Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 26-45 are currently pending in this case and have been examined and addressed below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
An access control means for (claims 26-45) controlling access to the user’s information
An authorising means for (claims 26-45) allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user
A profile creation means for (claims 26-43) allowing profiles for users to be created and stored on the repository
Receiving means for (claims 26-43) receiving any information of the group including user identification information, user genetic information, user medical information, practitioner identification information, practitioner field of practice, practitioner's associated professional governing bodies, and practitioner's professional license number
A reporting means for (claims 41-42) compiling a report containing any information stored on the user's profile
A notification means for (claim 43) notifying the user or the authorised health practitioner when research reveals new genetic information which would have an influence on the recommendations provided to the user
Because the “access control means for” and “authorising means for” limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The disclosure provides on page 12 that access means are in the form of a dedicated software application stored on the user’s personal computing device or a web-based application accessible by an internet browser on any computing device. Therefore, the claim limitations will be interpreted to be an application stored on a computing device.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 26, 36, 41 and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “profile creation means for”, “receiving means for”, “reporting means for”, “notification means for” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification states on page 9 that “profile creation means” allows profiles to be created and includes “receiving means” for receiving information of the user or health practitioner, but provides no detail about the specific structure performing the function. Additionally, page 13 states that “reporting means” compiles a report containing any information stored on the user’s profile, but does not disclose a specific structure that performs the function. Furthermore, page 14 states that “notification means” notifies the user or an authorized health practitioner, but does not disclose a specific structure that performs the function. Therefore, claims 26, 41, and 43 are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 36 recites the limitation “the user’s linked personal computing device” in line 3. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26, 41, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed functions of allowing profiles to be created, receiving information of the user or health practitioner, compiling a report containing any information stored on the user’s profile, and notifying the user or an authorized health practitioner. The specification does not demonstrate that the applicant has made an invention that achieve the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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 26-45 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.
Step 1: Claims 26-45 are drawn to a machine. As such, claims 26-45 are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One: In prong one of step 2A, the claim(s) is/are analyzed to evaluate whether it/they recite(s) a judicial exception.
Independent Claim 1: A genetic health information system including:
a repository on which information of a user is stored, the information including genetic information;
an access control means for controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user;
and a profile creation means for allowing profiles for users to be created and stored on the repository, wherein the profile creation means includes receiving means for receiving any information of the group including user identification information, user genetic information, user medical information, practitioner identification information, practitioner field of practice, practitioner's associated professional governing bodies, and practitioner's professional license number.
Independent Claim 44: A genetic health information system including:
a repository on which information of a user is stored, the information including genetic information;
and an access control means for controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user, wherein information of the user is automatically updated by obtaining medical or activity information from a smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository.
Independent Claim 45: A genetic health information system including:
a repository on which information of a user is stored, the information including genetic information;
and an access control means for controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user, wherein the authorising means is initiated by a registered health practitioner upon submission of a request to the particular user, using an identifier of the user, which request is sent to and received by the user's linked personal computing device, wherein the request includes a prompt to grant or deny access to the user's information, wherein upon granting of permission, the user is provided with a TOTP to pass on to the health practitioner for input into the system.
(Examiner notes: The above claim terms underlined are additional elements that fall under Step 2A - Prong Two analysis section detailed below)
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). Therefore, controlling access to the user’s information, allowing the user to provide a health practitioner with authorization access, profile creation, receiving information, information of the user is automatically updated by obtaining medical or activity information, submitting a request to access user’s information, and providing the user with a TOTP to pass on to the health practitioner for input are directed to managing personal interactions or personal behavior.
The dependent claim 27 is directed to profile creation to allow profiles for health practitioners to be created.
The dependent claim 28 is directed to the user medical information includes historical medical information of any one or more of the group including medical concerns, illnesses, diagnoses, treatments, prescribed drugs, previous medical practitioners, family medical history, sleep quality, exercise regimes, allergies, vaccination history, surgical procedures, lifestyle habits, dietary information, mental health history, reproductive health, laboratory test results, imaging reports, vital signs, immunizations, alternative medicine usage, genetic test results, social determinants of health, substance use history, environmental exposures, preventive screenings, therapeutic interventions, rehabilitation progress, medication allergies, medical imaging history, and organ donation preferences.
