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
Applicant's election with traverse of Group I, drawn to the process of impedance-based tissue proximity assessment, and Species A2, B1, C1, D1, and E2, drawn to Figures 4, 8, 9, 14, and 20 respectively, in the reply filed on 9/30/25 is acknowledged. The traversal is on the ground(s) that a serious search and/or examination burden is not present, particularly between Group I and III. This is not found persuasive because the inventions of Groups 1 and III remain independent and distinct as different statutory classes of invention necessitating different search and examination, particularly requiring different search in view of different classification and divergent subject matter and that they raise different non-prior art issues.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/30/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: the positive recitation of “each electrode” should apparently read “each of the plurality of electrodes”. Appropriate correction is required.
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 1-7 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 positively recites “a medical device” in line 1 and line 3, rendering the claim indefinite. The scope of the claim is indeterminate with regard to if (i) the “a medical device(s)” are the same, (ii) the “a medical device(s)” are distinct, and/or (iii) the relationship amongst the “a medical device(s)”. In light of the instant Specification one of ordinary skill would not be apprised of the metes and bounds of the scope of the claimed invention given the ambiguity. Depending claims 2-7 inherit and do not remedy the indefiniteness.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the steps of identifying, determining and plotting may be considered a mental process.
For independent claim 1, the claim(s) recite(s) a process of Identifying electrode locations in space that is subdivided into sub-regions, determining tissue proximity based on electrode impedance, and plotting electrode locations and tissue proximity status within 3D space. As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data , printing it out, and using the data to mentally extract, classify or learn from data features to determine and plot electrode, impedance, and tissue proximity in space.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of applying drive signals to a plurality of medical electrodes, measuring electrode responses, and generating impedance values therefrom are well-known, routine and conventional medical diagnostic activities amounting to insignificant data gathering as pre-solution activity.
Depending claims 2-7 inherit and do not remedy the non-statutory deficiency noted above. Despite further clarifying steps relating to establishing, assessing, comparing, assigning and resetting baselines values; generating indications; and detecting lesion formation, the additional clarifying limitations do not integrate into a practical application nor do they amount to significantly more than the abstract idea that may be performed mentally and/or by pen and paper.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deno et al. (US 2017/0042449 A1, hereinafter Deno).
For claim 1, Deno discloses a method for use with a medical device (860) (Figs 3, 34) configured for insertion within a patient (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]), comprising:
identifying a location of each electrode (54) of a medical device having a plurality of electrodes (plurality of electrodes 54 on plurality of splines 57) in a three-dimensional space (Fig 3) (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]), wherein the three-dimensional space is sub- divided into a plurality of sub-regions (cliques of step 136 in Fig 8) (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]);
applying a drive signal ([0059-0064]) to each of the plurality of electrodes of the medical device (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]);
measuring a response ([0059-0064]) of each electrode to the drive signal and generating an impedance value for each electrode (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]);
determining a tissue proximity status (Fig 8) ([0090-0099]) of each electrode based on the impedance value generated for each electrode (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]); and
plotting locations and tissue proximity status of each electrode within the three- dimensional space (Figs 8, 13-17, 27, 34) ([0078-0099, 0121-0144, 0188-0189]).
For claim 2, Deno discloses the method of claim 1, further comprising: establishing a baseline impedance value for each sub-region of the three- dimensional space based on impedance values collected by one or more electrodes identified as located within the sub-region of the three-dimensional space (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
For claim 3, Deno discloses the method of claim 2, wherein establishing a baseline impedance value for each sub-region includes: assigning each sub-region containing at least one electrode a baseline impedance value corresponding to the impedance value for an electrode disposed in the sub-region (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]); and assessing a subsequent impedance value generated for an electrode based on a comparison of the subsequent impedance value for the electrode with a baseline impedance value for a sub-region in which the electrode is located (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
For claim 4, Deno discloses the method of claim 3, wherein the assessing of the subsequent impedance further comprises: determining a sub-region does not have an assigned value baseline impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]); and assigning the sub-region the subsequent impedance value as a baseline impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
For claim 5, Deno discloses the method of claim 3, wherein the assessing of the subsequent impedance further comprises: determining a subsequent impedance value is greater than a baseline impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]); and generating an indication of tissue proximity based on a difference between the subsequent impedance value and the baseline impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
For claim 6, Deno discloses the method of claim 3, wherein the assessing of the subsequent impedance further comprises: determining a subsequent impedance value is less than a baseline impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]); and resetting the baseline impedance value to the subsequent impedance value (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
For claim 7, Deno discloses the method of claim 1, further including: detecting lesion formation at one of the plurality of sub-regions based on a comparison of plurality of impedance values measured over time by one or more of the plurality of electrodes (Figs 8, 13-17, 27, 34) ([0059, 0078-0099, 0121-0144, 0188-0189]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for impedance electrode contact assessment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791