DETAILED ACTION
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 .
Election/Restrictions
Applicant elected the species of 7-methylguanosine during a telephonic interview of June 9, 2026, with Charles A. Thomas. During the telephonic interview Applicant indicated at the Examiner’s request that he would email the examiner to identify the claims that are readable on the elected species. The examiner did not received a follow-up email.
Applicant further elected method of treatment claims corresponding to claims 1-47 and 87, as well as preterm birth as the elected subject population, without traverse. Claims directed to combination therapy are also withdrawn in view of the election of a specific compound.
Status of the Claims
Claims 1-88 are pending. Claims 48-86 are withdrawn for being directed to a non-elected invention. Claims 2-9, 13-19, 22-35, 37-43, 46, and 48-86 are withdrawn for being directed to a non-elected species or combination.
Claims 1, 10-12, 20, 21, 36, 44, 45, 47, and 87 are examined.
The examiner did not find prior art relevant to the use of 7-methylguanosine administration. However, a Scope of Enablement Rejection is set forth below with respect to the elected species. The examiner did locate prior art that teaches administration of allopregnanolone for treating preterm birth. As such, the identified prior art has been applied to the claims in an effort to expedite prosecution. Claims not drawn to the elected species remain withdrawn. The rejection of those claims is an effort to allow Applicant to amend withdrawn claims during the course of prosecution and to make prior art of record.
Claim Objections
Claim 47 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. Claim 22 is also a multiple dependent claim. See MPEP § 608.01(n). Accordingly, claim 23 has not been further treated on the merits. Similarly, claim 46 is also a multiple dependent claim. Accordingly, claim 47 has not been further treated on the merits.
Claim Rejections - 35 USC § 112
Claims 87 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The phrase “or an alternative steroidal compound thereof” is not clear.
Claim 87 is reject as it refers to “the method of claim 66” despite claim 66 being a product claim. Correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 10-12, 20, 21, 36, 44, 45, and 87 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating preterm birth through administration of allopregnanolone (see prior art applied below), does not reasonably provide enablement for the elected species 7-methylguanosine for treating preterm birth nor does it provide for the enablement of derivatives and any metabolite within the synthesis pathway thereof and an alternate steroidal compound thereof of all of the claimed agents. A derivative can be any agent derived from the same. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below
Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claimed invention pertains to compounds and their derivatives for treating preterm birth and related conditions.
The State of the Prior Art and the Relative Skill of those in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
Hong et al., “Postpartum plasma metabolomic profile among women with preeclampsia and preterm delivery: implications for long-term health,” BMC Medicine (2020)18:277, teaches that women with medically indicated preterm delivery had significantly different levels of 16 metabolites in amino acid, nucleotide, and steroid classes. See Abstract. Table 2 on page 7 provides a showing of metabolites that were significantly different for each measured preterm delivery subgroup compared to term delivery. Of the few listed 1-methylguanine and 7-methylguanine are included.
The examiner notes that Example 1 refers to correlations for strong prediction of gestational progress citing WO2020061590. This WO doc mentions 7-methylguanine on a single occasion and does not mention a derivative thereof or 7-methylguanosine at all. Similarly, the Liang et al. article does not mentioned 7-methylguanine or 7-methylguanosine.
Further, the examiner notes that Chou et al., “Maternal Arsenic Exposure and DNA Damage Biomarkers, and the Associations with Birth Outcomes in a General Population from Taiwan,” PLOS One 2014 Feb 18;9(2):e86398 provides teachings on 7-methylguanosine during pregnancy.
Chou teaches 7-methylguanosine was used as a DNA damage biomarker. Maternal urinary inorganic arsenic exposure was positively associated with 7-MeG. Further, 7-MeG showed an independent and significant prediction for a decreased Apgar score. Even further, “Adverse birth outcomes and decreased 1-min Apgar scores were associated with increased maternal levels of iAs and 7-Meg in the general population.” See p7, 2nd full par.
N7-MeG was significantly associated with decreased birth length and 1-min Apgar scores after adjustment for maternal age, pre-pregnant BMI, mode of delivery, gestational age, and newborn sex. Thus, N7-MeG appeared to be a more sensitive biomarker than 8-oxodG for maternal DNA damage related to newborn adverse outcomes.
According to Table 6, the risk of low birth weight is also correlated with 7-MeG. Additionally, smoking is associated with several adverse outcomes of pregnancy including increased 7-MeG levels. Chou also notes that 7-MeG may be a sensitive and effective biomarker for newborn health. See p9, 3rd and 4th full par.
