Prosecution Insights
Last updated: April 19, 2026
Application No. 18/026,546

POTENT BINDING AGENTS FOR ACTIVATION OF THE HEDGEHOG SIGNALING PATHWAY

Non-Final OA §112
Filed
Mar 15, 2023
Examiner
SAOUD, CHRISTINE J
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Board Of Trustees Of The Leland Stanford Junior University
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
96%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allow Rate
433 granted / 748 resolved
-2.1% vs TC avg
Strong +38% interview lift
Without
With
+37.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
39 currently pending
Career history
787
Total Applications
across all art units

Statute-Specific Performance

§101
6.0%
-34.0% vs TC avg
§103
19.6%
-20.4% vs TC avg
§102
13.7%
-26.3% vs TC avg
§112
41.0%
+1.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 748 resolved cases

Office Action

§112
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 . Election/Restrictions Applicant’s election without traverse of Group I in the reply filed on 14 November 2025 is acknowledged. Claims 13-15 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 14 November 2025. While Applicant elected without traverse, Applicant insists that if search and examination of an entire application can be made without serious burden, the examiner must examine the entire application on the merits, citing MPEP §803. Applicant’s statement is noted, but Applicant is also reminded that the claims were found to lack unity of invention and burden is not a consideration when the claims are restricted according to 371 practice. As was pointed out in the Lack of Unity mailed on 18 September 2025, rejoinder of process claims may be possible if claims directed to the product are subsequently found allowable if the withdrawn process claims include all the limitations of an allowable product claim. Any consideration of rejoinder is premature at this point in prosecution. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The information disclosure statement (IDS) submitted on 15 March 2023, 02 January 2025 and 14 November 2025 have been considered by the examiner. It is noted that citation No. 1 on the IDS filed 14 November 2025 does not appear to be correct and therefore, it has been lined through. When citing a document which has been retrieved from the internet, MPEP §707.05(e) provides examples on listing documents retrieved from the internet. The citation which is provided indicates that Zhang et al. are the authors, but the document only lists Zhang as the author. Additionally, for electronic documents, the website address should be provided. The reference will be initialed once the citation has been correctly provided. It is additionally noted that citation No. 4 on the IDS filed 14 November 2025 does not appear to be complete as the document was obtained from the internet and the citation is not complete. Additionally, there is text at the top of the document which is obscured by the added text which was printed on it. This text at the top has information regarding the internet location, copyright holder and peer review information – this text should be visible as it is important for assessing the document. Drawings The drawings are objected to for the following reasons: The drawings do not comply with 37 CFR 1.84(a)(1) which requires India ink, or its equivalent that secures solid black lines be used for drawings. Several figures include gray text (see Figure 1A) or dotted lines (see Figure 1E) or gray hatching (see Figure 2B and 2C), to name a few. The gray shading is not compliant and results in unclear figures. The drawings do not comply with 37 CFR 1.84(a)(2). Based on the disclosure in the specification (paragraph [0018]), Figure 2 contains color or at least references color. If Figure 2 is meant to be shown in color, a petition for color photographs is required. In the absence of a color photograph, the drawing does not show the details which are described and is therefore, objected to for lack of clarity. The drawings do not comply with 37 CFR 1.84(b). Photographs are not ordinarily permitted but will be accepted if photographs are the only practicable medium for illustrating the claimed invention. However, the photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. Figures 4C, 4E, 5G, 6A-6D and 10 do not meet this requirement. The drawings do not comply with 37 CFR 1.84(u)(1). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.”. Figure 1 is presented on several sheets. While the partial views are identified by a capital letter, the partial views do not include the number of the figure and the second sheet of Figure 1 views is labeled as “FIG. 1(Cont.)” which is not compliant. None of the figures is compliant with 37 CFR 1.84(u)(1) as none of the partial views includes both the figure number followed by a capital letter. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Page 12, paragraph [0047]) of the specification contains amino acid sequences which do not have sequence identifiers associated with them (lines 12 and 15-19). Applicant should note that notation such as Gly9 and Glu9 are considered amino acid sequence with a length of 9 amino acids and therefore, are included in sequences which must be identified by a sequence identifier. Any amino acid sequence of at least 4 amino acids must be identified by a sequence identifier. If the sequences are not present in the Sequence Listing, a new Sequence Listing and CRF will be required in addition to a substitute specification, adding the identifiers to the specification. Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. The incorporation statement in paragraph [0003] is not compliant because the file size does not match the size of the file which was submitted to the PTO. The file size appears to be 38,223 bytes (see screenshot provided below). PNG media_image1.png 77 889 media_image1.png Greyscale Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Specification The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Specifically, the invention appears to be directed to an antigen-binding domain that binds Patched1 and not generically “potent binding agents” as currently drafted. The disclosure is objected to because of the following informalities: the specification does not comply with 37 CFR 1.52(a)(1)(iv-v). The text of the specification is not plainly and legibly written in permanent dark ink or its equivalent. The text at various locations in the specification is fuzzy and does not appear to be solid, black text. Upon magnification, the text is clearly pixilated which results in the lines of the text appearing fuzzy and not reproducible in a consistent manner, resulting in errors upon reproduction. See screenshot below: PNG media_image2.png 155 649 media_image2.png Greyscale The text has been magnified, but upon magnification, the lack of solid text is seen, which accounts for the “fuzzy” nature of the text and the reason for errors being introduced upon OCR of the text in certain sections. As a substitute specification is already required in order to comply with the Sequence rules (see objection above with regard to the Sequence disclosures), Applicant should make sure that the text of the substitute specification is in a black font to assure that the text will be composed of solid black lines which should obviate the above objection. The table at page 40 is not readable and correction is required. See screenshot below: PNG media_image3.png 345 510 media_image3.png Greyscale Appropriate correction is required. Claim Objections Claim 1 is objected to because of the following informalities: claim 1 contains the abbreviation “PTCH1” with no explanation as to the meaning of the abbreviation. It is common practice to spell out all terms at the first usage because some abbreviations may have different meanings depending on context and art area. Claims 2, 7, 9, 10 and 11 are objected to because of the following informalities: the claims all refer to various proteins as sequences. Claim 2 recites “wherein the ABD is a single variable region sequence”. Claim 7 refers to “a human Fc sequence”. Claim 9 recites “collagen binding sequence” and “linker sequence”. Claim 11 recites “cilia localization sequence”. However, the claims are directed to polypeptides and a polypeptide is not a “sequence”. Rather, a polypeptide may comprise an amino acid sequence, but the “sequence” is not the polypeptide. It is also noted that a “linker” may be a peptide or it could also be a chemical moiety. If the claims are intending a peptide linker, the terminology of “peptide linker” is suggested. Claim 5 is objected to because of the following informalities: the claim is not compliant with 37 CFR 1.52 (a)(1)(iv-v) as the text is not in solid black ink. Claims 5, 6, 10 and 12 all refer to an amino acid sequence by means of the Sequence identifier (which is required) and then additionally reproduce the amino acid sequence which is represented by the Sequence identifier. This is redundant and unnecessary. It is suggested that the amino acid sequence only be referenced by the Sequence identifier as this is what is required and reproduction of the amino acid sequence can result in errors being unnecessarily introduced into the claims. Appropriate correction is required. 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. Claims 1-5, 7-12 and 16-17 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. The instant claims are directed to a polypeptide comprising an antigen-binding domain that preferentially binds to and stabilizes a specific human PTCH1 conformation, which activates the Hedgehog signaling pathway. Claim 2 indicates that the binding domain is a single variable region sequence. Claim 3, indicates that the binding domain is a nanobody. Claim 4 indicates that the binding domain comprises the amino acid sequence of SEQ ID NO:10, “or a variant thereof”. Claim 5 states that the polypeptide comprises the amino acid sequence of SEQ ID NO:24 which has 5 variable positions which have up to 5 different amino acids being substituted at the recited positions. The specification discloses screening a yeast display library for nanobody clones that preferentially bound a PTCH1 mutant with NNQ substitutions compared to wild-type PTCH1. Affinity maturation was used to obtain clones derived from clone 23 (having the amino acid sequence of SEQ ID NO:10) which had substitutions at H105R and G106R in CDR3 as well as several variant residues at G50 in CDR2 (see [00114]). Only the G50T substitution (named T23) could be expressed and it was used for a second round of affinity maturation. A variant, named TI23 (SEQ ID NO:23) was obtained which had substitutions Y102I and T77N. TI23 strongly activates human Hedgehog pathway targets. The rest of the specification focuses on the functionality of TI23. The structures of the polypeptides comprising an antigen-binding domain as claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill USPQ2d 1780 (Fed. Cir. 2014) AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus. The decision states, “When a patent claims a genus using functional language to define a desired result, ‘the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’ Id. at 1349. We have held that 'a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or 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.’ Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus.” In the instant application, while a nanobody that binds a mutant PTCH1 protein and which activates Hedgehog signaling pathway has been obtained (SEQ ID NO:10 and SEQ ID NO:23), these antibodies have not been described in a way to support a generic claim to any/all antigen binding domains that preferentially bind to and stabilize a specific human PTCH1 conformation and which activate the Hedgehog signaling pathway. The disclosure of a single species (SEQ ID NO:10 and mutated form of SEQ ID NO:23) rarely is sufficient to provide support for a genus especially in light of a lack of disclosure of structure or disclosure of a correlation between structure and function. The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and ... cover any compound later actually invented and determined to fall within the claim's functional boundaries.”). In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification fails to exemplify a genus of antigen-binding domains that have the recited functions of claim 1. The specification does not provide any structural features of the claimed antibodies outside of SEQ ID NO:10 and 23. No reasonable structure-function correlation has been established that is commensurate in scope with the claims as no structural elements have been disclosed. The specification does not describe representative examples to support the full scope of the claims. Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.” Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genera of antigen-binding domains that preferentially bind to and stabilize “a specific human PTCH1 conformation” and which activate the Hedgehog signaling pathway. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of an antigen-binding domain which has the functionality as claimed does not distinguish a particular antigen-binding domain from any other antigen-binding domain and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406). Claim 5 recites an amino acid sequence with 5 variable positions. However, the recited formula does not find support in the instant specification. The specification discloses a nanobody which has the amino acid sequence of SEQ ID NO:10 and a nanobody which has the amino acid sequence of SEQ ID NO:23 which have the functionality required by claim 1. There is no teaching or disclosure of how the 5 variable positions in SEQ ID NO:24 can be altered and combined to arrive at an antigen-binding domain that has the functionality of claim 1. In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus, which are antibodies or fragments which have the recited characteristics pointed out above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116). 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(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 1-2 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. Claim 1 recites “a specific human PTCH1 conformation”. However, the metes and bounds of what is encompassed by this recitation is unclear and therefore the metes and bounds of the claim are indefinite. Claim 2 recites “wherein the ABD is a single variable region sequence”. The recitation of “single variable region sequence” is indefinite because the metes and bounds of such are unclear and indefinite. “Single variable region” is not the standard terminology for denoting a portion of an antigen-binding domain. It is not clear if the terminology is meant to refer to a single chain variable region of an immunoglobulin or that the antigen-binding domain is a single-domain variable region or that the antigen-binding domain is a single-domain antibody fragment (i.e. nanobody). Additionally, “single variable region” may also be referring to a single CDR of an antigen-binding domain but because the terminology is unique, the metes and bounds of what is being claimed is unclear and indefinite. 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. Claims 16 and 17 are 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 16 is directed to a pharmaceutical formulation comprising a polypeptide of claim 1. Claim 16 does not further limit the subject matter of claim 1 as the only component recited in the “formulation” is the polypeptide of claim 1. Claim 17 is directed to the pharmaceutical formulation of claim 16 “in a unit dose formula”. However, this recitation does not limit the subject matter of claim 16 as the composition is identical. Indicating that the compound is in a particular amount is not limiting of the claim from 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. Allowable Subject Matter Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm. 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, vanessa ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Christine J Saoud/Primary Examiner, Art Unit 1645
Read full office action

Prosecution Timeline

Mar 15, 2023
Application Filed
Jan 07, 2026
Non-Final Rejection — §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
96%
With Interview (+37.8%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 748 resolved cases by this examiner. Grant probability derived from career allow rate.

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