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 .
Priority
This application is a national stage entry of PCT/CN2022/085402 filed on 04/06/2022.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CHINA on 06/08/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I (claims 1-11) drawn to a compound of formula I and compositions thereof, and compound 21 having the following structure:
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as a species of a compound of formula I in the reply filed on March 17, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-11 are currently being examined as they read on the elected species.
Applicant’s elected species was not found in the prior art. Accordingly, the search was extended to include additional species.
Drawings
The drawings are objected to because Figure 1A is unclear and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-11 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.
Claims 1-11 of the instant application are drawn to a compound of formula I having the following structure: Z1-Q wherein Q is selected from
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and
Z1 is independently selected from H, alkyl, cycloalkyl, cycloalkylalkyl, heterocycloalkyl, heterocycloalkylalkyl, aryl, heteroaryl, arylalkyl, heteroarylalkyl, alkyloxyalkyl, alkoxycarbonyl, arylalkoxy, arylalkylthio, and acyl radical;
Z2 is independently selected from H, alkyl, cycloalkyl, cycloalkylalkyl, heterocycloalkyl, heterocycloalkylalkyl, aryl, heteroaryl, arylalkyl, heteroarylalkyl, alkyloxyalkyl, alkoxycarbonyl, arylalkoxy, arylalkylthio, and acyl radical;
R₁ to R₆ are each independently selected from hydrogen, halogen, C3-C6 cycloalkyl, and C1-C6 unsubstituted or substituted alkyl;
R₇ to R₁₀ are each independently selected from hydrogen, halogen, C3-C6 cycloalkyl, and C1-C6 unsubstituted or substituted alkyl;
R₁₁ to R₁4 are each independently selected from hydrogen, halogen, C1-C3 unsubstituted or substituted alkyl, or R₁₁ and R₁₂ together with the connected C atom form a carbonyl group (C=O); and
each substituent R₁₅ is independently selected from halogen, cyano, C1-C6 alkyl, C3-C9 unsubstituted or substituted cycloalkyl, C1-C6 haloalkyl, -CF₃, - NH₂, -NO₂, -SH, -SR₁₆, -OH, C1-C6 unsubstituted or substituted alkoxy, -NR₁₆R₁₇, (C3-C9) cycloalkyl, (C2-C6) alkynyl, (C4-C8) cycloalkenyl, (C4-C8) cycloalkenylalkyl, unsubstituted or substituted aryl, unsubstituted or substituted heteroaryl, -COOH, -COOR₁₆, -OCOOR16, C2-C8 alkenyl, -SO₂OR₁₆, -SO2NR₁₆R₁7, -SO2R16, -NR16SO2R17, -CONR16R17, -COR₁₆, -NR16COR17.
In the present case, the important factors leading to a conclusion of inadequate written description is the breadth of the claims, the absence of sufficient working examples of the compounds as claimed, and the lack of predictability in the art.
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 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) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows 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 applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 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). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the instant case, the claims are overly broad since the claims are drawn to an infinite number of compounds in comparison to what is actually disclosed in the instant specification.
Applicant has described in the instant specification compounds of formula I wherein:
Q is
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;
R1 and R2 are hydrogen;
R3 and R4 are hydrogen;
R5 and R6 are hydrogen or fluorine;
R7 and R8 are hydrogen;
R9 and R10 are hydrogen;
R11 and R12 are hydrogen;
R13 and R14 are hydrogen;
R15 is hydrogen, methyl, halogen, methoxy, cyano, -CF3, or COOCH3
There is no evidence that applicant was in possession of any compound containing any substituent as claimed for Q and R1-R15, other than those as detailed above. Thus the specification does not provide sufficient evidence to demonstrate that Applicant was in possession of any compound wherein Q is
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or any compound wherein R1-R4 and R7-R14 are other than hydrogen, or any compound wherein R5 and R6 are other than hydrogen or fluorine; or any compound wherein R15 is other than hydrogen, methyl, halogen, methoxy, cyano, -CF3, or COOCH3.
Thus the instant specification does not provide any evidence that Applicant was in possession of the compounds as claimed other than those as detailed above, prior to the effective filing date of the claimed invention.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a 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." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he 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, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus since Applicant has not described in adequate detail compounds other than those as detailed above and furthermore have not provided any evidence that such compounds exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the compounds other than those as detailed above prior to the effective filing date of the instant application. Thus the cited claims of the instant application are not supported by the instant specification and thus a rejection under 35 USC 112 (a) for failing to comply with the written description requirement is proper.
Claim Rejections - 35 USC § 112
Claims 1 and 9-11 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claims 1 and 9-11 of the instant application are drawn to a compound of formula I having the following structure: Z1-Q wherein Q is selected from
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, referred to as Q1 and Q2. The core structure of Q1 and Q2 are different because in Q1 the imidazolidinopyrimidone is fused with piperidine whereas in the Q2 it is fused with pyrrolidine. Therefore as a whole, the core structures are patentably distinct. Furthermore, when n is 2, Q1 is further patentably distinct from Q2 since the pyrimidone ring is fused with 2 rings that are patentably distinct from the 2 rings fused with the pyrimidone ring in Q2.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 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.
Claims 2-10 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.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus claim 2 and all claims dependent upon claim 2 (claims 3-7) are rejected.
Claims 2 and 6 are further indefinite since there are two definitions for R15 since R15 is defined in two places within the claims since the last 3 lines of the claims state “each R11 to R17 is independently….” Since R15 is within R11 to R17 the claims are indefinite since there is already a prior definition for R15 in the claims. Thus it is unclear what is the correct definition for R15. Thus claims 2 and 6 and all claims dependent upon claims 2 and 6 (claims 3-5 and 7) are rejected.
Regarding claim 3, the word "preferably" renders the claim indefinite because it is unclear whether the limitations following preferably are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites compounds wherein the ring of Z1 and Z2 are substituted with methyl, halogen, methoxy, cyano, -CF3, or COOCH3. There is insufficient antecedent basis for this limitation in the claim since claim 1 from which claim 8 depends does not claim Z1 and Z2 are optionally substituted with methyl, halogen, methoxy, cyano, -CF3, or COOCH3.
Regarding claim 9, the word "preferably" renders the claim indefinite because it is unclear whether the limitations following preferably are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation isotopes, and the claim also recites deuterium which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 10, the word "preferably" renders the claim indefinite because it is unclear whether the limitations following preferably are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 is further indefinite since it is unclear how the compound further comprises pharmaceutically acceptable salts, hydrates, solvates or crystal forms of the compound. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended.”
In the instant case, the compound is either in the form of a pharmaceutically acceptable salt, hydrate, solvate or crystal and thus does not comprise pharmaceutically acceptable salts, hydrates, solvates or crystal forms. Thus it is unclear if claim 10 is drawn to the combination of a compound of claim 1 and pharmaceutically acceptable salts, hydrates, solvates or crystals of some unrecited component, or if the claim is drawn to a compound of claim 1 in the form of a pharmaceutically acceptable salt, hydrate, solvate or crystal.
Conclusion
Claims 1-11 are rejected. Claims 12 and 13 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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