DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election, without traverse, of Group I and a multispecific antibody comprising the sequence of clone Ab 12 and 2-7 (see sequences below), in the reply filed on 12/08/25, is acknowledged.
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First Objection to the Drawings
3. The application appears to contain at least one drawing requiring color. For example, see Figure 10 referring to red and purple bars; Figure 18 referring to domains by color; Figure 19 referring to colored ribbons; Figure 45 referring to colored boxes; and/or Figure 205 noting differences in the figure that are highlighted in red. Applicant is asked to verify none of the other 223 figures also require color.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Objection to Specification and Second Objection to the Drawings
4. The disclosure and drawings are objected to because of the following informalities: Missing ST.25 sequence listing; Missing Incorporated by Reference paragraph for sequences; and Missing sequence identifiers in the Drawings (see below for more details). Appropriate correction is required.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
5. Items A) and B) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
FIRST: Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
SECOND Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
THIRD Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Status
6. Claims 1, 7, 9-15, 21 and 23-37 are pending. Claims 2-6, 8, 16-20, 22, and 38-51 are cancelled. Claims 10-11, 13-14, 24-25, and 27-37 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/25. Claims 1, 7, 9, 12, 15, 21, 23 and 26 are under consideration.
7. Because of the missing sequence information, claims 9, 12, 23 and 26 are not fully examinable (i.e. the actual sequences cannot be properly searched); however, in the interest of compact prosecution, and despite the missing sequence file, the following objections and rejections are made.
Claim Objections
8. Claims 9, 12, 23 and 26 are objected to because of the following informalities: claims recite non-elected inventions (e.g. non-elected sequences; see MPEP 2434). Appropriate correction is required.
Improper Markush Grouping Rejection
9. Claims 9, 12, 23 and 26 are rejected on the basis that each contains an improper Markush grouping of alternatives.
See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use (emphasis added). A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature; See MPEP § 706.03(y).
The Markush groupings for each structurally distinct antibody in each of claims 9, 12, 23 and 26 is assumed to be improper based on distinct sequence identifiers and because the alternatives defined by the Markush grouping would not share both a single structural similarity and a common use that flows from the substantial structural feature since the structures that are common to antibodies (i.e. framework areas) are generally unrelated to their antigen-binding function (i.e. CDRs).
To overcome this rejection, Applicant must first rectify the sequence deficiencies noted above and/or then subsequently may choose to set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims (although, note that the restriction requirement still holds) and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101
10. 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.
11. Claims 1, 7, 9, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. nature-based product) without significantly more.
The claims recite “An isolated multispecific antibody, wherein the antibody binds to at least one epitope in the receptor binding domain (RBD) of the spike protein (S) of a Severe Acute Respiratory Syndrome coronavirus (SARS-CoV2), and neutralizes SARS-CoV2”; which is directed to, and encompasses, naturally occurring human antibodies (e.g. see specification at inter alia [0258, 0277, 0323, 0368]). Therefore, the product claims are directed to a statutory category and Step 1 of the subject matter eligibility analysis is yes.
However, this judicial exception is not integrated into a practical application because the naturally occurring antibody (i.e. a naturally occurring antibody against a naturally occurring virus) does not appear to be markedly different from its naturally occurring counterpart in its natural state (e.g. has the same sequence of amino acids) since the antibody is not required to be modified in any way. Thus, although the product claims are directed to a statutory category, they are also directed to a judicial exception (e.g. nature-based products; thus, Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is no).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 1, 7, 9, and/or 12. Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (i.e. Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 1, 7, 9, 12, 15, 21, 23 and 26 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.
Claims 1 and 15 are indefinite because they are drawn to a multispecific antibody (claim 1) or an scFv antibody fragment (claim 15) but each only requires binding to one epitope in the RBD of the spike protein. Thus, it is unclear what the other specificity requires and clarification is required to ascertain what is included vs. what is excluded from the scope of the claim.
Claims 9, 12, 23 and 26 are claiming peptides by sequence number (i.e. by sequence identifier) but without providing the corresponding sequences of amino acids; thus, the metes and bounds of these claims are not ascertainable.
Other dependent claims do not clarify the issues identified above; accordingly, clarification is required to remove scope ambiguity.
Claim Rejections - 35 USC § 112
14. 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.
15. Claims 1, 7, 9, 12, 15, 21, 23 and 26 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
Instant claims are drawn to an isolated multispecific antibody, wherein the antibody binds to at least one epitope in the receptor binding domain (RBD) of the spike protein (S) of a Severe Acute Respiratory Syndrome coronavirus (SARS-CoV2), and neutralizes SARS-CoV2. Consequently, it is the Office’s position that (1) the independent claim constitutes a "broad generic claim” based on the lack of guidance regarding the actual structures required (i.e. the antibodies are claimed only by their functional ability to bind and neutralize something else, but are not actually claimed by any required structure per se); and (2) the claimed genus has substantial variation because of the numerous alternatives permitted.
However, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, the specification does not disclose a correlation between the necessary structure of the antibody (i.e. a particular sequence of amino acids), and the claimed function to be maintained (i.e. bind to at least one epitope in the receptor binding domain (RBD) of the spike protein (S) of a Severe Acute Respiratory Syndrome coronavirus (SARS-CoV2) and neutralize SARS-CoV2); and thus the specification does not distinguish the claimed genus from others, except by function. Although the term “antibody” does impart some structure, the structure that is common to antibodies is generally unrelated to its antigen-binding function; therefore, correlation is even less likely for antibodies than for other molecules. Accordingly, the specification does not define any structural features commonly possessed by members of the genus because, while the description of an ability of a claimed antibody may generically describe that molecule's function, it does not describe the molecule itself. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is; therefore it is only a definition of a useful result rather than a definition of what achieves that result. In addition, because the genus of antibodies, is highly variable (i.e. each different antibody protein sequence capable of binding to a particular structure would necessarily have a unique sequence; see MPEP 2434), the functional characteristics of binding and neutralizing something else, even if specific, is insufficient to describe the genus. Further, given the highly diverse nature of antibodies, particularly in the CDRs, even one of skill in the art cannot envision the structure of an antibody by only knowing its binding and/or neutralizing characteristics. Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a potentially massive number of antibodies claimed only by functional characteristics.
