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 3/25/26. Claims 51-52, 54-63, 65-71, and 73-78 are pending and under examination.
Withdrawn Rejections
The rejection of claims 52 and 53 under §112b is withdrawn in light of the amendments.
The rejection under §112b over “treating” is withdrawn. Applicant argues that “treatment” “encompasses” certain aspects. While this is true, the rejection never stated otherwise. Rather, whether or not treatment encompassed, e.g., inhibiting or curing the disease was set forth as indefinite only in the context of Applicant’s specification, which stated that this outcome must be “desired”. If the disease was inhibited but not cured, then it would be unclear if infringement occurred as it would depend if the practitioner desired just inhibition (infringing) or desired curing (not infringing).
Applicant further argues that one of ordinary skill in the art would recognize the desired effect of a CAR-T cell therapy. First, Applicant provides no objective evidence of this position and “arguments of counsel cannot take the place of factually supported objective evidence" (MPEP§2415). Second, even accepting this as true, it would not correct the deficiency set forth in the rejection because two different artisans could desire different outcomes, leading to a different conclusion as to infringement as set forth in the rejection.
However, Applicant also argues that treatment “is not restricted solely to the passage quoted by the Examiner”. In other words, Applicant argues that the sentence used as the basis of the rejection is not a definition. This is persuasive. The statement in the specification is that the term “generally means”, suggesting the term “treatment” might mean something else as well. As Applicant has stated for the record that the use of treatment as used in the instant claims is not one of those “general” times and should not be limited as such, the term treatment must be examined under an ordinary definition rather than a special one. Under an ordinary definition of treatment, the term would be defined by an outcome, not a personal desire, which the Examiner agrees is sufficiently defined so as to fairly warn others regarding the boundary of infringement.
In summary, Applicant does not persuasively argue that a POSITA would have recognized the metes and bounds of “desired”, but persuasively argues that this is not a special definition and so should not control the term. Therefore, the rejection is withdrawn.
The written description rejection is withdrawn in light of the amendments.
The double patenting rejection over co-pending application 18473057 is withdrawn. The instant claims are directed solely to a binding sequence comprising SEQ ID NOs: 38/2/4. The reference application has been amended to be directed at three binding sequences: 38/2/3, 1/39/3, 1/39/4. The reference application has amended the claims such that they are no longer directed to SEQ ID NO: 40.
Instant SEQ ID NO: 3 and reference SEQ ID NO: 4 differ by a single amino acid. Instant SEQ ID NO: 38 and reference SEQ ID NO: 1 differ by a single amino acid. As stated in the reasons for allowance set forth previously, even a single amino acid change in the CDR of an antibody is unpredictable. The instant application and the co-pending application are now drawn to patentably distinct subject matter.
Maintained Rejections and New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 55 and 56 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. This is a maintained rejection.
Claims 55 and 56 depend from claims 51 and 54, respectively. The only addition to the claims appears in the preamble, referring to the CAR-T cell as a “pharmaceutical composition”. The CAR T-cells themselves are a composition. Further, the term “pharmaceutical” does not appear to add any additional limitations. There is no specific definition of “pharmaceutical” or “pharmaceutical composition”. Under an ordinary definition of the term, a “pharmaceutical” does not require any specific element. When reading the preamble in the context of the entire claim, the recitation “pharmaceutical composition” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. As such, these claims do not further limit the claim from which they depend.
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.
Response to Arguments
Applicant's arguments filed 3/25/26 have been fully considered but they are not persuasive.
The only remaining rejection is the rejection under §112(d).
Applicant argues that paragraphs 147-152 of the specification provide guidance as to what might be included in a pharmaceutical composition. Notably, Applicant states the claimed pharmaceutical composition “may comprise further elements” (remarks 3/25/26 p.7; emphasis added). This is not persuasive because this is not the standard for §112(d). It is insufficient that the claim might comprise further elements; the claim must provide a further limitation.
For example, Applicant argues that the pharmaceutical composition might include a pharmaceutically acceptable carrier. However, such a carrier is not a requirement of the claims. Rather, as set forth in the rejection, there does not appear to be any required element of being a “pharmaceutical composition”. The antibody itself appears to meet that limitation, which is the only limitation of claim 51. Claim 51 does not preclude, e.g., comprising a carrier; claim 51 cannot preclude any of the examples provided by Applicant without similarly violating the requirements of §112(d). When reading the preamble in the context of the entire claim, the recitation “pharmaceutical composition” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) does not provide a further limitation as required. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
A phone call was made to Applicant’s representative, Allyson Malecha, on 4/16/26 regarding a potential examiner’s amendment. However, the Examiner was unable to reach said representative.
The Examiner notes that adding any of the elements recited by Applicant’s response of a pharmaceutical composition into claims 55 and 56 as a positive limitation would suffice to overcome the rejection. For example, “and a pharmaceutically acceptable carrier” would provide an additional limitation to claim 51 sufficient to overcome the rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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