DETAILED ACTION
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 .
Status of Claims
The amended claims filed 04/27/2026 are acknowledged and entered.
Claims 1, 7-10 and 24 have been amended
Claims 2-6, 18, and 20-23 are cancelled
Claims 15-17 are withdrawn.
Claims 1, 7-14, 19, 24-25 are pending and examined on their merits.
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Objections
Specification - Withdrawn
The disclosure was objected to because of the following informalities:
a) It contains an embedded hyperlink and/or other form of browser-executable code.,
Applicant has corrected the informalities in the substitute specification and the objection is withdrawn.
Drawings - Withdrawn
The Drawings were objected to because nucleotide and/or amino acid sequences appearing in Figures 1-2 are not identified by sequence identifiers in accordance with 37 CFR 1.821 (d).
Applicant has corrected the informalities in the substitute specification and the objection is withdrawn.
Claim Rejections - 35 USC § 112(b) -Withdrawn
The rejections for 1 and 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in view of claim 1 amendment.
Claim Rejections - 35 USC § 112(a) - Withdrawn
The rejections for claims 1, 7, 11-14, 19, and 24-25 for lack of written description, based the specification described only a small species of antibodies while the claims encompassed a vast, functionally defined genus is withdrawn in view of claim 1 amendment.
The rejections for claims 1, 11-14, 19, and 24-25 for lack of enablement, based on undue experimentation would be required to practice the full scope of the claims is withdrawn in view of claim 1 amendment.
Rejections Maintained
Claim Rejections - Improper Markush Grouping - Maintained
Claims 1-3, 19 and 24-25 remain rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives. Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejections are maintained.
Applicant’s Arguments:
- (a) As amended, independent claim 1 recites four specific CDR combinations, each corresponding to one of the four defined antibodies, presented as discrete alternatives using "or" clauses (a) through (d), rather than in Markush format. As a result, each alternative represents a discrete antibody defined by a fixed set of six CDRs, thereby eliminating the possibility of uncontrolled variation across the CDR regions.
- (b) The claimed antibodies share a sufficient degree of structural similarity and a common utility to support the propriety of grouping these alternatives within a single claim. Specifically, all of the claimed antibodies are directed to binding the RBD of the SARS-CoV-2 spike protein and neutralizing the virus, and may be understood as belonging to a common functional and structural class in that they all bind the same epitope and share the same antigen-binding specificity, notwithstanding differences in their individual CDR sequences. Accordingly, the claim does not encompass arbitrary variants, but rather a limited and structurally defined set of antibodies sharing a common antigen-binding architecture.
Each alternative listed in amended claim 1 represents a distinct, fully specified antibody species.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
Applicant argues that the four antibodies bind the same epitope and share the same antigen-binding specificity. This is not found persuasive because the different antibodies comprise distinct CDRs and are distinct antibodies
While the antibodies bind the same antigen, RBD, there is no evidence showing they bind the same exact epitope within the antigen and that they share the same binding properties. When comparing the HCDR3 (see below) we can clearly see there is sufficient amino acid differences in the sequences that may dramatically affect antigen-binding function as evidenced by Rudikoff (cited previously) and Paul (cited previously). Although only HCDR3 is used below as an example, an artisan would understand that the sequence differences in the CDRs overall would amount to structural differences in the antibody binding region as a whole.
heavy chain CDR3 of SEQ ID NO: 11 (ARDLEEAGGMDV)
heavy chain CDR3 of SEQ ID NO: 13 (ARPIVGARAGMDV)
heavy chain CDR3 of SEQ ID NO: 16 (ARDKNEGAMDV)
heavy chain CDR3 of SEQ ID NO: 18 (ARSYGDYFIDY)
For example, when comparing SEQ ID NO: 11 (12 amino acids) with SEQ ID NO: 13, (13 amino acids), the only alignment is ARXXXX(X)XGMDV with the mismatched 6 or 7 amino acids in the middle. In other words, the percentage of identify between SEQ ID NO: 11 and 13 is low. The different antibodies comprise distinct CDRs and are distinct antibodies. The sequence comparison demonstrates that the variously claimed CDRs do not share common structural features as the search results indicates that the variously claimed antibodies share less than about 60% sequence similarity.
In addition, the Court has indicated in Amgen Inc vs Sanofi ( 2017-1480, Fed Cir, 2017) that the disclosure of a well characterized antigen is insufficient for an adequate written description of the antibody that binds the antigen. Thus, antibodies that bind a specific antigen but having distinct amino acid sequences are not obvious variants of antibodies that bind the same antigen but having completely distinct amino acid sequences, especially given that the epitopes that the antibodies bind are distinct. Applicant has not demonstrated that the individual antibodies have a common core amino acid structure nor that the different antibodies bind to the same epitope. Thus, it has been interpreted that the claimed antibodies are distinct products and are not obvious variants of each other.
New Objections / Rejections Based on Amendments
Claim objections
Claims 1 and 7 are objected because:
(a) Claim 1 recites: “antigen-binding fragment is selected from Fab, scFv, or single-domain antibodies, …” but the antibody comprises 6 CDRs which cannot be the case for a single chain domain antibody.
(b) Claims 1 and 7 are objected to because the periods at the end of the claim are missing.
(c) Claim 1 is objected to because it recites the limitation "An antibody or antigen binding fragment thereof, wherein the antigen-binding fragment is selected from Fab, scFv, or single-domain antibodies, that binds to ….”. This limitation is unclear because “antibody” is defined to include the antibody or antigen-binding fragment thereof described in any one of [1] to [10], selected from the group consisting of immunoglobulin molecules, monoclonal antibodies, human antibodies, chimeric antibodies, CDR- grafted antibodies, Fab, Fab', F(ab')2, Fd, Fv, disulfide- bound Fv, scFv, single domain antibodies, nanobody antibodies, diabody antibodies, bispecific antibodies, and multi-specific antibodies.. However, the CDRs or variable regions could be found on one antigen-binding fragment molecules or of polyclonal antibodies. Recitation’s clarity is improved by the following changes: adding “monoclonal” to the limitation. So, the recitation reads: “A monoclonal antibody or antigen binding fragment thereof, wherein the antigen-binding fragment is selected from Fab or scFv that binds to …….”. In Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention. Therefore, adding “monoclonal” to the recitation will satisfy this objection.
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 14 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. Claim 14 is dependent on claim 1. Claim 1 recited the limitation “An antibody or antigen binding fragment thereof, wherein the antigen-binding fragment is selected from Fab, scFv, or single-domain antibodies, that binds to, ….” Claim 14 fails to further limit the subject matter of the claim upon which they depend. Instead, the claim 14 recitation “The antibody or antigen-binding fragment thereof according to claim 1, selected from the group consisting of immunoglobulin molecules, monoclonal antibodies, human antibodies, chimeric antibodies, CDR-grafted antibodies, Fab, Fab', F(ab')2, Fd, Fv, disulfide-bound Fv, scFv, single domain antibodies, nanobody antibodies, diabody antibodies, bispecific antibodies, and multi-specific antibodies.” is broader in scope. 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.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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