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 .
Detailed Action
Summary
This is the Final Office Action based on application 18/027609 election response filed 03/30/2026.
Claims 1-2, 10-13, & 56-57 are pending and have been fully examined.
Claims 3-9 & 14-55 are cancelled.
Claim 57 is newly added.
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.
The claimed invention of claims 1-2, 10-13, & 56-57 are rejected under 101 because they are directed to a natural correlation without significantly more.
Through 101, inquiry analysis:
Step 1: Is the claim directed to a statutory category of invention?
Yes, independent Claim 1 and the claims that depend therefrom are drawn towards a statutory category of a method.
Step 2A, Prong One: Identify if there is a law of nature/natural phenomenon/abstract ideas.
For independent Claim 1 and those dependent therefrom, they recite the relationship/natural correlation of the claimed biomarkers (wherein the biomarker is L-malic acid, fumaric acid, and HPHPA) with autism spectrum disorder. This is a natural correlation/law of nature judicial exception (shown in the comparison of biomarkers levels to a control, and identifying the patient is affected/needing treatment based on that).
Claim 1 and those dependent therefrom also contain limitations for “determining,” “risk,” and “comparing,” values to a control and dependent on the comparison the “identifying,” which as claimed is akin to diagnosing happens. These things as claimed are mental processes which are abstract idea judicial exceptions.
Further, Claim 1 recites, “assessing or determining,” and “comparing,” to a control which is an ASD negative individual and “identifying,” which are all mental processes or simple math and therefore abstract idea judicial exceptions.
Step 2A Prong Two: Are the judicial exceptions integrated into practical application?
The judicial exceptions are not integrated into a practical application in independent claim 1.
Claim 1 recites the additional elements including:
“measuring,”
providing a blood, plasma, serum, or urine same; and
“treating the subject in need thereof,” “with an ASD treatment regime.”
The claimed providing of a biological sample does nothing to practically apply the judicial exceptions. It is pulled (and the determining or assessing) happens from there to use the claimed natural correlation judicial exception. Therefore—as claimed it is extra-solution activity.
With respect to the claimed, “measuring,” no actual measuring or detecting takes place and instead the levels of the claimed biomarkers are done through, “determining or assessing,” of what is in a biological sample. Even if general measurement device was claimed, such as GC-MS--- for general measuring and especially when recited at a high level of generality, there is no meaningful limitation, such as a particular machine or a transformation of a particular article. As claimed the measuring is done to gather data to perform the claimed judicial exceptions and there is nothing claimed which distinguishes it from conventional data gathering activity. Data gathering to be used in an abstract idea or with the claimed natural correlation, is insignificant extra-solution activity, and therefore not a particular practical application. See MPEP 2106.05(g).
Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (or natural correlation) (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
Further—after the biomarker levels are determined (data is gathered) and a judicial exception of “comparing,” and the implicit diagnosis is performed and then a treatment is performed “when,” they satisfy certain conditions. The examiner notes that applicant has replaced, “ if,” with “when.” Both of these terms read conditionally though- making the following treatment not always required to occur, but only “when” certain conditions are present. Claiming that the conditions are specifically measured or detected could help solve this issues, however it will not take care of all issues with respect to the 101.
It is further claimed that a microbiota- modifying therapy is administered to the subject in need thereof when ASD is found and that the microbiota-modifying therapy is one and/or two, or three of a (1) probiotic or nutritional supplement, (2) a reduced carbohydrate diet, and or a ketogenic diet. None of these “therapy,”/ies are considered to be specific though as they are just human diet. Any ingested material can be considered to be a “nutritional supplement,” and probiotics, reduced carbohydrate, a ketogenic diets are eaten by many on a regular basis, even without trying to specifically adhere to a “diet,” per say. Therefore- there is no practical application through particular and specific treatment here.
See MPEP 2106.04(d)(2)(a)- with respect to what a particular treatment is and is not and also the Vanda memorandum.
