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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 2/13/26, amended claim(s) 1, 4-5, 8, 11-12, 14-16, 19, 24-26, 28, 31-32, 35-41, 43, and 45-46 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a thoracic impedance measurement module,” in claim 12, which corresponds to a “processor” (see para [0018]-[0019] of Applicant’s specification as originally filed; and “a thoracic impedance measurement module,” in claim 36, which corresponds to a “processor” (see para [0018]-[0019] of Applicant’s specification as originally filed.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-46 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “comparing … the measured impedance data to simulated impedance data obtained from a plurality of models of the region of interest,” “for each model of the plurality of models, determining … a fit of the model based on a comparison between the simulated impedance data obtained from the model and the measured impedance data,” and “integrating … individual resistivity estimates obtained from the plurality of models based on a fit of the model such that an individual resistivity estimate from a better fitting model is weighted more heavily in a final resistivity estimate than another individual resistivity estimate from a worse fitting model.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “performing, using a measurement module connected to a plurality of electrodes, multiple impedance measurements on a region of interest to obtain measured impedance data, with the plurality of electrodes configured to be placed in contact with skin of a chest of a subject.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0085] of U.S. Patent Application Publication No. 2021/0001119 to Ordonez et al. (hereinafter “Ordonez”), para [0008] of U.S. Patent Application Publication No. 2020/0138335 to Stender and Alice v. CLS Bank. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Independent claim 12 fails to recite patent-eligible subject matter for similar, if not the exact same, reasoning as that of independent claim 1. Independent claim 12 differs in that is recites “a plurality of electrodes on a chest of a human subject,” and “a thoracic impedance detection module connected to the electrodes.” However, these additional elements are not “significantly more” as evidenced by para [0008] of U.S. Patent Application Publication No. 2020/0138335 to Stender and Alice v. CLS Bank, which held that generic computer structure does not otherwise transform a patent-ineligible claim into an eligible one. Dependent claim(s) 4-8, 11, 15-19, and 24 fail to cure the deficiencies of independent claim(s) by merely reciting additional abstract ideas and/or further limitations on abstract ideas already recited. Dependent claim(s) 2-3, 13, and 20 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0008] of Stender. Dependent claim(s) 9 and 22 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by col. 1, lines 51-54 of U.S. Patent No. 5,280,429 to Withers. Dependent claim(s) 10 and 23 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0023] of U.S. Patent Application Publication No. 2012/0056620 to Feinberg et al. (hereinafter “Feinberg”). Dependent claim 14 does not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0003] of U.S. Patent Application Publication No. 2003/0212319 to Magill. Dependent claim 21 does not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0022] of U.S. Patent Application Publication No. 2016/0143553 to Chien. Thus, claim(s) 1-24 is/are rejected under 35 U.S.C. 101.
Claim 25 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “summarizing … a plurality of models of the region of interest into a single sample model that represents the region of interest,” “generating … stimulated impedance data using the single sample model,” and “fitting … the simulated impedance data to the measured impedance data to produce a final resistivity estimate for the region of interest.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “performing, using a measurement module connected to a plurality of electrodes, multiple impedance measurements on a region of interest to obtain measured impedance data, with the plurality of electrodes configured to be placed in contact with skin of a chest of the human subject.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0085] of U.S. Patent Application Publication No. 2021/0001119 to Ordonez et al. (hereinafter “Ordonez”), para [0008] of U.S. Patent Application Publication No. 2020/0138335 to Stender and Alice v. CLS Bank. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 25 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Independent claim 36 fails to recite patent-eligible subject matter for similar, if not the exact same, reasoning as that of independent claim 25. Independent claim 36 differs in that is recites “a plurality of electrodes on a chest of a human subject,” and “a thoracic impedance detection module connected to the electrodes.” However, these additional elements are not “significantly more” as evidenced by para [0008] of U.S. Patent Application Publication No. 2020/0138335 to Stender and Alice v. CLS Bank, which held that generic computer structure does not otherwise transform a patent-ineligible claim into an eligible one. Dependent claim(s) 26-28, 31-32, 35, 39-41, and 46 fail to cure the deficiencies of independent claim(s) by merely reciting additional abstract ideas and/or further limitations on abstract ideas already recited. Dependent claim(s) 29-30, 37, and 42 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0008] of Stender. Dependent claim(s) 33 and 44 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by col. 1, lines 51-54 of U.S. Patent No. 5,280,429 to Withers. Dependent claim(s) 34 and 45 do not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0023] of U.S. Patent Application Publication No. 2012/0056620 to Feinberg et al. (hereinafter “Feinberg”). Dependent claim 38 does not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0003] of U.S. Patent Application Publication No. 2003/0212319 to Magill. Dependent claim 43 does not recite “significantly more” because they are well-known, routine, and conventional as evidenced by para [0022] of U.S. Patent Application Publication No. 2016/0143553 to Chien. Thus, claim(s) 25-46 is/are rejected under 35 U.S.C. 101.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 21 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism.
For claim 21, the claim language “three first electrodes on the front of the chest and three second electrodes on the left side of the chest” encompasses a human organism. Specifically, a “chest” is a human organism and the electrodes are “on” the chest.
Allowable Subject Matter
Claim(s) 1-46 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
U.S. Patent Application Publication No. 2016/0242673 to Grychtol et al. (hereinafter “Grychtol”) discloses a method of detecting lung fluid status of a human subject (para [0109]), the method comprising: performing multiple impedance measurements on a region of interest to obtain measured impedance data (para [0035]-[0037]); for each of the models, determining a fit of the model (para [0177]).
U.S. Patent Application Publication No. 2021/0027461 to Santos et al. (hereinafter “Santos”) discloses a method of detecting lung fluid status of a human subject (Abstract), the method comprising: performing multiple impedance measurements on a region of interest to obtain measured impedance data (para [0042]-[0043]); comparing the measured impedance data to simulated impedance data obtained from a plurality of models of the region of interest (para [0065]-[0066] and [0080]-[0081]); for each of the models, determining a fit of the model based on a comparison between the simulated impedance data obtained from the model and the measured impedance data; and integrating individual resistivity estimates obtained from the models based on a fit of the model such that the individual resistivity estimate from a better fitting model is weighted more heavily in a final resistivity estimate than an individual resistivity estimate from a worse fitting model.
U.S. Patent Application Publication No. 2014/0276166 to Drori et al. (hereinafter “Drori”) discloses a method of detecting lung fluid status of a human subject (Abstract) (para [0017]), the method comprising: performing multiple impedance measurements on a region of interest to obtain measured impedance data (para [0084]).
U.S. Patent Application Publication No. 2006/0184060 to Belalcazar et al. (hereinafter “Belalcazar”) discloses comparing the measured impedance data to simulated impedance data obtained from a plurality of models of the region of interest (para [0053] and [0066]).
U.S. Patent Application Publication No. 2015/0297099 to Arad et al. (hereinafter “Arad”) discloses determining a fit of the model based on a comparison between the simulated impedance data obtained from the model and the measured impedance data (para [0157] and [0190]).
U.S. Patent Application Publication No. 2016/0135741 to Chetham et al. (hereinafter “Chetham”) discloses integrating individual resistivity estimates (para [0160]).
However, the prior art of record does not disclose and would not have rendered obvious the ordered combination of elements recited in the claim(s).
Response to Arguments
Applicant's arguments filed 2/13/26 have been fully considered. Some of the rejections are withdrawn in view of Applicant’s amendments and arguments and some are maintained. With respect to the maintained rejections, Applicant’s arguments do not appear commensurate in scope with the claim language. Although para [0031] of Applicant’s specification discloses a technique that is an improvement “a single 4-wire impedance measurement technique,” that technique is not particularly claimed. For example, para [0031] of Applicant’s specification identifies that this improved technique uses “a limited number of (e.g., 5-6) electrodes.” The claim does not recite that a limited number of electrodes such as “5 or 6 electrodes.” Instead, claim 1, for example, recites “a plurality of electrodes,” which encompasses more than 5 or 6 electrodes and is not narrowly tailored towards that improved technique disclosed in Applicant’s specification. Additionally, para [0031] discloses that the electrodes are combined with “a priori knowledge of the region of interest, or domain, with multiple 4-wire impedance measurements being performed to extract the domain information including the resistivity of the lung region.” This subject matter is not particularly detailed in the recited claim language either. Therefore, to make Applicant’s arguments more persuasive, the examiner respectfully suggests tailoring the claim language to the improved technique disclosed at para [0031] of Applicant’s specification as originally filed.
With respect to the argument that each claim is not being analyzed, this appears to be an argument against the format of the rejection. The rejection lays out each claim and the reasoning why each claim is rejected. However, claims that are rejected using the same reasoning are grouped together. Therefore, if Applicant prefers, the examiner can copy and past the exact same words and the exact same reasoning and make a single, different sentence for each claim. It wouldn’t change the thrust of the rejection at all. But the examiner did not do that in the first place because it seemed redundant and the current way the rejection is written is more succinct.
Lastly, the rejection of claim 21 under 35 U.S.C. 101 for a human organism is maintained since claim 21 wasn’t amended. It appears that this may have just been a typo and the examiner presumes will be corrected in the next response. Then the examiner can withdraw the rejection once it is addressed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791