Prosecution Insights
Last updated: October 24, 2026
Application No. 18/364,581

MULTI-BIOMARKER ASSAY TO ASSESS MULTIPLE SCLEROSIS DISEASE ACTIVITY

Non-Final OA §101§103
Filed
Aug 03, 2023
Priority
Aug 03, 2022 — provisional 63/394,662
Examiner
SWITZER, JULIET CAROLINE
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The United States Government as represented by the Department of Veterans Affairs
OA Round
1 (Non-Final)
42%
Grant Probability
Moderate
1-2
OA Rounds
6m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
219 granted / 516 resolved
-17.6% vs TC avg
Strong +54% interview lift
Without
With
+54.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
48 currently pending
Career history
573
Total Applications
across all art units

Statute-Specific Performance

§101
20.3%
-19.7% vs TC avg
§103
22.4%
-17.6% vs TC avg
§102
15.1%
-24.9% vs TC avg
§112
32.0%
-8.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 516 resolved cases

Office Action

§101 §103
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 . Drawings New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because: The lettering is not of proper size, uniform density, and well-defined in Figure(s) 1 and 3. See 37 CFR 1.84(p)(1) – (5). (“Numbers, letters, and reference characters must measure at least .32 cm (1/8 inch) in height.”) The margins are not of proper size in Figure(s) 1-5. See 37 CFR 1.84(g). Each panel needs to be individually labeled, e.g., FIG. 1A, 1B, 3A – 3D, 4A and 4B. See 37 CFR 1.84(u)(1) and (2), In Figure(s) 1 - 5 the reference characters, sheet numbers, and view numbers are not all oriented in the same direction so as to avoid having to rotate the sheet. See 37 CFR 1.84(p)(1). The numbering of the sheets of drawings bearing FIG(s). 1 - 5 is not in compliance with all aspects of 37 CFR 1.84(t). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance. INFORMATION ON HOW TO EFFECT DRAWING CHANGES Replacement Drawing Sheets Drawing changes must be made by presenting replacement sheets which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments section, or remarks, section of the amendment paper. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). A replacement sheet must include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of the amended drawing(s) must not be labeled as “amended.” If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified. Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and within the top margin. Annotated Drawing Sheets A marked-up copy of any amended drawing figure, including annotations indicating the changes made, are required by the examiner. The annotated drawing sheet(s) must be clearly labeled as “Annotated Sheet” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. Timing of Corrections Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application. If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the “Notice of Allowability.” Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136 for filing the corrected drawings after the mailing of a Notice of Allowability. Claim Interpretation Attention is directed to MPEP 904.01 [R-08.2012]. The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis. It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated: The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim. Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated: II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein: II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE PNG media_image1.png 18 19 media_image1.png Greyscale The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added) Attention is directed to MPEP 2111 [R-10.2019]. As stated therein: During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard: The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added). Attention is directed to MPEP 2173.04 [R-10.2019]. As stated therein: Breadth of a claim is not to be equated with indefiniteness. In re Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d 786, 788, 166 USPQ 138, 140 (CCPA 1970) ("Breadth is not indefiniteness."). A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added) Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0194714 A1 (Rus et al.). Rus et al., teach: [0057] In a first embodiment, the invention is thus generally drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease by monitoring levels of mRNA expression of certain biomarkers. In particular, the invention is drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease, comprising [0058] (i) determining mRNA expression levels for one or more biomarkers selected from the group consisting of SIRT1, RGC-32, FasL and IL-21 in a population of cells, [0059] (ii) determining mRNA expression levels for L13 in the same population of cells, and [0060] (iii) calculating a ratio of biomarker mRNA expression to L13 mRNA expression, wherein when the biomarker is SIRT1 and the SIRT1/L13 ratio is <3.06±10%, the subject is determined to be undergoing relapse, wherein when the biomarker is RGC-32 and the RGC-32/L13 ratio is <1.27±10%, the subject is determined to be undergoing relapse, wherein when the biomarker is FasL and the FasL/L13 ratio is <52.6±10%, the subject is determined to be undergoing relapse, and wherein when the biomarker is IL-21 and the IL-21/L13 ratio is >16.9±10%, the subject is determined to be undergoing relapse. [0061] In this embodiment, the range encompassing the noted SIRT1/L13 ratio can also be about ±9%, ±8%, ±7%, ±6%, ±5%, ±4%, ±3%, ±2%, or ±1%. In certain preferred aspects, the SIRT1/L13 ratio is about <3.01, <3.02, <3.03, <3.04, <3.05, <3.06, <3.07, <3.08, <3.09, <3.10, <3.11, or <3.12. [0062] In this embodiment, the range encompassing the noted RGC-32/L13 ratio can also be about ±9%, ±8%, ±7%, ±6%, ±5%, ±4%, ±3%, ±2%, or ±1%. In certain preferred aspects, the RGC-32/L13 