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
Election/Restrictions
Applicant's election with traverse of Group II (TCRs comprising SEQ ID NOs 7-9 and/or 10-12) and methods of using said TCRs to treat/prevent cancer as well as the species of Seq 179 (C159, L223, I225, V226) and Seq ID NO: 180 (C169) in the reply filed on 2/12/26 is acknowledged.
As an initial matter, Applicant states that the Examiner set forth a lack of unity of invention between groups I-IV (remarks p.3); this is likely a typo as the Examiner discussed the lack of unity for all of the groups (I-IX).
Applicant further argues that the Examiner articulated the shared technical feature as “an isolated population of cells for adoptive cell therapy”, which is inaccurate as the Restriction Requirement never uses this phrase. The restriction requirement mailed 12/12/25 explicitly notes the shared technical feature as “a TCR specific for CD20” (Restriction requirement p. 4).
The substance of the traversal is on the ground(s) that:
All of the claimed TCRs recognize CD20 p188-196 presented by HLA-A2. Applicant offers Example 4 in support of this assertion. Applicant argues that this is the special technical feature shared by the claimed TCRs.
This is not found persuasive. Applicant’s argument of binding CD20 p188-196 is not claimed and not required. Whether or not certain embodiments of the claims bind these positions, TCRs with the claimed sequences that bind elsewhere on CD20 are within the scope of the claims. See the last “wherein” clause of claim 1 which includes TCRs that “has antigenic specificity for a CD20 amino acid sequence presented by a [HLA] Class I molecule”. The Examiner properly identified that there is no common structure because there was no sequence in common to all claimed sequences, and therefore the binding to CD20 as claimed is the shared technical feature.
Further, while Applicant points to example 4, Applicant does not explain why example 4 supports their position. It is unclear from example 4 whether or not each claimed grouping possesses the asserted special technical feature. Example 4 states that the example demonstrates T cells engineered to express “each of inventive TCRs recognized CD20+/HLA-A2+ cell lines”, i.e., does not state that this CD20 binding was specific to any particular region of CD20. While the example references certain figures, these do not appear to specify which of the claimed embodiments are being expressed. If it is less than all of them individually, e.g., showing SEQ 1-3 binds the asserted amino acids (absent SEQ 4-6), SEQ 4-6 binds the asserted amino acids (absent 1-3), Seq 1-6 binds the asserted amino acids, etc., then the evidence would not support Applicant’s position. Applicant’s claim is that three binding domains of the α-chain alone or three binding domains of the ß-chain alone is sufficient to bind this specific epitope whereas there is adequate cause to doubt this assertion (see §112 written description rejection below).
If, on the other hand, these are cell lines that express “each of inventive TCRs” (expressing all embodiments in a single cell or cell population) then one would be unable to determine if all of the TCRs bind individually or if some subset is responsible for the binding. In figures 4A-4C, only one cell line appears to be labeled with the p188-196 designation, so it is unclear how this supports Applicant’s assertion that every claimed embodiment (the 27 combinations claimed) within the scope of claim 1—or that every possible embodiment within the scope of the claim—possesses the alleged, unclaimed property.
Applicant argues Mackall discloses CARs rather than TCRs and so are not MHC-restricted.
This is not persuasive because, while Mackall discloses CARs, Mackall also discloses TCRs, e.g., claim 2. The disclosure of an alternative does not discount the disclosure of TCRs. Further, Applicant does not elaborate on why CD20 being “presented” by an HLA class I molecule alters the binding properties of the TCR; the instant claims, e.g., claim 1, are directed to a composition comprising a TCR, not the step of binding itself. Finally, the TCRs are not claimed as being “restricted” in this manner, only that they are capable of binding “a CD20 amino acid sequence presented by [HLA Class I]”. If the TCR also binds other molecules presented in other ways, that is within the scope of the claim.
Applicant argues examination of the patent application would be most expeditious by examining all of the claims and species together. Whether this is true or not, Applicant does not point to any portion of the unity of invention analysis which requires taking this into consideration. Speed of examination does not appear to find basis in the PCT rules for unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
After examination, elected group II claim 1 is allowable over the prior art. Claim 1 is generic to the species election of a full α and ß chain. As such, the species election is withdrawn. The Group restriction remains in place.
Claims 1, 7-19, 23, 28, 30-31, 33, and 36 are pending and under examination.
Notice
Applicant is advised that should claims such as 7, 8, and 9 be found allowable, claims which duplicate that claim language will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Under one interpretation (see §112b rejection below), claim 10 does not offer an additional limitation. If this interpretation is correct, then the dependent claims of claim 10 (e.g., claim 11) are duplicates of those that depend from claim 1 (e.g., claim 7).
Claim 14 fails to further limit claim 10 (see §112d rejection below). Claims such as claim 17 are duplicates of claims such as claim 12.
