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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 1/27/23. Claims 101-122 are pending and under examination.
Claim Objections
Claim 119 is objected to because of the following informalities: the claim is a method of detecting cells in a subject. The first step is “administering” but there is no indication in the claim as to the target of this administration. The preamble (in a subject) and second step (detecting…in a subject) make clear that the administration must also be to the subject and this should be explicit in the administration step, e.g., administering to the subject. Appropriate correction is required.
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 107 and 117-119 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 107 recites the limitation "the nucleic acid" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. Claim 101 does not recite a nucleic acid and there is no previous recitation of “a nucleic acid” in either claim 101 or 107. There is a nucleic acid in claim 105, but claim 107 does not depend from this claim.
Claim 117 recites the inclusion of “reagents for preparation of the labeled CD8 binding agent”. First, this phrase lacks antecedent basis. There is no “a labeled CD8 binding agent” in any of claims 101, 116, or 117. Second, the metes and bounds of the phrase are unclear. The specification uses the term once: at paragraph 236, examples are provided of the chelating agent or a radionuclide label. Reasonably, the phrase would include other chelating agents and other labels, e.g., those in claim 108. However, while the examples are only illustrative of compounds that form part of the end complex (the VHH, conjugation moiety, label), it is unclear if the phrase is limited to just those reagents. Alternately, the phrase is meant to include any reagent that might somehow be used to “prepare” the compound. An ordinary definition of the term reagent is any substance with a chemical or biological activity (Webster; form 892). This might include water, buffers, or any number of other chemicals or biomolecules which might somehow be used to prepare the compound. The term “use” does not impart any specific, active step while “prepare” may or may not encompass any step at any part of the process, such as a cell expressing the VHH, the chemical synthesis of the chelator, or regents used to isolate/create a radionuclide. These reagents may or may not end up as part of the final conjugated VHH but could nevertheless be considered part of the “preparation” process. It is unclear if the “preparation of the labeled CD8 binding agent” refers to the reagents that end up as part of the binding agent, those reagents used in the labeling process, or any reagent used at any stage of production that ultimately ends up forming a labeled binding agent. The claimed phrase, even when read in light of the specification, fails to properly inform others as to the breadth of the scope. While breadth is not the same as indefiniteness, it is unclear how broad the phrase is meant to be and so renders the phrase indefinite.
Claim 118 recites “using the CD8 binding agent of claim 116”; however, the claim does not set forth any steps involved in the method/process. The term “using” is not a positive, active step and a claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced; see MPEP §2173.05(q).
Claim 119 recites “administering the labeled CD8 binding agent of claim 116”. This phrase lacks antecedent basis because there is no “a labeled CD8 binding agent” in any of claims 101, 116, or 119.
Therefore, claims 107 and 117-119 are indefinite.
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.
Claim 117 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The phrase “reagents for preparation of the labeled CD8 binding agent” is indefinite as above. The broadest reasonable interpretation is that the phrase includes any reagent that might be involved in some way during the ultimate production of the labeled binding agent.
Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed.
The claims are directed to the genus of all reagents that might somehow be used in any possible method that leads to the production of the labeled conjugate. Where a claim recites a genus, one means of providing adequate written description and evidence of possession is through providing sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the specification does not disclose any require structure, physical property, chemical property, or method of making the reagents. The phrase requires only the functional characteristic that it might be used somehow in the preparation of the binding agent. Clearly, this is not an adequate description of the genus as a whole as this does not provide any particular characteristic other than an intended use, which describes the utility of the reagent but does not describe any aspect of the reagent itself.
In a second way, the specification might provide a representative number of species for the claimed genus that would convey to the artisan possession of the whole genus. However, in this case, the species disclosed to not represent the full breadth of all possible members of the genus. The specification discloses two specific examples: at paragraph 236, examples are provided of the chelating agent or a radionuclide label. The specification also includes other examples of “labels” (e.g., claim 108) and so the genus of “label” is considered sufficiently described. However, the only chelating moiety disclosed is the moeity of formula 1. No “reagents” for preparation other than this chelating moeity and the genus of labels are provided to represent the genus of reagents claimed.
For a representative number of species, MPEP §2163(II)(A)(3)(a)(ii) states “when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus”. This description is lacking. While other chelating agents may be known in the art, the specification does not make clear which of those chelating agents are suitable for “preparation” of the labeled CD8 binding agent. While methods of conjugation are known in the art, it is unclear which such methods—and which reagents of those methods—are envisaged within the claimed genus. Moreover, the examples are limited to those “reagents” that represent part of the final structure (the VHH, the chelator, the label) and do not represent the substantial variation of every reagent which might be used at any point in the preparation process, such as those reagents used to produce the molecule of Formula 1, the reagents used to express/produce the antibody, or any of the reagents/processes used to create the genus of all labels.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of 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). As discussed above, the breadth of what is claimed is extensive and highly varied while the examples in the specification are significantly more limited. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Therefore, claim 117 does not meet the written description requirement.
Allowable Subject Matter
Claims 101-106, 108-116, and 120-122 are allowed.
Claim 101 is directed to a VHH with specific CDRs. The VHH format of antibody is known (US 12473338 claim 4; form 892) and antibodies which bind CD8 are known (US20160363593 claim 5 and 8; form 892). No prior art document was discovered that discloses the instant CDRs.
CDRs represent the binding sequences of an antibody. Further, these sequences are highly unpredictable when altering even a single amino acid (Kussie; form 892). The prior art does not disclose the claimed combination of CDRs nor does the prior art provide clear motivation to arrive at this combination. Because of this, the claims are non-obvious.
No co-pending US applications or patents appear to claim the same VHH as that of instant claim 101. As such, there is no double patenting rejection to be made at this time. Note that the VHH appears to be disclosed in WO2025087303, but this document is not valid as prior art and does not appear to have a corresponding US filing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675