Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed July 9, 2026, is acknowledged and has been entered. Claim 19 has been canceled.
Claims 1-10 and 19 are pending and are under examination.
Grounds of Rejection Withdrawn
Unless specifically reiterated below, the grounds of rejection set forth in the previous Office action have been obviated by Applicant's amendment.
Grounds of Rejection Maintained
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0134173 A1 (Tuohy et al, IDS) and US 2017/0202960 A1 (Brito et al, IDS).
Regarding claims 1, 6 and 19, Tuohy et al discloses a vaccine composition comprising: a) a polypeptide comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED) (para [0051], “The human AMHR2” and Figure 19, para [0053], "In certain embodiments of the methods, compositions and kits provided herein, the AMHR2 polypeptide has an amino acid sequence ... In some embodiments, the consecutive amino acids are identical to an amino acid sequence in the extracellular domain of AMHR2"(see Figure 19)); and b) an adjuvant comprising: oil and water emulsions, a surfactant and a buffer (para [0072], "Pharmaceutical compositions suitable for parenteral administration comprise AMHR2 polypeptides and/or nucleic acids described herein in combination with …emulsions ... buffers", para [0073] “surfactant” and para [0076] “oil and water emulsions” for induction of an immune response (see abstract).
Tuohy et al does not disclose using an oil that is squalene oil or a non-ionic surfactant in compositions for inducing an immune response, or the other limitations of claims 2-5 and 7-10.
Brito et al discloses relevant to claims 2-5 and 7-10, peptide vaccines for inducing an immune response using squalene oil, a non-ionic surfactant, and an emulsifier (para [0013] the invention relates to cationic oil-in-water emulsions that contain high concentrations of cationic lipids and have a defined oil:lipid ratio. The oil and cationic lipid are separate components of the emulsions, and preferably the oil is not ionic” and para [0016] “nonionic surfactant” and para [0148]. Brito et al disclose para [0067], "An exemplary cationic emulsion of the invention is referred herein as "CMF3." Wherein the oil of CMF32 is squalene (at 4.3% w/v) ... CMF32 also includes the surfactants SPAN85 (sorbitan trioleate) and Tween 80 (polysorbate 80) at 0.5% w/v Tween 80, 0.5% w/v SPAN85, see also (para [0130]-[0134]). Brito et al discloses the compositions comprise a citrate buffer with a “pH of about 6.2 to about 6.8” (para [0027]” Brito et al discloses the compositions with a first component that is squalene oil and emulsifier and a second component that is a buffer and nonionic surfactant in a nano-emulsion with a size of about 80 nm to 160 nm (para [0216]-[0223] and para [0275]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to combine these references and incorporate the adjuvants comprising squalene oil, polysorbate 80, sorbitan trioleate and citrate buffer of Brito et al into the oil and water vaccine emulsion of Tuohy et al comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain, which is negatively charged above a pH of 5.5 based on the sequence of Tuohy et al, to optimize the vaccines of Tuohy et al in order to create a nano-emulsion vaccine to induce an immune response in humans to human Anti-Mullerian Hormone Receptor Type II extracellular domain. Notably, Tuohy et al provides motivation to create into an oil and water vaccine emulsion comprising human Anti-Mullerian Hormone Receptor Type II extracellular domain, but does not specifically identify known oil and water vaccine emulsions which are defined by Brito et al, so one would have been motivated to use the teachings of Brito to make squalene oil and water vaccine nano-emulsions that are encompassed by the claims because the art taught that these components at such amounts can be used in squalene oil and water vaccine nano-emulsions at such pHs to create compositions useful for inducing an immune response.
In this case, with respect to the amounts of the components and pH of the composition, the art taught that the skilled artisan can readily determine the proper amount of the components and proper pH in an oil and water vaccine as evidenced by the prior art, so these compositions also would have been considered obvious, absent a showing otherwise. Notably, as evidenced by the references, these components of a vaccine were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the vaccine of Tuohy using the teaching of Brito would be seen as routine optimization, absent a showing otherwise, because one would see these limitations as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results. Furthermore, one of skill in the art would have expected success in making such compositions as the prior art of Brito et al discloses how to make such oil and water emulsions.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
Applicant has traversed the rejection arguing that “a POSA would not be motivated to use the nucleic acid vaccine formulation disclosed in Brito for the polypeptide vaccines of the instant claims.
