Detailed Action
Pursuant to a preliminary amendment filed on March 14, 2025, claims 1 – 16, and 18 - 21 are currently pending in the instant application. Claims 1, 5, 6, 8, 11, 13, 14, 15 and 18 are independent claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 15, 2024 has been considered. An initialed copy of the IDS accompanies this Office Action.
Priority
The present application filed August 15, 2024, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/CN2023/076790, filed February 17, 2023, which claims the benefit of PCTCN2022076580, filed February 17, 2022. Certified translated copies of the PCTCN2022076580 were filed on 08/15/2024.
Therefore, the earliest priority date is February 17, 2022.
Nonstatutory 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.
The instant claims 1 – 16 and 18 – 21 are rejected on the grounds of nonstatutory double patenting of the claims of Patent US 11970517 B2 (hereinafter referred to as “ ’517 ”) published April 30, 2024. Although the conflicting claims are not identical, they are not patentably distinct from each other because instant application claims 1 – 16 and 18 - 21 are anticipated by claims 1 – 15 of patent ‘517.
Patent ‘517 teaches a polypeptide comprising a hydrophilic segment and a hydrophobic segment, wherein the hydrophilic segment comprises Seq ID No: 15.
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The instant application teaches a method of generating a peptide capable of dissolving a protein aggregate, the method comprising identifying a naturally occurred protein having a Champ region and a peptide generated according to the method (instant claim 5) . Seq ID No: 15 of patent ‘517 has 100% alignment with instantly claimed Seq ID No: 2 (See alignment below).
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Therefore, the claims of patent ‘517 are “species” of the claims of the instant invention. Specifically, patent ‘517 is narrower as it requires that the polypeptide require a hydrophobic and hydrophilic region, while the instant application require only a peptide with a charged amphipathic (Champ) region of 40 to 100 amino acid residues Thus claims 1 – 16 and 18 – 21 of the instant invention are anticipated by claims 1 – 15 of the patent ‘517.
Claim Rejections - 35 USC § 112(a) - Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112, first paragraph:
(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.
Claims 1 – 16 and 18 – 21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 – 16 and 18 - 21 encompass a method of generating a peptide capable of dissolving a protein aggregate, wherein the method comprises identifying a naturally occurred protein having a charged amphipathic (Champ) region of 40 to 100 amino acids, wherein
At least 30 percent of the amino acid residues in the Champ region are charged amino acid residues selected from Asp, Glu, Arg, and Lys, wherein at least 80 percent of the charged amino acid residues are in the N-terminus or C-terminus of the Champ region,
14 percent to 26 percent of the amino acid residues in the Champ region are hydrophobic amino acid residues selected from Phe, Cys, Leu, Val, and Ile, and
At least 10 percent of the amino acid residues in the Champ region are polar amino acid residues selected from Ser, Asn, Thr, Gln, Tyr, Cys, and His, and
generating a peptide consisting of the champ region. Overall, what these statements
indicate is that the Applicant must provide adequate description of such core structure and function related to that method such that the Artisan could determine the desired effect. Hence, the analysis below demonstrates that Applicant has not determined the core structure and function for full scope of the claimed method.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude that the inventors had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was "ready for patenting", or by describing distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention (January 5, 2001 Fed. Reg., Vol. 66, No. 4, pp. 1099-11). MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. Moreover, MPEP 2163 states: [A] biomolecule sequence described only by a functional characteristic, without any known or disclosed characteristic, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.
In analyzing whether the written description requirement is met for the claimed method, it is first determined whether the examples describe a method of generating a peptide capable of dissolving a protein aggregate, wherein the method comprises identifying a naturally occurred protein having a charged amphipathic (Champ) region of 40 to 100 amino acids, wherein
At least 30 percent of the amino acid residues in the Champ region are charged amino acid residues selected from Asp, Glu, Arg, and Lys, wherein at least 80 percent of the charged amino acid residues are in the N-terminus or C-terminus of the Champ region,
14 percent to 26 percent of the amino acid residues in the Champ region are hydrophobic amino acid residues selected from Phe, Cys, Leu, Val, and Ile, and
At least 10 percent of the amino acid residues in the Champ region are polar amino acid residues selected from Ser, Asn, Thr, Gln, Tyr, Cys, and His, and
Generating a peptide consisting of the champ region.
The instant claims encompass a genus of peptides that are only defined by the Champ region and having the ability to dissolve protein aggregates. The claims do not require that these peptides possess any particular conserved structure or other disclosed distinguishing feature. Thus, there is no structure/function correlation for the claimed genus of peptides able to dissolve a protein aggregate.
From the specification, it is clear that Applicant has possession of the charged amphipathic peptides of Seq ID Nos 1 – 15 (see Example 1 and Figure 1). The claims are drawn to proteins with a requirement of a certain functional capability, e.g, able to dissolve a protein aggregate. Thus, the claims are not limited to a protein with a specific amino acid sequence. The claims only require the claimed peptides to share some degree of structural similarity to the polypeptides of Seq ID Nos: 1 – 15. However, the specification only describes polypeptides having the amino acid sequence of Seq ID Nos: 1 – 15, and fails to teach or describe any other variants of the peptides comprising the amino acid sequences of Seq ID Nos: 1 – 15.
