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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
Claim Status
Claims 1, 7, and 15 have been amended.
Claim 9 has been cancelled.
Claim 14 has been withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 01/16/2026.
Claims 1-2, 4-8, 10-13, and 15-18 are under consideration.
Withdrawn Rejections
Rejections of claims 1-2, 4-13, and 15-18 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of amendments to the claims.
Rejections of claims 1-2 under 35 U.S.C. 102(a)(1) as being anticipated by Van Audenaerde et al., 2018 (“PO-417 Antitumoral effects of IL-15 and CD40 stimulations as a novel combination immunotherapy for pancreatic cancer”, in IDS filed 08/30/2022) are hereby withdrawn in view of amendments to the claims which narrow their scope.
New Objections
Claim Objections
Claim 5 is objected to because of the following informalities: the instant claim does not explain the acronym “IV” at its first iteration. The acronym must be fully spelled out prior to its first iteration, after which point it may be used in place of the term it acronymizes. Appropriate correction is required.
New Rejections
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 1-2, 4-8, 10-13, and 15-18 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.
Instant claims 1-2, 4-8, 10-13, and 15-18 are drawn to “a combination comprising IL-15 and a CD40 agonist for use in the treatment of a pancreatic cancer in a mammal”. As recited, it is unclear what statutory category of invention the instant claims are drawn to. The claims begin by reciting a combination of IL-15 and a CD40 agonist, which reflects that the instant invention is drawn to a product or composition. The succeeding lines are drawn to a method of use for the composition, which is a separate category of invention. The language reciting “for use in” carries no patentable weight as recited, which renders the scope of the dependent claims unclear due to the language used to describe the invention in the independent claim.
Instant claim 1 recites the use of IL-15 and a CD40 agonist, wherein at least one of the two proteins is used in a subtherapeutic dose. The claims proceed to describe that at least the said CD40 agonist is used in a subtherapeutic dose, but provides no guidance for the IL-15 proteins that are also to be administered. The claims do not ascertain what the “standard” dosage for IL-15 is, nor do they state what a subtherapeutic dosage would be in this context.
Instant claim 4 recites that “said IL-15 is used at a dose of from about 0.1 to about 50 μg per kg body weight”. It is unclear what is encompassed by the term “used” in this particular context. Applicant is invited to amend the claims to read “administered” for clarity.
Modified Rejections Necessitated by Amendment
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 1-2 and 15-16 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.
The term “subtherapeutic dose of less than about 300 μg per kg of body weight” and “subtherapeutic dose of said CD40 agonist is from about 20 to about 300 μg per kg of body weight” in instant claims 1-2 and 15 is a relative term which renders the claim indefinite. The term “subtherapeutic dose” is not defined by the claim or limited in the instant specification; the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no “standard” therapeutic dose in the claim provided to base a “subtherapeutic” dose from.
Response to Arguments
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive.
Applicant argues “that the term “subtherapeutic dose” is explicitly defined in the instant specification” on page 7, lines 34-38 and this is sufficient to ascertain what is encompassed within the instant claims. This is not found persuasive.
While the instant claims have been amended to recite that a subtherapeutic dose is any value of less than about 300 μg per kg of body weight, this limitation remains broad and unclear as it encompasses a blanket range of values without providing the experimental data to support it. In order to claim a dosage as novel, Applicant must provide support for the specific range of values they have claimed. The instant claims instead encompass a blanket range of values from 0 μg per kg of body weight to 300 μg per kg of body weight, without narrowing a range that would be effective when used in combination with another protein as claimed. Additionally, the claims fail to recite the dosage of the second component of the claimed combination, the IL-15 protein. According to the instant specification on page 6, the inventors have found that by “using this specific combination, at least one of the components can be used at subtherapeutic dosages, thereby reducing the risk of side-effects associated with high dosages of said components”. As such, more specific language is required to recite the dosage as disclosed in the specification. Applicant is reminded that the claims are to be fully encompassing and that limitations from the instant specification are not read into the instant claims.
As such, the rejection has been modified in view of amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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