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 .
The amendment filed on October 24, 2025 has been received and considered. By this amendment, claims 21-25, 29, 30, 33, 34, 36, 37, and 40 are amended and claims 21-40 are now pending in the application.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on November 7, 2025 has/have been acknowledged and is/are being considered by the Examiner.
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.
Claims 21, 22, and 24-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings (U.S. 2006/0085042, previously cited) in view of Kuzma et al. (U.S. 2006/0271109). Regarding claim 21, Hastings discloses an implantable device 20/220/420 comprising: a housing 702 including a distal end and an opposing proximal end (see Figures 7 and 8); circuitry situated within the housing (see Figure 4 and “circuitry not shown in FIG. 4. Any electronic circuitry contained within the seed, including the voltage controlled switch, is constructed with components that consume very little power, for example CMOS. Power for such circuitry is either taken from a micro-battery contained within the seed, or supplied by draining a small amount of charge from capacitor 405.”, paragraph [0068]); an antenna 410 electrically connected to the circuitry (see Figure 4 and “a receiver coil 410 that is capable of being inductively coupled to a magnetic field source generating a time-varying magnetic field at the location of coil 410, such as would be generated by the transmitter 50 and the antenna 60 shown in FIG. 1. The RF current in the external antenna may be a pulsed alternating current (AC) or a pulsed DC current, and thus the current induced through the receiver coil 410 would likewise be an AC or pulsed DC current.”, paragraph [0067]); an elongated member 715/720 including a distal end and an opposing proximal end, the proximal end of the elongated member mechanically coupled to the distal end of the housing (see Figures 7 and 8); electrodes in the elongated member configured to receive electrical energy from the circuitry (“For example, tines 715, 720, 750 and 755 (see FIG. 7) may be plated with a suitable conductive material to serve as electrodes that extend into the epicardial space. Current passing between the distal tines and the proximal seed electrode would then pass through refractory tissues”, paragraph [0133]. Because tines 715/720 are cylindrical in shape, it is respectfully submitted that when plated with a conductive material to serve as electrodes they would satisfy the broadest reasonable interpretation for “ring electrodes” as claimed); and a tether 735/735A mechanically coupled to and extending from the proximal end of the housing (see Figures 7-9). However, tether 735/735A of Hastings is described as a pull wire or an extraction wire and is not described as a suture. Kuzma teaches an implantable microstimulator 100 that includes an extraction line 162 that “can be any suitable material, such as suture material” (see Figure 3 and paragraph [0034]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the suture material, as taught by Kuzma, for the material of the extraction wire of Hastings, as it has been held that simple substitution of one known element for another to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 22, Hastings discloses an attachment structure 740 including a distal end and an opposing proximal end, the distal end of the attachment structure mechanically coupled to the proximal end of the housing, and wherein the suture is mechanically connected to proximal end of the attachment structure (see Figures 7-9 and “The wire 735 has stopper device 740 that is attached to the wire 735 at a point that is proximal of the seed 220 body. The stopper device 740, like the junction point 725, is larger than the seed body central bore 730, and thus constrains how far the lead junction point 725 can be extended forward of the seed body 702. The stopper device 740 is positioned on the wire 735 at a location that is far enough away from the rear-end of the seed body 702 such that wire 735 may be pushed distally far enough to free the constrained tine 720 from the seed body central bore 730.”, paragraph [0086]).
Regarding claim 24, Hastings discloses that the suture extends more proximal than the proximal end of the attachment structure (see Figures 7-9).
Regarding claim 25, Hastings discloses that the suture does not extend distal to the proximal end of the attachment structure (the suture of Hastings as modified by the material of Kuzma is considered the portion of wire 735 to the left of stopper 740 shown in Figure 7).
Regarding claim 26, Hastings discloses that the elongated member is made of a flexible material (“the adjustable tines 1110E may comprise a shape memory alloy material, such as nitinol or the like, that is capable of returning to its biased shape after being elastically deformed within the central bore 1130E”, paragraph [0111]. In this embodiment, housing is element 1122E, the circuitry is the same circuitry for the seed as previously discussed, the antenna is the same antenna for the seed as previously discussed, the elongate member is 1110E, the electrodes are the conductive coating on elongate member 1110E, and the tether is 1170E).
