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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/11/2026 has been entered.
Claim Objections
Claims 1, 11, 12, and 22 are objected to because of the following informalities:
Claim 1, line 7: “electrodes” should be replaced with “electrode”;
Claim 11, line 2: “at least a pair” should be replaced with “at least one pair”;
Claim 12, line 2: “first or second locations” should be replaced with “a first or second location”;
Claim 12, line 3: “at least a pair” should be replaced with “at least one pair”;
Claim 12, line 4: “locations” should be replaced with “location”; and
Claim 22, line 2: –the– should be inserted before “first”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 6, and 8-22 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.
Claim 1 recites “wherein the corrective term is a product of the electrical resistance gradient
δ
R
δ
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and a muscle permittivity constant (ε)” in lines 17-18, which is new matter. The recitation indicates that the corrective term consists of a product of the electrical resistance gradient
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δ
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and a muscle permittivity constant (ε). However, formula 1 of ¶ [0051] of the published specification indicates that a corrective term includes other elements. Paragraphs [0142]-[0145] also indicate the corrective term includes other elements. Therefore, the specification does not provide support for the above limitation.
Claims 3, 6, and 8-22 are rejected by virtue of their dependence from claim 1.
Claims 1, 3, 6, and 8-22 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.
Claim 1 recites “the body part of which a muscle section (S) is determined” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear whether this recitation refers to “a body part” on line 2. For the purposes of examination, the recitation of “a part of the body that is different from the body part of which a muscle section (S) is determined” will be interpreted to be “a second body part which is different from the body part for which the contractile cross section area is determined”.
Claim 1 recites “a muscle section (S) is determined” in lines 9-10. It is unclear what it means to “determin[e] a muscle section”. Are parameters of the muscle determined? Is the location or composition of the muscle section determined? Although ¶ [0090] of the published application recites “The muscle section is also know by a skilled person as contractile Cross Section Area (cCSA)”, the recitation does not clearly redefine the term. Claims 3, 10-13, 17, and 20-21 are rejected for reciting “muscle section is further determined” or “muscle section (S) is further determined”, which are unclear for similar reasons. For the purposes of examination, the recitations of “the muscle section (S)” and “muscle section” in the dependent claims will be interpreted to be “the contractile cross section area”.
Claims 3, 6, and 8-22 are rejected by virtue of their dependence from claim 1.
Claims 6, 8, and 9 recite “the corrective term comprises…”. Claim 1 recites “the corrective is a product of the electrical resistance gradient
δ
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and a muscle permittivity constant (ε)” in lines 17-18. The recitation in claim 1 indicates that the corrective term excludes any additional elements. However, claims 6, 8, and 9 indicate that the corrective term includes additional elements. Therefore, it is unclear how the corrective term and its elements should be interpreted. The Examiner suggests replacing “is” in claim 1, line 17 with “comprises”.
Claim 17 recites “each muscle section of the body part being determined according to claim 1” in lines 3-4. However, claim 1 does not positively recite how the muscle section is determined. Therefore, it is unclear how each muscle section is determined according to claim 1.
Claim 21 recites “a first electrical resistance value measured at a first electrode located at a first location of the body part” in lines 8-9 and “a second electrical resistance value measured at a second electrode located at a second location of the body part” in lines 9-10. Claim 1 recites “at least two electrical resistance values from at least three electrodes located on different locations of the body” in lines 4-6. It is unclear how the limitations of claim 21 are related to the limitation of claim 1. The specification does not create a distinction between the values, electrodes, and locations of claims 1 and 21, which suggests that they are the same. However, the variations in language suggest that they are different. Therefore, it is unclear whether the limitations of claims 1 and 21 are the same as, related to, or different from each other. The Examiner suggests using consistent claim language.
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, 3, 6, and 8-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-19 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a process, which is a statutory category.
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. Additionally or alternatively, claim 1 is directed to an abstract idea in the form of mathematical concepts.
