DETAILED ACTION
Applicant' s arguments, filed 09/08/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/16/2022, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-9, 12-13, and 15-20 are the current claims hereby under examination.
All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2023/0072666 A1.
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 .
Claim Rejections - 35 USC § 112(b)
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 1-9, 12-13, and 15-20 are 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 1 recites “wherein the integrated circuity is configured to select either the second electrode or the third electrode based on which of the second electrode and the third electrode has a stronger signal for sensing” but it is unclear what metrics are considered or compared to determine a “stronger signal for sensing”. For the purposes of this examination, the “strength” of a signal for sensing will be considered as any type of signal quality or amplitude metric.
Claims 2-9, 12-13, and 15-20 depend from claim 1 and are rejected by virtue of their dependency.
Claim 9 recites “the accelerometer is used to determine whether the implantable medical device has flipped” in lines 1-2 however it is unclear if the accelerometer itself is making such a determination or if the accelerometer provides data to some form of processor. It is further unclear how this determination is being made. For the purposes of this examination, the limitation will be interpreted as being carried out by processing circuitry and any method of determining device rotation in any axis will be considered analogous to the claimed determination.
Claim 12 recites “determine sensing capability” but it is unclear what this limitation is meant to convey or how it is being determined. The specification does not define what parameter “sensing capability” is referring to and one of ordinary skill in the art would not be reasonably appraised of the scope of this limitation. For the purpose of this examination, the limitation will be interpreted as referring to any factor which affects sensor performance.
Claim 12 recites “determine sensing capability” but it is unclear if this limitation is the same as, related to, or different from “a stronger signal for sensing” of claim 1. For the purposes of this examination, the sensing capability will be considered as the metric for determining the “strength” of a signal for sensing.
Claim 13 recites “measure impedance on a sensed signal of the second electrode to determine the sensing capability of the second electrode” but it is unclear if the impedance measurement itself is the “sensing capability” or if the impedance measurement is merely used as an input to determine sensing capability. It is unclear what “sensing capability” entails and how it is determined. For the purposes of this examination, the sensing capability will be interpreted as analogous to impedance. This rejection is similarly applied to claim 17.
Claim 18 recites “an accelerometer used for determining a period of electrode inactivity, wherein the integrated circuitry is configured to select either the second electrode of the third electrode during the period” but it is unclear how accelerometer measurements are related to electrode activity and how they are used to “determine a period of electrode inactivity”. It is unclear determination is being performed using accelerometer signals to indicate “electrode inactivity”. It is unclear if the step of “select either the second electrode of the third electrode during the period” is the same selection as claim 1 or a different selection. The scope of the claim and its relationship to the other functions of the claimed device is unclear and a prior art search is unable to be performed at this time.
Claim 20 recites “wherein the stronger signal is a signal for sensing a patient’s cardiac activation signals” but it is unclear if this limitation is meant to be an intrinsic property of the “stronger” signal or if the “stronger” signal is selected based on it being able to sense a patient’s cardiac activation signals. It is unclear how two signals which each sense a patient’s cardiac activation signals are meant to be compared to determine which is “stronger”. For the purposes of this examination, this limitation will be interpreted as the selected stronger signal being capable of sensing cardiac activity.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9, 12-13, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites select either the second electrode or the third electrode based on which of the second electrode and the third electrode has a stronger signal for sensing” but the specification does not appear to describe how the strength of a signal for sensing is determined. In particular, paragraphs 0064 and 0074 provide only generic statements of functionality that the stronger signal is selected but do not provide a particular method or metric to determine a signals strength for sensing.
Claim 9 recites “the accelerometer is used to determine whether the implantable medical device has flipped” in lines 1-2 however the specification does not describe how such a determination is carried out. In particular paragraph 0073 merely provides a statement of functionality but does not detail how the determination is carried out.
