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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on August 6, 2026 has been entered.
Claims 1, 4-6, 8-10, 37-42 and 44-48 have been amended. Claims 2-3 and 32-36 have been canceled. Claims 1, 4-6, 8-11 and 37-48 are currently pending and under examination.
Objections Withdrawn
2. In view of Applicant’s amendment, the objection to claim 6, which stated should said claim be found allowable, claim 48 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof is withdrawn.
Rejections Withdrawn
3. In view of Applicant’s amendments, the rejection as it pertains to claims 1, 4-6 and 8-11 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with the written description requirement is maintained for the reasons set forth in the previous office action is withdrawn.
4. In view of Applicant’s amendments, the rejection of claim(s) 6, 8 and 48 under 35 U.S.C. 102)(a)(1) as being anticipated by Elton et al., International Journal for Parasitology, 2019; 49: 115-125 is withdrawn.
Rejections Maintained
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.
5. The rejection of claims 37-48 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 is maintained for the reasons set forth in the previous office action. 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
The claimed invention is drawn to compositions selected from the group consisting of compositions 1-112 defined as follows: 1 (SEQ ID NOs 1 and 3), 2 (SEQ ID NOs: 1-3), 3 (SEQ ID NOs: 1, 3, and 5), 4 (SEQ ID NOs: 1, 3, and 6), 5 (SEQ ID NOs: 1, 3, and 7), 6 (SEQ ID NOs: 1-3 and 5), 7 (SEQ ID NOs: 1-3 and 6), 8 (SEQ ID NOs: 1-3 and 7), 9 (SEQ ID NOs: 1, 3, 5, and 6), 10 (SEQ ID NOs: 1, 3, 5, and 7), 11 (SEQ ID NOs: 1, 3, 6, and 7), 12 (SEQ ID NOs: 1-3, 5, and 6), 13 (SEQ ID NOs: 1-3, 5, and 7), 14 (SEQ ID NOs: 1-3, 6, and 7), 15 (SEQ ID NOs: 1, 3, and 5-7), 16 (SEQ ID NOs: 1-3 and 5-7), 17 (SEQ ID NOs: 1 and 2), 18 (SEQ ID NOs: 1, 2, and 5), 19 (SEQ ID NOs: 1, 2, and 6), 20 (SEQ ID NOs: 1, 2, and 7), 21 (SEQ ID NOs: 1, 2, 5, and 6), 22 (SEQ ID NOs: 1, 2, 5, and 7), 23 (SEQ ID NOs: 1, 2, 6, and 7), 24 (SEQ ID NOs: 1, 2, and 5-7), 25 (SEQ ID NOs: 1 and 5), 26 (SEQ ID NOs: 1, 5, and 6), 27 (SEQ ID NOs: 1, 5, and 7), 28 (SEQ ID NOs: 1 and 6), 29 (SEQ ID NOs: 1 and 6), 30 (SEQ ID NOs: 1, 6, and 7), 31 (SEQ ID NOs: 1 and 7), 32 (SEQ ID NOs: 2 and 3), 33 (SEQ ID NOs: 2, 3, and 5), 34 (SEQ ID NOs: 2, 3, and 6), 35 (SEQ ID NOs: 2, 3, and 7), 36 (SEQ ID NOs: 2, 3, 5, and 6), 37 (SEQ ID NOs: 2, 3, 5, and 7), 38 (SEQ ID NOs: 2, 3, 6, and 7), 39 (SEQ ID NOs: 2, 3, and 5-7), 40 (SEQ ID NOs: 3 and 5), 41 (SEQ ID NOs: 3, 5, and 6), 42 (SEQ ID NOs: 3, 5 and 7), 43 (SEQ ID NOs: 3 and 5-7), 44 (SEQ ID NOs: 3 and 6), 45 (SEQ ID NOs: 3, 6, and 7), 46 (SEQ ID NOs: 3 and 7), 47 (SEQ ID NOs: 3 and 5), 48 (SEQ ID NOs: 3 and 6), 49 (SEQ ID NOs: 3 and 7), 50 (SEQ ID NOs: 3, 5, and 6), 51 (SEQ ID NOs: 3, 5, and 7), 52 (SEQ ID NOs: 3, 6, and 7), 53 (SEQ ID NOs: 5 and 6), 54 (SEQ ID NOs: 5 and 7), 55 (SEQ ID NOs: 5-7), 56 (SEQ ID NOs: 6 and 7), 57 (SEQ ID NOs: 3 and 5), 58 (SEQ ID NOs: 3, 5, and 1), 59 (SEQ ID NOs: 3, 5, and 6), 60 (SEQ ID NOs: 3, 5, and 49), 61 (SEQ ID NOs: 3, 5, and 50), 62 (SEQ ID NOs: 3, 5, 1, and 6), 63 (SEQ ID NOs: 3, 5, 1 and 49), 64 (SEQ ID NOs: 3, 5, 1, and 50), 65 (SEQ ID NOs: 3, 5, 6, and 49), 66 (SEQ ID NOs: 3, 5, 6, and 50), 67 (SEQ ID NOs: 3, 5, 49, and 50), 68 (SEQ ID NOs: 3. 