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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/20/25 has been entered.
Claims Status
Claims 1-6 have been amended. Clams 7-30 have been cancelled. Claims 1-6 are under examination.
Declaration under 37 C.F.R. 1.132
The Chiu Declaration under 37 CFR 1.132 filed December 20, 2025, is insufficient to overcome the 35 U.S.C. 103(a) rejection of amended claims 1-6 as set forth in the last Office action because in view of the foregoing, when all the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Rejections Maintained
The rejection of newly amended claims 1-6 is maintained under the 35 U.S.C. 102(a)(2) as being anticipated by Brogdon et al. (WO 2016/057841 A1, 4/14/2016; claiming priority to U.S. Provisional Application 62/061,644 filed 10/08/2014), for the reasons of record set forth in the Final Office action mailed, August 6, 2025, pages 3-5.
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.
The claims are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brogdon et al. (WO 2016/057841 A1, 4/14/2016; claiming priority to U.S. Provisional Application 62/061,644 filed 10/08/2014).
Claim 1 is drawn to a preparation comprising anti-IL-17 antibody molecules, wherein a plurality of the anti-IL-17 antibody molecules are in a reduced state at cysteine at light chain position 97 (CysL97), wherein the anti-IL-17 antibody molecules comprise a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, wherein the anti-IL-17 antibody molecules have been recombinantly produced by Chinese Hamster Ovary (CHOI cells, and wherein the preparation of anti-IL-17 antibody molecules at least 90% intact anti-IL-17 antibody molecules as measured by non-reducing CE-SDS and at least 90% activity.
Claim 2 is drawn to the preparation of anti-IL-17 antibody molecules claim 1, wherein the activity is measured by cystamine-CEX.
Claim 3 is drawn to the preparation of anti-IL-17 antibody molecules of claim 1, wherein the activity is measured by a cell-based assay.
Claims 4 is drawn to the preparation of anti-IL-17 antibody molecules of claim 3, wherein the cell-based assay comprises an assay for inhibition of IL-17-dependent release of IL-6.
Claim 5 is drawn to the preparation of anti-IL-17 antibody claim 1, wherein the preparation of anti-IL-17 exhibits at least 95% intact anti-IL-17 antibodies as measured by non-reducing CE-SDS and at least 95% activity.
Claim 6 is drawn to the preparation of anti-IL-17 antibody molecules of claim 5, wherein the activity is measured by cystamine-CEX.
Brogdon discloses an IL-17 inhibitor secukinumab (CAS Registry Numbers: 875356-43-7 (heavy chain) and 875356-44-8 (light chain)), which is also known as AIN457 and COSENTYX®; and that secukinumab is a recombinant human monoclonal IgGl/κ antibody that binds specifically to IL-17A, and is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line (pages 200-201, [0544]), wherein the sequences of said heavy chain and light chain are 100% identical to the present SEQ ID NO: 15 and 14, respectively. Therefore, the reference anticipates claims 1-6. The invention is drawn to a product and not a method of making a product. It should be noted that the present claims are considered product-by-process claim; however, the only method step of making the product (a preparation of said anti-IL-17 antibody) is that the anti-IL-17 antibody is recombinantly produced by CHO cells (claim 1, for example). There is not any other step for making said preparation/antibody recited. As such, the teachings of a prior art reference, which teaches making secukinumab in CHO cells are considered meeting the limitations of the claims even though the reference does not expressly teach that the anti-IL-17 antibody is in a reduced state at CysL97 of the light chain. Therefore, the reference anticipates the present claims.
With respect to the limitations such as “wherein a plurality of the anti-IL-17 antibody molecules are in a reduced state at cysteine at light chain position 97 (CysL97), wherein the anti-IL-17 antibody molecules comprise a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, wherein the anti-IL-17 antibody molecules have been recombinantly produced by Chinese Hamster Ovary (CHOI cells, and wherein the preparation of anti-IL-17 antibody molecules at least 90% intact anti-IL-17 antibody molecules as measured by non-reducing CE-SDS and at least 90% activity, wherein the activity is measured by cystamine-CEX, wherein the activity is measured by a cell-based assay and wherein the cell-based assay comprises an assay for inhibition of IL-17-dependent release of IL-6” represent the inherent properties of the preparation/antibody made by CHO cells, and are not in any way limiting the preparation/ antibody. Therefore, these limitations do not carry patentable weight for product itself; and the reference anticipates claims 1-6.
Applicant’s Arguments
A. Applicant urges that they disagree with the Office’s position. Applicant refers to the Declaration by Dr. Chiu filed on December 20, 2025, the instant claims have four key elements (1) an anti-IL-17 antibody of the recited SEQ ID Nos. (secukinumab) in a reduced state at CysL97; (2) 90% activity; (3) 90% intactness; (4) and produced recombinantly in CHO Cells.
