DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the application filed 1/28/26. Claims 1-6, and 8-20 are pending.
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, and 8-20 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 11-20 are drawn to a method, and claims 1-6 and 8-10 are drawn to a system.
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-6, and 8-20 recite(s) a mental process, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance)
In particular, the claims 1 and 11 recite a method and system for:
determine that a potential interaction exists between the pharmaceutical therapeutic and the digital therapeutic with respect to the first healthcare goal based on the interaction information for the first healthcare goal; and
generate feedback to reach the first healthcare goal.
The language of claims 1 and 11 encompasses performance of the limitations(s) in the mind, but for the recitation of generic computer components.
In the instant case, the limitations of determining that a potential interaction exists between the pharmaceutical therapeutic and the digital therapeutic with respect to the first healthcare goal based on the interaction information for the first healthcare goal; and generating feedback to reach the first healthcare goal are a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind.
For example, but for the “a processor” language, “determining” and “generating“ in the context of these claims encompasses the user reviewing the received information and mentally determining how to proceed or provide feedback. 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.
As explained in MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). (emphasis added) As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978).
Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.
The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").
Moreover, courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1 and 11 further recite: receive at least one of an identification of a pharmaceutical therapeutic for reaching a first healthcare goal or an identification of a digital therapeutic for reaching the first healthcare goal from a device used by a clinician…; retrieve interaction information relating to potential for interactions for the first healthcare goal. The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. In the instant case the additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 1 and 11 recite: a central computer with a memory that stores instructions; and a processor that executes the instructions. The additional components is/are generic components performing well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “The processor 1110 may be a general-purpose processor or may be part of an application specific integrated circuit (ASIC). The processor 1110 may also be a microprocessor, a microcomputer, a processor chip, a controller, a microcontroller, a digital signal processor (DSP), a state machine, or a programmable logic device. The processor 1110 may also be a logical circuit, including a programmable gate array (PGA), such as a field programmable gate array (FPGA), or another type of circuit that includes discrete gate and/or transistor logic. The processor 1110 may be a central processing unit (CPU), a graphics processing unit (GPU), or both. Additionally, any processor described herein may include multiple processors, parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices.” (par. 136-of pgpub)
The application explains: “References to a computing device comprising “a processor” should be interpreted to include more than one processor or processing core, as in a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed among multiple computer systems. The term computing device should also be interpreted to include a collection or network of computing devices each including a processor or processors.” (see par. 137). Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 1 and claim 11:
- 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));
- 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;
.Claims 2-10 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2-6, and 8-10 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 2-6, and 8-10 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 12-20 are dependent from Claim 11 and include(s) all the limitations of claim(s) 11. However, the additional limitations of the claims 12-20 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 12-20 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is 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.
Claim(s) 1-5, 8-15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jain et al (US 20200119986 A1).
Claim 1, 11 Jain discloses a system method for optimizing therapeutical treatments, comprising:
a central computer with a memory that stores instructions (fig. 1; par. 48-50); and a processor that executes the instructions, wherein, when executed by the processor, (fig. 1; par. 48-50; par. 57) the instructions cause the system to:
receive at least one of an identification of a pharmaceutical therapeutic for reaching a first healthcare goal or an identification of a digital therapeutic for reaching the first healthcare goal; (par. 34- accessing a database of pharmaceutical data indicating cancer medications and effects of the cancer medications; storing records indicating cancer medications currently or previously used by the first user and current physiological data for the first user; evaluating applicability of the digital therapeutics programs for the first user based on the records for the first user, comprising: (i) determining current or expected effects of cancer medications currently or previously used by the first user; )
retrieve interaction information relating to potential for interactions for the first healthcare goal; (par. 34: accessing a database of pharmaceutical data indicating cancer medications and effects of the cancer medications; storing records indicating cancer medications currently or previously used by the first user and current physiological data for the first user; evaluating applicability of the digital therapeutics programs for the first user based on the records for the first user, comprising: (i) determining current or expected effects of cancer medications currently or previously used by the first user; par. )
determine that a potential interaction exists between the pharmaceutical therapeutic and the digital therapeutic with respect to the first healthcare goal based on the interaction information for the first healthcare goal; and (par. 34- (ii) determining scores indicating relationships between the determined effects and the digital therapeutics programs. Automatically varying the program states comprises varying the program states for the first user based on the scores indicating relationships between the determined effects for the first user and the digital therapeutics programs; par. 211- all effects of current medications of a user and former medications of a user can be determined. The scores in the mapping 920 are determined for each of these effects. Then, for each program, the relevance scores may be combined by weighting the values. Scores corresponding to likely effects may be weighted or discounted according to the likelihood from the medication database 910.)
generate feedback to reach the first healthcare goal. (par. 212-214- user pharmacogenomics data can also be used to identify or verify relationships between specific genetic features and effects of medications. For example, given the self-reported assessment results for pain, mood, and other characteristics, as well as activity levels detected with sensor data and confirming messages from caregivers and friends and family, the system 310 can identify correlations among specific genetic features, or combinations of genetic features, and certain effects of medications. This information may be used to update the medication database to provide scores for effect probability and intensity that are more specific for people with certain genetic profiles than for the population as a whole)
Claims 1 and 11 have been amended to further recite: receiving/ receive at least one of an identification of a pharmaceutical therapeutic or an identification of a digital therapeutic…from a device used by a clinician or a patient proposing a resolution for reaching the first healthcare goal.
