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 .
Remarks
In response to communications sent July 11, 2022 claim(s) 1-20 are pending in this application; of these claim 1 is in independent form.
Response to Amendment
The preliminary amendments to the claims and specification that were filed July 11, 2022 are acknowledged and have been entered into the record.
Drawings
The drawing(s) filed on July 11, 2022 are accepted by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Note that the priority document, EP20151044.3, includes 13 figures instead of 23 and has less textual description in the specification that would correspond to the missing figures. The difference between the foreign priority document and the PCT application appears to be mainly the teachings of the Patient Digital Signatures. Nevertheless, the claims of the preliminary amendment sent July 11, 2022 do not recite this concept. Furthermore, the priority document, EP20151044.3, includes similar claims to the instant application. And the new claims in the preliminary amendment appear to mention elements recited in the specification of the priority document EP20151044.3. Therefore, the claims of the instant application are afforded the earlier filing date of January 9, 2020.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: July 11, 2022 and January 3, 2023.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 14 is objected to because of the following informalities: The claim omits the character “(i)” as part of the list containing “(ii)”, … etc. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: The claim omits a period. Appropriate correction is required.
Claim Interpretation
The phrase “and/or” is interpreted as “or” under the broadest reasonable interpretation.
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 17 and 20 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 17 recites the limitation "the imaging techniques”, “the physical tests", and “the biomarker determination” in lines 1-5. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending claim 17 to depend from claim 4 instead of claim 3.
Claim 20 recites the limitation "the pharmaceutical composition" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending claim 20 to recite “the method of claim 13” and “the treatment” instead of “the pharmaceutical composition”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 recites “the pharmaceutical composition of claim 13”; however claim 13 is a process claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process, a type of abstract idea. This judicial exception is not integrated into a practical application because mental processes are the entirety of the claims, with the following exceptions: claims 14 and 15 recite a general purpose computer that merely “applies” the mental process; claim 17 recites imaging and laboratory techniques that are not integrated into a practical application but instead are necessary pre-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are well-understood, routine, and conventional. The laboratory techniques of claim 17 are “Determining the level of a biomarker in blood by any means,” Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). Regarding claim 17, the MRI is well-understood, routine, and conventional based on US 20100203569 A1, US 20210003570 A1, US 20130184173 A1, US 20130184167 A1, and US 20190127798 A1, which all mention MRI in the context of diagnostic informatics.
Claims 13 and 20 are not rejected because it recites a particular treatment or prophylaxis that are guided by the mental process.
1. A method for providing a state of a disease in a subject (this is a statutory class of a process), the method comprising the steps of:
a) determining at least two parameters indicative of a disease state in the subject at a first time point (an evaluation that can be performed in the human mind, a type of mental process, a judicial exception);
b) combining the determined parameters in a) to provide a signature indicative of the disease state at the first time point (an evaluation that can be performed in the human mind, a type of mental process, a judicial exception);
c) repeating steps a) and b) to provide at least one further signature at a second time point (repeated mental process noted above; repetitions of mental processes are still mental processes);
d) combining the provided signatures in step c) to provide a progression marker indicative of the disease state in the subject (an evaluation that can be performed in the human mind, a type of mental process, a judicial exception).
2. The method of claim 1, further comprising step e) repeating steps a) to d) in order to monitor disease progression in the subject based on an alteration of a final signature provided in step d) (repeated mental process noted above; repetitions of mental processes are still mental processes).
3. The method of claim 1, wherein the disease is a disease of the central nervous system (CNS) (a limitation to the mental process noted in the independent claim).
4. The method of claim 1, wherein the at least two parameters are provided based on data obtained from:
imaging techniques (broadest reasonable interpretation includes simplistic data about images that does not require much computational intensity; hence it is a limitation to a mental process note for the independent claim);
(ii) patient surveys regarding symptoms experienced by the subject (an evaluation that can be performed in the human mind, a type of mental process, a judicial exception; may involve the aid of paper and pencil);
(iii) environment data including weather information, vision tests, social interaction assessment, quality of life (a limitation to the mental process noted in the independent claim);
(iv) cognitive tests (a limitation to the mental process noted in the independent claim);
(v) physical tests (a limitation to the mental process noted in the independent claim; using the data from the physical tests are a mental process); and/or
(vi) biochemical marker determination (a limitation to the mental process noted in the independent claim; using the data from the biomarker identification is a mental process).
