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
Claims 2 and 12 are cancelled.
Claims 21 and 22 are new.
Claims 1, 3-11 and 13-22 are pending.
Claims 3-9 and 17-20 are withdrawn.
Claims 1, 10, 11, 13-16, 21 and 22 are under examination. Applicant’s amendment has necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 7/8/26 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 Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1, 2, 10, 11 and 13-16 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph; claims 1, 2, 10, 11 and 13-16 were rejected under 35 U.S.C. 103 as being unpatentable over Strittmatter et al. (WO2008134034) and Taylor et al. (The Journal of Biological Chemistry 2009;284(34):22590-22600 (NPL reference 14 on the IDS filed 10/18/23)) and FDA Learn About Your Medicines [online] retrieved on 9/9/25 from: https://www.fda.gov/patients/learn-about-your-medicines; 2018: 5 pages).
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, 10, 11, 13-16, 21 and 22 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 a 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; of record), 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; of record) report that soluble PrPc attenuate innate immunity by engaging the NMDA-R/LRP1 receptor complex (Title; abstract). The claimed source is from a mouse (Claim 21), which is a natural source.
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 anti-inflammatory agent does not appear to do anything different from what is expected of PrPc. There is no indication in the specification that the claimed anti-inflammatory agent has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring soluble PrPc. The discovery of properties inherent in the protein is not sufficient for the 101 analysis. “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass ’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). Therefore, the 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 (Sept 2B: NO). Accordingly, the claims do not amount to significantly more than the judicial exception itself and do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 10-11 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leblanc et al. (FR2808278; English translation; of record).
Regarding claims 1, 10, 11 and 22, 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. The PrPc or an analogue thereof naturally interacts with NMDAR/LRP1 receptor complex to regulate innate immunity and provides anti-inflammatory effect as well as wherein the recombinant soluble derivative of PrPc or the analogue thereof counteracts inflammatory responses triggered by Pattern Recognition Receptor (PRR) by blocking cytokine mRNA expression and inhibiting IKB phosphorylation wherein the Pattern Recognition Receptor (PRR) is in macrophages and selected from the group consisting of Toll-like Receptor (TLR)2, TLR4, TLR7, TLR9, and Nucleotide Binding Oligomerization Domain Containing-1 (NOD1) and NOD2. 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).” See also MPEP 2145(II): 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).
The intended use for regulating innate immunity in a disease such as inflammatory bowel disease or used for treating a disease in which innate immunity plays an important role 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).
Regarding the functional limitations of the recombinant soluble derivative of PrPc or an analogue thereof, the Supreme Court, in De Forest Radio Co. v. General Elec. Co., 283 U.S. 664, 685, 51 S.Ct. 563, 569, 75 L. Ed. 339, said: "It is method and device which may be patented and not the scientific explanation of their operation." Applicants are not entitled to a patent for this scientific explanation. De Forest Radio Co. v. General Electric Co., 283 U.S. 664, 51 S.Ct. 563, 75 L. Ed. 1339. See 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). Once a prima facie case of anticipation has been established, the burden shifts to the Appellants to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
Consequently, Leblanc et al. disclose the same anti-inflammatory agent and compositions as claimed.
Claim(s) 1, 10-11 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strittmatter et al. (WO2008134034; of record).
Regarding claims 1, 10-11 and 22, 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. It is the Examiner’s position that the soluble PrPc polypeptide of Strittmatter et al. is no different from the instantly claimed PrPc or analogue thereof. The PrPc or an analogue thereof naturally interacts with NMDAR/LRP1 receptor complex to regulate innate immunity and provides anti-inflammatory effect as well as wherein the recombinant soluble derivative of PrPc or the analogue thereof counteracts inflammatory responses triggered by Pattern Recognition Receptor (PRR) by blocking cytokine mRNA expression and inhibiting IKB phosphorylation wherein the Pattern Recognition Receptor (PRR) is in macrophages and selected from the group consisting of Toll-like Receptor (TLR)2, TLR4, TLR7, TLR9, and Nucleotide Binding Oligomerization Domain Containing-1 (NOD1) and NOD2. These limitations 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).” See also MPEP 2145(II): 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).
The intended use for regulating innate immunity in a disease such as inflammatory bowel disease or used for treating a disease in which innate immunity plays an important role is inherent in the composition of Strittmatter 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). See MPEP § 2112.01 above. Once a prima facie case of anticipation has been established, the burden shifts to the Appellants to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
Consequently, Strittmatter et al. disclose the same anti-inflammatory agent and compositions as claimed.
Claim(s) 1, 10-11 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor et al. (The Journal of Biological Chemistry 2009;284(34):22590-22600 (NPL reference 14 on the IDS filed 10/18/23)).
Regarding claims 1, 10, 11, 21 and 22, Taylor et al. disclose compositions of recombinant PrP in Tris-HCl buffer (Page 22592, right column Mass Spectrometry) where the recombinant PrP is derived from murine PrP residues 23-231 (Page 22591, left column Recombinant Proteins). Thus, Taylor et al. disclose the same anti-inflammatory agent as claimed which inherently has the same characteristics of interacting with a NMDA-R/LRP1 receptor complex to regulate innate immunity and provide an anti-inflammatory effect, and wherein the recombinant soluble derivative of PrPc or the analogue thereof counteracts inflammatory responses triggered by Pattern Recognition Receptor (PRR) by blocking cytokine mRNA expression and inhibiting IKB phosphorylation and those of claim 22. Once a prima facie case of anticipation has been established, the burden shifts to the Appellants to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
The intended use for regulating innate immunity in a disease such as inflammatory bowel disease or used for treating a disease in which innate immunity plays an important role is inherent in the composition of Taylor 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). See MPEP § 2112.01 above. See also MPEP 2145(II): 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).