Claim 12 recites “determine sensing capability” but the specification does not describe what a determination entails or how it is performed. In particular paragraphs 0071-0072 only provides a statement of functionality which does not describe how the determination is carried out or what the parameter “sensing capability” comprises.
Claim 13 recites “measure impedance of the sensed signal of the second electrode to determine the sensing capability of the second electrode” but the specification does not describe how such a determination is performed or describe what the sensing capability refers to. In particular, paragraphs 0071-0072 merely provides a statement of functionality. This rejection is similarly applied to claim 17.
Claim 18 recites “an accelerometer used for determining a period of electrode inactivity, wherein the integrated circuitry is configured to select either the second electrode of the third electrode during the period” but the specification does not describe how the accelerometer inputs are used to “determine a period of electrode inactivity”. The specification does not describe the particular steps of the determination and provides only a generic statement of functionality in paragraph 0073.
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 1-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Landherr US Patent Application Publication Number US 2017/0065207 A1 hereinafter Landherr in view of Lim US Patent Application Publication Number US 2019/0232066 A1 hereinafter Lim, further in view of Fay US Patent Application Publication Number US 2016/0242667 A1 hereinafter Fay.
Regarding claim 1, Landherr discloses an implantable medical device (Abstract) comprising:
a core assembly having a first proximal end and a first distal end wherein the core assembly includes a battery, a first electrode positioned at the first distal end, and integrated circuitry (Paragraphs 0065-0066: the core assembly, battery assembly, circuit components and electrode 210; Fig. 2 references 204, 206, and 210 comprise the “core assembly”. The core assembly is an elongate body and the side which connects to the header assembly may be considered the proximal end);
a header having a second proximal end and a second distal end, wherein the second proximal end of the header is coupled to the first proximal end of the core assembly, the header forming a housing with an open interior space (Paragraphs 0065-0066: the header includes an interior space; Fig. 2 references 202 and 204, the proximal end of the header mates with the proximal end of the core assembly);
a scaffold assembly positioned within the interior space (Paragraph 0066: the scaffold assembly; Fig. 2 reference 212); and
a second electrode supported by the scaffold assembly (Paragraph 0066: electrode 208 supported by the scaffold assembly; Fig. 2 references 212 and 208).
Landherr fails to further disclose the device wherein the header comprises a third electrode supported by the scaffold assembly on opposite sides of the scaffold assembly from the second electrode and wherein the integrated circuity is configured to select either the second electrode or the third electrode based on which of the second electrode and the third electrode has a stronger signal for sensing.
Lim teaches an implantable medical device (Abstract) and thus falls within the same field of endeavor as Applicant’s invention.
Lim teaches a third electrode on opposite sides of the header from the second electrode (Paragraph 0065: the multiple electrodes may be provided on opposite sides of the header). Lim further teaches the device comprises switches to allow the system to select what electrodes are to be recorded from. The desired electrodes are connected to the appropriate circuits by the switches thereby facilitating electrode programmability (Paragraph 0049)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify Landherr by incorporating a third electrode on the opposite side of the header from the second electrode and the electrode switching selection mechanism as taught by Lim in such a manner where the third electrode is also supported by the scaffold of Landherr because having an electrode present on both sides of the header would allow the device to operate effectively even if it was rotated from a desired implantation orientation as taught by Lim paragraph 0064 which indicates that the electrode facing the heart may be activated, and Landherr indicates that the scaffold assembly is responsible for supporting the electrode of the header (Landherr: paragraph 0065). Furthermore, implementing the switching assembly to select a desired electrode to record from is beneficial because reducing the number of recording electrodes to only those most desired may reduce processing requirements and improve a signal to noise ration and thereby result in lower power expenditure and improved quality of data.
Landherr in view of Lim fails to further teach the device wherein the integrated circuity is configured to select either the second electrode or the third electrode based on which of the second electrode and the third electrode has a stronger signal for sensing.
