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 .
Response to Amendment
Applicant’s amendment to the claims, filed 06 March 2026, has been received and entered. Claims 107 and 114 have been amended and claims 1-106 have been canceled. Claims 107-124 are currently pending in the instant application.
Election/Restrictions
Applicant's election with traverse of Group I, claims 107-113, in the reply filed on 06 March 2026 is acknowledged. The traversal is on the ground(s) that each of the identified groups relates to a common inventive concept and the claims are therefore properly examinable together. This is not found persuasive because “common inventive concept” is not sufficient for establishing unity of invention. As was pointed out in the Lack of Unity mailed on 23 January 2026, the common technical feature of caninized anti-IL31 antibody with a substitution of N434H did not make a contribution over the prior art of U.S. Pat. Pub. 2020/0023076 and WO2018/073185 for the reasons of record.
The requirement is still deemed proper and is therefore made FINAL.
Claims 114-124 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 23 January 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 October 2022 and 21 May 2026 have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
The above text is found at [00017], however, the application file does not seem to contain any color drawings. Figure 2B refers to color. However, the Figure is in black and white. The details which are referred to by color cannot be determined because the Figure is not in color. Either the Figure needs to remove the reference to color and annotate the features in some other manner or Applicant may want to consider filing color drawings.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings are objected to because:
Figures 2A, 2C contain amino acid/nucleic acid sequences. Sequence should not be repeated in the figures. Pursuant to 37 CFR 1.83(a), sequence that are included in the “Sequence Listing XML” should not be duplicated in the drawings.
Figure 2B is found on multiple pages with “cont”. which is not compliant with 37 CFR 1.84(u)(1).
The Figure labels are not in solid black text which is not compliant with 37 CFR 1.84(l).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Specifically, paragraph [000230] contains an amino acid sequence with no Sequence identifier; BAP tag (AGLNDIFEAQKIEWHE). If this amino acid sequence is not already included in the Sequence listing, Applicant will also need to submit a new CRF which includes the omitted sequence (which will then require a corrected incorporation statement which reflects the new CRF).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it does not include “that which is new in the art to which the invention pertains”. The claims are directed to methods which administer an anti-IL31 antibody with a canine constant domain with an N434H mutation; none of this is conveyed in the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The disclosure is objected to because of the following informalities:
The Brief Description of the Drawings indicates that at least one drawing is executed in color however, only black/white drawings are presented. The Description of Figure 2B is unclear because the details which are indicated to be in color are not visible.
The Description at [000226] does not comply with 37 CFR 1.52(a)(1)(iv-v). The text of this paragraph is not in permanent dark ink or its equivalent as the letters do not have solid black lines and therefore, there is insufficient clarity and contrast between the paper and the writing. See screenshot below:
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The description at [000226], last line, indicates that “[c]onstructs which bound to protein A were purified and quantified as described in Bergeron et al. for protein quality”. However, it is not clear which publication by “Bergeron et al.” would contain the described methods for the purification and quantification which is referenced. Therefore, this passage is unclear and deficient.
Appropriate correction is required.
The use of the terms BIACORE and SAPIDYNE, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The terms are found at [000135] and while they are capitalized, they do not include a proper symbol indicating use in commerce and the generic terminology is not provided. The specification should be reviewed for any other instances of their use or other trademarked products which are not properly identified.
Additional terms, which are also trade names, are found at [000211] (TWEEN and PLURONICS) and [000234] (Gyrolab xP™, Watson™, Excel™). Again, the terms are lacking a proper symbol indicating use in commerce and generic terminology.
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.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see [000225]). 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.
Claim Rejections - 35 USC § 112
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.
Claims 107 and 110 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 a method which administers an antibody wherein said antibody comprises a canine IgG constant domain which comprises an Fc constant region having a CH3 domain and having a substitution at amino acid residue 434 numbered according to the EU index as in Kabat, does not reasonably provide enablement for an antibody having a substitution at amino acid residue 434 numbered according to the EU index as in Kabat and lacking the CH3 domain. 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.