Consequently, Taylor et al. disclose the same anti-inflammatory agent and compositions as claimed.
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 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 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(a) 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(a) as being unpatentable over Leblanc et al. (FR2808278; English translation) as applied to claims 1, 10, 11 and 22 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(a).
Applicant claims, for example:
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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(a) as being unpatentable over Strittmatter et al. (WO2008134034) as applied to claims 1, 10, 11 and 22 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(a).
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Strittmatter et al. (WO2008134034), as applied to claims 1, 10, 11 and 22 above, and Taylor et al. (The Journal of Biological Chemistry 2009;284(34):22590-22600 (NPL reference 14 on the IDS filed 10/18/23)).
Applicant claims, for example:
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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 references of Strittmatter et al. and Taylor et al. are discussed in detail above and those discussions are incorporated by reference.
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 a recombinant polypeptide derived from S-PrP consisting of residues 23-231 of mouse PrPc. This deficiency in Strittmatter et al. is cured by the teachings of Taylor et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to employ a recombinant polypeptide derived from S-PrP consisting of residues 23-231 of mouse PrPc in the invention of Strittmatter et al., as suggested by Taylor et al., produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationale. First, Strittmatter et al. has knowledge of both human and murine full length PrP [0107, 0114] and teaches a soluble PrPc polypeptide (Claim 6) where a soluble PrPc polypeptide is taught as one lacking a signal sequence and a functional GPI anchor; hence truncated. It is known through Taylor et al. that shed PrPc is soluble and that recombinant murine PrP residues 23-231 is a soluble polypeptide and is readily available for purchase from a commercial source. The artisan would then have a reasonable expectation of success in employing a PrPc derived from recombinant mouse PrPc residues 23-231 as the soluble PrPc polypeptide in the kit of Strittmatter et al. as the shed soluble form of PrPc for treatment of human subjects with human diseases/conditions.
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:
Applicant’s arguments filed 7/8/26 are directed to withdrawn rejections. With regard to the 103 rejection over Strittmatter in view of Taylor and FDA Learn About Your Medicines, Applicant argues that Strittmatter does not teach or suggest the claimed anti-inflammatory agent with the features recited in claim 1, as now amended. Respectfully, the Examiner has a different perspective. “In general, a limitation or the entire invention is inherent and in the public domain if it is the ‘natural result flowing from’ the explicit disclosure of the prior art.” Schering, 339 F.3d at 1379 (citing Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed.Cir.2001); In re Kratz, 592 F.2d 1169, 1174 (CCPA 1979)). In some cases, the inherent property corresponds to a claimed new benefit or characteristic of an invention otherwise in the prior art. In those cases, the new realization alone does not render the old invention patentable. See Atlas Powder, 190 F.3d at 1347 (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's function, does not render the old composition patentably new to the discoverer.”) 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).” (See MPEP 2112(I)(II)). In the present case, a composition of matter claim is under examination. As a matter of claim drafting, therefore, the discoverer of a new use must protect his discovery by means of process or method claims and not product claims.” In re Hack (CCPA 06/04/57). See In re Dillon (Fed. Cir. 11/09/90) (en banc) (“composition claims on appeal are not structurally or physically distinguishable from the prior art compositions by virtue of the recitation of their newly-discovered use”). The prior art of Strittmatter teaches and suggests soluble PrPc compositions that implicitly have the same functional characteristics as claimed whether Strittmatter knew it or not. To hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property. Consequently, it is of no consequence that claim 1 now recites a specific receptor-mediated immunomodulatory mechanism and PRR-response profile or that these functional characteristics were unknown in the prior art. The fact of the matter is that the claimed soluble PrPc was known in the prior art before the effective filing date of the instant application and the claimed functional characteristics are a natural property of the soluble cellular prion protein.
Regarding the combination of Strittmatter and Taylor, the Examiner has articulated that Taylor provides a readily available commercial source of the soluble PrPc of use in the invention of Strittmatter. The ordinary artisan can obtain and employ that commercially available soluble PrPc to use in the invention of Strittmatter with a reasonable expectation of success.
On page 9 of remarks, Applicant asserts: “the claimed anti-inflammatory agent recited in claim 1, as now amended, is based on the discovery of an entirely different biological function of soluble PrPc rather than simply a new therapeutic use of a known molecule.” Discovery of a new function or explanation of how the agent operates in the prior art is insufficient to sustain a patent. As stated above, from MPEP 2112 I: “[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). See also MPEP 2144.08(A)(4)(d): “However, the prior art need not disclose a newly discovered property in order for there to be a prima facie case of obviousness.” Dillon, 919 F.2d at 697, 16 USPQ2d at 1904-05 (and cases cited therein). Respectfully, Applicant’s arguments have been carefully considered but are not persuasive.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
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.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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