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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse in the reply filed on 7 April 2026, is acknowledged.
Applicants provided a compliant species election of compound 102:
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(from claim 16), which is a species of genus formula I (instant claim 1) and genus formula VII (instant claim 7) wherein: ring “A” is a partially saturated / partially unsaturated 6-membered carbocyclic ring; R17A and R17B are each hydrogen (H); R16 is X16-RD wherein X16 is -NRZS(O)y- wherein RZ is H and “y” is 2; RD is methyl-substituted phenyl (“–(CH2)m-C6aryl wherein “m” is 0”); R15A and R15B are each H; R7A and R7B are each H; R6A and R6B are each H; “n” is 1 and RA is oxo; and R9 and R13 are each methyl (“A- XA-RX wherein A is -C1alkylene “-CH2”-) and XA is absent; and RX is H).
Applicants’ elected species and all instantly claimed species that fall within this genus:
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are free of the prior art.
Therefore, Instant claim 16 is free of the prior art.
The Examiner extended the Markush search to the full scope of instant claim 7 genus formulae VII and VIII but did not find any prior art.
The Examiner extended the Markush search to the full scope of instant claim 1 genus formula I and II but did not find any prior art.
The Examiner has maintained the Election of Species Requirement until Applicants place the claims in condition for allowance by amending the claims to overcome each of the two 35 USC 112(a) rejections, below.
Current Status of 18/560,179
This Office Action is responsive to the amended claims of 7 April 2026.
Claims 1-20 have been examined on the merits. Claims 1, 3, 5, 9-10, and 14 are original. Claim 16 is currently amended. Claims 2, 4, 6-8, 11-13, 15, and 17-20 are previously presented.
Priority
The instant application’s effective filing date is 11 May 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7 April 2026; and 10 November 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-6 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. This rejection constitutes a lack of possession rejection under 35 USC 112(a) written description.
The statute 35 USC 112(a) and the first paragraph of pre-AIA 35 USC 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010).
Furthermore, the written description requirement under 35 USC 112(a) requires that Applicant/patentee/inventor show he/she was in possession of the invention that is claimed at the time of filing. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ("reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material"); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.) Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").
A question as to whether a specification provides an adequate written description may arise in the context of determining whether an original claim is described sufficiently (see, e.g., LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1733 (Fed. Cir. 2005); Enzo Biochem, 323 F.3d at 968, 63 USPQ2d at 1616 (Fed. Cir. 2002); Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398)), whether new or amended claims are supported by the description of the invention in the application as filed (see, e.g., In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989)), whether a claimed invention is entitled to the benefit of or priority to an earlier filing date under 35 U.S.C. 119, 120, 365, or 386 (see, e.g., New Railhead Mfg. L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 63 USPQ2d 1843 (Fed. Cir. 2002); Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993)), or whether a specification provides support for a claim corresponding to a count in an interference (see, e.g., Martin v. Mayer, 823 F.2d 500, 503, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987); Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 (CCPA 1971)). Compliance with the written description requirement is a question of fact which must be resolved on a case-by-case basis. Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991). See MPEP 2163.
Applicants have demonstrated possession of species of claims 7 and 16:
In reviewing the claims and the Specification, the Examiner notes Applicants’ Specification demonstrates Applicants/inventor had possession of compounds 101-106 from instant claims 7 and 16 (see Specification para [097] starting on page 22; see, also, synthesis reactions examples 1-2 on pages 30-34) at the time the application was filed: the para [097] table shows physicochemical data which highlights Applicants actually had possession of these species/compounds and the two synthesis examples (each written in past tense are more than mere prophetic words, in fact, these two synthesis examples also demonstrate possession).
However, there are a plurality of species of genus formulae I and II of instant claim 1 that Applicants have not demonstrated actual possession of within the Specification (also, there are no drawings to consult). Recall, too, that enablement and written description are separate inquiries. See MPEP 2163. Evidence of enablement is not the same as evidence Applicants were in possession of each species of the genus formulae I and II of instant claim 1. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Thus, physicochemical data of claimed species (such as the Table appearing at para [097] of the Specification) and actual reduction to practice demonstrated with synthesis examples 1-2 (page 30 of Specification) are ways Applicants can demonstrate actual possession of claimed species. However, mere prophetic statements do not suffice for showing evidence of possession. See MPEP 2163.
