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 .
Claim Status
Applicant’s preliminary amendments and remarks, filed 11/20/2022, are acknowledged.
Claims 2-12, 27-35, 37-60 and 62-99 are canceled.
Claim 61 is amended.
Claims 1, 13-26, 36, and 61 are pending.
DETAILED ACTION
Election/Restrictions
Applicant’s group election without traverse of Group III, claim 26, drawn to a monoclonal antibody or fragment thereof in the reply filed on 03/31/2025 is acknowledged.
Applicant’s species election without traverse of clone 1.11D in the reply filed on 03/31/2025 is acknowledged.
Examiner has determined that Applicant’s species election is free of the prior art. As such, examiner extended the search to include all nonelected species. The nonelected species are also found free of the prior art.
Because the antibody species of claim 26 are free of the prior art, claims 1, 13-25, 36, and 61, previously withdrawn from consideration as a result of a restriction requirement, are rejoined. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions Groups I-IV, as set forth in the Office action mailed on 02/26/2025, is hereby withdrawn and claims 1, 13-25, 36, and 61 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
As such, claims 1, 13-26, 36, and 61 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/09/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, the 9-page and 15-page information disclosure statements fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Particularly, NPL 14 of the 9-page IDS and NPL 24 of the 15-page IDS have not been placed in the application file, thus the information referred to therein has not been considered.
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.
Drawings
The drawings are objected to because FIG.2 and FIG. 3 recite “Inhibitor Cncentration” which should read “Inhibitor Concentration”. 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.
The drawings are objected to because there is a period (.) after “FIG. 12” that should be removed. 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 - 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.
Additionally, Specific deficiency – Nucleotide and/or amino acid sequences appearing in claim 21 (e.g., LALA) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Page 108, last paragraph: “Freestyleä” should read “Freestyle™”.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 103-104 and 106). 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.
The use of the term Mycograb™, Xenomouse™, DOCK-AND-LOCK™, DNL™, Herceptin®, Genentech, Roche, Cremophor EL™, Tet-On Advanced™, Tet-On 3G™, MAXCYTE® VLX™, WINNONLIN, Tween 20™, Ambion RNAqueous, Freestyle™, Thermo Fisher Scientific, ForteBio, GE, Amicon, Sigma, Bio-Rad, Octet, Invitrogen, New England Biolabs, NCBI, Genscript, CellLytic B™, ForteBio BLITz, ATCC, and Fuconazole™, 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.
Claim Objections
Claim 20 is objected to because of the following informalities: the phrase “scFv (single chain fragment variable)” should be amended to read “single chain fragment variable (scFv)”. 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 1, 13-26, 36, and 61 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 1, 13-19, 26, and 36 recite the language “clone-paired heavy and light chain CDR sequences”. The term “clone-paired” renders the claims indefinite. It is unclear if the pairing is only for the CDR sequences for the specific heavy or light chain, or if all CDR sequences for the clone must be selected together.
Claims 1, 13-19, 26, and 36 recite the language “wherein the heavy chain or light chain … sequences are selected from Table XX”, or similar language. This limitation incorporates tables in the claims which makes the claims incomplete because the claims can be written reciting the sequences disclosed within these tables. MPEP2173.05(s) states:
Where possible, claims are to be complete in themselves. Incorporation by reference “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).
As such claims 1, 13-19, 26, and 36 (and the dependent claims) are rejected.
The term “reducing” in claim 13 is a relative term which renders the claim indefinite. The term “reducing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification nor the claims provide method steps that one of skill in the art would have to perform in order to reduce the likelihood of infection. As such, claim 13 and its dependent claims are rejected.
Additionally, claim 13 recites “reducing likelihood of infection”. This renders the claim indefinite because one cannot prevent infection as candida would inherently have to cross into or otherwise touch the body to encounter the antibody, meaning that the person would be infected. The fact that the antibody would have to contact the candida on or in the body means that the antibody is not preventing infection. As such, claim 13 and its dependent claims are rejected.
Claim 14-19 recite the phrase “light and heavy chain variable nucleotide sequences” or “light chain variable sequence and a heavy chain variable sequence”. It is unclear what is required by the term “variable”. The term could refer to a variable region, or could refer to variability within the sequence. Therefore the term “variable” renders the claims indefinite.
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, claims 15 and 18 recite the broad recitation “having at least…70%”, and the claims also recite “80%, or 90%” which is the narrower statement of the range/limitation. The claim(s) are 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.
