Prosecution Insights
Last updated: April 19, 2026
Application No. 18/554,705

NOVEL ANTI-INFLAMMATORY THERAPEUTICS AND METHOD OF USE THEREOF

Non-Final OA §101§102§103§112
Filed
Oct 10, 2023
Examiner
ARNOLD, ERNST V
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of California
OA Round
3 (Non-Final)
48%
Grant Probability
Moderate
3-4
OA Rounds
3y 0m
To Grant
61%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
658 granted / 1370 resolved
-12.0% vs TC avg
Moderate +13% lift
Without
With
+12.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
59 currently pending
Career history
1429
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
43.2%
+3.2% vs TC avg
§102
16.4%
-23.6% vs TC avg
§112
19.2%
-20.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1370 resolved cases

Office Action

§101 §102 §103 §112
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 . Claim Status Claim 12 is cancelled. Claims 1-11 and 13-20 are pending. Claims 3-9 and 17-20 are withdrawn. Claims 1, 2, 10, 11 and 13-16 are under examination as they read upon the elected subject matter. Applicant’s amendments have necessitated modification of the existing rejections. Accordingly, this Action is FINAL. Withdrawn rejections Applicant's amendments and arguments filed 12/10/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 11 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant has amended the claim to overcome the rejection. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application. 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 1-2, 10, 11 and 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. These claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. Because the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and are nature-based products, the markedly different characteristics analysis is used to determine if the nature-based products are exceptions. The claims are directed to an anti-inflammatory agent comprising an isolated and purified soluble cellular prion protein (PrPc) that interacts with NMDAR/LRP1 receptor complex to regulate innate immunity and provide anti-inflammatory effect and kits of the anti-inflammatory agent with instructions. As evidenced by Mantuano et al. (J. Biol. Chem. (2020) 295(41) 14178–14188), cellular prion protein (PrPC) is a widely expressed glycosylphosphatidylinositol-anchored membrane protein where soluble PrPc is shed from the cell surface. (Abstract) Mantuano et al. (J Immunol. 2022 January 01; 208(1): 85–96) report that soluble PrPc attenuate innate immunity by engaging the NMDA-R/LRP1 receptor complex (Title; abstract). Accordingly, the claims are directed to a composition of matter comprising a naturally occurring protein and kits comprising the protein and so the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart in their natural state. In this case, the anti-inflammatory agent is compared to the naturally occurring PrPc as it occurs in nature. The claimed isolated and purified anti-inflammatory agent does not appear to be significantly different in structure or do anything different from what is expected of PrPc and therefore is not markedly different from that which occurs naturally. There is no indication in the specification that the claimed isolated and purified anti-inflammatory agent has any characteristics (structural, functional, or otherwise) that are markedly different from the naturally occurring soluble PrPc. Therefore, the isolated and purified anti-inflammatory agent does not appear to have markedly different characteristics from what occurs in nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following rationale. The limitation of “a pharmaceutically acceptable carrier or excipients for a proper administration” is an additional feature that does not appear to add significantly more to the exception because it can simply mean placing the anti-inflammatory agent into water. Additionally, combining an anti-inflammatory agent with carriers/excipients is well-understood, routine and conventional activity engaged in by the pharmaceutical community. Similarly, adding instructions does not change the structure, action or functional characteristics of the anti-inflammatory agent in any manner. Therefore, the claims as a whole adds nothing significantly more to the “product of nature” itself (Step 2B: NO). Accordingly, the claims do not amount to significantly more than the judicial exception itself and do not qualify as eligible subject matter. Response to Arguments: Applicant asserts that the claimed isolated and purified PrPc, or an analogue thereof, is not an endogenous molecule that occurs in nature. Applicant then acknowledges that physiological soluble PrPc is extremely low in abundance, which does occur in nature. Applicant asserts that physiological soluble PrPc is structurally heterogeneous but fails to describe in structural terms how that is markedly different from that which is claimed. Whether or not it is present in defined therapeutic concentrations is not relevant to the 101 analysis. At issue here is whether the isolated and purified PrPc is markedly different from that which occurs in nature. As far as the Examiner can discern, it is not. The same PrPc claimed by Applicant and the naturally occurring product of nature must interact with NMDA-R/LRP1 receptor complex. Claim 1 does not require any formulation with pharmaceutical carriers and/or excipients that would lift the claim to eligible subject matter. Accordingly, Applicant’s arguments are not persuasive. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-2 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leblanc et al. (FR2808278; English translation). Regarding claims 1-2 and 10-11, Leblanc et al. disclose a therapeutic and/or prophylactic composition comprising an effective amount of the agent according to claim 10 with an adjuvant and/or diluent and/or a pharmaceutically acceptable excipient and/or vehicle (Claim 12), which make for a proper administration, where claim 10 is directed to PrPc prion protein according to claims 1-4 and claim 1 is directed to isolated PrPc prion protein, which the Examiner reasonably interprets to be PrPc prion protein free of any membrane, which is naturally soluble. It is the Examiner’s position that the isolation of the PrPc prion protein naturally purifies it from other components. Especially, when no degree or other parameter of purification is claimed by Applicant. The PrPc or an analogue thereof naturally interacts with NMDAR/LRP1 receptor complex to regulate innate immunity and provides anti-inflammatory effect. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963). See also: MPEP 2112 II: “INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” The intended use for regulating innate immunity in a disease such as inflammatory bowel disease or used for treating a disease selected from the group consisting of inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriasis, Chronic Pain Disorders, Neurodegenerative Disease, and Multiple Sclerosis is inherent in the composition of Leblanc et al. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Consequently, Leblanc et al. disclose the same anti-inflammatory agent and compositions as claimed. Response to Arguments: Applicant asserts that Leblanc reports PrP antagonists and cleavage fragments thereof and does not disclose isolated and purified PrPc isoform formulated with a pharmaceutically acceptable carrier to be sued for systemic anti-inflammatory effect. Respectfully, the Examiner has a different perspective. The Examiner is not relying upon any teaching of cleavage fragments or antagonists in Leblanc. Rather, the Examiner is relying on Leblanc for expressly disclosing human or animal isolated PrPc prion protein (Claim 1), where the process of isolation inherently purifies the prion protein from other components. The same isolated PrPc prion protein disclosed by Leblanc naturally has the same properties claimed by Applicant. As stated above, the Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Applicant’s arguments are not persuasive. Claim(s) 1-2 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strittmatter et al. (WO2008134034). Regarding claims 1, 2 and 10-11, Strittmatter et al. disclose pharmaceutical kits comprising PrPc antagonist (Abstract; Claims 58-60), which is the PrPc antagonist of claims 1-57 (Claim 58), where the PrPc antagonist is a soluble PrPc polypeptide (Claim 6) that is formulated for administration (Claim 54; [0123, 0329]), thus making a composition comprising the soluble PrPc polypeptide immediately envisaged by the artisan. Strittmatter et al. define a soluble PrPc polypeptide as one lacking a signal sequence and a functional GPI anchor [0127], thus being isolated from those components and purified to the soluble form. It is the Examiner’s position that the soluble PrPc polypeptide of Strittmatter et al. is no different from the instantly claimed isolated and purified PrPc or analogue thereof. The limitations of “anti-inflammatory” and “interacts with NMDAR/LRP1 receptor complex to regulate innate immunity and provides anti-inflammatory effect” are inherent properties of the soluble PrPc polypeptide. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963). See also MPEP 2112(II): MPEP 2112 II: “INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” The intended use for regulating innate immunity in a disease such as inflammatory bowel disease or used for treating a disease selected from the group consisting of inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriasis, Chronic Pain Disorders, Neurodegenerative Disease, and Multiple Sclerosis is inherent in the composition of Leblanc et al. