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 .
Claims 1-20 are pending. Claims 1-20 are rejected herein.
Priority
This application discloses and claims only subject matter disclosed in prior Application No. 17/221,442, filed 02 April 2021, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a continuation or divisional. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) submitted on 06 February 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12142362. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims 1-20 are anticipated by the reference claims (claims 1-20 of US patent 12142362).
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 3,7,13 and 17 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 3 and 13 are indefinite because it is unclear what the statistical deviation is in reference to. Claims 7 and 17 are indefinite because it is unclear what the probabilistic vector is in reference to.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more. The claims recite a method and system for generating a thyroid malady nourishment program.
The limitations of (claim 1 being representative) obtaining a vigor element, identifying a thyroid status as a function of the vigor element, wherein identifying the thyroid status further comprises: obtaining a homeostatic element from a vigor database; producing a thyroid enumeration as a function of the vigor element; and identifying the thyroid status indicating thyroid medication status as a function of the homeostatic element and the thyroid enumeration using a status machine-learning model; determining an edible as a function of the thyroid status indicating thyroid medication status; and generating a nourishment program as a function of the edible is a process that, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e. managing personal behavior including following rule or instructions) but for the recitation of generic computer components.
That is, other than reciting (claims 1 and 11) “a computing device,” the claimed invention amounts to managing personal behavior or interaction between people (i.e. a person following a series of rules or steps). For example, but for the various general-purpose computer elements, the claims encompass a person using and manipulating data about the thyroid to identify thyroid status in the manner described in the identified abstract idea, supra. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer (se October 2019 Update: Subject Matter Eligibility at pg. 5). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of (claims 1 and 11) a “computing device” that implements the identified abstract idea.
This additional element is not exclusively described by the applicant and is recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. 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. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of using a general -purpose computer (or components thereof) to perform the noted steps amounts to no more than mere instructions to apply an exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Dependent claims (2-10 and 12-20) are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or an ordered combination. Claims 2 and 12 merely describe the manipulation of thyroid health data. Claims 3 and 13 merely describe producing thyroid status as a function of statistical deviation. Claim 4 and 14 merely describe identifying thyroid status via analysis of trends/movements in thyroid function. Claims 5 and 15 merely describe identifying thyroid status via analysis of physiological fascicles (see Spec. at para. [0034] for definition of physiological fascicle as a group and/or bundle of physiological cells, tissues and/or organs that are affected and/or influenced). Claim 6 and 16 merely describe using a machine learning model to determine to determine a measurable value associated with the health status of the individual’s thyroid gland. Claim 7 and 17 merely describe determining thyroid status via use of a data structure that represents one or more quantitative values and/or measures of probability associated with developing thyroid gland modifications. Claim 8 and 18 merely describe determining an ailment or collection of ailments that impact the thyroid gland and determining thyroid status. Claim 9 and 19 merely describes identifying thyroid status as a function of autoimmune markers. Claim 10 and 20 merely describes obtaining a functional goal for the thyroid treatment and using a machine learning model to generate a nourishment program.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 1-4,11-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0271440 A1 (hereafter Yun) in view of US 2016/0339086 A1 (hereafter Cohen).
Regarding Claim 1
A system for generating a thyroid malady nourishment program, the system comprising: a computing device, the computing device configured to: obtain a vigor element; [See Spec. at para. [0010] for the definition of vigor element. Yun teaches at para. [0043] a computing device. Yun teaches at Figure 1, Item 110, a homeostatic capacity evaluation model which obtains biometric data about the subject from the dynamic biometric obtainment model (teaches obtaining data about thyroid status or “obtain a vigor element”). Yun teaches at para. [0034] that biometric parameters analyzed include a wide array of physiological indicators and “sample analysis obtainable parameters” (i.e. measurements obtainable from bodily fluids and tissues etc.), thereby teaching the means by which thyroid status measurements could be taken. Yun at para. [0173] teaches obtaining biometric data via physiological sensors. Yun also teaches at para. [0059] obtaining a dynamic measure of homeostatic capacity of the subject, and at para. [0057] teaches that a thyroid disorder impacts homeostatic capacity.]
identify a thyroid status as a function of the vigor element, wherein identifying the thyroid status further comprises: obtaining a homeostatic element from a vigor database; [This limitation amounts to identifying thyroid status via an element of data associated with the health of the thyroid. Yun teaches at the Abstract and Figure 1 Item 140 evaluating homeostatic capacity as a function of a wide variety of biometric data from the subject and a biometric data database. Yun teaches at para. [0043] a computing device.]
