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 .
Status of the Claims
Claims 1-30 were originally filed May 16, 2023.
The amendment received November 17, 2023 amended claims 2, 5, 9, 14, 16, 19, 24, and 27 and cancelled claims 3, 4, 6, 7, 11, 15, 23, and 28-30.
The amendment received January 20, 2026 changed the status identifiers only.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 5, 8-10, 12, and 13) in the reply filed on January 20, 2026 is acknowledged.
Claims 14, 16-22, and 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected products and methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 20, 2026.
Applicant’s election of aminopeptidase N, salt solution, feed formulation, treatment, and PirA as the species in the reply filed on January 20, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: based on the species election, claims 10, 12, and 13 should be withdrawn. However, due to various issues with the claims, the claims are being examined. This does not preclude withdrawal of the claims upon amendment or a requirement for an additional species election.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/US2021/059561 filed November 16, 2021 which claims the benefit of 63/114,383 filed November 16, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 16, 2023 and June 12, 2023 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
See Figure 8.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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 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 paragraphs 40-42, 45-55, 143, 312-314, 317-322, and 329-333.
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 Objections
Claims 1, 2, 5, 8, and 12 are objected to because of the following informalities: “Vibrio spp.” Should read “Vibrio species” to delete the embedded periods in the claims. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “Vibiro spp. toxin” in line 2 should read “Vibrio species toxin”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: a space is missing between “toxins;” and “(c)”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: utilization of the full name along with the first recitation of the acronym is required. Appropriate correction is required.
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 1, 2, 5, 8-10, 12, and 13 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 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. This is a written description rejection.
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, 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 do 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 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of a Vibrio species toxin binding protein; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. The instant claims define the “Vibrio species toxin binding protein” by the functional limitation of “capable of binding or otherwise interacting with a Vibrio species toxin”. The claimed “Vibrio species toxin binding protein” is only defined by functional properties (e.g. “capable of binding or otherwise interacting with a Vibrio species toxin”; see claims 1, 2 – wherein only the target toxin is a limitation, 5 – wherein only a recombinant protein is required, 8-10, 12, and 13). The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of potential “Vibrio species toxin binding proteins”. Here, the Applicant claims the “Vibrio species toxin binding protein” only by vague functional language (i.e. “capable of binding or otherwise interacting with a Vibrio species toxin”) without specifying under what conditions the protein is “capable of binding” or shat “interacting” encompasses. The scope of these claims include a vast number of sequences because the specification and claims do not place any limit on the number of components (e.g. amino acid common core required for function), the type of components (e.g. specific amino acids in a common core), or how the components are combined. In addition, claim 2 only requires what the protein is capable of binding or otherwise interacting with (e.g. Vibrio species toxin; see (a)) or unspecified fragments (see (b)). Claim 5 only requires a recombinant protein (see (a)); 50% identity to SEQ ID NOs: 2, 4, 6, 8, or 10 which could dramatically alter the function of the sequences without indicating which residues are required for function; a 3mer without specifying which three amino acids are necessary for the function (see (c)) particularly since SEQ ID NO: 2 is a 959mer, SEQ ID NO: 4 is a 435mer, SEQ ID NO: 6 is a 690mer, SEQ ID NO: 8 is a 1106mer, and SEQ ID NO: 10 is a 987mer. Furthermore, the specification and claims do not place any limit on the number of components, the types of components, or the manner in which the components might be connected to achieve a “Vibrio species toxin binding protein”. Therefore, Applicants are using an inadequately described function to inadequately describe the claimed “Vibrio species toxin binding protein”. In addition, the “capable of” or “otherwise interacting” language further exacerbates this problem because the conditions under which the binding protein binds or interacts with the Vibrio species toxin are not specified. Consequently, there is no teaching that would allow a person of skill in the art to determine a priori that the Applicant was in possession of the full scope of the claimed invention at the time of filing because there is no common structural attributes that can link together all of the claimed “Vibrio species toxin binding protein”.
While the general knowledge and level of skill in the art for making and screening proteins is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the “Vibrio species toxin binding protein”. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant (e.g. many sequences), the limited examples in the specification (please refer to SEQ ID NOs: 2, 4, 6, 8, and 10) are insufficient to teach the entire genus.
The specification discloses only limited examples that are not representative of the claimed genus of a “Vibrio species toxin binding protein”; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous proteins that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
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, 2, 5, 8-10, 12, and 13 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear under what conditions the “Vibrio species toxin binding protein” is “capable” of binding. While it is best if structural limitations regarding the “Vibrio species toxin binding protein” are utilized, definite functions could also be utilized (e.g. specifically binds).
Claims 1, 2, 5, 8-10, 12, and 13 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “otherwise interacting” requires. While it is best if structural limitations regarding the “Vibrio species toxin binding protein” are utilized, definite functions could also be utilized (e.g. specifically binds).
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim is open, closed, etc. (see “is or comprises”). This could also be considered a broad limitation with a more narrow limitation depending on the metes and bounds of “is”. See MPEP § 2173.05(c).
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim is open, closed, etc. (see “is” in line 3).
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear which fragments would have the required function of independent claim 1 from which claim 2 depends.
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the claim is open, closed, etc. (see “is” in lines 2, 4, 5).