Thus, it is not clear that 7-MeG has a similar effect to 7-methylguanine and a correlation of 7-methylguanine and preterm birth was recognized by Hong. Similarly, Chou recognized 7-methylguanosine as a biomarker for DNA damage generically, even if the study was performed by observing correlations secondary to detrimental effects of arsenic.
Accordingly, at the time the invention was made, the relative skill of those in the art tasked with identifying compounds exerting an activity of interest would have been high, as the ordinarily skilled artisan would have had, at minimum, a Ph.D. and experience with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods. Deciding which technique to use would have been determined by the skilled artisan’s knowledge regarding the compound and target of interest. Ligand based drug design relies on knowledge of a compound or compounds of interest (i.e., ligands) to derive new compounds that will, in theory, similarly interact with the target of interest to elicit the activity of interest. Conversely, structure based drug design relies on knowledge of the three dimensional structure of the target of interest (i.e., receptor, ion channel, or enzyme) to derive new compounds that will, in theory, interact with the target of interest to elicit the activity of interest. In either case, the compounds derived from these techniques (applied alone or in combination) are then subjected to in vitro testing for validation.
The Level of Predictability in the Art: Once a compound has been identified by ligand based and/or structure based drug design methods as potentially binding to the target molecule, it must be evaluated. However, as discussed by Anderson (Chem and Biol 10:787-797, 2003), “it is important to consider that the ranking assigned by the scoring function is not always indicative of a true binding constant, since the model of the target:ligand interaction is inherently an approximation. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molecule could fail in vitro assays… Finally, leads are brought into the wet lab for biochemical evaluation” (Page 794, Column 1). By that point, as noted by Thiel (Nature Biotechnol 2:513-519, 2004), “libraries are small and hit rates are on the order of one in ten” (Page 517, Column 2). This low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. Indeed, modifying even a single atom in a compound can dramatically change the compound’s overall structure and - even though complementarity in one portion of the compound might be improved by the chemical revision - the overall binding or activity might be severely compromised.
The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples.
The instant Specification provides 5 Examples starting on page 36, paragraph 126 through page 42, paragraph 142. Example 1 found compound with a correlation to progesterone levels in the blood. Example 2 assessed uterine smooth muscle contraction with a non-elected steroid compound. DHEA-S, THDOC, estriol-16-glucoronide, androstane-3,17-diol, or progesterone. Example 3 observed similar compounds in a uterine muscle strip assay. Example 4, observed preterm birth treatment in mouse models. Again the compounds tested were not the elected species. Example 5 provides for treatment of preterm birth with various compounds referring to Figures 9 and 9B as a schematic. In this case 7-methylguanine was administered at a dose of 30 mg/kg for 4 doses. Data was not provided nor was the statistical significance of the data revealed. Further, 7-methylguanosine was not administered, but is presumably a metabolite of 7-methylguanine.
The examiner notes that 7-methylguanine and 7-methylguanosine differ in chemical structure and function.
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7-Methylguanosine is shown below.
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Further, the instant Specification merely refers to recognizing a correlation of 7-methylguanine to preterm birth.
Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use” (emphasis added). Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims". Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed.
As noted above, the instant Specification provides 5 Examples starting on page 36, paragraph 126 through page 42, paragraph 142. Example 1 found compound with a correlation to progesterone levels in the blood. Example 2 assessed uterine smooth muscle contraction with a non-elected steroid compound. DHEA-S, THDOC, estriol-16-glucoronide, androstane-3,17-diol, or progesterone. Example 3 observed similar compounds in a uterine muscle strip assay. Example 4, observed preterm birth treatment in mouse models. Again the compounds tested were not the elected species. Example 5 provides for treatment of preterm birth with various compounds referring to Figures 9 and 9B as a schematic. In this case 7-methylguanine was administered at a dose of 30 mg/kg for 4 doses. Data was not provided nor was the statistical significance of the data revealed. Further, 7-methylguanosine was not administered, but is presumably a metabolite of 7-methylguanine.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Claim Rejections - 35 USC § 112
Claims 1, 11, 12, and 36 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.
Claims 1, 11, 12, and 36 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
The claims contain 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(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim 1 recites “derivative” and “or a metabolite within the synthesis pathway thereof”.
The MPEP § 2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. Although the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus, if the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office (PTO) Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention" Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106). Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP §2163. However, if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP §2163.
Level of skill and knowledge in the art: The level of skill in the art is high.
Partial structure: As to the claimed derivative or metabolite within the synthesis pathway thereof, no specific examples are given that would demonstrate possession of or put the public in possession of the claimed derivatives of the claimed compounds other than those specific derivatives or metabolites shown in the Specification. There are many derivatives and potential metabolites that are not disclosed nor recognized.
