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 .
Election/Restrictions
Applicant’s election without traverse in the reply filed on 07/29/2026 is acknowledged. Applicant elects the following species:
one AIBP sequence: the amino acid sequence of SEQ ID NO: 21
one amino acid sequence N-terminal to the AIBP amino acid: the amino acid sequence of SEQ ID NO: 2
one disease, disorder, symptom: neuropathic pain
Information Disclosure Statement
The information disclosure statement (IDS) filed 09/18/2023 has been considered and the references therein are of record.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Applicant’s amendment to the claims filed 07/29/2026 introduced specific amino acid sequences that were not correctly identified with SEQ ID NOs and submitted in a Sequence Listing. The unelected claims 27-28 recite amino acid residues 25 to 288 of NCBI Reference Sequences, yet neither sequence was submitted in the Sequence Listing. Appropriate correction is required.
Claim Rejections - 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, 7, 15-18, 20-21, and 29 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.
Claims 1, 7, 15-18, 20-21, and 29 are rejected for recitation of intended result/effect without conferring some structural or material difference on the scope of the claim. The claims recite, or are dependent upon, the functional language of any amino acid sequence N-terminal to the AIBP amino acid sequence comprised of 8 and 40 contiguous amino acid residues acid of which between 3 and 12 amino acid residues are independently selected from the group consisting of arginine (R), histidine (H) and lysine (K), without specifying any specific structures required to perform the functions. Therefore, the claims do not provide the necessary structures that must be present to perform the requisite functions. The mechanism steps and requisite structure are merely implied by the functional language and thus the scope of the claim is undefined. Absent additional active method steps and structure, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims are rejected since they fail to meet all (3) criteria set forth in MPEP 2173.05(g).
Claim 18 is indefinite in the recitation of the phrase “comprised of or having contained therein” because it is unclear as to the scope encompassed by “comprised of” vs “having contained therein” and as to how the scope encompassed by these phrases differs.
Claims 18 and 20 are indefinite in the recitation of the phrase “optionally” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP §2173.05(d).
Claim 27-28 recites the limitation "the method of claim 1”, but claim 1 is a product, not a method claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a) (Written Description)
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.
Claims 1, 7, 15-18, 20-21, and 29 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 1 recites any amino acid sequence N-terminal to the AIBP amino acid sequence, wherein the amino acid sequence N-terminal to the AIBP amino acid sequence is comprised of between 8 and 40 contiguous amino acid residues acid of which between 3 and 12 amino acid residues are independently selected from the group consisting of arginine (R), histidine (H) and lysine (K), which encompasses a genus of agents. Dependent claims 7, 15-18, 20-21, and 29 do not limit the genus to a specific species, including the elected species, and are therefore included in this rejection. In regards to elected species of claims 20 and 29, the claims recite a method of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of any and all neuropathic pain, including neuropathic pain that is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection, which encompasses a genus of agents. These claims do not require that the genus of the claims possess any particular structure or other distinguishing feature that is characteristic of the genus as a whole.
Therefore, the claims are drawn to a genus of binding agents for which there is inadequate written description. 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 (see MPEP 2163(II)(3)(a)(i)(A), reduction to drawings MPEP 2163(II)(3)(a)(i)(B), 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 MPEP 2163(II)(3)(a)(i)(C).
From the specification, it is clear that Applicant is in possession of the elected species of SEQ ID NO: 21 and SEQ ID NO: 2 that is capable of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of Toll-like receptor 4 (TLR4)-mediated inflammation-induced neuropathic pain and neuropathic pain caused by chemotherapy. The claims, however, are not limited to those species but also includes a vast array of potential peptides and neuropathic pains and the specification fails to provide a representative number of species within the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genus as a whole, or representative number of species within the genus, the specification does not provide adequate written description of the claimed genus.
Claim Rejections - 35 USC § 112(a) (Enablement)
Claims 1, 7, 15-18, 20-21, and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the elected species of SEQ ID NO: 21 and SEQ ID NO: 2 that is capable of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of Toll-like receptor 4 (TLR4)-mediated inflammation-induced neuropathic pain and neuropathic pain caused by chemotherapy, does not reasonably provide enablement for the genera of any amino acid sequence N-terminal to the AIBP amino acid sequence, wherein the amino acid sequence N-terminal to the AIBP amino acid sequence is comprised of between 8 and 40 contiguous amino acid residues acid of which between 3 and 12 amino acid residues are independently selected from the group consisting of arginine (R), histidine (H) and lysine (K) or a method of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of any and all neuropathic pain, including neuropathic pain that is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions.