The following constitute claimed subject matter that Applicants have not demonstrated actual possession of for purposes of satisfying the possession requirement of written description under 35 USC 112(a):
Lack of possession of species at variable R16:
The two actual synthesis examples within Specification pages 30-34 and the chart of compounds with physicochemical and cLogP data (starting on page 22 of the Specification) demonstrate Applicants had possession of species with -NRz-S(O)y-RD at variable R16 of instant claim 1 but do not show that Applicants were in possession of all the other species of instant claim 1’s variable R16. For example, a review of the Specification shows that Applicants have not demonstrated possession of species of instant claim 1 wherein: variable X16 of R16 is -S(O)N, -S(O)-, NC(O)-, -C(O)N, -NC(S)-, and -C(S)N, (see instant claim 1 for the specific sub-genera of X16 of R16, etc.).
Lack of possession of species at Ring A:
Furthermore, Applicants have not demonstrated actual possession of the plurality of species of ring A as claimed in instant claim 1, other than compounds 101-106 (para [097] Specification page 22) which have partially unsaturated and saturated 6-membered carbocyclic rings at “ring A”. Thus, Applicants have not shown possession of 5- or 6-membered unsaturated, partially saturated, or saturated heterocyclic rings at “ring A” AND Applicants have not shown possession of 5-membered carbocyclic rings that are unsaturated, partially saturated, or saturated.
Therefore, given the above, claim 1 is rejected under 35 USC 112(a) written description since Applicants have not demonstrated possession of the plurality of species claimed for variables R16 and ring A of instant claim 1, as per, above. Moreover, claims 2-6 are similarly rejected under 35 USC 112(a) since these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
How to render moot this rejection: please amend instant claim 1 so that it encompasses the compounds 101-106 (para [097] of Specification). Amendments must have support in the original disclosure. Please compare/contrast amendments made to claim 1 with those in claims 7 and 16 to avoid duplicate independent claims.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Here, Applicant provides no guidance as to ‘prodrugs'. The artisan understands that prodrug forms are generally determined a posteriori, and it is only through trial and error that prodrugs are identified. The artisan understands the concept of prodrugs, however the artisan does not per se understand what specifically describes a specific prodrug form. The reference HAN (Han, H. “Targeted Prodrug Design to Optimize Drug Delivery.” AAPS Pharmsci. (2000), Vol. 2 (1) article 6, pp. 1-11), acknowledges there is no specific definition for prodrug (e.g. page 1), but that in general, the 'prodrug' is an inactivated form of the drug that activates in vivo to the active form. While some prodrugs are simply esters or salts, other prodrug forms are not chemically or structurally related to their active form, one example being glucose as the prodrug form of hydrogen peroxide (Table 1, page 5), as is hypoxanthine, thus posing a problem as to understanding what is the exact prodrug form of a compound, as hydrogen peroxide has two prodrug forms in the limited set of compounds exemplified in Han.
According to the reference ETTMAYER (Ettmayer, P., et al. “Lessons Learned from Marketed and Investigational Prodrugs.” J. Med. Chem. (2004) 47(10), pages 2393-2404), prodrugs are often accidental discoveries. Furthermore, the reference TESTA (Testa, B. “Prodrug research: futile or fertile?” Biochem. Pharm. (2004) 68, pages 2097-2106), teaches that, “A number of challenges await medicinal chemists and biochemists carrying out prodrug research, such as the additional work involved in synthesis, physicochemical profiling, pharmacokinetic profiling and toxicological assessment. Two of these challenges are introduced here, namely biological variability and toxicity potential. The challenge of biological variety results principally but not only from the huge number and evolutionary diversity of enzymes involved in xenobiotic metabolism. Inter- and intra-species differences in the nature of these enzymes, as well as many other differences such as the nature and level of transporters, may render prodrug optimization difficult to predict and achieve.” (Testa, page 2098).
Methods of making compounds, in general, are known to the artisan, however the methods of making any specific prodrug are complex and poorly understood, requiring an undue amount of experimentation to determine if a compound is actually a prodrug, and the instant specification fails to provide guidance to overcome the complexity and difficulties known to the artisan, as discussed above.
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.
How to render moot this rejection: please remove all limitations drawn to “prodrugs” from all the claims.
Conclusion
No claims are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound of instant claims 1, 7, and/or 16.
The reference ACS (American Chemical Society. Chemical Abstract Service. RN 2865105-54-8. Entered into STN: 5 December 2022), discloses the compound:
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(see enclosed ACS reference).
However, ACS is a close art but not a prior art reference since it was first made available to the public on 5 December 2022, which is after the instant application’s effective filing date is 11 May 2021.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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