The terms “alter”, “enhance”, and “increase” in claim 21 are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In claim 21, the phrase “GASD/ALIE” renders the claim indefinite. The slash mark renders the term indefinite. It is unclear if both sequences must be present, or if the slash mark indicates alternatives.
In claim 21, the phrase “LALA, N297, GASD/ALIE, YTE or LS mutation” renders the claim indefinite. It is unclear if the sequences and locations listed are being mutated to contain a different sequence than those shown, or if they represent the already mutated form. Further, it is unclear at what positions the mutations must occur, because there is no comparison to a parent sequence.
In claim 21, the term “cell line engineered with a defined glycosylating pattern” renders the claim indefinite for at least two reasons. First, a cell line is not “engineered with a… glycosylating pattern”. It is unclear what is meant by this phrase. Second, the term “defined” is a relative term which renders the claim indefinite. The term “defined” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 21 recites “eliminate or enhance” within parentheticals. It is not clear if the language recited in the parentheses is limiting, or if it is only exemplary.
Regarding claim 21, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 25, the term “genetic delivery with an RNA or DNA sequence” renders the claim indefinite. The term is not standard in the art, and is not defined by the specification. It is unclear if the “genetic delivery” indicates mutation of existing genes or administration of exogenous nucleic acids that are expressed in the subject.
Claim 36 is drawn to a hybridoma or engineered cell encoding an antibody or antibody fragment, wherein the antibody or antibody fragment comprises clone-paired heavy and light chain CDR sequences, wherein the heavy chain CDR sequences are selected from Table 3, and the light chain CDR sequences are selected from Table 4. This claim is indefinite because cells do not encode for proteins. Furthermore, the claim recites a product (i.e., a hybridoma or engineered cell) and a method (i.e., “encoding”) in the same claim. As such, it is unclear if Applicant is claiming a product or the method of producing the product.
The term “protects” in claim 61 is a relative term which renders the claim indefinite. The term “protects” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification nor the claims provide a standard or definition for one of skill in the art to understand what is encompassed by the term. As such, claim 61 is rejected.
Claim Rejections - 35 USC § 112(a) Enablement
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 13-25 and 61 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 treating candidiasis with antibodies 1.10C and 1.11D, does not reasonably provide enablement for reducing the likelihood of infection of a subject at risk of contracting Candida. 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.
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.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.
261, 270 (1916) which postured the question: is the experimentation needed to practice the
invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858
F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does
not use the term "undue experimentation," it has been interpreted to require that the claimed
invention be enabled so that any person skilled in the art can make and use the invention without
undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence
to support a determination that a disclosure does not satisfy the enablement requirement and whether
any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content
of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant for this rejection are: (A) the breadth of the claims; (B) the nature of the invention; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention
is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is
commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one
skilled in the art could make and use the entire scope of the claimed invention without undue
experimentation.
The nature of the invention is a method of treating a subject infected with Candida or reducing the likelihood of infection of a subject at risk of contracting Candida comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises clone-paired heavy and light chain CDR sequences, wherein the heavy chain CDR sequences are selected from Table 3, and the light chain CDR sequences are selected from Table 4. Therefore, the nature of the invention is a biochemical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the functionality of the claimed method, with a reasonable expectation of success, because it would not be predictable from the disclosure of any one particular species may or may not work; see MPEP § 2164.03. Particularly, it is unpredictable that the claimed antibodies or antibody fragments would reduce the likelihood or prevent Candida infection.
In regard to Wands factors (C), (D), and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a). The claims encompass reducing the likelihood (or preventing) of infection of a subject at risk of contracting Candida. However, as stated above, one cannot prevent infection as candida would inherently have to cross into or otherwise touch the body to encounter the antibody, meaning that the person would be infected. The administration can increase an immune response, but the fact that the antibody would have to contact the candida on or in the body means that the antibody is not preventing infection. According to the CDC, candidiasis occurs when Candida, a yeast that lives in parts of the body, grows out of control (see attachment). While the CDC has a webpage titled “Preventing Candidiasis”, because candida is inherently in the body, candida infections cannot be prevented. Further, the tips for “prevention” provided by the CDC are more so measures that reduce the spread or severity of the candida infection and not the prevention of the infection itself. Even medications used to treat candida infections may increase the risk of candidiasis. Thus, it is unpredictable that any given medication can prevent the risk of candida infections.