The case law applies to the instant claims which require multiple genera of polypeptides that are capable of treating and preventing any kind of neuropathic pain, yet the inventors have disclosed no amino acid sequences for any of the claimed genera and have only disclosed use of the elected species and the species recited in the Sequence Listing.
In Amgen, the Supreme Court has stated:
“An antibody' s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.' Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12.
Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody' s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody' s structure and function. Ibid.”
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentec, Inc., V. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that: "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all of the disclosure related to the process is within the skill of the art","[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement". The instant specification is not enabling for the full scope of the claimed invention because one cannot follow the guidance presented therein and practice the claimed method without first making a substantial inventive contribution.
Given that structure is essential to function; and given the unpredictability within the art with respect to creating binding proteins, a person having ordinary skill in the art would have to perform further experimentation in order to make the genera of any amino acid sequence N-terminal to the AIBP amino acid sequence, wherein the amino acid sequence N-terminal to the AIBP amino acid sequence is comprised of between 8 and 40 contiguous amino acid residues acid of which between 3 and 12 amino acid residues are independently selected from the group consisting of arginine (R), histidine (H) and lysine (K) that are capable of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of any and all neuropathic pain, including neuropathic pain that is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection encompassed by the claims and use them in the method claimed, commensurate in scope with the breadth of the claims. Given the nature of the invention, a skilled artisan would have to make many polypeptides, then use those in the method claimed of treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of any and all neuropathic pain, including neuropathic pain that is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection in order to demonstrate making and using with a reasonable expectation of success. The specification provides no evidence for the genera of the claimed polypeptides. The specification provides no evidence for a method treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of neuropathic pain that is generated or caused by, or is a sequelae to, arthritis, diabetes, or viral infection. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed. Thus, the claims lack enablement.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-7, 9, 11-12, 15-18, 20-21, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al., 2018 (US20180360993A1) in view of Wikipedia, 2019 (see instant PTO-892).
For the purposes of compact prosecution, the instant claims will be interpreted to be readable on the elected species.
The elected species are drawn to an isolated or recombinant polypeptide that comprises a human ApoA-I Binding Protein (AIBP) with SEQ ID NO: 21 and an amino acid sequence N-terminal to the AIBP amino acid sequence with SEQ ID NO: 2. The elected species are drawn to a pharmaceutical composition comprising the polypeptide or a nucleic acid vector encoding the polypeptide and where it is formulated for intrathecal injection. The elected species are drawn to treating, ameliorating, preventing, reversing or decreasing the severity or duration of, or decreasing the severity of symptoms of neuropathic pain by administration of the polypeptide or a nucleic acid encoding the polypeptide. The elected species are drawn to a kit comprising the polypeptide. The elected species are drawn to the neuropathic pain being caused is chemotherapy or Toll-like receptor 4 (TLR4)-mediated inflammation-induced neuropathic pain.
Miller teaches a recombinant AIBP, where human AIBP (as set forth in SEQ ID NO: 5) was cloned into a pAcHLT-C vector behind the polyhedrin promoter that contains N terminal His-tag (Materials & Methods, para[0218]). As evidenced by NovoPro pAcHLT-C vector Map, insertion of human AIBP (as set forth in SEQ ID NO: 5) into a pAcHLT-C vector behind the polyhedrin promotor using EcoR1 restriction enzyme would result in an animo sequence N-terminal to the human AIBP (Db) that would have 100% identical sequence identity to instant SEQ ID NO: 2 (Qy), as shown below.
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Miller teaches a human AIBP having the sequence set forth in SEQ ID NO: 5 (Db) that has 100% sequence identity to instant SEQ ID NO: 21 (Qy), as shown below.