ratio is about <1.22, <1.23, <1.24, <1.25, <1.26, <1.27, <1.28, <1.29, <1.30, <1.31, <1.32, or <1.33. [0063] In this embodiment, the range encompassing the noted FasL/L13 ratio can also be about ±9%, ±8%, ±7%, ±6%, ±5%, ±4%, ±3%, ±2%, or ±1%. In certain preferred aspects, the FasL/L13 ratio is about <52.55, <52.56, <52.57, <52.58, <52.59, <52.6, <52.61, <52.62, <52.63, <52.64, <52.65 or <52.66. [0064] In this embodiment, the range encompassing the noted IL-21/L13 ratio can also be about ±9%, ±8%, ±7%, ±6%, ±5%, ±4%, ±3%, ±2%, or ±1%. In certain preferred aspects, the IL-21/L13 ratio is about >16.85, >16.86, >16.87, >16.88, >16.89, >16.9, >16.91, >16.92, >16.93, >16.94, >16.95, or >16.96. [0065] In the various aspects of this embodiment, mRNA expression levels for one, two, three or all of the four biomarkers is determined. It is noted that the L13 mRNA and L13 protein were used as a “mRNA standard” and “protein standard” In support of this position it is noted that Rus et al. describes L13 as a housekeeping gene. As seen at paragraphs [0105]: [0105] The expression of SIRT1 and HDAC3 in unstimulated PBMCs was next examined in relation to disease activity. Expression of SIRT1, HDAC3, and L13 (a housekeeping gene) mRNA was measured by real-time PCR. (Emphasis added) The aspect of performing “real-time polymerase chain reaction (RT-PCT)” [sic] is deemed to fairly suggest limitations of claims 8 and 18. As seen at paragraph [0092]: The results were normalized to L13 ribosomal protein, a housekeeping gene. (Emphasis added) It is further noted that dependent claims 2 and 11 specify that “L13 mRNA” is “the mRNA standard”. Rus et al., in paragraphs [0014] and [0016] – [0019] teach: [0014] In certain aspects of this embodiment, mRNA expression levels for one, two, three or all of the four biomarkers is determined. *** [0016] In a second embodiment, the invention is generally drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease by monitoring levels of protein expression of certain biomarkers. In particular, the invention is drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease, comprising [0017] (i) determining protein expression levels for SIRT1 in a population of cells, [0018] (ii) determining protein expression levels for L13 in the same population of cells, and [0019] (iii) calculating a ratio of SIRT1 protein expression to L13 protein expression, wherein when the SIRT1/L13 ratio is <0.645±10%, the subject is determined to be undergoing relapse. The above showing is deemed to fairly suggest limitations of claim 4. Rus et al., in paragraph [0015] teach: [0015] In certain aspects of this embodiment, when the subject is determined to be undergoing relapse, the method further comprises administering a therapeutically effective amount of a treatment for RRMS to the subject. The treatment may be, for example, glatiramer acetate (GA), beta-interferons, teriflunomide, fingolimod, dimethyl fumarate, and natalizumab. (Emphasis added) The above showing is deemed to fairly suggest limitations of dependent claims 5, 6, 14, 15 and 16. Rus et al., teach: [0067] In a second embodiment, the invention is generally drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease by monitoring levels of protein expression of certain biomarkers. In particular, the invention is drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease, comprising [0068] (i) determining protein expression levels for SIRT1 in a population of cells, [0069] (ii) determining protein expression levels for L13 in the same population of cells, and [0070] (iii) calculating a ratio of SIRT1 protein expression to L13 protein expression, wherein when the SIRT1/L13 ratio is <0.645±10%, the subject is determined to be undergoing relapse. [0071] In this embodiment, the range encompassing the noted SIRT1/L13 ratio can also be about ±4%, ±3%, ±2%, or ±1%. In certain preferred aspects, the SIRT1/L13 ratio is about <0.61, <0.62, <0.63, <0.64, <0.645, <0.65, <0.66, <0.67, <0.68, <0.69, or <0.70. Rus et al., at paragraph [0073], teach: [0073] In a third embodiment, the invention is generally drawn to methods for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) will respond to treatment with glatiramer acetate (GA). (Emphasis added) The above showing is deemed to fairly suggest limitations of claim 10 and dependent claims 10-19. Rus et al., at paragraph [0029], teaches: [0029] In each of the embodiments and aspects of the invention, the population of cells may be, but is not limited to, peripheral blood mononuclear cells (PBMCs), CD4+ T cells, CD8+ T cells, MAB328+ cells, GFAP+ cells, leukocytes, monocytes, glial cells, dendritic cells, and neurons. (Emphasis added) The above showing is deemed to fairly suggest limitations of claims 7 and 17. Rus et al., at paragraph [0035] teach performing Western blot analysis (claims 9 and 19) and that beta-actin as the protein standard. As disclosed therein: An example of a western blot relevant to the expression of histone H3K9ac (upper panel). Higher levels of H3K9ac were found during relapses (p<0.05). Results are expressed as ratios to beta-actin (lower panel). (FIG. 5B) An example of a western blot relevant to the expression of histone H3K9me2 (upper panel). Levels of H3K9me2 in MS patients did not differ significantly from those in controls. Results are expressed as ratios to beta-actin (lower panel). (FIG. 5C, FIG. 5D) (Emphasis added) In view of the above showing, it would have been quite obvious to one of ordinary skill in the art at the time of the invention to have adapted the methods and means of Rus et al., whereby one would be able to determine “whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing a relapse of the disease” and to also determine “whether a subject having relapsing-remitting multiple sclerosis (RRMS) will respond