DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on 07/25/22 and 08/27/25 were filed and entered. The submissions are in compliance with the provisions of 37 CFR 1.97 and have been considered by the Examiner.
Election/Restrictions
3. Applicant’s election, without traverse, of Group I and SEQ ID NO: 2, in the reply filed on 08/27/25, is acknowledged. However, upon further consideration, the sequence election is withdrawn and SEQ ID NO: 1-24 will be considered.
Claim Status
4. Claims 1-5, 10-13, 18, 20, 22, 27, 29-31, 39, 41, 43, and 45 are pending and under consideration. Claims 6-9, 14-17, 19, 21, 23-26, 28, 32-38, 40, 42, 44, and 46-47 are cancelled. Claims 5, 10- 13, 18, 20, 22, 27, 29-31, 39, 41, and 45 are amended. Claims 18, 22, 27, 29-31, 39, 41, and 43 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/27/25. Claims 1-5, 10-13, 20, and 45 are under examination.
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 20 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Accordingly, clarification is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-5, 10-13, 20, and 45 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Instant claims are drawn to compositions comprising (a) one or more Babesia microti (Bm) antigens that comprise an amino acid sequence having at least 90%-95% sequence identity to the amino acid sequences of any one of SEQ ID NOs: 1-24, or one or more antigenic fragments thereof; and (b) a pharmaceutically acceptable carrier or diluent. The asserted utility of the claimed composition is to confer protective immunity and/or immunization against babesiosis in a subject in need thereof (e.g. see page 3, lines 20-22; and page 16, line 29 to page 17, line 15).
Consequently, it is the Office’s position that (1) the claim(s) constitute(s) a "broad generic claim” based on the lack of 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) and/or “one or more” antigens in a composition; and (2) 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 polypeptide 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 the claimed function to be maintained (e.g. confer protective immunity and/or immunization against babesiosis). It is noted that while the description of the ability of a claimed polypeptide antigen sequence may generically describe that molecule's function, it does not describe the molecule itself. For example, the specification fails to identify critical amino acids or subsequences within each of SEQ ID NOs: 1-24 that must be retained in order to maintain the claimed 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, 90-95% 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. Thus, disclosure of function alone is little more than a wish for possession and it does not satisfy the written description requirement; See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Further, MPEP §2163 states that if a biomolecule is described only by a functional characteristic (as in the instant case), without any disclosed correlation between function and structure of the sequence (as in the instant case), it is not sufficient for written description purposes, even when accompanied by a method of obtaining the claimed sequences; emphasis added. MPEP §2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. For example, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g. see In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618). Further, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "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).
In the instant case, the specification describes that there are currently no vaccines or prophylactic antibiotic regimens for treating and/or protection against human babesiosis (i.e. a developing and thus necessarily unpredictable art; e.g. page 1, lines 20-30). The specification reports 24 Babesia microti antigens which displayed IgG reactivity during the resolution of B. microti infection in cd4-deficient mice, of which, 16 antigens were identified as lgG reactive at time of peak infection; and of the antigens identified as gaining IgG reactivity from time of peak infection to time of partial resolution, only 7 were not reactive at time of peak infection; of the antigens identified as gaining IgG reactivity from time of partial resolution to time of full resolution, only 1 antigen was not reactive at time of peak infection or had not gained reactivity by time of partial resolution; and that among these 24 distinct antigens, 15 are predicted to lack a signal peptide and are referred to as “group #3 antigens”; of the 9 antigens predicted to contain a signal peptide, only 3 had an IgG reactivity which was inversely correlated with parasitemia at time of peak infection or time of partial resolution; and that these 3 antigens are referred to as “group #1 antigens” while the other 6 antigens are referred to as “group #2 antigens” as they are predicted to contain a signal peptide but displayed IgG reactivity at time of peak infection or partial resolution which was not inversely correlated with parasitemia measured at the respective time point (see Figure 19). The specification states “Any of the 24 distinct antigens, which are listed in Figure 20, may be used individually or in combination as a Bm antigen vaccine to confer protection from babesiosis…” (e.g. see page 54, lines 13-15); however, the specification does not adequately support this statement. For example, several of the sequences are identified as “unknown function” and several of them were not identified as reactive at peak (e.g. see Figures 16 and 20).
Accordingly, the specification provides complete structural information for SEQ ID NOs: 1-24 (see Table 1); however, the claims, as written, also encompass partial structures of SEQ ID NO: 1-24 (e.g. antigenic fragments, 90-95% sequence variants, fragments of variants and/or variants of the fragments) with the ability to confer protective immunity and/or immunization against babesiosis in a subject in need thereof. However, the specification does not adequately describe these partial structures. The specification does not adequately describe compositions comprising as little as one, but as many as 24, of the antigens per se, and/or the partial structures thereof, wherein the composition conferred protective immunity and/or immunization against babesiosis in any subjects. Further, the specification states only 16 antigens were identified at time of peak infection as exhibiting an IgG reactive (e.g. see Example 3; Figure 10).