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Miller teaches this recombinant AIBP can treat, ameliorate, prevent, reverse, decrease the severity or duration of chemotherapeutic-induced peripheral neuropathy such as cisplatin-induced allodynia and inflammation-induced neuropathic pain comprising a Toll-like receptor 4 (TLR4)-mediated inflammation-induced neuropathic pain (abstract, claim 1, & Fig 1-2). Miller teaches intrathecal administration of recombinant AIBP prevents LPS-induced tactile allodynia in mice (Fig 5). Miller teaches intrathecal administration of recombinant AIBP alleviates pre-existing allodynia in mice (Fig 6). Miller teaches intrathecal administration of recombinant AIBP prevents intraplantar formalin-evoked delayed tactile allodynia in mice (Fig 7). Miller teaches intrathecal administration of recombinant AIBP reduces cisplatin-induced tactile allodynia in mice (Fig 8). Miller teaches this recombinant AIBP can be administered in a pharmaceutical composition via nucleic acid (claim 1 & para[0162-0169). Miller teaches this recombinant AIBP reduces the inflammatory responses in microglia by reducing inflammation caused by lipid rafts containing TLR4 in spinal microglia (para[0124-0130, 0229-0231, 0244-0247, & 0249]). Miller teaches a kit comprising the polypeptide (para[0143]).
Miller does not explicitly teach that the EcoR1 restriction site was used to insert human AIBP into the pAcHLT-C vector.
Wikipedia teaches that restriction enzymes are used in a wide variety of genetic techniques and that EcoR1 is a restriction enzyme that generates sticky end of DNA that makes ligation reaction more efficient, such as in vector DNA (Uses).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Miller and Wikipedia. One with ordinary skill in the art would be motivated to make and use the claimed invention because Miller only discloses that the AIBP was inserted into a pAcHLT-C vector behind the polyhedrin promoter but is silent as to which restriction enzyme was used, motivating an ordinary artisan to pick a restriction site, such as EcoR1. In view of Wikipedia’s teaching that EcoR1 produces sticky ends that make ligation reactions in vector DNA more efficient, an ordinary artisan would find it obvious to use the EcoR1 restriction site in the vector, thereby producing the recombinant AIBP. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims do not contribute anything non-obvious over the prior art.
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 elected species of claims 1, 6-7, 9, 11-12, 15-18, 20-21, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US10729788B2 in view of Wikipedia, 2019. Although the claims at issue are not identical, they are not patentably distinct from each other.
The elected species are discussed above.
The patented claims recite a method for treating, ameliorating, reversing or decreasing the severity or duration of a neuropathic pain, or reversing a chemotherapeutic-induced peripheral neuropathy (CIPN), wherein the method comprises: (a) providing or having provided a formulation or a pharmaceutical composition comprising: an ApoA-1 Binding Protein (APOA1 BP) polypeptide compound or composition; and (b) administering or having administered the formulation or the pharmaceutical composition of (a) by in vivo intrathecal injection to a subject in need thereof, thereby treating, ameliorating, reversing or decreasing the severity or duration of the neuropathic pain, or reversing the chemotherapeutic-induced peripheral neuropathy (CIPN). The patented claims recite that the ApoA-I Binding Protein (APOA1BP) polypeptide or protein, is a mammalian APOA1BP polypeptide or peptide. The patented claims recite that the mammalian APOA1BP polypeptide or peptide is a human APOA1BP. The patented claims recite that the APOA1BP polypeptide or peptide is a recombinant APOA1BP, polypeptide or peptide having an APOA1BP activity, or APOA1BP activity-stimulating compound or composition. The patented claims recite that the APOA1BP polypeptide or peptide is a synthetic APOA1BP polypeptide or peptide. The patented claims recite that the APOA1BP polypeptide or peptide is a recombinant or a synthetic APOA1BP. The patented claims recite that the formulation or pharmaceutical composition is formulated for administration in vivo; or formulated for enteral or parenteral administration, or for oral, intravenous (IV) or intrathecal (IT) administration. The patented claims recite that the APOA1BP polypeptide or peptide or the formulation or pharmaceutical composition, is formulated in or with a nanoparticle, a particle, a micelle or a liposome or lipoplex, a polymersome, a polyplex or a dendrimer. The patented claims recite that the nanoparticle, particle, micelle or liposome or lipoplex, polymersome, polyplex or dendrimer further comprise or express a cell or CNS penetrating moiety or peptide or a CNS targeting moiety or peptide. The patented claims recite that the APOA1BP polypeptide or peptide or the formulation or pharmaceutical composition, is formulated in or as a nanoparticle, a liposome, a tablet, a pill, a capsule, a gel, a geltab, a liquid, a powder, an emulsion, a lotion, an aerosol, a spray, a lozenge, an aqueous or a sterile or an injectable solution, or an implant, wherein optionally the implant is an intrathecal implant. The patented claims recite that the neuropathic pain comprises an inflammation-induced neuropathic pain. The patented claims recite that the neuropathic pain is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection. The patented claims recite that the neuropathic pain is generated or caused by, or is a sequelae to, a post-surgical pain. The patented claims recite that the CIPN is a cisplatin-induced CIPN or allodynia. The patented claims recite that the subject is a human. The patented claims recite that the subject is an animal.
