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 preliminary amendment filed on 10/22/24. Claims 1-20 are pending.
The IDS filed on 10/22/24 and 5/15/26 have been considered.
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 14 and 19 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.
Claims 14 and 19 recite an “ALSFRS-R evaluation.” However, the claim language does not previously establish the basis of the abbreviation/acronym. It is unclear from the claim language what this evaluation is. The full name should be used the first time the abbreviation is introduced in the claim section.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 recites dependency from itself. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
In the interest of compact prosecution, claim 15 with be treated with the claims dependent from claim 14.
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 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.
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 1-9, and 12-14;(15) and 16-20 are drawn to a system, and claim 10 is drawn to a method; claim 11 is drawn to a product (CRM) 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. 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 1-20 recite(s) a method, system and product for certain methods of organizing human activities, 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) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method and system are drawn to organizing medications and mealtimes(managing personal behavior or relationships or interactions between people)
In particular, claims 1, 10 and 11 recite a method, product and system for:
setting a dietary restriction period according to meal-related information related to a predetermined meal of a first
presenting a medication notification based on mealtime information indicating mealtime when the predetermined meal is ingested and the dietary restriction period
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). (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. 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 1,10 and 11 recite(s) additional limitation(s), including: circuitry of an information processing apparatus. The additional component(s) is/are generic components that perform conventional functions 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 information processing apparatus 10 may be a so-called server terminal, and constitutes a part of the information processing system 1 by executing information processing with the first user terminal 20 and/or the second user terminal 30 via the network NW. The information processing apparatus 10 may be, for example, a workstation or a general-purpose computer such as a personal computer, or may be logically realized by cloud computing. In the information processing apparatus 10, an application or the like capable of communicating with the first user terminal 20 and/or the second user terminal 3.” (par. 43 of the PG-Pub)
The application explains: “The first user terminal 20 may be, for example, a general-purpose computer such as a workstation or a personal computer, or may be a mobile communication device such as a smartphone or a tablet device. The first user terminal 20 may also be a digital device such as a wearable device worn by the user. On the first user terminal 20, an application or the like that enables communication with the information processing apparatus 10 and/or the second user terminal 30,.” (see par. 44) 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.
Claims 2-9 and 12-20 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. (Claim 15 will also be treated as dependent from claim 14) However, the additional limitations of the claims 2-9 and 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 or the additional steps amount to insignificant extra solution activities. Therefore, claim(s) 2-9 and 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) 1-6, 9-13; and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayter et al (US 20220000399 A1).
Claim 1 Hayter teaches an information processing system, comprising:
an information processing apparatus comprising circuitry configured to set a dietary restriction period according to meal-related information regarding a predetermined meal of a first user, and (par. 98—99: a reminder generated by the meal monitor application according to a predetermined schedule, which can be set and/or modified by the user; par. 217- providing meal schedule);
present a medication notification based on mealtime information indicating mealtime when the predetermined meal is ingested and the dietary restriction period. (par. 117 and 280; par. 169-171: System 100 can also (or alternatively) issue a medication or other treatment output at 320; par. 232-process when meal is ingested. )
Claim 2 Hayter teaches the information processing system according to claim 1, wherein the meal-related information includes at least one of a plurality of meal type information indicating degree of the predetermined meal. (par. 13-meal types; par. 84; par. 120-The meal information can include a meal type, for example, whether the meal is breakfast, lunch, snack, dinner, or dessert, etc)
Claim 3 Hayter teaches the information processing system according to claim 2, wherein the meal-related information includes meal content information indicating a content of the predetermined meal, the meal content information is information of meal menu or ingredient set by an input operation or a selection operation by the first user or a related user related to the first user, or information of meal menu or ingredient estimated from an acquired image, and the meal type information is set based on the information of meal menu or ingredient. (par. 120-121; Fig. 3A )
Claim 4 Hayter discloses the information processing system according to claim 3, wherein the related user is at least one among a family member of the first user, a caregiver who cares for the first user, a medical professional involved with the first user, and a representative who acts on behalf of the first user. (par. 14-caregivers)
Claim 5 Hayter teaches the information processing system according to claim 2,wherein the circuitry of the information processing apparatus is configured to set the dietary restriction period according to the degree of the predetermined meal indicated by the meal type information. (par. 13-a person with responsibility for dietary selections can utilize the presented information to determine whether meal contents, types, and/or times of administration can or should be adjusted to alleviate an undesirable trend in the aggregate analyte data, such as a reduction in the occurrence of hypoglycemic or hyperglycemic events.; par. 102-103)