Claim 107 is directed to a method which administers an antibody which comprises a canine IgG constant domain and having a substitution at amino acid residue 434 numbered according to the EU index as in Kabat. This amino acid position is located in the CH3 domain of the heavy chain (see [00018] of the instant disclosure). Claim 110 recites “wherein the canine IgG constant domain comprises an Fc constant region having CH2 or CH3 domain, or a combination thereof”. However, if the canine IgG constant domain only had the CH2 domain, there claims could not have a canine IgG constant domain with the recited substitution in claim 107, therefore, the claims are not enabled for their full scope. While claim 107 does not state that the CH3 domain is optional, it must be interpreted this way because of the limitations in claim 110. The claims are clearly not enabled for an antibody with a substitution at the recited position if the antibody does not possess the amino acid which is stated to be substituted.
Claims 107, 110 and 113 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims do not provide an adequate written description for methods which administer an antibody comprising a canine IgG constant domain and having a substitution at amino acid residue 434 numbered according to the EU index as in Kabat and wherein said method provides a half-life of the antibody for a period ranging from about 25 days to about 35 days for an antibody having an Fc constant region lacking either the CH2 or CH3 domain. First, the claimed method administers an antibody which has a substitution at amino acid residue 434 numbered according to the EU index as in Kabat in the IgG constant domain. This amino acid position, according to the EU index, is found in the CH3 domain (see the instant specification at [00018]). The instant specification does not provide a written description of a method which administers an antibody that lacks the CH3 domain nor provides explanation of how such a substitution would be present in a canine IgG constant domain if the domain that contains the amino acid position is lacking. However, the claims clearly encompass such an embodiment as evidenced by claim 110. Next, the claimed method is directed to maintaining a level of antibody over a period of time and claim 113 requires that the half-life of the antibody to be from about 25 days to about 35 days. The instant specification only exemplifies antibodies which comprise an intact canine IgG constant region (both the CH2 and CH3 domains) with a substitution at amino acid residue 434 numbered according to the EU index as in Kabat in the IgG constant domain. According to the instant specification, the modification in the CH3 region at amino acid 434 increases the IgG half-life by increasing affinity to FcRn, but this increase in affinity was only established for antibodies that possessed an intact canine IgG constant region and there is no disclosure of what result would be achieved with an IgG constant domain that lacked the CH2 domain. In fact, FcRn binding does not occur on a single domain alone, but rather, the binding site for FcRN is located at the interface between the CH2 and CH3 domains. One of ordinary skill in the art would not readily conclude that an antibody which lacked the CH2 domain would necessarily result in an antibody which the stated half-life of the instant claims because the increased half-life is dependent on binding to FcRN and the specification did not determine binding with a molecule that only possessed the CH2 domain or the CH3 domain in the absence of the other domain. While the singular CH2 and CH3 domains can bind to FcRN, the binding affinity, and therefore, the half-life would not be identical to that of what was determined for the intact IgG constant domain and therefore, it would not be expected that a single domain would provide the range of half-life recited in claim 113. Additionally, one of ordinary skill in the art would not necessarily conclude that an antibody comprising a modified IgG constant domain for the recited mutation would necessarily have a longer half-life compared to an intact IgG constant domain as the intact constant domain would have the entire interface present for binding FcRN while the modified domain would only possess the CH3 domain. The specification does not provide an adequate written description of such and therefore, no comparison to a wild-type canine IgG constant domain was made or could be made or could be speculated upon. The instant specification has not adequately described the full scope of the antibodies which are encompassed by the claims and therefore, the claims lack an adequate written description for the claimed subject matter.
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 107-113 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.
