Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Claims 1-76, 78-104 are canceled. Claim 77 is amended. New claims 105-123 are added. Claims 77, 105-123 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 5/24/2024; 10/4/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
Under WIPO Standard ST.26, SEQ ID NOs: 7, 23, 39, 55, 71 containing <4 amino acids are prohibited.
Applicant should amend the specification to replace relevant SEQ ID NOs: with the actual sequences.
Thus, the specification is herein objected to until references to said SEQ ID NOs: are removed from the specification (See MPEP 2412.03; See 37 CFR 1.831(b) and 1.831(j); https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01.pdf).
Appropriate correction is required.
Claim Objections
4. Applicant is advised that should claim 105 be found allowable, claim 106 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
5. Claims 77, 118 are objected to because of the following informalities:
As to claim 77, under WIPO Standard ST.26, SEQ ID NO: 71 containing <4 amino acids is prohibited.
Applicant should amend the claim to replace SEQ ID NO: 71 with the actual amino acid sequence.
Thus, the claim is herein objected to until reference to said SEQ ID NO: is removed from the specification (See MPEP 2412.03; See 37 CFR 1.831(b) and 1.831(j); https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01.pdf).
As to claim 118, the claim recites “… the amino acid sequences of SEQ ID NO: 65 …”. The claim should recite “… the amino acid sequence of SEQ ID NO: 65 …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 114, 122 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 114, 122 recite “use of a secondary antibody”. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").
Claim Rejections - 35 USC § 112
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.
7. Claims 114, 122 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.
See claims 114, 122 as submitted 10/4/2024.
Claims 114, 122 recite “use of a secondary antibody”. It is not clear if the claims intend to recite a process with steps or not.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (See MPEP 2173.05(q)). Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
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.
8. Claims 118-123 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 114, 122 as submitted 10/4/2024.
Each of the claims is thus drawn, inherently or explicitly, to antibody that binds to influenza B virus neuraminidase (NA), wherein the antibody comprises a variable heavy chain region that is at least 95% identical to the amino acid sequences of SEQ ID NO: 65 and a variable light chain region that is at least 95% identical to the amino acid sequence of SEQ ID NO: 66. Thus, the claims are drawn to compositions comprising or methods of using a genus of antibodies comprising a variable heavy chain region that is at least 95% identical to the amino acid sequences of SEQ ID NO: 65 and a variable light chain region that is at least 95% identical to the amino acid sequence of SEQ ID NO: 66, and having the ability to bind to influenza B virus neuraminidase (NA).
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: antibody 4F11 [0043]; Figures 16, 17; correlating to SEQ ID NOs: 65-72 (4.1 Sequence Information); Table 5.
However, by reciting wherein said antibody has comprises a variable heavy chain region that is at least 95% identical to the amino acid sequences of SEQ ID NO: 65 and a variable light chain region that is at least 95% identical to the amino acid sequence of SEQ ID NO: 66, the scope of the claim also reads upon amino acid sequences with the minimum percent identity of 95% but without the complete CDRs of SEQ ID NOs: 67-72. (It is noted that claim 77 requires the complete six CDRs (heavy chain and light chain)).
It is known in the art that even the most minor differences can have significant effects on antigen-antibody binding ability. The art relating to antibodies recognizes that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity that is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982)(See 892-Notice of References Cited). Rudikoff et al. teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
Therefore, in light of the knowledge in the art, broad scope of the claim, and the teachings in the specification, there is still a high level of uncertainty as to which antibodies fall within the scope of the indicated genus and show binding activity to influenza B virus neuraminidase (NA).
In view of the fact that the examples provided do not demonstrate possession of the genus encompassing antibodies showing the binding activity to influenza B virus neuraminidase (NA), there is insufficient written description support for the indicated genus of antibodies, and therefore for the methods of using them.
For the reasons above, and in view of the uncertainty as to which antibodies would be able to bind to influenza B virus neuraminidase (NA) comprising a variable heavy chain region that is at least 95% identical to the amino acid sequences of SEQ ID NO: 65 and a variable light chain region that is at least 95% identical to the amino acid sequence of SEQ ID NO: 66, the application has not provided sufficient written description support for the use of the genus of antibodies identified in claim 118. The application therefore fails to provide adequate support for methods of using this genus of antibodies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
9. Claims 77, 105-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11254733 in view of Reece et al. (US 6242582B1)(See PTO-892: Notice of References Cited).
See claims 77, 105-123 as submitted 10/4/2024.
Claims 1-13 of U.S. Patent No. 11254733 recite an isolated antibody that binds to an influenza B virus neuraminidase (NA), wherein the antibody comprises: (i) a variable heavy chain region complementarity determining region (CDR) 1 comprising the amino acid sequence of SEQ ID NO: 67, (ii) a variable heavy chain region CDR2 comprising the amino acid sequence of SEQ ID NO: 68, (iii) a variable heavy chain region CDR3 comprising the amino acid sequence of SEQ ID NO: 69, (iv) a variable light chain region complementarity determining region (CDR) 1 comprising the amino acid sequence of SEQ ID NO: 70, (v) a variable light chain region CDR2 comprising the amino acid sequence of SEQ ID NO: 71, and (vi) a variable light chain region CDR3 comprising the amino acid sequence of SEQ ID NO: 72; wherein the antibody comprises a variable heavy chain region comprising the amino acid sequence of SEQ ID NO: 65 and a variable light chain region comprising the amino acid sequence of SEQ ID NO: 66; wherein the antibody is an immunoglobulin comprising two identical heavy chains and light chains; wherein the antibody is a monoclonal antibody; wherein the antibody is chimeric antibody; wherein the antibody is a humanized antibody; wherein the antibody is a scFv, Fab, F(ab′)2 or sdFv; wherein the antibody is an IgG; wherein the antibody is conjugated to a detectable agent or therapeutic agent; a kit comprising the antibody of claim 1, and optionally instructions for use of the antibody in the prevention or treatment of an influenza virus infection or an influenza virus disease, or in the detection of an influenza B virus.
Claims 1-13 of U.S. Patent No. 11254733 do not teach method of detecting; secondary antibody; cells; in vitro.
Reece et al. teaches: method of detecting influenza virus; compounds binding to neuraminidase (abstract); influenza B (column 3, line 40); secondary antibody (Example 15); antibody detection kits, in vitro assay, cells (column 7).
One of ordinary skill in the art would have been motivated to use antibody as taught by claims 1-13 of U.S. Patent No. 11254733 with the method as taught by Reece et al. Reece et al. teaches detection of influenza B and neuraminidase using binding compounds, and claims 1-13 of U.S. Patent No. 11254733, which also teaches binding compound to influenza B and neuraminidase, teaches such a compound (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using antibody as taught by claims 1-13 of U.S. Patent No. 11254733 with the method as taught by Reece et al. There would have been a reasonable expectation of success given the underlying materials and methods (methods of detecting influenza B as taught by Reece et al. and claims 1-13 of U.S. Patent No. 11254733) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
It is noted that the double patenting prohibition does not appear to apply to the instant case as U.S. Patent No. 11254733 was issued February 22, 2022, which is before the filing date of the instant divisional application (5/24/2024)(See MPEP 804.01).
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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