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 .
Claim Status
Claims 2-8 and 16 have been cancelled; claims 1, 9-13, and 15 have been amended; and, claims 17-20 have been newly added, as requested in the amendment filed on 03/26/2026. Following the amendment, claims 1, 9-15, and 17-20 are pending in the instant application.
Claims 1, 9-15, and 17-20 are under examination in the instant office action.
Priority - Updated
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, it is noted that the claim to foreign priority has not been perfected, as no English copy of the foreign priority document has been provided.
Claims 1, 9-15, and 17-20 have an effective filing date of August 9, 2022 corresponding to PCT/CN2022/111112, as the claim to foreign priority has not been perfected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/26/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification - Objection Withdrawn
The specification was objected to for containing an embedded hyperlink and/or other form of browser executable code, Applicant has amended the specification to remove “https://” at Paragraph 0042. As such, the objection to the specification is withdrawn.
Claim Objections - Withdrawn
Claim 1 was objected to for reciting “Blys” instead of “BLys”. Claim 1 has been amended such that it no longer recites “Blys”. As such, the objection to claim 1 is withdrawn.
Claim 4 was objected to for reciting “one or more modifications of amino acid at positions”. Claim 4 has been cancelled, rendering its objection moot. As such, the objection to claim 4 is withdrawn.
Claim 5 was objected to for reciting “deletion or insertion of amino acid”. Claim 5 has been cancelled, rendering its objection moot. As such, the objection to claim 5 is withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
Claims 1-14 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. Claim 1 was considered indefinite as it was unclear if the TACI extracellular domain is constantly bound to BLys and/or APRIL, or if the TACI extracellular domain has the ability to bind BLys and/or APRIL; claim 1 has been amended to remove all recitations of BLys and APRIL. Claims 2-3, 7, and 9 were considered indefinite for the recitation of “an amino acid sequence set forth in SEQ ID NO…” as it was unclear if the intended scope is meant to be full-length sequences or if it is to include any fragments thereof; claims 2-3 and 7 have been cancelled, rendering their rejection moot, and claim 9 has been amended to recite “the amino acid sequence set forth in”, which is clear and definite. Claim 11 was considered indefinite for the recitation of “more preferably”; claim 11 has been amended to remove the recitation of “more preferably”. Claim 12 was considered indefinite for the recitation of “about”; claim 12 has been amended to remove “about”. In view of the above, the rejection of claims 1-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claims 1-15 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. Applicant has amended independent claims 1 and 15 to recite “the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4”, which is adequately described by the instant specification. As such, the rejection of claims 1-15 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 is withdrawn.
Claims 1-15 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, regarding scope of enablement. Applicant has amended independent claims 1 and 15 to recite that the subject has been diagnosed with IgA nephropathy, and as such the instant claims no longer read on methods of “preventing” IgA nephropathy. Furthermore, as noted above, independent claims 1 and 15 to recite “the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4”. In view of the claim amendments, the instant claims are considered to be enabled. As such, the rejection of claims 1-15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, regarding scope of enablement is withdrawn.
Claim Rejections - 35 USC § 102 - Withdrawn
Claims 2-8 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT") as evidenced by WO 2022/206872 A1 (machine translation of the description utilized; previously cited on PTO-892; herein after referred to as “Langyong”).
Claims 2-8 have been cancelled, rendering their rejection moot. As such, the rejection of claims 2-8 under 35 U.S.C. 102(a)(1) as being anticipated by NCT as evidenced by Langyong is withdrawn.
Double Patenting - Withdrawn
Claims 2-8 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-11 of copending Application No. 17/052,079 (herein after referred to as "reference application") in view of Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT").
Claims 2-8 were provisionally rejected, and new claims 17-20 are newly rejected, on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the copending Application Nos. listed below in view of Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT").
Application No.
Brief Description of the Invention
Pertinent Claims
17310431
Aqueous Liquid Pharmaceutical Formulation of TACI-Fc Fusion Protein and Method of Treating an Autoimmune Disease Thereof
1, 18
18257872
Method for Treating Sjogren's Syndrome Comprising Administering TACI-Fc Fusion Protein
1-9, 12-17
18705927
Method for Treating Myasthenia Gravis Comprising Administering TACI-Fc Fusion Protein and Medicament Thereof
1-9, 11-13, 18, 20
18730789
Liquid Formulation of TACI-Fc Fusion Protein, Method of Production, Pharmaceutical Product, Pre-Filled Syringe, and Method of Treating an Autoimmune Disease Thereof
1, 11-12, 17-19, 24
19114798
Method for Treating Membranous Nephropathy Comprising Administering TACI-Fc Fusion Protein
1-9, 15-18
With regard to the above-listed claim rejections under nonstatutory double patenting, it is noted that claims 2-8 have been cancelled, rendering their rejections moot. As such, the above-listed claim rejections under nonstatutory double patenting in view of NCT are withdrawn.
