Patent Application 18921679 - METHODS OF ACHIEVING SAFE AND SUSTAINED CONTROL - Rejection

Patent Application 18921679 - METHODS OF ACHIEVING SAFE AND SUSTAINED CONTROL

Title: METHODS OF ACHIEVING SAFE AND SUSTAINED CONTROL OF IL-17-DEPENDENT CONDITIONS IN SUBJECTS RESPONSIVE TO TREATMENT WITH AN ANTI-IL 17A/F NANOBODY

Application Information

• Invention Title: METHODS OF ACHIEVING SAFE AND SUSTAINED CONTROL OF IL-17-DEPENDENT CONDITIONS IN SUBJECTS RESPONSIVE TO TREATMENT WITH AN ANTI-IL 17A/F NANOBODY
• Application Number: 18921679
• Submission Date: 2025-04-08T00:00:00.000Z
• Effective Filing Date: 2024-10-21T00:00:00.000Z
• Filing Date: 2024-10-21T00:00:00.000Z
• Examiner Employee Number: 78243
• Art Unit: 1674
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 1
• 103 Rejections: 0

Cited Patents

No patents were cited in this rejection.

Office Action Text

    DETAILED OFFICE ACTION

The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 

Applicant's species elections without traverse of A3 (the regimen of claim 24), and B1 (dermatological condition) filed on 14 March 2025 are acknowledged.  

Applicant’s amendment filed on 14 March 2025 is acknowledged and entered.  Following the amendment, claims 4, 6, 9, 15, 19 and 20 are canceled, claims 5, 10, 14, 17, 24 and 25 are amended, and the new claims 41-49 are added.    
Currently, claims 1-3, 5, 7, 8, 10-14, 16-18, 21-25 and 41-49 are pending, and claims 24, 25 and 41-49 are under consideration. Claims 1-3, 5, 7, 8, 10-14, 16-18, 21-23 are withdrawn from further consideration as being drawn to a non-elected species. 

Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 1/21/2025 is acknowledged and has been considered.  A signed copy is attached hereto.

Priority acknowledgement
This application claims benefit of PCT/IB2023/054122 filed 04/21/2023, which claims priority from U.S. provisional application 63/333,920 filed 04/22/2022, which is acknowledged.  

Claims
Claims 41, 42, 46 and 47 are objected to for the following informalities, appropriate correction is required for each item:
Claim 41 recites “which is a method for treating psoriasis (...), atopic dermatitis, ..., or pyoderma gangrenosum”; the following is suggested: “wherein the IL-17-dependent dermatological condition is selected from the group consisting of psoriasis, atopic dermatitis, ..., and pyoderma gangrenosum”.  
Claim 42 recites “wherein the nanobody comprises sonelokimab”; the following is suggested: “wherein the nanobody is sonelokimab.”
Claim 46 recites “which is a method for treating psoriasis”; the following is suggested: “wherein the IL-17-dependent dermatological condition is psoriasis”.
Claim 47 recites “wherein treatment is withdrawn after ...”; the following is suggested: “wherein the nanobody treatment is withdrawn after ...”.

Rejections under 35 U.S.C. §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. 

Claims 24, 25 and 41-49 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 pre-AIA  the applicant regards as the invention.
Claim 24 is indefinite for the recitation “at a dose of 30 - 240 mg every two to four weeks continuously for more than 24 weeks to achieve full skin clearance followed by withdrawal ...” because of the following reasons: “to achieve full skin clearance” represents the treatment result or efficacy after the treatment, thus, it is unclear how a patient can be selected prior to the treatment in order for the patient to achieve such a result after the treatment.  Treatment result or efficacy cannot be predicted or demanded as it is out of anyone’s control once the therapeutic agents are administered; for example, what if a patient is never be able to achieve said full skin clearance after more than 24 weeks of treatment?  The metes and bounds of the claim, therefore, cannot be determined.  Claims 25, 44 and 45 are similarly indefinite.
Claim 25 is further indefinite for the recitation “achieves a complete clearance of the disease in 40% or more of subjects still exhibiting symptoms of ... at week 24 of treatment” 
because it is unclear what it is meant; for example, does it mean that the subjects being treated achieve a complete clearance while still exhibiting symptoms or something else?  The metes and bounds of the claim, therefore, cannot be determined.
Claim 41 is indefinite for the recitation “which is a method for treating psoriasis (including but not limited to plaque psoriasis, moderate-to-severe plaque psoriasis, ...), atopic dermatitis, ...” because it is unclear 1) whether “including but not limited to plaque psoriasis, ...” in the parentheses is a part of the limitations of the claim; and 2) if so, how is “including but not limited to ...” supposed to define the scope of the claim.  The metes and bounds of the claim, therefore, cannot be determined.  Deleting “(including but not limited to plaque psoriasis, moderate-to-severe plaque psoriasis, ...)” is suggested.  
Claim 47 is indefinite for the recitation “wherein treatment is withdrawn after the subject reaches a PASI score of 75-100 or an IGA score of 0 or 1” because it is unclear whether “a PASI score of 75-100 or an IGA score of 0 or 1” is the same as “achieve full skin clearance” as recited in claim 24, from which claim 47 is indirectly dependent.  The claim is further indefinite for the following reason: 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 47 recites the broad recitation “a PASI score of 75” (for example), and the claim also recites (from claim 24) “achieve full skin clearance”, which is the narrower statement of the range/limitation (PASI 100?). The claim is 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.  
Claim 48 is indefinite for the recitation “wherein withdrawal of treatment with the nanobody is for a period of 4 weeks or more” because it is unclear what the upper limit is for “4 weeks or more”, i.e., could it be forever, or the treatment would resume at some point?  The metes and bounds of the claim, therefore, cannot be determined.  
Claim 49 is similarly indefinite for the recitation “wherein withdrawal of treatment with the nanobody is for a period of 4 to 20 weeks” because it is unclear whether such indicates that the treatment would resume after the withdrawal period (even if “full skin clearance” (claim 24) remains)?
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.

