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 amendments and remarks, filed 10/06/2025, are acknowledged.
Claims 2-12, 15, 18, 27-35, 37-60, and 62-99 are canceled.
Claims 1, 13, 14, 16, 17, 19-21, 25, 26, 36, and 61 are amended.
Claims 1, 13, 14, 16, 17, 19-26, 36, and 61 are pending.
As such, claims 1, 13, 14, 16, 17, 19-26, 36, and 61 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2025 is 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.
Withdrawn Objections
The objections to the drawings are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the drawings on 10/06/2025.
The sequence disclosure objection is withdrawn. The issue regarding the specification missing the incorporation by reference paragraph has been sufficiently addressed through amendments to the specification on 10/06/2025.
The specification objections are withdrawn in part. Issues regarding minor informalities and hyperlinks have been sufficiently addressed through amendments to the specification on 10/06/2025.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 10/06/2025.
Withdrawn Rejections
Applicant’s arguments, see page 15, filed 10/06/2025, with respect to claims 1, 13-26, 36, and 61 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 15 and 18 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
The rejection of claims 13-25 and 61 under 35 USC 112(a) as allegedly being enabled for treating candidiasis with antibodies 1.10C and 1.11D and not reasonably enabling for reducing the likelihood of infection of a subject at risk of contracting Candida is modified in favor of the new limitations added in the amendment filed 10/06/2025. Specifically, Examiner acknowledges that that claims 15 and 18 are canceled thus rendering the rejection moot. Applicant’s arguments, see page 15, filed 10/06/2025, with respect to claims 13-25 and 61 rejected under 35 USC 112(a) have been fully considered.
New Objections Necessitated by Amendment
Claim Objections
Claims 14, 16, 17, and 19 are objected to because of the following informalities:
Claims 14, 16, 17, and 19: “VH” and “VL” are acronyms and/or abbreviations which should be spelled out on first occurrence.
Appropriate correction is required.
New Rejections Necessitated by Amendment
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 14, 16, 17, and 19 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 14, 16, 17, and 19 recite the limitation "the VH and VL" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Maintained Objections and Rejections
Specification
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.
Applicant’s Arguments
Applicant respectfully requests reconsideration and withdrawal of the objections. Applicant indicates that the Examiner objected to the specification of the application because of several alleged informalities; without conceding to the correctness of the Examiner’s position and solely in an effort to expedite prosecution, Applicant respectfully submit amended claims herewith (see page 14 of the Remarks filed on 10/06/2025).
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive. As stated above, the Examiner acknowledges the amendments to the specification addressing the minor informalities and hyperlinks. However, not all trade names or marks recited in the specification have been amended to include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. As such, the specification objection is maintained.
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 24 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 treating the subjects recited in claims 24 and 61. 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 comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises heavy and light chain CDR sequences recited in claim 13 and wherein the subject is a pregnant female, a sexually active female, a female undergoing fertility treatments, or a pregnant female subject infected with Candida. 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 treat the demographic of subjects recited in claims 24 and 61.
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 treating a subject infected with Candida comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises heavy and light chain CDR sequences recited in claim 13 and wherein the subject is a pregnant female, a sexually active female, a female undergoing fertility treatments, or a pregnant female subject infected with Candida. However, according to the CDC candidiasis occurs when Candida, a yeast that lives in parts of the body, grows out of control (previously provided with the Office Action mailed 06/04/2025). 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 treat 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; previously provided with the Office Action mailed 06/04/2025) 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; previously provided with the Office Action mailed 06/04/2025) 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; previously provided with the Office Action mailed 06/04/2025), 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 treat a specific demographic with 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 comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises heavy and light chain CDR sequences recited in claim 13 and wherein the subject is a pregnant female, a sexually active female, a female undergoing fertility treatments, or a pregnant female subject infected with Candida.
The working examples provided by Applicant do not demonstrate a method of treating a pregnant female, a sexually active female, a female undergoing fertility treatments, or a pregnant female subject infected with Candida comprising delivering to said subject an antibody or antibody fragment, wherein the antibody or antibody fragment comprises heavy and light chain CDR sequences recited in claim 13. 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 treated a pregnant female, a sexually active female, a female undergoing fertility treatments, or a pregnant female subject infected with 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 treating 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.
Applicant’s Arguments
Applicant respectfully requests reconsideration and withdrawal of the rejection. Applicant indicates that the Examiner rejected claims 12-25 and 61 because the specification, while being enabled for treating candidiasis with antibodies 1.10C and 1.11D, allegedly does not reasonably provide enablement for reducing the likelihood of infection of a subject at risk of contracting Candida. Without conceding to the correctness of the Examiner’s position and solely in an effort to expedite prosecution, Applicant respectfully submit amended claims herewith (see page 15 of the Remarks filed on 10/06/2025).
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive in part. The Examiner acknowledges the amendments to the claims; specifically, claim 13 was amended to remove the language “or reducing the likelihood of infection of a subject at risk of contracting Candida” and add the specific CDR sequences. As such, the rejection was amended to remove claims 13-23 and 25 to reflect the changes of the claim language. However, the specification fails to provide support that the recited antibodies can treat the specific demographic of subjects recited in claims 24 and 61. As recited in the rejection, there are various factors such as challenges with fungal cell wall inhibition as described by Hani, 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. Thus, one of skill in the art would be subjected to undue experimentation to determine that the claimed antibodies or antigen binding fragments can treat a specific demographic with candida infection. As such, the enablement rejection is maintained.
Allowable Subject Matter
Claims 1, 13, 20-23, 25, 26, and 36 appear to be free of the art. Specifically, the sequences recited in claims 1, 13, 14, 16, 17, 19, 26, and 36 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
Claims 1, 13, 20-23, 25, 26, and 36 are allowable.
Claims 14, 16, 17, 19, 24, and 61 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
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