DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II, claims 11-20, and the Species: proteins Salp14, Salp26A, TSLPI, IsPDIA3, TIX5, P32, and SG27, in the reply filed on May 11, 2026 is acknowledged. The traversal is on the ground(s) that the claims recite a proper Markush group. Applicants also argue that it would not place a serious burden for the Examiner to examine all of the claims int their entirety.
This has been fully and carefully is not found persuasive because the claims are rejected below for being an improper Markush grouping. Applicants can see the rationale below. Additionally, the claims recite a composition with so many potential different combinations of different proteins with different immune responses, different structures, etc., it would place a serious burden to examine all of these species and potential combinations as well as each single valent individual protein composition, together.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-20 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.
Claims 11-20 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the 19 different proteins as a possible single valent composition and the 19 different proteins in any possible combination, e.g., 3 of the proteins, 6 of the proteins, 4 of the proteins, in all different combination, is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The proteins possess different structure and they do not have a common use, as their “use” is to provide a therapeutic immune response and each different composition would produce a different immune response which could not be predicted. It is well known in the prior art that combination/multivalent vaccines are highly unpredictable. Reduced immunogenicity can occur when multiple antigens are delivered as mixtures. In this situation, the immune system can become overloaded, resulting in an impaired response to any vaccine component. The combination several different antigens into a single multivalent injection may result in competition among the different components and adversely affect the immunogenicity of any individual component. See Fattom et al. Vaccine Vol. 17, Number 2, January 1999, pp. 126-133(8) and NIH GUIDE, Volume 22, Number 28, Multicomponent Vaccine Development, August 6, 1993. The instant specification has not provided results with any of the multitude of combination vaccines recited in instant claims 6-9. Given the inherent unpredictability of combination vaccines combined with the very large and divergent group of antigens recited in the claims, the claims do not constitute a proper Markush grouping.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use, i.e., elicit the same immune response.
Claims 11-15 are vague and indefinite because the mere recitation of a name, i.e., Salp14, Salp26A, TSLPI, IsPDIA3, TIX5, P32, and SG27, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. These terms constitute laboratory designations and do not convey any particular structure. The claim should provide any structural properties, such as the amino acid sequence of the protein, which would allow for one to identify the protein without ambiguity. The mere recitation of a name does not adequately define the claimed protein(s). Further, while the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claims 12, 14 and 15 are vague and indefinite because the claims recite “wherein the at least one tick-salivary protein comprises” followed by a list of proteins. This makes it unclear if only one tick-salivary protein is to be included in the scope of the claim or if all of the recited proteins are intended to be included. The use of the term “at least one” appears to mean just that, that the claim only requires one of the recited proteins. This is how the claims are being interpreted. NOTE: If claims 14 and 15 are limited to all of the proteins listed therein, they are a non-elected species (though as, stated above, they are part of an improper Markush rejection). Appropriate clarification and/or correction is required.
Claim 17 is vague and indefinite due to use of parentheticals and the phrase “equivalent to MF59”. The metes and bounds of this are not readily understood. It is also unclear if this means “addavax” is equivalent to MF59 or if the claim intends to encompass any adjuvant which may have any equivalency in any manner to MF59.
Additionally, “addavax” is a trademark/trade name. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific adjuvant composition and, accordingly, the identification/description is indefinite.
Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-15 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural process without significantly more. The claim(s) recite(s) composition comprising at least one tick salivary protein. This judicial exception is not integrated into a practical application because animals can acquire tick immunity naturally through tick bites and said bites necessarily contain the recited salivary proteins. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because said claims merely require the “administration” of tick salivary proteins. While claim 19 recites various routes of administration, said routes do not constitute “significantly” more as a tick bite subcutaneously administer saliva (and consequently tick salivary proteins). Given that there is no limitation regarding the structure of the tick salivary proteins they necessarily encompass naturally occurring tick salivary proteins. Further, “for generating tick immunity” (claim 20) is an intended use only, a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, there must be a structural difference between the claimed product or it meets the claim. A “pharmaceutically acceptable carrier” (claim 18) reads on water and therefore would be inherent in the preparation of the compositions.