B. Applicant urges that the present application demonstrates that the CHO cell preparations of the recited anti-17 antibody do not necessarily meet the activity and/or intactness levels recited in the claims. Applicant refers to paragraphs 17-18 and Table 3 of the instant specification. Applicant argues that Brogden’s disclosure of CHO cell produced secukinumab does not explicitly or necessarily disclose the recited preparation of anti-IL17 antibodies or anticipate the claimed invention.
Examiner’s Response to the Applicant’s Arguments
A. This argument is not persuasive for the reasons of record. As discussed previously, the present claims are considered product-by-process claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim"). See MPEP 2113. Therefore, there is nothing that distinguishes the claimed invention from the prior art of record.
B. Applicant has referred to Table 3 of the instant specification. Table 3 discloses the activity and purity of antibody obtained after the samples from different reactivation treatment. It should be remembered that the claims are drawn to a product. In the instant case, secukinumab. Applicants are concentrating on how the product is made, rather than the product itself. Based on the information presented in the declaration filed December 20, 2025, it appears that applicants are discussing a method of making and not a product. There is no evidence of record that shows how the claimed product differs from secukinumab. As such, the process for producing the anti-IL-17 antibody, i.e., recombinantly produced by a mammalian cell such as CHO cells, as taught by the cited prior art references, meet the process limitations for producing the same anti-IL-17 preparation in the present claims. Therefore, the products made by the same method (as recited) would be considered the same in the absence of evidence to the contrary. As applicant argues that production of secukinumab in CHO cell culture and downstream processing (e.g., purification) can produce secukinumab preparations that have varying activity and levels of intact antibody, it is clear that it is the process, besides the recombinant production of the antibody, such as purification method and cysteine selective reduction step, which determine the natures of the preparation, such as the antibody activity and levels of intact antibody. However, while applicants try to claim a known (antibody) product by process, the claims, as written, do not recite the critical downstream processing steps so that the product made by such processes would have the desired features as claimed. Mere argument that it cannot be held that the activity and intactness limitations recited in the instant claims are inherently met by the cited references is not persuasive.
Claims 1-6 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Padova et al. (WO 2006/013107, 2/9/2006, provided by applicants), and as evidenced by CAS Registry: secukinumab/AIN457 sequences (CAS Registry Numbers: 875356-43-7 (heavy chain) and 875356-44-8 (light chain); 2/27/2006), for the reasons of record set forth in the Final Office action mailed August 6, 2025.
The claims are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Padova et al. (WO 2006/013107, 2/9/2006, provided by applicants), and as evidenced by CAS Registry: secukinumab/AIN457 sequences (CAS Registry Numbers: 875356-43-7 (heavy chain) and 875356-44-8 (light chain); 2/27/2006).
Claim 1 is drawn to a preparation comprising anti-IL-17 antibody molecules, wherein a plurality of the anti-IL-17 antibody molecules are in a reduced state at cysteine at light chain position 97 (CysL97), wherein the anti-IL-17 antibody molecules comprise a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, wherein the anti-IL-17 antibody molecules have been recombinantly produced by Chinese Hamster Ovary (CHOI cells, and wherein the preparation of anti-IL-17 antibody molecules at least 90% intact anti-IL-17 antibody molecules as measured by non-reducing CE-SDS and at least 90% activity.
Claim 2 is drawn to the preparation of anti-IL-17 antibody molecules claim 1, wherein the activity is measured by cystamine-CEX.
Claim 3 is drawn to the preparation of anti-IL-17 antibody molecules of claim 1, wherein the activity is measured by a cell-based assay.
Claims 4 is drawn to the preparation of anti-IL-17 antibody molecules of claim 3, wherein the cell-based assay comprises an assay for inhibition of IL-17-dependent release of IL-6.
Claim 5 is drawn to the preparation of anti-IL-17 antibody claim 1, wherein the preparation of anti-IL-17 exhibits at least 95% intact anti-IL-17 antibodies as measured by non-reducing CE-SDS and at least 95% activity.
Claim 6 is drawn to the preparation of anti-IL-17 antibody molecules of claim 5, wherein the activity is measured by cystamine-CEX.
