DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment of 3/17/23 has been entered in full. Claims 8, 10 and 11 are amended. Claims 1-13 are pending.
Claim Objections
Claims 4, 10, 12 and 13 are objected to because of the following informalities:
In claim 4, line 1, “claim 3,wherein” should be “claim 3, wherein”
In claim 10, line 3, “SEQ ID NO:3” should be “SEQ ID NO: 3”. Compare with claim 4, line 2.
In claim 12, line 2, “a step for” should be a “a step of”.
In claim 12, line 3, “WT-α-syn” should be “wildtype α-synuclein”.
In claim 13, line 1, “WT-α-syn” should be “wildtype α-synuclein”.
The remaining claim(s) are objected to for depending from an objected claim.
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 3-5 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 pre-AIA the applicant regards as the invention.
Claim 3 recites, in line 3, “amino acid residues 125-133 of α-synuclein (SEQ ID NO: 1)”. However, the sequence of SEQ ID NO: 1 only has 112 residues. Thus, it is unclear what residues are being referred to in the claim, as there are no residues numbered 125-133 in SEQ ID NO: 1.
Claim 5 is directed to “[a] monoclonal antibody produced by the hybridoma of claim 2.” However, while claim 2 references the hybridoma of claim 1, it is directed to an antibody per se. Therefore, the scope of the antibody of claim 5 is unclear. For purposes of advancing prosecution, claim 5 is interpreted as depending from the hybridoma of claim 1, 3 or 4.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Claim Rejections - 35 USC § 112(d)
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claim 11 is 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.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Claim 11 limits the monoclonal antibody of claim 2 to “a fragment of a whole antibody”. The antibody of claim 2 is a monoclonal antibody produced by the hybridoma of claim 1, which is the cell line deposited with the ATCC as PTA-127017. The specification teaches that this hybridoma is also known as 4B1, and produces an antibody given the same designation (¶ 67-68). The specification further teaches that this antibody has a heavy and light chain (¶ 30), and thus is a full-length antibody. Thus, parent claim 2 is limited to a whole antibody, which does not encompass a fragment of a whole antibody. Therefore, dependent claim 11 is of improper dependent form because it is directed to an antibody outside the scope of the parent claim, and thus fails to further limit the subject matter of parent claim X.
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.
Claim Rejections - 35 USC § 112(a), deposit
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, 2, 5, 11 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 is directed to a hybridoma cell line as deposited with the American Type Culture Collection under patent deposit accession number PTA-127017. Claims 2, 5 and 11 are directed to an antibody produced by such a hybridoma. Claim 13 is directed to an immunoassay used an antibody produced by such a hybridoma.
The sequences of the heavy and light chains of the antibody produced by the hybridoma cell line are not disclosed by the specification. As such, possession of the hybridoma cell line is required to make and use the hybridoma and antibody product of the claims. As a required element the hybridoma cell line must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If a required element is not so obtainable or available, the enablement requirements of 35 U.S.C. §112(a), may be satisfied by a deposit of the element; e.g., hybridoma expressing the antibody.
There is no guidance provided by the instant specification as to a repeatable method to obtain the hybridoma cell line. The specification instead states that the antibody was deposited with the American Type Culture Collection (ATCC) on June 24, 2021 (page 16, lines 16-19).
Such a statement is an insufficient assurance that all of the conditions of 37 CFR sections 1.801 through 1.809 have been met. If the deposits have been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that,
(1) the deposits have been accepted by an International Depository Authority under the provisions of the Budapest Treaty;
(2) all restrictions upon public access to the deposits will be irrevocably removed upon the grant of a patent on this application; and
(3) the deposit will be replaced if viable samples cannot be dispensed by the depository is required.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves these specific matters to the discretion of each State.
As the deposit currently does not sufficient assurance that all of the conditions of 37 CDR section 1.801 through 1.809 have been met, the claims lack enablement because it would require undue experimentation to try to make the claimed antibody without any availability to the reference antibody by which the claimed antibody is defined.
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 3-10 and 12 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.
Per MPEP 2163, 35 U.S.C. 112(a) requires, “separate and distinct from the enablement requirement”, that the “specification shall contain a written description of the invention…” (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)). In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a), it is necessary to understand what Applicants are claiming and what Applicants have possession of.