Fay teaches a medical device having a plurality of electrodes for sensing tissue contact (Abstract). Thus, Fay is reasonably pertinent to the problem at hand.
Fay teaches a device with a plurality of electrodes being adjacent to, or embedded within, tissue. The device may employ several methods to assess tissue contact of the electrode to the patient’s tissue. The assessment method may include a comparison of the amplitudes of measured cardiac activation (Paragraph 0108). The device may also measure impedance between electrodes in order to determine tissue contact and the degree of tissue contact for each of the electrodes (Paragraphs 0110-0111). Fay teaches that the magnitude of sensed signals may be used to determine a degree of electrode contact.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the tissue contact determination methods taught by Fay into the device of Landherr in view of Lim such that the electrode selection of Landherr in view of Lim may be performed using the contact determination values of Fay because detecting tissue contact and the degree of contact may be an important factor in selecting which electrodes are desirable to record from since electrodes with greater tissue contact may provide the highest magnitude, or strongest, signals as taught by Fay (Fay: paragraph 0111) and may be more desirable for measurement.
All below rejections are written with the understanding that Landherr in view of Lim further in view of Fay as presented in the above rejection of claim 1 teaches a device with electrodes on opposite sides of the header being supported by the scaffold assembly.
Regarding claims 2-3 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr further discloses the device wherein the second electrode is flush with a first exterior surface of the header; and wherein the third electrode is flush with a second exterior surface of the header (Paragraph 0065: the electrode may be flush with the exterior surface).
Regarding claims 4-5 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr further at least suggests the device wherein the second electrode is flush with an interior region of the header; and wherein the third electrode is flush with the interior region of the header.
Landherr in view of Lim further in view of Fay as described in the above rejection of claim 1 teaches that the medical device comprises electrodes on opposite sides of the header. Landherr teaches that the electrodes of the header may be positioned by the scaffold assembly to form a portion of the exterior surface (Paragraph 0065). Thus configurations where the electrodes form part of the exterior surface but are not flush with their respective surfaces are contemplated.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the electrodes of Landherr in view of Lim further in view of Fay to be flush with an interior region of the header because Landherr contemplates configurations where the electrodes are not flush with the exterior surface of the header and configuring the electrodes to be flush with an interior surface would result from routine optimization and experimentation of the construction of Landherr in view of Lim. Furthermore, constructing Landherr in view of Lim in the described manner does not produce any surprising technical effect or alter the principle functionality of Landherr in view of Lim and is thus a mere rearrangement of parts.
Regarding claim 6 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr further discloses the device further comprising an antenna positioned within the interior space (Paragraphs 0065-0066: the antenna supported by the scaffold assembly within the interior space of the header).
Regarding claim 7 Landherr in view of Lim further in view of Fay teaches the medical device of claim 6. Modified Landherr further discloses the device wherein the antenna is positioned on an exterior surface of the scaffold assembly (Paragraph 0066: the antenna is supported by the scaffold assembly; Paragraphs 0068-0070 describe the antenna and how it may be supported by the scaffold assembly including how the antenna may be at least partially circumferentially arranged around an exterior section of an upper portion of the scaffold).
Regarding claim 8 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr further suggests the device wherein the core assembly includes an accelerometer.
Landherr discloses that the IMD may include additional sensors for monitoring physiological parameters of the patient including an accelerometer (Paragraph 0057). Landherr fails to explicitly disclose the accelerometer being located within the core assembly.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to configure Landherr in view of Lim further in view of Fay such that the accelerometer contemplated by Landherr is located within the core assembly of Landherr because the particular placement of the accelerometer does not alter its recited function and placing the accelerometer in the core is a mere rearrangement of parts with no surprising technical effect.
Regarding claim 12 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr fails to further disclose the device wherein the integrated circuitry is configured to determine sensing capability of the second electrode and sensing capability of the third electrode.