Additionally, with respect to the claimed antibodies, the art teaches the unpredictability of antibody-based immunotherapy. Christiansen et al (Mol Cancer Ther, 2004, 3:1493-1501) teach numerous factors that inhibit successful therapeutic application of antibodies including low or heterogeneous expression of target antigens by tumor cells, high background expression of target antigen on normal cells, host antibody immune responses to the antibodies themselves, insufficient antitumor response after antibody binding, as well as significant physical barriers preventing antibody binding or delivery to a solid tumor mass, including the vascular endothelium, stromal barriers, high interstitial pressure, and epithelial barriers (abstract; p. 1493, col. 2; p. 1496, col. 1, last paragraph through p. 1498, col. 2). Topp et al (Journal of Controlled Release, 1998, 53:15-23) also teach the complications and unpredictability involved with treating tumors using antibody therapy. Topp et al teach that there are several barriers to successful delivery of antibody drugs to extravascular sites of action within target tissues: the antibody drugs must be absorbed into the blood stream, carried by the circulatory system to the capillaries in the target tissue, cross the capillary endothelial cells and the underlying basement membrane that supports the capillary structure and penetrate through the matrix of cells and extracellular components that comprises the tissue itself, bind to the cell surface receptor, initiate endocytosis, encounter possible drug degradation and drug release. Additional connective tissue barriers may also be encountered (p. 15, both columns; Figure 1). While some antibody drugs have been shown to be effective in vitro the results of clinical trials have been disappointing. The inability of the antibodies to penetrate the tumor mass could be a cause of this lack of clinical efficacy. Topp et al cautions against extrapolating in vitro results to in vivo therapy stating that the cell culture system has some limitations including a lack of well-developed extracellular matrix (“stroma”) that is present in many tumors. Normal components of tumor stroma include collagen, fibronectin and glycosaminoglycans (p. 21, col. 2).
While the art is drawn to treating cancers, the same logic can be made with respect to administering antibodies for candida infections. There are various factors such as challenges with fungal cell wall inhibition (see Hani et al, Infectious Disorders - Drug Targets, 2015, Vol. 15, No. 1: 42-52), high background expression of target antigen on normal cells or host antibody immune responses to the antibodies themselves as described by Christiansen et al, or the several other barriers regarding successful delivery of antibody drugs to extravascular sites of action within target tissues as described by Topp et al that one of skill must consider to determine the function of an antibody. One of skill in the art would be subjected to undue experimentation to determine that the claimed antibodies or antigen binding fragments can reduce the likelihood of a subject contracting a candida infection.
In regard to Wands factors (F), (G) and (H), the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech
Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004).
The claims are drawn to a method of treating a subject infected with Candida or reducing the likelihood of infection of a subject at risk of contracting Candida comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises clone-paired heavy and light chain CDR sequences, wherein the heavy chain CDR sequences are selected from Table 3, and the light chain CDR sequences are selected from Table 4.
The working examples provided by Applicant do not demonstrate a method of reducing the likelihood of infection of a subject at risk of contracting Candida. Applicant demonstrates that anti-peptide antibodies 1.10C and 1.11D protect mice from death by C. albicans in the C57B/L6 mouse disseminated candidiasis model (see Fig. 8), and a single dose of 1.10C provided better protection than the standard of care anti-fungal fluconazole (see Example 5). In addition, 1.11D demonstrated a clear dose response (Fig. 8), and a cocktail containing both antibodies provided complete protection (see pg. 103). However, the specification fails to provide support that the claimed antibodies can reduce the likelihood (or prevent) of infection of a subject at risk of contracting Candida. Thus, in the absence of empirical determination, one skilled in the art would be subjected to undue experimentation to determine if the claimed method of administering the claimed antibodies would result in reducing the likelihood of infection at risk of contracting Candida as recited in the claims.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. 112 first paragraph.
Allowable Subject Matter
The sequences recited in claim 26 appear to be free of the art. The closest prior art is Williamson et al (US 2011/0189183 A1; publication date: 08/04/2011; previously submitted with the restriction requirement mailed 02/26/2025). While Williamson et al does not disclose the CDR sequences, Williamson et al disclose of antibodies that immunospecifically bind to species of the genus Candida and methods of prevention, treatment and diagnosis of Candida infection and/or treatment of one or more symptoms of Candida infection (see Abstract). Williamson et al disclose that the heavy chain and light chain sequences are domain-exchanged (see [0011]-[0019], and claims 1-2 and 13). Williamson et al define “domain-exchanged” as an antibody fragment that contains two copies each of a light chain and heavy chain, which are folded in the domain-exchanged configuration, where each heavy chain variable region pairs with the opposite light chain variable region compared to a conventional antibody, and an interface is formed between adjacently positioned VH domains (i.e., clone-pairs) (see [0123]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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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.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674