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
Status of the Claims
1. Claims 1-19 are the original claims filed 9/25/2023. IN the preliminary amendment of 9/25/2023, Claims 2-7, 9, 10, 12-17 and 19 are amended and new Claim 20 is added. In the preliminary amendment of 6/7/2024, claim 19 is amended. In the reply of 5/28/2026, no amendments are made to the claims. Claims 1-20 are pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 1-18) in the reply filed on 5/28/2026 is acknowledged. Claims19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2026.
3. Applicant’s election without traverse of species (b) (a variant of SEQ ID NO: 8 or a truncated fragment of the variant) in the reply filed on 5/28/2026 is acknowledged. Species (a) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2026.
4. Claims 1-2, 4 and 6-18 are the claims under examination.
Priority
5. USAN 18/284,009, filed 09/25/2023, is a National Stage entry of PCT/CN2022/ 084256, International Filing Date: 03/31/2022, that claims foreign priority to CN 202110348497.6, filed 03/31/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Objections
Specification
6. The disclosure is objected to because of the following informalities:
a) The use of the term Tween, Tris, dynabeads, Biacore, DuoSet, Celltiter-glo, megalign, DNASTAR, which is a trade name or a mark used in commerce, has been noted in this application. The term 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.
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.
b) The specification contains peptide sequences > 4 amino acids in length that are required to be identified by sequence identifier pursuant to 37 CFR 1.821-1.825. See [0030, 0043] for (GxS)y.
Appropriate correction is required.
Claim Objections
7. Claims 1-2, 4 and 6-18 are objected to because of the following informalities:
a) Amend claims 1-2, 4 and 6-18 in generic clam 1 to recite “A Transmembrane Activator and CAML Interactor (TACI) polypeptide.”
b) Amend claims 1-2, 4 and 6-18 with proper punctuation, i.e., consistent use of “,” or “;” within each of the claims. Amend claim 1 to insert the term “and” between the limitation starting with “the truncated fragment” and the limitation starting with “the variant” to identify them as being inclusive.
c) Claims 1-2, 4 and 6-18 are objected to for reciting duplicative language, specifically the phrase, “the variant is a variant having one or more amino acid replacements. That portion of the phrase “is a variant” can be deleted for brevity and without a change in scope.
d) Claims 7-8 and 10-15 are objected to because claims 7 and 10 make reference to two sets of claims to different features: claim 6 (fusion protein) and claim 1 (TACI polypeptide) (MPEP 608.01(n)).
e) Amend claim 9 to recite “the linker in the polypeptide chain shown in a, b, or c is a sequence selected from the group consisting of a sequence selected from the group consisting of [a] (GxS)y
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.
8. Claims 4, 8-9, 11, 13-14 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 4, 8-9, 11, 13-14 are indefinite for reciting the term “preferably.” The term renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
c) Claim 8 is indefinite of the phrase “capable of.” The limitation implies that some undefined structure or condition is what predicates whether the activity (associating or reducing) does or does not occur. Capacity and capability suggest that the activity may sometimes occur but not always, and what determines the degree or amount of the activity is not definite by the use of the phrase.
d) Claims 9 and 14 are indefinite for reciting a peptide sequence > 4 amino acids in length that is required to be identified by sequence identifier pursuant to 37 CFR 1.821-1.825. See (GxS)y.
e) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “(GxS)y linker, wherein X is an integer selected from the group consisting of 1 to 5, and Y is an integer selected from the group consisting of 0 to 6”, and the claim also recites “SEQ ID NO: 65 or SEQ ID NO: 66”, which is the narrower statement of the range/limitation.
SEQ ID NO: 65 or SEQ ID NO: 66 correspond to GGGS and GGGGS, respectively.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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
9. Claims 1-2, 4 and 6-18 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 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.
Claim interpretation
Claims 1-2 and 4 drawn to a variant of a TACI sequence of SEQ ID NO: 8 consisting of residue substitutions at any one or more of 49, 52, 53, 57, 65, 82 and 83 and a truncated fragment thereof.
Claims 6-8, 10-14, 16-18 drawn to a fusion protein comprising a variant of a TACI sequence of SEQ ID NO: 8 consisting of residue substitutions at any one or more of 49, 52, 53, 57, 65, 82 and 83 or a variant truncated fragment thereof, and an Fc region.