Claim 107 is directed to a method “for maintaining the therapeutic level of an anti-IL31 antibody in a dog” comprising “administering to said dog an effective amount of said antibody”. However, the claim is indefinite as the metes and bounds of “the therapeutic level” are unknown as the claim does not indicate what condition is being treated such that one might understand what “the therapeutic level” would be. Additionally, without knowing what condition is being treated, one cannot determine what an “effective amount” would encompass. Another reading of the administration step would be that the “effective amount” is that which maintains a level of a protein over a period of days rather than being effective to provide a therapeutic level – these two amounts are not necessarily the same because an “effective amount” might provide a therapeutic level and result at administration but might also not provide a level over 7-210 days. Therefore, the metes and bounds of the instant claims are not clear. Claims 108-113 depend from claim 107 and do not remedy the deficiencies noted in claim 107, therefore, these claims are also indefinite.
Claim 107 is indefinite for the recitation of “wherein said antibody further comprises a variable light chain having the amino acid sequence set forth in SEQ ID NO.:68 and a variable heavy chain having the amino acid sequence set forth in SEQ ID NO.:70”. The amino acid sequences set forth in SEQ ID NO:68 and 70 are the light/heavy chains which are composed of both the variable chains and the constant domains. Because claim 107 is directed to a method which comprises administering an antibody wherein the antibody comprises a canine IgG constant domain with a particular substitution and wherein said antibody further comprises the chains having the amino acid sequences of SEQ ID NO:68 and 70, it is not clear if the antibody has two constant domains attached to the same antibody or if the wrong sequence identifiers were referenced for the variable light/heavy chains. The recitation of “further comprises” would be interpreted as the limitation following the limitation would be additional structure in addition to the structure already recited. But, as currently drafted, this interpretation would mean that there are 2 canine IgG constant domains, one generically recited with a substitution and the additional domains being specifically recited via the amino acid sequence of SEQ ID NO:68 and 70. Therefore, the claim is indefinite as it is not clear what structures are intended for the antibody used in the method of the claim.
Claim 108 recites the limitation “a higher therapeutic life” in line 2. However, the metes and bounds of “therapeutic life” are unclear and indefinite as the instant specification does not use this terminology nor does this terminology appear to be a term of the art. Perhaps the claim intends “half-life” however, as the claim does not recite this, it is not clear what is actually intended or encompassed by the claim.
Claims 108 and 109 recite the limitation "the wild-type canine IgG constant domain" in lines 2-3. These claims depend from claim 107, which does not recite a wild-type canine IgG constant domain. Claim 107 refers to an antibody which comprises a canine IgG constant domain which comprises a substitution. Therefore, there is insufficient antecedent basis for this limitation in the claims.
Claim 113 recites the limitation "the half-life" in line 1. Claim 113 depends from claim 107 and claim 107 does not refer to half-life. Therefore, there is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 108, 109 and 112 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 108 depends from the method of claim 107 and recites the limitation “wherein the antibody having said substitution has a higher therapeutic life than an anti-IL31 antibody having the wild-type canine IgG constant domain”. However, claim 108 is merely characterizing the properties of the antibody from claim 107 and therefore, does not materially limit the subject matter of the claim from which it depends as the recited property/characteristic is already possessed by the antibody in claim 107.
Claim 109 depends from the method of claim 107 and recites the limitation “wherein the antibody having said substitution has a higher half-life than an anti-IL31 antibody having the wild-type canine IgG constant domain”. However, claim 109 is merely characterizing the properties of the antibody from claim 107 and therefore, does not materially limit the subject matter of the claim from which it depends as the recited property/characteristic is already possessed by the antibody in claim 107.
Claim 112 depends from either of claim 108 or 109 and recites “wherein the wild-type canine IgG constant domain comprises the amino acid sequence set forth in SEQ ID NO:2”. Claim 112 does not appear to further limit the subject matter of the claims from which it depends as “the wild-type canine IgG constant domain” implies that there is a singular molecule that is “the wild-type canine IgG constant domain” and therefore, the amino acid sequence of that domain would be inherent to the recitation of “wild-type canine IgG constant domain”. Therefore, claim 112 appears to be further characterizing a property already possessed by the compound identified in claims 108 and 109 and therefore, is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 107-113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michels et al. (Vet. Dermatol. 2016; 27: 478-e129) in view of WO2018/073185 (cited by Applicant) and as evidenced by U.S. Pat. Pub. 2020/0023076 A1.