Regarding claim 27, Hastings discloses that the elongated member is shaped to include a curve when unconstrained (see embodiment of Figures 11E-F).
Regarding claim 28, it is respectfully submitted that the recitation “the flexible material is reflowed to include a set, curved shape” is directed to the method by which the elongate member is made rather than further defining the structure of the elongate member itself. As such, this is considered a product by process recitation that fails to further define the claimed invention over that of the prior art.
Regarding claim 29, it is respectfully submitted that the extraction wire 735 of Hastings, as modified by Kuzma to be a suture material satisfies the claim limitation of “the suture is not electrically active” as claimed.
Regarding claim 30, Hastings discloses tines 715/720/750/755/1130/1105E/1110E mechanically connected to the implantable device (see Figures 7-9 and 11A-W).
Regarding claim 31, Hastings discloses that the tines are more proximal than the proximal end of the antenna housing (because claim 31 depends from claim 30 that depends from claim 21, the “antenna housing” is the housing as recited in claim 21, see Figures 7-9 and 11A-W).
Regarding claim 32, Hastings discloses that the flexible material is linear, when in a catheter, and in the set, curved shape when external to the catheter (“the adjustable tines 1110E may comprise a shape memory alloy material, such as nitinol or the like, that is capable of returning to its biased shape after being elastically deformed within the central bore 1130E”, paragraph [0111]).
Regarding claim 33, Hastings discloses an implantable device system comprising: an implantable device 20/220/420; a delivery tool 760 including a distal end and an opposing proximal portion; and a catheter 615; the implantable device comprising: a housing 702 including a distal end and an opposing proximal end (see Figures 7 and 8); circuitry situated within the housing (see Figure 4 and “circuitry not shown in FIG. 4. Any electronic circuitry contained within the seed, including the voltage controlled switch, is constructed with components that consume very little power, for example CMOS. Power for such circuitry is either taken from a micro-battery contained within the seed, or supplied by draining a small amount of charge from capacitor 405.”, paragraph [0068]); an antenna 410 electrically connected to the circuitry (see Figure 4 and “a receiver coil 410 that is capable of being inductively coupled to a magnetic field source generating a time-varying magnetic field at the location of coil 410, such as would be generated by the transmitter 50 and the antenna 60 shown in FIG. 1. The RF current in the external antenna may be a pulsed alternating current (AC) or a pulsed DC current, and thus the current induced through the receiver coil 410 would likewise be an AC or pulsed DC current.”, paragraph [0067]); an elongated member 715/720 including a distal end and an opposing proximal end, the proximal end of the elongated member mechanically coupled to the distal end of the housing (see Figures 7 and 8); electrodes in the elongated member configured to receive electrical energy from the circuitry (“For example, tines 715, 720, 750 and 755 (see FIG. 7) may be plated with a suitable conductive material to serve as electrodes that extend into the epicardial space. Current passing between the distal tines and the proximal seed electrode would then pass through refractory tissues”, paragraph [0133]. Because tines 715/720 are cylindrical in shape, it is respectfully submitted that when plated with a conductive material to serve as electrodes they would satisfy the broadest reasonable interpretation for “ring electrodes” as claimed); an attachment structure 740 including a distal end and an opposing proximal end, the distal end of the attachment structure mechanically coupled to the proximal end of the housing, the proximal end of the attachment structure configured to mate with the distal end of the delivery tool (see Figures 7-9 and “The wire 735 has stopper device 740 that is attached to the wire 735 at a point that is proximal of the seed 220 body. The stopper device 740, like the junction point 725, is larger than the seed body central bore 730, and thus constrains how far the lead junction point 725 can be extended forward of the seed body 702. The stopper device 740 is positioned on the wire 735 at a location that is far enough away from the rear-end of the seed body 702 such that wire 735 may be pushed distally far enough to free the constrained tine 720 from the seed body central bore 730.”, paragraph [0086]); and a tether 735/735A mechanically connected to and extending from the proximal end of the attachment structure (see Figures 7-9). However, tether 735/735A of Hastings is described as a pull wire or an extraction wire and is not described as a suture. Kuzma teaches an implantable microstimulator 100 that includes an extraction line 162 that “can be any suitable material, such as suture material” (see Figure 3 and paragraph [0034]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the suture material, as taught by Kuzma, for the material of the extraction wire of Hastings, as it has been held that simple substitution of one known element for another to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 34, Hastings discloses that the suture includes a length longer than the delivery tool (“The seed extraction wire 735 is attached to the junction point 725, and extends proximally through the entire length of the seed central bore 730, and from there continues proximally through the delivery catheter 615 and outside the body (not shown in FIG. 7).”, paragraph [0085]).
