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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 08/18/2026 has been entered.
3. Claims 1, 5-6, 12-14, 17, 19-21, 25-27, 30-32, 39-40 and 42-43 are pending and under consideration.
4. Applicant’s IDS document filed on 08/18/2026 has been considered.
5. 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.
6. Claims 1, 5, 12-14, 17, 19-21, 25-27, 30-32, 39-40 and 42-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 10-11, 14, 17, 20-21, 28-30, 33, 35-36, 42, 44, 46, 48-49, 61-62, 68 , 70 and 73 of copending Application No. 19/445,942 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 4-7, 10-11, 14, 17, 20-21, 28-30, 33, 35-36, 42, 44, 46, 48-49, 61-62, 68 , 70 and 73 are directed to the same polypeptides, fusion proteins, compositions and methods of instant claims 1, 5-6, 12-14, 17, 19-21, 25-27, 30-32, 39-40 and 42-43.
Reference SEQ ID NOs 3, 13, 23, 33, 43, 53, 63 and 73 all comprise the VHH of instant SEQ ID NOs:40 and 116 which each comprise the 3 CDRs of instant SEQ ID NOs 56, 54 and 58.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. 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.
8. Claims 1, 5-6 and 12-14 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.
A. Claim 40 recites the abbreviation “NHL” after the recitation of “low grade/follicular non-Hodgkin’s lymphoma” in line 3 rather than after “non-Hodgkin’s lymphoma” in line 2. The abbreviation of NHL is used numerous times after it is introduced in line 3 and it appears that it is used to indicate “non-Hodgkin’s lymphoma” and not “low grade/follicular non-Hodgkin’s lymphoma” in the claim. Appropriate correction is required.
B. Claim 1 recites “wherein at least one VHH” in line 6, but the claim should recite “wherein the at least one VHH” for proper antecedent basis to further limit the at least one VHH which was introduced in line one of claim 1. There is insufficient antecedent basis for this limitation in the claim.
C. Claims 5-6 and 12-14 recite “wherein at least one VHH” in lines 1-2 of each claim, but the claims should recite “wherein the at least one VHH” or “wherein the at least one VHH that binds CD33” for proper antecedent basis to further limit the “at least one VHH” which was introduced in line one of claim 1. There is insufficient antecedent basis for this limitation in the claim.
Correction is required.
9. 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.
10. Claims 25-26, 31 and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for :
the polypeptide of claim 1 wherein the polypeptide further comprises an Fc region selected from the group consisting of SEQ ID NOs: 74-109;
an immunoconjugate comprising the polypeptide of claim 1 and a cytotoxic agent wherein the cytotoxic agent is selected from the group consisting of a calicheamicin, an auristatin, a dolastatin, a tubulicin, a maytansinoid, a cryptophycin, a duocarmycin, an esperamicin, a pyrrolobenzodiazepine, and an enediyne antibiotic and
the method of claim 39 further comprising administering an additional therapeutic agent wherein the additional therapeutic agent is an anti-cancer agent selected from the group consisting of a chemotherapeutic agent, an anti-cancer biologic, radiation therapy, CAR-T therapy, and an oncolytic virus, does not reasonably provide enablement for :
the polypeptide of claim 1 wherein the polypeptide comprises an Fc region selected from SEQ ID NOs: 74-109;
an immunoconjugate comprising the polypeptide of claim 1 and a cytotoxic agent wherein the cytotoxic agent is selected from a calicheamicin, an auristatin, a dolastatin, a tubulicin, a maytansinoid, a cryptophycin, a duocarmycin, an esperamicin, a pyrrolobenzodiazepine, and an enediyne antibiotic and
the method of claim 39 further comprising administering an additional therapeutic agent wherein the additional therapeutic agent is an anti-cancer agent selected from a chemotherapeutic agent, an anti-cancer biologic, radiation therapy, CAR-T therapy, and an oncolytic virus.
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. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized 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, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification is not enabled for the polypeptide of claim 1 wherein the polypeptide further comprises an Fc region selected from SEQ ID NOs: 74-109. This recitation reads on subsequences of SEQ ID NOs 74-109 which can be “selected” from those sequences. The specification is not enabled for use of Fc with subsequences of SEQ ID NOs: 74-109.
The specification is not enabled for an immunoconjugate comprising the polypeptide of claim 1 and a cytotoxic agent wherein the cytotoxic agent is selected from a calicheamicin, an auristatin, a dolastatin, a tubulicin, a maytansinoid, a cryptophycin, a duocarmycin, an esperamicin, a pyrrolobenzodiazepine, and an enediyne antibiotic. This recitation reads on sub-components of calicheamicin, an auristatin, a dolastatin, a tubulicin, a maytansinoid, a cryptophycin, a duocarmycin, an esperamicin, a pyrrolobenzodiazepine, and an enediyne antibiotic which can be “selected” from those agents. The specification is not enabled for use of sub-components of these agents.
The specification is not enabled for the method of claim 39 further comprising administering an additional therapeutic agent wherein the additional therapeutic agent is an anti-cancer agent selected from a chemotherapeutic agent, an anti-cancer biologic, radiation therapy, CAR-T therapy, and an oncolytic virus. This recitation reads on sub-components of the chemotherapeutic agent, anti-cancer biologic, radiation therapy, CAR-T therapy, and oncolytic virus which can be “selected” from those agents. The specification is not enabled for use of sub-components of these agents.
The specification is enabled for polypeptides of claim 1 further comprising an Fc region because an Fc region is not a part of the VHH recited in claim 1.
Applicant is requested to amend the claim language of claims 26, 31 and 43 to recite “selected from the group consisting of” for proper Markush language and enablement of the claim recitations.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 24, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