In particular, claim 1 recites the following limitations:
[A1]: determining the contractile cross section area as a function of a sum of a term of conductivity and a corrective term;
[B1]: the term of conductivity is a product of an electrical resistance gradient
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δ
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between said at least two electrodes and a muscle conductivity constant (σ)
[C1]: the corrective term is a product of the electrical resistance gradient
δ
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δ
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and a muscle permittivity constant (ε).
These elements [A1]-[C1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is mentally determining a cross section area using the mathematical formula of ¶ [0118] of the published application. Additionally or alternatively, the elements [A1]-[C1] are directed to an abstract idea because they are mathematical algorithms and/or formulas. See at least ¶ [0118] of the published application with regards to the mathematical nature of the determination of the muscle section.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements:
[A2]: measuring, by means of a bioelectrical impedance analyzer, at least two electrical resistance values from at least three electrodes located on different locations of the body, wherein at least two of said at least three electrodes are located along said body part and are part of an electrodes array adapted for measuring electrical potentials, wherein at least one electrode of the at least three electrodes are located on a part of the body that is different from the body part of which a muscle section (S) is determined; and
[B2]: determining, by means of a processing unit.
The element [A2] does not integrate the judicial exception into a practical application because it amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea. See MPEP 2106.04(d) and 2106.05(g).
The element [B2] does not integrate the judicial exception into a practical application because it amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d); MPEP 2106.05(f).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional elements:
[A2]: measuring, by means of a bioelectrical impedance analyzer, at least two electrical resistance values from at least three electrodes located on different locations of the body, wherein at least two of said at least three electrodes are located along said body part and are part of an electrodes array adapted for measuring electrical potentials, wherein at least one electrode of the at least three electrodes are located on a part of the body that is different from the body part of which a muscle section (S) is determined; and [B2]: determining, by means of a processing unit.
The element [A2] does not amount to significantly more than the judicial exception because it amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea. See MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. For example, the element is taught by US 4649932 A (Smith) in Fig. 1 and Col.4 , lines 47-68; US 5,309,917 A (Wang) in Fig. 1 and Col. 5, lines 32-47; and US 2005/0177062 A1 (Skrabal) in Fig. 9. The plurality of disclosures indicate the well-understood, routine, and conventional nature of the element.
The element [B2] does not amount to significantly more than the judicial exception because it amounts to significantly more than the judicial exception because the elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d); MPEP 2106.05(f); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 3, 6, and 8-22 depend from claim 1, and they recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) except for the following limitations.
Claim 11 recites “at least a pair of electrical resistance values being measured at a single measurement frequency or at different measurement frequencies”. However, this element does not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception because the element amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea. See MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional and evidenced by US 8,026,731 B1 (Emery)(previously cited) in Col. 1, lines 21-57, which discloses that in prior art approaches, multiple frequencies may be employed, and/or currents may be passed through multiple electrodes at once. Claims 20-21 recite similar limitations which do not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception for similar reasons.
Claim 12 recites “first or second locations of the locations of the body part at which respectively first and second electrical resistance values of the at least a pair of electrical resistance values are measured is identical to another first or second locations of the locations of the body part at which respectively a first and a second electrical resistance values of another pair of electrical resistance values are measured”. However, this element does not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception because the element amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea. See MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional and evidenced by US 8,026,731 B1 (Emery) (previously cited) and US 2005/0043895 A1 (Schechter) (previously cited). Emery teaches prior art approaches to the problem of electrical impedance tomography have typically involved passing currents between various pairs of electrodes arrayed around the periphery of the object to be imaged (Col. 1, lines 21-57), which results in pairs of electrical resistance values. Schechter teaches that it is conventional to repeat measurements over time to generate a time dependent impedance curve Z(t) (¶ [0081]), which results in measurements taken at the same locations. Claim 22 recites similar limitations which do not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception for similar reasons.