5. The method of claim 4, wherein
the cognitive tests comprise eSDMT, language testing, problem solving testing, memory testing, focus testing, mood testing and/or mental agility testing (mental processes typically performed by a doctor); and/or
the physical tests comprise walking, tight rope, climbing stairs, wobbler, U-turn, musical chairs, figures writing, screen to nose, cuddle a cloud, standing-up/sitting-down, level of activity, sleep, and/or heart rate (data from tests is a mental process; the tests result in data according to parent-claim 4).
6. The method of claim 4, wherein data results from passive data collection and/or wherein data results from active data collection (insignificant pre-solution activity; it is well-understood, routine, and conventional based on similarity to “using the Internet to gather data”, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362; this claim has only this individual element that is not abstract, therefore the combination of additional elements is well-understood routine and conventional).
7. The method of claim 1, wherein at least one parameter is determined by or using a mobile device (applying a mental process with the aid of a general purpose computer, but the mental process can be performed with paper and pen; applying a mental process on a general purpose computer is well-understood routine and conventional; see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); this claim has only this individual element that is not abstract, therefore the combination of additional elements is well-understood routine and conventional).
8. The method of claim 2, wherein the respective method steps are repeated according to steps c) or e), respectively, after a time interval determined based on the disease state (limitations to the timing of the mental process are still a mental process).
9. The method of claim 2, the method further comprising a step of selecting the parameters to be determined in step a) based on the disease state and/or disease progression (limitations to the mental process are a mental process).
10. The method of claim 1, wherein in steps b) and/or d), the parameters and/or signatures are combined in a weighted manner (limitations to the mental process are a mental process).
11. The method of claim 1, wherein the method comprises using statistical methods, pattern recognition techniques, digital image processing, and/or artificial intelligence techniques (small and simple instances of each of these techniques can be performed with paper and pen; the broadest reasonable interpretation of the claim includes the small and simple instances).
12. A method for determining efficacy of therapy of a disease, the method comprising using the method of claim 2, wherein therapy is determined to be efficient if the alteration of the final signature provided in step d) is below a pre-determined threshold (limitations to the mental process are a mental process).
14. A mobile device comprising a processor, at least one sensor, a database and software which is tangibly embedded in said device and, when running on said device, carries out the method of claim 1 (applying a mental process on a general purpose computer; applying a mental process on a general purpose computer is well-understood routine and conventional; see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); this claim has only this individual element that is not abstract, therefore the combination of additional elements is well-understood routine and conventional).
15. A system comprising a mobile device comprising at least one sensor and a remote device comprising a processor and a database as well as software which is tangibly embedded to said device and, when running on said device, carries out the method of claim 1, wherein said mobile device and said remote device are operatively linked to each other (applying a mental process on a general purpose computer; applying a mental process on a general purpose computer is well-understood routine and conventional; see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); this claim has only this individual element that is not abstract, therefore the combination of additional elements is well-understood routine and conventional).
16. The method of claim 3, wherein the disease of the CNS is multiple sclerosis (MS), progressing MS, relapsing-remitting MS with clinical disease activity, relapsing-remitting MS with disability progression, secondary progressive MS, secondary progressive MS with disability progression, primary progressive MS, or primary progressive MS with disability progression (limitations to the mental process are a mental process)
17. The method of claim 3, wherein the imaging techniques includes magnetic resonance imaging (MRI) and/or optical coherence tomography (OCT) (pre-solution activity that is well-understood, routine, and conventional imaging techniques; for evidence, see US 20100203569 A1, US 20210003570 A1, US 20130184173 A1, US 20130184167 A1, and US 20190127798 A1, which all mention MRI in the context of diagnostic informatics; the examiner argues that the combination of imaging diagnostics and laboratory diagnostics is well-understood, routine, and conventional tasks performed by doctors in combination and are therefore not significantly more than the abstract idea);
wherein the physical tests comprises testing motoric and/or fine motoric capabilities and/or function, walking, vision, sleep (mental process handling of data derived from physical tests); and
wherein the biochemical marker determination comprises determining a biochemical marker from a sample obtained from the subject, wherein the sample comprises blood, spinal cord fluid, cerebral spinal fluid, saliva and/or lymph (pre-solution activity that is well-understood, routine, and conventional laboratory techniques; these are determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017); the examiner argues that the combination of imaging diagnostics and laboratory diagnostics is well-understood, routine, and conventional tasks performed by doctors in combination and are therefore not significantly more than the abstract idea).