“truncated fragment”: to understand the scope in the specification is at
[0142] In one aspect, in the present disclosure, TACI sequence fragments of different lengths are designed, and a novel TACI sequence fragment SEQ ID NO: 8 (which does not comprise amino acid residues at positions 13 and 14 of the extracellular region (positions 13 and 14 in natural order of SEQ ID NO: 1) that cause TACI cleavage) is finally obtained, which has better TACI cleavage resistance and good TACI polypeptide functional activity. In addition, by further truncating the N-terminus and the C-terminus of SEQ ID NO: 8, a TACI polypeptide fragment with better functional activity comprising amino acid residues at positions 48-85 of SEQ ID NO: 8 but not amino acid residues at positions 34-66 of SEQ ID NO: 1 (natural order) is obtained. In addition, amino acid residues at part of the positions of the TACI polypeptide fragment are replaced to obtain a TACI polypeptide with better binding activity, blocking function, stability, and druggability.
“replacement”: the specification at
[0103] The term “amino acid mutation” includes amino acid substitutions (also known as amino acid replacements), deletions, insertions, and modifications. Any combination of substitutions, deletions, insertions, and modifications can be made to obtain a final construct, as long as the final construct possesses the desired properties, such as reduced binding to the Fc receptor. Amino acid sequence deletions and insertions include deletions and insertions at the amino terminus and/or the carboxyl terminus of a polypeptide chain. Specific amino acid mutations may be amino acid substitutions. In one embodiment, the amino acid mutation is a non-conservative amino acid substitution, i.e., replacement of one amino acid with another amino acid having different structural and/or chemical properties. Amino acid substitutions include replacement with non-naturally occurring amino acids or with derivatives of the 20 native amino acids (e.g., 4-hydroxyproline, 3-methylhistidine, ornithine, homoserine, and 5-hydroxylysine).
The POSA could reasonably interpret the meaning of the variant of a TACI polypeptide (SEQ ID NO: 8) or a variant TACI “truncated fragment” thereof as comprising residues 48-85 of SEQ ID NO: 8 being substituted at one or more residues of 49, 52, 53, 57, 65, 82 and 83 with any kind of natural, non-natural or even synthetic amino acid at any one or more of the residues in any combination.
Notably, the purpose of the substitutions is to improve functional activity for the variant TACI polypeptide (SEQ ID NO: 8) or the variant TACI polypeptide fragment (residues comprising positions 48-85 of SEQ ID NO: 8) such as binding activity, blocking function, stability, and druggability or at least according to [0142].
The interpretation encompasses a genus of TACI variants beyond those taught in the specification. Because applicant seeks patent protection for all such TACI variants, this genus must be adequately described. A description adequate to satisfy 35 U.S.C. § 112(a) must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed (Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation omitted, alteration in original). The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent’s specification” (In re Katz Interactive Call Processing Patent Litig. 639 F.3d 1303, 1319 (Fed. Cir 2011).
Scope of the claimed genus
The TACI variation may encompass any number and kind of amino acids that are natural or non-natural or even mimetics. The variation may encompass the presence of non-naturally occurring thiol groups, e.g., methionine or cysteine, which is potentially disadvantageous because these amino acids can lead to misfolding or mis-conjugation problems. The genus encompassed by the claims is therefore very large and there is substantial variation within the genus.
Summary of species disclosed in the specification
Working examples for TACI variants and TACI variant-Fc fusion proteins are appreciated and acknowledged as part of the disclosure for the instant application as filed. However, none of the species of variant TACI proteins shown in the working examples of the specification are readily or easily discernable as to how they correspond to the claimed residue replacements for a variant sequence of SEQ ID NO: 8 or the variant fragment thereof as instantly claimed.
Applicants are requested to identify how TACI-Mab1 and TACI-Mab2 correlate to the variant sequence of SEQ ID NO:8 and the variant fragments thereof (Figures 6-13).
Applicants are requested to identify the TACI fusion proteins shown in Table 4, specifically how the “Simultaneous introduction of stability mutations” relates to the variant sequence of SEQ ID NO:8 and the variant fragments thereof, i.e., residues one or more of 49, 52, 53, 57, 65, 82 and 83 being mutated by replacement.