Step 2B: Do the claims recite any elements which are significantly more than the judicial exceptions?
Independent Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no particularity or specificity of measurement, detection, treatment, or other limitations that makes the claims significantly more than the claimed judicial exceptions.
Claim 1 recites the additional elements including:
providing a blood, plasma, serum, or urine same;
“measuring,” and
“treating the subject in need thereof,” “with an ASD treatment regime.”
Both the claimed providing of a biological sample, the claimed general “measuring,” and the claimed generalized treatment for autism do nothing to add significantly more to the judicial exceptions.
Taking of a blood sample or other biological sample from a patient, “measuring,” and treatment for the disease that that is diagnosed (autism) are things that are well-understood, routine and conventional activity (WURC) for those in the field of diagnostics. This is evidenced by the fact that prior art teaches of them, and is especially true at the level of generality claimed.
Further MPEP 2106.05 (d) II for examples of laboratory techniques that have been shown to be routine and conventional. “The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity…”
Further claimed microbiota- modifying therapy is administered to the subject in need thereof when ASD is found and that the microbiota-modifying therapy is one and/or two, or three of a (1) probiotic or nutritional supplement, (2) a reduced carbohydrate diet, and or a ketogenic diet. All of these “therapy,”/ies are considered though to be well understood, routine and conventional in the art, as they are just human diet. Any ingested material can be considered to be a “nutritional supplement,” and probiotics, reduced carbohydrate, a ketogenic diets are eaten by many on a regular basis, even without trying to specifically adhere to a “diet,” per say.
The dependent claims undergo a similar analysis.
Claim 2 does not change the matters above. It adds that a spectroscopy technique is used. This remains a mechanism to perform a data pull to accomplish the judicial exceptions, so does not practically apply. Spectroscopy is also WURC in the art so does not add significantly more.
Claim 10 does not change the matters above. It adds that a spectroscopy technique which could be something like GC-MS is used. This remains a mechanism to perform a data pull to accomplish the judicial exceptions, so does not practically apply. GC-MS and the other claimed detection techniques are also WURC in the art so does not add significantly more.
Claim 11 does not change the matters above. It claims that the claimed comparing/comparison is done using a multivariate statistical analysis. However, at the level of generality claimed comparing using multivariate statistical analysis, still reads as performing general math by the human mind. Therefore, this is an abstract idea and does nothing to practically apply, nor does it add significantly more.
Claim 12, does not change the matters above. It claims that the claimed comparing/comparison is done using a multivariate statistical analysis which is either principal component analysis or partial least squares projects to latent structures. However, at the level of generality claimed comparing using the claimed multivariate statistical analysis, still reads as performing general math by the human mind. Therefore, this is an abstract idea and does nothing to practically apply, nor does it add significantly more.
Claim 13 does not change the matters above. It specifies where/who the sample is taken from. However a biological sample is still a biological sample. Taking the sample is used for data pull to perform the judicial exceptions so does not practically apply. It is also WURC so does not add significantly more.
Claim 56 does not change the matters above. Claim 56 adds that the spectroscopy unit is linked to a communication technology or processing device, directly or wirelessly and that the processing device has a memory which can store measurement data. However, again, at the level of generality claimed, this does not to practically apply the judicial exceptions. Also linking spectroscopy units to communication technology or processing device, directly or wirelessly and processing devices with memory which can store measurement data are WURC in the art so does not add significantly more.
Claim 57 does not change matters above. It just specifies that the treatment is repeated or that another of the claim possible treatments in Claim 1 is administered “when,” certain conditions are met. As the treatments have not changed from Claim 1, nor has the “when,” this carries the same analysis are for the treatments in Claim 1.
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 1-2, 10-13, & 56-57 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.
With respect to Claim 1, the phrase, “in need thereof” in claim preamble and claim body is a relative term which renders the claim indefinite. The term “in need thereof,” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase, “in need thereof,” can mean different things to different people so is unclear in the claim. One person might think a person with autism spectrum disorder having the same symptoms might need treatment, while another person might not think the same person needs treatment. Therefore, this is a relative term and requires correction.
