DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 11/27/2024 is acknowledged.
Claims 1-2, 4-18, 23 and 25-26 are pending.
3. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
4. 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.
5. Claims 13-17 and 25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 13 and 14 are indefinite in the recitation of a polypeptide chain “derived from” the respective antibody clone, because neither the nature nor acceptable degree of derivation is defined.
(ii) Claim 13 is indefinite in the recitation of the phrase “second heavy chain derived from a different antibody clone to the first heavy chain,” because it is unclear whether the intended meaning is “second heavy chain derived from an antibody clone different from the antibody clone from which the first heavy chain is derived,” or something different.
(iii) Claim 13 is further indefinite in the recitation of “a quaternary epitope that arises through binding higher order structures constituting the trimeric spike protein,” because the origin or identity of the spike protein is unknown.
(iv) Claim 15 is indefinite, because the recitation of the “bispecific antibody” lacks proper antecedent basis in the base claim.
(v) Claims 16-17 and 25 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claim 23 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method for treating a subject having a disease or a complication associated with SARS-CoV-2 coronavirus infection, does not reasonably provide enablement for a method for treating a subject having a disease or a complication associated with a generically recited coronavirus 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 without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
A person of ordinary skill in the art would readily understand that any therapeutic effect of the claimed antibody would be mediated by its binding to its target, i.e. spike protein of the SARS-CoV-2 coronavirus. Since it is at best unpredictable whether the antibody would bind to a different coronavirus, experimentation aimed at treating infections with other coronaviruses would be unnecessarily, and improperly, extensive and undue.
8. Claim 26 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of identifying the presence of SARS-CoV-2 coronavirus or spike protein thereof, does not reasonably provide enablement for a a method of identifying the presence of a generically recited coronavirus, or a generically recited component or fragment thereof.
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 without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
A person of ordinary skill in the art would readily understand that identification is mediated by binding of the claimed antibody to its target, i.e. the spike protein of the SARS-CoV-2 coronavirus. Since the antibody is not expected to bind to other components or fragments of SARS-CoV-2, and it is at best unpredictable whether the antibody would bind to a different coronavirus, experimentation aimed at practicing the method as generically recited would be unnecessarily, and improperly, extensive and undue.
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1-2, 4-6, 8-10, 15-18, 23 and 25-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Screaton et al. (US 20240043507, cited on IDS).
Claim interpretation: claim 1 recites an antibody comprising a heavy chain variable region defined by the recited CDR sequences and/“or” a light chain variable region defined by the recited CDR sequences. Accordingly, the claim reads on antibodies which comprise only the specified light chain sequences.
Screaton teaches anti-SARS-CoV-2 antibodies comprising light chain variable regions of SEQ ID NOS: 64 and 184, which are identical to instant SEQ ID NOS: 9 and 14, respectively (see SCORE). Instant light chain variable region of SEQ ID NO: 9 comprises CDRs of SEQ ID NOS: 6, 7 and 8, and instant light chain variable region of SEQ ID NO: 14 comprises CDRs of SEQ ID NOS: 11, 12 and 13 (Table 1 of instant specification). Accordingly, Screaton’s antibodies are within the scope of at least instant claim 1.
Limitations of claims 2, 8-10, 15-17 and 25 are inherent in Screaton’s antibodies. Limitations of claims 4-6 are taught by Screaton e.g. at [0212] and [0223], limitations of claims 18 and 23 are taught by Screaton e.g. at [0008], and limitations of claim 26 are taught by Screaton e.g. at [0021].
11. 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 §§ 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 terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer 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 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/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1-2, 4-6, 8-10, 15-18, 23 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12030927.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘927.
As addressed in section 9 above, claim 1 reads on antibodies which comprise only the specified light chain sequences.
Claims 1-2 of US ‘927 recite an antibody capable of binding to the spike protein of coronavirus SARS-CoV-2 which comprises a light chain variable domain comprising SEQ ID NO: 954, which is identical to instant SEQ ID NO: 24 (see SCORE) and comprises CDRs of SEQ ID NOS: 21, 22 and 23 (Table 1 of instant specification).
Limitations of instant claims 2 and 8-10 are inherent in antibody claimed in US ‘927. Additional instant claim limitations are recited in the following US ‘927 claims:
Instant US ‘927
4 3-4
5-6 13-14
15-17 5-7
18 9
23 11
25 8
26 17
13. Claims 1-2, 4-6, 8-10, 15-18, 23 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications:
USSN PG Pub. No.
18/264,226 20240043507 (see section 9 above)
18/264,241 20240036054 (cited on IDS)
18/664,079 20240376178 (cited on IDS)
18/839,067 20250154231
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of each of the copending applications, which recite anti-SARS-CoV-2 antibodies comprising the same light chain CDRs as presently claimed.
Specifically, USSN ‘226 recites antibodies number 55 and 165 (claim 1) which, according to Table 1 of USSN ‘226 comprise light chain sequences of 64 and 184 identical to instant SEQ ID NOS: 9 and 14 (see SCORE, and section 9 above).
USSN ‘241 recites antibody Beta-25 (claim 1) which, according to Table 2 of USSN ‘241 comprises light chain sequence of SEQ ID NO: 464, identical to instant SEQ ID NO: 19, which comprises CDRs of SEQ ID NOS: 16, 17 and 18 of instant claim 1.
Claim 4 of each of USSN ‘079 and USSN ‘067 recites antibodies listed in Tables 1 to 3. Table 1 of each application lists antibodies with light chains of SEQ ID NOS: 64 and 184, and Table 2 of each application lists antibodies with light chains of SEQ ID NOS: 464 and 594. These four sequences are identical to instant SEQ ID NOS: 9, 14, 19 and 24, respectively, which comprise CDRs of instant claim 1.
The limitations of instant claims 2, 4-6, 8-10, 15-18, 23 and 25-26 are either inherent or recited in the claims of the copending applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 7, 11 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all relevant limitations of the base claim and any intervening claims.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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