Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Claims 1-20 are under consideration.
Information Disclosure Statement
2. The information disclosure statements were (IDS) submitted on 8/8/2024; 1/8/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Claims 2-7, 9, 11, 13-20 are objected to because of the following informalities: For improved language, claims 2-7, 9, 11, 13-20 should recite a comma after dependency (for examples, “… of claim 1, wherein …”.
Appropriate correction is required.
4. Applicant is advised that should claim 7 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claims 7, 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
See claims 7, 20 as submitted 8/8/2024.
Claims 7, 10 each depend on claim 1 and recite amino acid having at least 95% sequence identity with SEQ ID NO: 10. Such a recitation does not appear to be further limiting of claim 1, which recites DARPin having at least 95% sequence identity to SEQ ID NO: 12. An alignment between SEQ ID NO: 12 and SEQ ID NO: 10 only appears to show only 89% identity between the two sequences (See NCBI Blast Sequence Alignment of SEQ ID NO: 12 and SEQ ID NO: 10 (2026))(See PTO-892: Notice of References Cited), wherein “Query” is SEQ ID NO: 12 and “Sbjct” is SEQ ID NO: 10, excerpt below:
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-2, 7-9, 12-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 1-2, 7-9, 12-20 as submitted 8/8/2024.
Each of the claims is drawn, inherently or explicitly, to a SARS-CoV-2 neutralizing protein, said protein comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12. Thus, the claims are drawn to compositions comprising a genus of any SARS-CoV-2 neutralizing proteins, said proteins comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: SEQ ID NO: 12 [0032]; trimeric DARPin protein structure (Fig. 5); recitations of DARPin having at least 80%, 90%, 95% or 99% sequence identity to SEQ ID NO: 12 [0030]; FSR16m and FSR22 for neutralizing SARS-CoV-2 [0054].
While it is known in the art that DARPins can recognize targets with specificities and affinities that equal or surpass those of antibodies ((abstract); See Pluckthun, “Designed Ankyrin Repeat Proteins (DARPins): Binding Proteins for Research, Diagnostics, and Therapy,” Annu. Rev. Pharmacol. Toxicol. 55: 489-511 (2015))(See PTO-892: Notice of References Cited), it is also well known that protein structure determines protein function, and even minor changes can alter function. For example, Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982)(See PTO-892: Notice of References Cited) teaches: that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (p. 1979). Further, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title).
Thus, while the specification as indicated above identifies SEQ ID NO: 12, DARPin protein structure, and variants such as FSR16m and FSR22, in view of challenges known in the art as indicated above, it does not identify a representative sample of proteins that neutralize SARS-CoV-2, especially in view of the breadth of the claims to DARPins having at least 95% sequence identity to SEQ ID NO: 12. Thus, the application does not identify a representative sample of SARS-CoV-2 neutralizing proteins as claimed clearly within the breadth of the claimed genus.
There is no apparent common conserved structure to the different proteins comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12 that distinguishes those that neutralize SARS-CoV-2 as compared to those that do not. There is therefore a high level of uncertainty as to which proteins fall within the scope of the indicated neutralize SARS-CoV-2.
The specification does not provide a specific structure of any proteins comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12 within the genus that correlates with the required function. Because there is no identification of structures common to each protein comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12, nor sufficient representative examples of the protein by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of proteins comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12 through identification of a structure and function. While the proteins are required to neutralize SARS-CoV-2, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a protein comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12 does not demonstrate that such a protein would be able to neutralize SARS-CoV-2.
For the reasons above, and in view of the uncertainty as to which proteins comprising a designed ankyrin repeat protein (DARPin) having at least 95% sequence identity to SEQ ID NO: 12 would be able to neutralize SARS-CoV-2, the application has not provided sufficient written description support for the genus of proteins identified in claim 1. The application therefore fails to provide adequate support for methods of using this genus of proteins.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 1, 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chen et al. (WO2020231930-A1)(See PTO-892: Notice of References Cited).
See claims 1, 8 as submitted 8/8/2024.
Chen et al. teaches: DARPins (abstract); including 3.5B (SEQ ID NO: 10), which has 96.5% identity with instant SEQ ID NO: 12 (See Result 4 of STIC Sequence Search 20260803_133217_us-18-837-026a-12.szlim165_DX.rag in Supplemental Content Tab); compositions [0003](as recited in claim 8).
