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 and species of anti-IL-8 antibody which is “STLX18”, represented by sections (a) and (b) of claims 31, 45 and 47, in the reply filed on 04/16/2026 is acknowledged.
Claims 35-44 and claims 47-50 in part are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
In view of the lack of anticipation or obviousness by prior art of claim 31 as it is drawn to species (a) and (b), the search and examination was extended for the remaining species [(c)-(hh)].
Power of Attorney
The Power of Attorney filed 10/14/2025 is of record and is acknowledged.
Specification
ABSTRACT
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Because the Abstract should not refer to speculative applications, it is suggested that “…antibodies would be useful in methods…” be changed to, for example, ‘antibodies are useful in methods’.
DISCLOSURE
The disclosure is objected to because of the following informalities: in [004], line 3, “important regulatory of” should be “important regulator of”. Generally interleukin-8 is represented with a hyphen between “IL” and “8” but not always, e.g., lines 1 and 2 of [0051] and [0052]. When used in claims, there is a hyphen as IL-8. It is suggested one form be used throughout the entire application, either with or without a hyphen, for consistency. In [00330], line 4, it appears “provisional” should be “professional”.
Appropriate correction is required.
The use of the term Thermo Fisher, Sino Biological, Chimerigen and Fortebio ([00257]-[00258]) and R&D Systems and Biolegend ([00263]) and AlivaMab ([00282]), each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is encouraged to review the specification for other occurrences of trade names or marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See end of [00286].
Claim Objections
Claims 33 and 45 are objected to because of the following informalities: In claim 33, “a single chain antibodies” has a singular article and plural noun. In claim 45, the method is “inhibiting tumor growth… in a human in need….” Either “in need” should be deleted or “thereof” should be added after “need” to clarify that the inhibition, etc, is in a human or in a human in need thereof, which in this claim are basically the same thing. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 31, 33, 45, 47 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.
Claims 31, 45 and 47 are indefinite because they refer to CDR sequences “set forth in Table 1F” and then separately list VL and VH CDR sequences, making the claim confusing. MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” This rejection could be obviated by removing the reference to Table 1F.
Claim 33 is indefinite because it depends from claim 31 and is drawn to “The isolated anti-IL-8 antibody of claim 31, wherein said antibody comprises an IgG, an Fv, an scFv, an Fab, an F(ab’)2, a minibody,…” It is unclear if the structures recited in the claim are intended to be in addition to the IL-8-binding antibody of claim 31 or are further defining the structure of the antibody of claim 31. If it is the former, it is suggested a word such as “further” be place before “comprises”; however, if it is the latter, then it is suggested the word “comprising” be replaced with “is”.
Claim Rejections - 35 USC § 112(a)
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.
Claim 33 is 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.
Assuming claim 33 intends that the claimed antibody ‘is’, as opposed to ‘further comprises’, the recited antibody types listed in the claim, then not all the antibody types are supported by written description in the specification. The specification discloses the antibody having the variable heavy chain CDR1-3 and variable light chain CDR1-3 in Table 1F. These antibodies comprising both a variable heavy and light chain region (VH and VL, respectively) meet the written description provision of 35 USC 112, first paragraph. However, the claims are directed to or encompass antibodies that are nanobody, single domain antibody or heavy chain antibodies. None of these antibodies that do not comprise both a heavy and light chain variable region meet the written description provision of 35 USC 112(a).
The specification explains in [00282] that monoclonal antibodies (mAbs) were produced by immunization of AlivaMab® mice, hybridoma fusion and screening for high affinity antibodies. From these, “Recominant human IgG1 antibodies were generated,…” Paragraphs [0282]-[0285] and Tables 1A-1F describe the CDRs and variable heavy and variable light chain regions (VH and VL, respectively) that comprise the CDRs of these antibodies. The antibody of independent claim 31 comprises a VH having HCDR1-3 and a VL having LCDR1-3. There is no disclosure of a nanobody, single domain antibody or heavy chain only antibody as recited in claim 33.
Kunik et al. (Prot. Eng. Design Selection, 26(10):599–609, June 10, 2013) teaches antibodies are able to distinguish different antigen (Ag) epitopes through the differences in an antibody’s amino acid composition and length, where the antigen binding region (ABR) of an antibody corresponds roughly to the six CDRs (p. 599, last paragraph, and p. 600, col. 1, third full paragraph). Further, “Residues within ABRs can contribute to Ag binding either directly, by contacting the Ag, or indirectly by shaping the ABR in a way that allows other reisudes to contact the Ag.” These include residues in the HCDR1-3 and LCDR1-2 (p. 602, col. 2, second full paragraph). Figure 5 shows energetic contributions of ABRs to Ag binding, with all six CDRs showing contributions to Ag binding. On the other hand, single domain antibody structures are distinct from mouse immunization-produced IgG antibodies, with binding relying on a single variable set of three CDRs, usually derived by immunization of camels (Yan et al., J. Transl. Med. 12:343, 2014, p. 2, col. 1, second paragraph). While phage display libraries can be used to identify single domain antibodies binding an antigen, these antibodies do not have LCDRs and are different from the VH of a traditional immunoglobulin comprising HCDR1-3. Making such constructs based on the teaching of the instant specification would require undue experimentation. Even though the three CDRs comprised by each of the VH and VL (e.g., SEQ ID NO:41, 44, 53, 60, 67 and 76, respectively) in order and separated by framework regions are enabled for use as part of a full-length immunoglobulin antibody or antigen-binding fragment thereof, for example a single chain construct (scFv) or Fab, this is not the case for antibody types that do not comprise all six VH/VL CDRs.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly 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 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.” (See Vas-Cath at page 1116).