The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 
Claims 24, 25, 41 and 43-49 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 pre-AIA  the inventor(s), at the time the application was filed, had possession of the claimed invention.  
Claims 24, 25, 41 and 43-49 are directed to a method of treating an IL-17-dependent dermatological condition with a nanobody that binds to an IL17A/A homodimer, an IL17-A/F heterodimer, and/or an IL-17F/F homodimer (claim 24, for example), which nanobody reads on any or all nanobodies meeting the functional limitation of the claims.  Thus, the claims encompass a very broad genus of the nanobody as there is no structural limitation associated with the nanobody.  However, the specification merely discloses one nanobody that binds to an IL17A/A, an IL17-A/F, and/or an IL-17F/F, i.e., sonelokimab (SEQ ID NO: 1); and no other nanobody meeting the limitations of the claims is ever identified or particularly described in the specification.  
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement."  “[A]pplicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.  The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.)  The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991). 
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus.  Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.  In the instant case, only one nanobody, sonelokimab (SEQ ID NO: 1), is disclosed in the specification, i.e., only one species disclosed for the claimed broad genus of “a nanobody”.  Given the fact that the structures of monoclonal antibodies or nanobodies differ each from each other, especially in the CDR regions, there is no way to predict the sequence structure of any other nanobody based on that of sonelokimab (i.e., SEQ ID NO:1) and the functional limitation.  
Thus, with the exception of sonelokimab of SEQ ID NO: 1, one of skill in the art cannot "visualize or recognize" the members of the claimed genus.  "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly,119 at 1568.  Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. Accordingly, the specification does not provide adequate written description of the claimed broad genus of the nanobody.  Due to the limited species disclosed (one) that meets the limitations of the claims; the extremely broad breadth of the claimed genus, and the lack of structural limitation and lack of predictability for the structures of the encompassed nanobodies, one skilled in the art would not conclude that the applicant was in possession of the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it.  The compound itself is required.  See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.  One cannot describe what one has not conceived.  See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.  
Therefore, only the nanobody sonelokimab (SEQ ID NO:1), but not the full breadth of the claims (“a nanobody which specifically binds to an IL17A/A, an IL17-A/F, and/or an IL-17F/F”) meets the written description provision of 35 U.S.C. §112, first paragraph.  Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). 

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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 47 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.    
Claim 47 recites “wherein treatment is withdrawn after the subject reaches a PASI score of 75-100 or an IGA score of 0 or 1”, which PASI 75 (for example) is not considered “achiev[ing] full skin clearance” as recited in claim 24, from which claim 47 is indirectly dependent.  As such, claim 47 fails to include all the limitations of the claim upon which it depends.  
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.

Rejections Over Prior Art:
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 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. 

Claim interpretation: As the claims are indefinite for the reasons above, they are interpreted as the following (for the purpose of the prior art rejection set forth below): claim 24: the limitation “to achieve full skin clearance followed by withdrawal of treatment with the nanobody” is not given patentable weight since such efficacy cannot be predicted, hence, such patients cannot be pre-selected; claim 25: is treated like claim 24 because it is unclear what it is meant; claim 47: is treated like claim 24 as it fails further limiting claim 24; and claims 48 and 49: the additional limitations recited are not given patentable weight because they are indefinite and not meaningful (see above rejection under 35 U.S.C. 112(b)). 
 
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.

Claims 24, 25 and 41-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT03384745 (v1, 12/27/2017).
Clinical Trial NCT03384745 discloses a phase 2b study of the efficacy, safety, and tolerability of M1095 (sonelokimab) in subjects with moderate to severe psoriasis, wherein six arms were tested, including: the subjects received 30 mg subcutaneous injections at Week 0, 2, 4, 8, 12 and q4w (Arm 2); or 60 mg subcutaneous injections at Week 0, 2, 4, 8, 12 and q4w (Arm 3); or 120 mg subcutaneous injections at Week 0, 2, 4, 6, 8, 10, 12 and q4w (Arm 5) (2nd – 3rd pages, under “Arms and Interventions”).  These regimens meet the limitations of claims 24, 25 and 41-43 and 46-49.  Therefore, the reference anticipates the claims.  With respect to the limitations in claims 44 and 45, they represent the efficacy or result of the treatment, thus, would be inherent properties of the method of treatment taught by the prior art reference.  Therefore, the reference also anticipates claims 44 and 45.

Conclusion:
No claim is allowed.


Advisory Information:	
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872.  The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM.  If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857.  The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.

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/DONG JIANG/
Primary Examiner, Art Unit 1674
3/28/25