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how “recombinant” alters the protein.
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “modifications” would increase binding affinity or specificity.
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear which amino acids of SEQ ID NOs: 2, 4, 6, 8, or 10 are required in the 50-99% identical protein to retain function.
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what fragment retains function particularly a 3mer when SEQ ID NO: 2 is a 959mer, SEQ ID NO: 4 is a 435mer, SEQ ID NO: 6 is a 690mer, SEQ ID NO: 8 is a 1106mer, and SEQ ID NO: 10 is a 987mer. In addition, it is unclear how a 3mer is a protein (i.e. a 3mer would be a peptide).
Claim 5 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the CBR, SEQ ID NO: 11, or a zinc binding region have the function of independent claim 1 from which claim 5 depends.
Claims 8-10, 12, and 13 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear which fragments would have the required function of independent claim 1 from which claim 8 depends.
Claims 8-10, 12, and 13 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what makes a carrier “suitable”.
Claims 9 and 10 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what is required for the feed formulation to be “suitable for a crustacean” or a “shrimp”.
Claims 9 and 10 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what is required for the formulation to be “adapted for delivery in a water source”.
Claims 12 and 13 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what is required for the formulation to be effective to treat or prevent an infection, disease, or symptom.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 (a) is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is dependent on independent claim 1. Claim 1 requires a “Vibrio species toxin binding protein”. Claim 5 (a) requires that the protein is “recombinant”. The method of making the protein does not alter the protein structure. Therefore, section (a) of claim 5 fails to further limit the protein of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 is dependent on claim 9 which is dependent on claim 8 which is dependent on independent claim 1. Claim 9 refers to a feed formulation for a crustacean. Dependent claim 10 requires that the feed formulation is for a shrimp. Therefore, dependent claim 10 does not alter the formulation but simply refers to the intended use of the feed formulation. Thus, dependent claim 10 fails to further limit the components of the feed formulation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 is dependent on claim 8 which is dependent on independent claim 1. Claim 1 requires a “Vibrio species toxin binding protein”. Claim 8 requires a carrier. Claim 12 simply refers to the intended use of the “Vibrio species toxin binding protein” and carrier. Thus, dependent claim 12 does not alter the structure of the “Vibrio species toxin binding protein” or carrier and fails to further limit independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 is dependent on claim 12 is dependent on claim 8 which is dependent on independent claim 1. Claim 1 requires a “Vibrio species toxin binding protein”. Claim 8 requires a carrier. Claim 12 simply refers to the intended use of the “Vibrio species toxin binding protein” and carrier (i.e. treat or prevent an infection, disease, or a symptom) and claim 13 refers to a disease (i.e. AHPND). Thus, dependent claim 13 does not alter the structure of the “Vibrio species toxin binding protein” or carrier and fails to further limit independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 5, 8-10, 12, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to “Vibrio species toxin binding protein” including aminopeptidase N, alkaline phosphatase, midgut membrane bound cadherin, etc. without significantly more. The claims recite the protein alone, in combination with a carrier, or as a food formulation. This judicial exception is not integrated into a practical application because the present claims are drawn to a product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is unclear how or if the carrier or the food stuff would alter the final structure of the protein (e.g. how is the carrier associated with the protein, etc.). In addition, carriers and food formulations are well-understood, routine, and conventional in the art.
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.
Claims 1, 2, 5, 8-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prather et al. WO 2019/210175 published October 31, 2019.
For present claims 1, 2, 5, 8-10, 12, and 13, Prather et al. teach aminopeptidase N (e.g. containing CBR, GAMEN, and zinc binding regions) and carriers (please refer to the entire specification particularly the abstract; paragraphs 2, 5, 21, 29, 31, 77, 79, 114, 376, 385, 516, and 517; claims).
Therefore, the teachings of Prather et al. anticipate the presently claimed protein.
Claims 1, 2, 5, 8-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexander-Miller WO 2017/091707 published June 1, 2017.
For present claims 1, 2, 5, 8-10, 12, and 13, Alexander-Miller teach aminopeptidase N, fragments and variants thereof, and carriers (please refer to the entire specification particularly the abstract; pages 2, 3, 6-8, 11; claims).
Therefore, the teachings of Alexander-Miller anticipate the presently claimed protein.
Claims 1, 2, 5, 8-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haaning et al. WO 2016/062857 published April 28, 2016.
For present claims 1, 2, 5, 8-10, 12, and 13, Haaning et al. teach aminopeptidase N and carriers in feed formulations for crustations including shrimp (please refer to the entire specification particularly the abstract; pages 1, 2, 12, 13, 14, 143-157, 159).
Therefore, the teachings of Haaning et al. anticipate the presently claimed protein.
Claims 1, 2, 5, 8-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapeller-Libermann et al. WO 01/00811 published January 4, 2001.
For present claims 1, 2, 5, 8-10, 12, and 13, Kapeller-Libermann et al. teach aminopeptidase N, variants, and fragments thereof including GAMEN (present SEQ ID NO: 11) with carriers for oral administration, water, PBS, and sodium chloride (please refer to the entire specification particularly the abstract; pages 2-4, 6, 9, 12, 14, 66-68; claims).
Therefore, the teachings of Kapeller-Libermann et al. anticipate the presently claimed protein.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658