Further with respect to Claim 1, in step d), i) & ii)--- “at least about 2 times or less,” is confusing/unclear since the phrase requires “ at least,” “about 2 times,” but can also be “or less,” meaning that the levels do not need to be “at least about 2 times.” What the required level is, is unclear in the claims and requires correction. Are there words missing here?
With respect to Claim 11, it depends on Claim 1, however, “4-hydroxymandelic acid,” is not required in Claim 1 and instead fumaric acid is claimed in addition to the other two biomarkers of L-malic acid and HPHPA. Therefore, it is unclear if applicant is no longer using fumaric acid in Claim 11, or if the inclusion of 4-hydroxymandelic acid is being further added, or if instead it is a typo. Applicant should clear this up in the claims. (4 hydroxymandelic acid is also in Claims 3-4, but is claimed as sort of a potential treatment wherein the level of it can be adjusted).
Further with respect to Claim 1, “reduced,” in “reduced carbohydrate,” is a relative term that could mean something different to different people reading the invention. Therefore, it is a relative term and not clear in the claim language.
Claims 2, 10-13, & 56-57 are also rejected due to their dependency on Claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
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.
Claims 1-2, 10-13, & 56-57 are rejected under 35 U.S.C. 103 as being obvious over YOU in US 20220373563 in view of XIONG in Urinary3-(3-Hydroxyphenyl)-3-hydroxypropionid Acid, 3-Hydroxyphenylacetic Acid, and 3-Hydroxyhippuric Acid Are Elevated in Children with Autism Spectrum Disorders
(as cited on IDS dated 06/14/2023) and further in view of HSIAO in US 20140065132.
With respect to Claim 1, YOU teaches of a method of diagnosis and of a device using a metabolite as a marker. The method comprises: measuring the content of at least one marker in a sample of a subject and comparing same with the content of the corresponding marker in a healthy control, and of using an algorithm constructed by machine learning to process the content of the marker. Particularly, the marker is a metabolite in human urine or blood. The change pattern of a metabolite in urine is mined by means of a machine learning algorithm to provide diagnoses for children suffering from ASD. The device based on a predetermined algorithm provided by the present application can provide a new strategy for diagnosis of ASD (abstract, paragraph 0013).
YOU more specifically teaches of assessing for the presence of metabolites/ a metabolite profile including fumaric acid, and malic acid (paragraphs 0016-0017). (L-malic acid as claimed, is the naturally occurring, biologically active form of malic acid and is the form of malic acid that is metabolized for energy in the human body. DL malic acid is synthetic and not naturally found in living systems, but DL-malic acid is commonly used in supplements and drinks.) YOU even further teaches of assessing for HPHPA (Table I).
YOU even further teaches of using the method for early treatment of autism spectrum disorder--- which reads on the broadly claimed “treating the subject in need thereof with an ASD treatment regimen,” since any treatment for ASD can be considered an ASD treatment regimen (paragraph 0003).
More specifically to the claims, YOU teaches of providing the sample (paragraph 0005) wherein the sample is urine or blood sample (paragraph 0013), using gas chromatography and mass spectrometry (paragraphs 0050-0051). As shown by the instant application (see instant application, Claim 10—applicant considers gas chromatography and gas chromatography mass spectrometry a spectroscopic technique,
Detecting/measuring the content of the biomarkers (paragraph 0006, 0050-0051),
Using machine learning algorithm to process/ “assessing,” data as claimed to obtain a mathematical model for diagnosing autism spectrum (paragraph 0007), and
Comparing the concentration levels of the measured biomarkers to a control sample taken from an ASD-negative individual (YOU teaches the control group being a healthy group, which in this context means autism negative (abstract, paragraph 0091), through broadest reasonable interpretation (BRI)),
Identifying a subject in need to treatment if the measured concentration of fumaric and malic acid are less than the control sample (Table 3). This less than reads on the claimed ranged of identifying, the levels of fumaric acid and malic acid being “at least about 2 times or less than the levels,” since the levels can just be “less than,” “the at least about 2 times,” in comparison to control through broadest reasonable interpretation as this limitation is unclear as shown in the 112 rejection.
