DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to an application filed 25 February 2025, which is a continuation-in-part of a chain of applications that claim priority to provisional applications filed as early as 6 November 2023
Claims 1-15 are currently pending and have been examined.
Information Disclosure Statement
The three information disclosure statements (IDS) submitted on 2 February 2026 have been considered by the Office to the extent indicated.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings contain lines of insufficient weight, text of insufficient size and/or shading that make the drawings illegible, see Figs. 2b-5b, 7, 9, 10 and 12A-15B. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
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.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. What follows is an incomplete listing of errors.
Claims 1, 9 and 13-15 recite one of the following limitations organization O or patient P. It is unclear what the Applicant is referring to with these limitations.
The following claims contain the following terms:
1. reliably and efficiently;
9. typically; and
11. unexpectedly or uncharacteristically.
The above terms are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 7, 8, 12 and 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following claims contain the following undefined acronyms that render the claim indefinite because it is unclear what the acronyms are referring to:
1,3,10,13-15. IMU;
8. UPDRS, PDQ, EDSS, PDDS, LEFS, EQ-5D, SF-36 or SF-12.
Acronyms need to be defined the first time the appear in each claim tree.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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 1-15 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
Claims 1-15 are within the four statutory categories. Claims 14 are drawn to a computerized healthcare method providing healthcare remotely to end-users, which is within the four statutory categories (i.e. process). Claims 1-13 are drawn to a computerized healthcare system providing healthcare remotely to end-users, which is within the four statutory categories (i.e. machine). Claim 15 is drawn to a non-transitory medium for predicting a patient medical event, which is within the four statutory categories (i.e. manufacture).
Prong 1 of Step 2A
Claim 1 recites: A computerized healthcare system providing healthcare remotely to end-users, the system comprising at least one instance of:
an interface uploading IMU data recorded by a healthcare-providing organization O's end users' communication devices' accelerometers; and
a hardware processor which maps indications derived from the IMU data to care actions, where said care actions comprise at least one allocation of at least one organizational resource from among a set of available organizational resources which the organization allocates to its end-users or patients or members,
thereby to reliably and efficiently allocate available organizational resources to at least one organization's patients.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of a certain method of organizing human activity because they recite a process that is managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – mapping IMU data to care actions in order to allocate resources), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claims 14 and 15 are identical as the abstract idea for claims 1, because the only difference between claims 1, 14 and 15 is that claim 1 recites a system, whereas claim 14 recites a method and claim 15 recites a non-transitory computer-readable media.
Dependent claims 2-13 include other limitations, for example claims 2-8 and 12 is directed to score prediction and claims 9-11 and 13 recite elements related to captured data, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 2-13 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 2-13 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 14 and 15.
Prong 2 of Step 2A
Claims 1-15 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer and the accelerometer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs 33 and 39 of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to IMU, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 2-13 include other limitations, but these limitations also amount to no more than mere instructions to apply the exception (e.g. the recitation of the accelerometer of claims 2-6 and data training of claims 4-6), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-13), and/or do not include any additional elements beyond those already recited in independent claims 1, 14 and 15, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-15 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the accelerometer and the structural components of the computer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraphs 33 and 39 of the Specification discloses that the additional elements (i.e. the accelerometer and the structural components of the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, 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); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, 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.
Dependent claims 2-13 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 14 and 15, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. (e.g. the recitation of the accelerometer of claims 2-6 and data training of claims 4-6), and/or generally link the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 2-13), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 8 and 10-15 is/are rejected under 35 U.S.C. 102(a)(1 and/or 2) as being anticipated or clearly anticipated by Lipsmeier et al. (U.S. PG-Pub 2022/0346699 A1).
As per claim 1, 14 and 15, Lipsmeier discloses a computer program product, comprising a non-transitory tangible computer readable medium having computer readable program code embodied therein, a method and a computerized healthcare system providing healthcare remotely to end-users (Lipsmeier, Figs. 1 and 2B.), the system comprising at least one instance of:
an interface uploading IMU data recorded by a healthcare-providing organization O's end users' communication devices' accelerometers (Lipsmeier, paragraphs 63 and 65, system collects passive data of patient from various devices, which is then uploaded to a server.); and
a hardware processor which maps indications derived from the IMU data to care actions, where said care actions comprise at least one allocation of at least one organizational resource from among a set of available organizational resources which the organization allocates to its end-users or patients or members, thereby to reliably and efficiently allocate available organizational resources to at least one organization's patients (System calculates threshold value, patient movement and performance scores for the patient, and determines a treatment strategy to apply based thereon, see paragraphs 66-69. It is the Office’s position that applying an organization applying any treatment would by applying an organizational resource from a set of available resources.).
A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see MPEP 2114 (II) and Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). “Language that suggest or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2111.04.
The following limitation is interpreted as an intended use of the claimed invention: thereby to reliably and efficiently allocate available organizational resources to at least one organization's patients.
The prior art is capable of performing the intended use recitation, therefore the prior art meets the limitations.
