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 .
Information Disclosure Statement
The Information Disclosure Statements filed 07/12/2023 and 02/06/2025 have been considered by the Examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 8: “information. providing” should be changed to “information; providing”. Please change period to semicolon.
Claim 4 objected to because of the following informalities:
Line 3: “at least one instructions” should be changed to “at least one instruction”.
Claim 20 objected to because of the following informalities:
Lines 4-5: “one or more first modules selected from the group consisting of” is repeated twice. Please delete one of the instances of this phrase.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“vagal nerve stimulation module … for reduc[ing] inflammation in the joint of the subject and/or increase[ing] the production of anti-inflammatory factors in the joint” in claim 3.
“joint exercise module … for reduc[ing] inflammation in the joint of the subject ” in claim 5.
“adiponectin secretion module … for increase[ing] a secretion of adiponectin from adipose tissue” in claim 8.
“joint exercise module induces normalization of the balance between (i) sympathetic innervation on the synovial membrane, (ii) sensory innervation on the synovial membrane, and (iii) Oncostatin M production” in claim 15.
“one or more first modules for preventing or ameliorating arthritis in a joint of the subject” in claim 18.
“a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more tasks to prescribe treatment for preventing or ameliorating arthritis in a joint of the subject” in claim 18.
“an administrative portal configured to provide one or more options to an administrator of the system to perform one or more tasks to manage access to the system by the healthcare provider”. In claim 18.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification:
Figs. 17A-L; Par. [0020]; Par. [0103]
Figs. 14A-E; Par. [0017]; Par. [0108]
Par. [0104-0106]
Par. [0041]; Par. [0108]
Figs. 5, 14A-E, 17A-L; Par. [0103-0108]
Figs. 11 and 19-20; Par. [0014]; Par. [0022-0023]; Par. [0132-0138]
Figs. 11 and 21-22; Par. [0024-0025]; Par. [0114]; Par. [0141-0146]
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 16 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. The limitation of claim 16 “administering to the subject one or more drugs for preventing or ameliorating arthritis, wherein the one or more drugs are administered to the subject in an amount and/or frequency that is less than an amount and/or frequency prescribed to an average arthritis patient” is not found to have support in the Applicant’s specification. The Applicant’s specification simply re-iterates this claim limitation verbatim (Par. [0180-0181]). The Examiner questions what drugs are administered and what amount/frequency was recommended to be prescribed. The Applicant’s specification does not answer either of these questions. The Examiner also questions what determination (if any) in claim 1 (from which claim 16 depends) leads to this administration of drugs. There is also no answer to this question in the Applicant’s specification. The Examiner also questions how the drugs are administered. Are the drugs given through injection, liquid medicine, pills, or some other method? There is also no answer to this question in the Applicant’s specification. Therefore, claim 16 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 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 limitation “an adiponectin secretion module”, “a vagal nerve stimulation module”, and “a joint exercise module” in line 10, whereas an adiponectin secretion module, a vagal nerve stimulation module, and a joint exercise module were already introduced in claim 1 (lines 3-4). It is unclear whether the Applicant intended to claim the same or a different adiponectin secretion module, vagal nerve stimulation module, and joint exercise module. Consider changing to “the adiponectin secretion module”, “the vagal nerve stimulation module”, and “the joint exercise module”.
The limitation “one or more first modules” renders claim 1 (line 11) indefinite. It is unclear whether the Applicant intended to recite “first modules” here since “second modules” appeared to be the subject of this particular limitation, since second modules were introduced immediately before in the claim.
Claim 3 recites the limitation "the production of anti-inflammatory factors" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The limitation “external reviewer” renders claim 10 (line 2) indefinite. It is unclear what an external reviewer is. Is this a person or doctor? The Applicant’s specification appears to give multiple meanings for this term (Par. [0112] of Specification) and so it is unclear how to interpret this term in order to determine the scope of this claim.
Claim 12 recites the limitation “a camera” in line 2, whereas a camera was already introduced in a claim that claim 12 depends from (claim 11). It is unclear whether the Applicant intended to claim the same or a different camera. Consider changing to “the camera”.
Claim 15 recites the limitation "the balance" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the synovial membrane" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “arthritis” in line 2, whereas arthritis was already introduced in a claim that claim 16 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different arthritis. Consider changing to “the arthritis”.
