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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 are rejected under 35 U.S.C. 101 because Claims 1 to 9 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.
Each of Claims 1 to 9 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 to 9 recites at least one step or instruction for observing, judging or evaluating data, which is grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 1 to 9 recites an abstract idea.
Specifically, Claim 1 recites A device for in-vivo measurement of absolute loads in tissue (abstract), the device comprising:
a stimulator/monitor (additional element) including:
(a) a stimulator probe (additional element) adapted to apply a transverse stimulation to tissue of an individual at a first location along a longitudinal axis to produce a shear wave traveling through the tissue along the longitudinal axis;
(b) at least one motion sensor (additional element) detecting transverse motion of the tissue at a predetermined second location along the longitudinal axis separated from the first location to provide a measured shear wave signal (observation, which is a mental process under the 2019 PEG); and
a machine learning processor (additional element) receiving the measured shear wave signal from the first motion sensor (additional element) without independent calibration information derived from an actual force applied to the tissue (observation, which is a mental process under the 2019 PEG), and outputting an absolute load value of load on the tissue along the longitudinal axis (judgement or evaluation, which is a mental process under the 2019 PEG);
wherein the machine learning processor (additional element) is trained using a teaching set linking multiple measured shear wave signals to absolute load values of tissue of different individuals (judgement or evaluation, which is a mental process under the 2019 PEG) obtained on a data collection stimulator/monitor (additional element) equivalent to the stimulator/monitor (additional element).
Specifically claim 2 recites the device of claim 1 further including a second motion sensor (additional element) detecting transverse motion of the tissue at a predetermined third location along the longitudinal axis separate from the second location to provide a second measured shear wave signal (observation, which is a mental process under the 2019 PEG) and wherein the machine learning processor receives the measured shear wave signal and second measured shear wave signal registered to each other (observation, which is a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 3-9 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 1 (and its respective dependent Claims 2-9) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a sensing unit, a memory and at least one computer processor are generically recited computer elements in independent Claim 1 (and its respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and its respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., at least one computer processor as claimed). In other words, independent Claim 1 and its dependent claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and insignificant extra-solution activity related to a sensing unit collecting data. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 2-9 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: a stimulator/monitor, a stimulator probe, at least one motion sensor, a machine learning processor.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for a stimulator/monitor, a stimulator probe, at least one motion sensor, a machine learning processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that 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) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Furthermore, Thelen (U.S. Patent Application Publication No. 20190200900) discloses a stimulator/monitor, a stimulator probe, at least one motion sensor, a machine learning processor (paragraphs 0007, 0066-0069). The recitation of the above-identified additional limitations in Claims 1-9 amounts to mere instructions to collect data with extra-solution activity and implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claims 1-9 are directed to applying an abstract idea (e.g., mental process) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-9 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-9 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-9 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-9 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
Regarding claim 1, the claim recites a device for in-vivo measurement of absolute loads in tissue. Thus, the claim is directed to a machine/apparatus, which is one of the statutory
categories of invention. The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception: "receiving the measured shear wave signal…outputting an absolute load value..." These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper. Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered: "A device…a stimulator/monitor…a stimulator probe…at least one motion sensor…a machine learning processor…" These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g). The claims still do not exemplify an improvement. If the improvement is a new way of data processing without calibration, then the improvement cannot be solely within the judicial exception. The claims seem to be just outputting data.
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 YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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