As per claims 2, 3, 7, 8 and 10-13, Lipsmeier discloses claim 1, discussed above. Lipsmeier also discloses:
2. wherein the processor is configured to predict externally generated scores from raw data recorded by the accelerometers (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.);
3. wherein the processor comprises a biomarker or indication that estimates indexes directly from IMU data recorded by the accelerometers (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.);
7. wherein the externally generated scores comprise scores indicative of a motor disease such as but not limited to, multiple sclerosis or Parkinson's or malfunction of lower extremities (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.);
8. wherein the externally generated scores comprise at least one of: UPDRS scores PDQ scores EDSS scores generated by a human clinician such as a neurologist PDDS scores derived from a PDDS patient questionnaire LEFS scores derived from an LEFS patient questionnaire EQ-5D scores SF-36 or SF-12 scores (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.).
10. wherein recording of IMU data is unobtrusive and/or frequent and/or continuous and/or does not require activation and/or passive (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.);
11. wherein said indications comprise characterizations of extent of motion during time-interval/s, to identify time-windows in which an end-user was immobile, or less mobile, and which are unexpectedly or uncharacteristically long (System collects mobility data over time using passive devices, see paragraphs 10, 12, 74, 77 and 78.); and
13. wherein at least one indication from among the indications derived from patient P's IMU data comprises a putative new diagnosis for patient P, such as a possible new stroke or possible new fall or possible new bout of influenza or possible new fracture (System creates a new diagnosis of severity of a Parkinson’s diagnosis, see paragraph 48.).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being obvious over Lipsmeier further in view of Becich et al. (U.S. PG-Pub 2023/0266342 A1), hereinafter Becich.
As per claims 4-6, Lipsmeier discloses claim 1, discussed above. Lipsmeier also discloses:
4. wherein the processor comprises process to predict the externally generated scores from the raw data recorded by the accelerometers (Lipsmeier discloses that passive movement data collected via smartphone was predictive of various health scores, such as PDQ-39 and UPDRS scores, see paragraphs 77, 84 and 87.);
5. wherein the externally generated scores comprise at least one score generated by at least one human clinician (PDQ-39 is derived from patient questionnaires, see Lipsmeier paragraphs 75-76.); and
6. wherein the externally generated scores comprise at least one score derived from a patient questionnaire (PDQ-39 is derived from patient questionnaires, see Lipsmeier paragraphs 75-76.) , and … scores derived from a patient questionnaire filled out by at least one individual, paired with raw data recorded from the at least one individual by the accelerometers (Lipsmeier discloses patient questionnaires, see paragraphs 70-72 and 74-76.).
Lipsmeier fails to explicitly disclose:
4. at least one classifier trained to predict scores;
5. classifier is trained using, for training data, scores generated by at least one human clinician for at least one individual, paired with raw data recorded from the at least one individual by the accelerometers; and
6. the classifier is trained using, for training data, scores.
Becich teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
4. at least one classifier trained to predict scores (Becich, paragraphs 101-114.);
5. classifier is trained using, for training data, scores generated by at least one human clinician for at least one individual, paired with raw data recorded from the at least one individual by the accelerometers (Becich, paragraphs 101-114; the Office notes that EDSS scores are generated by a human clinician, as evidenced by Applicant’s claims.); and
6. the classifier is trained using, for training data, scores (Becich, paragraphs 101-114.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the improvement in personal healthcare for patients of Lipsmeier to include a classifier trained to predict scores, including scores generated by a clinician, as taught by Becich, in order to generate an improvement in personal healthcare for patients that provided more accurate results via training models based on historic patient data. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Lipsmeier and Becich are directed to the electronic processing of patient healthcare data and specifically to diagnosis improvement.
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over Lipsmeier further in view of Fuh et al. (U.S. PG-Pub 2018/0268927 A1), hereinafter Fuh.
As per claim 9, Lipsmeier discloses claim 1, discussed above. Lipsmeier fails to disclose but Fuh discloses which includes plural instances of the interface (e.g. plural secure data channels) and/or of the processor, for plural healthcare providing organizations O1, . . . ON respectively, and wherein said organizational resources, which at least one organization Oj allocates to its end-users or patients or members, includes referrals to outside organizations, other than organization Oj, which typically perform care actions not performed within the organization Oj (Fuh, Fig. 2.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the improvement in personal healthcare for patients of Lipsmeier to include cloud processing across multiple organizations, as taught by Wirth, in order to generate an improvement in personal healthcare for patients that operated across a plurality of organizations thereby providing improved healthcare to a larger patient population. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Lipsmeier and Fuh are directed to the electronic processing of patient healthcare data and specifically to diagnosis improvement.
Claim 12 is rejected under 35 U.S.C. 103 as being obvious over Lipsmeier further in view of Wirth et al. (U.S. PG-Pub 2023/0207127 A1), hereinafter Wirth.
As per claim 12, Lipsmeier discloses claim 2, discussed above. Lipsmeier fails to disclose but Wirth discloses wherein the externally generated scores comprise scores indicative of a respiratory disease such as but not limited to asthma or chronic obstructive pulmonary disease (COPD) (Wirth, paragraphs 17, 26 and 96.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the improvement in personal healthcare for patients of Lipsmeier to include other externally generated scores, as taught by Wirth, in order to generate an improvement in personal healthcare for patients that provided more accurate results for a variety of conditions. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Lipsmeier and Wirth are directed to the electronic processing of patient healthcare data and specifically to diagnosis improvement.
Conclusion
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
5 February 2026