5, 1, 6, and 49), 69 (SEQ ID NOs: 3, 5, 1, 6, and 50), 70 (SEQ ID NOs: 3, 5, 1, 49, and 50), 71 (SEQ ID NOs: 3, 5, 6, 49, and 50), 72 (SEQ ID NOs: 3, 5, 2, 6, 49, and 50), 73 (SEQ ID NOs: 3 and 1), 74 (SEQ ID NOs: 3. 1, and 6), 75 (SEQ ID NOs: 3, 1, and 49), 76 (SEQ ID NOs: 3, 1, and 50), 77 (SEQ ID NOs: 3, 1, 6, and 49), 78 (SEQ ID NOs: 3, 1, 6, and 50), 79 (SEQ ID NOs: 3, 1, 49, and 50), 80 (SEQ ID NOs: 3, 1, 6, 49, and 50), 81 (SEQ ID NOs: 3 and 6), 82 (SEQ ID NOs: 3, 6, and 49), 83 (SEQ ID NOs: 3, 6, and 50), 84 (SEQ ID NOs: 3, 6, 49, and 50), 85 (SEQ ID NOs: 3 and 49), 86 (SEQ ID NOs: 3, 49, and 50), 87 (SEQ ID NOs: 3 and 50), 88 (SEQ ID NOs: 5 and 1), 89 (SEQ ID NOs: 5, 1, and 6), 90 (SEQ ID NOs: 5, 1, and 49), 91 (SEQ ID NOs: 5, 1 and 50), 92 (SEQ ID NOs: 5, 1, 6, and 49), 93 (SEQ ID NOs: 5, 1, 6, and 50), 94 (SEQ ID NOs: 5, 1, 49, and 50), 95 (SEQ ID NOs: 5, 1, 6, 49, and 50), 96 (SEQ ID NOs: 5 and 6), 97 (SEQ ID NOs: 5, 6, and 49), 98 (SEQ ID NOs: 5, 6, and 50), 99 (SEQ ID NOs: 5, 6, 49, and 50), 100 (SEQ ID NOs: 5 and 49), 101 (SEQ ID NOs: 5, 49, and 50), 102 (SEQ ID NOs: 5 and 50), 103 (SEQ ID NOs: 1 and 6), 104 (SEQ ID NOs: 1 and 49), 105 (SEQ ID NOs: 1 and 50), 106 (SEQ ID NOs: 1, 6, and 49), 107 (SEQ ID NOs: 1, 6, and 50), 108 (SEQ ID NOs: 1, 49, and 50), 109 (SEQ ID NOs: 6 and 49), 110 (SEQ ID NOs: 6 and 50), 111 (SEQ ID NOs: 6, 49, and 50), and 112 (SEQ ID NOs: 49 and 50).
Dependent claims require that said composition comprise one or more variants and fragment of said one or more Bm antigen indicated as being present in the composition, where the sequence of the one or more variants has at least 80%, 85%, 90%, 95%, 97%, or 99% identity to the sequence of the corresponding Bm antigen indicated as being present in the composition.
The claims encompass a vast genus of compositions comprising one or more variants of Bm antigens. Those antigens are not limited to those full length amino acid sequences as defined by the specification but also those that have yet to be defined and are encompassed by the various combination of antigens envisioned by the one or more variants of compositions 1-112, as identified above, in addition to those envisioned by the compositions comprising the one or more variant where the sequence of the one or more variant has at least 80%, 85%, 90%, 95%, 97%, or 99% identity to the sequence of the corresponding Bm antigen or fragment thereof of that particular variant. The specification does not adequately describe all that is envisioned by the breadth of the claim as drafted.