Further, MPEP §2163 states that if a biomolecule is described only by a functional characteristic (as in the instant case), without any disclosed correlation between function and structure of the sequence (as in the instant case), it is not sufficient for written description purposes, even when accompanied by a method of obtaining the claimed sequences. MPEP §2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance (as in the instant case), the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. The courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g. see In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618). Further, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]; emphasis added. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Accordingly, the specification also does not provide adequate written description to identify the broad genus of the claims, claimed only by functional characteristics and not structures per se, because inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus. It is noted that several structurally distinct antibodies appear to be described and identified by sequence, but the specification lacks the sequence information (see objections above) and thus it is not clear how many and/or how variable these sequences are and therefore, based on the missing information, the antibodies are not adequately described. Thus the specification represents little more than a wish for possession; See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Therefore, it is the Office’s position that one of skill in the art would not conclude that Applicant was in possession of the entire broad and highly variable genus.
With regards to the state of the art, the functional characteristics of any antibody are determined by its structure (i.e. its sequence of amino acids) as evidence by the art. For example, Sela-Culang et al. 2013 (The structural basis of antibody-antigen recognition; Frontiers in Immunology 4(302):1-13) teach the hypervariable loops within the variable domains of antibody polypeptides are widely assumed to be responsible for antigen recognition while the constant domains are believed to mediate effector activation, but that recent analysis indicates that their clear functional separation between the two regions is an over-simplification (see abstract). Sela-Culang teaches some residues within the CDRs may not participate in antigen binding and some residues outside the CDRs (e.g. in framework regions and in the constant domains) often contribute critically to the integration with the antigen (see abstract). Sela-Culang teaches understanding the role of each structural element is essential for successful engineering of binding polypeptides (e.g. page 2, left column). Sela-Culang teaches almost all of the residues predicted to be part of an epitope may be considered as correct predictors as they will bind to some antibodies but also are false predictors as they don’t bind to the others and accordingly that predicting that a residue is not in an epitope may be either a true negative or a false negative depending on the anybody considered (page 2, right column). Sela-Culang teaches each CDR has its own unique amino-acid composition different from the composition of the other CDRs and that each CDR has a unique set of contact preferences favoring certain amino acids over others (page 5-6, bridging). Sela-Culang teaches the combined action of all six CDRs is the evolutionary response of the immune system that enables the antibody polypeptide to recognize virtually any surface patch on the antigen (page 6). Thus, the art supports that the skilled artisan requires guidance on the critical structures of the antibody protein sequence per se and thereby does not provide adequate written description support for which structural features of a particular polypeptide would predictably retain their functional activities of either binding or neutralizing.
Consequently, neither the specification nor the state of the art provides sufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.). In addition, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent; Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010).
Given the above analysis of the factors as a whole, which the courts have determined are critical in determining whether Applicant is in possession of, or the specification supports, the claimed invention, it is the Office’s position that Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102
16. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
17. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
16. Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen et al. 2020 (Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail; Science 369: 1010-1014; of record; available 05/15/2020).
Hansen teaches fully human and neutralizing antibodies against the receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein (e.g. see abstract; page 1, 3rd column; page 2, first column; and Figures 1B and 3; meeting limitations found in instant claims 1 and 7).
Therefore, Hansen anticipates the invention as claimed.
Claim Rejections - 35 USC § 102
17. Claims 1, 7, 15 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Babb et al. 2020 (US 10,787,501; published 09/09/20 and filed 05/25/20).
Babb teaches neutralizing, therapeutic, human anti-SARS-CoV-2 spike proteins (e.g. column 1, line 65 to column 2, line 5; Table 4 and Example 1; meeting limitations found in instant claims 1, 7, 15 and 21). Babb teaches the antibodies and fragments thereof, including scFv fragments, may be multispecific (e.g. column 2, lines 57-62; and column 16, lines 1-5; meeting limitations found in instant claims 1 and 15). Babb teaches epitopes include RBD (e.g. see column 17, lines 35-55; and Example 1; meeting limitations found in instant claims 1 and 15).
Therefore Babb anticipates the invention as claimed.
Provisional Double Patenting
18. 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.
19. Claims 1, 7, 15, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 15-23, 26, 39, and 43-47 of copending Application No. 17/919486 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to substantially the same antibodies.
For example, instant claims are drawn to an isolated multispecific antibody, wherein the antibody binds to at least one epitope in the receptor binding domain (RBD) of the spike protein (S) of a Severe Acute Respiratory Syndrome coronavirus (SARS-CoV2), and neutralizes SARS-CoV2; and wherein the antibody is a fully antibody.
Similarly, co-pending claims are drawn to an isolated monoclonal antibody, wherein the monoclonal antibody binds to an epitope in the receptor binding domain (RBD) of the spike protein (S) of a Severe Acute Respiratory Syndrome coronavirus (SARS-CoV2), and neutralizes SARS-CoV-2; and wherein the monoclonal antibody is a fully human antibody.
Therefore the claims encompass substantially the same antibodies and fragments thereof. However, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
20. No claims are allowed.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on (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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/MARY MAILLE LYONS/
Examiner, Art Unit 1645
December 29, 2025