The term “an amount and/or frequency prescribed to an average arthritis patient” in claim 16 is a relative term which renders the claim indefinite. The term “an amount and/or frequency prescribed to an average arthritis patient” is 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. Because of this relative term, the limitation of using an amount and/or frequency that is less than this value is also rendered indefinite.
Claim 17 recites the limitation “arthritis” in line 2, whereas arthritis was already introduced in a claim that claim 17 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different arthritis. Consider changing to “the arthritis”.
Claim 18 recites the limitation “arthritis” in lines 3 and 7, whereas arthritis was already introduced in claim 18 (line 1). It is unclear whether the Applicant intended to claim the same or a different arthritis. Consider changing to “the arthritis”.
Claim 18 recites the limitation “joint” in lines 3 and 7, whereas a joint was already introduced in claim 18 (line 1). It is unclear whether the Applicant intended to claim the same or a different joint. Consider changing to “the joint”.
*All other claims are rejected due to their dependency on a rejected claim.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of providing instructions to a subject, collecting information, and outputting second instructions based on the collected information) without significantly more.
Step 1
Independent claims 1, 18, 19, and 20 are directed to a method, system, computing system, and non-transitory computer readable medium, and thus meet the requirements for step 1.
Step 2A, Prong 1
Regarding claims 1, 18, 19, and 20, the following steps recite an abstract idea:
“providing … one or more first modules … comprising one or more first instructions for the subject to follow” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make judgements and/or offer opinions regarding instructions to provide a subject in order to prevent or ameliorate arthritis in a joint of the subject.
“providing … one or more second modules … comprising one or more second instructions” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make judgements and/or offer opinions regarding instructions to provide a subject in order to prevent or ameliorate arthritis in a joint of the subject based on the adherence information.
“provid[ing] one or more options to a healthcare provider to perform one or more tasks to prescribe treatment for preventing or ameliorating arthritis in a joint of the subject based on information” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human can determine (i.e., evaluate/make judgements) options for prescribing treatment for a subject based on information.
“provid[ing] one or more options to an administrator of the system to perform one or more tasks to manage access to the system by the healthcare provider” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human can determine (i.e., evaluate/make judgements) options for performing tasks to manage access to a system.
Step 2A – Prong 2
Regarding claims 1, 18, 19, and 20, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
“a sensor” is recited at a high level of generality. Par. [0113] explains that the sensor comprises one or more of: a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a Global Positioning System (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, a touch sensor, and a thermometer. The sensor’s involvement is insignificant extra-solution activity in that the sensor is merely used to gather and collect data [MPEP 2106.05(g)].
“an electronic device”, “a vagal nerve stimulation module”, “a joint exercise module”, “an adiponectin secretion module”, “a server”, “a digital apparatus”, “a digital application”, “a healthcare provider portal”, “an administrative portal”, “a display”, “a transmitter”, “a receiver”, and “a processor” are recited at a high level of generality. The electronic device/digital apparatus is explained to include a CPU, a memory, an input/output I/F, and a communication I/F (Fig. 10 and Par. [0083]). The one or more modules (i.e., including the vagal nerve stimulation, joint exercise, and adiponectin secretion modules) are generally described as digital therapeutics modules (see at least Par. [0039-0040] and [0074]). The server is described as one of various apparatuses capable of supporting wired or wireless communication (Par. [0088]). A digital application is described as an application or an ‘app’ (Par. [0014] and [0114]). A healthcare provider portal is described as a doctor’s web and an administrative portal is described as an administrator’s web (Par. [0014] and [0114]). The display is described as an electronic display (Par. [0087]). The transmitter and receiver are described as electronic components that transmit/receive information with a computing system (Par. [0093]). The processor is described as a CPU for a digital apparatus (Par. [0083-0084]). The involvement of the “electronic device”, “vagal nerve stimulation module”, “joint exercise module”, “adiponectin secretion module”, “server”, “digital apparatus”, “digital application”, “healthcare provider portal”, “administrative portal”, “display”, “transmitter”, “receiver”, and “processor” is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. The involvement of “transmitting” and “receiving” information and instructions amounts to merely gathering and outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]. The involvement of “display[ing] … one or more first modules” amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)].
Furthermore, the “sensor”, “electronic device”, “vagal nerve stimulation module”, “joint exercise module”, “adiponectin secretion module”, “server”, “digital apparatus”, “digital application”, “healthcare provider portal”, “administrative portal”, “display”, “transmitter”, “receiver”, and “processor”, along with their associated functions and components, do not add any meaningful limitation to the abstract idea when considered in combination because these elements are recited at a high level of generality and their related functions and components are merely implementing the abstract idea on a computer.