Further, the as-Filed Specification does not teach the process of generating the peptide. Example 1 teaches the analysis of a Champ peptide capable of dissolving protein aggregates, but does not teach the process of generating the peptide (Paragraph [0082]).
Before the effective filing date of the claimed invention, it was known in the art that using amphipathic peptides from natural proteins to create tunable nanostructures is challenging because of their heterogeneity and great tendency to form aggregates, as evidenced by Hong et al. (Hong, H. et al. Small amphipathic peptides are responsible for the assembly of cruciferin nanoparticles. Sci Rep 7, 7819 (2017). https://doi.org/10.1038/s41598-017-07908-z) (Abstract).
Additionally, it was known in the art that amphipathic peptides tend to occupy the boundaries of liquid-ordered domains and significantly increase the energy barrier of the domain-domain fusion, which might lead to misregulation of raft clustering and adverse consequences for normal cell processes, as evidenced by Pinigin et al. (Pinigin KV et al. Amphipathic Peptides Impede Lipid Domain Fusion in Phase-Separated Membranes. Membranes (Basel). 2021 Oct 20;11(11):797. doi: 10.3390/membranes11110797. PMID: 34832026; PMCID: PMC8618981.) (Abstract).
Both of these references teach that there is a lot of unpredictability in the usage and function of the amphipathic peptides.
As shown supra, there is no structure/function correlation for all the claimed genus of peptides that are capable of dissolving a protein aggregate
Therefore, the specification does not contain a written description of the invention, and a 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 can make and use the same, nor does it set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. This limited information is not deemed sufficient to reasonably convey to one skilled in the art that Applicant is in possession of the method of generating a peptide capable of dissolving a protein aggregate.
Claim Rejection - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 4 and 15 - 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite in the recitation of “…capable of dissolving a protein aggregate” in lines 1 - 2 , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention.
Note, it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138.
Claim 1 is indefinite for the recitation of “naturally occurred protein” in line 3. It is unclear how the protein could have been “naturally occurred.” One of ordinary skill in the art would know that the appropriate term is “naturally occurring,” and thus, the metes and bounds of the claim cannot be determined.
Claims 1 is indefinite as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps can include, for example, any steps regarding how the peptide is generated, including any modifications, any steps of culturing to generate the peptide, isolating and selecting the peptide of interest. A claim that does not set forth any steps involved in the method/process is unclear as to what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 15 is indefinite for the recitation of “the cell” in line 2. There is a lack of antecedent basis for the term “the cell.”
Claim 16 is indefinite for the recitation of “the cell is …. In vitro or in vivo” is lines 1 – 2. It is unclear how the cell can be “in vitro” or “in vivo.” One of ordinary skill in the art would know that the administration can be “in vitro” or “in vivo.” Thus, the metes and bounds of the claim cannot be determined.
Claim 16 is indefinite for the recitation of “and/or” in line 2. It is unclear what the metes and bounds of this term, as “and” could interpreted in claim 16. Specifically, it is unclear whether the cell is a neuronal cell or is in vitro or in vivo. Thus, the metes and bounds of the claim cannot be determined.
Claims 2 – 4 are indefinite insofar as they ultimately depend from claim 1.
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 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.
Claims 5 – 16 and 18 - 21 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by McNally et al. (hereinafter referred to as “McNally”) (US 20140037637 A1, published February 6, 2014).
Regarding claim 5, McNally teaches a peptide (claim 21).
Regarding claim 6 – 12, McNally teaches that the polynucleotide is contained in an AAV9 vector (claims 11, 14, and 17).
Regarding claim 13, McNally teaches that host cells are cultured to express the peptide (Paragraph [0076]).
Regarding claim 14, McNally teaches that the pharmaceutical composition comprises a protein (Paragraph [0127]).
Regarding claims 15 – 16, McNally teaches that the peptide is expressed recombinantly by introducing a nucleic acid encoding a protease-substrate peptide into host cells that are cultured to express the peptide (Paragraph [0076]).
Regarding claims 18 – 21, McNally teaches a method of treating a patient having a transforming growth factor beta (TGF.beta.) superfamily protein-related disease, comprising administering an effective amount of a peptide (Paragraph [0008]). McNally teaches that Huntington’s disease is a TBF.beta related disease (Paragraph [0093]). McNally teaches that the pharmaceutical composition is administered by intracerebral injection (Paragraph [0127]).
Product-by-Process Claims
Instant claims 5 – 16 and 18 - 21 are determined to be product-by-process claims. The structural element of a peptide (as taught in claim 5) is obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. Moreover, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Conclusion
Claims 1 – 16, and 18 – 21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VYOMA SHUBHAM TIWARI/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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