The dependent claim 29 is directed to the user medical information includes current medical information of any one or more of the group including current medical concerns, illnesses, diagnoses, treatments, prescribed drugs, exercise regimes, sleep quality, stress levels, blood pressure, blood oxygen levels, heart rate, body temperature, respiratory rate, weight, height, BMI (Body Mass Index), cholesterol levels, blood sugar levels, allergies, immunization status, medication adherence, symptoms, pain levels, mental health status, cognitive function, dietary habits, alcohol or substance use, reproductive health, recent medical procedures, wound healing progress, surgical recovery status, vital signs, laboratory test results, and imaging reports.
The dependent claim 30 is directed to the user medical information includes activity information which includes a historical record of overall measurement of activity or inactivity, steps, heart rate, exercises, training sessions, specific sports associated with the user. duration of physical activities, calories burned, distance covered, average pace or speed, workout intensity levels, rest periods, sleep patterns, sedentary time, active time, exercise goals and achievements, training plans, fitness assessments, heart rate variability, recovery metrics, exercise equipment usage, workout classes attended, personal bests, performance metrics, exercise-related injuries, exercise frequency, exercise preferences, and training load.
The dependent claim 31 is directed to the information of the user includes references to external information which pertain to the medical information of the user.
The dependent claim 32 is directed to the genetic information includes any one or more of the group including genetic variants, single nucleotide polymorphisms (SNPs), gene expression profiles, chromosomal abnormalities, DNA methylation patterns, epigenetic modifications, copy number variations, mitochondrial DNA data, haplogroups, genetic predispositions, disease-associated genetic markers, carrier status for inherited conditions, pharmacogenomic information, pharmacogenetic information, genotype- phenotype correlations ancestry or ethnic origins, genetic relatedness to other individuals, genetic testing results, genetic counselling records, genotyping or sequencing data, familial genetic history, non-coding RNA analysis, structural variations, gene function annotations, protein-protein interaction networks, pathway analysis results, regulatory elements, disease risk scores, polygenic risk scores, genetic traits or phenotypes, gene ontology annotations, genetic correlations, genome- wide association study (GWAS) results, and population-level genetic data.
The dependent claim 33 is directed to the pharmacogenetic information includes a comprehensive list of drugs and their effects on the user given the user's specific genotype.
The dependent claim 34 is directed to the information is automatically updated by obtaining medical or activity information.
The dependent claim 35 is directed to allow a health practitioner to access any user profile to which access has been duly authorized.
The dependent claim 36 is directed to authorising being initiated by a registered health practitioner submitting a request to the particular user, using an identifier of the user.
The dependent claim 37 is directed to the request to grant or deny access to the user’s information, wherein upon granting of permission, the user is provided with a TOTP to pass on to the health practitioner.
The dependent claim 38 is directed to the request includes identification details of the health practitioner requesting access.
The dependent claim 39 is directed to successful entry of the TOTP by the health practitioner permits access to the user's profile.
The dependent claim 40 is directed to permit access to the user's profile for a limited time.
The dependent claim 41 is directed to compiling a report containing an information.
The dependent claim 42 is directed to the report includes any one or more of the group including: a comprehensive list of possible drugs to be used along with the corresponding efficacy and potential results in relation to the genetic information of the user; details of the use of a particular drug by the user having a particular genotype, including precautionary details of the use of the particular drug; details of alternative drugs which are used by the user; and a detailed analysis of logic processes utilised to make various recommendations for allowing the health practitioner to view and verify the steps taken to reach a particular recommendation
The dependent claim 43 is directed to notifying the user or the authorised health practitioner when research reveals new genetic information which would have an influence on the recommendations provided to the user.
Each of these steps of the preceding dependent claims 27-43 only serve to further limit or specify the features of independent claims 26, 44, and 45 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
As such, the Examiner concludes that the preceding claims recite an abstract idea (Step 2A – Prong One: YES).
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Claim 26 recites the use of a repository on which information of a user is stored. The claim further recites the use of an access control, in this case to controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user. The repository on which information of a user is stored and access control are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 27 recites the use of a profiles for health practitioners to be stored on the repository, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claims 34 and 44 recite the use of a smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository, in this case to , only recites the a smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 35 recites the use of an access control means includes a login system for allowing access to the information stored on the repository, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claims 36 and 45 recite the use of a request is sent and received by the user's linked personal computing device, only as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 37 and 45 recites the use of a prompt, in this case to grant or deny access to the user's information, only recites the prompt as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2)) amounting to instruction to implement the abstract idea using a general purpose computer.
The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claim(s) is/are directed to an abstract idea (Step 2A – Prong two: NO).
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception.
