DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group I (drawn to a polypeptide) and the species of canine Fc, substitution L235A, and SEQ ID NO:2 in the Response filed on October 16, 2025 is acknowledged.
Claims 1-20 are pending.
Claims 3-6, 9, and 17-20 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected inventions/species.
Claims 1, 2, 7, 8, and 10-16 are currently under consideration as they read on the elected invention.
3. The instant specification is objected to following reasons:
The instant specification on page 1 is missing “Incorporation by Reference of Sequence listing” paragraph.
Since the "Sequence Listing XML" is not the text of the specification, but rather is sequence data in an XML file format, an incorporation by reference statement is needed to ensure that the content of the "Sequence Listing XML," submitted to the USPTO as an XML file, is considered part of the disclosure capable of providing 35 U.S.C. 112(a) support for the disclosure and any claims relating to nucleotide and/or amino acid sequences. The incorporation by reference statement identifies: (i) the name of the file; (ii) the date of creation of the file; and (iii) the size of the file in bytes Note that this requirement pertaining to applicant submission of a "Sequence Listing XML" does not apply to a sequence listing that is part of an international application and communicated to the USPTO under PCT Article 20, for a national phase application. See MPEP 2413.04.
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An example of the required paragraph is as follows: “The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on August 18, 2022, is named 17800630_1_1.txt and is 38600 bytes in size.”
4. 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. Claims 1, 2, 7, 8, and 10-16 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.
A) Claims 1, 2, 7, 8, and 10-16 are indefinite in the recitation of amino acid position 235 without setting forth the numbering system. There are several numbering systems used when referring to the amino acid positions in the Fc region. For example, Presta (US 6,737,056) teaches that EU and Kabat are two different systems. In Table 6, Presta teaches that S239 in EU numbering is also referred as position 252 in Kabat. It is suggested that the claims be amended to recite the particular numbering system used (e.g. EU numbering system if there is support in the instant specification).
B) Claims 11 and 12 are indefinite in the recitation of “at least one of C1q and an Fc” because the metes and bounds of the phrase are unclear. It is not clear if the phrase is referring to “at least one of C1q” or “either C1q or an Fc”.
C) Claim 13 is indefinite in the recitation of “wherein said polypeptide’s ability to bind to FcRN and/or Protein A is not substantially impaired relative to the corresponding wild type polypeptide”. The term “substantially impaired” is a relative term which renders the claim indefinite. The term “substantially impaired” is not defined by the claim, 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.
In addition, claim 13 recites the limitation "the corresponding wild type polypeptide" in line 1. There is insufficient antecedent basis for this limitation in the claim.
6. 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.
7. Claim 2 is 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.
Claim 2 recites “the sequences of amino acids 234 to 331 (according to Kabat numbering) of GeneBank accession Nos. AF354264, AF354265, AF354266, AF354267 and disclosed by Striezel et al., page 220”.
The instant specification discloses Striezel et al. page 220 in, e.g. [0048] of the PGPUB of the instant application US 2023/0348577) but does not disclose the detailed information with respect to this reference. [0046] of the PGPUB of the instant application appears to discloses Strietzel et al. regarding the feline wild-type sequence. However, note that where possible, claims are to be complete in themselves.
The claim relies upon the availability of the GeneBand Accession NOs to support the essential material for practice the claimed invention.
The incorporation of essential material in the specification by reference to GeneBank accession Nos. AF354264, AF354265, AF354266, AF354267 and disclosed by Striezel et al., page 220 is improper. Applicant is required to amend the disclosure to include the material incorporated by reference. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973).
An application as filed must be complete in itself in order to comply with 35 U.S.C. 112; however, this does not bar incorporation by reference. See Ex parte Schwarze, 151 USPQ 426 (Bd. of Appeals, 1966). An application for a patent when filed may incorporate "essential material" by reference to (1) a United States patent or (2) an allowed U.S. application, subject to the conditions set forth below. "Essential material" is defined as that which is necessary to (1) support the claims, or (2) for adequate disclosure of the invention (35 U.S.C. 112). "Essential material" may not be incorporated by reference to (1) patents or applications published by foreign countries or regional patent offices, to (2) non-patent publications, to (3) a U.S. patent or application which itself incorporates "essential material" by reference or to (4) a foreign application. See In re Fouche, 169 USPQ 429; 439 F.2d 1237 (CCPA 1971).