18. The method of claim 7, wherein said mobile device comprises a smartphone, smartwatch, wearable sensor, portable multimedia device or tablet computer (applying a mental process on a general purpose computer; applying a mental process on a general purpose computer is well-understood routine and conventional; see Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); this claim has only this individual element that is not abstract, therefore the combination of additional elements is well-understood routine and conventional).
19. The method of claim 11, wherein the artificial intelligence techniques includes machine learning and/or neural networks, wherein the used method/technique is adapted based on the provided signatures (small and simple instances of each of these techniques can be performed with paper and pen; the broadest reasonable interpretation of the claim includes the small and simple instances; therefore these elements are mental processes).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017181147 A1 (“Hagstrom”).
As to claim 1, Hagstrom teaches a method for providing a state of a disease in a subject (Hagstrom Para [0006]: method for providing a prediction about the state of multiple sclerosis in an individual), the method comprising the steps of:
a) determining at least two parameters indicative of a disease state in the subject at a first time point (Hagstrom Para [0067]: a multivariate model involving two or more biomarkers);
b) combining the determined parameters in a) to provide a signature indicative of the disease state at the first time point (Hagstrom Para [0066]: combining the biomarker data from samples with clinical assessments as an input into a predictive model; the Examiner interprets the paired dataset of biomarker & clinical assessment data to be a “signature”);
c) repeating steps a) and b) to provide at least one further signature at a second time point (Hagstrom Para [0066]: providing the observations from multiple time points using a longitudinal study approach);
d) combining the provided signatures in step c) to provide a progression marker indicative of the disease state in the subject (Hagstrom Para [0066]: provide a validated predictive model based on the data from the longitudinal studies that use the combination of biomarkers and clinical states as inputs; Hagstrom Para [0006] teaches that the prediction is an assessment of the disease activity and risk of progressing to a relapse).
As to claim 2, Hagstrom teaches the method of claim 1, further comprising step e) repeating steps a) to d) in order to monitor disease progression in the subject based on an alteration of a final signature provided in step d) (Hagstrom Para [0002]: the data from the predictive model can be used for patient monitoring regarding multiple sclerosis).
As to claim 3, Hagstrom teaches the method of claim 1, wherein the disease is a disease of the central nervous system (CNS) (Hagstrom Para [0006]: multiple sclerosis).
As to claim 4, Hagstrom teaches the method of claim 1, wherein the at least two parameters are provided based on data obtained from:
imaging techniques (Hagstrom Para [0102]: MIR Image data);
(ii) patient surveys regarding symptoms experienced by the subject (Hagstrom Para [0075]: an EDSS score, which the Examiner interprets as a survey used to assess symptoms of multiple sclerosis);
(iii) environment data including weather information (these elements are recited in the alternative and therefore don’t need to all be mapped), vision tests (Hagstrom Para [0074]: vision information), social interaction assessment (these elements are recited in the alternative and therefore don’t need to all be mapped), quality of life (these elements are in the alternative and do not all need to be mapped);
(iv) cognitive tests (this element is claimed in the alternative and does not need to be mapped);
(v) physical tests (this element is claimed in the alternative and does not need to be mapped); and/or
(vi) biochemical marker determination (Hagstrom Para [0036]: biomarker determination).
As to claim 5, Hagstrom teaches the method of claim 4, wherein
the cognitive tests comprise eSDMT, language testing, problem solving testing, memory testing, focus testing, mood testing and/or mental agility testing (this element is claimed in the alternative and does not need to be mapped); and/or
the physical tests comprise walking (Hagstrom Para [0074]: mobility as a test for symptoms), tight rope (Hagstrom Para [0074]: balance as a test for symptoms), climbing stairs, wobbler , U-turn, musical chairs, figures writing, screen to nose, cuddle a cloud, standing-up/sitting-down, level of activity, sleep, and/or heart rate (these elements are claimed in the alternative and do not need to all be mapped).
As to claim 6, Hagstrom teaches the method of claim 4, wherein data results from passive data collection (these elements are in the alternative, and therefor do not need to be mapped) and/or wherein data results from active data collection (Hagstrom Para [0058]: blood samples taken via biopsy; the Examiner interprets that blood tests are active data collection).