Claim Rejections - 35 USC § 112 - New, As Necessitated by Amendment
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.
Claim 20 is 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. In the instant case, claim 20 fails to further limit the subject matter of the claim from which it depends. MPEP 2111.04 recites that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In claim 20, the “wherein” clause is not given patentable weight as it simply expresses the intended result of a process step positively recited in claim 1 (i.e., the intended result of administering a therapeutically effective amount of a TACI-Fc fusion protein to a subject diagnosed with IgA nephropathy, wherein the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4). As such, the recitation of the intended result in claim 20 does not serve to further limit the method recited in independent claim 1. 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 § 102 - Maintained
Claims 1 and 9-15 stand as rejected, and new claims 17-20 are newly rejected, under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT") as evidenced by WO 2022/206872 A1 (machine translation of the description utilized; previously cited on PTO-892; herein after referred to as “Langyong”).
Claims 1 and 9-15 stand as rejected for reasons already of record.
With regard to new claims 17-19, as noted in the previous Office Action (11/26/2025), NCT discloses a study of RC18 (i.e., Tai Ai) in the treatment of human subjects with IgA nephropathy (Study Identification and Study Description). It is specifically noted that that RC18 is the research name for Telitacicept, and Tai Ai (or Tai’ai) is the brand name of the drug in China. The sequence of RC18/Telitacicept/Tai Ai is an inherent feature of the fusion protein, and said sequence is evidenced by Langyong The study is an interventional treatment, Phase II randomized study (see Study Design) wherein the arms of the study include those depicted in the table below (Arms and Interventions); the study discloses administering RC18 to a patient at a dose of 160 mg or 240 mg subcutaneously once a week, continuously for 24 weeks, for the treatment of IgA nephropathy. NCT discloses that all patients included in the study must have a biopsy confirmed diagnosis of IgA nephropathy, but patients having any secondary IgA nephropathy are excluded (Eligibility); thus, the study of NCT is specific to patients having been diagnosed with primary IgA nephropathy. Thus, NCT therefore meets all of the structural/sequence limitations of instant claims 1, 9-10 and 15, and further meets the dosages/administration schedule/route of instant claims 11-13 and 17-19.
With regard to new claim 20, MPEP 2111.04 recites that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. The determination of whether each of clauses (i) “adapted to” or “adapted for”, (ii) “wherein”, and (iii) “whereby” is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In new claim 20, the “wherein” clause is not given patentable weight as it simply expresses the intended result of a process step positively recited in claim 1 (i.e., the intended result of administering a therapeutically effective amount of a TACI-Fc fusion protein to a subject diagnosed with IgA nephropathy, wherein the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4). Therefore, claim 20 is anticipated by NCT, as evidenced by Langyong, because the references anticipate the method of claim 1, including all active method steps, the claimed TACI-Fc fusion protein, and the claimed patient population, and as such the intended result would necessarily occur.
Response to Arguments - 35 USC § 102
Applicant's arguments filed 03/26/2026 (herein after referred to as “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on Page 8 of Remarks that independent claims 1 and 15 have been amended to recite “wherein the 24-hour urine protein level decreases in the subject after administering the TACI-Fc fusion protein to the subject”, and Applicant argues that NCT no longer discloses each and every element of claims 1 and 15 as amended. Thus, Applicant argues that claims 1 and 9-15 are not anticipated by NCT as evidenced by Langyong.
With regard to Applicant’s argument, it is noted that MPEP 2111.04 recites that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. The determination of whether each of clauses (i) “adapted to” or “adapted for”, (ii) “wherein”, and (iii) “whereby” is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In independent claims 1 and 15, the “wherein” clause is not given patentable weight as it simply expresses the intended result of a process step positively recited in claim 1 (i.e., the intended result of administering (i) a therapeutically effective amount of a TACI-Fc fusion protein (see claim 1) or (ii) a pharmaceutical composition comprising a TACI-Fc fusion protein (see claim 15) to a subject diagnosed with IgA nephropathy, wherein the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4). Therefore, claims 1 and 15 stand as anticipated by NCT, as evidenced by Langyong, because the references anticipate the methods of claims 1 and 15, including all active method steps, the claimed TACI-Fc fusion protein and/or pharmaceutical composition thereof, and the claimed patient population, and as such the intended result “wherein the 24-hour urine protein level decreases in the subject after administering the TACI-Fc fusion protein to the subject” would necessarily occur.