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the repository on which information of a user is stored, access control, profiles for health practitioners to be stored on the repository, smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository, access control means includes a login system for allowing access to the information stored on the repository, request is sent and received by the user's linked personal computing device, and the prompt in independent claims 26, 44, and 45 and dependent claims 27-43 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
This conclusion is based on a factual determination. Applicant’s own disclosure on page 8 acknowledges that the “repository 12 forms part of a database (not shown) of a central processing unit (not shown)”. The disclosure also acknowledges on page 11 that “the smart device (not shown) periodically communicates information updates to the repository 12". Furthermore, page 12 discloses that “access control means 20 includes a login system 42 for allowing access to the information stored on the repository 12…The access means 44 is in the form of a dedicated software application (not shown) which is stored on the user's personal computing device (not shown). Alternatively, the access means 44 is in the form of a web-based application (not shown) which is accessible by an internet browser (not25 shown) any computing device (not shown)”.
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, claims 26-45 are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 26-29, 31-33, 35, and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gostyla et al. (US-20200135314-A1)[hereinafter Gostyla].
As per Claim 26, Gostyla discloses a genetic health information system in paragraphs [0004-0005] and [0024] (personalized medication management and alert system, wherein the personalized medication management and alert system is based on genetic health information) including: a repository on which information of a user is stored, the information including genetic information in paragraphs [0004-0005] (memory storing user information, information including genetic information); an access control means for controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user in paragraphs [0069-0070] (controlling access to the user's information by allowing a doctor (synonymous to a health practitioner) authorization access to supply the user with healthcare information based on the user's genetic information); and a profile creation means for allowing profiles for users to be created and stored on the repository, wherein the profile creation means includes receiving means for receiving any information of the group including user identification information, user genetic information, user medical information, practitioner identification information, practitioner field of practice, practitioner's associated professional governing bodies, and practitioner's professional license number in paragraphs [0004-0005] (creating and storing user profiles on the memory, wherein profile creation is based on receiving genetic information and user personal information, wherein personal information includes medical information (Examiner notes that the genetic and user personal information meet the "any information of the group" limitation)).
As per Claim 27, Gostyla discloses a genetic health information system as claimed in claim 26 Gostyla also discloses wherein the profile creation means is configured to allow profiles for health practitioners to be created and stored on the repository in paragraphs [0004-0005] and [0069-0070] and Figures 11 and 12 (creating and storing a profile for doctors, referred to as caregivers, on the memory).
As per Claim 28, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein the user medical information includes historical medical information of any one or more of the group including medical concerns, illnesses, diagnoses, treatments, prescribed drugs, previous medical practitioners, family medical history, sleep quality, exercise regimes, allergies, vaccination history, surgical procedures, lifestyle habits, dietary information, mental health history, reproductive health, laboratory test results, imaging reports, vital signs, immunizations, alternative medicine usage, genetic test results, social determinants of health, substance use history, environmental exposures, preventive screenings, therapeutic interventions, rehabilitation progress, medication allergies, medical imaging history, and organ donation preferences in paragraphs [0052] and [0055] and [0061] and Figure 5 (medical information includes patient medical history (synonymous to historical medical information) including illnesses, diagnoses, patient's ancestry (synonymous to family medical history), allergies, and lifestyle habits (Examiner notes that illnesses, diagnose, patient's ancestry, allergies, and lifestyle habits meets the "any one or more of the group" limitation)).
As per Claim 29, Gostyla discloses a genetic health information system as claimed in claim 26 Gostyla also discloses wherein the user medical information includes current medical information of any one or more of the group including current medical concerns, illnesses, diagnoses, treatments, prescribed drugs, exercise regimes, sleep quality, stress levels, blood pressure, blood oxygen levels, heart rate, body temperature, respiratory rate, weight, height, BMI (Body Mass Index), cholesterol levels, blood sugar levels, allergies, immunization status, medication adherence, symptoms, pain levels, mental health status, cognitive function, dietary habits, alcohol or substance use, reproductive health, recent medical procedures, wound healing progress, surgical recovery status, vital signs, laboratory test results, and imaging reports in paragraphs [0004-0005] and [0007] and [0033-0034] (user medical information includes illnesses, any medications (synonymous to prescribed drugs), allergies, diet, lifestyle, weight, and height (Examiner notes that illnesses, any medications, allergies, diet, lifestyle, weight, and height meet the "any one or more of the group" limitation)).
As per Claim 31, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein the information of the user includes references to external information which pertain to the medical information of the user in paragraphs [0035-0036] (the user information includes references to third party databases (synonymous to external information) which pertain to the medical information of the user).
