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
Acknowledgement is hereby made of receipt and entry of the communication filed on Mar. 26, 2026. Claims 1-9 and 11-28 are pending and are currently examined.
Claim Objection
(Previous objection- withdrawn) The claims 1-3, 12 and 15 are objected.
This objection is withdrawn in view of the amendment filed on Mar. 26, 2026.
(New objection) Claim 1 is objected to because of the following informalities:
The word “and” need to be added after the “SEQ ID NO: 2” and “SEQ ID NO: 5”, respectively. Also, the semicolon “;” should be changed to comma “,” after the SEQ ID NOs: 2 and 5, respectively.
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.
(New Rejection-necessitated by amendment) Claims 1-9 and 11-28 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.
The amended claim 1 recites phrases such as “CDR 1 consisting of a sequence shown as SEQ ID NO: 1” that renders the claim indefinite. It is not clear if the “a sequence” means a full-length SEQ ID NO: 1 or a part of it. For example, two amino acids of the SEQ ID NO: 1 can be considered as “a sequences”. Also, the term “shown as” in the phrase renders the claim indefinite. It is unclear what the “shown as” is represented for. Therefore, one of ordinary skill in the art will not know the metes and bounds of the claims. AT the same time, these rejections are also extended to all the rest CDR sequences for SEQ ID NOs: 2-6, respectively.
Amending the claims to recite “CDR1 consisting of the amino acid sequence of SEQ ID NO: 1” or similar language is suggested to overcome this rejection. This suggestion is applied to all the rest CDR sequence for SEQ ID NOs: 2-6, respectively.
In addition, the newly added claims 16-18 also recite the terms “a sequence”, “shown as” that render the claims indefinite. It is unclear what the “shown as” means here. For example, it is unclear if “shown as” indicates an exemplary sequence, a consensus sequence, etc. Also, it is not clear if the “a sequence” include the full-length of SEQ ID NOs: 7-8 or just a portion of them. Also, it is not clear what the “a sequence” is for “comprising the heavy chain CDRs according to claim 1 and having at least 80% identity to SEQ ID NO: 7” (claim 16) or “comprising the light chain CDRs according to claim 1 and having at least 80% identity to SEQ ID NO: 8” (claim 17).
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Please note: the following previous rejections under 35 U.S.C. 112(b) is withdrawn.
(Previous rejection- withdrawn) The claims 1-3 and 7 recite the term “separated” that renders the claim indefinite. It is not clear what the “separated” referred to, and if the “separated” is the same as “isolated”.
This rejection is withdrawn in view of the amendment filed on Mar. 26, 2026.
(Previous rejection- withdrawn) Regarding the claims 2-3, 5-6, 9 and 11, 13-14, the term “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are parts of the claimed invention.
This rejection is withdrawn in view of the amendment filed on Mar. 26, 2026.
(Previous rejection- withdrawn) Regarding claims 11 and 14, they recite a term “effective amount” that renders the claims indefinite. It is unclear what amount administrated can be an effective amount. Although the instant specification discloses that “the term "effective amount" refers to an amount or dose that is sufficient to achieve or at least partially achieve the desired effect after single or multiple administration. The term "therapeutically effective amount" refers to an amount that produces the desired effect in a treated subject, including improvement of conditions of the subject (e.g., improvement of one or more symptoms), the “desired effect” is unclear to decide the “effective amount.
This rejection is withdrawn in view of the amendment filed on Mar. 26, 2026.
(Previous rejection- withdrawn) Claims 12 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
This rejection is withdrawn in view of the amendment and argument filed on Mar. 26, 2026.
Claim Rejections - 35 USC § 112(a)
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.
(New rejection) Claims 16-17 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.
The claims 16 and 17 are directed to an antibody or antigen-binding fragment comprising the heavy chain CDRs/light chain CDRs according to claim 1 having at least 80% identity to SEQ ID NO: 7 and SEQ ID NO: 8, respectively.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
Here the written description rejection is made because the claims are interpreted as being drawn to a CDR region recited as being “at least 80% identity” to the instant claimed SEQ ID NOs 7-8. This means that up to 20% amino acids sequences of the CDRS can vary.
The instant specification discloses that the anti-RSV antibody or antigen-binding fragment thereof of the present disclosure includes a heavy chain variable region VH and/or a light chain variable region VL. The heavy chain variable region includes 3 heavy chains variable region CDRs of an antibody shown in Table 2, and has at least 7 5%...80% …or 99% identity to the amino acid sequence shown as SEQ ID NO: 7, and an anti-RSV antibody including the above VH has the RSV-binding activity (See [0013] and [0015]), and the light chain variable region includes 3 light chain variable region CDRs of the antibody shown in Table 2, and has at least 75%...80%... or 99% identity to the amino acid sequence shown as SEQ ID NO: 8, and an anti-RSV antibody including the above VL has the RSV-binding activity (See [0017] and [0019]). However, the specification does not indicate which portions of the claimed SEQ ID NOs: 7-8 are essential to retain the ability to has the RSV-binding activity or which portions of SEQ ID NOs: 7-8 can be modified or altered up to 20% and still retain the ability for RSV-binding as claimed.
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. 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. (Proc Natl Acad Sci U S A. 1982 Mar;79(6):1979-83.). 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.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "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." (See page 1117.).
As discussed above, the skilled artisan cannot envision the detailed sequences and structures of an antibody or antibody fragment that are "at least 80% identical” to SEQ ID NOs: 7-8. therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112 (Enablement)
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.
(Previous rejection- withdrawn) Claims 11 and 14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
This rejection is withdrawn in view of the amendment and argument with the clinical trials evidence filed on Mar. 26, 2026.
Allowable Subject Matter
The nucleic acid sequence SEQ ID NOS: 1-8 are free of prior art.
Responses to Applicant’s Remarks
Applicant’s arguments filed on Mar. 26, 2026 has been received and fully considered as follows:
1). Applicant’s amendments regarding the objections are considered. The objections are withdrawn.
2). Applicant’s amendments and arguments regarding the rejections under 35 U.S.C. 112 (b) for claims 1-3 and 7, claims 2-3, 5-6, 9 and 11, 13-14 and claims 11 and 14 are considered and these rejections are withdrawn. However, a new rejection-necessitated by amendment is issued for the amended base claim 1 along with the new claims 16-18.
3). Applicant’s amendment regarding the rejections under 35 U.S.C. 112 (b) for claims 12 and 15 as being incomplete for omitting essential steps is considered. The rejection is withdrawn.
4). Applicant’s argument on the rejections under 35 U.S.C. 112 (Enablement) is considered based on the amendment and the arguments with the clinical trials provided in the instant Remarks. The rejection is withdrawn.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am-5:00 pm, EST.
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/RUIXUE WANG/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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