CTNF 18/041,072 CTNF 98173 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims The amendments to the claims filed December 1, 2023 are acknowledged and entered. Claims 1-17 are pending. Priority This application is a 371 of PCT/US2021/037117, filed June 11, 2021, which claims the benefit of 63/064,279, filed August 11, 2020. Information Disclosure Statement Acknowledgement is made of the Information Disclosure Statements filed on February 8, 2023 and February 6, 2026. All references have been considered except where marked with a strikethrough. Specification 06-31 AIA The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification. Election/Restriction 18-18 REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). 18-20 AIA This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. The species are as follows: Compounds regarded as an “optically active P2-ligand precursor” that are disclosed in the specification at, for instance, paragraph [0010] and Figures 1-2 . Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: Claims 1-8 . 18-07 AIA The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: 18-07-03 AIA Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is considered met when the alternatives are of a similar nature. When the Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as being of a similar nature where the following criteria are fulfilled: (A) all alternatives have a common property or activity; AND (B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR (B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains. The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The phrase “recognized class of chemical compounds” means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved. The chemical compounds regarded as an “optically active P2-ligand precursor” are not regarded as being of similar nature because: (1) the alternatives do not all share a common structure and (2) the alternatives do not all belong to a recognized class of chemical compounds. The “optically active P2-ligand precursor” of the instant claims requires no structural feature and therefore there is no chemical class to which these compounds can be assigned. During a telephone conversation with Mr. Ricardo J. Moran on March 4, 2026 a provisional election of species of an “optically active P2-ligand precursor” corresponding to compound 9, disclosed in Figure 1 and paragraphs [0010] of the specification, was made without traverse. Affirmation of this election must be made by applicant in replying to this Office action. The elected species reads on claims 1-9 and 17. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. The elected species, compound 9 (pictured below for convenience), was found in the prior art. The search has therefore been limited to the elected species. PNG media_image1.png 110 124 media_image1.png Greyscale Claims 1-8 (all in part, other than the elected species) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 9 and 17 are drawn to the elected species and are presently under examination. Claims 10-16 are drawn to compounds set forth in method claims 4-8 and are presently under examination. Claim Objections 07-29-01 AIA Claim 9 is objected to because of the following informalities: Line 2 of the claim recites “precursor is compound” and should instead recite “precursor is a compound” Appropriate correction is required. Claim Rejections - 35 USC § 112a 07-30-01 AIA 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. 07-31-01 Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims require “an optically active P2-ligand precursor” and a “derivative” of D-xylose or D-glucose. Claim 1-8 do not require that the optically active P2-ligand precursor possess any particular conserved structure, or other distinguishing feature. Claims 1 and 4-9 do not require that the derivative possess any particular conserved structure, or other distinguishing feature. The specification does not describe or teach any particular conserved structure, or other distinguishing feature which defines the genus of compounds represented by an optically active P2-ligand precursor or a derivative of D-xylose or D-glucose. Therefore, the skilled artisan would not recognize that Applicants were in possession of the invention as broadly claimed at the time the application was filed. The full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph. To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath , 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli , 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood , 107 F.3d at 1572. According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406.” According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement, “The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar , 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc. , 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow , 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).” Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers , 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute 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.")". Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision Applicant may overcome this rejection by amending the claims to recite a specific compound or compounds which are regarded as derivatives of D-xylose and D-glucose and specific compounds regarded as an “optically active P2-ligand precursor” for which Applicant has written support in the specification. Applicant, for instance, could amend the claim to incorporate the compounds of claims 2, 3 and 9. Claim Rejections - 35 USC § 112b 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. MPEP 2173 states 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph requires that a patent application 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 primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. Regarding claim 1, the phrase “optically active P2-ligand precursor” and the term “derivative” render the scope of the claim unclear because the specification does not provide any definition or direction otherwise for determining which chemical structures/compounds meet these limitation. Based on the direction provided by Applicant, a person skilled in the art would not be able to determine the metes and bounds of the invention, and thus what constitutes infringement, because the specification does not clearly define what compounds are embraced by the claim. Claims 2-9 depend from claim 1 and include the limitation “optically active P2-ligand” and/or “derivative”, do not cure the above deficiencies, and therefore are also indefinite. It is suggested that Applicant amend claim 1 to recite specific derivatives of D-xylose and D-glucose and specific compounds regarded as an “optically active P2-ligand precursor” for which Applicant has written support in the specification. Applicant, for instance, could amend the claim to incorporate the compounds of claims 2, 3 and 9. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 9 and 17 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ghosh et al. (US 8,802,724 B2) (hereinafter “Ghosh”) . Instant claim 17 is drawn to a compound corresponding to compound 9 (see e.g. Figure 1) which corresponds to the instantly elected species of optically active P2-ligand precursor. Instant claim 1 is drawn to a method for making an optically active P2-ligand precursor (e.g. the elected species, compound 9) comprising converting D-xylose or a derivative thereof or D-glucose or a derivative thereof to the optically active P2-ligand precursor. Instant claim 9 depends from claim 1 and recites wherein the optically active P2-ligand precursor is the elected species, compound 9. Regarding instant claim 17, Ghosh teaches compound 11 (col 25, lines 10-35; pictured below for convenience) which corresponds the elected species, compound 9. PNG media_image2.png 161 598 media_image2.png Greyscale Regarding claims 1 and 9, Ghosh teaches compound 11, which corresponds to the instant elected species, can be prepared from alcohol 10 (col 14, lines 5-20; pictured below for convenience). Alcohol 10 is structurally similar to the linear, open chain, form of glucose and could be derived from glucose. Because the specification provides no definition or guidance for identifying a D-glucose derivative, a person skilled in the art would reasonably conclude that Alcohol 10 is a D-glucose derivative within the scope of the claim. Ghosh thus teaches the instant method of making an optically active P2-ligand precursor comprising converting a derivative of D-glucose to the optically active P2-ligand precursor. PNG media_image3.png 279 223 media_image3.png Greyscale Ghosh teaches all limitations of the instant claims and therefore anticipates the invention. Claims 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Selliah et al. (WO97/23223) (hereinafter “Selliah”). Regarding claim 10, Selliah teaches compound 5 which corresponds to the claimed compound (see Scheme 1 on page 12; pictured below for convenience; compound 5 is the enantiomer of the instant claims). PNG media_image4.png 157 398 media_image4.png Greyscale Regarding claim 12, Selliah teaches compound 9 which corresponds to the claimed compound (see Scheme 1 on page 12; pictured below for convenience; compound 9 is the enantiomer of the instant claims). PNG media_image5.png 165 343 media_image5.png Greyscale Regarding claim 14, Selliah teaches compound 10 which corresponds to the claimed compound (see Scheme 1 on page 12; pictured below for convenience; compound 10 is the enantiomer of the instant claims). PNG media_image6.png 150 289 media_image6.png Greyscale Regarding claims 11, 13 and 15, Selliah discloses the compounds are prepared from enantiomerically pure compound 1 (see page 13-14; Example 1; Scheme 1). Moreover, Selliah teaches the exact enantiomer of the claimed compounds as noted above. Selliah therefore teaches compounds 5, 9 and 10 are enantiomerically pure as required by the claims. Selliah teaches all limitations of the instant claims and therefore anticipates the invention. Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated Kesteleyn et al. (WO03/022853) (hereinafter “Kesteleyn”). Kesteleyn teaches compound III.5 (see page 32, Example 3) which corresponds to the compound of claim 16. Kesteleyn teaches all limitations of the instant claims and therefore anticipates the invention. PNG media_image7.png 151 328 media_image7.png Greyscale Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. March 11, 2026 /KEVIN S MARTIN/Examiner, Art Unit 1624 Application/Control Number: 18/041,072 Page 2 Art Unit: 1624 Application/Control Number: 18/041,072 Page 3 Art Unit: 1624 Application/Control Number: 18/041,072 Page 4 Art Unit: 1624 Application/Control Number: 18/041,072 Page 5 Art Unit: 1624 Application/Control Number: 18/041,072 Page 6 Art Unit: 1624 Application/Control Number: 18/041,072 Page 7 Art Unit: 1624 Application/Control Number: 18/041,072 Page 8 Art Unit: 1624 Application/Control Number: 18/041,072 Page 9 Art Unit: 1624 Application/Control Number: 18/041,072 Page 10 Art Unit: 1624
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