Di Padova discloses a human monoclonal antibody to human IL-17, AIN457 (also known as secukinumab), which comprises the VH and VL of SEQ ID NO:8 and 10, respectively. Additionally, Di Padova teaches that the AIN457 antibody has a high binding affinity for IL-17 with a KD for binding to IL-17 of about 0.188-0.036 nM, and this high binding affinity makes the AIN457 antibody particularly suitable for therapeutic applications (page 21, 4th paragraph). Further, Di Padova teaches that the antibody chains can be produced in a cell culture, the DNA constructs must first be inserted into either a single expression vector or into two separate but compatible expression vectors, which is/are then transferred into a suitable host organism; and a suitable host organism may be a bacterium, a yeast or a mammalian cell line, this latter being preferred (page 20, 3rd - 5th paragraphs). As evidenced by CAS Registry, human clone AIN457 comprises the heavy chain sequence with CAS Registry Numbers: 875356-43-7; and the light chain sequence with CAS Registry Numbers: 875356-43-8, which are 100% identical to the present SEQ ID NO: 15 and 14, respectively. Thus, the monoclonal antibody AIN457 produced in a mammalian cell culture, as taught by Di Padova would read on claims 1-6.
With respect to the limitations such as “wherein a plurality of the anti-IL-17 antibody molecules are in a reduced state at cysteine at light chain position 97 (CysL97), wherein the anti-IL-17 antibody molecules comprise a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, wherein the anti-IL-17 antibody molecules have been recombinantly produced by Chinese Hamster Ovary (CHOI cells, and wherein the preparation of anti-IL-17 antibody molecules at least 90% intact anti-IL-17 antibody molecules as measured by non-reducing CE-SDS and at least 90% activity, wherein the activity is measured by cystamine-CEX, wherein the activity is measured by a cell-based assay and wherein the cell-based assay comprises an assay for inhibition of IL-17-dependent release of IL-6” represent the inherent properties of the preparation/antibody made by CHO cells, and are not in any way limiting the preparation/ antibody. Therefore, these limitations do not carry patentable weight for product itself; and the reference anticipates claims 1-6.
Applicant’s Arguments
Are the same as indicated above.
Response to Applicant Arguments
Have been addressed above.
The rejection of newly amended claims 1-6 is maintained under are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Di Padova et al. (WO 2006/013107, 2/9/2006, provided by applicants), and as evidenced by CAS Registry: secukinumab/AIN457 sequences (CAS Registry Numbers: 875356-43-7 (heavy chain) and 875356-44-8 (light chain), 2/27/2006) and further in view of Di Padova et al. (WO 2014/122613A1, 8/14/2014).
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application is currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
The claims are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Di Padova et al. (WO 2006/013107, 2/9/2006, provided by applicants), and as evidenced by CAS Registry: secukinumab/AIN457 sequences (CAS Registry Numbers: 875356-43-7 (heavy chain) and 875356-44-8 (light chain), 2/27/2006), and further in view of Di Padova et al. (WO 2014/122613A1, 8/14/2014).
Claim 1 is drawn to a preparation comprising anti-IL-17 antibody molecules, wherein a plurality of the anti-IL-17 antibody molecules are in a reduced state at cysteine at light chain position 97 (CysL97), wherein the anti-IL-17 antibody molecules comprise a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, wherein the anti-IL-17 antibody molecules have been recombinantly produced by Chinese Hamster Ovary (CHOI cells, and wherein the preparation of anti-IL-17 antibody molecules at least 90% intact anti-IL-17 antibody molecules as measured by non-reducing CE-SDS and at least 90% activity.
Claim 2 is drawn to the preparation of anti-IL-17 antibody molecules claim 1, wherein the activity is measured by cystamine-CEX.
Claim 3 is drawn to the preparation of anti-IL-17 antibody molecules of claim 1, wherein the activity is measured by a cell-based assay.
Claims 4 is drawn to the preparation of anti-IL-17 antibody molecules of claim 3, wherein the cell-based assay comprises an assay for inhibition of IL-17-dependent release of IL-6.
Claim 5 is drawn to the preparation of anti-IL-17 antibody claim 1, wherein the preparation of anti-IL-17 exhibits at least 95% intact anti-IL-17 antibodies as measured by non-reducing CE-SDS and at least 95% activity.
Claim 6 is drawn to the preparation of anti-IL-17 antibody molecules of claim 5, wherein the activity is measured by cystamine-CEX.
The teachings of Di Padova (2006) are reviewed above. Di Padova does not specifically teach that the mammalian cell used for producing the antibody is CHO cell.