Fay teaches a device with a plurality of electrodes being adjacent to, or embedded within, tissue. The device may employ several methods to assess tissue contact of the electrode to the patient’s tissue. The assessment method may include a comparison of the amplitudes of measured cardiac activation (Paragraph 0108). The device may also measure impedance between electrodes in order to determine tissue contact and the degree of tissue contact for each of the electrodes (Paragraphs 0110-0111). The tissue contact determination is considered analogous to “sensing capability” as Fay teaches that the degree of contact influences the magnitude of a sensed electrical response in paragraphs 0108 and 0111 and thus the degree of contact is a measure of “sensing capability”.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the tissue contact determination, or sensing capability determination, taught by Fay into the device of Landherr in view of Lim further in view of Fay such that the electrode selection of Landherr in view of Lim further in view of Fay may be performed using the contact determination values because detecting tissue contact and the degree of contact may be an important factor in selecting which electrodes are desirable to record from since electrodes with a certain degree of tissue contact may be most desirable and may result in improved signal detection and quality.
Regarding claims 13 and 17 Landherr in view of Lim further in view of Fay teaches the medical device of claim 12. Modified Landherr fails to further disclose the device wherein the integrated circuitry is configured to measure impedance on a sensed signal of the second electrode and an impedance on a sensed signal of the third electrode to determine the respective sensing capability of the second electrode and the sensing capability of the third electrode.
Fay teaches a device with a plurality of electrodes being adjacent to, or embedded within, tissue. The device may measure impedance between electrodes in order to determine tissue contact and the degree of tissue contact for each of the electrodes (Paragraphs 0110-0111). The tissue contact determination is considered analogous to “sensing capability” as Fay teaches that the degree of contact influences the magnitude of a sensed electrical response in paragraphs 0108 and 0111 and thus the degree of contact is a measure of “sensing capability”
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the tissue contact determination, or sensing capability determination, taught by Fay into the device of Landherr in view of Lim further in view of Fay because detecting a degree of tissue contact may allow the system to detect which electrodes are likely to produce the highest quality data and which are likely to produce large amounts of noise.
Regarding claim 20 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr fails to further disclose the device wherein the stronger signal is a signal for sensing a patient's cardiac activation signals (Paragraph 0056: the device records cardiac activation signals; Paragraph 0059: the electrodes record cardiac signals).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Landherr US Patent Application Publication Number US 2017/0065207 A1 hereinafter Landherr in view of Lim US Patent Application Publication Number US 2019/0232066 A1 hereinafter Lim in view of Fay US Patent Application Publication Number US 2016/0242667 A1 hereinafter Fay as applied to claim 8 above and further in view of Lee US Patent Application Publication Number US 2019/0365290 A1 hereinafter Lee.
Regarding claim 9 Landherr in view of Lim further in view of Fay teaches the medical device of claim 8. Modified Landherr fails to further disclose the device wherein the accelerometer is used to determine whether the implantable medical device has flipped.
Lee teaches an accelerometer that may be used to determine the orientation of a medical device with respect to gravity (Abstract). Thus, Lee falls within the same field of endeavor as Applicant’s invention.
Lee teaches a medical device with a processor and an orientation sensor such as a 3-axis accelerometer to determine an orientation vector of the sensor relative to the patient. The device determines the roll, pitch, and yaw of the sensor relative to the patient (Paragraph 0103; Figs. 5A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the 3-axis accelerometer to determine a roll, pitch, and yaw of the device relative to the patient as taught by Lee into the device of Landherr in view of Lim further in view of Fay because determining the orientation of the device relative to a reference or desired orientation can allow the device to compensate for rotation and migration and may provide the device with information regarding which sensors are facing in the most appropriate direction for sensing which Lim teaches as desirable (Lim: Paragraph 0049: selecting the electrodes based upon orientation of the IMD relative to a physiological area of interest) .
