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 .
Claims 23-41 are pending and are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I claims 23-32 and 36 and the monoclonal antibody species 9F2G5 in the reply filed on 11/5/25 is acknowledged.
The elected monoclonal antibody species 9F25 and the other species 2B10C1, 1D4H5, 2D5F7, 10E7E2, 7C6E8-1, 7C6E8-2, 6H1G8 AND 7H6A2 are free of prior art.
Claims 23-32 and 36 are allowable. Claims 33-35 and 37-41, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I-III, as set forth in the Office action mailed on 8/5/25, is hereby withdrawn and claim 33-35 and 37-41 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Information Disclosure Statement
The information disclosure statement filed 2/19/25 has been considered and an initialed copy is allowed.
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 - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See paragraph 235 for disclosure of the peptide GPV-MI-KK-GPV-P2.
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.
Specification
Please update the status of U.S. Patent Application No. 18/143,046 which is now abandoned and U.S. Patent Application No. 16/722,846 which has been patented as U.S. Patent No. 11,707,511 in the first paragraph of the specification.
In paragraph 224, please update the status of U.S. Patent Application No. 16/722,846 now U.S. Patent No. 9649375.
The use of the term BIACORE (paragraph 184), GENESCRIPT (paragraph 263), and CELLINE (paragraph 265), 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.
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.
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 37-41 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 for treating Candida infection, the method comprising administering to the subject an antibody comprising the CDRS of 2B10C1, the CDRS of 1D4H5, the CDRS of 2D5F7, the CDRS of 10E7E2, the CDRS of 7C6E8-1, the CDRS of 7C6E8-2, the CDRS of 6H1G8 AND the CDRS of 7H6A2 as set forth in claim 23, does not reasonably provide enablement for a method for treating or preventing any other microbial infection including other fungal infections, bacterial infections, viral infections and protozoal infections.. 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
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, the amount of direction provided by the inventor, the existence of working examples, state of the prior art, the level of predictability in the art and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention and Breadth of the Claims
The nature of the invention is drawn to a method of treating or preventing a microbial infection, wherein the microbial infection wherein the microbial infection comprise fungal infection, bacterial infection, viral infection or a protozoal infection by administering a monoclonal antibody raised against a Candida antigen. See table 4 paragraph 280. These monoclonal antibodies B10C1, 1D4H5, 2D5F7, 10E7E2, 7C6E8-1, 7C6E8-2, 6H1G8 AND 7H6A2 whose complementarity regions are set forth in claim 1.
Guidance in the specification and the existence of working examples
The specification discloses monoclonal antibodies raised against Candida antigen peptides a. See paragraph 283 table 5.
The preventive effect of each monoclonal antibody (mAb) was examined by passive transfer experiments. Mice were administered the monoclonal antibody and then challenged with a lethal dose of Candida cells. See paragraph 284.
The specification teaches that mAbs 6H1G8 and 9F2G5 provided best protection, evidenced by highest survival and lowest fungal burdens in targeted organs. mAbs 10E7E2 and 3H7E3 also provided some protection with 25% survival, and lower fungal loads in targeted organs. 6HG8 and 9F2G5 were able to almost clear fungal burden and See paragraph 415 and figure 15. 1
The breadth of fungi, bacteria, viruses and protozoa is large. See paragraphs 69-72. These microbes are differ biologically and there is no common mechanism of pathogenesis amongst fungi, bacteria, viruses and protozoa.
State of the prior art and the level of predictability in the art
The state of the prior art does not teach the use of the instant mAb as a universal vaccine to induce an immune response against fungi, bacteria, viruses and protozoa. The specification does not provide any evidence to support the use of mAb antibodies to specific Candida antigens to treat or prevent non-Candida infections. Proof-of-principle studies support the concept of generating “universal” vaccines that target multiple heterologous pathogens via conserved target antigens and such vaccines can, in principle, target microbial pathogens across different kingdoms to confer cross-kingdom protection. See Rivera et al. Cell Host & Microbe, Volume 17, Issue 4, 421 – 423, 2015.
Amount of Direction Provided by the Inventor
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) (“Nascent technology, however, must be enabled with a specific and useful teaching.’
The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.” (citations omitted)).< The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. See MPEP 2164.03.
More guidance or direction and/or working example is needed to correlate the any antibody dependent mechanism of the disclosed mAbs with treating or preventing the full breadth of fungal infections, viral infection, protozoan infection, and bacterial infection.
The specification does not teach that the protective epitope recognized by these monoclonal antibodies are conserved across fungi, bacteria, virus, and protozoa and does not disclose the mechanism whereby the monoclonal antibodies that bind particular Candida antigens are sufficient to overcome the obstacles raised by having a universal vaccine. The obstacles to consider include, for example, intracellular vs extracellular microbes and multiple virulent mechanisms etc.
There are currently no vaccines for the prevention of fungal infection in the clinic, although experimental vaccines based on fungal cell wall targets are in development. See Rudkin et al. Nat Commun 9, 5288 (2018). https://doi.org/10.1038/s41467-018-07738-1 at p. 2 column 1 last paragraph.
More guidance and/or working example would be needed to use the anti-Candida monoclonal antibodies to treat and/or prevent other fungal infections, viral infections, protozoan infections and bacterial infections.
In view of these considerations, the specification is not enabling for the full scope of the invention.
Allowable Subject Matter
Claims 23-36 are allowed. The sequences recited in claims 23 and 32 appear to be free of prior art.
Status of Claims
Claims 23-36 are allowed. Claims 37-41 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645