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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/686,639, filed on 03/04/2022.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Response to Amendment
The amendments under 37 CFR 1.132 filed 06/03/2025 is sufficient to overcome the 35 USC 112(b) rejection of claim 1-3. The rejection has been withdrawn.
Claims 1-3 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 17/687,022 has been withdrawn.
The amendments under 37 CFR 1.132 filed 06/03/2025 is insufficient to overcome the 35 USC 101 rejection of claims 1-3 as set forth in the last Office action because: 35 USC 101 Step 2A Prong One and Two are still held to be valid.
Response to Arguments
Applicant's arguments filed 06/03/2025 have been fully considered but they are not persuasive.
Examiner respectfully disagrees with applicants’ arguments for 35 USC 101 Step 2A Prong One and Two. Step 2A Prong One relates these steps to methods of organizing human activity and not a metal process. Regarding to Step 2A Prong Two, applicant argues the additional elements improve the technology. However, an improvement to the abstract ideas of advanced bioimpedance for assessing local or total body bone mineral density, delivering cost-effective, rapid, and user-friendly solutions does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to advanced bioimpedance for assessing local or total body bone mineral density, delivering cost-effective, rapid, and user-friendly solutions. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Applicant further argues that there would be no motivation to further evaluate the bone mineral density of the subject using bioimpedance vector analysis (BIVA) disclosed by Piccoli, as monitoring is already being performed. As such, one having ordinary skill in the art would have no reasonable motivation to combine Piccoli with Arad to accomplish the claimed invention. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Arad teaches the use of bioimpedance technology for accurate measurement of bone mineral density (([0067] One goal of some embodiments of the invention is to improve diagnostics and monitoring of osteoporosis in hospitals and clinics by providing a simple, sensitive and accurate measurement of bone mineral density that can be used on a patient on a routine basis) ([0077] embodiments of the present invention there is provided a method of measuring Bone Mineral Density (BMD) including providing a model of a plurality of constituents of at least a portion of a subject body).
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 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.
Step 1 – Statutory Categories of Invention:
Claims 1-3 are drawn to a method, which is a statutory category of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a method for bioimpedance vector analysis to evaluate local or whole body bone mineral density in part performing the steps of (a) attaching at least two electrode sets on the hands and the feet of a subject in a way that the hands or the feet of a subject to form a measurement loop, measuring and obtaining a resistance and a reactance of a subject with the at least two electrode sets of a bioimpedance measuring instrument, obtaining a height of said subject, and then dividing said resistance by the height of said subject to obtain a first value, and dividing said reactance by the height of said subject to obtain a second value; and (b) according the obtained first value and the obtained second value, comparing said obtained first value and said obtained second value with a bioimpedance vector analysis chart to evaluate the local or whole body bone mineral density of said subject.
Dependent claim 2 recites, in part, wherein in step (a), the plural electrode sets each comprise a sensing electrode and a current electrode; said sensing electrode and said current electrode are configured to be 1-10 cm apart.
Dependent claim 3 recites, in part, wherein in step (a), said subject is to perform the measurement in a supine, standing or sitting position selectively.
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people similar to iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using ordinary machinery its ordinary capacity [MPEP 2106.05(f)].
Claim 1 and 3 recite at least two electrode sets on the hands and the feet of a subject in a way that the hands or the feet of a subject to form a measurement loop and a bioimpedance measuring instrument. Claim 2 recites, in part, the plural electrode sets each comprise a sensing electrode and a current electrode; said sensing electrode and said current electrode are configured to be 1-10 cm apart. The specification does not provide specific structure or further description for the bioimpedance measuring instrument with an electrode set comprising a sensing electrode and a current electrode. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea.