The patented claims do not explicitly teach a recombinant human ApoA-I Binding Protein (AIBP) with SEQ ID NO: 21 and an amino acid sequence N-terminal to the AIBP amino acid sequence with SEQ ID NO: 2. The patented claims are silent as to the specific sequence for the APOA1 BP (also called AIBP).
However, US10729788B2 teaches a recombinant AIBP, where human AIBP (as set forth in SEQ ID NO: 5) was cloned into a pAcHLT-C vector behind the polyhedrin promoter that contains N terminal His-tag (Materials & Methods, para[0218]). As evidenced by NovoPro pAcHLT-C vector Map, insertion of human AIBP (as set forth in SEQ ID NO: 5) into a pAcHLT-C vector behind the polyhedrin promotor using EcoR1 restriction enzyme would result in an animo sequence N-terminal to the human AIBP (Db) that would have 100% identical sequence identity to instant SEQ ID NO: 2 (Qy), as shown below.
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US10729788B2 teaches a human AIBP having the sequence set forth in SEQ ID NO: 5 (Db) that has 100% sequence identity to instant SEQ ID NO: 21 (Qy), as shown below.
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US10729788B2 does not explicitly teach that the EcoR1 restriction site was used to insert human AIBP into the pAcHLT-C vector.
Wikipedia teaches that restriction enzymes are used in a wide variety of genetic techniques and that EcoR1 is a restriction enzyme that generates sticky end of DNA that makes ligation reaction more efficient, such as in vector DNA (Uses).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of US10729788B2 and Wikipedia. One with ordinary skill in the art would be motivated to make and use the claimed invention because US10729788B2 does not recite a specific sequence for the APOA1BP in the claims, which would motivate an ordinary artisan to look at the specification to obtain the sequences in order to synthesize the polypeptide. Yet in the specification, US10729788B2 only discloses that the AIBP was inserted into a pAcHLT-C vector behind the polyhedrin promoter to make the recombinant AIBP, but is silent as to which restriction enzyme was used, motivating an ordinary artisan to pick a restriction site, such as EcoR1. In view of Wikipedia’s teaching that EcoR1 produces sticky ends that make ligation reactions in vector DNA more efficient, an ordinary artisan would find it obvious to use the EcoR1 restriction site in the vector, thereby producing the recombinant AIBP recited in the patented claims. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Therefore, instant claims are rejected as being unpatentable over Patent US10729788B2 in view of Wikipedia.
The elected species of claims 1, 6-7, 9, 11-12, 15-18, 20-21, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US11478556B2 in view of Wikipedia, 2019 and Buture et al., 2016. Although the claims at issue are not identical, they are not patentably distinct from each other.
The elected species are discussed above.
The patented claims recite a method for treating, ameliorating, reversing or decreasing the severity or duration of a primary headache, wherein the method comprises: (a) providing or having provided a formulation or a pharmaceutical composition comprising: an ApoA-I Binding Protein (APOA1BP) polypeptide compound or composition; and (b) administering or having administered the formulation or the pharmaceutical composition of (a) to a subject in need thereof, thereby treating, ameliorating, reversing or decreasing the severity or duration of the primary headache, or (b) administering the formulation or the pharmaceutical composition comprising: an ApoA-I Binding Protein (APOA1BP) polypeptide compound or composition to a subject in need thereof, thereby treating, ameliorating, reversing or decreasing the severity or duration of the primary headache. The patented claims recite that the primary headache is a migraine. The patented claims recite that the primary headache is a cluster headache. The patented claims recite that the ApoA-I Binding Protein (APOA1BP) polypeptide is a mammalian APOA1BP polypeptide. The patented claims recite that the ApoA-I Binding Protein (APOA1BP) polypeptide is a human APOA1BP polypeptide. The patented claims recite that the subject is a human. The patented claims recite that the subject is an animal. The patented claims recite that the APOA1BP polypeptide is a recombinant APOA1BP polypeptide. The patented claims recite that the APOA1BP polypeptide is a synthetic APOA1BP polypeptide. The patented claims recite that the formulation or pharmaceutical composition is formulated for administration in vivo; or is formulated for enteral or parenteral administration. The patented claims recite that the formulation or pharmaceutical composition is formulated for administration by in vivo intrathecal injection. The patented claims recite that the formulation or pharmaceutical composition is formulated for oral administration. The patented claims recite that the formulation or pharmaceutical composition is formulated for intravenous (IV) administration. The patented claims recite that the APOA1BP polypeptide or the formulation or pharmaceutical composition, is formulated in or with a nanoparticle, a particle, a micelle or a liposome or lipoplex, a polymersome, a polyplex or a dendrimer. The patented claims recite that the APOA1BP polypeptide or the formulation or pharmaceutical composition, is formulated in or as a nanoparticle, a liposome, a tablet, a pill, a capsule, a gel, a geltab, a liquid, a powder, an emulsion, a lotion, an aerosol, a spray, a lozenge, an aqueous or a sterile or an injectable solution, or an implant.The patented claims recite that the implant is an intrathecal implant.