Di Padova (2014) teaches anti-IL-17A human monoclonal antibodies such as XAB1 (XAB2, XAB3, XAB4 and XAB5) (abstract; the paragraph bridging pages 4-5; and page 85, line 17, for example). additionally, Di Padova (2014) teaches that antibodies of the disclosure can be produced in a host cell transfectoma using, for example, a combination of recombinant DNA techniques and gene transfection methods as is well known in the art (e.g., Morrison, S. 1985, Science 229: 1202) (page 60, lines 11-13); and that mammalian host cells for expressing the recombinant antibodies of the disclosure include Chinese Hamster Ovary (CHO cells) (page 63, lines 14-18, for example).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to recombinantly produce the AIN457 antibody using a mammalian cell CHO cell following the teachings of Di Padova (2006), and Di Padova (2014). The person of ordinary skill in the art would have been motivated to do so for therapeutic applications and reasonably would have expected success because CHO cells are commonly used for recombinant production of proteins, and Di Padova (2014) specifically teaches that CHO cells can be used for producing the anti-IL-17A human monoclonal antibodies.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Applicant’s Arguments
Applicant urges, as explained by Dr. Chiu, discloses production of an entirely different anti-IL-17 antibodies. Applicant urges that none of these antibodies have cysteine in a CDR. Id. Thus, the unique developments problems faced with commercial manufacture of the presently recited antibody preparations are neither taught nor suggested in ‘613 or any combination of ‘613 or what was known in the art. Applicant urges that Dr. Chiu’s declaration discloses that it was surprising that the inventors of the ‘977 application were able to obtain preparations of the recombinantly produced secukinumab having the activity and intactness levels required by the claims. In fact, a person of ordinary skill in the art at the time the present application was filed and would have been highly motivated to avoid further development of an antibody like secukinumab given the unpredictability of development of antibodies having an unpaired cysteine.
Response to Applicant Arguments
As indicated above, the claimed invention is directed to a product and not a method of making. It should be noted that Applicant’s arguments are direct to the process of making the product and not the product itself. Applicant’s arguments nor declaration have shown that the claimed product differs from secukinumab. Thus, there is nothing on the record that shows that the two products differ.
The rejection of newly amended claims 1-6 is maintained under rejected under nonstatutory double patenting.
Double Patenting Rejections: The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) 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 Page 8 Application/Control Number: 18/800,977 Art Unit: 1674 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.
Newly presented claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-20 of copending Application No. 19/065,656 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Claims 7-20 of the ‘656 application are directed to a preparation comprising secukinumab in a reduced state at cysteine at light chain position 97 (CysL97) and in a re-oxidized state at conserved cysteines, wherein secukinumab comprises a heavy chain of SEQ ID NO:15 with or without the C-terminal lysine and a light chain of SEQ ID NO:14, and has been recombinantly produced by CHO cells, and the preparation of secukinumab exhibits at least 90% intact secukinumab as measured by non-reducing CE-SDS and at least 90% activity and a plurality of the conserved cysteines are not oxidized to form disulfide bonds (the independent claim 7, for example); or a preparation comprising the same secukinumab in a reduced state at cysteine at light chain position 97 (CysL97) and in a re-oxidized state at conserved cysteines, wherein secukinumab has been recombinantly produced by mammalian cells, such as CHO cells, and the preparation of secukinumab is re-equilibrated such that it exhibits at least 90% intact Page 9 Application/Control Number: 18/800,977 Art Unit: 1674 secukinumab as measured by non-reducing CE-SDS and at least 90% activity (the independent claim 13 and claim 20, for example). SEQ ID NO: 14 and 15 of the ‘656 application are 100% identical to the present SEQ ID NO: 14 and 15, respectively. Therefore, the conflicting claims are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Newly presented 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66 and 67 of copending Application No. 17/683,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons of record set forth in the last Office action. Claims 66 and 67 of the ‘888 application are directed to a purified preparation of secukinumab antibodies produced by the method of claim 63 (claim 66), wherein the level of intact secukinumab in the preparation is at least about 90%, as measured by sodium dodecyl sulfate capillary electrophoresis (CE-SDS), and wherein the level of activity of secukinumab in the preparation is at least about 90%, as measured by cystamine-CEX (claim 67); and wherein claim 63 is dependent from claim 48, which is drawn to a method for selectively reducing CysL97 in a preparation of IL-17 antibodies that has been recombinantly produced by mammalian cells. As such, the purified preparation of secukinumab antibody of claims 66 and 67 of the ‘888 application reads on the preparation of anti-IL-17 antibody of the present claims. Therefore, the conflicting claims are not patentably distinct from each other.
Applicant’s Arguments
Applicants urge that the withdrawal of the rejection over 19/065,656. Applicants urge without agreeing with the rejection that they have filed a terminal disclaimer over US 27.683,888.
Examiner’s Response to Applicant’s Argument
Both the rejection and the provisional rejection will be maintained. The claims are not allowed, and there is nothing on the record that shows that a terminal disclaimer was filed.
Status of Claims
No claims allowed.
Conclusion
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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