Claim 1 and 3 recite at least two electrode sets on the hands and the feet of a subject in a way that the hands or the feet of a subject to form a measurement loop and a bioimpedance measuring instrument. Claim 2 recites, in part, the plural electrode sets each comprise a sensing electrode and a current electrode; said sensing electrode and said current electrode are configured to be 1-10 cm apart. The use of a bioimpedance measuring instrument, said electrode set comprising a sensing electrode and a current electrode is well-understood, routine, and conventional. This position is supported by Piccoli et al. A new method for monitoring body fluid variation by bioimpedance analysis: The RXc graph, Kidney International, Volume 46, Issue 2, 1994, Pages 534-539, ISSN 0085-2538, https://doi.org/10.1038/ki.1994.305. Where in Piccoli recites a bioimpedance measuring instrument ([Pg. 534, Para. 3] The two components of the whole-body impedance vector, Resistance (R) and Reactance (Xc), were recorded from single representative stable measurements, conducted by the same operator), plural electrode sets of said bioimpedance measuring instrument said electrode sets comprising a sensing electrode and a current electrode attached to the hands and feet to form a measurement loop ([Pg. 534, Para. 3] BIA was performed with an impedance plethysmograph, which emitted 800 1sA and 50 kHz alternating sinusoidal current (model BIA-109 RJL/Akern Systems, Detroit, Michigan, USA) and was connected to surface electrodes (standard, tetrapolar placement on the right hand and foot) strictly following the method reported elsewhere [5, 6, 8]). Claim 2 further recites said the plural electrode sets each comprise a sensing electrode and a current electrode, wherein Liedtke (US 9591987 B1) further supports this position. Liedtke teaches a bioimpedance measuring instrument ([45] FIG. 8, a diagram of a system 400 is shown illustrating an integrated bioelectrical analysis system in accordance with another example embodiment of the invention. In one example, the system 400 may be configured to perform one or more of an electrocardiogram (EKG or ECG), a bioelectrical impedance analysis (BIA), and/or a body composition analysis (BCA), and automatically generate the appropriate report(s)), the plural electrode sets each comprise a sensing electrode and a current electrode and attached to the hands and feet to form a measurement loop ([11] The electrodes 110, 114, 118, and 122 are configured as detecting electrodes and the electrodes 112, 116, 120, and 124 are configured as signal injection electrodes). Further, Arad (US 20160100791 A1) teaches a bioimpedance measuring instrument ([0131] An induced current bio-impedance technique was proposed in recent studies as an alternative method for applying current in volume conductors while avoiding direct contact with a patient's skin) (FIG. 3 is a simplified illustration of an example embodiment of the invention). Arad further teaches plural electrode sets of said bioimpedance measuring instrument, said electrode sets comprising a sensing electrode and a current electrode and attached to the hands and feet to form a measurement loop ([0063], [0104] an injection electrode for injecting electric current into the portion of the subject, such that at least part of the current flows through the at least one bone constituent, a pickup electrode for measuring a value of electric potential at a surface of the subject).
Therefore, the bioimpedance measuring instrument, said plural electrode sets comprising a sensing electrode and a current electrode additional elements are not sufficient to amount to significantly more than the recited judicial exception.
Furthermore, each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements do not have sufficient structure in the specification to be considered a not well-understood, routine, and conventional use of generic computer components. Note that the specification can support the conventionality of generic computer components if “the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” (Berkheimer in III. Impact on Examination Procedure, A. Formulating Rejections, 1. on p. 3).
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
For the reasons stated, these claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. § 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccoli A et al. (Piccoli A, Rossi B, Pillon L, Bucciante G. A new method for monitoring body fluid variation by bioimpedance analysis: The RXc graph, Kidney International, Volume 46, Issue 2, 1994, Pages 534-539, ISSN 0085-2538, https://doi.org/10.1038/ki.1994.30) in view of Arad (US 20160100791 A1).