The patented claims do not explicitly teach the recombinant polypeptide comprises a human ApoA-I Binding Protein (AIBP) with SEQ ID NO: 21 and an amino acid sequence N-terminal to the AIBP amino acid sequence with SEQ ID NO: 2. The patented claims are silent as to the specific sequence for the APOA1 BP (also called AIBP). The patented claims do not explicitly teach that primary headaches, including migraines and cluster headaches, involve neuropathic pain.
However, US11478556B2 teaches a recombinant AIBP, where human AIBP (as set forth in SEQ ID NO: 5) was cloned into a pAcHLT-C vector behind the polyhedrin promoter that contains N terminal His-tag (Materials & Methods, para[0218]). As evidenced by NovoPro pAcHLT-C vector Map, insertion of human AIBP (as set forth in SEQ ID NO: 5) into a pAcHLT-C vector behind the polyhedrin promotor using EcoR1 restriction enzyme would result in an animo sequence N-terminal to the human AIBP (Db) that would have 100% identical sequence identity to instant SEQ ID NO: 2 (Qy), as shown below.
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US11478556B2 teaches a human AIBP having the sequence set forth in SEQ ID NO: 5 (Db) that has 100% sequence identity to instant SEQ ID NO: 21 (Qy), as shown below.
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US11478556B2 does not explicitly teach that the EcoR1 restriction site was used to insert human AIBP into the pAcHLT-C vector.
Wikipedia teaches that restriction enzymes are used in a wide variety of genetic techniques and that EcoR1 is a restriction enzyme that generates sticky end of DNA that makes ligation reaction more efficient, such as in vector DNA (Uses).
Buture teaches that primary headaches, including migraines and cluster headaches, involve neuropathic pain (Abstract; Context; Results 3.1 The Trigeminovascular System and the Trigeminocervical Complex; Results 3.2. Neurogenic Inflammation; Results 3.4. Migraine; Results 3.5. Cluster Headache; and Conclusion).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of US11478556B2, Wikipedia, and Buture. One of ordinary skill in the art would be motivated to make and use the claimed invention because US11478556B2 does not recite a specific sequence for the APOA1BP in the claims, which would motivate an ordinary artisan to look at the specification to obtain the sequences in order to synthesize the polypeptide. Yet in the specification, US11478556B2 only discloses that the AIBP was inserted into a pAcHLT-C vector behind the polyhedrin promoter to make the recombinant AIBP, but is silent as to which restriction enzyme was used, motivating an ordinary artisan to pick a restriction site, such as EcoR1. In view of Wikipedia’s teaching that EcoR1 produces sticky ends that make ligation reactions in vector DNA more efficient, an ordinary artisan would find it obvious to use the EcoR1 restriction site in the vector, thereby producing the recombinant AIBP recited in the patented claims. Furthermore, since the patented claims teach that recombinant AIBP can treat headaches, including migraines and cluster headaches, an ordinary artisan would find it obvious that the recombinant AIBP would treat neuropathic pain because Buture teaches that primary headaches, including migraines and cluster headaches, involve neuropathic pain. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Therefore, instant claims are rejected as being unpatentable over Patent US11478556B2 in view of Wikipedia and Buture.
Conclusion
No claims are allowed.
Advisory Information
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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