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 .
Claims Status
The remarks and amendments filed 9/22/2025 are acknowledged.
Claims 21 and 24-32 are pending.
Claims 1-20 and 22-23 are cancelled.
Claims 21 and 24-25 are amended.
Claims 28-32 are new.
Election/Restrictions
Applicant's election with traverse of Group V, claims 21 and 24, in the reply filed on 09/22/2025 is acknowledged. The traversal is on the ground(s) that amended claims 25, 26, 27-31, and 32 comprise the technical feature of the CD7-blocking molecule with the specific structure of Formula II. This is not found persuasive because claims 25-32 do not share the same technical feature as claims 21 and 24. Group V, claims 21 and 24, relate to a CD7-blocking molecule, which is a protein, while the remaining claims, i.e. 25-32, relate to a nucleic acid molecule encoding the CD7-blocking molecule. There is no similar structure or function between a protein and a nucleic acid.
The requirement is still deemed proper and is therefore made FINAL.
Claims 25-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/22/2025.
Therefore, claims 21 and 24 are under examination.
Priority
The instant application is a 371 of PCT/CN2020/130945 and claims priority to People’s Republic of China application CN201911150678.7.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C.
119 (a)-(d) and receipt is acknowledged of certified copies of papers required by 37
CFR 1.55. Although the certified copy of the foreign priority document was received, the
Examiner is unable to determine whether or not the Chinese foreign priority document
discloses what is presently claimed because the document is in Chinese. Therefore,
priority is given with the effective filing date of 11/23/2020, which is the PCT filing date.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/23/2022 and 07/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Drawings
The drawings are objected to because Figures 4A, 5, 7, 9, 11, 12, 13A, 13B, 15, 19, 20, 23B, 23C, 23D, 24A, 24B and 25B comprise multiple panels. 37 CFR 1.84(u) states that the different views must be numbered in consecutive Arabic numerals and that "partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter". Each panel should be separately numbered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 recites an acronym (i.e. CD7). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
Claim Interpretation
Claims 21 recites the limitation “…wherein the CD7-blocking molecule has a structure as shown in the following Formula II…”. The “has” is being interpretated as “comprising” the components of Formula II in the specific order N to C terminus as recited in instant claim 21.
Claim Rejections - 35 USC § 112(b)
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.
Claims 21 and 24 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.
Claim 21 recites the limitation “an amino acid sequence” in regards to the endoplasmic reticulum retention sequence of SEQ ID NO: 10. The “an” makes it unclear if this requires the entire amino acid sequence of the named SEQ ID NO, or if only two consecutive recited amino acids within the sequence of the named SEQ ID NO are required. Therefore, the scope of this claim is indefinite.
Note: The 112(b) rejection can be overcome by amending the claim to say “the
amino acid sequence.”
Additionally, claim 21 recites “anti-CD7 nanobodies”. The term “nanobody” is trademarked. While not per se indefinite, the term must be analyzed to determine how the mark or name is used in the claim. Here, the trademark is used as a claim limitation to describe a particular structure and thus the claim scope is uncertain since the mark or name cannot be used to properly identify any particular material or product but rather only identifies the source of the material. See MPEP 2173.05(U).
Note: The Examiner recommends amending the claim to recite “anti-CD7 VHH antibodies” in place of “anti-CD7 nanobodies” to overcome this rejection.
Further, claim 21 recites “A CD7-blocking molecule, which comprises one or more anti-CD7 nanobodies… wherein the CD7-blocking molecule has a structure as shown in the following Formula II: L’-VHH-ER (II) wherein,…VHH’ is a binding region comprising two anti-CD7 nanobodies…”. It is unclear how the molecule could comprise only one anti-CD7 nanobody, as recited in the preamble, since the body of the claim also recites that that the VHH comprises two anti-CD7 nanobodies. Therefore, the scope of this claim is indefinite.
Claim 24, which depends from claim 21, is therefore rejected for the same reasons as set forth above.
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 24 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 24, which depends from claim 21, recites the CD7-blocking molecule according to claim 21, whose amino acid sequence is set forth in SEQ ID NO: 2 or SEQ ID NO: 1. SEQ ID NO: 1 is a nucleic acid sequence but depends from a claim requiring a CD7-blocking molecule, i.e. a protein. Therefore, SEQ ID NO: 1 does not further limit the CD7-blocking molecule of claim 21. 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.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al., 2016 (7/10/2025 IDS) in view of Feldman (WO 2015112830; instant PTO-892) and Png (US 20180179280; instant PTO-892).