producing a thyroid enumeration as a function of the vigor element; [The Specification at para.[0015] teaches that a thyroid enumeration is a measurable value associated with the health status of the individual’s thyroid gland. This limitation amounts to producing a thyroid health related data value(s) using a machine learning model. Yun at para. [0057] teaches that a thyroid disorder impacts homeostatic capacity. Yun at Figure 1 Item 140 and the Abstract teaches using machine learning to evaluate the homeostatic capacity of a subject (using machine learning to obtain a measurable value associated with the health status of the individual’s thyroid gland).]
and identifying the thyroid status indicating thyroid medication status as a function of the homeostatic element and the thyroid enumeration using a status machine-learning model; [Yun teaches at the Abstract using machine learning models and biometric data (thyroid enumeration) to determine homeostatic capacity (the homeostatic element), which Yun states at para. [0057] that a thyroid disorder impacts homeostatic capacity (represents thyroid status). Yun teaches at para. [0059] embodiments of such methods include: obtaining a dynamic measure of homeostatic capacity for the subject, e.g., as described above, and administering a therapy to the subject in a manner sufficient to modulate the subject’s dynamic measure of homeostatic capacity to more closely approximate a target dynamic measure of homeostatic capacity and treat the subject for the condition.]
determine an edible as a function of the thyroid status indicating thyroid medication status; [Yun teaches at para. [0059] embodiments of such methods include: obtaining a dynamic measure of homeostatic capacity for the subject, e.g., as described above, and administering a therapy to the subject in a manner sufficient to modulate the subject’s dynamic measure of homeostatic capacity to more closely approximate a target dynamic measure of homeostatic capacity and treat the subject for the condition. This teaches determine an edible as a function of the thyroid status indicating thyroid medication status.]
Yun may not explicitly teach:
and generate a nourishment program as a function of the edible.
Cohen teaches:
and generate a nourishment program as a function of the edible. [Cohen teaches at para. [0010] and para. [0013] an oral form of nutritional supplementation to treat thyroid pathology. Cohen teaches at para. [0027] that certain embodiments of the invention will be executed with state-of-the-art technology, which would include a computing device.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen, with the motivation of improving the healthy function of the human thyroid gland (Cohen at para. [0004]).
Regarding Claim 11
Due to its similarity to Claim 1, Claim 11 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Regarding Claim 2,
Yun/Cohen teach the system of claim 1. Yun teaches:
wherein obtaining the vigor element further comprises receiving a proneness indicator and obtaining the vigor element as a function of the proneness indicator. [The Specification at para. [0010] defines “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” The Specification at para. [0010] defines a “proneness indicator” as “an element of data associated with the likelihood for a thyroid system modification to occur.” Yun at para. [0053] teaches predicting predisposition for developing a disease (proneness indicator). Yun at the Abstract and Figure 1 teaches providing a homeostatic capacity evaluation, thereby teaching obtaining the vigor element.]
Regarding Claim 3,
Yun/Cohen teaches the system of claim 1. Yun teaches:
wherein identifying the thyroid status further comprises: identifying a statistical deviation as a function of the thyroid enumeration and homeostatic element; and producing the thyroid status as a function of the statistical deviation.[The Specification at para. [0015] teaches that a “thyroid enumeration is a measurable value associated with the health status of the individual’s thyroid gland…” The Specification at para. [0013] teaches that a “homeostatic element is an element of datum representing a mechanism that adjusts an individual’s health system to maintain a constant and/or balanced health system, such as but not limited to a homeostatic mechanism and or a homeostasis.” Yun at para. [0175] teaches that a variety of statistical methods are employed to determine homeostatic capacity, which encompasses thyroid status (thereby teaching identifying a statistical deviation as a function of the thyroid related data and homeostatic element).]
Regarding Claim 4,
Yun/Cohen teach the system of claim 1. Yun teaches:
wherein identifying the thyroid status further comprises determining a status movement and identifying the thyroid status as a function of the status movement. [The specification at para. [0028] recites “a status movement is a trend and/or movement of an individual’s thyroid function.” This limitation amounts to identifying the thyroid status (homeostatic capacity reflects thyroid status) of someone undergoing medication treatment (which would induce a trend in their patient data). Yun at para. [0060] teaches that a wide variety of medical interventions may be administered to the subjects. Yun at para. [0054] teaches that subjects may undergo treatment to achieve at least the amelioration of symptoms (i.e. thereby teaching the trend or status movement in patient thyroid related data). Yun at Figure 1 teaches providing a homeostatic capacity evaluation (determining thyroid status).]