The specification does not place any structure, chemical or functional limitations on what is envisioned by “variants”; nor does adding the limitation of ‘one or more variant has at least 80%, 85%, 90%, 95%, 97%, or 99% identity’ convey a common structure or function and therefore, said limitations are not adequately described in the specification. The specification and the claims do not provide any guidance on the structure of the antigens nor does it provide any guidance as to what changes can or cannot be made. For example, Houghten et al. (Vaccines, 1986, Edited by Fred Brown: Cold Spring Harbor Laboratory) states that changes/modifications (addition, substitution, deletion or inversion) of one or more amino acids in a polypeptide will alter antigenic determinants and therefore affect antibody production (p. 21) as well as antibody binding. Houghten et al. also teach that "... combined effects of multiple changes in an antigenic determinant could result in a loss of [immunological] protection." and “A protein having multiple antigenic sites, multiple point mutations, or accumulated point mutations at key residues could create a new antigen that is precipitously or progressively unrecognizable by any of the antibodies..." (p. 24). Houghten et al. teach that point mutations at one key antigen residue could eliminate the ability of an antibody to recognize this altered antigen (p. 24). It is not always possible to make peptides that retain immunodominant regions and immunological activity if the regions have been altered.
Moreover, as written said variant and variant of a fragment can be a multitude of variations, which Applicant is not in possession of. This description is extremely important because changes in the structure could ultimately impact its intended function as a single amino acid can alter the function of a given protein. Bowie et al. (Science, 1990, 257:1306-1310) 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, carry out the instructions of the genome. Bowie et al. further teach 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 (column 2, page 1306).
“A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Further, it is not sufficient to define it solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court’s example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of the variants /fragments of fragments as claimed does not distinguish a particular variant/ fragment from others having the same activity or function and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Structural features that could distinguish “variants /fragments of fragments”, “fragments comprising at least 10 amino acids”, or “at least 50 amino acids” etc. in the genus from others in the protein class are missing from the disclosure and the claims. No common structural attributes identify the members of the genus. The general knowledge and level of skill in the art do not supplement the omitted description, because specific, not general guidance is needed. Since the disclosure does not describe the common attributes or structural characteristics that identify members of the genus, and because the genus is highly variant without function is insufficient to describe the genus of “variants/fragments” of that function equivalently. One of skill in the art would reasonably conclude that the disclosure of a single immunogenic composition comprising a specific Bm antigen set forth as the composition of 17, 25, 104, 105 or more specifically, SEQ ID NOs: 1, 2, 5, 16, 49-50 and combinations thereof are a representative number of variants/fragments thereof to adequately describe the genus as claimed. As such the specification lacks written description for the highly variant genus and one skilled in the art would not recognize that applicants had possession of the genus of claimed compositions as instantly claimed.
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of variants or fragments thereof, the skilled artisan could not immediately recognize or distinguish members of the claimed genus and hence for not meet the written description requirements.
Applicant argues that:
1) Claims 37-48 do not require that any fragments or variants be "antigenic”. If there are concerns about the lengths of fragments and/or levels of variability, Applicant requests separate consideration of each of claims 38-42 and 44-48, as these claims specify minimum lengths and/or levels of sequence identity. Claims 38 and 39, for example, specify that any fragment present in the composition of claim 37 comprises at least 50 (claim 38) or at least 100 (claim 39) amino acids of the corresponding Bm sequence indicated as being in the composition. The fragments are "of the sequence of the corresponding Bm antigen" (i.e., not variants). The Applicant respectfully submits that the structures of these fragments are clearly supported in the application, and thus these fragments are adequately described, by the presentation of the full-length sequences themselves.
Applicant’s arguments have been fully considered, but are deemed non-persuasive.
As it pertains to Point 1, the claims recite both variant and fragment. The Examiner concurs; fragment is not as egregious as it describes a piece of a larger known protein; particularly where the fragment is not structurally defined. The variant, however, remains problematic. Specifically, a variant refers to or implies a specific difference or alteration within said protein as compared to the reference sequence. “Variants” (i.e. which 5-10% of amino acids may be substituted within a sequence) has substantial variation because of the numerous options and combinations of options permitted; none of which have been adequately described.
