claims 10-13, Rogers discloses the claimed invention of claim 1; except for comprising a controller and a reservoir containing a beneficial agent, the controller being coupled to a dispenser that is coupled to the reservoir to dispense the beneficial agent; wherein the beneficial agent includes a medication; the beneficial agent includes a gene therapy material; the beneficial agent includes living cells to seed at least one location of the heart that is damaged. However, Santini teaches a similar implant (abstract and par. 0120 disclose an implantable device used to treat heart failure) comprising a controller and a reservoir containing a beneficial agent (par. 0122 discloses reservoir systems releases cell cultures; par. 0044 and Fig. 6 discloses a reservoir and a controller), the controller being coupled to a dispenser that is coupled to the reservoir to dispense the beneficial agent (par. 0105 discloses the controller is connected to the reservoir and par. 0122 discloses controlled release of cell cultures from the reservoir) ; wherein the beneficial agent includes a medication; the beneficial agent includes a gene therapy material (par. 0079 and 0118 disclose delivery of gene therapy materials); the beneficial agent includes living cells to seed at least one location of the heart that is damaged (par. 0122 and par. 0120). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant in Rogers to include a controller and a reservoir containing a beneficial agent, the controller being coupled to a dispenser that is coupled to the reservoir to dispense the beneficial agent; wherein the beneficial agent includes a medication; the beneficial agent includes a gene therapy material; the beneficial agent includes living cells to seed at least one location of the heart that is damaged, as taught and suggested by Santini, for providing a controlled release of beneficial agents at the preselected environment (par. 0012). Regarding claims 14-16, Rogers discloses the claimed invention of claim 1; except for comprising at least one of the first and second tubular limbs includes at least one sensor to sense at least one biological parameter; the at least one sensor includes at least one pressure sensor to sense blood pressure and wherein the at least one sensor includes at least one of: a chemical sensor, a distance sensor, a sensor having circuitry to detect electro physiological data, a movement sensor, and a location sensor. However, Santini teaches a similar implant (abstract and par. 0120 disclose an implantable device used to treat heart failure) comprising at least one sensor to sense at least one biological parameter; the at least one sensor includes at least one pressure sensor to sense blood pressure and wherein the at least one sensor includes at least one of: a chemical sensor, a distance sensor, a sensor having circuitry to detect electro physiological data, a movement sensor, and a location sensor (par. 0087 discloses a chemical sensor, par. 0120 discloses detecting blood pressure). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant in Rogers to include at least one of the first and second tubular limbs includes at least one sensor to sense at least one biological parameter; the at least one sensor includes at least one pressure sensor to sense blood pressure and wherein the at least one sensor includes at least one of: a chemical sensor, a distance sensor, a sensor having circuitry to detect electro physiological data, a movement sensor, and a location sensor, as taught and suggested by Santini, for accurately detecting patient parameters for proper management of treatment (par. 0120) . 07-21-aia AIA Claim s 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (2016/0120647) “Rogers” in view of Rafiee et al. (2018/0098850) “Rafiee ‘850” . Rogers discloses the claimed invention of claim 1; except for wherein the elongate flexible tether includes radiopaque material along its length and wherein the elongate flexible tether is a hollow braided suture, and the radiopaque material within the elongate flexible tether includes a radiopaque wire disposed within a length of heat shrunk polymeric tube that resides within a hollow core of the elongate inner tether. However, Rafiee ‘850 teaches a similar elongate flexible tether 50 (abstract and Fig. 1A) comprising radiopaque material along its length (claim 3) and wherein the elongate flexible tether 50 is a hollow braided suture (par. 0092), and the radiopaque material within the elongate flexible tether includes a radiopaque wire disposed within a length of heat shrunk polymeric tube that resides within a hollow core of the elongate inner tether (claim 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant in Rogers to include wherein the elongate flexible tether includes radiopaque material along its length and wherein the elongate flexible tether is a hollow braided suture, and the radiopaque material within the elongate flexible tether includes a radiopaque wire disposed within a length of heat shrunk polymeric tube that resides within a hollow core of the elongate inner tether, as taught and suggested by Rafiee ‘850, for allowing the tether to be visible under fluoroscopy and for using materials that allow for sufficient tensioning whilst protecting the myocardial tissue (par. 0011). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /YASHITA SHARMA/Supervisory Patent Examiner, Art Unit 4100 Application/Control Number: 18/151,601 Page 2 Art Unit: 4100 Application/Control Number: 18/151,601 Page 3 Art Unit: 4100 Application/Control Number: 18/151,601 Page 4 Art Unit: 4100 Application/Control Number: 18/151,601 Page 5 Art Unit: 4100 Application/Control Number: 18/151,601 Page 6 Art Unit: 4100 Application/Control Number: 18/151,601 Page 7 Art Unit: 4100 Application/Control Number: 18/151,601 Page 8 Art Unit: 4100 Application/Control Number: 18/151,601 Page 9 Art Unit: 4100 Application/Control Number: 18/151,601 Page 10 Art Unit: 4100 Application/Control Number: 18/151,601 Page 11 Art Unit: 4100