Consequently, the specification also does not provide adequate written description to identify the broad and variable genus of the claims because, inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the genus as there appears to be only one “species” (i.e. one example) sufficiently described for each of the 24 Bm antigens claimed (i.e. SEQ ID NO: 1-24), but no compositions comprising as little as one but up to 24 of the antigens (or the variants or fragments thereof) and the functional ability to confer protective immunity. It is noted that there are more than 15 million unique ways to select one to 24 sequences for the compositions claimed (i.e. ∑1-24 for [x = n!/(r!(n-r)!)] equals 16,847,195 different combinations) and this calculation does not account for variants and fragments that would dramatically increase the number of combinations allowed to an almost uncountable number.
Accordingly, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of (1) the numerous antigenic fragments, 90-95% sequence variants, fragments of variants and/or variants of the fragments with both the claimed structural attributes and functional properties and/or (2) compositions having as little as 1 but up to 24 antigens and the ability to confer protective immunity, have not yet been identified. MPEP 2163 which states an adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed; see, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Accordingly, it is the Office’s position that one of skill in the art would not accept the disclosure of one fully described sequence for each of the 24 options as either a sufficient number and/or variety of “representative species” for all of the antigenic fragments, 90-95% sequence variants, fragments of variants and/or variants of the fragments and/or the millions and millions of combinations encompassed by “…one or more Babesia microti (Bm) antigens…”), encompassed by the broad and variable generic claims. Therefore, it is the Office’s position that one of skill in the art would not conclude that Applicant was in possession of the entire genus.
With regards to the state of the art at the time of filing, developing antigens for compositions for protective immunity against babesiosis was under development and thus, necessarily unpredictable, as evidenced by, for example Verma et al. 2017 (Genome-wide search to identify immunodominant babesia microti antigens for diagnostics and vaccination; American Journal of Tropical Medicine and Hygiene; Vol. 95, No. 5, Supp. Supplement 1, pp.174. Abstract Number: 552) which teaches there is no FDA-licensed vaccine to ameliorate parasite burden and clinical disease and no laboratory test for diagnosis of acute infection or for screening of blood donors; and in spite of the recent availability of the full genome sequence of Babesia microti, there is a scarcity of well-defined, immunodominant B. microti antigens for vaccine efficacy studies (see abstract). Similarly, Krause et al. 2019 (Human babesiosis; International Journal for Parasitology 49: 165-174) teaches no human Babesia vaccines have been developed and even the prospect for a near-term development of such a vaccine is remote (e.g. see section 7). Thus, the state of the art provides evidence for a lack of an art-recognized structure-function correlation for antigenic polypeptides used alone or in combinations and/or for 90-95% sequence variants and/or antigenic fragments thereof. Accordingly, the state of the art supports that even the skilled artisan requires guidance on the critical structures of the polypeptide antigen per se (e.g. its sequence and/or critical domains within its sequence) and therefore does not provide adequate written description support for which structural features of each polypeptide antigen would predictably retain their functional activity (i.e. the state of the art is not sufficient to identify which amino acids must be conserved in a fragment or variant in order to maintain the claimed functions).
Consequently, neither the specification nor the state of the art provides sufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.). Given the above analysis of the factors as a whole, which the courts have determined are critical in determining whether Applicant is in possession of or the specification supports the claimed invention, Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
9. Claims 1-5, 10-13, 20, and 45 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required, are set forth in In re Wands, 8 USPQ2d 1400. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims. Although all the factors were considered, the most relevant ones are discussed below. In the instant case:
Nature of the invention: The nature of the invention is/are compositions comprising (a) one or more Babesia microti (Bm) antigens that each comprise an amino acid sequence having at least 90%-95% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 1-24, or one or more antigenic fragments thereof; and (b) a pharmaceutically acceptable carrier or diluent. Therefore, the nature of the invention is a chemical case, where there is natural unpredictability in performance of certain species or sub-combinations other than those specifically enumerated; see MPEP 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the full scope of the claimed invention, with a reasonable expectation of success, because it would not be predictable from the disclosure of one particular species (e.g. a fully described sequence) what other species (e.g. sequence variations and/or antigenic fragments thereof) may or may not work; MPEP 2164.03.