YOU does not teach specifically of HPHPA being at least 10 times greater than found in the control, or of fumaric and malic acid being specifically two times less than the control. Further, though YOU teaches of using the method to identify early treatment, YOU does not teach of a positive treatment step.
XIONG is used to remedy this and more specifically teaches of a GC- MS method to detect biomarkers of autism where HPHPA is measured as a biomarker (abstract). Further, XIONG teaches that the measured levels in autism patients of HPHPA are over 10 times greater than those in the control patients (looking at the mean levels on Table 1).
Even further, XIONG teaches of administering oral vancomycin treatment to the patient with autism who has high levels of HPHPA (abstract).Vancomycin is a treatment which adjusts the composition of gut microbiota.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of measuring HPHPA levels 10 times or more higher than control and then treating the patient as is done in XIONG in the method of YOU due to the advantages such treatment with vancomycin has shown for treatment as patients have shown improved eye contact and communication and also with respect to intestinal symptoms in children with autism (Page 4, column 1 & column 2, first paragraph).
YOU and XIONG do not teach of the claimed treatment of ASD with a probiotic or nutritional supplement, a reduced carbohydrate, or ketogenic diet.
HSIAO is used to remedy this and teaches of a method for diagnosis and treatment of autism spectrum disorder (abstract). HSIAO further teaches of administering a probiotic treatment to the patient with autism spectrum disorder (paragraph 0022, 0047), which also includes other nutritional supplements (paragraph 0059, 0077), and even further of repeat or administering the supplement again over time (paragraph 0057-0059) until it is administered in “adequate amounts,” (paragraph 0059) and of adjusting treating to higher levels/giving more treatment is a clinical response is not adequate (paragraph 0093).
It would have been obvious to one of ordinary skill in the art to treat a patient with ASD with nutritional supplements as is done in HSIAO in the methods of YOU an XIONG due to the advantage probiotics have for ameliorating gastrointestional distress (HSIAO, paragraph 0017, 0022).
With respect to Claim 2, YOU teaches of measuring urine or blood sample (paragraph 0013) using gas chromatography and mass spectrometry(paragraphs 0050-0051). As shown by the instant application(see instant application Claim 10, applicant considered gas chromatography and GC-MS a spectroscopic technique).
With respect to Claim 10, YOU teaches of measuring a urine or blood sample (paragraph 0013), using gas chromatography and mass spectrometry (paragraphs 0050-0051).
With respect to Claim 11, YOU teaches of using a multivariate statistical analysis which is partial least squares (paragraph 0011, 0057, 0097, 0014-0015).
With respect to Claim 12, YOU teaches of using a multivariate statistical analysis which is partial least squares (paragraph 0011, 0057, 0097, 0014-0015).
YOU does not teach of using principal component analysis.
XIONG teaches of analysis of the data by principal component analysis/PCA (Page 2, column 2, paragraph 2, last 2 lines).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success due to the advantage PCA has for differentiating samples (Page 2, column 2, last paragraph, lines 1-3).
With respect to Claim 13, YOU teaches of the subject being a child who is 3 years or younger (paragraph 0032, 0069). YOU also teaches of using an autism group and a control group (paragraph 0098). Also- YOU teaches of the control group being a healthy group, which in this context means autism negative (abstract, paragraph 0091). The healthy groups read on the ASD- negative sample groups.