Regarding claim 35, Hastings discloses that delivery tool includes a lumen 765 extending therethrough from the proximal end of the delivery tool to the distal end of the delivery tool (“The tube has a lumen 765 extending longitudinally through its entire length so that the wire 735 extends through the tube lumen 765.”, paragraph [0089]).
Regarding claim 36, Hastings discloses that the suture is sized to fit through the lumen (“The tube has a lumen 765 extending longitudinally through its entire length so that the wire 735 extends through the tube lumen 765.”, paragraph [0089]).
Regarding claim 37, Hastings discloses that the delivery tool includes a structure in the proximal portion configured to retain a proximal portion of the suture (“The tube has a lumen 765 extending longitudinally through its entire length so that the wire 735 extends through the tube lumen 765.”, paragraph [0089], where the lumen 765 is considered to “retain a proximal portion of the tether”).
Regarding claim 38, it is respectfully submitted that the description of detachment mechanism 745 as being “a mechanical configuration where the proximal detachable portion of the lead 735 may be unscrewed from the remainder of the lead 735, or where the lead 735 is pushed and turned in a certain way to effect detachment of the proximal portion from the remainder of the lead 735” describes a luer cap as is known in the art.
Regarding claim 39, Hastings discloses that the elongated member is made of a flexible material (“the adjustable tines 1110E may comprise a shape memory alloy material, such as nitinol or the like, that is capable of returning to its biased shape after being elastically deformed within the central bore 1130E”, paragraph [0111]. In this embodiment, housing is element 1122E, the circuitry is the same circuitry for the seed as previously discussed, the antenna is the same antenna for the seed as previously discussed, the elongate member is 1110E, the electrodes are the conductive coating on elongate member 1110E, and the tether is 1170E) and shaped to include a curve when unconstrained (see embodiment of Figures 11E-F). Further, it is respectfully submitted that the recitation “the flexible material is reflowed to include a set, curved shape” is directed to the method by which the elongate member is made rather than further defining the structure of the elongate member itself. As such, this is considered a product by process recitation that fails to further define the claimed invention over that of the prior art.
Regarding claim 40 it is respectfully submitted that the extraction wire 735 of Hastings, as modified by Kuzma to be a suture material satisfies the claim limitation of “the suture is not electrically active” as claimed.
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hastings (U.S. 2006/0085042) in view of Kuzma (U.S. 2006/0271109) as applied to claims 21, 22, and 24-40 above, and further in view of Yakovlev et al. (WO 2014/205129). Hastings in view of Kuzma provides the invention substantially as claimed, but fails to disclose a separate antenna housing including a distal end and an opposing proximal end, the distal end of the antenna housing mechanically connected to a proximal end of the circuitry housing, the antenna situated within the antenna housing. Yakovlev teaches an implantable device 200 including a distal portion and a proximal portion (310 is an elongate member with a distal portion and a proximal portion, see Figures 3 and 4), wherein the device includes circuitry in a first housing (active implanted system 200 of Figure 2 is sealed within housing), an antenna in a separate second housing in the proximal portion (antennas 520 are housed within separate flexible extension 510 that is attached at the proximal end of implant 310, see Figure 5 and paragraphs [0079], [0081], and [0083]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hastings in view of Kuzma to include the antenna in a separate housing, as taught by Yakovlev, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796