Regarding Claim 8,
Yun/Cohen teach the system of claim 1. Yun teaches:
wherein identifying the thyroid status includes determining a thyroid malady and producing the thyroid status as a function of the thyroid malady.[Yun at para. [0053] teaches diagnosis of a condition of the thyroid. The Examiner notes that there is no functional difference between the labels “thyroid status” and “thyroid malady.” As such, the condition determination of Yun meets this claim.]
Regarding Claim 12,
Yun/Cohen teach the method of claim 11. Yun teaches:
wherein obtaining the vigor element further comprises receiving a proneness indicator and obtaining the vigor element as a function of the proneness indicator. [The Specification at para. [0010] defines “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” The Specification at para. [0010] defines a “proneness indicator” as “an element of data associated with the likelihood for a thyroid system modification to occur.” Yun at para. [0053] teaches predicting predisposition for developing a disease (proneness indicator). Yun at the Abstract and Figure 1 teaches providing a homeostatic capacity evaluation, thereby teaching obtaining the vigor element.]
Regarding Claim 13,
Yun/Cohen teaches the method of claim 11. Yun teaches:
wherein identifying the thyroid status further comprises: identifying a statistical deviation as a function of the thyroid enumeration and homeostatic element; and producing the thyroid status as a function of the statistical deviation. [The Specification at para. [0015] teaches that a “thyroid enumeration is a measurable value associated with the health status of the individual’s thyroid gland…” The Specification at para. [0013] teaches that a “homeostatic element is an element of datum representing a mechanism that adjusts an individual’s health system to maintain a constant and/or balanced health system, such as but not limited to a homeostatic mechanism and or a homeostasis.” Yun at para. [0175] teaches that a variety of statistical methods are employed to determine homeostatic capacity, which encompasses thyroid status (thereby teaching identifying a statistical deviation as a function of the thyroid related data and homeostatic element).]
Regarding Claim 14,
Yun/Cohen teach the method of claim 11. Yun teaches:
wherein identifying the thyroid status further comprises determining a status movement and identifying the thyroid status as a function of the status movement. [The specification at para. [0028] recites “a status movement is a trend and/or movement of an individual’s thyroid function.” This limitation amounts to identifying the thyroid status (homeostatic capacity reflects thyroid status) of someone undergoing medication treatment (which would induce a trend in their patient data). Yun at para. [0060] teaches that a wide variety of medical interventions may be administered to the subjects. Yun at para. [0054] teaches that subjects may undergo treatment to achieve at least the amelioration of symptoms (i.e. thereby teaching the trend or status movement in patient thyroid related data). Yun at Figure 1 teaches providing a homeostatic capacity evaluation (determining thyroid status).]
Regarding Claim 18,
Yun/Cohen teach the method of claim 11. Yun teaches:
wherein identifying the thyroid status includes determining a thyroid malady and producing the thyroid status as a function of the thyroid malady. [Yun at para. [0053] teaches diagnosis of a condition of the thyroid. The Examiner notes that there is no functional difference between the labels “thyroid status” and “thyroid malady.” As such, the condition determination of Yun meets this claim.]
Claim 5,9,15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0271440 A1 (hereafter Yun) in view of US 2016/0339086 A1 (hereafter Cohen) in view of Li (Distinct histopathological features of Hashimoto’s thyroiditis with respect to IgG4 related disease).
Regarding Claim 5,
Yun/Cohen teach the system of claim 1. Yun teaches:
wherein identifying the thyroid status further comprises: producing a physiological influence as a function of the vigor element; [The Spec. at para. [0010] teaches a “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” This limitation amounts to producing a physiological influence as a function of an element of data associated with an individual’s biological system. The physiological influence is apparent. Homeostatic capacity could reflect the physiological influence of thyroid pathology. Biometric data could be the vigor element. Yun at Figure 1, Item 110 teaches obtaining biometric data from the subject and at Figure 1, Item 130 obtaining biometric data (i.e. which they define to include pH level and temperature) from a database. Yun at the Abstract teaches using the biometric data to determine homeostatic capacity (encompasses physiological influence).]
determining a physiological fascicle as a function of the physiological influence; [The Specification at para. [0034] teaches that “a physiological fascicle is a group and/or bundle of physiological cells, tissues and/or organs that are affected and/or influenced.” This limitation amounts to determining the physiological influence of a thyroid disorder on a group of thyroid cells. Yun teaches at para. [0057] that thyroid disorder impacts homeostatic capacity. Yun teaches at the Abstract measuring homeostatic capacity (physiological influence).]