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 1, 7-19, 23, 28, 30-31, 33, and 36 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 1 lists certain options, such as (a) stating “SEQ ID NOs: 1-3”. Initially, this would reasonably suggest that the TCR must comprise SEQ ID NOs 1, 2, and 3. However, other options such as (s) state “all of SEQ ID NOs: 1-6”. The use of “all of” clearly indicates that each of the six sequences are required, leading to confusion over the options that do not use “all of”. There appears to be a distinction between those options that use “all of” and those that do not, but this distinction is unclear. It is possible that the options lacking “all of” are meant to be interpreted as “or”, e.g., comprising the amino acid sequences of SEQ ID NOs 1, 2, or 3. It is also possible that the recitation of “all of” is not meant to impart any distinction, though this raises the question of why a distinction is made.
This is also seen in claim 7. There is a list of 54 alternatives, as noted by the “or” before the last element of the list. Other elements are also clear, such as “both of” which clearly requires the first listed sequence and also requires one of the other two listed sequences in the same labeled option. However, it is unclear what the difference is between, e.g., (i) and (ii). SEQ ID NO: 56 in (i) is clearly one alternative. The use of an additional “or” in (ii) creates confusion. In one case, sequence 57 and 58 are additional alternatives, but this would not explain the use of the inconsistent claim language rather than 57 being (ii) and 58 being (iii), etc. In another interpretation, this is similar to the “both of” language, such that 56 is required and also one of seq 57 or 58, though this would also not be clear where one option ends and another begins. Further, sequences 57 and 58 are not synonyms as they represent different amino acid sequences.
Applicant is allowed to be their own lexicographer. However, taken as a whole and in light of the specification, it is unclear how Applicant is intending to define the scope of the claims.
Therefore, claims 1, 7-19, 23, 28, 30-31, 33, and 36 are indefinite.
Claims 1, 7-9, 19, 23, 28, 30-31, 33, and 36 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 1 and 7-9 are directed to TCRs that bind CD20 and comprise certain sequences. Claim 10 requires these same sequences, only adding that these sequences are found in the “functional portion” of the TCR.
The specification as a whole does not disclose the instant sequences in any position other than the functional portion. In one interpretation, claim 10 violates §112d for not providing a further limitation. In another interpretation, claim 1 is claiming embodiments where the sequences are entirely non-functional sequences. While the existence of inoperative embodiments is not necessarily a deficiency (MPEP §2164.08(b)), the existence of claim 10 suggests that, in this case, it is. This is because while inoperative embodiments are generally excluded on their face by the claim language, claim 10 requires those inoperative embodiments form a core of the invention in claim 1.
The instant specification defines “functional portion” at paragraph 61: “any part or fragment of the TCR of the invention, which part or fragment retains the biological activity of the TCR of which it is a part (the parent TCR)”. In other words, the “non-functional” portion does not retain the biological activity of the parent, which is binding CD20.
As it is unclear which of these interpretations is correct, the claims are indefinite.
Therefore, claims 1, 7-9, 19, 23, 28, 30-31, 33, and 36 are indefinite.
Claims 1, 7-19, 23, 28, 30-31, 33, and 36 are 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 instant claims are directed to T-cell receptors (TCRs). These TCRs must have antigenic specificity for CD20 when presented by an HLA Class I molecule. The claim also contains a partial structure for such molecules. These include defining partially defining the α-chain (e.g., SEQ ID NOs: 1-3), partially defining the ß-chain (e.g., SEQ ID NOs: 4-6), or requiring both the α and ß chains (e.g., comprising all of SEQ ID NOs: 1-6).
One means of providing adequate written description and evidence of possession of a claimed genus 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 discloses certain species but does not correlate any particular shared structure within these species to the genus as a whole responsible for the required function; there is no identification of any particular structure that must be conserved throughout the genus. For example, across the 27 alternatives of claim 1, there is no common or consensus sequence that is disclosed as responsible for the claimed binding property. For example, SEQ ID NO: 7 does not share any amino acids at the same position as SEQ ID NO: 10 (option c vs option d).
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 does not demonstrate that options such as (a), (b), or (c) possess the required binding properties. Thus, it does not appear that options a-r are representative of the genus. Options s-aa represent nine embodiments where it is reasonable that these possess the required function. However, TCRs are varied and unpredictable and so even nine species are insufficient to fairly represent the breadth of all TCRs that bind CD20.
The art recognizes that description of an antigen does not provide any relevant information on the sequence for the TCR that binds that antigen; Lee (form 892) states “as yet it is not possible to…predict TCRs recognizing a given antigen or…predict antigens recognized by a given TCR” (p.2 C1). The art also recognizes that just an α chain or just a ß chain does not define the binding region of a TCR; Garcia (form 892) teaches the combination of α and ß chain “participate in the interaction with the pMHC complex” (p.209 C1), that there are three regions on each chain that serve the same function as antibody CDRs which define the primary contact points of the molecule (p.209 C2-3), and that the combination of the CDR3 in the α and ß chains creates a binding groove (abstract).