The specification does not provide adequate written description to identify this broad genus because, inter alia, the specification does not disclose a correlation between the necessary structure of the antigen (e.g. which amino acids must be maintained and which may be substituted in a variant). It is noted that while the description of the ability of a claimed antigen sequence may generically describe that molecule's function, it does not describe the molecule itself. For example, the specification fails to identify the critical amino acids beyond each of the particular identified combinations of sequences identified as compositions of 1-112 that must be retained to maintain functional activity as compared to which amino acids may be eliminated in a sequence variant.
Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a massive number of partial structures claimed only by a functional characteristic (i.e. 80-99% sequence variants, fragments of variants and/or variants of the fragments) because, without an art-recognized structure-function correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. The rejection of claims 1, 4-5 and 9-11, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-13, 18, 20, 22 and 45 of copending Application No. 17/779,633 (reference application US 20220395564) is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to compositions and kits selected from the group consisting of compositions 1-112 of Tables 2-9, wherein the composition comprises each of the Bm antigens indicated as being present in the composition or one or more antigenic variants and/or antigenic fragments thereof.
Meanwhile the co-pending claims are drawn to a composition (and kit) comprising one or more Babesia microti (Bm) antigens that each comprise an amino acid sequence having at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 1-24, or one or more antigenic fragments thereof; and a pharmaceutically acceptable carrier or diluent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant will address this rejection upon the indication of otherwise allowable subject matter.
Applicant’s request is granted. Occasionally, the Examiner becomes aware of two copending applications that were filed by the same inventive entity, or by different inventive entities having a common inventor, and/or by a common assignee, or that claim an invention resulting from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 103 (c)(2) and (3), that would raise an issue of double patenting if one of the applications became a patent. Where this issue can be addressed without violating the confidential status of applications ( 35 U.S.C. 122), the courts have sanctioned the practice of making applicant aware of the potential double patenting problem if one of the applications became a patent by permitting the examiner to make a "provisional" rejection on the ground of double patenting. In re Mott, 539 F.2d1291, 190 USPQ 536 (CCPA 1976); In re Wetterau, 356 F.2d 556, 148 USPQ 499 (CCPA 1966). Therefore, until this is the only remaining rejection of record, the provisional rejection is maintained.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
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.
7. Claims 1, 4-5, 9-11 and 37-42 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.