As per Claim 32, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein the genetic information includes any one or more of the group including genetic variants, single nucleotide polymorphisms (SNPs), gene expression profiles, chromosomal abnormalities, DNA methylation patterns, epigenetic modifications, copy number variations, mitochondrial DNA data, Page 4 of 8 Application No. 18/870,945<<<application number>>> Preliminary Amendment haplogroups, genetic predispositions, disease-associated genetic markers, carrier status for inherited conditions, pharmacogenomic information, pharmacogenetic information, genotype- phenotype correlations ancestry or ethnic origins, genetic relatedness to other individuals, genetic testing results, genetic counselling records, genotyping or sequencing data, familial genetic history, non-coding RNA analysis, structural variations, gene function annotations, protein-protein interaction networks, pathway analysis results, regulatory elements, disease risk scores, polygenic risk scores, genetic traits or phenotypes, gene ontology annotations, genetic correlations, genome- wide association study (GWAS) results, and population-level genetic data in paragraphs [0007] and [0027] and [0031] and [0052] (genetic information includes single nucleotide polymorphisms (SNPs) and pharmacogenetic information (Examiner notes that SNPs and pharmacogenetic information meet the "any one or more of the group" limitation)).
As per Claim 33, Gostyla discloses a genetic health information system as claimed in claim 32, Gostyla also discloses wherein the pharmacogenetic information includes a comprehensive list of drugs and their effects on the user given the user's specific genotype in paragraphs [0027] and [0031-0032] and [0040] (pharmacogenetic information includes whether any conflicts or interactions exist with medications given the user's genetic information).
As per Claim 35, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein the access control means includes a login system for allowing access to the information stored on the repository, wherein the login system is configured to allow a health practitioner to access any user profile to which access has been duly authorized in paragraphs [0069-0070] and Figure 11 (login system that allows access to the information stored in the memory, wherein the login system allows the doctor to access the user profile which has been authorized).
As per Claim 41, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses including a reporting means for compiling a report containing any information stored on the user's profile in paragraphs [0048] and [0071] (generating a report containing information stored on the user's profile).
As per Claim 42, Gostyla discloses a genetic health information system as claimed in claim 41, Gostyla also discloses wherein the report includes any one or more of the group including: a comprehensive list of possible drugs to be used along with the corresponding efficacy and potential results in relation to the genetic information of the user; details of the use of a particular drug by the user having a particular genotype, including precautionary details of the use of the particular drug; details of alternative drugs which are used by the user; and a detailed analysis of logic processes utilised to make various recommendations for allowing the health practitioner to view and verify the steps taken to reach a particular recommendation in paragraph [0071] (the report includes a comprehensive list of all known drugs that could present medical issues in relation to the user genetic information (Examiner notes that the comprehensive list of all known drugs that could present medical issues in relation to the user genetic information meets the "any one or more of the group" limitation")).
As per Claim 43, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses including a notification means for notifying the user or the authorised health practitioner when research reveals new genetic information which would have an influence on the recommendations provided to the user in paragraphs [0031] and [0034-0035] and [0040-0041] and [0046-0048] (on-going notifications for notifying the user when research reveals a gene (synonymous to new genetic information) which would have an influence on the medication recommendations provided to the user).
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 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gostyla et al. (US-20200135314-A1)[hereinafter Gostyla], in view of Tran et al. (US-20210233656-A1)[hereinafter Tran].
As per Claim 30, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein the user medical information includes activity information which includes a historical record of overall measurement of activity or inactivity, exercises, training sessions, specific sports associated with the user. duration of physical activities, exercise frequency, in paragraphs [0033] and [0063] and Figure 7 (user medical information includes activity information including amount of exercise (synonymous to a historical record of overall measurement of activity or inactivity), exercises, training sessions, sports training frequency (synonymous to specific sports associated with the user duration of physical activities), exercise frequency).