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.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kantor et al (US 20010046499 A1; published November 29, 2001).
Kantor teaches compositions and methods for conferring immunity to tick bites and for the prevention of tick-borne diseases. See abstract. Paragraph [0004] recites that the invention also relates to vaccines or pharmaceutical compositions comprising one or more of the polypeptides or antibodies of this invention. Also within the scope of this invention are diagnostic kits comprising a polypeptide, nucleic acid or antibody of this invention. Paragraph [0075] recites that in preferred embodiments, the invention provides fifteen novel I. scapularis polypeptides and compositions and methods comprising the polypeptides. More specifically, this invention provides a Salp9 polypeptide, a Salp10 polypeptide, a Salp13 polypeptide, a Salp14A polypeptide, a Salp14B polypeptide, a Salp15 polypeptide, a Salp16A polypeptide, a Salp17 polypeptide, a Salp20 polypeptide, a Salp25A polypeptide, a Salp25B polypeptide, a Salp25C polypeptide, a Salp25D polypeptide, a Salp26A polypeptide, and a Salp26B polypeptide. Paragraph [0076] Also within the scope of the invention are polypeptides that are at least 75% homologous in amino-acid sequence to the aforementioned polypeptides. In preferred embodiments, the polypeptides are at least 80%, 85%, 90% or 95% homologous in amino-acid sequence to an amino-acid sequence set forth herein. In more preferred embodiments, the homologous polypeptides have the biological activity or activities of the tick polypeptides of the invention. Paragraph [0099] As used herein, an "I. scapularis polypeptide" T is a polypeptide encoded by a DNA sequence of I. scapularis. For example, I. scapularis polypeptides include but are not limited to the Salp9 polypeptide, Salp10 polypeptide, Salp13 polypeptide, Salp14A polypeptide, Salp14B polypeptide, Salp15 polypeptide, Salp16A polypeptide, Salp17 polypeptide, Salp20 polypeptide, Salp25A polypeptide, Salp25B polypeptide, Salp25C polypeptide, Salp25D polypeptide, Salp26A polypeptide, and Salp26B polypeptide provided herein, and fragments or derivatives thereof. Paragraph [0201] teaches the compositions may include pharmaceutically acceptable carriers and adjuvants which are known to those of skill in the art. These carriers and adjuvants include, for example, RIBI, ISCOM, ion exchangers, alumina, aluminum stearate, lecithin, serum proteins, such as human serum albumin, buffer substances, such as phosphates, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts or electrolytes such as protamine sulfate, disodium hydrogen phosphate, sodium chloride, zinc salts, colloidal silica, magnesium trisilicate, polyvinyl pyrrolidone, cellulose-based substances, and polyethylene glycol. Adjuvants for topical or gel-base forms may be selected from the group consisting of sodium carboxymethylcellulose, polyacrylates, polyoxyethylene-polyoxypropylene-b- lock polymers, polyethylene glycol, and wood wax alcohols. Paragraph [0204] teaches that any pharmaceutically acceptable dosage route, including parenteral, intravenous, intramuscular, intralesional or subcutaneous injection, may be used to administer the polypeptide or antibody composition. For example, the composition may be administered to the patient in any pharmaceutically acceptable dosage form including those which may be administered to a patient intravenously as bolus or by continued infusion over a period of hours, days, weeks or months, intramuscularly--including paravertebrally and periarticularly--subcutaneously, intracutaneously, intra-articularly, intrasynovially, intrathecally, intralesionally, periostally or by oral or topical routes. Preferably, the compositions of the invention are in the form of a unit dose and will usually be administered to the patient intramuscularly. Claims 34-37 of the reference teach methods of conferring tick immunity comprising administering said polypeptides. NOTE: as stated in the 112, second paragraph rejection above, the use of the term “at least one” in claims 12, 14 and 15, is interpreted to mean that the claim only requires one of the recited proteins listed.