As to claim 7, Hagstrom teaches the method of claim 1, wherein at least one parameter is determined by or using a mobile device (Hagstrom Para [0077]: at least one datum is determined by accessing a server to retrieve laboratory data).
As to claim 8, Hagstrom teaches the method of claim 2, wherein the respective method steps are repeated according to steps c) or e), respectively, after a time interval determined based on the disease state (Hagstrom Para [0066]: longitudinal studies over multiple time points that are determined based on the observations of subjects with a disease state).
As to claim 9, Hagstrom teaches the method of claim 2, the method further comprising a step of selecting the parameters to be determined in step a) based on the disease state and/or disease progression (Hagstrom Para [0067]: teaches various methods for determining the most important biomarkers by learning from disease states for a predictive model that relies on biomarker training data).
As to claim 10, Hagstrom teaches the method of claim 1, wherein in steps b) and/or d), the parameters and/or signatures are combined in a weighted manner (Hagstrom Para [0067]: the parameters are combined using weights because they are subject to a linear regression).
As to claim 11, Hagstrom teaches the method of claim 1, wherein the method comprises using statistical methods (Hagstrom Para [0067]: using a linear regression technique), pattern recognition techniques (Hagstrom Para [0082]: observing patterns using florescence using an automatic reader), digital image processing (Hagstrom Para [0075]: using Magnetic Resonance Imaging, MRI, which entails some digital image processing from raw signals), and/or artificial intelligence techniques (Hagstrom Para [0067]: using a neural network).
As to claim 12, Hagstrom teaches a method for determining efficacy of therapy of a disease (Hagstrom Para [0115]: a prediction demonstrating a therapeutic efficacy), the method comprising using the method of claim 2, wherein therapy is determined to be efficient if the alteration of the final signature provided in step d) is below a pre-determined threshold (Hagstrom Para [0120]: administration of a treatment by eliminating the disease, which the examiner interprets to have a threshold of any value slightly above zero; see also Hagstrom Para [0115]).
As to claim 13, Hagstrom teaches a method of treating a subject with a disease of the central nervous system (CNS) (Hagstrom Para [0006]: multiple sclerosis), wherein treatment is initiated/adapted based on the disease state and/or progression of the disease determined by the method of claim 1 (Hagstrom Para [0108]: the assessment of multiple sclerosis activity is informative for determining the course of treatment for the individual), wherein treatment administered to the subject comprises interferon beta-1a, interferon beta-1b (this element is claimed in the alternative and does not need to be mapped), an agent specifically binding to CD52 (Hagstrom Para [0117]: a therapeutic agent of alemtuzumab, a CD52 antibody), an agent specifically-binding to CD20, an agent specifically binding to integrin (these elements are claimed in the alternative and do not need to all be mapped).
As to claim 14, Hagstrom teaches a mobile device comprising a processor (Hagstrom Para [0002]: a processor), at least one sensor (Hagstrom Para [0002]: an input device), a database (Hagstrom Para [0002]: a database) and software which is tangibly embedded in said device (Hagstrom Para [0002]: software on machine readable data storage) and, when running on said device, carries out the method of claim 1 (Hagstrom Para [0001]: the computer performing the assessment of multiple sclerosis activity).
As to claim 15, Hagstrom teaches a system comprising a mobile device comprising at least one sensor(Hagstrom Para [0002]: an input device) and a remote device comprising a processor and a database as well as software which is tangibly embedded to said device (Hagstrom Para [0123]: a server farm) and, when running on said device, carries out the method of claim 1, wherein said mobile device and said remote device are operatively linked to each other (Hagstrom Para [0123]: computers connected through a network).