Additionally, the nine complete TCRs described in the specification does not allow the skilled artisan to envisage even a single other species. For example, description of SEQ ID NOs: 1-3 is insufficient to describe any molecule other than the one paired with SEQ ID NOs: 4-6. As above, the antigen does not describe the binding sequence and a binding sequence does not describe the antigen. Further, both Garcia and Engel (form 892) note that TCRs are highly sensitive to mutations, where even a single amino acid difference can alter the binding target or abrogate binding altogether (Garcia p.209 C3; Engel abstract), further confirmed by Travaglino (form 892; p.326 C2). This is similar to the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor' s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11). TCRs possess similar limitations and unpredictability and so the same conclusion may be drawn: defining a TCR by only the α-chain or only the ß-chain is not an adequate description of the genus of TCRs that bind CD20.
Finally, it is noted that claim 1 does not require that the sequences are responsible for any function at all. Claim 10, depending from claim 1, requires the “functional portion” comprises the same sequence combinations as claim 1. Under §112(d), a dependent claim must provide a further limitation. As the only additional limitation is requiring these sequences to be the “functional portion”, this must indicate that claim 1 encompasses the embodiments where those sequences are not functional. The instant specification defines “functional portion” at paragraph 61: “any part or fragment of the TCR of the invention, which part or fragment retains the biological activity of the TCR of which it is a part (the parent TCR)”. In other words, the “non-functional” portion does not retain the biological activity of the parent, which is binding CD20.
As such, claim 1 is also directed to TCRs that contain the claimed sequences but where those sequences do not participate in the function of the TCR. In those cases, the TCR is defined wholly by a desired function and an unrelated structure, which does not meet the written description requirements.
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 artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. 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, claims 1, 7-19, 23, 28, 30-31, 33, and 36 fail to meet the written description requirement.
Claims 1, 7-19, 23, 28, 30-31, 33, and 36 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 combination of six binding domains in elements s-aa of claim 1 within the functional portion of a TCR, does not reasonably provide enablement for less than all six sequences nor for the sequences in non-functional portions of the TCR. Further, while enabled for treating cancer, the claims are not enabled for preventing cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims are drawn to TCRs that bind CD20 (claim 1), comprising certain sequences. In some cases, these sequences are in the functional portion of the TCR (claim 10), while in others they are in the non-functional portion (claim 1). These sequences are three of the binding domains in the α-chain, three in the ß-chain, or a combination of the α and ß chains
While the TCR is claimed by only a single chain, the specification discloses α/ß combinations binding to CD20. The specification does not appear to demonstrate single chains possessing the claimed binding functionality.
The art recognizes that description of an antigen does not provide any relevant information on the sequence for the TCR that binds that antigen; Lee states “as yet it is not possible to…predict TCRs recognizing a given antigen or…predict antigens recognized by a given TCR” (p.2 C1). The art also recognizes that just an α chain or just a ß chain does not define the binding region of a TCR; Garcia teaches the combination of α and ß chain “participate in the interaction with the pMHC complex” (p.209 C1), that there are three regions on each chain that serve the same function as antibody CDRs which define the primary contact points of the molecule (p.209 C2-3), and that the combination of the CDR3 in the α and ß chains creates a binding groove (abstract).
It would require undue experimentation by the artisan to, for example, take a TCR comprising SEQ ID NOs: 7-9 in the α chain and couple this with the infinite possible ß chains to determine for themselves which combinations bound CD20. The art recognizes the critical nature of the two chains combined such that even combining the α-chain of one TCR with the ß-chain from another may or may not work, the results being unpredictable.
Further, such binding would only be expected when these sequences are found in the functional portion of the TCR. Claim 10 specifies that the sequences are in the functional portion, indicating that claim 1 positively claims the sequences in the non-functional portion. These sequences could not contribute to binding by definition of “non-functional” and it is left to others to determine TCRs that comprise the claimed sequences but where the functional binding portions are entirely undefined.
Claim 10 is included because, in addition to defining the functional binding region by only three of the required six sequences, claim 10 must be a “polypeptide”. The term “polypeptide” is defined in the instant specification as a single chain of amino acids connected by one or more peptide bonds (paragraph 60). As above, the art recognizes binding specificity of a TCR comes from the interaction of two separate chains. Antibodies are capable of binding their antigen as a single chain, such as in scFvs. While the specification discloses the inventive sequences being a recombinant antibody (paragraph 79), the current claims are explicitly to a TCR, not an antibody. The specification does not disclose any examples of a single chain TCR nor does the art of record demonstrate such. Rather, Engel attempts single chain clones but fails to replicate the expected phenotype (p.477).
Regarding preventing cancer, the definition of prevention is in paragraph 125, though this description is unclear as to which terms refer to treatment and which to prevention. For example, paragraph 125 describes an example of promoting the regression of a tumor, but this is an example of “treatment or prevention”, where it is unclear if this is an example of one or both terms. However, the nature of the disclosure suggests this is an example of treatment. Regression is generally not within the ordinary definition of prevention and, if the examples apply to both terms, it confuses the meaning of the two terms themselves. Prevention clearly encompasses delaying onset of the cancer.
Claim 36 is explicit in that the method is treating or preventing cancer, not symptoms thereof. Thus, to be enabled, the compositions must be reasonably expected to prevent cancer itself. However, the claim also states “wherein the cancer expresses a CD20 amino acid sequence”. The claims are read such that the appearance of a CD20 expressing cancer is prevented, but this is not enabled. The instant specification contains no examples of preventing cancer. The term “onset” occurs only in paragraph 125 as a prophetic disclosure of what might be possible, but this is not supported by any objective evidence.
On the contrary, one example at paragraph 131 of a cancer to be prevented is pancreatic cancer. The art does not recognize any therapeutic that prevents such cancer. Cancer.org (form 892) states that there is “no sure way to prevent pancreatic cancer”. While there is reason to believe that a TCR that binds CD20 would be effective to target CD20 cancer cells, it would require undue experimentation to determine if circulating CD20 TCRs would prevent or delay cancer in the first place. Further, there is no reason to expect this outcome as the cancer must exist and present CD20 for the TCR to be therapeutic.
Therefore, claims 1, 7-19, 23, 28, 30-31, 33, and 36 are not enabled for their full scope.
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 10 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.
Under §112(d), a dependent claim must further limit the claim from which it depends. Claim 10 recites the same structural combinations as claim 1, with the addition that these sequences are in the “functional portion” of the TCR. However, the specification considered as a whole does not describe these sequences as anything other than the functional portion of the TCR. Reading the specification, one of skill in the art would not understand the instant invention to be directed to sequences devoid of any function. As such, claim 10 fails to further limit claim 1.
An alternate interpretation of the claim is that claim 1 is the TCR (“an isolated or purified T-cell receptor”) whereas claim 10 is just the functional portion of the TCR coupled to a non-TCR polypeptide. This, too, would fail the requirements of §112d as claim 1 requires the polypeptide is a TCR. Claim 10, only requiring the functional portion, would not require the TCR of claim 1 and so not include all the limitations of the claim from which it depends.
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 14 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 14 depends from claim 10. Claim 14 is “an isolated or purified protein”; claim 10 is “an isolated or purified polypeptide”. The term “polypeptide” is defined in the instant specification as a single chain of amino acids connected by one or more peptide bonds (paragraph 60). A “protein” is one or more polypeptide chains (paragraph 70). Thus, a “protein” may be a single polypeptide and so does not require a further limitation.
Claim 14 comprises at least one of the polypeptides of claim 10. Claim 10 also requires at least one of the polypeptides of claim 10.
There does not appear to be any additional limitation in claim 14 and so the claim fails to meet the requirements of §112(d).
Allowable Subject Matter
For the reasons set forth in the written description rejection, the six binding domains (three on the α chain and three on the ß chain) are necessary to define the binding specificity of a TCR. Further, changes to those domains are unpredictable. Thus, absent the prior art disclosing the same, specific sequence combinations of the instant claims, such combinations are considered non-obvious. In addition to the evidence in the written description rejection, see US 12522644 (form 892; EFD 3/3/20), which discloses a TCR comprising instant SEQ ID NO: 12 (SEQ ID NO: 2); see claim 1. This TCR binds human gp100, not CD20, nor does the sequence comprise instant SEQ ID NO: 10 or 11. This is further evidence that the instant sequences cannot be altered or paired with different sequences than those disclosed as well as further supporting the conclusion that it would not have been obvious to combine disparate sequences into the same TCR with a reasonable expectation that the TCR will bind CD20. While the individual sequences of SEQ ID NOs: 10-12 were known in the prior art (see search results), these were either not in the context of a TCR or was a TCR that does not bind CD20.
Other close prior art includes CN105802909 (form 892; an English translation is not provided as the relevant sequences are in English), which also discloses TCRs. Specifically, the document discloses the ß-chain of SEQ ID NO: 17, which comprises both instant SEQ ID NOs: 10 and 11. However, the reference document sequence contains a shorter CDR3:
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For the reasons above, introducing two additional amino acids (AS) and a single mutation (W[Wingdings font/0xE0]Y) is not a priori predictable and so does not make obvious the instantly claimed combination of SEQ ID NOs: 10-12.
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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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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/Adam Weidner/Primary Examiner, Art Unit 1675
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