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Landherr US Patent Application Publication Number US 2017/0065207 A1 hereinafter Landherr in view of Lim US Patent Application Publication Number US 2019/0232066 A1 hereinafter Lim in view of Fay US Patent Application Publication Number US 2016/0242667 A1 hereinafter Fay as applied to claim 1 above and further in view of Gelbart US Patent Application Publication Number US 2009/0192441 A1 hereinafter Gelbart.
Regarding claim 15 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr fails to further disclose the device wherein the integrated circuitry includes a Kelvin connection to the second electrode and the third electrode.
Gelbart teaches a surgical tool with a sensor at the tip for analyzing the electrical properties of the tissue in contact with the sensor (Abstract). Thus, Gelbart is reasonably pertinent tot eh problem at hand.
Gelbart teaches a device where multiple sensing electrodes are configured as a four wire system or Kelvin electrodes which allows the electrodes to be less sensitive to electrode-tissue interface problems (Paragraph 0016).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the second and third electrodes of Modified Landherr to include a Kelvin connection as taught by Gelbart because Gelbart teaches that such a configurations makes the electrodes less sensitive to electrode-tissue interface problems (Gelbart: Paragraph 0016).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Landherr US Patent Application Publication Number US 2017/0065207 A1 hereinafter Landherr in view of Lim US Patent Application Publication Number US 2019/0232066 A1 hereinafter Lim in view of Fay US Patent Application Publication Number US 2016/0242667 A1 hereinafter Fay as applied to claim 1 above and further in view of Sommer US Patent Application Publication Number US 2003/0204232 A1 hereinafter Sommer.
Regarding claim 16 Landherr in view of Lim further in view of Fay teaches the medical device of claim 1. Modified Landherr further discloses the device wherein the second electrode and the third electrode are electrically connected to respective electrical connectors which are coupled to the integrated circuitry (Paragraph 0066: the interconnects are attached to the electrodes and configured to connect with the integrated circuitry).
Modified Landherr fails to further disclose that the electrodes are welded to electrical connectors.
Sommer teaches an implantable electrical lead having two or more electrodes electrically insulated from each other and electrically coupled to individual insulated filars (Abstract; Paragraph 0028). Thus, Sommer falls within the same field of endeavor as Applicant’s invention.
Sommer teaches that electrodes may be coupled to individual filars by means such as laser welding (Paragraph 0039).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize laser welding as taught by Sommer to couple the electrodes of Modified Landherr to their respective interconnects because Modified Landherr discloses that the electrodes are electrically coupled to the interconnects which connect the electrodes to the integrated circuitry (Landherr: Paragraphs 0066 and 0075) but fails to disclose how this coupling is formed. The laser welding taught by Sommer provides Modified Landherr an acceptable means of forming the electrical coupling and is a simple substitution of the joining method of Sommer for the joining method of Modified Landherr with no surprising technical effect.
Claim 18 is not rejected over the prior art as the scope of the claim is unclear and a proper prior art search and mapping is unable to be performed given the present indefiniteness of the claim.
Claim 19 is further not rejected over the prior art by virtue of being dependent upon claim 18 but would be rejected in substantially the same manner as claim 8 if claim 18 were definite.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. US 11523746 B2 hereinafter Pacemakers in view of Landherr, Lim, Lee, Fay, Gelbart, and Sommer as described above. In particular,
Present claim 1 is unpatentable over Pacemakers claims 1, 4, and 5-6, or claims 11-12 and in view of Landherr which teaches the battery (Paragraph 0065) or in view of Lim which also teaches a battery (Paragraph 0043)
Present claims 2-5 are unpatentable over Pacemakers claims 1, 4, and 5-6, or claims 11-12 and in view of Landherr in view of Lim which teaches or reasonably suggests the electrode configurations as described in the above 103 rejections of claim 2-5.
