DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The request filed on 25 June 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 17/188,648 is acceptable, and an RCE has been established. An action on the RCE follows
Applicant’s amendment filed on 25 June 2025 is acknowledged and entered. Following the amendment, claim 1 is amended.
Currently, claims 1, 3, 4, 7, 8, 10-19 and 21-33 are pending, and claims 1, 4, 7, 8, 12, 13, 15 and 19 are under consideration. Claims 3, 10, 11, 14, 16-18 and 21-33 remain withdrawn from further consideration as being drawn to a non-elected invention/species.
Withdrawal of Objections and Rejections:
The scope of enablement rejection of claims 1, 4, 7, 8, 12, 13, 15 and 19 under 35 U.S.C. 112(a) is withdrawn in view of applicant’s amendment.
Formal Matters:
Claims
Claim 1 is objected to for the following informalities, appropriate correction is required:
Claim 1 recites “a variant IL- 33 sequence, wherein the variant IL-33 sequence …” in lines 1-2; “further wherein the variant IL-33 sequence is encoded by …” in lines 3-4; and “at least one biological activity of the IL-33 sequence” in the last line; the following is suggested: delete the four “sequence” after “IL-33” (it is a product being claimed, not a sequence).
Rejections under 35 U.S.C. §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, 4, 7, 8, 12, 13, 15 and 19 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite and confusing for the recitation “wherein the variant IL-33 sequence comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 2 or SEQ ID NO:4, and further wherein the variant IL-33 sequence is encoded by a nucleic acid comprising a nucleotide sequence selected from the group consisting of: a nucleotide sequence having at least 93% identity to the nucleotide sequence as set forth in SEQ ID NO: 1, a nucleotide sequence as set forth in SEQ ID NO: 1, a nucleotide sequence having at least 93% identity to the nucleotide sequence as set forth in SEQ ID NO:3” because SEQ ID NO: 1 encodes SEQ ID NO: 2, and SEQ ID NO: 3 encodes SEQ ID NO: 4; therefore, it cannot be that the variant IL-33 is encoded by SEQ ID NO: 1 or 3;
Claim 7 is indefinite and confusing for the recitation “wherein the IL-33 is selected from the group consisting of proIL-33 and mtrIL-33” because it is unclear what the identity of proIL-33 and mtrIL-33 is, for example, is the variant considered here? The metes and bounds of the claim, therefore, cannot be determined. Claim 8 is similarly indefinite.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
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.
Written Description
Claims 1, 4, 7, 8, 12, 13, 15 and 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, 7, 8, 12, 13, 15 and 19 encompass a variant IL- 33, wherein the variant IL-33 comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 2 or SEQ ID NO:4, and is encoded by a nucleic acid comprising a nucleotide sequence having at least 93% identity to the nucleotide sequence of SEQ ID NO: 1 or 3, and wherein the variant IL-33 retains at least one biological activity of the IL-33. However, while the specification discloses the human mtrIL-33 of SEQ ID NO:2, and the human proIL-33 (SEQ ID NO:4), and two murine proIL-33 and mtrIL-33 of SEQ ID NO: 6 and 8, respectively, it does not disclose any % variant of SEQ ID NO: 2 or 4, which meets the limitations of the claims.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." “[A]pplicant must convey with reasonable clarity to those skilled in the art that, as of the 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.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. In the instant case, 0 species of the claimed % variant of the IL-33 of SEQ ID NO: 2 or 4, which meets the limitations of the claims was ever identified or particularly described in the specification. In addition, the specification provides no description of structural features common to the members of these genus; and no sufficient teachings regarding the structure-function relationship of SEQ ID NO:2 or 4, such as identification of any particular portion of SEQ ID NO:2 or 4 that must be conserved, and which 5% of the sequence of SEQ ID NO: 2 or 4 can be varied while retaining the desired functional properties of the IL-33 variant. Therefore, it is unpredictable as to which 5% of SEQ ID NO:2 or 4 can be altered while retaining the desired functional properties. As such, with the exception of the IL-33 of SEQ ID NO: 2 or 4, the skilled artisan cannot envision the detailed chemical structure of the encompassed % variants of said the IL-33 variant, therefore, conception is not achieved regardless of the complexity or simplicity of the method of making a % variant. In view of 0 species of the claimed % variant disclosed; the lack of description of structural features common to the members of the genus; and the lack of predictability, those of ordinary skill in the art would not have concluded that the applicant was in possession of the claimed genus of the % variant of the IL-33 based on disclosure of SEQ ID NO:2 and 4. "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly,119 at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id.
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, only the IL-33 of SEQ ID NO: 2 or 4, but not the full breadth of the claims (“at least 95% identity to …”) meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Prior Art Rejections
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 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 7, 8, 12, 15 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Tsunoda et al. (JP 2010208985A, 9/24/2010; Google translation provided), and in view of Schmitz et al. (US200/50203046A1, 9/15/2005), for the reasons of record set forth in the previous Office Actions mailed on 3/14/2024, and 12/30/2024.
The newly amended claim 1 recites “[A] vaccine comprising an antigen and IL-33 or a variant IL- 33 sequence, wherein the variant IL-33 sequence comprises an amino acid sequence having at least 95% identity to SEQ ID NO: 2 or SEQ ID NO:4, and further wherein the variant IL-33 sequence is encoded by a nucleic acid comprising a nucleotide sequence selected from the group consisting of: a nucleotide sequence having at least 93% identity to the nucleotide sequence as set forth in SEQ ID NO: 1, a nucleotide sequence as set forth in SEQ ID NO: 1, a nucleotide sequence having at least 93% identity to the nucleotide sequence as set forth in SEQ ID NO:3, and a nucleotide sequence as set forth in SEQ ID NO:3, …”. As such, the structural or sequence identity of the IL-33 (not the variant) is not defined in the claim, therefore, any IL-33 in the prior art would read on the IL-33 of the claim, i.e., the instant prior art rejection still applies.
Claims 1, 4, 7, 8, 12, 13, 15 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Tsunoda et al. (JP 2010208985A, 9/24/2010; Google translation provided), and Schmitz et al. (US2005/0203046A1, 9/15/2005), as applied to claims 1, 4-9, 12, 15, 19 and 20 above, and further in view of Wieking et al. (Cancer Gene Ther. 2012 Oct;19(10):667-74. Epub 2012 Aug 24; provided by applicants), for the reasons of record set forth in the previous Office Actions mailed on 3/14/2024, and 12/30/2024.
The rejection is maintained in view of applicants amendment for the same reason above.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DONG JIANG/
Primary Examiner, Art Unit 1674
10/28/25