to treatment”. In view of the above presentation and in the absence of convincing evidence to the contrary, claims 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0194714 A1 (Rus et al.). Claim Rejections - 35 USC § 101, Judicial Exception 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. Effective December 16, 2014, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618), which is found at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf. These guidelines were updated July 17, 2024, in the federal register can be found at 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence. Additionally, attention is directed to Gottschalk, Comr. Pats. v. Benson, et al. (US, 1972) 175 USPQ 673, 675: The Court stated in MacKay Co. v. Radio Corp., 306 U.S. 86, 94, 40 USPQ 199, 202, that “While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.” That statement followed the long-standing rule that “An idea of itself is not patentable.” Rubber-Tip Pencil Co. v. Howard, 20 Wall. 498, 507. “A principle, in the abstract, is a fundamental truth; an original cause; a motive; and these cannot be patented, as no one can claim in either of them an exclusive right.” LeRoy v. Tatham, 14 How. 156, 175. Phenomena of nature, though just discovered, mental processes, abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. As we stated in Funk Bros. Seed Co. v. Kalo Co., 333 U.S. 127, 130, 76 USPQ 280, 281, “He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” We dealt there with a “product” claim, while the present case deals only with a “process” claim. But we think the same principle applies. (Emphasis added) Here the “process” claim is so abstract and sweeping as to cover both known and unknown uses of the BCD to pure-binary conversion. The end use may (1) vary from the operation of a train to verification of drivers’ licenses to researching the law books for precedents and (2) be performed through any existing machinery or future-devised machinery or without any apparatus. (Emphasis added) Attention is also directed to the precedential decision in Ariosa Diagnostics, Inc., et al. v. Sequenom, Inc., et al. 115 USPQ2d 1152 (Fed. Cir. 2015): In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297. If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. Id. at 1298. *** Mayo made clear that transformation into a patent-eligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features” to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added) *** Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. *** Sequenom and amici encourage us to draw distinctions among natural phenomena based on whether or not they will interfere significantly with innovation in other fields now or in the future. The Supreme Court cases, however, have not distinguished among different laws of nature or natural phenomenon according to whether or not the principles they embody are sufficiently narrow. See, e.g., Parker v. Flook, 437 U.S. 584 (1978) (holding narrow mathematical formula unpatentable). In Parker v. Flook, the Supreme Court stated the issue in the case as follows: “The question in this case is whether the identification of a limited category of useful, though conventional, post-solution applications of such a formula makes respondent’s method eligible for patent protection.” Id. at 585. The answer to that question was “no” because granting exclusive rights to the mathematical formula would be exempting it from any future use. Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. As noted in Sequenom: First, we determine whether the claims at issue are directed to a patent-ineligible concept. Id. at 1297. As seen in the Interim Guidelines, one asks the question Is the claim to a process, machine, manufacture or composition of matter? In the present case, claims 1-9 are drawn to “a method for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) is undergoing relapse of the disease”; and claims 10-19 are drawn to “a method for determining whether a subject having relapsing-remitting multiple sclerosis (RRMS) will respond to treatment with GA”. Next, in applying Step 2A, Prong 1, of the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG): Does the claim recite an abstract idea, law of nature, or natural phenomenon? In the present case, the claim(s) is/are directed to an abstract idea. In applying Step 2A, Prong 2, of the 2019 PEG: Does the claim recite additional elements that integrate the judicial exception into a practical application? In the present case, the claim(s) have not been found to recite additional elements that integrate the judicial exception into a practical application. As presently worded, the cited methods recite multiple steps of “determining” and “calculating” without reciting means and conditions by which the acts of “determining” and “calculating” are to be performed. As noted above in Sequenom, For process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”). (Emphasis added) In the present case, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the cited methods recite multiple steps of “determining” and “calculating” without reciting means and conditions by which the acts of “determining” and “calculating” are to be performed. Absent such limitations, the claimed methods are deemed to constitute an abstract idea. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Bradley L. Sisson/Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Aug 03, 2023
Application Filed
May 19, 2026
Non-Final Rejection mailed — §101, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
42%
Grant Probability
96%
With Interview (+54.0%)
3y 8m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 516 resolved cases by this examiner. Grant probability derived from career allowance rate.

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