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Applicants are requested to identify the TACI fusion proteins shown in Table 7, specifically how the “Mutation position in TACI sequence” relates to the variant sequence of SEQ ID NO:8 and the variant fragments thereof, i.e., residues one or more of 49, 52, 53, 57, 65, 82 and 83 being mutated by replacement.
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The specification teaches that the natural order for numbering is relative to wild type human TACI-0 (SEQ ID NO: 1) at [0141] and not to SEQ ID NO:8.
SEQ ID NO: 1 comprising SEQ ID NO: 8 (highlighted text) shows the natural order of numbering for SEQ ID NO: 8. The natural order of numbering for SEQ ID NO: 8, relative to the wild type SEQ ID NO: 1, is residues 21-116.
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SEQ ID NO: 8 has its own numbering of 1-96 residues.
Are the disclosed species representative of the claimed genus?
Given the instant claim language for the invention compared to the laboratory names used in those data shown for TACI variants and TACI variant-Fc proteins in the specification, an assessment is not feasible. The mutation residues in the working examples are identified by residue for the length of the TACI protein fragment, per se, being tested, and NOT by the instant claimed numbering system, namely, “in natural order relative to the sequence of SEQ ID NO: 8.” The instant claimed invention is not clear or definite much less whether and how it is supported by the disclosure in the current application in order to meet the written description requirements.
Examiner’s comment: Applicants are advised to rewrite the claims with respect to the phrase “wherein the positions for the amino acid replacements are amino acid residue positions numbered in natural order relative to the sequence SEQ ID NO: 8” in order for the POSA to understand how the instant claimed invention relates to the residue numbering shown in the actual working examples of the application as filed.
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)(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. Claim(s) 1-2, and 4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kelly et al (WO 2006052493A1; 2006-05-18).
The claims are interpreted assuming, arguendo, that the residue numbering in Kelly is in natural order of TACI (SEQ ID NO: 10) relative to the instant claimed sequence of SEQ ID NO: 8, and that shows 100% local identity:
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Claims 1-2 and 4 are anticipated by Kelly.
AS regards claims 1-2 (residues 82 and 83) and 4 (residue 82A), Kelly teaches examples of a TACI variant that correspond to generic residues 82 and 83 of the instant claims:
“A total of 12 TACI residues resulted in significant loss of affinity for APRIL and/or BAFF when mutated to alanine (F78, Y79, D80, L82, L83, 187, R84, 192, G94, Q95, H96 and P97) (Table 6, below). These residues map to a concave surface on the TACI_d2 structure and indicate that both sub-modules of TACId2 are important for ligand binding.
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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.
11. Claim(s) 6-8 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (WO 2006052493A1; 2006-05-18).
The claims are interpreted assuming, arguendo, that the residue numbering in Kelly is in natural order of TACI (SEQ ID NO: 10) relative to the instant claimed sequence of SEQ ID NO: 8, and that shows 100% local identity:
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Claims 6-8 and 16-18 are prima facie obvious over Kelly.
AS regards claim 6 (residues 82 and 83; residue 82A), Kelly teaches examples of a TACI variant that correspond to generic residues 82 and 83 of the instant claims:
“A total of 12 TACI residues resulted in significant loss of affinity for APRIL and/or BAFF when mutated to alanine (F78, Y79, D80, L82, L83, 187, R84, 192, G94, Q95, H96 and P97) (Table 6, below). These residues map to a concave surface on the TACI_d2 structure and indicate that both sub-modules of TACId2 are important for ligand binding.
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As regards claims 6-8 for TACI fusion protein, Kelly teaches immunoadhesins comprising TACI-constant domain fusions such as immunoglobulin constant domains
“As used herein, the term "immunoadhesin" designates antibody-like molecules which combine the binding specificity of a heterologous protein (an "adhesin") with the effector functions of immunoglobulin constant domains. Structurally, the immunoadhesins comprise a fusion of an amino acid sequence with the desired binding specificity which is other than the antigen recognition and binding site of an antibody (i.e., is "heterologous"), and an immunoglobulin constant domain sequence. The adhesin part of an immunoadhesin molecule typically is a contiguous amino acid sequence comprising at least the binding site of a receptor or a ligand. The immunoglobulin constant domain sequence in the immunoadhesin can be obtained from any immunoglobulin, such as IgG-I, IgG-2, IgG-3, or IgG-4 subtypes, IgA (including IgA-I and IgA-2), IgE, IgD or IgM. For example, useful immunoadhesins according to this invention are polypeptides that comprise the BAFF binding portions of a polypeptide of this invention without the transmembrane or cytoplasmic sequences of the TACI receptor. In one embodiment, a polypeptide of this invention is fused to a constant domain of an immunoglobulin sequence. For example, a sequence of Formula I, II or III can be fused to an Fc region of an IgG molecule.”