With respect to Claim 56, YOU teaches of measuring a urine or blood sample (paragraph 0013), using gas chromatography and mass spectrometry (paragraphs 0050-0051). As shown by the instant application (see instant application, Claim 10—applicant considers gas chromatography and gas chromatography mass spectrometry a spectroscopic technique). YOU further teaches of using a machine learning algorithm, which is an algorithm used by a computer (which has a processor/processing device and memory) to simulate or implement human learning behaviors (paragraph 0074, 0075). The machine learning algorithm processes the data to obtain a diagnostic algorithm for autism (paragraph 0007, 0009, 0028-0029, 0095-0096, Table IV). Since the data from the gas chromatography mass spectrometry is used by the machine learning algorithm, that means it is “directly or wirelessly linked,” to a processing device through broadest reasonable interpretation (BRI)).
With respect to Claim 57, YOU teaches of a method of diagnosis and of a device using a metabolite as a marker. The method comprises: measuring the content of at least one marker in a sample of a subject and comparing same with the content of the corresponding marker in a healthy control, and of using an algorithm constructed by machine learning to process the content of the marker. Particularly, the marker is a metabolite in human urine or blood. The change pattern of a metabolite in urine is mined by means of a machine learning algorithm to provide diagnoses for children suffering from ASD. The device based on a predetermined algorithm provided by the present application can provide a new strategy for diagnosis of ASD (abstract, paragraph 0013).
YOU more specifically teaches of assessing for the presence of metabolites/ a metabolite profile including fumaric acid, and malic acid (paragraphs 0016-0017). (L-malic acid as claimed, is the naturally occurring, biologically active form of malic acid and is the form of malic acid that is metabolized for energy in the human body. DL malic acid is synthetic and not naturally found in living systems, but DL-malic acid is commonly used in supplements and drinks.) YOU even further teaches of assessing for HPHPA (Table I).
YOU even further teaches of using the method for early treatment of autism spectrum disorder--- which reads on the broadly claimed “treating the subject in need thereof with an ASD treatment regimen,” since any treatment for ASD can be considered an ASD treatment regimen (paragraph 0003).
More specifically to the claims, YOU teaches of providing the sample (paragraph 0005) wherein the sample is urine or blood sample (paragraph 0013), using gas chromatography and mass spectrometry (paragraphs 0050-0051). As shown by the instant application (see instant application, Claim 10—applicant considers gas chromatography and gas chromatography mass spectrometry a spectroscopic technique,
Detecting/measuring the content of the biomarkers (paragraph 0006, 0050-0051),
Using machine learning algorithm to process/ “assessing,” data as claimed to obtain a mathematical model for diagnosing autism spectrum (paragraph 0007), and
Comparing the concentration levels of the measured biomarkers to a control sample taken from an ASD-negative individual (YOU teaches the control group being a healthy group, which in this context means autism negative (abstract, paragraph 0091), through broadest reasonable interpretation (BRI)),
Identifying a subject in need to treatment if the measured concentration of fumaric and malic acid are less than the control sample (Table 3). This less than reads on the claimed ranged of identifying, the levels of fumaric acid and malic acid being “at least about 2 times or less than the levels,” since the levels can just be “less than,” “the at least about 2 times,” in comparison to control through broadest reasonable interpretation as this limitation is unclear as shown in the 112 rejection.
YOU does not teach specifically of HPHPA being at least 10 times greater than found in the control, or of fumaric and malic acid being specifically two times less than the control. Further, though YOU teaches of using the method to identify early treatment, YOU does not teach of a positive treatment step.
XIONG is used to remedy this and more specifically teaches of a GC- MS method to detect biomarkers of autism where HPHPA is measured as a biomarker (abstract). Further, XIONG teaches that the measured levels in autism patients of HPHPA are over 10 times greater than those in the control patients (looking at the mean levels on Table 1).
Even further, XIONG teaches of administering oral vancomycin treatment to the patient with autism who has high levels of HPHPA (abstract).Vancomycin is a treatment which adjusts the composition of gut microbiota.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of measuring HPHPA levels 10 times or more higher than control and then treating the patient as is done in XIONG in the method of YOU due to the advantages such treatment with vancomycin has shown for treatment as patients have shown improved eye contact and communication and also with respect to intestinal symptoms in children with autism (Page 4, column 1 & column 2, first paragraph).
