DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 79-106, drawn to a polypeptide having IgE protease activity in the reply filed on March 9, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Applicant’s election of species of SEQ ID NO: 380 without traverse is acknowledged. Applicants state that claims 79-89 and 91-108 read on the elected species. Upon further review, SEQ ID NO: 380 reads on claims 79, 80, 86, 87, 89, 91, 92, and 93. SEQ ID NO: 380 does not include an amino acid position X1 of SEQ ID NO: 917 as recited in claim 81 and claims dependent therefrom and the claims are therefore withdrawn as drawn to non-elected species. Applicant did not elect a second polypeptide comprising a second Fc domain, therefore claims 99-104 are withdrawn. Claims 94-98 are included even though a Fc domain was not provided by applicant in the election of species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 81-85, 86 (in part), 87 (in part), 88, 90, 99-104, 107 and 108 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 9, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Claims 79, 80, 86, 87, 89, 91-98, 105, and 106 are currently under examination, drawn to the elected species of SEQ ID NO: 380.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. The priority date is May 1, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 30, 2025 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Applicant is referred to [0143] and [0145].
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Appropriate correction is required.
Claim Objections
Claim 86 is objected to because of the following informalities: there appears to be a typographical error with a placement of a comma after 95%. Suggest removing the comma. 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.
Claim 93 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.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Claim 93 refers to tables, but the claim can incorporate the SEQ ID NOs that are disclosed in the table.
Claims 79, 80, 86, 87, 89, 91-98, 105, and 106 are currently under examination, drawn to the elected species of SEQ ID NO: 380.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 79, 80, 89, and 91-93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCBI Reference Sequence: WP_164335234.1 (March 2, 2020).
NCBI discloses the disclosed sequence that comprises the polypeptide structure currently claimed with the recited amino acids at the positions recited. Position 122 in SEQ ID NO: 1 is a T, while the sequence cited has a S. The polypeptide does not have both 1-61 and 380-529 amino acids of SEQ ID NO: 1 as recited in claim 91. In reference to claim 92, the polypeptide has the structure being claimed and therefore necessarily has the functional attribute.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.")
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Claim(s) 79, 80, 89, 91-98, 105, and 106 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mitchell et al. (WO 2025/030053 A1).
Mitchell et al. disclose SEQ ID NO: 108 that comprises the polypeptide structure currently claimed with the recited amino acids at the positions recited. Position 122 in SEQ ID NO: 1 is a T, while the sequence cited has a S. The polypeptide does not have both 1-61 and 380-529 amino acids of SEQ ID NO: 1 as recited in claim 91. In reference to claim 92, the polypeptide has the structure being claimed and therefore necessarily has the functional attribute.
Mitchell et al. disclose the fusion protein of the polypeptide with a Fc domain (see e.g. claims 639-647).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.")
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Claim Rejections - 35 USC § 103
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.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 79, 80, 89, and 91-98, 105, and 106 are rejected under 35 U.S.C. 103 as being unpatentable over NCBI Reference Sequence : WP_164335234.1 (March 2, 2020), Mitchell et al. (WO 2025/030053 A1), and Li et al. (US 2024/0148841 A1).
NCBI discloses the disclosed sequence that comprises the polypeptide structure currently claimed with the recited amino acids at the positions recited. Position 122 in SEQ ID NO: 1 is a T, while the sequence cited has a S. The polypeptide does not have both 1-61 and 380-529 amino acids of SEQ ID NO: 1 as recited in claim 91. In reference to claim 92, the polypeptide has the structure being claimed and therefore necessarily has the functional attribute. NCBI does not disclose a fusion with a Fc domain conjugated.
Mitchell et al. disclose SEQ ID NO: 108 that comprises the polypeptide structure currently claimed with the recited amino acids at the positions recited. Position 122 in SEQ ID NO: 1 is a T, while the sequence cited has a S. The polypeptide does not have both 1-61 and 380-529 amino acids of SEQ ID NO: 1 as recited in claim 91. In reference to claim 92, the polypeptide has the structure being claimed and therefore necessarily has the functional attribute.
Mitchell et al. disclose the fusion protein of the polypeptide with a Fc domain (see e.g. claims 639-647).
Li et a. further discloses compositions and methods related to compositions comprising an Ig protease fusion protein. Compositions and methods for therapeutic treatment, such as of autoimmune diseases, allergies, or other immunological disorders, or in combination with the administration of another therapeutic, with such Ig protease fusion protein (see e.g. the abstract). Li et al. discloses a composition comprising an Ig protease fusion protein, comprising: (i) an Ig protease domain, and (ii) an Fc domain, optionally, wherein the Ig protease fusion protein has an increased circulating half-life relative to a naturally occurring Ig protease (see claim 1).
Therefore, it would have been obvious to the person having ordinary skill in the art to manufacture the fusion protein as currently claimed with an Fc domain, because the art has disclosed the benefits of conjugation with a Fc domain for pharmaceutical delivery of protease pharmaceutical compositions.
Conclusion
No claims are allowed.
Claim 86 drawn to polypeptides comprising the amino acid sequence having at least 95% identity to SEQ ID NO: 380 and claim 87 drawn to the amino acid sequence comprising SEQ ID NO: 380 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 other polypeptides of claims 86 and 87 are withdrawn based on the identification of a species that is applied as prior art to the examined claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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