Step 2B
The additional elements of claims 1, 18, 19, and 20, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “sensor”, “electronic device”, “vagal nerve stimulation module”, “joint exercise module”, “adiponectin secretion module”, “server”, “digital apparatus”, “digital application”, “healthcare provider portal”, “administrative portal”, “display”, “transmitter”, “receiver”, and “processor”, along with their associated functions and components, are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
“sensing, using a sensor of the electronic device, adherence by the subject” is well-understood, routine, and conventional, as evidenced by Cronin, et al. (U.S. PGPub No. 2018/0110959) at Par. [0053] (“Some embodiments are based on understanding that the memory of the wearable device can store multiple sleep aid techniques associated with different instructions, different doze-off times, and different sensors that can check if the user follows the instructions”).
Additionally, “transmit[ting] adherence information” and “receiv[ing] one or more second instructions” is receiving and transmitting data, a well-understood, routine, and conventional computer activity [MPEP 2106.05(d)(II) Symantec]. Also, the involvement of the “server”, the “electronic device”, and the “digital apparatus” includes is receiving and transmitting data, a well-understood, routine, and conventional computer activity [MPEP 2106.05(d)(II) Symantec].
Additionally, the involvement of the “processor”, “digital application”, “healthcare provider portal”, and “administrative portal” which stores software instructions is storing and retrieving information in memory, a well-understood, routine, and conventional computer activity [MPEP 2106.05(d)(II) Versata Dev. Group, Inc.].
The “vagal nerve stimulation module”, “joint exercise module”, and “adiponectin secretion module” are considered digital therapeutic modules comprising instructions and associated effects (see Par. [0040] of instant specification). The involvement of digital therapeutics is well-understood, routine, and conventional, as evidenced by Jain, et al. (U.S. PGPub No. 2019/0243944) at Par. [0004] (“One of the advantages of the system is the ability to use a common set of digital therapeutics programs to provide unique, adaptive, personalized interventions for a wide variety of users”).
The involvement of the “display” is well-understood, routine, and conventional, as evidenced by Shum (U.S. PGPub No. 2007/0021269) at the Abstract (“… an electronic device, including conventional electronic display devices that are known and commercially available (e.g., cellular telephones, PDAs, pagers, beepers, MP3 or other audio players, radios, portable televisions, portable DVD players, other video playing devices, watches, etc.”).
In this case, well-known elements of a general computer system and well-known elements for data collection/analysis/outputting are used to implement the abstract idea. Also, generally linking the use of the judicial exception to the field of arthritis prevention/treatment is not indicative of an inventive concept [MPEP 2106.05(h)].
Dependent claims
Regarding dependent claims 2, 6, the limitations only further generally link the use of the judicial exception to the field of arthritis prevention/treatment.
Regarding dependent claims 11-13, the limitations only further define insignificant extra-solution activity of gathering data.
Regarding dependent claims 3-5, 7-9, 14-17, the limitations only further define the abstract idea.
Regarding dependent claims 10, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Therefore, claims 1-20 are unpatentable under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-7, 10-15, and 17-20 are rejected under 35 U.S.C. 102(A)(1) and 102(A)(2) as being anticipated by House, et al. (U.S. Patent No. 10,327,939 – cited on IDS).
