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 3/20/26. Claims 51-54, 56-59, and 62-76 are pending and under examination.
Withdrawn Rejections
The rejection under §112b over “treating” is withdrawn.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”. The rejection then set forth that 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.
The enablement rejection is withdrawn in light of the amendments.
The double patenting rejection over co-pending application 19/239816 is withdrawn. The instant claims have been amended and are directed to binding sequence combinations comprising SEQ ID NOs: 38/2/3, 1/39/3, and 1/39/4. The reference application is directed at three binding sequences: 38/2/4. The instant application is amended such that the claims are no longer directed to SEQ ID NO: 40.
Reference SEQ ID NO: 3 and instant SEQ ID NO: 4 differ by a single amino acid. Reference SEQ ID NO: 38 and instant 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 62 and 70 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.
Claim 62 depends from claim 52. 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, this claim does not further limit the claim from which it depends.
Similarly, claim 70 depends from claim 52 where the only difference is in the preamble claiming the composition as a “kit” for a particular use. There is no specific element required by a “kit” to distinguish a kit from the composition itself. Moreover, an intended use in the preamble does not define any particular element required by the body of the claim. As such, claim 70 does not provide a further limitation.
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 3/20/26 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 3/20/26 p.7). 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 CAR-T itself appears to meet that limitation, which is the only limitation of claim 52. Claim 52 does not preclude, e.g., comprising a carrier. Rather, claim 52 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.
The same follows with claim 70. Applicant argues that the kit “may” comprise an additional reagent. This is the limitation of instant claim 71, which has not been rejected under §112(d). The key difference is that claim 71 requires the additional reagent, in which case the CAR-T alone is no longer within the scope of claim 71, i.e., there is a further limitation. Claim 52 may also include an additional reagent, though it is not required in the same way that it is not required by claim 70. As above, if claim 52 did not also encompass the possibility of an additional reagent, then claim 70 would be deficient under §112(d) for not including all the limitations of the claim from which it depends.
Applicant argues a kit “typically” includes a label. This is not persuasive because there is no requirement that the kit of claim 70 contain a label. A kit without a label is also within the scope of claim 70. Applicant argues other elements that might be in a kit, but does not point to any element required by a “kit”.
The Examiner notes that adding any of the elements recited by Applicant’s response of a pharmaceutical composition as a positive limitation would suffice to overcome the rejection. For example, “and a pharmaceutically acceptable carrier” would provide an additional limitation to claim 62 sufficient to overcome the rejection. Similarly, a required additional element would overcome the rejection with respect to the kit in the same way that claim 71 provides a further limitation to claims 52/70.
Allowable Subject Matter
Claims 51-54,56-59,63-69 and 73-76 are allowed.
Claims 71-72 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The reasons for allowance are set forth in the office action mailed 1/22/26.
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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