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 .
FINAL DETAILED ACTION
1. Applicant’s response filed on December 17, 2025 is acknowledged. Claims 1-3 and 6 have been amended. Claims 13, 14, 21, 24-29 and 31 have been canceled. Claims 32-48 have been added. Claims 1-6, 8-11, and 32-48 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on December 17, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Objections Withdrawn
3. In view of Applicant’s amendment, the objection to claim 1 for minor informalities is withdrawn.
4. In view of Applicant’s amendments, the objection to claim 1 for relying on Tables 2-9 is withdrawn.
Rejections Withdrawn
5. In view of Applicant’s response, the rejection of claims 1-6, 8-10, and 29 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 by the use of parenthesis in addition to the ‘for example’- ‘(e.g., each) and by the use of the phrase “antigenic variants” and “antigenic fragment” is withdrawn.
6. In view of Applicant’s amendment, the rejection of claim(s) 1-3, 9-11 and 31 under 35 U.S.C. 102)(a)(1)/102(a)(1) as being anticipated by Reed et al.; WO 01/85947 A2; published: 11/15/01 is withdrawn.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.
7. The rejection of claims 1-6, 8-11, and newly added claims 32-48 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 antigenic variant of said one or more Bm antigen indicated as being present in the composition, 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 indicated as being present in the composition, or an antigenic fragment thereof.
The claims encompass a vast genus of compositions comprising Bm antigens, one or more antigenic variants as well as one or more antigenic fragments. 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 antigenic variants and/or antigenic fragments of compositions 1-112, as identified above, in addition to those envisioned by the compositions comprising the one or more antigenic variant where the sequence of the one or more variant has at least 80% (new claim 37), 85%, 90%, 95%, 97%, or 99% identity to the sequence of the corresponding Bm antigen, or an antigenic fragment thereof of that particular variant. The specification does not adequately describe all that is envisioned by the breadth of the claim as drafted. When considering the intended use of the composition as described by the specification the specification has not at all described instances where variants and fragments and variants of said variants and fragments are capable of prevention, treatment or the ability to monitor babesiosis.
The specification does not place any structure, chemical or functional limitations on what is envisioned by “variants/fragments”; 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, fragment 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”, “antigenic 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/antigenic variant/antigenic fragments thereof” 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 antigenic variants/fragments and 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) What is meant by antigenic variants and fragments of antigen protein sequences is something that is well known in the art and those of skill in the art, in being made aware of a reference base sequence, will understand that antigenic variants and fragments of such a base sequence have also been described. Further, new claims are added which specify the presence of full-length sequences that have 100% identity to sequences specified in the claims.
Applicant’s arguments have been fully considered, but are deemed non-persuasive.
As it pertains to claim 1, contrary to Applicant’s rebuttal, the Office’s position remains that the claims lack guidance regarding “antigenic fragments” (i.e. sequences less than full length) and/or “variants” (i.e. which 5-10% of amino acids may be substituted within a sequence). Additionally, the claimed genus has substantial variation because of the numerous options and combinations of options permitted. However, 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 and/or eliminated in an antigenic fragment) and any intended function to be maintained (e.g. confer antigenicity, protective immunity and/or immunization against babesiosis). 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 an antigenic fragment and/or substituted in a sequence variant.
Consequently, the specification fails to describe the common attributes or structural characteristics that identify the members of this genus and because the genus of sequences is highly variable (i.e. each sequence has a unique structure; see MPEP 2434), the functional characteristics of the ability to confer protective immunity and/or immunization against babesiosis, is insufficient to describe the genus. 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. antigenic fragments, 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.
8. The rejection of claims 1-5, 9-11, 29 and 31 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.
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.
9. The rejection of claim(s) 6, 8 and newly added claim 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 maintained for the reasons set forth in the previous office action. The rejection is moot as it pertains to claims 1-3 and 11.
Independent claim 6 is drawn to claims 6and 48 are drawn a composition comprising: a Bm antigen of SEQ ID NO: 49, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 50, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 51, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 52, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 53, or an antigenic variant and/or antigenic fragment thereof; and/or a Bm antigen of SEQ ID NO: 54, or an antigenic variant and/or antigenic fragment thereof; or two or more of said Bm antigens, or antigenic variants and/or antigenic fragments thereof, wherein (i) any antigenic variant present in the composition comprises a sequence having at least 80% identity to the sequence of the corresponding Bm antigen indicated as being present in the composition; and (ii) any antigenic fragment present in the composition comprises at least 10 amino acids of the sequence of the corresponding Bm antigen indicated as being present in the composition.
Elton discloses the recent sequencing of the B. microti genome which revealed many novel genes encoding proteins that can now be tested for their suitability as subunit vaccine candidates and diagnostic serological markers. Elton used the B. microti genome sequence to identify 54 genes that are predicted to encode surface-displayed and secreted proteins expressed. It was demonstrated that the proteins contain conformational, heat-labile, epitopes and use them to serologically profile the kinetics of the humoral immune responses to two strains of B. microti in a murine infection model. Using sera from validated human infections, we show a concordance in the host antibody responses to B. microti infections in mouse and human hosts. Finally, Elton shows that BmSA1 expressed in mammalian cells can elicit high antibody titers in vaccinated mice using a human-compatible adjuvant. Their library of recombinant B. microti cell surface and secreted antigens constitutes a valuable resource that could contribute to the development of a serological diagnostic test and vaccines (see abstract).
Further, Elton discloses that the proteins are administered with adjuvants (see page 120 section 3.5; claim 11). Here, we have used the genome sequence of B. microti R1 strain to compile a panel of recombinant proteins that represents the repertoire of cell surface and secreted proteins for the blood stage antigens of B. microti. We have focused on extracellular proteins because they are directly accessible to the host immune system and thus are considered attractive vaccine targets and serological diagnostic markers (see page 122; Table 1; composition 105; SEQ ID NOs: 1, 3, 6, 7 and 50; all preceding paragraphs meeting claims 1-3, 6 and 8).
Highlighted below in order:
SEQ ID NO: 6
SEQ ID NO: 1
SEQ ID NO: 50
SEQ ID NO: 3
SEQ ID NO: 7
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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.
Applicant argues that:
1) Several of these proteins are listed in Table 1 of the reference, but there are no indications of combinations at all, not to mention those of the present claims. Additionally, the species under examination are compositions comprising two or more specifically listed B. microti sequences. The Office action does not indicate wherein in Elton compositions are not described by Elton.
Applicant’s arguments have been fully considered, but are deemed non-persuasive.
With regard to Point 1, claims 6, 8 and 48 only require, in part, a Bm antigen of SEQ ID NO: 49, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 50, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 51, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 52, or an antigenic variant and/or antigenic fragment thereof; a Bm antigen of SEQ ID NO: 53, or an antigenic variant and/or antigenic fragment thereof; and/or a Bm antigen of SEQ ID NO: 54, or an antigenic variant and/or antigenic fragment thereof. The Office takes the position that the two or more is an alternative option and not a requirement of the rejected claims. With that said, Elton discloses antigens of B. microti selected from SEQ ID NO 1, 6 and 50 as identified in Table 1, which are highly immunoreactive and are tested for vaccine candidacy.
New Grounds of Objection and Rejection Necessitated by Amendment
Claim Objections
10. Applicant is advised that should claim 6 be found allowable, claim 48 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Conclusion
11. No claim is allowed.
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
13. 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, Daniel Kolker can be reached at (571) 272-3181. 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 March 24, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645