Regarding claim 1, House teaches a method of preventing or ameliorating arthritis in a joint of a subject (Abstract; Col. 1, lines 12-14 – method for administering therapy to restore limb motion to patients in need. One of ordinary skill in the art would recognize that such therapy would help prevent or ameliorate arthritis in a subject), the method comprising: (Fig. 1, # 104 – patient computing device; Fig. 5, # 502 – exercise administration module) providing, by an electronic device to the subject, one or more first modules selected from the group consisting of a vagal nerve stimulation module, a joint exercise module, and an adiponectin secretion module, each of the one or more first modules comprising one or more first instructions for the subject to follow (Col. 4, lines 20-29; Col. 8, lines 36-62 – Fig. 5 illustrates the modules of the physical therapy administration application; Col. 8, line 63-Col. 9, line 14 – exercise administration module); sensing, (Figs. 1-3, # 106 – server, # 104 – patient computing device; 128 – patient motion capture device, i.e. sensor) using a sensor of the electronic device, adherence by the subject to the first instructions of the one or more first modules, wherein the electronic device transmits adherence information, based on the adherence, to a server (Col. 4, lines 20-29 – the server 106 is configured to receive data and/or communications from, and/or transmit data and/or communications to the therapist computing device 102 and the patient computing device 104 via the communication network; Col. 5, line 62-Col. 6, line 8; Col. 6, lines 43-59; Col. 12, lines 26-48 – the exercise module 516 may further capture the motion of one or more limb landmarks of the patient during an exercise using the patient motion capture device 128 and may compare each movement of a patient’s limb landmark, such as an elbow, to the target movements of the corresponding limb landmark), and (Fig. 5, # 130, 508, 514, 516, and 518; Figs. 9A-B; Fig. 22, # 2318, 2320) receives one or more second instructions from the server based on the adherence information. providing, by the electronic device to the subject, one or more second modules selected from the group consisting of an adiponectin secretion module, a vagal nerve stimulation module, and a joint exercise module, each of the one or more first modules comprising one or more second instructions (Col. 10, lines 42-58 – The patient monitoring module 508 enables the therapist to review a patient’s response to a physical therapy session such as the patient’s limb motion compared to the desired limb motion. The patient monitoring module 518 enables the therapist to enter recommendations for subsequent physical therapy sessions; Col. 11, line 58-Col. 12, line 24; Col. 21, lines 56-64).
Therefore, claim 1 is unpatentable over House, et al.
Regarding claim 2, House teaches the method of claim 1, wherein the arthritis is selected from the group consisting of osteoarthritis, rheumatoid arthritis, juvenile arthritis, spondyloarthropathy, lupus erythematosus, gout, infectious arthritis, reactive arthritis, psoriatic arthritis, fibromyalgia, and scleroderma (Abstract; Col. 1, lines 12-14 – House’s method for administering therapy to restore limb motion would be understood by one of ordinary skill in the art to ameliorate types of arthritis. For instance, osteoarthritis can cause pain and stiffness in the hip and knee, for which therapy to restore limb motion would be able to ameliorate arthritis).
Therefore, claim 2 is unpatentable over House, et al.
Regarding claim 3, House teaches the method of claim 1, wherein (Fig. 6) the one or more first modules comprise the vagal nerve stimulation module, and the vagal nerve stimulation module comprises one or more first instructions to reduce inflammation in the joint of the subject and/or increase the production of anti-inflammatory factors in the joint (Col. 5, line 62-Col. 6, line 8 – visual and auditory cues that provides feedback to help the patient achieve desired limb motion (which will reduce inflammation in the joint); Col. 9, lines 6-14; Col. 12, lines 41-48).
Therefore, claim 3 is unpatentable over House, et al.
Regarding claim 4, House teaches the method of claim 1, wherein the one or more first modules comprise the vagal nerve stimulation module, and the vagal nerve stimulation module comprises at least one instructions selected from the group consisting of sense stimulation instructions for sight, sound, touch, taste, and smell (Col. 5, line 62-Col. 6, line 8 – visual and auditory cues; Col. 12, lines 41-48).
Therefore, claim 4 is unpatentable over House, et al.
Regarding claim 5, House teaches the method of claim 1, wherein (Fig. 5, # 502 and 516) the one or more first modules comprise the joint exercise module, and the joint exercise module comprises one or more first instructions to reduce inflammation in the joint of the subject (Col. 8, line 64-Col. 9, line 14; Col. 12, lines 25-48).
Therefore, claim 5 is unpatentable over House, et al.
Regarding claim 6, House teaches the method of claim 1, wherein the joint of the subject is selected from the group consisting of a shoulder joint, an elbow joint, a sacroiliac joint, a hip joint, a knee joint, a joint of the wrist or hand, a joint of the ankle or foot, a neck joint, and an intervertebral joint (Col. 12, lines 25-48).
Therefore, claim 6 is unpatentable over House, et al.
Regarding claim 7, House teaches the method of claim 5, wherein (Figs. 5-6) the joint exercise comprises one or more of walking, running, stretching, and bending the joint at a predetermined angle and/or speed (Col. 8, line 64-Col. 9 – flexing/bending elbow; Col. 12, lines 25-48).
Therefore, claim 7 is unpatentable over House, et al.
Regarding claim 10, House teaches the method of claim 1, wherein the server receives the one or more second instructions from an external reviewer (Col. 10, lines 43-58 – recommendations for subsequent physical therapy sessions following patient monitoring by the therapist (i.e., external reviewer)).
