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 election without traverse filed October 29, 2025, is acknowledged and has been entered. Applicant has elected Group I.
The amendment filed October 29, 2025, is acknowledged and has been entered. Claims 12, 14, 30-31 and 33-35 have been canceled.
Claims 1-10 and 19 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement has been considered.
Claim Rejections-35 U.S.C. § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is 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 pre-AIA the applicant regards as the invention.
Claim 19 is 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 pre-AIA the applicant regards as the invention.
The claim is indefinite in the recitation of relative terminology, i.e., “nearly an entire human AMHR2-ED” providing a standard for determining what constitutes “nearly an entire human AMHR2-ED” in the art to unambiguously interpret the claims. For example, is nearly an entire human AMHR2-ED 99% of the human AMHR2-ED, 95% of the human AMHR2-ED, 90% of the human AMHR2-ED or is some other amount of the human AMHR2-ED nearly an entire human AMHR2-ED? Similarly, the specification does not provide a limiting definition of “nearly an entire human AMHR2-ED”. Therefore, the metes and bounds of the subject matter that Applicant regards as the invention will also vary widely and it cannot be determined what is nearly an entire human AMHR2-ED, so that the metes and bounds cannot be unambiguously determined. Accordingly, these claims fail to delineate the metes and bounds of the subject matter that Applicant regards as the invention with the requisite particularity and clarity to satisfy the requirement set forth under 35 U.S.C. § 112, second paragraph.
Accordingly, this claim is indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
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 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, 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 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.
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.
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Claims 1-10 and 19 are provisionally 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 provisionally 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.
Conclusion
No claims are allowed.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
January 23, 2026