DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/1/2026 is acknowledged.
Claims 1-20 are pending. Claims 15, 18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-14, 16-17, and 19 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 11/6/2024 and 3/7/2025 have been considered. Signed copies are enclosed.
Specification
The use of the terms EMULSIGEN, MONTANIDE, and MF59, which are trade names or marks used in commerce, have been noted in this application on pages 7 and 26. The terms 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.
It is noted that the cited occurrences of improper use are only exemplary and applicant should review the specification to correct any other use of trademarks.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14, 16-17, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to various Bm86Dock modules. The modules comprise SEQ ID NO:2-3 and variants thereof. All claims require the composition to induce an immune response and some dependent claims add specific immune responses, including binding with protective or neutralizing antibodies and treatment or prevention of tick infestations.
The claims recite SEQ ID NO:2-3 and variants thereof as well as the fragment consisting of SEQ ID NO:1. The claims include variants of SEQ ID NO:2-3. The specification states that Bm86Dock is a small well-folded soluble molecule and states that Bm86Dock variants have thermal stability, are safe, induce broad protection, and do not carry mutations in surface residues that form conformational and/or linear epitopes. There is no limit to the number of mutations that can be made to SEQ ID NO:2-3. Therefore, the claims encompass an essentially unlimited number of variants that must have specific functional characteristics. The specification discloses the fragment SEQ ID NO:1, the wild-type SEQ ID NO:2 (Bm86Dock), a single mutant with the sequence of SEQ ID NO:3 (Bm86Dock002), and a version of these with a spytag attached. Only Bm86Dock and Bm86Dock002 were tested for their characteristics. No other variants are disclosed or shown to have any of the functional requirements.
The claims are thus drawn to a large genus of variants with no correlation provided between the structure and the required function. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 SEQ ID NO:1-6, the skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, 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 for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Protein chemistry is probably one of the most unpredictable areas of biotechnology. Consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted. Bowie et al. (Science, 1990, 247:1306-1310) teach that an amino acid sequence encodes a message that determines the shape and function of a protein and that it is the ability of these proteins to fold into unique three-dimensional structures that allows them to function and carry out the instructions of the genome and further teaches that the problem of predicting protein structure from sequence data and in turn utilizing predicted structural determinations to ascertain functional aspects of the protein is extremely complex (column 1, page 1306). Bowie et al. further teach that while it is known that many amino acid substitutions are possible in any given protein, the position within the protein's sequence where such amino acid substitutions can be made with a reasonable expectation of maintaining function are limited. Certain positions in the sequence are critical to the three dimensional structure/function relationship and these regions can tolerate only conservative substitutions or no substitutions at all (column 2, page 1306). The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138, 1990) who teach that replacement of a single lysine reside at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al. (Mol. Cell. Biol., 8:1247-1252, 1988) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein. Clearly, it could not be predicted that polypeptide or a variant that shares only partial homology with a disclosed protein or that is a fragment of a given SEQ ID NO. will function in a given manner.
Therefore, only SEQ ID NO:1-6, but not the full breadth of the claims, meet the written description provision of 35 USC 112, first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115).
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14, 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 pre-AIA the applicant regards as the invention. Claims not specifically mentioned below are included because they include the issue of the parent claim.
Claims 1-3 are indefinite because they are drawn to both a product and a process. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parteLyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph). In the instant case, the claim is drawn to a product (a Bm86Dock) and to a process (wherein the product elicits an immune response).
Claim 1 is rendered indefinite by the confusing use of both comprising and consisting. The claim states that the module comprises a sequence selected from a group “consisting or SEQ ID NO:2, SEQ ID NO:3 and variants thereof, or an amino acid sequence having an immunogenic fragment consisting of SEQ ID NO:1”. It is not clear how the module can comprise a sequence but then have the sequence limited by “consisting”. Further, it is not clear whether the reference to SEQ ID NO:1 is part of the Markush group or in addition to it. If it is part of the group, then the group is improper because it must be a closed group.
Claim 6 is rendered indefinite by the parenthetical reference “(mi3)”. It is not clear whether this is supposed to be an exemplification of I3-01 or an abbreviation or a specific version that is required by the claim.
Claim 16 is rendered indefinite by the recitation of the trademarks Emulsigen, Montanide, and MF59. If a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. Further, 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, the claim recites several broad recitations (“the Montanide range of adjuvants”, Water-in-oil emulsions, and Oil-in-water emulsions), and the claim also recites Emulsigen adjuvants, Montanide adjuvants, Freund’s, and MF59 which are 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. Finally, the claim initially states that the compositions must comprise a carrier and/or an adjuvant. The claim then goes on to list the adjuvants. Therefore, it is not clear if the adjuvant is actually required by the claim.
Claims 17 and 19 are rendered indefinite by the phrase “aluminum oxyhydroxide hydrogel (AlOH)”. The abbreviation AlOH is not the correct chemical abbreviation for aluminum oxyhydroxide, which is, in fact, “AlO(OH)”.
Claim 19 is indefinite because it is not clear if the 5 to 200 micrograms is the amount of Bm86Dock-NP and aluminum oxyhydroxide hydrogel together or the amount of Bm86Dock-NP or the amount of the total composition comprising the NP, the adjuvant, and the storage buffer or Tris.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (US Patent Application Publication 2018/0085443).
The instant claim is drawn to a recombinant Bm86Dock module.
Li et al disclose a vaccine comprising the Rm86Texas protein which is a variant of the instantly claimed SEQ ID NO:2 and 3 (see abstract, figure 1, and sequence listing).
Claims 1, 3-5, 7, 12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gonzalez-Mora et al (Pharmaceutics 13:1-17, 2021).
The instant claims are drawn to recombinant Bm86Dock modules.
Gonzalez-Mora et al disclose vaccines comprising BM86 antigen displayed on the surface of bacteriophage M13 (see abstract). The phage particles serve as self-assembling multimeric protein scaffolds with the Bm86 displayed on the outer surface. The Bm86 antigens are variants of the instantly claimed SEQ ID NO:2-3 and they contain epitopes of the native Bm86 and they elicit an immune response (see page 5-8). The phage particle contains at least 5 polypeptide subunits. In order to be administered, the composition must have had some sort of pharmaceutical carrier.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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