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 .
Election/Restriction
It is acknowledged that applicant elects with traverse the anti-TSLP nanobodies species Nb 7-54 before humanization; SEQ ID NO: 14-21. Applicant submits that Nb 7-54 before humanization and Nb 7-54 after humanization (as set forth in SEQ ID NO: 14-16, 18-19, & 23-25) share the same inventive concept and should be treated as a single inventive group because the CDRs remain identical before and after humanization. Applicant submits that Groups c and d are not patentably distinct and requests that they be examined together. Examiner accepts this and withdraws the election requirement between Groups a and b, Groups c and d, and Groups e and f. Examiner maintains that Group a-b (Nb 10-63), Group c-d (Nb 7-54), and Groups e-f (Nb 5-31) are patentably distinct species as they have different CRDs. As such, the anti-TSLP nanobodies of Nb 7-54 before humanization (SEQ ID NO: 14-21) and Nb 7-54 after humanization (SEQ ID NO: 14-16, 18-19, 23-25) will be examined together.
Information Disclosure Statement
The information disclosure statements (IDS) filed 02/22/2024, 06/18/2024, and 06/10/2025 has been considered and the references therein are of record.
Claim Objections
Claim 7 is objected to because the claim recites “selected from the group consisting of:” yet there is only one group: “an anti-TSLP nanobody of claim 1.” There is no list of options from which to select.
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.
Claims 4-6, 12, 14-15, and 17-19 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.
Claims 4-6 and 12 are indefinite because it is unclear as to how multiple nanobodies of claim 1, which are a sub-portion of an antibody (the VHH domain), can be joined together to form a complete antibody without the necessary light chain and heavy chain constant region. Claim 1 consists of the nanobody alone, which is only the VHH region of an antibody, therefore combining multiple VHH regions together would not create an “antibody” since an antibody requires the VHH, the light chain, and the heavy chain constant region. As defined in the specification on pages 12-13, the terms “antibody” and “nanobody” are distinct and not interchangeable.
Claim 14 is indefinite because of the recitation of the term “pharmaceutically acceptable vector.” Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “pharmaceutically acceptable vector” in claim 14 is not a standard term of the art, unlike the term ““pharmaceutically acceptable carrier.” The term is indefinite because the specification does not clearly redefine the term. For purpose of compact prosecution, the term will be interpreted to mean “pharmaceutically acceptable carrier.”
Claim 15 recites the limitation “(b)” yet the claim does not contain an “(a)” limitation. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the claim is indefinite for being grammatically incorrect by reciting “and/or” in an incorrect context.
Claim 17 recites the limitation "vector" in “a vector that is acceptable for the detection.” There is insufficient antecedent basis for this limitation in the claim. Page 5 of the specification defines a vector as a nucleic acid molecule. The claim is indefinite because it is unclear as to what structure the nucleic acids possess to make the vector “acceptable” for detection. Said another way, it is unclear as to the identity of the “vector” and how a vector consisting of nucleic acids is “acceptable” for detection. The specification fails to resolve this lack of clarity.
Claims 18-19 recites the limitation “immunoconjugate” of claim 7 and 17, respectively, yet neither claim contains an immunoconjugate. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 4-6 and 12 are 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. Claims recite the genus of antibody which is broader than the species of nanobody. Claims 4-6 and 12 do not limit claim 1 because a nanobody is a sub-portion of an antibody. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 101
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.
Claims 15 and 19 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a non-statutory category of invention. MPEP 2106 sets forth the multistep process for determining subject matter eligibility. The first step is to determine if the claims are directed to a statutory category of invention: Processes, Machines, Manufactures, or Compositions of Matter. The claims are directed to the use of a nanobody. The use of a product is not a statutory category of invention. Therefore, the claims are directed to ineligible subject matter.
Relevant Art
The prior art does not reasonably suggest an anti-TSLP nanobody with the complementary determining region CDR region of the VHH chain in the nanobody being CDR1 shown in SEQ ID NO:14, the CDR2 as shown in SEQ ID NO:15, and the CDR3 as shown in SEQ ID NO: 16.
The closest prior art is Tang et al., 2020 (US20200306392A1), Haridas et al., 2020, and Wu et al., 2013. Ting teaches an anti-Her2 nanobody having the sequence set forth in SEQ ID NO: 1 (Db) that has 100% sequence identity to instant SEQ ID NO: 14 (Qy), as shown below.
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175
650
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Greyscale
Haridas teaches an Interferon-related developmental regulator N-terminal domain-containing protein having the sequence set forth in UniProt A0A6J3MCI7_9PEZ (Db) that has 100% sequence identity to instant SEQ ID NO: 15 (Qy), as shown below.
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156
619
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Wu teaches the sequence set forth in SEQ ID NO: 206368 (Db) that has 43.3% sequence identity to instant SEQ ID NO: 16 (Qy), as shown below.
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161
643
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Greyscale
Although the prior art teaches the sequences of CDR1 and 2, the prior art does not reasonably suggest combining all three CRDs represented in SEQ ID NOs: 14-16 into a nanobody.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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/JOSEPH D. CESARE/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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