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Consequently, Strittmatter et al. disclose the same anti-inflammatory agent and compositions as claimed. Response to Arguments: Applicant asserts that Strittmatter reports PrP antagonists and does not disclose isolated and purified PrPc isoform as claimed. However, Applicant has produced no evidence that the soluble PrPc polypeptide of Strittmatter is any different from the claimed isolated and purified PrPc claimed in terms of structure or function. Applicant alleges that a PrP antagonist produces biological effects opposite of those of the isolated and purified PrPc agonist claimed. However, the term “agonist” does not appear in the claimed subject matter and instant claim 2 requires that it is a soluble PrPc. Thus, the disclosure of Strittmatter meets the claimed structural limitations and by extension the functional limitations as well. While Applicant asserts that the PrP taught by Leblanc and Strittmatter are substantially different from the isolated and purified PrPc isoform which interacts with NMDA-R/LRP1 receptor complex for its therapeutic activation, the Examiner does not find a structural difference and Strittmatter did not have to recognize those properties. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” The Examiner has also provided evidence supporting the Examiner’s position on soluble PrPc. As discussed supra, Mantuano et al. (J Immunol. 2022 January 01; 208(1): 85–96) report that soluble PrPc attenuates innate immunity by engaging the NMDA-R/LRP1 receptor complex. Consequently, the preponderance of evidence supports the Examiner’s position. Consequently, the soluble PrPc of Strittmatter must also behave in the same manner. In this record, there is no evidence otherwise. Respectfully, Applicant’s arguments have been carefully considered but are not persuasive. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Leblanc et al. (FR2808278; English translation) as applied to claims 1-2, 10 and 11 above, in view of FDA Learn About Your Medicines [online] retrieved on 9/9/25 from: https://www.fda.gov/patients/learn-about-your-medicines; 2018: 5 pages). This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103. Applicant claims, for example: PNG media_image1.png 342 1152 media_image1.png Greyscale Level of Ordinary Skill in the Art (MPEP 2141.03) MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmaceutical formulation, human physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)). Determination of the scope and content of the prior art (MPEP 2141.01) It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103. The reference of Leblanc et al. is discussed in detail above and that discussion is incorporated by reference. Regarding claims 13 and 15, FDA Learn About Your Medicines teaches that instructions for use (IFU) are to help the patient use the product properly. Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143) The difference between the instant application and Leblanc et al. is that Leblanc et al. do not expressly teach adding instruction for treating or preventing inflammation in a patient in need thereof. This deficiency in Leblanc et al. is cured by the teachings of FDA Learn About Your Medicines. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add instructions to the therapeutic composition formulated with pharmaceutically acceptable carrier or excipients for a proper administration of Leblanc et al., as suggested by FDA Learn About Your Medicines, to make a kit with instructions and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because instructions are important to help the patient use the therapeutic composition properly as taught by FDA Learn About Your Medicines. The ordinary artisan would add such instructions to the therapeutic composition of Leblanc et al. formulated in a pharmaceutically acceptable carrier or excipients for a proper administration to make a kit with instructions with a reasonable expectation of success. The informational content of non–functional descriptive material is not entitled to weight in the patentability analysis. See In re Lowry, 32 F.3d 1579, 1583 (Fed. Cir. 1994). Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Strittmatter et al. (WO2008134034) as applied to claims 1, 2, 10 and 11 above. Determination of the scope and content of the prior art (MPEP 2141.01) It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103. The reference of Strittmatter et al. is discussed in detail above and that discussion is incorporated by reference. Strittmatter et al. teach pharmaceutical kits comprising PrPc antagonist (Abstract; Claims 58-60) which is the PrPc antagonist of claims 1-57 (Claim 58) where the PrPc antagonist is a soluble PrPc polypeptide (Claim 6) that is formulated for administration (Claim 54; [0123, 0329]). As asserted above, it is the Examiner’s position that the soluble PrPc polypeptide of Strittmatter et al. is no different from the claims PrPc or analogue thereof. Strittmatter et al. teach compositions containing soluble PrPc polypeptide with a suitable pharmaceutically acceptable carrier, excipients and auxiliaries [0328, 0332], which make for a proper administration. Additional therapeutic agents can be added (Claims 52-53, 59-60). The kits can further comprise instructions for administration/use [0357, 0358]. Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143) The difference between the instant application and Strittmatter et al. is that Strittmatter et al. do not expressly teach adding instructions for treating or preventing inflammation in a patient in need thereof to the kit. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add instructions to the kit of Strittmatter et al. formulated in a pharmaceutically acceptable carrier or excipients for a proper administration to make a kit with instructions and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Strittmatter et al. direct the artisan to add instructions. The ordinary artisan would add such instructions to the kit of Strittmatter et al. formulated in a pharmaceutically acceptable carrier or excipients for a proper administration to make a kit with instructions with a reasonable expectation of success. The informational content of non–functional descriptive material is not entitled to weight in the patentability analysis. See In re Lowry, 32 F.3d 1579, 1583 (Fed. Cir. 1994). The Examiner also notes that Strittmatter et al. suggest adding anti-inflammatory agents (Claims 53 and 60), which would render obvious instructions for treating or preventing inflammation in a patient in need thereof as well. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary. Response to Arguments: On pages 7-8 of remarks, Applicant argues the 103 rejections together. Applicant maintains their position that “neither Leblanc nor Strittmatter teaches the claimed anti-inflammatory agent, and/or the composition thereof, comprising the isolated and purified PrPc isoform formulated with a pharmaceutically acceptable carrier and/or excipient to be used for systemic anti-inflammatory effect, as recited in claims 1, 2, and 10-11.” Applicant further submits that: “both Lablanc[sic] and Strittmatter report PrP pathways with pathological processes rather than therapeutic immunomodulation, which kindly "teach away" from using the claimed PrPc isoform. Since neither Leblanc nor Strittmatter teaches or suggests the PrPc isoform for immunomodulation/anti-inflammatory effect via activating the NMDA-LRP1 receptor complex, one skilled artisan would not have been able to come up with the claimed invention in view of Leblanc and/or Strittmatter, alone or in combination.” The Examiner has carefully considered Applicant’s arguments but they are not persuasive. A composition of matter claim is under examination; not a process. How the composition of matter is used is not provided patentable weight because such use is inherent in the composition of matter. In the present case, the Examiner has shown how each and every structural limitation of the composition is met by the prior art references. On page 9 of remarks, Applicant cites Mantuano as demonstrating that PrPc activation of NMDA/LRP1 leads to reduced inflammatory cytokines and that neither Leblanc nor Strittmatter teaches or suggests this novel therapeutic discovery. Respectfully, neither Leblanc nor Strittmatter had to recognize that “novel therapeutic discovery” because such is inherent in the disclosures of both Leblanc and Strittmatter even though they did not recognize it. See MPEP 2112(II). The examiner also respectfully points out the following from MPEP § 2112.01: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Furthermore, the Examiner notes MPEP 2145(II): Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In summary, Applicant’s arguments have been carefully considered but are not persuasive. Applicant has failed to provide any evidence that the claimed isolated and purified PrPc or analogue thereof is any different from the soluble PrPc of the prior art references. The regulation of innate immunity and providing of anti-inflammatory effect claimed by Applicant naturally flow from the soluble PrPc compositions of the prior art. The case law is clear: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). The ultimate determination of obviousness under 35 U.S.C. § 103 is a legal conclusion based on underlying findings of fact. In re Kotzab, 217 F.3d 1365, 1369 (Fed.Cir.2000). In the present case, the prior art of record has isolated and purified soluble PrPc and produced compositions therewith. Any anti-inflammatory activity of the isolated and purified PrPc compositions of the prior art is inherent in the material itself because no other components are present in claim 1 to achieve this effect. The claims remain rejected. Conclusion No claims are allowed. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30. 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, Brian Y Kwon can be reached at 571-272-0581. 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. /ERNST V ARNOLD/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Oct 10, 2023
Application Filed
Sep 09, 2025
Non-Final Rejection — §101, §102, §103
Dec 10, 2025
Response Filed
Dec 30, 2025
Final Rejection — §101, §102, §103
Feb 28, 2026
Response after Non-Final Action
Mar 05, 2026
Request for Continued Examination
Mar 12, 2026
Response after Non-Final Action
Apr 09, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
48%
Grant Probability
61%
With Interview (+12.9%)
3y 0m
Median Time to Grant
High
PTA Risk
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