DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
2. Applicant’s amendments and remarks, filed 08/06/2026, are acknowledged. Claims 22, 24-27, 30-31, 33, 35-38, 41-42, and 44 are amended. As such, 22-51 are pending and under examination.
Maintained Rejections/Objections
Claim Objections
3. Applicant is advised that should claims 22-32 be found allowable, claims 33-43 and 44-51 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Comparing the independent claim 22 with the independent claim 44 (for example), the only difference is that claim 22 recites an additional limitation of “at least 90% of the light chains of the secukinumab molecules comprise a reduced cysteine at L97”. However, the limitation does not alter the nature of the preparation of the secukinumab, structurally or functionally, or the method steps for producing. Thus, claims 22, 33 and 44 (and their dependent claims), as written, read on the same method of producing a secukinumab composition.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 22-51 remain objected to for the reasons of record set forth in the last Office action mailed on 05/06/2026, pages 3-4
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.
4. Claims 22-51 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 particular out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention .
The rejection is maintained for reason of record (pp. 3-4, Office action mailed 06 May 2026) and for the reason discussed below. For convenience, the rejection is repeated herein, modified to adhere to the amendments:
Claim 22, 33 and 44 are indefinite because it is incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: critical active ingredients and method steps for the following reasons. Claim 1 is directed to a method for producing a secukinumab composition, which comprises i. reducing a plurality of secukinumab molecules. Without specifying the reducing agent, the claim requires that in the composition the secukinumab molecules comprise conserved disulfide bonds formed by conserved cysteine residues, and a masked cysteine at position L97 of the light chain. Additionally, the claim recites “ii. Re-oxidizing the secukinumab molecules to produce a composition that comprises a plurality of the secukinumab molecules” without specifying said re-oxidizing conditions. While the limitations specifically require that the conserved cysteine residues are re-oxidized to form the conserved disulfide bonds; at least 90% of the light chains of the secukinumab molecules comprise a reduced cysteine at L97; and at least 90% of the secukinumab molecules are intact as measured by CE-SDS, the re-oxidizing conditions to ensure such results are, again, not specified. Thus, the claim demands very specific results while omitting the specific active ingredients and method steps (specific conditions) that would lead to said results. Furthermore, it is unclear as to how the specific results recited in the limitations in claims 22, 33 and 44 are determined. The metes and bounds of the claim, therefore, cannot be determined.
Claims 24, 27, 32, 35, and 38 are indefinite and confusing for the recitation “measured by cystamine-CEX” because it is unclear as to why cystamine-CEX is used since the reducing agent or the conditions for re-oxidation is never specified.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Applicant’s Arguments
A) Applicant argues a skilled person would understand there are wide number of different individual reaction mixture conditions and method steps along this response surface that can be identified and used. Applicant argues that the specification teaches how to make and use models to identify suitable reaction mixture conditions and demonstrates that these models can predict experimental outcomes.
B) Applicant argues that the amendment of reciting structural elements such as reducing agent cysteine at a concentration of 4 mM to 14 mM in an aerobic reaction mixture narrows the method.
Response to Arguments
Applicant’s remarks filed 08/06/2026 have been acknowledged and are not found persuasive.
A) Applicants arguments that one of skill would understand the wide number of individual reaction mixture condition and method steps, however, without reciting the actual mixture condition and methods steps, one of skill would not be able to determine the steps for producing a secukinumab composition. Applicant further argues the specification identifies these condition, however, although the specification identifies the specific reaction conditions, this is not taught in the breadth of the claims.
B) Applicant argues that reciting structure elements such as reducing agent cysteine, a concentration and aerobic mixture narrows the method, however, the claims teach the re-oxidization of the secukinumab molecules without disclosing the oxidizing agent and an aerobic mixture without reciting the specific aerobic conditions. The claim demands very specific results while omitting the specific active ingredients and method steps (specific conditions) that would lead to said results such as concentrations, pH, temperatures, time, and reaction mix.
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.