Claim(s) 11, 12 and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fikrig et al. (WO 2004/019883).
Fikrig et al. disclose the use of compositions comprising tick salivary proteins to induce tick immunity (see paragraph [0040]). Fikrig et al. further discloses that said salivary proteins can include Salp14 (see paragraph [0036]); that said compositions can be multicomponent vaccines comprising multiple salivary proteins (see paragraphs [0051] and [0069]-[0071]); that said compositions can comprise an adjuvant such as incomplete Freund’s adjuvant (see paragraphs [0081] and [0121]; that said compositions can be administered to a patient parentally, intravenously, intramuscularly, intralesionally, subcutaneously, periostally, orally or by topical routes (see paragraphs [0129] and [0146]); and that said compositions can be administered to any mammal including humans (see paragraph [0129]). NOTE: as stated in the 112, second paragraph rejection above, the use of the term “at least one” in claims 12, 14 and 15, is interpreted to mean that the claim only requires one of the recited proteins listed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kantor et al (US 20010046499 A1; published November 29, 2001) and Fikrig et al. (WO 2004/019883) in view of Schuijt et al. (Cell Host and Microbe, Vol. 10, pages 136-146) and Embers et al. (Frontiers in Cellular and Infection Microbiology, Vol. 3 Article 6, pages 1-15).
The teachings of the Kantor and Fikrig references are disclosed above. However, they do not explicitly disclose the TSLPI tick salivary protein in their compositions.
Schuijt et al. disclose the use of recombinant TSLPI protein to immunize mice (see page 6) and that TSLPI has potential as a component in a multivalent tick protein-based vaccine (see page 9).
Embers et al. disclose the both TSLPI protein and Salp14 would be useful in combination vaccines against ticks (see page 7).
It would have been obvious for the skilled artisan to utilize the TSLPI protein of Schujit and Embers et al. in the vaccine compositions of Fikrig et al. in order to take advantage of the protective capabilities of the TSLPI protein.
One would have had a reasonable expectation of success as Fikrig et al. discloses that their multicomponent vaccine can comprise other protective tick polypeptides (see paragraph [0070]) and Embers et al. disclose that the TSLPI protein would be a good component in a multicomponent vaccine (see page 7).
Moreover, the courts have determined that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Consequently, given the compositions of the cited references are for the same use, combining them in a single composition for that use is deemed to be obvious.
Claim Rejections - 35 USC § 112-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejected claims are drawn to compositions comprising a therapeutically effective amount of tick-salivary proteins (i.e. Salp 10, Salp14, Salp15, Salp25A, Salp25D, TSLPI. TIX5, etc.). There is no limitation with regard to the sequence of any of the tick salivary proteins nor the tick species from which they are derived.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of vaccines, Applicant must adequately describe the immunoepitopes within a given tick salivary protein that induce a protective immune response against a given species. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of vaccines to which the claims are drawn, such as a correlation between the structure of the immunogen (the sequence of the tick salivary proteins generally and the sequences of the tick salivary proteins specifically (Salp14, Salp26A, TSLPI, IsPDIA3, TIX5, P32, and SG27) and its recited function (inducing a protective immune response against a given tick species), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of vaccines. The specification, however, does not disclose any structure associated with the other recited salivary proteins nor does it disclose the use of any tick salivary protein to induce a protective response to any other tick species. As set forth supra, the specification fails to provide a baseline sequence for any of the encompassed tick salivary proteins and is equally silent with regard which amino acid residues in a given tick salivary protein are essential for the induction of a protective immune response against a given tick species, or which amino acids might be added, replaced or deleted so that the resultant polypeptide retains the immunological characteristics of its parent. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of polypeptides to which the claims refer; and accordingly, the specification fails to adequately describe at least a substantial number of members of the claimed genus of vaccines. The specification discloses that the term “tick-immunity” refers an immune response against antigens involved in tick feeding and that this response may include or be characterized by shorter tick feeding times and/or lower engorgement weight. The specification further discloses that hosts possessing tick-resistance or tick immunity may be less susceptible to or immune from tick- bite transmitted pathogens and conditions, including but not limited to Lyme disease,