Therefore, claim 10 is unpatentable over House, et al.
Regarding claim 11, House teaches the method of claim 1, wherein (Fig. 3, # 128) the sensor comprises one or more selected from the group consisting of a camera, an accelerometer, a magnetometer, a light sensor, a microphone, a proximity sensor, a touch sensor, a gyroscope, a Global Positioning System (GPS) sensor, an ambient light sensor, a fingerprint sensor, a pedometer, a heart rate sensor, and a thermometer (Col. 6, lines 43-59 – video cameras).
Therefore, claim 11 is unpatentable over House, et al.
Regarding claim 12, House teaches the method of claim 11, wherein (Figs. 5-6) the sensor comprises a camera, and wherein the electronic device is configured to detect an angle at which the subject is bending the joint (Col. 6, lines 43-59 – video cameras; Col. 8, line 64-Col. 9, line 14 – therapist records and the exercise requires maintaining an angle of the upper arm at the shoulder).
Therefore, claim 12 is unpatentable over House, et al.
Regarding claim 13, The method of claim 12, wherein (Fig. 5, # 512) the adherence information comprises one or both of the angle at which the subject is bending the joint, and a difference between the angle at which the subject is bending the joint and a predetermined angle at which the subject is instructed to bend the joint (Col. 11, lines 29-57 – a graph of the difference in limb angles of the patient relative to the limb angles during the target limb trajectory).
Therefore, claim 13 is unpatentable over House, et al.
Regarding claim 14, House teaches the method of claim 13, wherein, if the difference between the angle at which the subject is bending the joint and the predetermined angle at which the subject is instructed to bend the joint is greater than a predetermined threshold, the method further comprises providing to the subject one or more additional instructions to adjust the angle at which the subject is bending the joint until the difference is less than or equal to the predetermined threshold (Col. 5, line 62-Col. 6, line 8 – visual and/or auditory cue to provide guidance to the patient with respect to desired limb motion; Col. 6, lines 24-42).
Therefore, claim 14 is unpatentable over House, et al.
Regarding claim 15, House teaches the method of claim 5, wherein (Fig. 5, # 135, 502, and 516) the joint exercise module induces normalization of the balance between (i) sympathetic innervation on the synovial membrane, (ii) sensory innervation on the synovial membrane, and (iii) Oncostatin M production (Col. 8, line 64-Col.9, line 14 – the exercise modules in House would necessarily have this same effect of inducing normalization between these three factors by recommending exercise).
Therefore, claim 15 is unpatentable over House, et al.
Regarding claim 17, House teaches the method of claim 1, wherein the method is performed without administering one or more drugs for preventing or ameliorating arthritis to the subject (Abstract; Col. 1, lines 12-14 – House teaches administering therapy and not drugs/medicine).
Therefore, claim 17 is unpatentable over House, et al.
Regarding claim 18, House teaches a system for preventing or ameliorating arthritis in a joint of a subject (Abstract; Col. 1, lines 12-14 – system for administering therapy to restore limb motion to patients in need. One of ordinary skill in the art would recognize that such therapy would help prevent or ameliorate arthritis in a subject), comprising: (Figs. 1-3, # 114 and 124 – patient and therapist applications) a digital apparatus configured to execute a digital application comprising one or more first modules for preventing or ameliorating arthritis in a joint of the subject (Col. 4, lines 20-29; Col. 5, lines 47-61; Col. 8, lines 36-62 – Fig. 5 illustrates the modules of the physical therapy administration application; Col. 8, line 63-Col. 9, line 14 – exercise administration module), wherein (Figs. 1-3, # 106 – server, # 104 – patient computing device; 128 – patient motion capture device, i.e. sensor) the digital apparatus comprises a sensor for sensing adherence by the subject to a first set of instructions of the one or more first modules (Col. 4, lines 20-29 – the server 106 is configured to receive data and/or communications from, and/or transmit data and/or communications to the therapist computing device 102 and the patient computing device 104 via the communication network; Col. 5, line 62-Col. 6, line 8; Col. 6, lines 43-59; Col. 12, lines 26-48 – the exercise module 516 may further capture the motion of one or more limb landmarks of the patient during an exercise using the patient motion capture device 128 and may compare each movement of a patient’s limb landmark, such as an elbow, to the target movements of the corresponding limb landmark); (Fig. 1, # 102 – therapist computing device, i.e. healthcare provider portal) a healthcare provider portal configured to provide one or more options to a healthcare provider to perform one or more tasks to prescribe treatment for preventing or ameliorating arthritis in a joint of the subject based on information received from the digital application (Col. 7, lines 51-Col. 8, line 4); and (Fig. 1, # 106 – server computing device, i.e. administrative portal, 130) an administrative portal configured to provide one or more options to an administrator of the system to perform one or more tasks to manage access to the system by the healthcare provider (Col. 6, line 60-Col. 7, line 19).
