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 .
Status of the Application
This communication is in response to application filed on January 5, 2024.
Claims 1-6 are pending and presented for examination on the merits.
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.
Claim Rejections - 35 USC § 112
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 1-6 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
In claim 1, the limitations “receiving, by a digital therapy solution generator, digital therapy solution data” and “generating, by the digital therapy solution generator, a digital therapy solution based on the digital therapy solution data” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed functions and to clearly link the structure, material, or acts to the functions; i.e., receiving digital therapy solution data; and generating a digital therapy solution based on the digital therapy solution data.
MPEP 2181 II. B. recites in relevant part
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, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) ("[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’") (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
Regarding the limitations identified above, although the present disclosure recites “hardware” in paragraph [0026] (“The digital therapy module library 100, the digital therapy solution generator 120, and the digital therapy solution tester 140 may be individual hardware devices or an integrated hardware device.”), neither the Drawings, Specification or original claims disclose the hardware being programmed with an algorithm for performing the claimed functions.
Please note that the requirement for the disclosure of an algorithm cannot be avoided if it is argued that one of ordinary skill in the art is capable of writing the software to convert a general purpose computer to a special purpose computer to perform the claimed function. (Blackboard, 574 F.3d at 1385, 91 USPQ2d at 1492 (explaining that "[t]he fact that an ordinarily skilled artisan might be able to design a program to create an access control list based on the system users’ predetermined roles goes to enablement[,]" whereas "[t]he question before us is whether the specification contains a sufficiently precise description of the ‘corresponding structure’ to satisfy [pre-AIA ] section 112, paragraph 6, not whether a person of skill in the art could devise some means to carry out the recited function") MPEP 2181 II. B.). Thus, the specification does not provide sufficient details such that one of ordinary skill in the art would understand which structure or structures perform(s) the claimed functions.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-3 depend from claim 1 and do not cure the deficiencies above. Claims 4-5 recite substantially similar language as claims 1-3 are rejected for the same reasons above.
Therefore, claims 1-6 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
Claim 1 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As described above, the disclosure does not provide adequate structure to perform the following claimed functions: receiving digital therapy solution data; and generating a digital therapy solution based on the digital therapy solution data. The specification does not demonstrate that applicant has made an invention that achieves the claimed functions because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Please note that the requirement for the disclosure of an algorithm cannot be avoided if it is argued that one of ordinary skill in the art is capable of writing the software to convert a general purpose computer to a special purpose computer to perform the claimed function. (Blackboard, 574 F.3d at 1385, 91 USPQ2d at 1492 (explaining that "[t]he fact that an ordinarily skilled artisan might be able to design a program to create an access control list based on the system users’ predetermined roles goes to enablement[,]" whereas "[t]he question before us is whether the specification contains a sufficiently precise description of the ‘corresponding structure’ to satisfy [pre-AIA ] section 112, paragraph 6, not whether a person of skill in the art could devise some means to carry out the recited function") MPEP 2181 II. B.). Thus, the specification does not provide sufficient details such that one of ordinary skill in the art would understand which structure or structures perform(s) the claimed functions.
Claims 2-3 depend from claim 1 and do not cure the deficiencies above.
Claims 4-5 recite substantially similar language as claims 1-3 are rejected for the same reasons above.
Therefore, claims 1-6 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter) (MPEP 2106.03).
Claim 1-3 fall within one of the four statutory classes; i.e., a process. Claims 4-6 fall within one of the four statutory classes; i.e., machine or manufacture.
Step 2A, Prong One: Evaluating whether the claim(s) recite(s) a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. (MPEP 2106.04).
Representative claim 1 recites
a method of developing a therapy solution through a modular digital therapy framework, the method comprising:
receiving, by a digital therapy solution generator, digital therapy solution data; and
generating, by the digital therapy solution generator, a digital therapy solution based on the digital therapy solution data.
The limitations of receiving digital therapy solution data; and generating a digital therapy solution based on the digital therapy solution data, as drafted, describe a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting “by a digital therapy solution generator”, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the “digital therapy solution generator” language, “receiving” and “generating” in the context of this claim encompasses a person receiving digital therapy solution data; and generating a digital therapy solution based on the digital therapy solution data (e.g., a person observing digital health data and based on it, coming up with a solution in their mind).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.1 Accordingly, the claim recites an abstract idea.
Independent claim 4 recites the same abstract idea as identified above and dependent claims 2-3 and 5-6 further narrow it.
Step 2A, Prong Two: Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and then evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. Prong Two distinguishes claims that are "directed to" the recited judicial exception from claims that are not "directed to" the recited judicial exception. (MPEP 2106.04).
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional element of digital therapy solution generator, which is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. (MPEP 2106.05(f) Mere Instructions To Apply An Exception).
Therefore, under Step 2A, Prong Two, the claims are directed to an abstract idea.
Step 2B: Identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). (MPEP 2106.05)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element listed above under Step 2A, Prong Two, amounts to no more than mere instructions to apply the exception using generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Therefore, claims 1-6 are not patent eligible.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Cox et al., (US 2022/0246289 A1, hereafter Cox).
As per claim 1, Cox titled Modular Digital Treatment System discloses a method of developing a therapy solution through a modular digital therapy framework, the method comprising:
receiving, by a digital therapy solution generator, digital therapy solution data ([Paragraph][0100] receiving, by treatment configurator, treatment package);
and generating, by the digital therapy solution generator, a digital therapy solution based on the digital therapy solution data ([0114] generating, by the treatment configurator, one or more digital therapies based on the treatment package).
As per claim 2, Cox further discloses wherein the digital therapy solution data includes data regarding a digital therapy module, a therapy algorithm, or an artificial intelligence (AI) model (Fig. 2 wherein treatment package 204 includes application configuration 218, treatment descriptor 219 and custom module 226. [0130] “each treatment package 204 comprises …an application configuration 218 and a treatment descriptor 219” [0138] “custom module 226 is a machine-learned model”).
Please note that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” (MPEP 2111.04). Although all optional elements have been addressed, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that the recitations further limit the claimed structure.
As per claim 3, Cox further discloses wherein the digital therapy solution is generated based on a combination of the digital therapy module, the therapy algorithm, or the AI model ([0114] one or more digital therapies based on the treatment package; and Fig. 2 wherein treatment package 204 includes application configuration 218, treatment descriptor 219 and custom module 226. [0130] “each treatment package 204 comprises …an application configuration 218 and a treatment descriptor 219” [0138] “custom module 226 is a machine-learned model”).
In addition, please note that claim 3 depends from claim 2 and claim 2 only requires one of: digital therapy module, a therapy algorithm, or an artificial intelligence (AI) model. As noted above, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed”. Although all three elements have been addressed in claim 3, it is only to evidence the breadth of knowledge in the art, and not as a tacit agreement that the recitations further limit the claimed structure.
Claims 4-6 recite substantially similar limitations as claims 1-3 and are rejected using the same art and rationale.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to the applicant' s disclosure.
Wall et al. (US 20210133509 A1) disclosing therapeutic modules receiving data from a plurality of sources and generating, by a digital therapy solution generator, a digital therapy solution based on the digital therapy solution data
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAJIME ROJAS whose telephone number is (571)270-5491. The examiner can normally be reached Monday - Friday 8:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAJIME ROJAS/Primary Patent Examiner, Art Unit 3682
1
Groupings of Abstract Ideas
Mathematical Concepts
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
Certain Methods Of Organizing Human Activity
fundamental economic principles or practices (including hedging, insurance, mitigating risk)
commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations)
managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)