As such, claims 1 and 9-15 stand as rejected, and new claims 17-20 are newly rejected, under 35 U.S.C. 102(a)(1) as being anticipated by NCT as evidenced by Langyong.
Double Patenting - Maintained
Claims 1 and 9-15 stand as provisionally rejected, and new claims 17-20 are newly rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-11 of copending Application No. 17/052,079 (herein after referred to as "reference application") in view of Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT").
Claims 1 and 9-15 stand as provisionally rejected, and new claims 17-20 are newly rejected, on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the copending Application Nos. listed below in view of Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; previously cited on PTO-892; herein after referred to as "NCT").
Application No.
Brief Description of the Invention
Pertinent Claims
17310431
Aqueous Liquid Pharmaceutical Formulation of TACI-Fc Fusion Protein and Method of Treating an Autoimmune Disease Thereof
1, 18
18257872
Method for Treating Sjogren's Syndrome Comprising Administering TACI-Fc Fusion Protein
1-9, 12-17
18705927
Method for Treating Myasthenia Gravis Comprising Administering TACI-Fc Fusion Protein and Medicament Thereof
1-9, 11-13, 18, 20
18730789
Liquid Formulation of TACI-Fc Fusion Protein, Method of Production, Pharmaceutical Product, Pre-Filled Syringe, and Method of Treating an Autoimmune Disease Thereof
1, 11-12, 17-19, 24
19114798
Method for Treating Membranous Nephropathy Comprising Administering TACI-Fc Fusion Protein
1-9, 15-18
Response to Arguments - Double Patenting
Applicant's arguments filed 03/26/2026 (herein after referred to as “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on Pages 8-10 of Remarks that independent claims 1 and 15 have been amended to recite “wherein the 24-hour urine protein level decreases in the subject after administering the TACI-Fc fusion protein to the subject”, and Applicant argues that none of the reference application claims nor NCT suggest each and every element of claims 1 and 15 as amended. Furthermore, Applicant argues that one of ordinary skill in the art would not reasonably expect that a TACI-Fc fusion protein could successfully be used to treat IgA nephropathy. None of the reference application claims are drawn to treating IgA nephropathy, and NCT is a phase 2 clinical trial protocol designed to examine the efficacy of telitacicept in patients with IgA nephropathy, but NCT does not contain any results demonstrating efficacy. The mere fact that a compound has entered into a phase 2 trial can hardly be considered to provide a reasonable expectation of success that the compound will be successful in treating the indication under exploration.
With regard to the arguments regarding independent claims 1 and 15 as amended, MPEP 2111.04 recites that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. The determination of whether each of clauses (i) “adapted to” or “adapted for”, (ii) “wherein”, and (iii) “whereby” is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In independent claims 1 and 15, the “wherein” clause is not given patentable weight as it simply expresses the intended result of a process step positively recited in claim 1 (i.e., the intended result of administering (i) a therapeutically effective amount of a TACI-Fc fusion protein (see claim 1) or (ii) a pharmaceutical composition comprising a TACI-Fc fusion protein (see claim 15) to a subject diagnosed with IgA nephropathy, wherein the TACI-Fc fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 4). Therefore, claims 1 and 15 stand as anticipated by NCT, as evidenced by Langyong, because the references anticipate the methods of claims 1 and 15, including all active method steps, the claimed TACI-Fc fusion protein and/or pharmaceutical composition thereof, and the claimed patient population, and as such the intended result “wherein the 24-hour urine protein level decreases in the subject after administering the TACI-Fc fusion protein to the subject” would necessarily occur.
With regard to the arguments regarding a reasonable expectation of success, MPEP 2143.02(I) recites that “[c]onclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). Thus, the disclosure of NCT for using telitacicept in the treatment of IgA nephropathy is considered sufficient to provide a reasonable expectation of success, even in the absence of efficacy data. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness, however Applicant’s arguments are merely directed to success rates of clinical trials as a whole, while providing no evidence supportive of the assertion that treating IgA nephropathy with the instantly claimed TACI-Fc fusion protein had no reasonable expectation of success.
As such, claims 1 and 9-15 stand as rejected, and new claims 17-20 are newly rejected, on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the above-listed reference applications in view of Clinical Study ID NCT04291781 (Version 2, Available 03/02/2020; herein after referred to as "NCT").
Conclusion
Claims 1, 9-15, and 17-20 are pending. Claims 1, 9-15, and 17-20 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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