Claim 1 and 37 are rendered vague and indefinite by the use of the phrase “ compositions 1-112 defined as follows: 1 (SEQ ID NOs 1 and 3), 2 (SEQ ID NOs: 1-3), 3 (SEQ ID NOs: 1, 3, and 5), 4 (SEQ ID NOs: 1, 3, and 6), 5 (SEQ ID NOs: 1, 3, and 7), 6 (SEQ ID NOs: 1-3 and 5), 7 (SEQ ID NOs: 1-3 and 6), 8 (SEQ ID NOs: 1-3 and 7), 9 (SEQ ID NOs: 1, 3, 5, and 6), 10 (SEQ ID NOs: 1, 3, 5, and 7), 11 (SEQ ID NOs: 1, 3, 6, and 7), 12 (SEQ ID NOs: 1-3, 5, and 6), 13 (SEQ ID NOs: 1-3, 5, and 7), 14 (SEQ ID NOs: 1-3, 6, and 7), 15 (SEQ ID NOs: 1, 3, and 5-7), 16 (SEQ ID NOs: 1-3 and 5-7), 17 (SEQ ID NOs: 1 and 2), 18 (SEQ ID NOs: 1, 2, and 5), 19 (SEQ ID NOs: 1, 2, and 6), 20 (SEQ ID NOs: 1, 2, and 7), 21 (SEQ ID NOs: 1, 2, 5, and 6), 22 (SEQ ID NOs: 1, 2, 5, and 7), 23 (SEQ ID NOs: 1, 2, 6, and 7), 24 (SEQ ID NOs: 1, 2, and 5-7), 25 (SEQ ID NOs: 1 and 5), 26 (SEQ ID NOs: 1, 5, and 6), 27 (SEQ ID NOs: 1, 5, and 7), 28 (SEQ ID NOs: 1 and 6), 29 (SEQ ID NOs: 1 and 6), 30 (SEQ ID NOs: 1, 6, and 7), 31 (SEQ ID NOs: 1 and 7), 32 (SEQ ID NOs: 2 and 3), 33 (SEQ ID NOs: 2, 3, and 5), 34 (SEQ ID NOs: 2, 3, and 6), 35 (SEQ ID NOs: 2, 3, and 7), 36 (SEQ ID NOs: 2, 3, 5, and 6), 37 (SEQ ID NOs: 2, 3, 5, and 7), 38 (SEQ ID NOs: 2, 3, 6, and 7), 39 (SEQ ID NOs: 2, 3, and 5-7), 40 (SEQ ID NOs: 3 and 5), 41 (SEQ ID NOs: 3, 5, and 6), 42 (SEQ ID NOs: 3, 5 and 7), 43 (SEQ ID NOs: 3 and 5-7), 44 (SEQ ID NOs: 3 and 6), 45 (SEQ ID NOs: 3, 6, and 7), 46 (SEQ ID NOs: 3 and 7), 47 (SEQ ID NOs: 3 and 5), 48 (SEQ ID NOs: 3 and 6), 49 (SEQ ID NOs: 3 and 7), 50 (SEQ ID NOs: 3, 5, and 6), 51 (SEQ ID NOs: 3, 5, and 7), 52 (SEQ ID NOs: 3, 6, and 7), 53 (SEQ ID NOs: 5 and 6), 54 (SEQ ID NOs: 5 and 7), 55 (SEQ ID NOs: 5-7), 56 (SEQ ID NOs: 6 and 7), 57 (SEQ ID NOs: 3 and 5), 58 (SEQ ID NOs: 3, 5, and 1), 59 (SEQ ID NOs: 3, 5, and 6), 60 (SEQ ID NOs: 3, 5, and 49), 61 (SEQ ID NOs: 3, 5, and 50), 62 (SEQ ID NOs: 3, 5, 1, and 6), 63 (SEQ ID NOs: 3, 5, 1 and 49), 64 (SEQ ID NOs: 3, 5, 1, and 50), 65 (SEQ ID NOs: 3, 5, 6, and 49), 66 (SEQ ID NOs: 3, 5, 6, and 50), 67 (SEQ ID NOs: 3, 5, 49, and 50), 68 (SEQ ID NOs: 3. 5, 1, 6, and 49), 69 (SEQ ID NOs: 3, 5, 1, 6, and 50), 70 (SEQ ID NOs: 3, 5, 1, 49, and 50), 71 (SEQ ID NOs: 3, 5, 6, 49, and 50), 72 (SEQ ID NOs: 3, 5, 2, 6, 49, and 50), 73 (SEQ ID NOs: 3 and 1), 74 (SEQ ID NOs: 3. 1, and 6), 75 (SEQ ID NOs: 3, 1, and 49), 76 (SEQ ID NOs: 3, 1, and 50), 77 (SEQ ID NOs: 3, 1, 6, and 49), 78 (SEQ ID NOs: 3, 1, 6, and 50), 79 (SEQ ID NOs: 3, 1, 49, and 50), 80 (SEQ ID NOs: 3, 1, 6, 49, and 50), 81 (SEQ ID NOs: 3 and 6), 82 (SEQ ID NOs: 3, 6, and 49), 83 (SEQ ID NOs: 3, 6, and 50), 84 (SEQ ID NOs: 3, 6, 49, and 50), 85 (SEQ ID NOs: 3 and 49), 86 (SEQ ID NOs: 3, 49, and 50), 87 (SEQ ID NOs: 3 and 50), 88 (SEQ ID NOs: 5 and 1), 89 (SEQ ID NOs: 5, 1, and 6), 90 (SEQ ID NOs: 5, 1, and 49), 91 (SEQ ID NOs: 5, 1 and 50), 92 (SEQ ID NOs: 5, 1, 6, and 49), 93 (SEQ ID NOs: 5, 1, 6, and 50), 94 (SEQ ID NOs: 5, 1, 49, and 50), 95 (SEQ ID NOs: 5, 1, 6, 49, and 50), 96 (SEQ ID NOs: 5 and 6), 97 (SEQ ID NOs: 5, 6, and 49), 98 (SEQ ID NOs: 5, 6, and 50), 99 (SEQ ID NOs: 5, 6, 49, and 50), 100 (SEQ ID NOs: 5 and 49), 101 (SEQ ID NOs: 5, 49, and 50), 102 (SEQ ID NOs: 5 and 50), 103 (SEQ ID NOs: 1 and 6), 104 (SEQ ID NOs: 1 and 49), 105 (SEQ ID NOs: 1 and 50), 106 (SEQ ID NOs: 1, 6, and 49), 107 (SEQ ID NOs: 1, 6, and 50), 108 (SEQ ID NOs: 1, 49, and 50), 109 (SEQ ID NOs: 6 and 49), 110 (SEQ ID NOs: 6 and 50), 111 (SEQ ID NOs: 6, 49, and 50), and 112 (SEQ ID NOs: 49 and 50)”. Multiple compositions defined within the recited compositions labeled as 1-112 are defined using identical components. It is unclear what is meant by said term, especially when more than one composition identified by differing numbers comprising the same sequences.