Jain teaches receiving/ receive at least one of an identification of a pharmaceutical therapeutic or an identification of a digital therapeutic…from a device used by a clinician or a patient proposing a resolution for reaching the first healthcare goal. The administrator also provides information identifying a digital therapeutic and enrolls the therapeutic into a management program (par. 52-56- interactive portal 132 enables the administrator to view management plan templates 134 and select a template to use to enroll a new device, such as a machine or piece of equipment; par. 93-94: enables the administrator to…select a template to use to enroll a new device or user. par. 126- The device 420 or its user has previously been enrolled to a management plan by an administrator.) The administrator also helps provide the proposed resolution reaching a user’s healthcare goal. (par. 55- the administrator can specify an initial management plan that meets the needs identified by the device; par. 56- an administrator can view an individual device's progress and, if appropriate, adjust a device's management plan manually through the administrator interface 132. As the server system 110 adjusts the management plans based on each device's individual circumstances, different management plans will have different segments of programs, different levels of the programs, and different combinations of the programs active).
Also, regarding the language “used by a clinician or a patient proposing a resolution for reaching the first healthcare goal,” the intended use /user of a device does not distinguish the claimed device over the prior art.
claims 2, 12 Jain discloses the system/ method, wherein the instructions cause the system further to: receive both of the identification of the pharmaceutical therapeutic for the first healthcare goal and the identification of the digital therapeutic for the first healthcare goal; (par. 34-therapeutic: accessing a database of pharmaceutical data indicating cancer medications and effects of the cancer medications; par. 204- the ability for various digital therapeutics programs to interact and dynamically set their can provide improved responsiveness and efficiency of the system. Accordingly, in some implementations, the system can be used with different types of users who are not cancer patients or cancer survivors; par. 214)
determine that the potential interaction exists between the pharmaceutical therapeutic and the digital therapeutic with respect to the first healthcare goal based on the interaction information for the first healthcare goal; and generate feedback specifying the potential interaction. (par. 213-214)
claim 3, 13 Jain discloses a system/ method, wherein the instructions cause the system further to: generate a score for the potential interaction between the pharmaceutical therapeutic and the digital therapeutic in reaching the first healthcare goal; and include the score in the feedback generated to reach the first healthcare goal. (par. 162-par. 206-207- The information about effects of the medications can indicate various scores, such as a likelihood score that a person taking the medication will experience the effect or a percentage indicating what percentage of people taking the medication experience the effect. Scores indicating the severity of the effect, e.g., an average measure for those who do experience the effect, can also be indicated; feedback: with information about how devices or users have progressed with different combinations of programs and levels active, the server system 310 can assign likelihood scores indicating, for example, a probability that each level of each program is to achieve a desired result, such as reduction of a negative outcome. The same analysis may be done to determine scores for different combinations of programs and levels. These likelihood scores may be used directly by the program state setting module 453. As another example, the likelihood scores may be assessed by the server system 310 to define rules that the program state setting module 453 applies to automatically initiate changes in program states.)
Claim 4, 14 Jain discloses system/ method wherein the instructions cause the system further to: receive only the identification of the pharmaceutical therapeutic for the first healthcare goal; determine an identification of a digital therapeutic which presents optimized potential for interaction with the pharmaceutical therapeutic for the first healthcare goal; and generate feedback specifying the digital therapeutic which presents the potential interaction with the optimized potential for interaction with the pharmaceutical therapeutic for the first healthcare goal. (par. 34; par. 204; (par. 213-214)
Claim 5, 15 Jain discloses a system/ method, wherein the instructions cause the system further to: receive only the identification of the digital therapeutic for the first healthcare goal; determine an identification of a pharmaceutical therapeutic which presents optimized potential for interaction with the digital therapeutic for the first healthcare goal; and generate feedback specifying the pharmaceutical therapeutic which presents the potential interaction with the optimized potential for interaction with the digital therapeutic for the first healthcare goal. (par. 34; par. 204; (par. 213-214)
Claim 17 Jain discloses a system/ method, wherein the at least one of the identification of the pharmaceutical therapeutic or the identification of the digital therapeutic for the first healthcare goal is or are received from a device used by a clinician or a patient proposing a resolution for reaching the first healthcare goal. (par. 56- an administrator can view an individual device's progress and, if appropriate, adjust a device's management plan manually through the administrator interface 132. As the server system 110 adjusts the management plans based on each device's individual circumstances, different management plans will have different segments of programs, different levels of the programs, and different combinations of the programs active).
