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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept of receiving electrical activity from electrodes to generate P wave electrical heterogeneity data. This judicial exception is not integrated into a practical application because the combination of additional elements fails to integrate the judicial exception into a practical application. The generically recited computer elements (e.g. computing apparatus, etc.) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, the external electrodes/data gathering steps required to compute the heterogeneity do not add a meaningful limitation to the system or method as they are insignificant extra solution activity, are merely a nominal or token extra solution component of the claims, and are nothing more than an attempt to generally link the system/method to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination the additional elements do not add significantly more to the exception. The additional elements only receive the electrical signals and process the data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving electrical activity from electrodes to generate P wave electrical heterogeneity data, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. computing apparatus, electrodes etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. In addition, the external electrodes/data gathering steps required to compute the heterogeneity do not add a meaningful limitation to the system or method as they are insignificant extra solution activity, are merely a nominal or token extra solution component of the claims, and are nothing more than an attempt to generally link the system/method to a particular technological environment. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 1 having a “computing apparatus”/processor, and corresponding method claim 13) is a system having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art. In addition, the external electrodes/data gathering steps required to compute the heterogeneity do not add a meaningful limitation to the system or method as they are insignificant extra solution activity, are merely a nominal or token extra solution component of the claims, and are nothing more than an attempt to generally link the system/method to a particular technological environment.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The computing apparatus/processor is recited so generically (no details whatsoever are provided other than that they are a memory and processor) that it represents no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the computing apparatus/processor, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/heterogeneity information. In addition, the external electrodes/data gathering steps required to compute the heterogeneity do not add a meaningful limitation to the system or method as they are insignificant extra solution activity, are merely a nominal or token extra solution component of the claims, and are nothing more than an attempt to generally link the system/method to a particular technological environment.. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving electrical activity from electrodes to generate P wave electrical heterogeneity data, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
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 1-20 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, line 6, “obtain electrical activity measured from tissue of a patient” is vague as line 3 has the same limitation and it is unclear if these are the same elements from line 3 or different elements. If they are the same, then it is suggested to use in line 6, “obtain the electrical activity measured from the tissue of the patient”.
In claim 1, in the next to last line “heterogeneity” is vague and the metes and bounds of the term cannot be ascertained from the disclosure. It is unclear exactly what a P-wave electrical “heterogeneity” includes or does not include. Is all that is required is a metric or a measurement value of a Pwave? A distribution value/metric of the Pwave? The applicant should put on the record what is meant by P wave electrical “heterogeneity”. Merriam Webster defines heterogeneity as “the quality or state of consisting of dissimilar or diverse elements”. Does this mean that an average or combination of two P waves will meet the claimed limitation of “heterogeneity”? Or since there is a window over which the cardiac activity is sensed, that the diverse elements can be just the voltage change over the window? Etc.
Similarly, claim 13 uses this language and is vague.
In claim 4, line 1, “wherein generating a P-wave…” is vague as this term has been previously used in claim 1. If it is the same element from claim 1, then “wherein generating the P-wave…” should be used in claim 4. In line 3, “the plurality of distribution metrics” lacks antecedent basis. It is suggested to depend the claim from claim 2.
In claim 5, “the distribution metric” lacks antecedent basis.
In claim 6, “wherein the external electrical activity is measured from tissue …during delivery of atrial pacing therapy” is vague and sounds more like a method step than a structural limitation. It is unclear if the atrial pacing therapy and elements needed to deliver the therapy are being positively recited, or if the claim is just meant as an intended/functional use recitation. If the limitation is meant as an intended use recitation, then it is suggested to use functional language such as “wherein the external electrodes are configured to measure…”.
In claim 9, “wherein determining acceptability…” is vague as this term has been previously recited. It is suggested to use “wherein the determining…”.
Similarly, claim 19 uses this language and is vague.
In claim 15, line 1, “wherein generating a P-wave…” is vague as this term has been previously used in claim 13. If it is the same element from claim 13, then “wherein generating the P-wave…” should be used in claim 15. In line 3, “the plurality of distribution metrics” lacks antecedent basis. It is suggested to depend the claim from claim 14.