Therefore, claim 18 is unpatentable over House, et al.
Regarding claim 19, House teaches (Fig. 1) a computing system for preventing or ameliorating arthritis in a joint of a subject in need thereof (Abstract; Col. 1, lines 12-14 – device for administering therapy to restore limb motion to patients in need. One of ordinary skill in the art would recognize that such therapy would help prevent or ameliorate arthritis in a subject; Col. 7, lines 20-40), comprising: (Fig. 1, # 104, 110, 120; Fig. 5, # 502 – exercise administration module) a display configured to provide, to the subject, one or more first modules selected from the group consisting of a vagal nerve stimulation module, a joint exercise module, and an adiponectin secretion module, each of the one or more first modules comprising one or more first instructions for the subject to follow (Col. 4, lines 20-29; Col. 8, lines 15-62 – display 110/120; Fig. 5 illustrates the modules of the physical therapy administration application; Col. 8, line 63-Col. 9, line 14 – exercise administration module); (Figs. 1-3, # 106 – server, # 104 – patient computing device; 128 – patient motion capture device, i.e. sensor) a sensor configured to sense adherence by the subject to the instructions of the one or more first modules (Col. 4, lines 20-29 – the server 106 is configured to receive data and/or communications from, and/or transmit data and/or communications to the therapist computing device 102 and the patient computing device 104 via the communication network; Col. 5, line 62-Col. 6, line 8; Col. 6, lines 43-59; Col. 12, lines 26-48 – the exercise module 516 may further capture the motion of one or more limb landmarks of the patient during an exercise using the patient motion capture device 128 and may compare each movement of a patient’s limb landmark, such as an elbow, to the target movements of the corresponding limb landmark); (Fig. 5, # 130, 508, 514, 516, and 518; Figs. 9A-B; Fig. 22, # 2318, 2320) a transmitter configured to transmit adherence information, based on the adherence, to a server; and a receiver configured to receive, from the server, one or more second instructions based on the adherence information (Col. 4, lines 20-29; Col. 10, lines 42-58 – The patient monitoring module 508 enables the therapist to review a patient’s response to a physical therapy session such as the patient’s limb motion compared to the desired limb motion. The patient monitoring module 518 enables the therapist to enter recommendations for subsequent physical therapy sessions; Col. 11, line 58-Col. 12, line 24; Col. 21, lines 56-64).
Therefore, claim 19 is unpatentable over House, et al.
Regarding claim 20, House teaches (Fig. 1) a non-transitory computer readable medium having stored thereon software instructions for preventing or ameliorating arthritis in a joint of a subject in need thereof (Abstract; Col. 1, lines 12-14 – device for administering therapy to restore limb motion to patients in need. One of ordinary skill in the art would recognize that such therapy would help prevent or ameliorate arthritis in a subject; Col. 7, lines 20-40) that, when executed by a processor (Col. 4, lines 20-29), cause the processor to: (Fig. 1, # 104, 110, 120; Fig. 5, # 502 – exercise administration module) display, by an electronic device to the subject, one or more first modules selected from the group consisting of one or more first modules selected from the group consisting of a vagal nerve stimulation module, a joint exercise module, and an adiponectin secretion module, each of the one or more first modules comprising one or more first instructions for the subject to follow (Col. 4, lines 20-29; Col. 8, lines 15-62 – display 110/120; Fig. 5 illustrates the modules of the physical therapy administration application; Col. 8, line 63-Col. 9, line 14 – exercise administration module); (Figs. 1-3, # 106 – server, # 104 – patient computing device; 128 – patient motion capture device, i.e. sensor) sense, by a sensor in the electronic device, adherence by the subject to the instructions of the one or more first modules (Col. 4, lines 20-29 – the server 106 is configured to receive data and/or communications from, and/or transmit data and/or communications to the therapist computing device 102 and the patient computing device 104 via the communication network; Col. 5, line 62-Col. 6, line 8; Col. 6, lines 43-59; Col. 12, lines 26-48 – the exercise module 516 may further capture the motion of one or more limb landmarks of the patient during an exercise using the patient motion capture device 128 and may compare each movement of a patient’s limb landmark, such as an elbow, to the target movements of the corresponding limb landmark); (Fig. 5, # 130, 508, 514, 516, and 518; Figs. 9A-B; Fig. 22, # 2318, 2320) transmit, by the electronic device, adherence information, based on the adherence, to a server; and receive, from the server, one or more second instructions based on the adherence information (Col. 4, lines 20-29; Col. 10, lines 42-58 – The patient monitoring module 508 enables the therapist to review a patient’s response to a physical therapy session such as the patient’s limb motion compared to the desired limb motion. The patient monitoring module 518 enables the therapist to enter recommendations for subsequent physical therapy sessions; Col. 11, line 58-Col. 12, line 24; Col. 21, lines 56-64).