Physical and/or chemical properties/Functional characteristics: The compounds of claim 1, including derivatives and metabolites within a synthesis pathway of those derivatives are compounds which are allegedly useful to treat preterm birth, among other related conditions. With regard to derivatives and metabolites in the synthesis of these derivatives, Applicant has not set forth compounds or substituents in the specification which Applicant considers derivatives thereof nor what synthesis pathways are used. Although the art recognizes the above definitions the terms are not explicitly defined by the specification in such a way as to demonstrate that the inventor had possession of the claimed derivatives, metabolites, or even all pathways for synthesizing the same.
Predictability of the Art: It is generally accepted in the art that formation of a particular ‘derivatives' for a given compound or series of compounds is unpredictable. As stated by Dorwald (Side Reactions in Organic Synthesis: A Guide to Successful Synthesis Design, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005, Preface): “Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why. Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task. In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work.
Method of making the claimed invention: Although the Specification provides a method for making the elected species, no method for making the derivatives encompassed by the claims has been disclosed. Only a limited number of compounds are shown to be synthesized by the instant Specification.
Summary: In the instant case, Applicant has not disclosed the structure, formula, chemical name, or physical properties of the numerous potential derivatives, metabolites, or synthesis pathways. Although some functional characteristics are disclosed or would be known to a person of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed ‘derivatives' in the instant application.
However, the MPEP states that written description for a genus (for example, the claimed ‘prodrugs,’ ‘analogs’ or ‘derivatives' of the elected compound species) can be achieved by a representative number of species within a broad generic. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims: the possible structural variations are limitless with respect to claimed derivatives and metabolites. In the instant case, however, the Specification does not disclose a sufficient variety of species to reflect this variance in the genus. While having written description of the elected compound and compounds identified in the Specification tables and/or examples, the Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
To overcome this rejection, Applicant can merely remove the terms/phrases derivative and a metabolite within the synthesis pathway.
NOTE: At this time, the examiner did not apply duplicative references. For example, the examiner did not apply Patil (US2020/0081013). This reference similarly treats a form of preterm birth with allopregnanolone. See prior art claim 1.
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.
Claims 1, 11, 12, and 36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Patil, (US2022/0291243).
Patil teaches analyzing a hormone panel from a pregnant female and measuring neurosteroids, including tetrahydrodeoxycorticosterone, pregnenolone, pregnenolone sulfate, and others. See prior art claims 1 and 3. Further, the method includes treating the pregnant female with compounds including allopregnanolone if a measured score is too low. See prior art claim 20. Such method is designed to treat/prevent spontaneous preterm delivery. See Abstract. Dependent claim 14 is directed to allopregnanolone.
As such, claims 1, 11, 12, and 36 are anticipated by the prior art.
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.
Claims 1, 11, 12, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Patil, (US2022/0291243), and in view of Sripada et al., “Allopregnanolone Elevations Following Pregnenolone Administration Are Associated with Enhanced Activation of Emotion Regulation Neurocircuits,” BIOL PSYCHIATRY 2013;73:1045–1053.
Patil teaches treating analyzing a hormone panel from a pregnant female and measuring neurosteroids, including tetrahydrodeoxycorticosterone, pregnenolone, pregnenolone sulfate, and others. See prior art claims 1 and 3. Further, the method includes treating the pregnant female with compounds including allopregnanolone if there score is too low. See prior art claim 20. Such method is designed to prevent spontaneous preterm delivery. See Abstract. Dependent claim 14 is directed to allopregnanolone.
Moreover, Sripada teaches that exogenous administration of pregnanolone is preferentially metabolized. Allopregnanolone serum levels have been reported to triple 2 hours after oral administration of 400 mg pregnenolone. See p1046, 2nd col., 1st par. Thus, the administration of pregnanolone will have an effect of substantially increasing allopregnanolone serum levels in a subject.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) .
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Patil and Sripada. One would be motivated to do so because the administration of allopregnanolone to a subject that is at risk of preterm or spontaneous birth is taught to be treated with the same. Moreover, it is known that serum levels of allopregnanolone will triple 2 hours after oral administration of 400 mg pregnenolone. As such, there is a reasonable and predictable expectation of success that increasing serum levels of allopregnanolone will treat preterm birth and this can be accomplished by administration of pregnanolone or allopregnanolone.
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, 11, 12, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 16, 17, 19, and 32 of copending Application No. 17/754,102. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘102 application are directed to treating preterm birth by administering estriol-16-glucoronide. The instant claims, such as claims 2, 13 and 25, makes clear that estriol-16-glucoronide is a compound that falls within the scope of those compounds contemplated for coadministration with a pregnenolone or derivative of 7-methylguanine. Thus, both sets of claims include administration estriol-16-glucoronide to a subject to treat preterm birth.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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