Yun may not explicitly teach:
and identifying the thyroid status as a function of the physiological fascicle.
Li teaches:
and identifying the thyroid status as a function of the physiological fascicle. [The Spec. at para. [0034] teaches that a “physiological fascicle is a group and/or bundle of physiological cells, tissues and/or organs that are affected and/or influenced.” The Spec. at para. [0010] teaches a “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” Thus, this claim amounts to obtaining data about the physiological influence of thyroid dysfunction on the level of cells, tissues and organs. Li at pg. 1092 at Figure 4 teaches histopathological staining to display patterns of stromal fibrosis in Hashimoto’s thyroiditis patients at the cell and tissue level. Li at pg. 1090 teaches determining gross pathology of Hashimoto’s thyroiditis patients at the organ level.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the methods of staining histopathological features of Hashimoto’s thyroiditis of Li with the motivation of improving thyroid diagnostic ability (Li at the Abstract).
Regarding Claim 9,
Yun/Cohen teach the system of claim 1. Yun/Cohen may not explicitly teach:
wherein identifying the thyroid status further comprises: determining an autoimmune element;
and identifying the thyroid status as a function of the autoimmune element
Li teaches:
wherein identifying the thyroid status further comprises: determining an autoimmune element; [Li at the Abstract teaches dividing Hashimoto’s thyroiditis patients into an IgG4 thyroiditis group and a non-IgG4 thyroiditis group, and comparing their fibrotic and other autoimmune responses via light microscopy and immunohistochemistry thereby teaching determining an autoimmune element.]
and identifying the thyroid status as a function of the autoimmune element. [Li teaches immunohistochemical staining (identifying the thyroid status) of the thyroid and high-powered image analysis software to determine quantification of IgG4 positive or IgG positive cells (the autoimmune element).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the methods of staining histopathological features of Hashimoto’s thyroiditis of Li with the motivation of improving thyroid diagnostic ability (Li at the Abstract).
Regarding Claim 15,
Yun/Cohen teach the method of claim 11. Yun teaches:
wherein identifying the thyroid status further comprises: producing a physiological influence as a function of the vigor element; [The Spec. at para. [0010] teaches a “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” This limitation amounts to producing a physiological influence as a function of an element of data associated with an individual’s biological system. The physiological influence is apparent. Homeostatic capacity could reflect the physiological influence of thyroid pathology. Biometric data could be the vigor element. Yun at Figure 1, Item 110 teaches obtaining biometric data from the subject and at Figure 1, Item 130 obtaining biometric data (i.e. which they define to include pH level and temperature) from a database. Yun at the Abstract teaches using the biometric data to determine homeostatic capacity (encompasses physiological influence).]
determining a physiological fascicle as a function of the physiological influence; [The Specification at para. [0034] teaches that “a physiological fascicle is a group and/or bundle of physiological cells, tissues and/or organs that are affected and/or influenced.” This limitation amounts to determining the physiological influence of a thyroid disorder on a group of thyroid cells. Yun teaches at para. [0057] that thyroid disorder impacts homeostatic capacity. Yun teaches at the Abstract measuring homeostatic capacity (physiological influence).]
Yun may not explicitly teach:
and identifying the thyroid status as a function of the physiological fascicle.
Li teaches:
and identifying the thyroid status as a function of the physiological fascicle. [The Spec. at para. [0034] teaches that a “physiological fascicle is a group and/or bundle of physiological cells, tissues and/or organs that are affected and/or influenced.” The Spec. at para. [0010] teaches a “vigor element” to be “an element of data associated with an individual’s biological system that denotes a health status of a thyroid system, wherein a health status is a measure of the relative level of physical well-being.” Thus, this claim amounts to obtaining data about the physiological influence of thyroid dysfunction on the level of cells, tissues and organs. Li at pg. 1092 at Figure 4 teaches histopathological staining to display patterns of stromal fibrosis in Hashimoto’s thyroiditis patients at the cell and tissue level. Li at pg. 1090 teaches determining gross pathology of Hashimoto’s thyroiditis patients at the organ level.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the methods of staining histopathological features of Hashimoto’s thyroiditis of Li with the motivation of improving thyroid diagnostic ability (Li at the Abstract).