Claim 19 recites “a computer program product comprising a non-transient, machine-readable medium storing instructions which, when the program is executed by a program, cause the computer to…” However, this element does not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception because the element amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d); MPEP 2106.05(f); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Response to Arguments
Claim Objections
There are new grounds of claim objections.
Claim Rejections under 35 U.S.C. §112
There are new grounds of claim objections under 35 U.S.C. §112(a), 112(b) necessitated by the claim amendments filed 02/11/2026.
Claim Rejections under 35 U.S.C. §101
Applicant asserts that amended claim 1 recites a particular arrangement of electrodes: “at least three electrodes located on different locations of the body, wherein at least two of said at least three electrodes are located along said body part and are part of an electrodes array adapted for measuring electrical potentials, wherein at least one electrode of the at least three electrodes are located on a part of the body that is different from the body part of which a muscle section (S) is determined.”
This argument is not persuasive because the element is not particular. It is recited at a high level of generality (e.g., using a generic bioelectrical impedance analyzer with a generic electrodes) using conventional elements applied in a conventional arrangements. For example, the electrodes and their arrangement are taught by US 4649932 A (Smith) in Fig. 1 and Col.4 , lines 47-68; US 5,309,917 A (Wang) in Fig. 1 and Col. 5, lines 32-47; and US 2005/0177062 A1 (Skrabal) in Fig. 9, wherein the plurality of disclosures indicate the well-understood, routine, and conventional nature of the element. Therefore, the Examiner maintains that the element amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea, which does not integrate the exception into a practical application of the exception or amount to significantly more than the judicial exception.
On pages 10-11 of the Remarks filed 02/11/2026, the Applicant asserts:
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These arguments are not persuasive. With reference to Thales Vixionix, MPEP 2106.05(f) indicates “the particular configuration of inertial sensors and the particular method of using the raw data from the sensors was more than simply applying a law of nature. Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The court found that the claims provided a system and method that ‘eliminate[d] many ‘complications’ inherent in previous solutions for determining position and orientation of an object on a moving platform.’ In other words, the claim recited a technological solution to a technological problem. Id.”
However, claim 1 does not include a particular configuration of sensors and a particular method for using the data from the sensors in order to provide a technological solution to a technological problem. First, the configuration of electrodes is not particular for the reasons listed above. Second, the specification does not clearly present how the arrangement and determination of the physiological measurement amounts to a technological solution to a technological problem. At most, in paragraph [0007] of the published application, the specification sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), which is not sufficient evidence for the claim improving technology.
On page 11, the applicant asserts:
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These argument is not persuasive. The Examiner considered the interaction of the electrical measurements and electrode arrangement with the remaining claim elements. The remaining claim elements do appear to use any of the electrical resistance values measured by the electrode arrangement. Even if one were to interpret the electrical resistance values as being related to the electrical resistance gradient, there is no indication that the electrode arrangement amounts to anything more than mere data gathering. Additionally, MPEP 2106.05(g) further indicates that necessary data gathering is still insignificant extra-solution activity.
On page 12, the applicant asserts:
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These arguments are not persuasive. MPEP 2106.04 indicates that questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). The analysis under steps 2A and 2B was performed above and did not result in an indication that the claim does not preempt the abstract idea. The Examiner maintains that electrodes in conjunction with the mathematical algorithm amounts to adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea for the reasons listed above. MPEP 2106.05(g) indicates that mere data gathering is insignificant extra-solution activity and does not amount to integration of the judicial exception into a practical application or significantly more than the judicial exception itself. Additionally, the electrode arrangement is well-understood, routine, and conventional which, despite providing a real-world medical context, does not impose a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
On page 12, the applicant asserts:
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This argument is not persuasive.
MPEP 2106.04(d)(1) indicates: “ The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology.”
However, the specification does not clearly present how the arrangement and determination of the physiological measurement amounts to a technological solution to a technological problem. At most, in paragraph [0007] of the published application, the specification sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), which is not sufficient evidence for the claim improving technology.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791