YOU and XIONG do not teach of the claimed treatment of ASD with a probiotic or nutritional supplement, a reduced carbohydrate, or ketogenic diet.
HSIAO is used to remedy this and teaches of a method for diagnosis and treatment of autism spectrum disorder (abstract). HSIAO further teaches of administering a probiotic treatment to the patient with autism spectrum disorder (paragraph 0022, 0047), which also includes other nutritional supplements (paragraph 0059, 0077), and even further of repeat or administering the supplement again over time (paragraph 0057-0059) until it is administered in “adequate amounts,” (paragraph 0059) and of adjusting treating to higher levels/giving more treatment is a clinical response is not adequate (paragraph 0093).
It would have been obvious to one of ordinary skill in the art to treat a patient with ASD with nutritional supplements as is done in HSIAO in the methods of YOU an XIONG due to the advantage probiotics have for ameliorating gastrointestional distress (HSIAO, paragraph 0017, 0022).
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
In applicant’s response dated 03/30/2026--- they mention the prior restriction requirement. They do not note why they do this. The restriction was made Final in the prior Non-Final office action. However--- it is also noted that applicant had cancelled all claims which were with respect to the un-elected group.
With respect to the 101 rejection, applicant argues that the claim amendments dated 03/30/2026 make the claims patent eligible since they add particular and specific treatment. The examiner disagrees and the 101 rejection is maintained for claims amended 03/30/2026. As applicant argues about subject matter that was amended into the claims 03/30/2026--- this is addressed in the 101 rejection above, and not in the response to arguments.
With respect to the prior claim objections, those are overcome due to amendments made 03/30/2026.
With respect to the 112 (b) rejection, some of the issues are overcome, however a few issues were not fixed and are maintained as shown above. Further- there was an additional clarity issued added in amendments dated 03/30/2026 for Claim 1.
With respect to the 103 rejection, applicant argues that the primary reference YOU does not teach of detection of HPHPA on Table 1 where the examiner recites it. The examiner disagrees. Please look again--- as YOU does in fact teach of detection of YOU even further teaches of detection of HPHPA Table I.
Applicant further argues that the prior art does not teach of the claimed metabolite panel. The examiner maintains that YOU does teach of the claimed panel, just maybe not in the succinct 3 biomarker way in which applicant is claiming it. Applicant argues that the YOU does not teach of the claimed levels of biomarkers detected. The examiner disagrees--- especially as some of the levels claimed are unclear. Specifically, YOU teaches of identifying a subject in need to treatment if the measured concentration of fumaric and malic acid are less than the control sample (Table 3). This less than reads on the claimed ranged of identifying, the levels of fumaric acid and malic acid being “at least about 2 times or less than the levels,” since the levels can just be “less than,” “the at least about 2 times,” in comparison to control through broadest reasonable interpretation as this limitation is unclear as shown in the 112 rejection. XIONG also teaches of detecting the claimed level for HPHPA.
Applicant even further argues that the claimed biomarker combination exhibits unexpected predictive power. The examiner notes that nothing is claimed about predictive power, so this argument is not commensurate in scope with the claims.
Applicant further argues that the prior art does not teach of the claimed treatment protocol. The examiner notes—that the claimed treatment protocol was newly amended into the claims dated 03/30/2026. Therefore, a new reference is used to teach of this. Please see the rejection above.
All claims remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WEST in WO 2015006160 (as cited on IDS dated 06/14/2023) teaches a method identifying biomarkers for autism (Page 17, 1st paragraph), in biofluids (Page 19, 1.24), analysis of biomarkers by mass spectrometry and comparison to a control (Page 17, 1st paragraph), and further teaches of many of the disclosed, non-claimed metabolites (Table 9, and Page 27, last paragraph). WEST also teaches of determining statistical significance (Page 21, 3rd paragraph).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights