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 Objections
Claims 12 and 15 are objected to because of the following informalities: the limitations "extra cellular" and "intra cellular" are written as two separate words versus "intracellular" and "extracellular" as amended in the applicant's specification.
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 12, 14-19, and 21-22 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.
Regarding Claim 12, the limitations recited in lines 34-35 and 40-42 are indefinite. It is unclear if a change in cell volume is calculated based on a frequency dependent factor, extracellular resistance, and total resistance, as recited in lines 34-35, or if a change in cell volume is calculated based on a frequency dependent factor, extracellular resistance, and intracellular resistance, as recited in lines 40-42. Are the parameters recited in lines 34-35 used in one type of equation to calculate a change in cell volume and the parameters recited in lines 40-42 used in a different type of equation to calculate a change in cell volume? It is unclear if there are multiple equations to calculate a change in cell volume or if there is a discrepancy in what parameters are recited.
Additionally, the limitation “said empirical model being the following approximation” recited in line 35 followed by the limitation identifying parameters in said empirical model recited in lines 36-39 of the claim are indefinite. These limitations are unclear as an “empirical model” was not recited within the claim. This lack of recitation of a formula leaves the first limitation, recited in line 35, open-ended and also fails to provide a model to link to the recited parameters recited in lines 36-39. It is being interpreted that the following formula was supposed to incorporated into the Claim 12’s limitation following “said empirical model being the following approximation”:
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Regarding Claim 21, the limitation "the calculated estimate of cell volume change" lacks proper antecedent basis. The limitation is being interpreted to mean "a calculated estimate of cell volume change".
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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 12, 14-19, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 12 follows.
STEP 1
Regarding Claim 12, the claim recites a series of steps or acts, including determining a relative difference – change - in cell volume; performing a first measurement cycle; applying a current corresponding to a cycle of different predetermined frequencies; measuring a resulting variating potential; calculating a measured impedance from the corresponding measured variating potential; calculating a total impedance absolute value from the corresponding measured impedance; storing each total impedance absolute value against its corresponding frequency; performing one or more subsequent measurement cycles; reading a corresponding frequency value; comparing said frequency values; determining a difference between the frequency values; and providing a time series of differences in frequency. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of determining a relative difference – change - in cell volume, comparing said frequency values, and determining a difference between the frequency values set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 12 fails to recite any application of determining a relative difference – change - in cell volume, comparing said frequency values, or determining a difference between frequency values in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on a determined cell volume or difference between frequency values, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 12 recites additional steps of performing a first measurement by applying a current, measuring a variating potential at predetermined frequencies, measuring impedance, and calculating a total impedance absolute value. The performing, measuring, and calculating steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the performing, measuring, and calculating steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Additionally, the steps of determining a change of cell volume that recite use of mathematical calculations, draws them to an Abstract Idea (Mathematical Concept).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Dependent Claims 14-19 and 21-22 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing. The performing, measuring, and calculating steps recited in the independent claim, Claim 12, maintain a high level of generality even when considered in combination with the dependent claims.
The determining, performing, applying, measuring, calculating, storing, reading, comparing, and providing steps recited in the independent claim, Claim 12, maintain a high level of generality even when considered in combination with the dependent claims.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding Claims 12, 14-19, and 21-22, none of the prior art teaches or suggests, either alone or in combination, a method comprising curve-fitting a calculated total impedance absolute value over a cycle of predetermined frequencies to the empirical model (that is currently missing from the claims but is assumed to be recited in Claim 12), in combination with the other claimed steps.
Response to Arguments
Applicant's arguments filed 02 December 2025 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome some of the prior claim objections, but current claim objections caused by the amendments are addressed in Paragraph 2 above.
Applicant’s amendments have overcome some of the prior 35 U.S.C. 112a and 112b rejections, but additional as well as pre-existing 35 U.S.C. 112b rejections are addressed in Paragraph 3 above. Regarding Claim 12, the above interpretation was made on the basis that limitations from the original Claim 13 were brought into the amended Claim 12. However, the formula recited above was not transferred appropriately and is currently missing from Claim 12. Additionally, it is to be noted by the examiner that a current 112a rejection does not exist. However, if the examiner’s interpretation is correct regarding the amended Claim 12 missing the recitation of the formula from the original Claim 13, the original 112a rejections that existed for Claim 13 regarding the discrepancies between the copied formula within the original Claim 13 and the specification will need to be addressed and corrected in the amended Claim 12. The examiner has recited what is interpreted to be the correct formula based on the specification in Paragraph 3 above.
Application’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The applicant had amended the claim to incorporate the limitation "performed by a sensor device". However, this limitation does not overcome the Abstract Idea. Even though the applicant has identified a device to perform the steps recited within Claim 12, the element "a sensor device" does not provide specific structure or unique features to overcome the Abstract Idea. According the specification, the “sensor device” contains generic parts such as a battery providing power to a device and electrodes that are sensing and measuring (Paragraph [0095] - The sensor device is preferably a battery powered, four electrode, light weight, body mountable, flexible patch that makes time resolved electrical resistance and reactance measurements over a wide range of frequencies). Given that these parts function in a way that is well known in the art, they are not considered to be a "particular machine or device" that contains specific-functioning parts unique to the device or method and therefore the 101 rejections stand. Additionally, some of the amendments to Claim 12 have created an additional type of 35 U.S.C. 101 rejection to be made. The analysis of the 35 U.S.C. 101 rejections are in Paragraphs 4 and 5 above.
Applicant’s amendments have overcome the prior 35 U.S.C. 103 rejections when taken into consideration that the examiner’s assumption about the missing equation in Claim 12 is correct.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791