Breadth of the claims: The broadest reasonable interpretation of the claims covers an astronomical number of distinct compositions comprising countless different partial structures (i.e. antigenic fragments, 90-95% sequence variants, fragments of variants and/or variants of the fragments of SEQ ID NOs 1-24) of the claimed sequences mixed-and-matched in combinations of one to 24 antigens for the asserted utility of conferring protective immunity and/or immunization against babesiosis in a subject in need thereof. It is noted that there are more than 15 million unique ways to select one to 24 sequences for the compositions claimed (i.e. ∑1-24 for [x = n!/(r!(n-r)!)] equals 16,847,195 different combinations) and this calculation does not account for variants and fragments that would dramatically increase the number of combinations allowed to an almost uncountable number. However, without guidance on which of the structural components are required (i.e. which amino acids within the sequences must be conserved) to maintain these claimed functions and without a disclosed correlation between function and structure, undue experimentation would be required to determine which of the numerous options and combinations of options actually work. Accordingly, undue experimentation would be required to practice the full scope of the claimed invention, with a reasonable expectation of success, because while enablement is not precluded by the necessity for routine screening, if a large amount of screening is required, the specification must provide a reasonable amount of guidance with respect to the direction in which the experimentation should proceed and such guidance has not been provided in the instant specification (see below).
Amount of direction provided by Inventor and Existence of Working Examples: The specification states that there are currently no vaccines or prophylactic antibiotic regimens for treating and/or protection against human babesiosis (i.e. a developing and necessarily unpredictable art; e.g. page 1, lines 20-30). The specification reports 24 Babesia microti antigens which displayed IgG reactivity during the resolution of B. microti infection in cd4-deficient mice, of which, 16 antigens were identified as lgG reactive at time of peak infection; and of the antigens identified as gaining IgG reactivity from time of peak infection to time of partial resolution, only 7 were not reactive at time of peak infection; of the antigens identified as gaining IgG reactivity from time of partial resolution to time of full resolution, only 1 antigen was not reactive at time of peak infection or had not gained reactivity by time of partial resolution; and that among these 24 distinct antigens, 15 are predicted to lack a signal peptide and are referred to as “group #3 antigens”; of the 9 antigens predicted to contain a signal peptide, only 3 had an IgG reactivity which was inversely correlated with parasitemia at time of peak infection or time of partial resolution; and that these 3 antigens are referred to as “group #1 antigens” while the other 6 antigens are referred to as “group #2 antigens” as they are predicted to contain a signal peptide but displayed IgG reactivity at time of peak infection or partial resolution which was not inversely correlated with parasitemia measured at the respective time point (see Figure 19). The specification states “Any of the 24 distinct antigens, which are listed in Figure 20, may be used individually or in combination as a Bm antigen vaccine to confer protection from babesiosis…” (e.g. see page 54, lines 13-15); however, the specification does not adequately support this statement. For example, several of the sequences are identified as “unknown function” and several of them were not identified as reactive at peak (e.g. see Figures 16 and 20).
Accordingly, the specification provides complete structural information for SEQ ID NOs: 1-24 (see Table 1); however, the claims, as written, also encompass partial structures of SEQ ID NO: 1-24 (e.g. antigenic fragments, 90-95% sequence variants, fragments of variants and/or variants of the fragments) with the ability to confer protective immunity and/or immunization against babesiosis in a subject in need thereof. However, the specification does not sufficiently disclose these partial structures. The specification does not sufficiently disclose compositions comprising as little as one but as many as 24 of the antigens per se, and/or the partial structures thereof, wherein the composition conferred protective immunity and/or immunization against babesiosis in any subjects. Further, the specification states only 16 antigens were identified at time of peak infection as exhibiting an IgG reactive (e.g. see Example 3; Figure 10). Therefore, the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification and the only way to determine if the functional property of an antigenic fragment or sequence variant is indeed retained, is empirical testing of each and every option encompassed. Consequently, based on the almost unfathomable number of possibilities, a non-routine amount of experimentation would be required to practice the invention, with a reasonable expectation of success, because testing such a vast number of options would be easily recognized by the skilled practitioner to be disproportionately demanding and thus rise to the level of non-routine.