Instant claims 3-13 are directed products (hybridomas or monoclonal antibodies) or methods (immunoassays). These claims relate to antibodies that bind to the protein α-synuclein, which is “[t]hought to play a central role in the pathobiology of Lewy body disease”, including Parkinson’s Disease (specification at ¶ 2-3).
Independent claim 3 is directed is a product-by-process claim; specifically a hybridoma, which is a cell expressing a monoclonal antibody, that is made by a method comprising immunizing a mouse with a peptide comprising amino acid residues 125-133 of synuclein, which the specification teaches have the amino acid sequence of YEMPSEEGY (SEQ ID NO: 2) (¶ 6). The term “peptide” is not defined by the instant specification, and thus encompasses any length of amino acid residues; and therefore, “the peptide comprising amino acid residues 125-133” encompasses any fragment of α-synuclein that includes residues 125-133. Claim 4 limits the peptide to SEQ ID NO: 3, which constitutes the peptide of SEQ ID NO: 2 with a cysteine residue attached to the N-terminus. Claim 5 is indefinite for the reasons set forth above, but has been interpreted as encompassing an antibody produced by the hybridoma claim 3 or 4. Claims 3-5 thus encompass hybridomas producing an antibody of any structure produced by immunizing an animal with a peptide comprising residues 125-133 of α-synuclein (claim 3), or a peptide of SEQ ID NO: 3 (claim 4), or each antibody per se (claim 5).
Independent claim 6 is also directed to product-by-process claim; specifically a monoclonal antibody made by a process comprising immunizing a laboratory animals with means for inducing antibodies recognizing aggregated, non-phosphorylated α-synuclein. The specification does not provide a definition of what constitutes “means for inducing antibodies recognizing aggregated, non-phosphorylated α-synuclein”, only teaching that a peptide comprising SEQ ID NO: 2, or a peptide of SEQ ID NO: 3, is an example of such means (¶ 44). Claims 7-10 further limit the process by which the antibody is made, by limiting the animal to a mouse (claim 7), that the means are conjugated to a carrier protein (claim 8) that is keyhole limpet hemocyanin (claim 9), or that the means is the peptide of SEQ ID NO: 3 (claim 10). Because, by definition, any antibody that binds “aggregated, non-phosphorylated α-synuclein” is made by “means for inducing antibodies that recognizing aggregated, non-phosphorylated α-synuclein”, these claims encompass any antibody that binds to aggregated, non-phosphorylated α-synuclein.
Independent claim 12 is directed to a method with the intended use of detection or quantitation of aggregated, non-phosphorylated α-synuclein, and which comprises a single “step for contacting a sample with means for binding WT-α-syn”. The instant specification teaches that the term “means for binding WT-α-syn” encompasses any antibody that is a “functionally equivalent” to an antibody disclosed in the specification (¶ 41), and further that “WT α-syn” is “the form that remains unphosphorylated at serine 129” (¶ 26). Thus, “means for binding WT-α-syn” encompasses any antibody that binds to α-synuclein that is unphosphorylated at serine 129. Thus, practicing the method of claim 12 encompasses use of any antibody that binds to α-synuclein that is unphosphorylated at serine 129.
Thus, each of claims 3-10 and 12 is a genus claim, either directed to a genus of products (claims 3-10), or a method of using a genus of products (claim 12). Each genus has a different but overlapping scope encompassing monoclonal antibodies having different structures. Claims 3-5 are directed to a genus of hybridomas producing an antibody of any structure produced by immunizing an animal with a peptide comprising residues 125-133 of α-synuclein (claim 3), or a peptide of SEQ ID NO: 3 (claim 4), or a genus of said antibodies (claim 5). Claims 6-9 encompasses any antibody that binds to aggregated, non-phosphorylated α-synuclein, and claim 10 encompasses any antibody these claims encompass any antibody that binds to aggregated, non-phosphorylated α-synuclein that is induced by immunization with a peptide of SEQ ID NO: 3. The method of claim 12 encompasses use of a genus of any antibody that binds to α-synuclein that is unphosphorylated at serine 129. Each genus is only limited structurally by having the structure of an antibody, and is only further defined by its functionality.