As to claim 16, Hagstrom teaches the method of claim 3, wherein the disease of the CNS is multiple sclerosis (MS) (Hagstrom Para [0006]: multiple sclerosis), progressing MS (Hagstrom Para [0052]: progressive multiple sclerosis), relapsing-remitting MS with clinical disease activity (Hagstrom Para [0052]: relapse-remitting multiple sclerosis), relapsing-remitting MS with disability progression (this element is claimed in the alternative and does not need to be mapped), secondary progressive MS (Hagstrom Para [0052]: secondary progressive multiple sclerosis), secondary progressive MS with disability progression (this element is claimed in the alternative and does not need to be mapped), primary progressive MS (Hagstrom Para [0052]: primary-progressive multiple sclerosis), or primary progressive MS with disability progression (this element is claimed in the alternative and does not need to be mapped)
As to claim 17, Hagstrom teaches the method of claim 3, wherein the imaging techniques includes magnetic resonance imaging (MRI) (Hagstrom Para [0075]: using Magnetic Resonance Imaging, MRI) and/or optical coherence tomography (OCT) (this element is claimed in the alternative and does not need to be mapped);
wherein the physical tests comprises testing motoric and/or fine motoric capabilities (these elements are claimed in the alternative and do not need to be mapped) and/or function, walking (Hagstrom Para [0074]: mobility as a test for symptoms), vision (Hagstrom Para [0074]: vision information), sleep (this element is claimed in the alternative and does not need to be mapped); and
wherein the biochemical marker determination comprises determining a biochemical marker from a sample obtained from the subject (Hagstrom Para [0077]: markers from a sample), wherein the sample comprises blood (Hagstrom Para [0077]: blood), spinal cord fluid (this element is claimed in the alternative and does not need to be mapped)), cerebral spinal fluid (Hagstrom Para [0077]: cerebrospinal fluid), saliva (Hagstrom Para [0077]: saliva) and/or lymph (Hagstrom Para [0077]: lymph).
As to claim 19, Hagstrom teaches the method of claim 11, wherein the artificial intelligence techniques includes machine learning (Hagstrom Para [0067]: machine learning) and/or neural networks (Hagstrom Para [0067]: neural network), wherein the used method/technique is adapted based on the provided signatures (Hagstrom Para [0067]: the method is built based on the biomarker selections).
As to claim 20, Hagstrom teaches the pharmaceutical composition of claim 13, wherein the pharmaceutical composition comprises glatiramer (Hagstrom Para [0117]: glatiramer), teriflunomide (Hagstrom Para [0117]: iteriflunomide), fingolimod (Hagstrom Para [0117]: fingolimod), dimethyl fumarate (Hagstrom Para [0117]: dimethyl fumarate), Siponimod (this element is claimed in the alternative and does not need to be mapped), cladribine (Hagstrom Para [0117]: cladribine), alemtuzumab (Hagstrom Para [0117]: alemtuzumab), mitoxantrone (this element is claimed in the alternative and does not need to be mapped), ocrelizumab (Hagstrom Para [0117]: ocrelizumab) and/or natalizumab (Hagstrom Para [0117]: natalizumab).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017181147 A1 (“Hagstrom”) in view of US 20160022167 A1 (“Simon”).
As to claim 18, Hagstrom teaches the method of claim 7, but does not teach wherein said mobile device comprises a smartphone, smartwatch, wearable sensor, portable multimedia device or tablet computer.
Nevertheless Simon teaches wherein said mobile device comprises a smartphone, smartwatch, wearable sensor, portable multimedia device or tablet computer (Simon Para [0007]-[0008]: using a smartphone as part of a multimodal input system for streams of biological sensor data intended for diagnostic purposes).
Hagstrom and Simon are in the same field of health informatics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hagstrom to include the teachings of Simon because multiple streams of real-time data help provide a more dynamic diagnosis (See Simon Para [0002]). There would be a reasonable expectation of success because Hagstrom already teaches a personal computer “of conventional design” (Hagstrom Para [0002]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20260045347 A1 pertinence: progression signature; continuation in part
US 20210003570 A1 pertinence: biomarker profiles for multiple sclerosis progression risk; involves an "earlier timepoint"; biosensor devices; age (a type of clinical information); specific treatments for multiple sclerosis; random forests
US 20160232324 A1 pertinence: progression through disease states; uses Hidden Markov Models
US 20130184173 A1 pertinence: biomarker progression in multiple sclerosis
US 20130184167 A1 pertinence: genetic markers for multiple sclerosis
US 20120071339 A1 pertinence: biomarkers for multiple sclerosis
US 20100203569 A1 pertinence: multiple sclerosis risk based on multiple markers
Tremlett, Helen, et al. "Serum proteomics in multiple sclerosis disease progression." Journal of proteomics 118 (2015): 2-11.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jesse P Frumkin whose telephone number is (571)270-1849. The examiner can normally be reached Monday - Saturday, 10-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSE P FRUMKIN/ Primary Examiner, Art Unit 1685 April 13, 2026