Regarding Claim 19,
Yun/Cohen teach the method of claim 11. Yun/Cohen may not explicitly teach:
wherein identifying the thyroid status further comprises: determining an autoimmune element;
and identifying the thyroid status as a function of the autoimmune element
Li teaches:
wherein identifying the thyroid status further comprises: determining an autoimmune element; [Li at the Abstract teaches dividing Hashimoto’s thyroiditis patients into an IgG4 thyroiditis group and a non-IgG4 thyroiditis group, and comparing their fibrotic and other autoimmune responses via light microscopy and immunohistochemistry thereby teaching determining an autoimmune element.]
and identifying the thyroid status as a function of the autoimmune element. [Li teaches immunohistochemical staining (identifying the thyroid status) of the thyroid and high-powered image analysis software to determine quantification of IgG4 positive or IgG positive cells (the autoimmune element).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the methods of staining histopathological features of Hashimoto’s thyroiditis of Li with the motivation of improving thyroid diagnostic ability (Li at the Abstract).
Claims 6,7,16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0271440 A1 (hereafter Yun) in view of US 2016/0339086 A1 (hereafter Cohen) in view of Chang (Thyroid Segmentation and Volume Estimation in Ultrasound Images).
Regarding Claim 6,
Yun/Cohen teach the system of claim 1. Yun/Cohen may not explicitly teach:
wherein producing the thyroid enumeration further comprises: determining an origin of malfunction;
and producing the thyroid enumeration as a function of the vigor element and the origin of malfunction using an origin machine-learning model.
Chang teaches:
wherein producing the thyroid enumeration further comprises: determining an origin of malfunction; [The Spec. at para. [0015] teaches “a thyroid enumeration is a measurable value associated with the health status of the individual’s thyroid gland…” This limitation amounts to determining a thyroid related diagnosis via data related to the health status of the thyroid. Chang at the Abstract teaches using calculated thyroid volume (thyroid enumeration) to diagnose pathology of the thyroid gland (determining an origin of malfunction).]
and producing the thyroid enumeration as a function of the vigor element and the origin of malfunction using an origin machine-learning model. [The definition of vigor element is included above. This claim amounts to determining a diagnosis (determining an origin of malfunction), and producing a measurable value associated with the health status of the individual’s thyroid gland via machine learning. Chang teaches at pg. 1348 using machine learning to assist determining the thyroid volume, which, Chang teaches at the Abstract, is a classic measurable means by which physicians diagnose thyroid pathology.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the thyroid segmentation and volume estimation of Chang, with the motivation of reducing the cost of thyroid diagnostic analysis (Chang pg. 1348 at the Abstract).
Regarding Claim 7,
Yun/Cohen teach the system of claim 1. Yun/Cohen may not explicitly teach:
wherein identifying the thyroid status further comprises determining a probabilistic vector and identifying the thyroid status as a function of the probabilistic vector.
Chang teaches:
wherein identifying the thyroid status further comprises determining a probabilistic vector and identifying the thyroid status as a function of the probabilistic vector. [The Spec. at para. [0035] teaches that a “probabilistic vector is a data structure that represents one or more quantitative values and/or measures of probability associated with developing thyroid gland modifications. For example, and without limitation, probabilistic vector may indicate that an individual’s thyroid gland function has a high probability of declining rapidly.” This limitation amounts to identifying the thyroid status as a function of the data/quantitative value reflective of the thyroid developing gland modifications (i.e. identifying thyroid status for example from data strongly predictive of thyroid cancer). Chang at the abstract teaches identifying (diagnosing) thyroid status as a function of the calculated thyroid volume. In this case, thyroid volume is the quantitative value associated with developing thyroid gland modifications.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the thyroid segmentation and volume estimation of Chang, with the motivation of reducing the cost of thyroid diagnostic analysis (Chang pg. 1348 at the Abstract).
Regarding Claim 16,
Yun/Cohen teach the method of claim 11. Yun/Cohen may not explicitly teach:
wherein producing the thyroid enumeration further comprises: determining an origin of malfunction;
and producing the thyroid enumeration as a function of the vigor element and the origin of malfunction using a origin machine-learning model.