The prior art recognizes that antibodies bind to epitopes of 5-7 amino acids (Benjamini et al, 1991. Immunology: A Short Course, 2nd edition, page 40 only). While the general structure of an antibody was well-known in the prior art, it is the structure of the complementarity-determining regions (CDRs) that determines the specificity of a particular antibody, and said CDR structure is not predictable based on the epitope to which it binds. Thus, even knowing the structure (CDRs) of one antibody does not allow the skilled artisan to predict the structure of other antibodies that bind to the same epitope or to the other epitopes in the same protein. The relevant art, Ferrara et al (2015. mAbs. 7(1): 32-41) teaches that there is substantial variation in the structure of antibodies that bind to a single protein, on the order of hundreds of different sequences; specifically, see page 36: "The number of different HCDR3s selected against the test antigens ranges from 74 to 460 (Table 3), with the actual number of different antibodies likely to be significantly higher when different VL chains and additional VH mutations are taken into account” (pg 36). Thus, there are at least hundreds of different antibody structures that bind to the α-synuclein, and some subset of these will also bind the aggregated, non-phosphorylated version of the protein.
Thus, the claims are genus claims because they encompass use of a genus of antibodies having the required functionality, e.g., binding to (1) a peptide comprising residues 125-133 of α-synuclein; (2) binding to aggregated, non-phosphorylated α-synuclein; or (3) binding to WT-α-synuclein. However, a product defined by function is not in and of itself sufficient to describe the product because it is only an indication of what the product does, rather than what it is; i.e., the specific structure of the product. It is only a definition of a useful result rather than a definition of what achieves that result. Per MPEP 2124, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition". Furthermore, in the instant case the specification does not establish a correlation between structure and function; i.e., the structure of one anti-α-synuclein antibody does not provide predictability regarding other antibody structures having the same functionality. Furthermore, the decision of the Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of the target protein (e.g., α-synuclein) is not in and of itself sufficient to provide a description of the genus of antibodies binding to said target.
Written description for a genus may also be satisfied through sufficient description of a relevant number of species. This is dependent on whether one of skill in the art would recognize necessary common attributes or features possessed by the members of the genus. Generally, in an unpredictable art, adequate description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Also, “[w]hen a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)). “[A] sufficient description of a genus … requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
In support of the genus of inhibitory anti-C2 antibodies, the specification provides only a single example of an antibody having the required functionality of each genus. Specifically, the specification describes the hybridoma producing the antibody 4B1, that was generated by immunizing mice with an immunogen having the sequence of CYEMPSEEGY (SEQ ID NO: 3) that was conjugated to KLH, as described in Example 1 of the specification. This antibody recognizes unphosphorylated but not phosphorylated α-synuclein (¶ 67), and recognizes aggregated but not monomeric α-synuclein (¶ 69). The specification does not describe any amino acid sequences of this antibody, such as heavy and/or light chain sequences, but indicates that the antibody has been deposited, which is sufficient to meet the written description requirement with respect to this specific antibody in and of itself.
However, the description of a single monoclonal antibody is not representative of a genus of monoclonal antibodies potentially encompassing hundreds of other members having different structures. Per MPEP 2163, "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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116).
Therefore, only
(1) a hybridoma generated by a method comprising immunizing a mouse with a peptide comprising CYEMPSEEGY (SEQ ID NO: 3), and wherein the hybridoma is the hybridoma cell line deposited with the American Type Culture Collection under patent deposit accession number PTA-127017;
(2) a monoclonal antibody made by the hybridoma of (1);
(3) a monoclonal antibody made by a process comprising immunizing a laboratory animal with means for inducing antibodies recognizing aggregated non-phosphorylated α-synuclein, wherein the antibody is the antibody produced by the hybridoma cell line deposited with the American Type Culture Collection under patent deposit accession number PTA-127017; and
(4) An immunoassay for the detection or quantitation of aggregated, non-phosphorylated α-synuclein comprising a step for contacting a sample with a monoclonal antibody produced by the hybridoma cell line deposited with the American Type Culture Collection under patent deposit accession number PTA-127017,
but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112(a). Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer (TD) 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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A TD must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains TD forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,351,623, issued 7/8/25, and which shares the same inventors and applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claim 5 encompasses a monoclonal antibody (mAb) produced by a hybridoma generated by a method of comprising immunizing a mouse with a peptide having the amino acid sequence of CYEMPSEEGY (SEQ ID NO: 3.