Anaplasma phagocytophilum, Powassan virus, A. phagocytophilum and Babesia microti. Finally, the specification discloses that the term "tick-salivary protein" refers to any protein present in tick saliva. Consequently, the instant claims encompass the use of any combination of tick-salivary proteins to induce “tick immunity” (which includes a protective immune response) to any and all tick species. The term “vaccinate” is defined as the use of a specific antigen to induce protective immunity to infection or disease induction. The specification does not provide substantive evidence that the claimed vaccines are capable of inducing a directed or protective immunity against a given tick salivary protein. This demonstration is required for the skilled artisan to be able to use the claimed vaccines for their intended purpose of limiting or preventing tick feeding. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed vaccines, i.e. would not be able to accurately predict if given immune response has been induced. The ability to reasonably predict the capacity of a single tick immunogen to induce a given immune response (e.g. protective immunity) from in vitro antibody reactivity studies is problematic. Ellis (Vaccines, W.B. Saunders Company, Chapter 29, 1988, pages 568-574) exemplifies this problem in the recitation that "the key to the problem (of vaccine development) is the identification of the protein component of a virus or microbial pathogen that itself can elicit the production of protective antibodies"(page 572, second full paragraph). Unfortunately, the art is replete with instances where even well characterized antigens that induce an in vitro neutralizing antibody response fail to elicit in vivo protective immunity. See Boslego et al (Vaccines and Immunotherapy, 1991, Chapter 17), wherein a single gonococcal pillin protein fails to elicit protective immunity even though a high level of serum antibody response is induced (page 212, bottom of column 2). Accordingly, the art indicates that it would require undue experimentation to formulate and use a successful vaccine without the prior demonstration of vaccine efficacy.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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 Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"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)”
And:
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, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
As evidenced by the teachings of Skolnick et al., the art is unpredictable. Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000) discloses the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (see, e.g., the abstract; and page 34, Sequence-based approaches to function prediction). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see, in particular, the abstract and Box 2). Thus, one skilled in the art would not accept the assertion, which is based only upon an observed similarity in amino acid sequence that a variant of a given polypeptide would necessarily have a given immunological property. The instant specification has failed to teach or disclose vaccine compositions comprising the claimed polypeptides that are capable of inducing a directed or protective immune response against a given tick species. The specification fails to teach or disclose data that demonstrates that the claimed vaccines can provide protection against infections caused by a given pathogen. There is no disclosure of subjects that have been immunized with the claimed vaccines nor is there a disclosure of challenge studies that have been conducted to establish the claimed vaccine’s ability to provide protection against a given tick species. Consequently, there is no correlation between structure and function as required by the Written Description requirement.
Therefore, because the art is unpredictable, in accordance with the, in accordance with the MPEP and the pertinent case law, the description of claimed polypeptides is not deemed representative of the genus of vaccines to which the claims refer.
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.
Claims 11-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-38 of copending Application No. 19/320,550.
Both sets of claims recite compositions comprising tick salivary proteins for use in generating tick immunity is a subject. Due to the language “comprising at least one of” in the instant claims, the scope of the claims overlap. Both sets of claims recite Salp10, Salp14, Salp15, Salp25D, TSLPI, etc. Co-pending claims 26-29 and 36-38 recite the same adjuvants, formulation/routes and pharmaceutically acceptable carrier as the instant claims. Accordingly, the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 7/1/26
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