As to the claim language “A SARS-CoV-2 neutralizing protein”, such a recitation is considered to be a statement of intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
Thus, Chen et al. anticipates the instant claims.
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.
8. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarez Vallina et al. (EP2420253A1)(See PTO-892: Notice of References Cited) in view of Sodroski et al. (WO0119958A2)(See PTO-892: Notice of References Cited).
See claim 10 as submitted 8/8/2024.
Alvarez Vallina et al. teaches: multifunctional and multivalent molecules with trimerization domain (title); including ligand binding structures including scFv and DARPins [0021](as recited in claim 10); fusion of trimerization regions to scFv [0006-0007]; such as fibritin [0006]; covalent binding [0021](as recited in claim 10).
Alvarez Vallina et al. does not teach SEQ ID NO: 14.
Sodroski et al. teaches: T4 fibritin trimeric sequence which has 100% identity with instant SEQ ID NO: 14 (See Result 5 of STIC Sequence Search Result 20260801_165755_us-18-837-026a-14.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use sequence as taught by Sodroski et al. with the method as taught by Alvarez Vallina et al. Alvarez Vallina et al. teaches use of fibritin, and Sodroski et al. teaches such a fibritin (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using sequence as taught by Sodroski et al. with the method as taught by Alvarez Vallina et al.
There would have been a reasonable expectation of success given the underlying materials (T4 fibritin domains as taught by Alvarez Vallina et al. and Sodroski et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
9. Claim 1, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12161691.
See claims 1, 8 as submitted 8/8/2024.
Claims 1-13 of U.S. Patent No. 12161691 recite a composition comprising an anti-toxin for treating or protecting against Clostridium difficile (C. difficile) infections, wherein the anti-toxin comprises a designed ankyrin repeat protein (DARPin) comprising at least one of U3 (SEQ ID NO:13) and 1.4E (SEQ ID NO:2), and wherein the anti-toxin binds to a region on toxin B (TcdB) that is critical for toxin translocation into host cytosol. It is noted that SEQ ID NO: 2 has 95.4% identity with instant SEQ ID NO: 12 (See Result 12 of STIC Sequence Search Result 20260803_133217_us-18-837-026a-12.szlim165_DX.rapbm in Supplemental Content Tab).
As to the claim language “A SARS-CoV-2 neutralizing protein”, such a recitation is considered to be a statement of intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 8 and claims 1-13 of U.S. Patent No. 12161691 recite DARPin having at least 95% identity to SEQ ID NO: 12.
10. Claims 1, 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/974684.
See claims 1, 8 as submitted 8/8/2024.
Claims 1-12 of copending Application No. 18/974684 recite a composition comprising an anti-toxin for treating or protecting against Clostridium difficile (C. difficile) infections, wherein the anti-toxin comprises a designed ankyrin repeat protein (DARPin) dimer comprising a first DARPin monomer selected from U3 (SEQ ID NO:13), 1.8H (SEQ ID NO:3) and 5.5A (SEQ ID NO:6) and a second DARPin monomer selected from 7.5A (SEQ ID NO:7), 1.2E (SEQ ID NO:1), 1.4E (SEQ ID NO:2) and 1.11E (SEQ ID NO:4). It is noted SEQ ID NOs: 6, 7, 2, 4 of claims 1-12 of copending Application No. 18/974684 have 95.8%, 95,8%, 95.4%, 96.1% identity, respectively, with instant SEQ ID NO: 12 (See Results 9, 10, 12, 16 of STIC Sequence Search Result 20260803_133217_us-18-837-026a-12.szlim165_DX.rapbm in Supplemental Content Tab).
As to the claim language “A SARS-CoV-2 neutralizing protein”, such a recitation is considered to be a statement of intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 8 and claims 1-12 of copending Application No. 18/974684 recite DARPin having at least 95% identity to SEQ ID NO: 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
11. With respect to 35 U.S.C. 101, SEQ ID NO: 12 is not considered to read upon a naturally occurring peptide, as the specification teaches: DARPin includes any protein comprised of ankyrin repeat peptides that has been designed and synthesized for highly specific and high affinity binding to a target protein [0025].
12. SEQ ID NOs: 5-8, 13 are free of the prior art of record.
13. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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