Claim 1 of ‘623 encompasses a mAb that specifically binds aggregated, non-phosphorylated α-synuclein comprising a heavy chain (VH) comprising HCDRs1-3 of SEQ ID NO: 7-9 and LCDRs1-3 of SEQ ID NO: 13-15. Dependent claim 3 further limits the antibody to one comprising a VH of SEQ ID NO: 6 and a VL of SEQ ID NO: 12. The specification of ‘623 defines the VH of SEQ ID NO: 6 and VL of SEQ ID NO: 12 as coming from the antibody 4B1 (page 49), which was generated by immunizing a mouse with a peptide having the amino acid sequence of CYEMPSEEGY (SEQ ID NO: 3). As such, the antibody of the claims of ‘623 inherently represents an antibody generated by immunizing a mouse with a peptide having the amino acid sequence of CYEMPSEEGY (SEQ ID NO: 3), and thus is not patentably distinct from the mAb of instant claim 5.
Claims 6 and 7 encompass a mAb made by a process comprising immunizing a laboratory animal with means for inducing antibodies recognizing aggregated, non-phosphorylated α-synuclein (claim 6), and further wherein the animal is a mouse (claim 7). The mAb of the claims of ‘623 binds to aggregated, non-phosphorylated α-synuclein as indicated in the preamble of the claim, and was made by immunizing a mouse, and therefore represents an mAb made by immunizing a mouse with means for inducing antibodies recognizing aggregated, non-phosphorylated α-synuclein. Thus, claims 6 and 7 and are not patentably distinct from the claims of ‘623.
Claims 8 and 9 further limit the mAb of claim 6 to one wherein the means for inducing Abs is conjugated to a carrier protein (claim 8) that is keyhole limpet hemocyanin (KLH) (claim 9). The specification of ‘623 further indicates that the process of making the 4B1 antibody of ‘623 involved conjugate the peptide to the carrier KLH (page 33). Therefore, the antibody of the claims of ‘623 is inherently one that was made by a process comprising immunizing a laboratory animal with means for inducing antibodies recognizing non-phosphorylated α-synuclein, wherein the means are conjugated to a carrier protein. As such, instant claims 8 and 9 are also not patentably distinct from the claims of ‘623.
Claim 10 further limits the mAb of claim 6 to one wherein the means for inducing Abs is a peptide having the amino acid sequence of CYEMPSEEGY (SEQ ID NO: 3). As set forth above, the antibody of the claims of ‘623 was made using such a peptide,. As such, instant claim 10 is also not patentably distinct from the claims of ‘623.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of co-pending application 19/262,944, filed 7/8/25, and which shares the same inventors and applicant with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claim 12 encompasses an immunoassay for the detection or quantitation of aggregated, non-phosphorylated α-synuclein comprising a step for contacting a sample with means for binding WT-α-syn. The instant specification teaches that the term “means for binding WT-α-syn” encompasses any antibody that is a “functionally equivalent” to an antibody disclosed in the specification (¶ 41), and further that “WT α-syn” is “the form that remains unphosphorylated at serine 129” (¶ 26). Thus, “means for binding WT-α-syn” encompasses any antibody that binds to α-synuclein that is unphosphorylated at serine 129.
Claim 15 of ‘944 is directed to an immunoassay for the detection or quantitation of aggregated, non-phosphorylated α-synuclein comprising a step for contacting a sample with the mAb of claim 1, which is a mAb that specifically binds aggregated, non-phosphorylated α-synuclein comprising a heavy chain variable region and a light chain variable region. Thus, the immunoassay of claim 15 utilizes means for binding WT-α-syn. As such, instant claim 12 is not patentably distinct from claim 15 of ‘944.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Note that while the above double patenting rejection is provisional, the instant application and the ‘944 application share the same “patent term filing date”, which is 9/17/21, taking into account any benefit under 35 U.S.C. 120, 121, 365(c), or 386(c)). Per MPEP 804.I.B.1.(b).(ii):
“If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted."
Thus, per MPEP 804, the provisional double patenting rejection set forth above should be maintained in the instant application unless overcome as indicated therein.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674