Claim 8, 18 Jain discloses a system/ method, wherein the instructions cause the system further to: receive information of an update to a digital therapeutic for the first healthcare goal; and update the interaction information for the first healthcare goal based on the update to the digital therapeutic for the first healthcare goal. (par. 209: From the medication records 930 and other user data, the server system 310 can learn the appropriate mappings 920 and effects of medications. For example, with the data collected and assessed by the server system 310, previously unknown side effects or benefits of certain medications or combinations of medications can be discovered. ; par. 214)
Claim 9, 19 Jain discloses a system/ method wherein the instructions cause the system further to: receive information of interactions between pharmaceutical therapeutics and digital therapeutics; and update interaction information for healthcare goals based on the information of interactions between pharmaceutical therapeutics and digital therapeutics. (par. 209: From the medication records 930 and other user data, the server system 310 can learn the appropriate mappings 920 and effects of medications. For example, with the data collected and assessed by the server system 310, previously unknown side effects or benefits of certain medications or combinations of medications can be discovered. )
Claim 10, 20 Jain discloses a system/ method,, wherein the instructions cause the system further to: receive the at least one of the identification of the pharmaceutical therapeutic for the first healthcare goal and a second healthcare goal or an identification of a digital therapeutic for the first healthcare goal and the second healthcare goal; weight the first healthcare goal and the second healthcare goal; retrieve interaction information for the first healthcare goal and the second healthcare goal; and determine that a potential interaction exists between the pharmaceutical therapeutic and the digital therapeutic with respect to the first healthcare goal and the second healthcare goal based on the interaction information for the first healthcare goal and the second healthcare goal. (par. 211: The scores in the mapping 920 are determined for each of these effects. Then, for each program, the relevance scores may be combined by weighting the values. Scores corresponding to likely effects may be weighted or discounted according to the likelihood from the medication database 910. Similarly, scores for effects estimated from medications that are not current may be discounted in some instances based on how long ago the corresponding medication was administered. Similarly, scores can be weighted by the typical intensity of the effect. By contrast, for actual effects experienced by the user, the scores from the mapping 920 may not be discounted, or may be increased. The weighted scores for a program may then be added or otherwise combined to give an overall measure of the likely relevance of the program to the user given the user's current medications and medication history.)
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.
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over (US 20200119986 A1) in view of Sterner et al ( US 20210050098 A1)
Claim 6, 16 Jain discloses a system/ method of claims 1 and 11 as explained, but does not disclose a system and method further comprising: an anonymization computer configured to anonymize data to be received at the central computer and provide the anonymized data to the central computer.
Sterner discloses a patient outcomes system in which data may be anonymized/de-identified before it is sent for additional analysis. ( par. 45-The patient information database 108a may provide information specific or personal to a patient or information regarding a patient population, e.g., a data set devoid of personal identifiers (i.e., de-identified) but identifying a trend among a population of patients.) At the time of the effective filing date, it would have been obvious to remove identifiers from the patient data before further analysis. One would have been motivated to include this feature to remove potential personal biases, and to minimize potential privacy and HIPAA violations.
Response to Arguments
Applicant's arguments filed 1/28/26 have been fully considered but they are not persuasive.
(A) Applicant argues the claims as a whole are not directed to an abstract idea, and that the claimed invention provides a real world technological improvement for the selection and usage of new digital health applications.
In response, the examiner disagrees. As drafted, the claimed invention is drawn to an abstract idea (e.g. mental process) without reciting significantly more. Additionally, the judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e).
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
The claim(s) must be evaluated to ensure the claim itself reflects the improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). The full scope of the claim under the broadest reasonable interpretation should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). (See MPEP 2106(a))
Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019).
The claimed invention is drawn to improving the process of selecting therapy for a user (e.g. patient), and is drawn to improving an abstract idea.
(B) Applicant argues that the Jain reference does not teach “receiving… from a device used by a clinician or a patient proposing a resolution for reaching the first healthcare goal.”
In response, regarding the language “used by a clinician or a patient proposing a resolution for reaching the first healthcare goal,” the intended user/user of a device does not distinguish the claimed device over the prior art.
The examiner also disagrees with applicant’s argument that the administrator merely views the individual’s progress and adjusts the device/ device plan. The administrator also provides information identifying a digital therapeutic and enrolls the therapeutic into a management program (par. 52-56- interactive portal 132 enables the administrator to view management plan templates 134 and select a template to use to enroll a new device, such as a machine or piece of equipment; par. 93-94: enables the administrator to…select a template to use to enroll a new device or user. par. 126- The device 420 or its user has previously been enrolled to a management plan by an administrator.) Moreover, the administrator helps provides the proposed resolution reaching a user’s healthcare goal. (par. 55- the administrator can specify an initial management plan that meets the needs identified by the device).
Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/
Primary Examiner, Art Unit 3684