Therefore, claim 20 is unpatentable over House, et al.
Claim Rejections - 35 USC § 103
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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over House, et al. (U.S. Patent No. 10,327,939 – cited on IDS) in view of Jain, et al. (U.S. PGPub No. 2019/0243944).
Regarding claim 8, House teaches the method of claim 1, as indicated hereinabove. House does not explicitly teach the limitation of instant claim 8, that is wherein the one or more first modules comprise the adiponectin secretion module, and the adiponectin secretion module comprises one or more first instructions to increase a secretion of adiponectin from adipose tissue.
Jain, directed to analogous art, teaches systems and methods for providing dynamic, individualized digital therapeutics for cancer prevention, detection, treatment, and survivorship (Title, Abstract). Jain also teaches the limitation of instant claim 8, that is wherein (Fig. 2) the one or more first modules comprise the adiponectin secretion module, and the adiponectin secretion module comprises one or more first instructions to increase a secretion of adiponectin from adipose tissue (Par. [0012] – pain or anxiety may be helped in some cases by walking, because walking may indirectly stimulate the immune system, change the environment of the patient, and affect other factors that eventually relieve the symptoms – it is noted that one of ordinary skill in the art would understand that walking results in adiponectin secretion; Par. [0053] – a program for physical activity may set a goal of a number of steps per day for the user to walk; Par. [0087]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Jain’s individualized model of recommending walking into House’s method, because doing so would be an example of using a known technique to improve similar methods in the same way. One of ordinary skill in the art would have desired implementing walking as an exercise in House’s exercise module because doing so would help improve patient’s pain or anxiety and stimulate the immune system (see Par. [0012] of Jain).
Therefore, claim 8 is unpatentable over House, et al. and Jain, et al.
Regarding claim 9, House, in view of Jain, renders obvious the method of claim 8, as indicated hereinabove. Jain also teaches the limitation of instant claim 9, that is wherein the one or more first instructions to increase the secretion of adiponectin from adipose tissue are selected from the group consisting of walking, biking, aerobic dance, and swimming (Par. [0012] and [0053] – walking).
Therefore, claim 9 is unpatentable over House, et al. and Jain, et al.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over House, et al. (U.S. Patent No. 10,327,939 – cited on IDS) in view of Alataris, et al. (U.S. PGPub No. 2020/0261722 – cited on IDS).
Regarding claim 16, House teaches the method of claim 1, as indicated hereinabove. House does not explicitly teach the limitation of instant claim 16, that is wherein the method is further comprising administering to the subject one or more drugs for preventing or ameliorating arthritis, wherein the one or more drugs are administered to the subject in an amount and/or frequency that is less than an amount and/or frequency prescribed to an average arthritis patient.
Alataris, directed to analogous art, teaches peripheral nerve stimulation to achieve therapeutic effects (Title, Abstract). Alataris also teaches the limitation of instant claim 16, that is wherein the method is further comprising administering to the subject one or more drugs for preventing or ameliorating arthritis, wherein the one or more drugs are administered to the subject in an amount and/or frequency that is less than an amount and/or frequency prescribed to an average arthritis patient (Par. [0032] – the present disclosure contemplates a method of treating rheumatoid arthritis in a human subject, comprising the steps of … administering an effective amount of a pharmaceutical such as a nonsteroidal anti-inflammatory drug (NSAID)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Alataris’ method of administering an effective amount of NSAID for ameliorating arthritis, because doing so would be an example of using a known te