Michels et al. teach the administration of lokivetmab (a caninized monoclonal antibody that binds and neutralizes canine IL31) to dogs for the treatment of atopic dermatitis (see page 681). Dogs were treated with 0.125, 0.5 or 2.0 mg/kg lokivetmab administered subcutaneously (see page 682 under “Study design” and “Duration of effect study”). The dogs were then challenged with IL-31 to induce pruritus before lokivetmab administration and again on days 1, 7, 14, 28, 42 and 56 post-lokivetmab administration to evaluate the duration of antipruritic effect of the antibody. This would be considered a therapeutic effect which would indicate the presence of a therapeutic level of anti-IL31 antibody. Michels et al. teach that a dose of 0.125 mg/kg lokivetmab achieved a significant reduction in pruritus up to day 14 and up to day 28 for a dose of 0.5 mg/kg and up to day 42 for a dose of 2.0 mg/kg (see page 683, column 1, top of page). Therefore, Michels et al. teaches a method of maintaining a therapeutic level of an anti-IL31 antibody in a dog over a period of time, wherein the period of time falls within the range of 7-210 days. Michels et al. does not disclose the amino acid sequences of the heavy/light chains of the antibody (lokivetmab), however, the structure of lokivetmab was known in the prior art. ‘076 teaches the amino acid sequences of the heavy and light chains of the antibody lokivetmab, which is the caninized anti-IL31 antibody (see Table 4) of Michels et al. The amino acid sequence of the heavy chain of this antibody (SEQ ID NO:535) differs from the amino acid sequence of SEQ ID NO:70 of the instant claim at position 434. The amino acid sequence of the light chain of this antibody (SEQ ID NO:536) is identical to that of SEQ ID NO:68 of the instant claims. The singular difference at position 434 is the amino acid substitution which is recited in claim 107. Michels et al. do not teach a method as currently claimed with an anti-IL31 antibody which comprises a canine IgG constant domain comprising a substitution at amino acid residue 434, numbered according to the EU index as in Kabat and wherein the substitution is N434H.
‘185 teaches that substitution of position 434 in canine IgG’s with histidine increases the half-life of the antibody and that affinity to FcRn is increased by one order of magnitude. Increasing the binding affinity to FcRn in an antibody increases the half-life of the antibody (see [0005] of the instant specification). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-IL31 antibody of Michels et al. by substituting position 434 of the IgG constant domain with histidine in order to increase the binding to FcRn, as taught by ‘185 because this would increase the half-life of the antibody and therefore, improve the effectiveness of the treatment of pruritus by prolonging the therapeutic effect. One would have been motivated to modify the anti-IL31 antibody of Michels et al. because increasing the half-life of the antibody would mean that the therapeutic benefits achieved by antibody administration would be extended and therefore, fewer administrations would be required to achieve the same duration of therapeutic effect. While the combination of references do not compare the substituted antibody to lokivetmab without the substitution, one of ordinary skill in the art would expect that the antibody comprising the substitution as taught by ‘185 would have a longer half-life because the substitution which is being made increases the binding to FcRn. While Michels et al. did not measure the half-life of lokivetmab, the antibody was shown to maintain a therapeutic level for at least 42 days at a dose of 2.0 mg/kg and therefore, it would reasonably be expected that the method of Michels et al. practiced with the N434H substitution of lokivetmab would necessarily result in a half-life from about 25 days to about 35 days as required by claim 113, absent evidence to the contrary. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, absent evidence to the contrary.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 107-113 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 97-103 of copending Application No. 19/570,699 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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