Kelly teaches published examples of TACI-Fc fusion proteins
“where Kim et al. (2003) found that each domain of TACI was capable of binding BAFF through its respective DxL motif (when measured in the context of Fc-fusion proteins), and that mutation of both DxL motifs in full-length TACI was required to eliminate BAFF-binding as detected qualitatively by co-immunoprecipitation.”
AS regards claim 16, Kelly teaches compositions comprising pharmaceutically effective components
“The present invention comprises a composition comprising a polypeptide of this invention, optionally further comprising a pharmaceutically acceptable carrier.”
"Carriers" as used herein include pharmaceutically acceptable carriers, excipients, or stabilizers which are nontoxic to the cell or mammal being exposed thereto at the dosages and concentrations employed. Often the physiologically acceptable carrier is an aqueous pH buffered solution. Examples of physiologically acceptable carriers include buffers such as phosphate, citrate, and other organic acids; antioxidants including ascorbic acid; low molecular weight (less than about 10 residues) polypeptide; proteins, such as serum albumin, gelatin, or immunoglobulins; hydrophilic polymers such as polyvinylpyrrolidone; amino acids such as glycine, glutamine, asparagine, arginine or lysine; monosaccharides, disaccharides, and other carbohydrates including glucose, mannose, or dextrins; chelating agents such as EDTA; sugar alcohols such as mannitol or sorbitol; salt- forming counterions such as sodium; and/or nonionic surfactants such as TWEEN™, polyethylene glycol (PEG), and PLURONICS™.
AS regards claim 17-18, Kelly teaches nucleic acids and host cells encoding and expressing the TACI-fusion proteins
“The present invention also provides nucleic acid molecules encoding the polypeptides, vectors comprising the nucleic acid molecules, host cells comprising the nucleic acid molecules or vectors comprising the nucleic acid molecules. According to one specific embodiment, the invention provides a method for producing a polypeptide comprising the step of culturing a host cell comprising the nucleic acid molecule according to this invention or a vector comprising the nucleic acid molecule, under conditions suitable for expressing the polypeptide from the vector. In a further embodiment, the polypeptide expressed by the host cell can be recovered.”
Kelly teaches the advantages of the TACI variants are the improved functional properties such as binding to BAFF or APRIL. Adding an Fc region to the TACI protein creates a fusion protein (e.g., telitacicept or atacicept) that acts as a powerful "decoy" receptor. This modification significantly improves the protein's stability, circulatory half-life, and therapeutic efficacy against autoimmune diseases. The disclosure in Kelly identifies multiple residues in the TACI protein region comprised of SEQ ID NO: 8 much less those identified as residues 82 and 83 and the fusion of such a TACI variants with an Fc region, all of which provide the motivation and a reasonable and predictable expectation of success in the making and using of the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. Claims 1-2, 4 and 6-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-12 and 21-31 of copending Application No. 19/107926 (reference application US 20260125451). The ref application is not afforded safe harbor under 35 USC 121 because the ref claims share no continuity nor restriction/speciation with the instant claimed invention.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a variant of a TACI sequence of SEQ 1 or ID NO: 8 consisting of residue substitutions at any one or more of 49, 52, 53, 57, 65, 82 and 83 and a truncated fragment thereof; or a fusion protein comprising a variant of a TACI sequence of SEQ ID NO: 1 or SEQ ID NO: 8 consisting of residue substitutions at any one or more of 49, 52, 53, 57, 65, 82 and 83 or a variant truncated fragment thereof, and an Fc region.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claims are allowed.
14. The sequences for SEQ ID NOS: 36-44 (Claim 9) and paired SEQ ID NOs: 55/56 and 57/58 (Claim 15) that are free from the art.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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, Wu Julie 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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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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