Regarding claim 21, Tang teaches PG002, a bivalent CD7 nanobody-based immunotoxin [see Abstract], comprising two VHH6’s (i.e. two anti-CD7 nanobodies) linked by a flexible linker, with a KDEL (i.e. endoplasmic reticulum retention motif) on the C terminus [see Page 34076; Figure 4A].
However, Tang does not specifically teach that the PG002 comprises a signal peptide on the N-terminus or that the endoplasmic reticulum retention sequence comprises the amino acid sequence of SEQ ID NO: 10.
Feldman teaches a GM-CSF receptor leader sequence (i.e. signal peptide) that may be positioned at the amino terminus of a polypeptide that may facilitate expression of the polypeptide on the surface of the cell [0021] and CARs comprising an antigen binding domain and can comprise the receptor leader sequence.
Png teaches compositions comprising an anti-CD7 CAR and an anti-CD7 protein expression blocker [see Abstract] which can comprise a localizing domain linked to the target-binding molecule [0006], and that the localizing domain can be SEQ ID NO: 8, an endoplasmic reticulum (ER) retention peptide [0087].
SEQ ID NO: 8 of Png has 100% sequence identity to SEQ ID NO: 10 of the instant claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bivalent CD7 nanobody-based immunotoxin of Tang to comprise a signal peptide linked to the N terminus of the VHH, as taught by Feldman. One would have been motivated to make this modification because Feldman teaches that the GM-CSF receptor leader sequence can be used for chimeric antigen receptors to facilitate protein expression. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoplasmic reticulum retention motif of Tang to specifically be the ER retention peptide comprising SEQ ID NO: 8 of Png. One would have been motivated to make this modification because Png teaches this sequence is a ER retention peptide sequence and can be used in anti-CD7 CARs. Further, one would have been motivated to use this sequence for the ER retention sequence because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Double Patenting
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.
Claims 21 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11, 13, and 14 of copending Application No. 18/253,819 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 21, claim 1 of the reference application teaches a method for preparing CD7-CAR-T cells, which comprises the following steps: (i) providing a sample to be processed containing T cells, (ii) sorting and activating the T cells contained in the sample, thereby obtaining activated T cells, (iii) introducing a first viral vector for expressing a CD7-blocking molecule into the activated T cells, thereby obtaining CD7-blocked T cells, and (iv) introducing a second viral vector for expressing a CD7-CAR into the CD7-blocked T cells, thereby obtaining the CD7-CAR-T cells, wherein, after the T cells are co-incubated with an activator for 12-36 h, preferably 18-30 h, more preferably 22-26 h, the first viral vector for expressing a CD7-blocking molecule is introduced into the activated T cells, claim 8 of the reference application teaches wherein the CD7-blocking molecule comprises one or more anti-CD7 nanobodies and an endoplasmic reticulum retention sequence, claim 11 of the reference application teaches wherein the CD7-blocking molecule has a structure as shown in the following Formula II: L’-VHH’-ER (II), wherein, each "-" is independently a linking peptide or peptide bond; L' is a signal peptide sequence; VHH' is a binding region comprising two anti-CD7 nanobodies; and ER is an endoplasmic reticulum retention sequence, claim 13 of the reference application teaches wherein the amino acid sequence of the ER is
shown in SEQ ID NO: 10.
SEQ ID NO: 10 of the reference application has 100% sequence identity to SEQ ID NO: 10 of the instant claim.
Regarding claim 24, claim 14 of the reference application teaches wherein the amino acid sequence of the CD7-blocking molecule is shown in SEQ ID NO: 1 or 2,
SEQ ID NOs: 1 and 2 of the reference application have 100% sequence identity to SEQ ID NOs: 1 and 2 of the instant claim, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. NCT04004637 (instant PTO-892) and Wang et al., 2025 (instant PTO-892)
- This is pertinent art to the instant application because it discloses CD7 CAR-T cells. Wang et al., 2025 (instant PTO-892) teaches that the CD7 CAR-T cells comprise a tandem CD7 nanobody to an ER/golgi retention signal peptide [page 207, left column, third paragraph]. However, NCT04004637 is not an enabling disclosure because it does not explicitly teach that the CD7 CAR-T cells comprise the structure of Formula II, as claimed in instant claim 21.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675