In particular, the disclosure of Brito relates to formulations for negatively-charged nucleic acid-based vaccines (e.g., an RNA molecule encoding a protein or peptide, small
interfering RNA, self-replicating RNA). Brito suggests that "there is a need to develop delivery systems that can deliver sufficient amounts of nucleic acid molecules (in particular RNA molecules) in vivo to elicit a therapeutic response, but that are not toxic to the host." (Brito, para. [0004]). The disclosure of Brito aims to address this technical challenge by developing an oil and water emulsion comprising a cationic lipid. Thus, a required feature of the Brito formulation is the cationic lipid, which allows for more negatively charged molecules (such as RNA molecules) to be formulated with emulsion particles, thereby increasing the efficiency of delivery. For instance, Example 1 describes cationic nanoemulsions that contain high concentrations of cationic lipid (DOTAP) for delivery of self-replicating RNA. Brito does not teach or suggest that a formulation lacking a cationic lipid would be suitable for delivery of any type of molecule. Thus, there would be no reason to combine the nucleic acid vaccine formulation of Brito with the peptide vaccine of Tuohy.
In addition, the peptide vaccine demonstrates significant and unexpected results when combined with the adjuvant (referred to as 'AddaVaxT''). Treatment with AMHR2-ED in AddaVax led to high serum titers of IgG (FIG. 2) and infiltration of T cells in murine ovarian tumors (FIG. 4). In addition, treatment of ovarian tumor-bearing mice with AMHR2-ED in AddaVax significantly improved overall survival (FIG. 3B) and attenuated tumor growth in established tumors (FIG. 3C). These data show that the peptide vaccine in the instant application is significantly improved when combined with the AddaVax adjuvant”.
In response, the disclosure of Brito is not limited to nucleic acid-based vaccines and Brito discloses using peptide in their vaccines (see para [0148]). Notably, the claims recite comprising language and thus the claimed vaccines can include any other component such as a cationic lipid (DOTAP), so the claimed vaccine do not require a formulation lacking a cationic lipid. Furthermore, based on the sequence of Tuohy et al the human Anti-Mullerian Hormone Receptor Type II extracellular domain is negatively charged above a pH of 5.5, so one also would have been motivated to use the vaccine adjuvant components of Brito to make a human Anti-Mullerian Hormone Receptor Type II extracellular domain vaccine because these components would be seen as predictable components that would increase an immune response to the human Anti-Mullerian Hormone Receptor Type II extracellular domain.
Then with respect to Applicant’s argument that “the peptide vaccine demonstrates significant and unexpected results when combined with the adjuvant (referred to as 'AddaVaxT''”, it is noted that the argument has been found insufficient to overcome the outstanding 103 rejections for the following reasons.
First, it is noted that as set forth in MPEP 716.02(a) and MPEP 716.02(e) that evidence of unexpected results must compare the claimed invention with the closest prior art, but that has not been done here. See also In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art."). Here it is noted that the claimed invention has not been shown to generate unexpected results compared to the human Anti-Mullerian Hormone Receptor Type II extracellular domain vaccines of Tuohy et al.
Secondly, it is noted that as set forth in MPEP 716.02(d) the objective evidence must be commensurate in scope with the claimed invention. In this case, it is noted that the claims encompass any vaccine with a portion of an Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED); and b) an adjuvant comprising: i) squalene oil,I i) a non-ionic surfactant,iii) an emulsifier, and iv) a buffer, while AddaVax is a specific composition with i) Sorbitan trioleate (0.5%w/v) in squalene oil (5%v/v), and ii) Tween 80 (0.5% w/v) in sodium citrate buffer (10 mM, pH 6.5), where the nano-emulsion is produced using a microfluidizer and filtered through a 0.22-pm filter to remove large droplets with a particle size of ~ 160 nm, so it is not apparent that any results are commensurate in scope with the claimed invention.
Furthermore, the specification does not recite that the results are unexpected and the argument does not present scientific reasoning to establish the results are unexpected. The argument merely states that “Treatment with AMHR2-ED in AddaVax led to high serum titers of IgG (FIG. 2) and infiltration of T cells in murine ovarian tumors (FIG. 4). In addition, treatment of ovarian tumor-bearing mice with AMHR2-ED in AddaVax significantly improved overall survival (FIG. 3B) and attenuated tumor growth in established tumors (FIG. 3C). These data show that the peptide vaccine in the instant application is significantly improved when combined with the AddaVax adjuvant” without establishing how high serum titers of IgG or significantly improved overall survival is unexpected in view of the prior art vaccines of Tuohy et al.
Accordingly, it is noted that the interpretation of the evidence is merely attorney argument. As set forth in MPEP 716.01:
Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) ("It is well settled that unexpected results must. be established by factual evidence." See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See MPEP § 2145 generally for case law pertinent to the consideration of applicant's rebuttal arguments.
Therefore, while the arguments of counsel about the results being unexpected are noted and been considered, they were not found persuasive as no affidavit or declaration including statements regarding the expectations of one of ordinary skill has been submitted. Here the prior art discloses a peptide vaccine with the amino acid sequence of the extracellular domain of AMHR2 and b) an adjuvant comprising: oil and water emulsions, a surfactant and a buffer and the argument and evidence submitted by Applicant is not sufficient to establish that the results referred to are unexpected.. Notably, as set forth in MPEP 716.02(b) the burden is on Applicant to establish that the results are unexpected and significant. Here, there is just an allegation that the results are unexpected without more.