Regarding claim 1, Piccoli et al. teaches a) attaching at least two electrode sets on the hands and the feet of a subject in a way that the hands or the feet of a subject to forma measurement loop ([Pg. 534, Para. 3] BIA was performed with an impedance plethysmograph, which emitted 800 1sA and 50 kHz alternating sinusoidal current (model BIA-109 RJL/Akern Systems, Detroit, Michigan, USA) and was connected to surface electrodes (standard, tetrapolar placement on the right hand and foot) strictly following the method reported elsewhere [5, 6, 8]) ([Pg. 538, Para. 3] the RXc graph method might yield better results with different BIA techniques, in particular combining multifrequency with different electrodes placements [26—28]), measuring and obtaining a resistance and a reactance of a subject with the at least two electrode sets of a bioimpedance measuring instrument ([Pg. 534, Para. 3] The two components of the whole-body impedance vector, Resistance (R) and Reactance (Xc), were recorded from single representative stable measurements, conducted by the same operator), obtaining a height of said subject ([Pg. 534, Para. 3] All subjects had height (H), weight, BMI, and BIA determined on the same day), and then dividing said resistance by the height of said subject to obtain a first value, and dividing said reactance by the height of said subject to obtain a second value ([Pg. 534, Para. 3] We standardized BIA measurements by the H of subjects, thus expressing both RIH and Xc/H in Ohm/m); and (b) according the obtained first value and the obtained second value, comparing said obtained first value and said obtained second value with a bioimpedance vector analysis chart (Fig 1 and 2; [Pg. 534, Para. 5] The "RXc point graph" was defined as a single measurement of the two height-standardized components of the impedance vector, namely R/H and Xe/H, recorded in the individual patient and plotted on the reference). Piccoli fails to teach a method of bioimpedance vector analysis technology to evaluate local or whole-body bone mineral density to evaluate the local or whole-body bone mineral density of said subject. However, Arad teaches a method of bioimpedance vector analysis technology to evaluate local or whole-body bone mineral density ([0067] One goal of some embodiments of the invention is to improve diagnostics and monitoring of osteoporosis in hospitals and clinics by providing a simple, sensitive and accurate measurement of bone mineral density that can be used on a patient on a routine basis), to evaluate the local or whole-body bone mineral density of said subject ([0077] embodiments of the present invention there is provided a method of measuring Bone Mineral Density (BMD) including providing a model of a plurality of constituents of at least a portion of a subject body). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Piccoli to include a method of bioimpedance vector analysis technology to evaluate local or whole-body bone mineral density to evaluate the local or whole-body bone mineral density of said subject. Doing so would use the values of resistance and reactance measured to calculate bone mineral density.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piccoli A et al. (Piccoli A, Rossi B, Pillon L, Bucciante G. A new method for monitoring body fluid variation by bioimpedance analysis: The RXc graph, Kidney International, Volume 46, Issue 2, 1994, Pages 534-539, ISSN 0085-2538, https://doi.org/10.1038/ki.1994.30) in view of Arad (US 20160100791 A1), and further in view of Liedtke (US 9591987 B1).
Regarding claim 2, Piccoli teaches the method of bioimpedance vector analysis technology to evaluate local or whole body bone mineral density as claimed in claim 1, wherein in step (a) said sensing electrode and said current electrode being 1-10 cm apart ([Pg. 534, Para. 3] for the interoperator variability (1 to 2 cm displacement of electrodes from the anatomical reference points)).
Piccoli fails to teach the plural electrode sets each comprise a sensing electrode and a current electrode. However, Liedtke teaches each said electrode set comprising a sensing electrode and a current electrode ([11] The electrodes 110, 114, 118, and 122 are configured as detecting electrodes and the electrodes 112, 116, 120, and 124 are configured as signal injection electrodes). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Piccoli to include the plural electrode sets each comprise a sensing electrode and a current electrode. Doing so creates a measuring loop for the current and sensing electrodes.
Regarding claim 3, Piccoli teaches the method of bioimpedance vector analysis technology to evaluate local or whole body bone mineral density as claimed in claim 1, but fails to teach wherein in step (a), said subject is instructed to perform the measurement of said bioimpedance measuring instrument in a supine, standing or sitting position selectively. However, Liedtke teaches wherein in step (a), said subject is to perform the measurement of said bioimpedance measuring instrument in a supine, standing or sitting position selectively ([44] In the step 302, a subject is prepared for testing by having the subject remove shoes and socks and lay in a supine position on a non-conductive surface (e.g., an examination table)). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Piccoli to include wherein in step (a), said subject is to perform the measurement of said bioimpedance measuring instrument in a supine, standing or sitting position selectively. Doing so ensures accurate and undisturbed measurements from the electrodes.
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 ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794