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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-172 are the original claims. In the preliminary amendment of 12/19/2024, claims 1-172 are canceled and new claims 173-201 are added. Claims 173-201 are the pending claims.
Priority
2. USAN 18/657,687, filed 05/07/2024, is a Continuation of 17/166,903, filed 02/03/2021, now U.S. Patent # 12012443, 17/166,903 is a Continuation of 15/555,951, filed 09/05/2017, now abandoned and having 1 RCE-type filing therein,
15/555,951 is a National Stage entry of PCT/US2016/021064, International Filing Date: 03/04/2016, PCT/US2016/021064 Claims Priority from Provisional Application 62/128,979, filed 03/05/2015.
The effective filing dates for nucleic acid molecules of SEQ ID NOs.:1, 6, 7, 10, 12, 14, and 15, and the amino acid sequence of SEQ ID NOs.:24, 29, 30, 33, 35, 37, and 38 is 03/05/2015. The effective filing date for the nucleic acid molecule of SEQ ID NO: 69 and the amino acid sequence of SEQ ID NO: 70 is 3/4/2016.
Information Disclosure Statement
3. AS of 9/30/2026, a total of one (1) IDS is filed: 1/3/2025. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Specification
4. The disclosure is objected to because of the following informalities:
a) The use of the term GenBank, which is a trade name or a mark used in commerce, has been noted in this application. It should be capitalized wherever it appears and be accompanied by the generic terminology with the “™” or “®” indicated. Applicants are requested to carefully review the entire specification for any other material omissions.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
5. Claim 196 is 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 196 ends with a double period. The POSA cannot reasonably ascertain whether and/or what inventive subject matter is intended or missing.
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.
Enablement (Prevention)
6. Claims 197-201 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability of the art, the breadth of the claims, the quantity of experimentation which would be required in order to practice the invention as claimed.
Claim interpretation
The method of treatment claims comprises both therapeutic and prophylactic endpoints based on the definition of “treatment” in the specification at
[0073] “Treat” or “treatment” or “ameliorate” refers to medical management of a disease, disorder, or condition of a subject (e.g., a human or non-human mammal, such as a primate, horse, dog, mouse, or rat). In general, an appropriate dose or treatment regimen comprising a host cell expressing a fusion protein of this disclosure, and optionally an adjuvant or adjunctive therapy, is administered in an amount sufficient to elicit a therapeutic or prophylactic benefit. Therapeutic or prophylactic/preventive benefit includes improved clinical outcome; lessening or alleviation of symptoms associated with a disease; decreased occurrence of symptoms; improved quality of life; longer disease-free status; diminishment of extent of disease, stabilization of disease state; delay of disease progression; remission; survival; prolonged survival; or any combination thereof.
The Patent Act requires that patent applicants describe the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Applicants seek patent protection for a method invention of prophylaxis against any CD220+/ antigen+ -expressing cancer using a fusion protein-expressing CD8+ T cell and a TCR- or a CAR-specific for the antigen. There is no provision of intrinsic or extrinsic evidence on the record for a prophylactic effect of the instant claimed fusion protein much less one expressed by a CD8+ T cell. The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. See the decision in Morse, Incandescent Lamp, and Holland Furniture, establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”)
Scope of Enablement (Therapeutic)
7. Claims 197-201 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 treating FBL and disseminated leukemia, with CD8+ T-cell transduced CD200R-CD28 constructs, does not reasonably provide enablement for treating any CD200+/antigen+ cancer with the inventive transduced T cell plus any TCR or any CAR. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability of the art, the breadth of the claims, the quantity of experimentation which would be required in order to practice the invention as claimed.
The method of treatment claims comprises therapeutic endpoints based on the disclosure that is shown to be enabled under Examples 4-5 for the T cell transduced with CD200R-CD28tm (SEQ ID NO: 29) and CD200R-9aas-CD28Cys (SEQ ID NO: 30) constructs. Notably the antigen for CD200 for each of the constructs in the sequence listing is for human CD200:
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The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19, 24 (CCPA 1970). "[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.'" Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)).
The scope of the instant claimed cancers; the absence of a single antigen defined for the CD200+ expressing cancer; the “effective amount” of the transduced CD8+ T cell; and the absence of a co-administered TCR or CAR is not commensurate with the scope the full breadth of cancers of the instant claimed invention. (See In Alza Corp. v. Andrx Pharmaceuticals LLC, where the court held that claims construed to cover both osmotic and non-osmotic dosages were invalid for lack of enablement.[25] In this case, the court found that "the quantity of experimentation, lack of guidance in the specification, absence of working embodiments, and breadth of the claims demonstrates that. ... [the] patent specification fails to enable a person of ordinary skill to make and use nonosmotic oral dosage.)
Conclusion
8. Claims 173-195 are in condition for allowance.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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