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 .
Election/Restrictions
Claims 2-3, 8-10, and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/19/26.
Applicant's election with traverse of the election of species in the reply filed on 2/19/26 is acknowledged. The traversal is on the ground(s) that the species are not mutually exclusive because the specification teaches using combinations of two or more different heart sound metrics together. This is not persuasive since the MPEP 806.04(b) specifically states “[F]or example, two different subcombinations usable with each other may each be a species of some common generic invention. If so, restriction practice under election of species and the practice applicable to restriction between combination and subcombinations must be addressed”. It is also noted that the applicant has argued the invention uses combinations of two or more “different heart sound metrics” and therefore has admitted they are species. The applicant also argues that independent claims 1 and 14 are generic and do not require any specific heart sound metric and therefore restriction is improper since all the species must be examined. This is not found persuasive because the examiner addressed this in the election of species using standard form paragraphs by stating that the independent claims (1 and 14) are generic. In addition 37 C.F.R. 1.146 “Election of species” addresses this—"In the first action on an application containing a generic claim to a generic invention (genus) and claims to more than one patentably distinct species embraced thereby, the examiner may require the applicant in the reply to that action to elect a species of his or her invention to which his or her claim will be restricted if no claim to the genus is found to be allowable.” Therefore, if the generic independent claim is found allowable, at that point the other species will be found allowable. The argument that no serious search burden exists is not persuasive as the applicant themselves have stated the species are “different heart sound metrics” and have “different analytical approaches”. In addition, due to the different text searches needed for the different species, there is a search burden. The argument that a search for a generic claim would necessarily encompass the subject matter of all the dependent claims is not persuasive. The applicant themselves have stated the species are “different heart sound metrics” and have “different analytical approaches”. Is the applicant stating that if the generic claim is found, then inherently all the dependent claims are found? Is the applicant arguing that the species are “not patentably distinct”? If so, they should clarify the arguments and if one species is found (or the generic independent claim), then all the species are found. Note that claims 2, 3, and 15 are withdrawn also as they did not read on the elected species 3.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-7, 11-14, and 18-20 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.
In claim 1, lines 6-8, “from the heart sound information sensed from the patient” and “in response to the electrostimulation being delivered to two or more candidate locations…” lack antecedent basis and are vague and unclear if the system is performing these functions. If the generation is “in response” to the electrostimulation being delivered to two or more locations, then the claim should first set forth that the stimulator, or controller controlling the stimulator, performs this function. In addition, the data receiver has only been set forth to receive heart sound information, but has not been set forth to receive heart sound information when the electrostimulation is being delivered. Finally, the electrostimulator has been set forth in line 4 to deliver the stimulation to “a location” and not “two or more candidate locations”.
In claim 4, line 2, “two or more candidate locations” is vague as this term is also used in claim 1. It is unclear if they are the same element or not. If they are not, then is the claim stating that 4 different locations are used to deliver the stimulation?
In claim 11, “the heart sound information sensed from the patient in response to the electrostimulation being delivered at the selected pacing location” lacks antecedent basis. Claim 1 or 11 has not previously set forth there is any sensing at this particular time.
In claim 12, it is unclear how selecting a second pacing location using cardiac electrical activity is used to “confirm the first selected pacing location”. Is all that is needed is the selection of a second pacing location?
In claim 14, line 5, “sensed from a patient…” is vague and in the passive voice and it is unclear if the claim is positively reciting/claiming a sensing of the heart sound information. If it is, then active voice should be used, such as “sensing heart sound information…”. If it is not, then it is suggested to delete “sensed”.
Similarly claim 19 has this problem.
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.
Claim 12 is 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.
The subject matter which was not described is the controller configured to select a second pacing location from two or more candidate locations using received cardiac electrical information, and to confirm the first pacing location using the second selected pacing location, in combination with the other elements and/or functions of the claim.
The applicant/inventor had a general idea of performing this action, but they did not possess the specific details of how the idea is carried out when they filed the application.
The disclosure only repeats the claim language of claim 12 (e.g. para. 24) but goes no further in explaining how the controller performs this function and how it confirms the first pacing location.
What electrical information is used? How does the second pacing location confirm the first pacing location”? It is unclear how selecting a second pacing location using cardiac electrical activity is used to “confirm the first selected pacing location”. Is all that is needed is the selection of a second pacing location? How does the second location confirm the first location?
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 7, 11, 13-14, and 18-19 are rejected under 35 U.S.C. 102a1 as being anticipated by An et al (2016/0106987). An discloses the claimed system and method limitations as follows:
--a data receiver circuit to receive heart sound information sensed from a patient (e.g. figure 2, element 220, etc.)
--an electrostimulator (e.g. figure 2, element 210, etc.) configured and/or positionable to deliver stimulation to a location at or near a cardiac conduction system, such as a septal site, RBB, LBB, His (e.g. figure 1, heart electrodes, 155, 142,141, 162, 161, 154, 153, 152, para. 43, etc.), and
--a controller circuit (e.g. figure 2, element 240, para. 62, etc.) to deliver stimulation to at least two candidate locations (e.g. figure 7, para. 10, etc.) and generate heart sound metrics for each location (e.g. figure 7, elements 710, 720, para. 10, etc.) and select at least one candidate location for subsequent stimulation based on the heart sound metrics (e.g. paras. 40, 105, etc.).
For claims 7 and 18, An measures an S1 intensity heart sound metric (e.g. paras. 14, 63, 66, etc.) to compare to a threshold to see if it exceeds the threshold (e.g. paras. 12, 27, 76, 80, etc.). For claim 13, An does disclose a control signal to initiate/adjust electrostimulation to restore cardiac synchrony as An adjusts stimulation to achieve capture and synchronization (e.g. paras. 7, 41, etc.). For claims 11 and 19, An discloses selecting a pacing location and adjusting the dosage or timing (e.g. para. 105, etc.) so that the desired capture status is achieved. This desired capture status is based on the HS metric (e.g. abstract, paras. 8, 9, etc.) and therefore will generate further heart sound metrics to determine the correct pacing dosage or timing (in the alternative, see the 103 rejection below).
Claim Rejections - 35 USC § 103
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.
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 6 and 20, and in the alternative, claims 11 and 19, are rejected under 35 U.S.C. 103 as being unpatentable over An et al. An discloses the claimed invention and the electrodes used at multiple locations, transmitting data to an external display, and adjusting the therapy at the selected pacing location to achieve desired capture status. An does not disclose selecting the pacing location by suggesting a His/septal selected depth of insertion of the His/septal distal tip, the real-time display of the heart sound metric during electrostimulation, and in the alternative, measuring the heart sound metric again/continuously for the selected pacing electrodes to determine the proper dosage or timing parameter. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by An, with selecting the pacing location by suggesting a His/septal selected depth of insertion of the His/septal distal tip, the real-time display of the heart sound metric during electrostimulation, and in the alternative, measuring the heart sound metric again/continuously for the selected pacing electrodes to determine the proper dosage or timing parameter, as well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of: directly stimulating the cardiac conduction zone to achieve effective stimulation and capture of the heart; allowing the physician to watch and monitor the diagnostic test and confirm the system is operating properly; and providing the proper pacing parameters once the electrodes are selected so as to achieve successful capture of the patient’s heart and/or to reduce power requirements by using only enough energy to achieve sufficient pacing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 5/22/26
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