Present claims 6 and 10 are unpatentable over Pacemakers claims 1, 4, 5-6, and 9 in view of Landherr for the differences of claim 1
Present claim 7 is unpatentable over Pacemakers claims 1, 4, 5-6, and 9 in view of Landherr for the differences of claim 1
Present claim 8 is unpatentable over Pacemakers claims 1, 4, and 5-6 or claims 11-12 in view of Landherr for the differences of claim 1 and which further teaches the accelerometer (Paragraph 0057)
Present claim 9 is unpatentable over Pacemakers claims 1, 4, and 6 or claims 11-12 in view of Landherr for the differences of claim 1 and which further teaches the accelerometer (Paragraph 0057) and in view of Lee which teaches the flipping detection (Paragraph 0103).
Present claims 12-13 and 17 are unpatentable over Pacemakers claims 1, 4, and 5-6, or 11-14 and in view of Landherr for the differences of claim 1
Present claim 15 is unpatentable over Pacemakers claims 1, 4, and 5-6 or claims 11-12 in view of Landherr for the differences of claim 1 and in view of Gelbart which teaches the Kelvin connection (Paragraph 0016)
Present claim 16 is unpatentable over Pacemakers claims 1, 4, and 5-6 or claims 11-12 in view of Landherr for the differences of claim 1 and in view of Sommer which teaches welded connections (Paragraph 0039)
Present claim 20 is unpatentable over Pacemakers claims 1, 4, and 5-6 or claims 11-12 in view of Landherr for the differences of claim 1 and the teaching of sensing cardiac activation signals (Paragraph 0039 and 0056)
Response to Arguments
Applicant's arguments filed 09/08/2025 have been fully considered but they are not persuasive.
In regards to the rejections previously presented under 35 USC 103:
Applicant argues that the newly added limitations of claim 1, in particular the selection based on signal strength is not taught by the previous art of record.
This argument is not found to be persuasive because Fay teaches that tissue contact affects the magnitude of sensed signals and that sensed signal amplitude can be used as a metric for assessing tissue contact (Paragraphs 0108 and 0110-0111) thus the selection of an electrode with greater tissue contact is considered analogous to the selection of an electrode with a “stronger signal for sensing” given the above presented clarity issues with the limitation of “stringer signal for sensing”
In regards to the rejections previously presented under 35 USC 112:
Applicant’s amendments are sufficient to overcome some but not all of the previously presented clarity rejections.
Applicant argues that the office action does not point to any authority that requires Applicant’s specification to provide the level of detail the Office asserts is allegedly lacking
This arguments is not found to be persuasive because the above presented rejection includes a quotation from 35 USC 112(a) upon which the rejection is based. In response to Applicant’s arguments, Examiner further cites MPEP 2161.01(I) which recites:
“The written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, applies to all claims including original claims that are part of the disclosure as filed. Ariad, 598 F.3d at 1349, 94 USPQ2d at 1170. As stated by the Federal Circuit, "[a]lthough many original claims will satisfy the written description requirement, certain claims may not." Id. at 1349, 94 USPQ2d at 1170-71; see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405-06 (Fed. Cir. 1997)("The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention."). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant [inventor] has made a generic invention that achieves the claimed result and do so by showing that the applicant [inventor] has invented species sufficient to support a claim to the functionally-defined genus.").
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand the inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. "[T]he description of one method for creating a seamless DWT does not entitle the inventor . . . to claim any and all means for achieving that objective." LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
The most relevant sections of the above except are bolded. The MPEP states that claims may lack written description when the claims define the invention in functional language by specifying a desired result. The claim may lack written description when the specification does not sufficiently describe how the function is performed or result achieved.
In the instant case, claims 1, 9, 12-13, and 18 each recite a limitation defined by functional language (the selection of claim 1 which results in a given electrode being selected and the determinations of claims 9, 12-13, and 18 which produce their respective recited output) but the specification does not describe how the selection and determinations are performed to result in the recited outputs. Thus the previously presented rejections are maintained and new grounds of rejection are presented based on the amended language.
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791