Gostyla discloses the activity information including the user medical information includes activity information which includes a historical record of overall measurement of activity or inactivity, exercises, training sessions, specific sports associated with the user. duration of physical activities, and exercise frequency. Gostyla does not disclose the activity information including steps, heart rate, calories burned, distance covered, average pace or speed, workout intensity levels, rest periods, sleep patterns, sedentary time, active time, exercise goals and achievements, training plans, fitness assessments, heart rate variability, recovery metrics, exercise equipment usage, workout classes attended, personal bests, performance metrics, exercise-related injuries, and exercise preferences, and training load. However, Tran discloses wherein the user medical information includes activity information which includes steps, heart rate, exercises, training sessions, calories burned, distance covered, average pace or speed, workout intensity levels, rest periods, sleep patterns, sedentary time, active time, exercise goals and achievements, training plans, fitness assessments, heart rate variability, recovery metrics, exercise equipment usage, workout classes attended, personal bests, performance metrics, exercise-related injuries, exercise preferences, and training load in paragraphs [0014] and [0021-0022] and [0025] and [0028-0029] and [0174] and [0201-0212] (user's fitness and health information includes exercises, steps, heart rate, movement speed (synonymous to average pace or speed), calories burned, distance covered, active minutes, heart beats values, exercise pattern, physical activity metrics (synonymous to performance and recovery metrics), exercise goals and achievements, personal bests, training plans, fitness assessments, workout intensity levels, exercise preferences, sleep patterns, rest periods, exercise equipment usage, workout classes attended, exercise-related injuries, and training load).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with activity information, as disclosed by Tran, for the purpose of optimizing user health status and improving health progress tracking, healthcare costs, and disease prevention [0012-0017].
Claims 34 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Gostyla et al. (US-20200135314-A1)[hereinafter Gostyla], in view of Tsui et al. (US-20080246629-A1)[hereinafter Tsui].
As per Claim 34, Gostyla discloses a genetic health information system as claimed in claim 26, Gostyla also discloses wherein information of the user is automatically updated by obtaining medical or activity information from a smart device, wherein the smart device periodically communicates information updates to the repository in paragraphs [0004-0005] and [0033] and [0039] (the user information is automatically updated by obtaining medical information from a device (synonymous to a smart device), wherein the device communicates information updates to the memory).
Gostyla discloses obtaining medical information from a device that communicates information updates to the memory, but does not disclose the device being capable of measuring health related data. However, Tsui discloses wherein information of the user is automatically updated by obtaining medical or activity information from a smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository in paragraphs [0025-0026] and [0044] and [0090-0091] and [0094] and [0101] (user data is automatically updated by obtaining medical or activity information from a mobile device integrated with sensors (synonymous to a smart device), wherein the mobile device is capable of measuring health related data, wherein the mobile device communicates the information updates to the memory).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with a smart device measuring health related data, as disclosed by Tsui, for the purpose of improving costs and quality of life in preventative health care [0003-0006].
As per Claim 44, Gostyla discloses a genetic health information system in paragraphs [0004-0005] and [0024] (personalized medication management and alert system, wherein the personalized medication management and alert system is based on genetic health information) including: a repository on which information of a user is stored, the information including genetic information in paragraphs [0004-0005] (memory storing user information, information including genetic information); and an access control means for controlling access to the user’s information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user in paragraphs [0069-0070] (controlling access to the user's information by allowing a doctor (synonymous to a health practitioner) authorization access to supply the user with healthcare information based on the user's genetic information), wherein information of the user is automatically updated by obtaining medical or activity information from a smart device, wherein the smart device periodically communicates information updates to the repository in paragraphs [0004-0005] and [0033] and [0039] (the user information is automatically updated by obtaining medical information from a device (synonymous to a smart device), wherein the device communicates information updates to the memory).
Gostyla discloses obtaining medical information from a device that communicates information updates to the memory, but does not disclose the device being capable of measuring health related data. However, Tsui discloses wherein information of the user is automatically updated by obtaining medical or activity information from a smart device capable of measuring health related data, wherein the smart device periodically communicates information updates to the repository in paragraphs [0025-0026] and [0044] and [0090-0091] and [0094] and [0101] (user data is automatically updated by obtaining medical or activity information from a mobile device integrated with sensors (synonymous to a smart device), wherein the mobile device is capable of measuring health related data, wherein the mobile device communicates the information updates to the memory).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with a smart device measuring health related data, as disclosed by Tsui, for the purpose of improving costs and quality of life in preventative health care [0003-0006].
Claims 36-40 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Gostyla et al. (US-20200135314-A1)[hereinafter Gostyla], in view of Shen et al. (US-20080172737-A1)[hereinafter Shen].
As per Claim 36, Gostyla discloses a genetic health information system as claimed in claim 26.
Gostyla does not disclose the following limitations. However, Shen discloses wherein the authorising means is initiated by a registered health practitioner upon submission of a request to the particular user, using an identifier of the user, which request is sent to and received by the user's linked personal computing device in paragraphs [0030] and [0050] and [0052-0054] (authorization is initiated by a medical provider (synonymous to a registered health practitioner) requests to the specified patient, using patient identification data (synonymous to an identifier of the user), the request is sent to and received by the patient's device).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with authorising being initiated by a registered health practitioner submitting a request to the particular user, using an identifier and the request is sent to and received by the user’s personal computing device, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
As per Claim 37, Gostyla and Shen disclose a genetic health information system as claimed in claim 36.