Chang teaches:
wherein producing the thyroid enumeration further comprises: determining an origin of malfunction; [The Spec. at para. [0015] teaches “a thyroid enumeration is a measurable value associated with the health status of the individual’s thyroid gland…” This limitation amounts to determining a thyroid related diagnosis via data related to the health status of the thyroid. Chang at the Abstract teaches using calculated thyroid volume (thyroid enumeration) to diagnose pathology of the thyroid gland (determining an origin of malfunction).]
and producing the thyroid enumeration as a function of the vigor element and the origin of malfunction using a origin machine-learning model. [The definition of vigor element is included above. This claim amounts to determining a diagnosis (determining an origin of malfunction), and producing a measurable value associated with the health status of the individual’s thyroid gland via machine learning. Chang teaches at pg. 1348 using machine learning to assist determining the thyroid volume, which, Chang teaches at the Abstract, is a classic measurable means by which physicians diagnose thyroid pathology.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the thyroid segmentation and volume estimation of Chang, with the motivation of reducing the cost of thyroid diagnostic analysis (Chang pg. 1348 at the Abstract).
Regarding Claim 17,
Yun/Cohen teach the method of claim 11. Yun/Cohen may not explicitly teach:
wherein identifying the thyroid status further comprises determining a probabilistic vector and identifying the thyroid status as a function of the probabilistic vector.
Chang teaches:
wherein identifying the thyroid status further comprises determining a probabilistic vector and identifying the thyroid status as a function of the probabilistic vector. [The Spec. at para. [0035] teaches that a “probabilistic vector is a data structure that represents one or more quantitative values and/or measures of probability associated with developing thyroid gland modifications. For example, and without limitation, probabilistic vector may indicate that an individual’s thyroid gland function has a high probability of declining rapidly.” This limitation amounts to identifying the thyroid status as a function of the data/quantitative value reflective of the thyroid developing gland modifications (i.e. identifying thyroid status for example from data strongly predictive of thyroid cancer). Chang at the abstract teaches identifying (diagnosing) thyroid status as a function of the calculated thyroid volume. In this case, thyroid volume is the quantitative value associated with developing thyroid gland modifications.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen with the thyroid segmentation and volume estimation of Chang, with the motivation of reducing the cost of thyroid diagnostic analysis (Chang pg. 1348 at the Abstract).
Claim 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0271440 A1 (hereafter Yun) in view of US 2016/0339086 A1 (hereafter Cohen) in view of WO 2018/031991 A1 (hereafter Bennett).
Regarding Claim 10,
Yun/Cohen teach the system of claim 1. Yun/Cohen may not explicitly teach:
wherein generating the nourishment program further comprises: obtaining a thyroid functional goal;
and generating the nourishment program as a function of the thyroid functional goal and the edible using a nourishment machine-learning model.
Bennett teaches:
wherein generating the nourishment program further comprises: obtaining a thyroid functional goal; [Bennett teaches at the Abstract use of a target biomarker template (i.e. an ideal biomarker panel). The target biomarker template is the thyroid functional goal.]
and generating the nourishment program as a function of the thyroid functional goal and the edible using a nourishment machine-learning model. [Bennett at the Abstract and para. [0071] teaches the use of machine learning to generate the recommended meal plan to minimize a deviation from a target biomarker template (represents thyroid functional goal).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen, with the machine learning meal plan method of Bennett, with the motivation of determining physician guidelines that are effective (Bennett at the Background).
Regarding Claim 20,
Yun/Cohen teach the method of claim 11. Yun/Cohen may not explicitly teach:
wherein generating the nourishment program further comprises: obtaining a thyroid functional goal;
and generating the nourishment program as a function of the thyroid functional goal and the edible using a nourishment machine-learning model.
Bennett teaches:
wherein generating the nourishment program further comprises: obtaining a thyroid functional goal; [Bennett teaches at the Abstract use of a target biomarker template (i.e. an ideal biomarker panel). The target biomarker template is the thyroid functional goal.]
and generating the nourishment program as a function of the thyroid functional goal and the edible using a nourishment machine-learning model. [Bennett at the Abstract and para. [0071] teaches the use of machine learning to generate the recommended meal plan to minimize a deviation from a target biomarker template (represents thyroid functional goal).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the homeostatic evaluation method of Yun with the compositions and methods for treating thyroid disease of Cohen, with the machine learning meal plan method of Bennett, with the motivation of determining physician guidelines that are effective (Bennett at the Background).
Conclusion
WO 2017149530 A1 (hereafter Netzer) teaches at system for selecting medications for a patient that is tangentially related to the specification.
Hoermann (Recent Advances in Thyroid Hormone Regulation: Toward a New Paradigm for Optimal Diagnosis and Treatment) teaches a general overview of diagnosis and treatment of the thyroid.
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/T.I.E./Examiner, Art Unit 3683 /CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683