For example:
28 (SEQ ID NOs: 1 and 6), 29 (SEQ ID NOs: 1 and 6), 30 (SEQ ID NOs: 1, 6, and 7), 31 (SEQ ID NOs: 1 and 7), 32 (SEQ ID NOs: 2 and 3), 33 (SEQ ID NOs: 2, 3, and 5), 34 (SEQ ID NOs: 2, 3, and 6), 35 (SEQ ID NOs: 2, 3, and 7), 36 (SEQ ID NOs: 2, 3, 5, and 6), 37 (SEQ ID NOs: 2, 3, 5, and 7), 38 (SEQ ID NOs: 2, 3, 6, and 7), 39 (SEQ ID NOs: 2, 3, and 5-7), 40 (SEQ ID NOs: 3 and 5), 41 (SEQ ID NOs: 3, 5, and 6), 42 (SEQ ID NOs: 3, 5 and 7), 43 (SEQ ID NOs: 3 and 5-7), 44 (SEQ ID NOs: 3 and 6), 45 (SEQ ID NOs: 3, 6, and 7), 46 (SEQ ID NOs: 3 and 7), 47 (SEQ ID NOs: 3 and 5), 48 (SEQ ID NOs: 3 and 6), 49 (SEQ ID NOs: 3 and 7), 50 (SEQ ID NOs: 3, 5, and 6), 51 (SEQ ID NOs: 3, 5, and 7), 52 (SEQ ID NOs: 3, 6, and 7), 53 (SEQ ID NOs: 5 and 6), 54 (SEQ ID NOs: 5 and 7), 55 (SEQ ID NOs: 5-7), 56 (SEQ ID NOs: 6 and 7), 57 (SEQ ID NOs: 3 and 5), 58 (SEQ ID NOs: 3, 5, and 1), 59 (SEQ ID NOs: 3, 5, and 6).
This is true of at least the following compositions:
Composition 28 is identical to composition 29 & 103;
Composition 40 is identical to composition 47& 57;
Composition 41 is identical to composition 50 & 59;
Composition 42 is identical to composition 51;
Composition 45 is identical to composition 52;
Composition 46 is identical to composition 49; and
Composition 48 is identical to composition 81
It is not clear core structures must be maintained especially when they are identical just with a different number to identify. As written, it is impossible to determine the metes and bounds of the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claim(s) 37-39 and 43-44 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Reed et al., US 2003/0109689 A1; published: 6/12/03.