Gostyla does not disclose the following limitations. However, Shen discloses wherein the request includes a prompt to grant or deny access to the user's information, wherein upon granting of permission, the user is provided with a TOTP to pass on to the health practitioner for input into the system in paragraphs [0030] and [0050] and [0052-0054] (the request includes a prompt to grant or deny access to medical information, upon granting of access, the healthcare provider will input the authorization ID code (synonymous to a TOTP)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with the request including a prompt to grant or deny access to the user’s information, upon granting permission the user is provided with a TOTP to pass on to the health practitioner for input, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
As per Claim 38, Gostyla and Shen disclose a genetic health information system as claimed in claim 36.
Gostyla does not disclose the following limitations. However, Shen discloses wherein the request includes identification details of the health practitioner requesting access in paragraphs [0052-0054] and [0059] and [0063] (the request includes primary user ID and password (synonymous to identification details) of the healthcare provider requesting access).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with the request includes identification details of the health practitioner requesting access, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
As per Claim 39, Gostyla and Shen disclose a genetic health information system as claimed in claim 37.
Gostyla does not disclose the following limitations. However, Shen discloses wherein successful entry of the TOTP by the health practitioner permits access to the user's profile in paragraphs [0053] and [0059] and [0062] (a successful entry of the authorization ID code by the healthcare provider permits access to the patient's medical record (synonymous to the user's profile)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with the successful entry of the TOTP by the health practitioner permits access to the user’s profile, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
As per Claim 40, Gostyla discloses a genetic health information system as claimed in claim 26 Gostyla also discloses wherein the authorisation means is configured to permit access to the user's profile in paragraphs [0069-0070] (authorization permits access to the user's profile).
Gostyla discloses authorization by permitting access to the user’s profile, but does not disclose permitting the access for a limited time. However, Shen discloses wherein the authorisation means is configured to permit access to the user's profile for a limited time in paragraphs [0030] and [0054] (authorization permits access to the patient's medical record for a limited time).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with permitting access to the user’s profile for a limited time, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
As per Claim 45, Gostyla discloses a genetic health information system in paragraphs [0004-0005] and [0024] (personalized medication management and alert system, wherein the personalized medication management and alert system is based on genetic health information) including: a repository on which information of a user is stored, the information including genetic information in paragraphs [0004-0005] (memory storing user information, information including genetic information); and an access control means for controlling access to the user's information, the access control means including an authorising means for allowing the user to provide a health practitioner with authorisation to access its information to enable the health practitioner to supply the user with healthcare information based on the genetic information of the user in paragraphs [0069-0070] (controlling access to the user's information by allowing a doctor (synonymous to a health practitioner) authorization access to supply the user with healthcare information based on the user's genetic information).
Gostyla does not disclose the following limitations. However, Shen discloses, wherein the authorising means is initiated by a registered health practitioner upon submission of a request to the particular user, using an identifier of the user, which request is sent to and received by the user's linked personal computing device in paragraphs [0030] and [0050] and [0052-0054] (authorization is initiated by a medical provider (synonymous to a registered health practitioner) requests to the specified patient, using patient identification data (synonymous to an identifier of the user), the request is sent to and received by the patient's device), wherein the request includes a prompt to grant or deny access to the user's information, wherein upon granting of permission, the user is provided with a TOTP to pass on to the health practitioner for input into the system in paragraphs [0030] and [0050] and [0052-0054] (the request includes a prompt to grant or deny access to medical information, upon granting of access, the healthcare provider will input the authorization ID code (synonymous to a TOTP)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a genetic health information system, as disclosed by Gostyla, to be combined with authorising being initiated by a registered health practitioner submitting a request to the particular user, using an identifier and the request is sent to and received by the user’s personal computing device, and the request including a prompt to grant or deny access to the user’s information, upon granting permission the user is provided with a TOTP to pass on to the health practitioner for input, as disclosed by Shen, for the purpose of adequately providing flexible and comprehensive access to the patient's medical records without compromising security of sensitive medical information [0004-0010].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ko, H., Song, M. A Study on the Secure User Profiling Structure and Procedure for Home Healthcare Systems (2016) teaches on a secure communication channel using a One-Time Password or OTP to keep patient information secure and prevent security risks.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682