In claim 16, “The method as in claim 1” is vague as claim 1 is not a method. It is suggested to depend this claim from claim 13. In line 1, “is measured…” is vague and in the passive voice. It is unclear if a method step is being recited or only that the method is capable of using this data. It is suggested to use active voice, such as “measuring…” to positively recite a method step.
In claim 18, the next to last line, “from obtained external electrical …activation” is vague as these terms are used previously in clam 18. If they are the same elements, then “generated from the obtained external…during the intrinsic activation” should be used.
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, 6-7, 9-11, 13, and 16-19 are rejected under 35 U.S.C. 102a1 as being anticipated by Ghosh et al (2019/0275339). Ghosh discloses the claimed limitations as follows:
--external skin electrodes to measure electrical activity of a patient (e.g. figures 1-3, elements 112, etc.)
--a computing apparatus (e.g. figures 1-3, element 140, paras. 25-31, etc.) connected to the electrodes to obtain the measured electrical activity from the electrodes (e.g. figures 1-3, computing apparatus connected to electrodes, etc.) and configured to
--generate a p-wave electrical heterogeneity based on the obtained electrical activity (e.g. figure 6, blocks 404, 406; paras. 25, 68, 71, 92, 113, etc.).
For claims 6 and 16, Ghosh discloses delivering atrial pacing therapy to determine acceptability of the pacing therapy based on the P wave heterogeneity (e.g. para. 7, figure 9, etc.). For claims 7 and 17, Ghosh discloses comparing the P wave electrical heterogeneity to a threshold value (e.g. paras. 23, 64, etc.). For claims 9 and 18, Ghosh discloses comparing the P wave electrical heterogeneity to a baseline P wave heterogeneity during intrinsic cardiac action (e.g. paras. 72-75, 110, etc.). For claims 10, 11, and 19, Ghosh discloses using a comparison percentage less than or equal to 20% for determining acceptable atrial pacing therapy (e.g. para. 75, etc.).
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.
Claims 2-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh et al in view of Elberse et al (9445746). Ghosh discloses the claimed invention and the use of a window to sense the Pwave (e.g. paras. 66-67, etc.) to generate multiple distribution metrics (e.g. paras. 64-71, etc.; for claim 4, the selection of a maximum distribution metric being the larger dark spot in the map to get a larger deviation between the two maps (e.g. para. 70, etc.—in the alternative, see Elberse below); for claim 5, the use of a standard deviation metric (e.g. paras 23, 64, 66, etc.)) and also using the Q onset (e.g. para. 37, etc.) but does not disclose that the window is a lookback window from the QRS onset and is less than 200 ms. Elberse discloses the use of a lookback window from the QRS onset that is less than 200ms as a way to easily find and isolate the Pwave (e.g. figure 6, col. 6, lines 11-36, etc.) and also using a maximum/peak metric (e.g. maximum/peak of p wave amplitude, col. 7, line 48 to col. 8, line 50, etc.) among the plurality of metrics to determine the acceptability of the placement of the lead. 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 Ghosh, with the window to find the Pwave being a lookback window from the QRS onset and is less than 200 ms, and in the alternative selecting the maximum distribution metric such as the maximum/peak of p wave amplitude, as taught by Elberse, since it would provide the predictable results of providing an easily way to find and isolate the Pwave for processing, and using a maximum signal to determine the acceptability of the placement of an implantable lead.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ghosh et al. Ghosh discloses the claimed invention and that the signal processing can contain filtering (e.g. para. 28, etc.) but does not state that the obtained electrical activity is filter to remove high frequency noise or invalid signals due to loss of electrode contact. 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 Ghosh, with using a filter to remove high frequency noise or invalid signals due to loss of electrode contact, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of providing conventional filtering of signals to remove noise from the received `signals so that the noise is not processed and/or an improper decision is made or therapy is unintentionally delivered due to a bad signal.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George R Evanisko/ Primary Examiner, Art Unit 3792 4/13/26
Prosecution Insights