Enablement
5. Claims 22-51 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The rejection is maintained for reasons of record (pp. 6-8, Office action mailed 06 May 2026) and for the reason discussed below. For convenience, the rejection is repeated herein, modified to include the new claims.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Claims 22-51 are directed to a method for producing a secukinumab composition, which comprises i. reducing a plurality of secukinumab molecules ; ii. Re-oxidizing the secukinumab molecules to produce a composition that comprises a plurality of the secukinumab molecules (claim 1, for example). While there is no reducing agent specified, and there is no re-oxidizing conditions defined, the claim requires the resulted composition to have the following specific features: in step i., reducing a plurality of secukinumab molecules which comprise: 1. conserved disulfide bonds formed by conserved cysteine residues, and 2. a masked cysteine at position L97 of the light chain; in step ii., re-oxidizing the secukinumab molecules to produce a composition that comprises a plurality of the secukinumab molecules in which. 1. a plurality of the conserved cysteine residues that were reduced in are re-oxidized to form the conserved disulfide bonds; 2. at least 90% of the light chains of the secukinumab molecules comprise a reduced cysteine at L97; and 3. at least 90% of the secukinumab molecules are intact as measured by non-reducing CE-SDS. As such, instead of defining the method with the specific active ingredient (such as a specific reducing agent and re-oxidizing condition) and specific method steps, the claimed method is defined by the resulted product of the method. However, according to the specification, the reducing agent and re-oxidizing conditions of the method are very specific and essential for making the resulted composition as claimed. Without such essential elements, it would be unpredictable as to the outcome of the method, let alone, the composition with all specific features as claimed. A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may be rejected under 35 U.S.C. 112, first paragraph, as not enabling. In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA1976). See also MPEP §2164.08(c). Such essential matter may include missing elements, steps or necessary structural cooperative relationships of elements described by the applicant(s) as necessary to practice the invention (MPEP 2172.01).
Due to the lack of essential elements and the complex and unpredictable nature of the invention, and the broad breadth of the claims in view of omitting the essential elements in the claims, undue experimentation would be required of the skilled artisan to make the claimed invention.
Applicants Arguments
A) Applicant argues the specification teaches a skilled person relevant process parameters for employing cysteine in an aerobic reaction mixture at 4 to 14 mM to achieve the selective reduction of secukinumab. Applicant argues the specification clearly teaches the skilled person both specific reaction mixture and process steps sufficient to achieve ethe claimed invention. Applicant directs to the specification that demonstrate the specific reaction mixtures and process steps as well as models that show high goodness of fit to experimental data that further quantitively prove the quality of the models. Applicant argues a
B) Applicant argues the specification is replete with broad and specific teachings that demonstrate the presently claimed invention
Response to Arguments
Applicant’s remarks filed 08/06/2026 have been acknowledged and are not found persuasive.
A) This argument is not persuasive as one skilled in the art would not be able to tell or figure out, from such large amount of data, a specific combination of agents/conditions that would ensure the specific results as required by the claims. Applicant argues that the specification provides the specific reaction mixture and process steps, however, this is not demonstrated in the breadth of the claims. The claims require the method for producing a secukinumab composition to result in at least 90% of the secukinumab molecules to comprise a reduced cysteine at L97 of the light chain. Without specific reaction conditions such as concentrations, pH, temperatures, time, reaction mix, etc, one skill would not be able to perform the method. Applicant argues that a skilled artisan with the parameters of reducing agent cysteine, a concentration and aerobic mixture would be employable to achieve the method, however, the claims teach the re-oxidization of the secukinumab molecules without disclosing the oxidizing agent and an aerobic mixture without reciting the specific aerobic conditions
B) Applicant argues that the specification is replete with broad and specific teaching that demonstrate the claims invention. Different working examples tested different parameters, such as concentrations, pH, temperatures, time, reaction mix, etc. Therefore, again, it is unclear what combination of the parameters would result in the specific secukinumab composition as required by the claims; and undue experimentation would be required of the skilled artisan to make the claimed invention.
MPEP 2164.08c states:
A feature which is taught as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112. See In re Mayhew, 527 F.2d 1229, 1233, 188 USPQ 356, 358 (CCPA 1976). In determining whether an unclaimed feature is critical, the entire disclosure must be considered. Features which are merely preferred are not to be considered critical. In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976).
Therefore, the rejection is maintained.
Conclusion
7. No claims are allowed
8. 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 Syed J Abbas whose telephone number is (571)272-0015. The
examiner can normally be reached M-Th, 9:00AM-4:00PM.
Application/Control Number: 18/140,535
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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