Therefore, applicant must provide full disclosure of the sequences of amino acids 234 to 331 (according to Kabat numbering) of GeneBank accession Nos. AF354264, AF354265, AF354266, AF354267 and disclosed by Striezel et al., page 220 within the instant specification, including proof of public availability of the biological material. If Applicant must rely upon the disclosure of Striezel et al, than Applicant must physically incorporate the reference into the instant specification in its entirety and also provide sequence listings in compliance with sequence rules. Applicant is also reminded of providing a Hawkins Declaration stating that the amendatory material consists of the same material incorporated by reference in the referencing application and that no new matter is being amended.
8. 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.
9. 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.
10. Claims 1, 2, 7, 8, and 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergeron et al. (US 9,617,334, reference on IDS).
Bergeron et al. teach a caninized anti-NGF antibody comprising a canine Fc fragment (e.g. see FIG. 2). Bergeron et al. teaches that the Fc region can be mutated to sessentially eliminate the effector functions (e.g. see lines 5-40 in col. 21). Bergeron et al. teach the amino acid sequence for the canine heavy chain constant region CAN-65E-HC of SEQ ID NO:44 (e.g. see lines 23-25 in col. 13). The prior art’s SEQ ID NO:44 is identical to the instant SEQ ID NO:2, except in 2 amino acids L
Query 1: prior art SEQ ID NO:44; Sbjct: instant SEQ ID NO:2
Query 1 ASTTAPSVFPLAPSCGSTSGSTVALACLVSGYFPEPVTVSWNSGSLTSGVHTFPSVLQSS 60
ASTTAPSVFPLAPSCGSTSGSTVALACLVSGYFPEPVTVSWNSGSLTSGVHTFPSVLQSS
Sbjct 1 ASTTAPSVFPLAPSCGSTSGSTVALACLVSGYFPEPVTVSWNSGSLTSGVHTFPSVLQSS 60
Query 61 GLYSLSSMVTVPSSRWPSETFTCNVAHPASKTKVDKPVPKRENGRVPRPPDCPKCPAPEA 120
GLYSLSSMVTVPSSRWPSETFTCNVAHPASKTKVDKPVPKRENGRVPRPPDCPKCPAPE
Sbjct 61 GLYSLSSMVTVPSSRWPSETFTCNVAHPASKTKVDKPVPKRENGRVPRPPDCPKCPAPEM 120
Query 121 AGAPSVFIFPPKPKDTLLIARTPEVTCVVVDLDPEDPEVQISWFVDGKQMQTAKTQPREE 180
G PSVFIFPPKPKDTLLIARTPEVTCVVVDLDPEDPEVQISWFVDGKQMQTAKTQPREE
Sbjct 121 LGGPSVFIFPPKPKDTLLIARTPEVTCVVVDLDPEDPEVQISWFVDGKQMQTAKTQPREE 180
Query 181 QFNGTYRVVSVLPIGHQDWLKGKQFTCKVNNKALPSPIERTISKARGQAHQPSVYVLPPS 240
QFNGTYRVVSVLPIGHQDWLKGKQFTCKVNNKALPSPIERTISKARGQAHQPSVYVLPPS
Sbjct 181 QFNGTYRVVSVLPIGHQDWLKGKQFTCKVNNKALPSPIERTISKARGQAHQPSVYVLPPS 240
Query 241 REELSKNTVSLTCLIKDFFPPDIDVEWQSNGQQEPESKYRTTPPQLDEDGSYFLYSKLSV 300
REELSKNTVSLTCLIKDFFPPDIDVEWQSNGQQEPESKYRTTPPQLDEDGSYFLYSKLSV
Sbjct 241 REELSKNTVSLTCLIKDFFPPDIDVEWQSNGQQEPESKYRTTPPQLDEDGSYFLYSKLSV 300
Query 301 DKSRWQRGDTFICAVMHEALHNHYTQESLSHSPGK 335
DKSRWQRGDTFICAVMHEALHNHYTQESLSHSPGK
Sbjct 301 DKSRWQRGDTFICAVMHEALHNHYTQESLSHSPGK 335
The alignment shows amino acid substitutions M234A, L235A and G237A in the prior art SEQ ID NO:44 compared to the instant SEQ ID NO:2 (see underscored amino acid residues in the sequence alignment above).
Given that the prior art antibody comprises the same at least one substitution at amino acid position 235 (L235A), the prior art antibody would inherently exhibit the same functions, e.g. reduced binding affinity to at least C1q and an Fc receptor relative to the wild type polypeptide comprising the wild type Fc fragment as recited in instant claims 11-15).
Therefore, the reference teachings anticipate the instant invention.
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641