Accordingly, after careful and complete consideration of Applicant’s response and the record as a whole, for these reasons and the reasons set forth previously, this rejection is being maintained.
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 1-10 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US Patent 11,090,284 in view of US 2019/0134173 A1 (Tuohy et al, IDS) and US 2017/0202960 A1 (Brito et al, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent recite methods of treating ovarian cancer by administering a composition comprising a polypeptide comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED) and an adjuvant. The claims do not recite the instantly claimed adjuvant or the other limitations of the instant claims.
Regarding claims 1, 6 and 19, Tuohy et al discloses a composition comprising: a) a polypeptide comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED) (para [0051], “The human AMHR2” and Figure 19, para [0053], "In certain embodiments of the methods, compositions and kits provided herein, the AMHR2 polypeptide has an amino acid sequence ... In some embodiments, the consecutive amino acids are identical to an amino acid sequence in the extracellular domain of AMHR2"); and b) an adjuvant comprising: oil and water emulsions, a surfactant and a buffer (para [0072], "Pharmaceutical compositions suitable for parenteral administration comprise AMHR2 polypeptides and/or nucleic acids described herein in combination with …emulsions ... buffers", para [0073] “surfactant” and para [0076] “oil and water emulsions” for induction of an immune response (see abstract).
Tuohy et al does not disclose using an oil that is squalene oil or a non-ionic surfactant in compositions for inducing an immune response, or the other limitations of claims 2-5 and 7-10.
Brito et al discloses relevant to claims 2-5 and 7-10, peptide vaccines for inducing an immune response using squalene oil, a non-ionic surfactant, and an emulsifier. (para [0013] the invention relates to cationic oil-in-water emulsions that contain high concentrations of cationic lipids and have a defined oil:lipid ratio. The oil and cationic lipid are separate components of the emulsions, and preferably the oil is not ionic” and para [0016] “nonionic surfactant” and para [0148]. Brito et al disclose para [0067], "An exemplary cationic emulsion of the invention is referred herein as "CMF3." Wherein the oil of CMF32 is squalene (at 4.3% w/v) ... CMF32 also includes the surfactants SPAN85 (sorbitan trioleate) and Tween 80 (polysorbate 80) at 0.5% w/v Tween 80, 0.5% w/v SPAN85, see also (para [0130]-[0134]). Brito et al discloses the compositions comprise a citrate buffer with a “pH of about 6.2 to about 6.8” (para [0027]” Brito et al discloses the compositions with a first component that is squalene oil and emulsifier and a second component that is a buffer and nonionic surfactant in a nano-emulsion with a size of about 80 nm to 160 nm (para [0216]-[0223] and para [0275]).
Therefore, in view of the patented claims and the references, it would have obvious to one of ordinary skill in the art to make compositions of the patent further wherein the adjuvant incorporates squalene oil, polysorbate 80, sorbitan trioleate and citrate buffer of Brito et al into the oil and water vaccine emulsion of Tuohy et al comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain to optimize the vaccines of Tuohy et al in order to create a nano-emulsion vaccine to induce an immune response in humans to human Anti-Mullerian Hormone Receptor Type II extracellular domain that can be used in the methods of the patent. Notably, the patent provides motivation to make compositions comprising human Anti-Mullerian Hormone Receptor Type II extracellular domain and an adjuvant and Tuohy et al provides motivation to create into an oil and water vaccine emulsion comprising human Anti-Mullerian Hormone Receptor Type II extracellular domain, but does not specifically identify known oil and water vaccine emulsions which are defined by Brito et al, so one would have been motivated to use the teachings of Brito to make squalene oil and water vaccine nano-emulsions that are encompassed by the claims because the art taught that these components at such amounts can be used squalene in oil and water vaccine nano-emulsions at such pHs to create compositions useful for inducing an immune response.
In this case, with respect to the amounts of the components and pH of the composition, the art taught that the skilled artisan can readily determine the proper amount of the components and proper pH in an oil and water vaccine as evidenced by the prior art, so these compositions also would have been considered obvious, absent a showing otherwise. Notably, as evidenced by the references, these components of a vaccine were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the vaccine of the patented claims using the teachings of Tuohy and Brito would be seen as routine optimization, absent a showing otherwise, because one would see these limitations as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results. Furthermore, one of skill in the art would have expected success in making such compositions as the prior art of Brito et al discloses how to make such oil and water emulsions.
Accordingly, one of skill in the art would consider the instant claims as an obvious variation of the patented claims, as evidenced by the references.