Independent claim 37 is drawn to a composition selected from the group consisting of compositions 1-112, wherein: (i) the composition comprises each Bm sequence indicated as being present in the composition, or one or more variant or fragment thereof, (ii) compositions 1-112 are defined as follows: 1 (SEQ ID NOs 1 and 3), 2 (SEQ ID NOs: 1-3), 3 (SEQ ID NOs: 1, 3, and 5), 4 (SEQ ID NOs: 1, 3, and 6), 5 (SEQ ID NOs: 1, 3, and 7), 6 (SEQ ID NOs: 1-3 and 5), 7 (SEQ ID NOs: 1-3 and 6), 8 (SEQ ID NOs: 1-3 and 7), 9 (SEQ ID NOs: 1, 3, 5, and 6), 10 (SEQ ID NOs: 1, 3, 5, and 7), 11 (SEQ ID NOs: 1, 3, 6, and 7), 12 (SEQ ID NOs: 1-3, 5, and 6), 13 (SEQ ID NOs: 1-3, 5, and 7), 14 (SEQ ID NOs: 1-3, 6, and 7), 15 (SEQ ID NOs: 1, 3, and 5-7), 16 (SEQ ID NOs: 1-3 and 5-7), 17 (SEQ ID NOs: 1 and 2), 18 (SEQ ID NOs: 1, 2, and 5), 19 (SEQ ID NOs: 1, 2, and 6), 20 (SEQ ID NOs: 1, 2, and 7), 21 (SEQ ID NOs: 1, 2, 5, and 6), 22 (SEQ ID NOs: 1, 2, 5, and 7), 23 (SEQ ID NOs: 1, 2, 6, and 7), 24 (SEQ ID NOs: 1, 2, and 5-7), 25 (SEQ ID NOs: 1 and 5), 26 (SEQ ID NOs: 1, 5, and 6), 27 (SEQ ID NOs: 1, 5, and 7), 28 (SEQ ID NOs: 1 and 6), 29 (SEQ ID NOs: 1 and 6), 30 (SEQ ID NOs: 1, 6, and 7), 31 (SEQ ID NOs: 1 and 7), 32 (SEQ ID NOs: 2 and 3), 33 (SEQ ID NOs: 2, 3, and 5), 34 (SEQ ID NOs: 2, 3, and 6), 35 (SEQ ID NOs: 2, 3, and 7), 36 (SEQ ID NOs: 2, 3, 5, and 6), 37 (SEQ ID NOs: 2, 3, 5, and 7), 38 (SEQ ID NOs: 2, 3, 6, and 7), 39 (SEQ ID NOs: 2, 3, and 5-7), 40 (SEQ ID NOs: 3 and 5), 41 (SEQ ID NOs: 3, 5, and 6), 42 (SEQ ID NOs: 3, 5 and 7), 43 (SEQ ID NOs: 3 and 5-7), 44 (SEQ ID NOs: 3 and 6), 45 (SEQ ID NOs: 3, 6, and 7), 46 (SEQ ID NOs: 3 and 7), 47 (SEQ ID NOs: 3 and 5), 48 (SEQ ID NOs: 3 and 6), 49 (SEQ ID NOs: 3 and 7), 50 (SEQ ID NOs: 3, 5, and 6), 51 (SEQ ID NOs: 3, 5, and 7), 52 (SEQ ID NOs: 3, 6, and 7), 53 (SEQ ID NOs: 5 and 6), 54 (SEQ ID NOs: 5 and 7), 55 (SEQ ID NOs: 5-7), 56 (SEQ ID NOs: 6 and 7), 57 (SEQ ID NOs: 3 and 5), 58 (SEQ ID NOs: 3, 5, and 1), 59 (SEQ ID NOs: 3, 5, and 6), 60 (SEQ ID NOs: 3, 5, and 49), 61 (SEQ ID NOs: 3, 5, and 50), 62 (SEQ ID NOs: 3, 5, 1, and 6), 63 (SEQ ID NOs: 3, 5, 1 and 49), 64 (SEQ ID NOs: 3, 5, 1, and 50), 65 (SEQ ID NOs: 3, 5, 6, and 49), 66 (SEQ ID NOs: 3, 5, 6, and 50), 67 (SEQ ID NOs: 3, 5, 49, and 50), 68 (SEQ ID NOs: 3. 5, 1, 6, and 49), 69 (SEQ ID NOs: 3, 5, 1, 6, and 50), 70 (SEQ ID NOs: 3, 5, 1, 49, and 50), 71 (SEQ ID NOs: 3, 5, 6, 49, and 50), 72 (SEQ ID NOs: 3, 5, 2, 6, 49, and 50), 73 (SEQ ID NOs: 3 and 1), 74 (SEQ ID NOs: 3. 1, and 6), 75 (SEQ ID NOs: 3, 1, and 49), 76 (SEQ ID NOs: 3, 1, and 50), 77 (SEQ ID NOs: 3, 1, 6, and 49), 78 (SEQ ID NOs: 3, 1, 6, and 50), 79 (SEQ ID NOs: 3, 1, 49, and 50), 80 (SEQ ID NOs: 3, 1, 6, 49, and 50), 81 (SEQ ID NOs: 3 and 6), 82 (SEQ ID NOs: 3, 6, and 49), 83 (SEQ ID NOs: 3, 6, and 50), 84 (SEQ ID NOs: 3, 6, 49, and 50), 85 (SEQ ID NOs: 3 and 49), 86 (SEQ ID NOs: 3, 49, and 50), 87 (SEQ ID NOs: 3 and 50), 88 (SEQ ID NOs: 5 and 1), 89 (SEQ ID NOs: 5, 1, and 6), 90 (SEQ ID NOs: 5, 1, and 49), 91 (SEQ ID NOs: 5, 1 and 50), 92 (SEQ ID NOs: 5, 1, 6, and 49), 93 (SEQ ID NOs: 5, 1, 6, and 50), 94 (SEQ ID NOs: 5, 1, 49, and 50), 95 (SEQ ID NOs: 5, 1, 6, 49, and 50), 96 (SEQ ID NOs: 5 and 6), 97 (SEQ ID NOs: 5, 6, and 49), 98 (SEQ ID NOs: 5, 6, and 50), 99 (SEQ ID NOs: 5, 6, 49, and 50), 100 (SEQ ID NOs: 5 and 49), 101 (SEQ ID NOs: 5, 49, and 50), 102 (SEQ ID NOs: 5 and 50), 103 (SEQ ID NOs: 1 and 6), 104 (SEQ ID NOs: 1 and 49), 105 (SEQ ID NOs: 1 and 50), 106 (SEQ ID NOs: 1, 6, and 49), 107 (SEQ ID NOs: 1, 6, and 50), 108 (SEQ ID NOs: 1, 49, and 50), 109 (SEQ ID NOs: 6 and 49), 110 (SEQ ID NOs: 6 and 50), 111 (SEQ ID NOs: 6, 49, and 50), and 112 (SEQ ID NOs: 49 and 50);
(iii) any variant present in the composition comprises a sequence having at least 80% identity to the corresponding Bm sequence indicated as being present in the composition; and (iv) any fragment present in the composition comprises at least 10 amino acids of the corresponding Bm sequence indicated as being present in the composition
Independent claim 43 is drawn to a composition comprising one or more of the following combinations:
SEQ ID NO: 1 and SEQ ID NO: 2,
SEQ ID NO: 1 and SEQ ID NO: 5,
SEQ ID NO: 1 and SEQ ID NO: 49,
SEQ ID NO: 1 and SEQ ID NO: 50,
SEQ ID NO: 1 and SEQ ID NO: 16,
SEQ ID NO: 2 and SEQ ID NO: 5,
SEQ ID NO: 2 and SEQ ID NO: 16,
SEQ ID NO: 2 and SEQ ID NO: 49,
SEQ ID NO: 2 and SEQ ID NO: 50, and
SEQ ID NO: 5 and SEQ ID NO: 16, or fragments or variants of one or more of said sequence identifiers.
Reed discloses pharmaceutical compositions comprising B. microti antigens (see paragraph 0024). In a further aspect, the present invention provides fusion proteins comprising either a first and a second inventive polypeptide (see paragraph 0054). Lastly, Reed discloses that their composition comprises amino acid sequence fragments having the following identities (see attached SCV results):
PNG
media_image1.png
376
398
media_image1.png
Greyscale
SEQ ID NO: 1 and 49 @ 75.7%
PNG
media_image2.png
595
496
media_image2.png
Greyscale
SEQ ID NO: 1 and 5 @84.1
PNG
media_image3.png
664
502
media_image3.png
Greyscale
SEQ ID NO: 5 and 1 @ 83.8%
PNG
media_image4.png
601
509
media_image4.png
Greyscale
SEQ ID NO 1 and 2 @65.3
PNG
media_image5.png
599
509
media_image5.png
Greyscale
SEQ ID NO: 1 and 49 @ 75.7%
PNG
media_image6.png
594
499
media_image6.png
Greyscale
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
9. Claims 6 and 8 are free of the prior art.
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reed US 6,306,396- SEQ ID NOs 1&5 (80.6%), 5&1(80.3%), 1&49(72.5%), 1&2(62.6%); Red US 6,451,315; Reed US2001/0029295 A1; Reed US2002/0169136; Cornillot et al., Nucleic Acids Research, 2012; 40(18): 9102-9114- discloses the genome from the pathogen Babesia microti- SEQ ID NO: 4 (99%) and 49-54 (100%); just the protein, no mention of compositions or multiple antigens together in a composition.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 September 3, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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