State of the Prior Art and Level of Predictability in the Art: With regards to the state of the art at the time of filing, developing antigens for compositions for the protective immunity against babesiosis was under development and thus, necessarily unpredictable, as evidenced by, for example Verma et al. 2017 (Genome-wide search to identify immunodominant babesia microti antigens for diagnostics and vaccination; American Journal of Tropical Medicine and Hygiene; Vol. 95, No. 5, Supp. Supplement 1, pp.174. Abstract Number: 552) which teaches there is no FDA-licensed vaccine to ameliorate parasite burden and clinical disease and no laboratory test for diagnosis of acute infection or for screening of blood donors; and in spite of the recent availability of the full genome sequence of Babesia microti, there is a scarcity of well-defined, immunodominant B. microti antigens for vaccine efficacy studies (see abstract). Similarly, Krause et al. 2019 (Human babesiosis; International Journal for Parasitology 49: 165-174) teaches no human Babesia vaccines have been developed and even the prospect for a near-term development of such a vaccine is remote (e.g. see section 7). Consequently, the claims are not enabled because even the skilled artisan cannot make and use the invention, with a reasonable expectation of success, without an undue amount of experimentation, based on the astronomically vast number of sequence variations and/or antigenic fragments, used alone or in an almost infinite number of combinations of “one or more”.
Relative Skill of Those in the Art: The relative level of skill of those in the art is deemed to be high (e.g. PhD level); however, even one of skill in the art could not predictably extrapolate the teachings in the specification, limited to SEQ ID NO: 1-24, to all of the other variants, antigenic fragments, fragments of variants , variants of fragments of SEQ ID NO: 1-24 in the millions and millions of unique combinations (see math above), having the ability to confer protective immunity against Babesia in a subject, as broadly as is claimed. The skilled artisan simply cannot envision the structures required, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method used to determine such structures and/or combinations of structures and/or to test for such properties, after the fact. Thus, even one of skill in the art, would have to engage in undue experimentation to determine which options and/or combination of options retain the necessary functional properties and thereby carry out the invention as claimed.
Quantity of Experimentation Necessary Based on Content of the Disclosure: The specification does not enable the genus because where the results are unpredictable, the disclosure of a single species (i.e. a single, well-defined sequence for each polypeptide antigen but no examples of compositions comprising as little as one of them having the ability to confer protective immunity against babesiosis) usually does not provide an adequate basis to support generic claims. This is because it is not obvious from the disclosure of one particular species, what other species will work; see MPEP 2164.03. One of skill in the art would neither expect nor predict the appropriate functioning of the numerous variants and antigenic fragments, alone or in combination, and accordingly, without such guidance, the experimentation left to those skilled in the art is unnecessarily and improperly extensive and undue. It is noted that providing methods for determining the functional properties of the variants and/or antigenic fragments and/or the one or more antigens per se, would not reduce the amount of experimentation required because the functional properties still must be determined empirically.
Therefore, in view of the lack of guidance and direction provided by Applicant there would be undue experimentation required to practice the claimed partial structures (e.g. sequence variations and antigenic fragments) and/or the claimed compositions with as little as one antigen but up to 24 haphazardly mixed-and-matched, with a reasonable expectation of success, absent a specific and detailed description in Applicant's specification of how to effectively make and/or use the invention.
Consequently, it is the Office’s position that Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102
10. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
11. 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.
12. Claims 1, 2, 4, 5, 10, 11, 13, 20 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al. 2003 (US 2003/0109689 A1).
Reed teaches methods, kits, and immunogenic compositions comprising physiologically acceptable carriers and one or more Babesia microti antigens including a 98.6% match to instant SEQ ID NO: 1 (e.g. see abstract; [0006, 0015]; and first alignment to Reed SEQ ID NO: 211 below; meeting limitations found in instant claims 1, 2, 4, 10, and 45).
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Reed teaches a different 92% match to instant SEQ ID NO: 1 (see second alignment to Reed SEQ ID NO: 86 below); meeting limitations found in instant claim 5.
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Reed teaches compositions formulated for oral administration (e.g. see [0083]; meeting limitations found in instant claim 20).
Therefore, Reed anticipates the invention as claimed.
Double Patenting
13. 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.
14. Claims 1-5, 10-13, 20, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11, 29, and 31 of copending Application No. 17/831012 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to substantially similar compositions comprising substantially the same polypeptide antigens from Babesia microti.
For example, instant claims are drawn to kits and compositions comprising (a) one or more Babesia microti (Bm) antigens that comprise an amino acid sequence having at least 90%-95% sequence identity to the amino acid sequences of any one of SEQ ID NOs: 1-24.
Similarly, co-pending claims are drawn to kits and compositions comprising 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; and wherein the tables include compositions comprising for example SEQ ID NOs: 1 and 2 (composition 1); 1, 3 and 5 (composition 3); 1-7 (composition 16); etc. see Table 2.
Therefore, the instant and co-pending claims encompass substantially the same antigens in substantially the same compositions (e.g. a composition comprising SEQ ID NOs 1-7) and are thereby not patentably distinct. However, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached on (571)-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
October 3, 2025