Claims 1-10 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 17 of US Patent 12,357,593 in view of US 2019/0134173 A1 (Tuohy et al, IDS) and US 2017/0202960 A1 (Brito et al, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent recite methods of treating ovarian cancer by administering a composition comprising a polypeptide comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED). The claims do not recite the instantly claimed adjuvant or the other limitations of the instant claims.
Regarding claims 1, 6 and 19, Tuohy et al discloses a composition comprising: a) a polypeptide comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain (AMHR-ED) (para [0051], “The human AMHR2” and Figure 19, para [0053], "In certain embodiments of the methods, compositions and kits provided herein, the AMHR2 polypeptide has an amino acid sequence ... In some embodiments, the consecutive amino acids are identical to an amino acid sequence in the extracellular domain of AMHR2"); and b) an adjuvant comprising: oil and water emulsions, a surfactant and a buffer (para [0072], "Pharmaceutical compositions suitable for parenteral administration comprise AMHR2 polypeptides and/or nucleic acids described herein in combination with …emulsions ... buffers", para [0073] “surfactant” and para [0076] “oil and water emulsions” for induction of an immune response (see abstract).
Tuohy et al does not disclose using an oil that is squalene oil or a non-ionic surfactant in compositions for inducing an immune response, or the other limitations of claims 2-5 and 7-10.
Brito et al discloses relevant to claims 2-5 and 7-10, peptide vaccines for inducing an immune response using squalene oil, a non-ionic surfactant, and an emulsifier. (para [0013] the invention relates to cationic oil-in-water emulsions that contain high concentrations of cationic lipids and have a defined oil:lipid ratio. The oil and cationic lipid are separate components of the emulsions, and preferably the oil is not ionic” and para [0016] “nonionic surfactant” and para [0148]. Brito et al disclose para [0067], "An exemplary cationic emulsion of the invention is referred herein as "CMF3." Wherein the oil of CMF32 is squalene (at 4.3% w/v) ... CMF32 also includes the surfactants SPAN85 (sorbitan trioleate) and Tween 80 (polysorbate 80) at 0.5% w/v Tween 80, 0.5% w/v SPAN85, see also (para [0130]-[0134]). Brito et al discloses the compositions comprise a citrate buffer with a “pH of about 6.2 to about 6.8” (para [0027]” Brito et al discloses the compositions with a first component that is squalene oil and emulsifier and a second component that is a buffer and nonionic surfactant in a nano-emulsion with a size of about 80 nm to 160 nm (para [0216]-[0223] and para [0275]).
Therefore, in view of the patented claims and the references, it would have obvious to one of ordinary skill in the art to make compositions of the patent further comprising an adjuvant, wherein the adjuvant incorporates squalene oil, polysorbate 80, sorbitan trioleate and citrate buffer of Brito et al into the oil and water vaccine emulsion of Tuohy et al comprising a human Anti-Mullerian Hormone Receptor Type II extracellular domain to optimize the vaccines of Tuohy et al in order to create a nano-emulsion vaccine to induce an immune response in humans to human Anti-Mullerian Hormone Receptor Type II extracellular domain that can be used in the methods of the patent. Notably, the patent provides motivation to make compositions comprising human Anti-Mullerian Hormone Receptor Type II extracellular domain and Tuohy et al provides motivation to create into an oil and water vaccine emulsion comprising human Anti-Mullerian Hormone Receptor Type II extracellular domain, but does not specifically identify known oil and water vaccine emulsions which are defined by Brito et al, so one would have been motivated to use the teachings of Brito to make squalene oil and water vaccine nano-emulsions that are encompassed by the claims because the art taught that these components at such amounts can be used squalene in oil and water vaccine nano-emulsions at such pHs to create compositions useful for inducing an immune response.
In this case, with respect to the amounts of the components and pH of the composition, the art taught that the skilled artisan can readily determine the proper amount of the components and proper pH in an oil and water vaccine as evidenced by the prior art, so these compositions also would have been considered obvious, absent a showing otherwise. Notably, as evidenced by the references, these components of a vaccine were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the vaccine of the patented claims using the teachings of Tuohy and Brito would be seen as routine optimization, absent a showing otherwise, because one would see these limitations as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results. Furthermore, one of skill in the art would have expected success in making such compositions as the prior art of Brito et al discloses how to make such oil and water emulsions.
Accordingly, one of skill in the art would consider the instant claims as an obvious variation of the patented claims, as evidenced by the references.
Applicant has traversed theses rejections essentially for the reasons set forth above, i.e., Brito relates to nucleic acid vaccines comprising cationic lipids and there are unexpected results.
In response, these arguments are not found persuasive essentially for the reasons set forth above, i.e., the claims encompass vaccines comprising cationic lipids, Brito discloses peptide vaccines and unexpected results have not been established as detailed above.
Accordingly, after careful and complete consideration of Applicant’s response and the record as a whole, for these reasons and the reasons set forth previously, these rejections are being maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
September 22, 2026
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