Claim 6 Hayter teaches the information processing system according to claim 1, wherein the circuitry of the information processing apparatus is configured to present the medication notification at a time of at least one among a first time when the dietary restriction period has elapsed from the mealtime indicated by the mealtime information, a second time before the first time by a predetermined period, and a third time after the first time by a predetermined period. (par. 102-103; Fig. 3A-3B)
claims 9 and 16 Hayter teaches the information processing system wherein the circuitry of the information processing apparatus is not configured to present the medication notification during a predetermined non-notification period in case that medication taken information is set. (par. 117; par. 280)
Claim 10 Hayter teaches an information processing method executed on a computer, comprising:
setting a dietary restriction period according to meal-related information related to a predetermined meal of a first user by using circuitry of an information processing apparatus configured to set the dietary restriction period a reminder generated by the meal monitor application according to a predetermined schedule, which can be set and/or modified by the user; par. 217- providing meal schedule);
presenting a medication notification based on mealtime information indicating mealtime when the predetermined meal is ingested and the dietary restriction period by using the circuitry of the information processing apparatus configured to present the medication notification (par. 117 and 280; par. 169-171: System 100 can also (or alternatively) issue a medication or other treatment output at 320; par. 232-process when meal is ingested)
Claim 11 Hayter teaches a non-transitory computer readable medium including a program stored thereon that, when executed by a computer, executes an information processing method, (par. 197) comprising:
setting a dietary restriction period according to meal-related information related to a predetermined meal of a first user; (par. 98—99: a reminder generated by the meal monitor application according to a predetermined schedule, which can be set and/or modified by the user; par. 217); and providing meal schedule and presenting a medication notification based on mealtime information indicating mealtime when the predetermined meal is ingested and the dietary restriction period. ( (par. 117 and 280; par. 169-171: System 100 can also (or alternatively) issue a medication or other treatment output at 320; par. 215; par. 232-process when meal is ingested)
Claim 12 and 17 Hayter teaches the information processing system, wherein the circuitry of the information processing apparatus is configured to set the dietary restriction period according to the degree of the predetermined meal indicated by the meal type information. (par. 88-89; par. 112-113)
Claims 13 and 18 Hayter discloses the information processing system wherein the circuitry of the information processing apparatus is configured to present the medication notification at a time of at least one among a first time when the dietary restriction period has elapsed from the mealtime indicated by the mealtime information, a second time before the first time by a predetermined period, and a third time after the first time by a predetermined period. (par. 110-112)
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) 7-8, 14-15 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al (US 20220000399 A1) in view of Park (PARK et al., (2015) "Association between nutritional status and disease severity using the amyotrophic lateral sclerosis (ALS) functional rating scale in ALS patients", Nutrition, Vol. 31, pp. 1362-1367).
Claims 7 , 14 and 19 Hayter discloses providing nutritional recommendations for diabetic patient/users (Fig. 21; Fig. 22A-B; par. 299; par. 303, par. 306)
Hayter does not disclose wherein the circuitry of the information processing apparatus is configured to acquire physical information of the first user and ALSFRS-R evaluation information of the first user and output a nutritional management target numerical value including a recommended nutritional intake suited to the first user.
Park discloses a system and method for monitoring physical parameters for ALS patients including ALSFRS-R evaluations and also discloses nutritional correlations to physical responses with the disease. (Abstract; pg. 1362-1363) At the time of the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the system/method of Hayter with the teaching of Park to provide nutritional recommendations for improved physical responses for patients with additional ailments (i.e. ALS). One would have been motivated to include this feature to assist a larger population of patients.
Claims 8, 15 and 20 Hayter teaches the information processing system, wherein the circuitry of the information processing apparatus is configured to generate nutritional intake information from a content of the predetermined meal and compare at least the nutritional intake information and the recommended nutritional intake to generate a comparison result. (Fig. 3a-b; par. 121; par. 133- The start of the overlaid trace 346 can be aligned with the analyte data at the meal start time 344. Thus, the user is given real-time visual feedback of the likely result of consumption of that problematic food. Alternatively, multiple traces can be overlaid where each trace represents a single past excursion from consumption of that meal type; par. 156- The association of analyte data with a meal event can be used in determining a glycemic impact of the meal event at 316; par. 368- the determined glycemic response or impact can then be output to the user at 318, such as visually on a display of the smartphone, as will be described below with respect to FIGS. 5A-F. In many embodiments, this is done immediately with a presentation of information about the corresponding meal event so that the user can immediately understand the impact of a particular meal on the user's analyte levels)
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/Primary Examiner, Art Unit 3684
Prosecution Insights