With the exception of the antibodies comprising both a variable heavy and variable light chain region referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed single domain-containing antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. 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 antibody 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 (Fed. Cir. 1991).
Therefore, only an anti-IL-8 antibody comprising a VH and VL, but not the full breadth of the claim meets the written description provision of 35 U.S.C. § 112(a). 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).
Claims 45-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inhibiting cancer or tumor growth and/or delaying progression thereof in a human in need thereof by administering an effective amount of an antibody comprising a VH and VL with the CDR1-3 sequences of a species of anti-IL-8 antibody as set forth in the claims, does not reasonably provide enablement for prophylaxis or prevention of cancer or a tumor by said antibody or wherein the amount of antibody is not an effective amount. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As defined in the specification in [00173], treating includes curing and prophylactic or preventative measures with respect to a tumor or cancer. The National Cancer Institute (NCI) offers the following information to patients diagnosed with cancer in the section entitled “Understanding the Difference Between Cure and Remission” (NCI, Retrieved online from: <URL:https://www.cancer.gov/about-cancer/diagnosis-staging/prognosis> [retrieved on 07/13/2026], May 29. 2024):
If you remain in complete remission for 5 years or more, some doctors may say that you are cured. Still, some cancer cells can remain in your body for many years after treatment. These cells may cause the cancer to come back one day. For cancers that return, most do so within the first 5 years after treatment. But there is a chance that cancer will come back later. For this reason, doctors cannot say for sure that you are cured. The most they can say is that there are no signs of cancer at this time.
Prevention is different than curing in that in order to be able to prevent a disease such as cancer, one must first be able to anticipate its onset and second be able to maintain administration throughout the duration of susceptibility so it does not occur. The term “preventing” generally carries the meaning of keeping something from happening. There is no guidance for or working example of anticipating the cancer or tumor encompassed by the instant claims, nor how to maintain treatment for the necessary duration to prevent the eventual onset of the cancer or tumor. Vaccines have been shown to be effective to prevent some specific cancers, e.g., Human Papillomavirus vaccine, but this is distinct from the use of antibodies per se for cancer prevention. There is no showing of cure or prevention of cancer in the instant application nor would the skilled artisan based on general knowledge of cancer treatment and in view of the cautions in the art related to “cure” of cancer have a reasonable expectation of preventing or curing cancer by using the instant antibody in the claimed method.
Finally, even for inhibition of growth of a tumor or cancer by administration of the instant antibody, if the amount administered is not an effective amount, then inhibition would not occur. Therefore, in order for any treatment to be enabled, the amount of antibody must be effective for said treatment.
Therefore, while the skilled artisan in the field of cancer treatment could reasonably expect inhibition of tumor or cancer growth using a sufficient effective dose of the claimed antibody, for the reasons discussed above and including the lack of in vivo data related to cancer treatment in the specification, showing in the art that neither cure nor prevention would reasonably have been expected by the skilled artisan at the time the invention was effectively filed, and the complexity of cancer treatment, with multiple receptors and ligands involved in cancer and/or support tumor stromal growth, it would require undue experimentation to practice the claimed method commensurate in scope with the claims.
Allowable Subject Matter
Claim 31 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 32 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
The prior art teaches anti-IL-8 antibodies. However, none anticipate or render obvious the instant antibodies due to differences in at least the HCDR sequences compared to the instant antibodies.
WO 2006/113643 A2, WO 2004/058797 A2 and WO 2019/089472 A1, all cited in the IDS filed 4/16/2026, teach anti-IL-8 blocking or inhibitory antibodies
Bilusic et al. (J. ImmunoTher. Canc. 7:240, 8 pages 2019) teaches a Phase I clinical trial of fully human monoclonal anti-IL-8 antibody HuMax-IL8 for treatment of tumors (Background). A single dose led to 73% of patients (15 total) having stable disease for 4-54 weeks (Results).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached at (571) 272-0857.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Official papers filed by fax should be directed to (571) 273-8300. NOTE: If applicant does submit a paper by fax, the original signed copy should be retained by the applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
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Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
July 14, 2026
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