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
The instant application, filed 07/06/2023, is a 371 filing of PCT/JP2022/000356, filed 01/07/2026, which claims foreign priority to JP2021-001758, filed 01/07/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Amendments and Claim Status
Claims 1-19 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 07/06/2023 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Restriction/Election
Applicant’s election without traverse of Group III in the reply filed on 05/28/2026 is acknowledged.
Furthermore, applicant’s election of a specific species of a compound of Formula (I), (S,Z)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-3-(4-(2-(10,1 1-dihydro- 5H-dibenzo[a,d] [7]annulene-5-yl)-3-((2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5- yl)sulfonyl)guanidino) phenyl)propanoic acid is also acknowledged.
Applicant asserts the right for rejoinder of the withdrawn product claims upon finding the method claims allowable. Respectfully, Applicant’s assertion is incorrect because, pursuant to MPEP § 821.04, in order to be eligible for rejoinder, a claim to a nonelected invention must depend from, or otherwise require all the limitations of an allowable claim. Applicant is further advised that rejoinder under MPEP § 821.04 (b) operates only in one direction: it permits withdrawn process claims to be rejoined once an elected product claim is found allowable. It does not provide a basis for rejoining withdrawn product claims where, as in the instant case, when the process is the elected invention. Accordingly, the withdrawn product claims and remaining method claims are not eligible for rejoinder.
The requirement is deemed proper and is therefore made FINAL.
In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species (Figure 1) makes a contribution over the prior art of record. Therefore, according to MPEP § 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Figure 1. Elected Species
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1143
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Figure 1. CAS Registry Number: RN 2803482-69-9; (S,Z)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-3-(4-(2-(10,1 1-dihydro- 5H-dibenzo[a,d] [7]annulene-5-yl)-3-((2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5- yl)sulfonyl)guanidino)phenyl)propanoic acid
Status of Claims
Claims 1-19 are pending in the instant application. Claims 1-8 and 12-14 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 9-11 and 15-19 read on an elected invention and species and are therefore under consideration in the instant application.
Specification
The disclosure is objected to because of the following informalities:
Throughout the instant specification, low resolution two-dimensional chemical drawings are used to exemplify the compounds of the instant disclosure. For example, see below on page 39 of the specification:
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533
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As seen in the image above, the compounds are difficult to see, and the resolution of the compounds is of varying degree, even within the same molecule (see bottom right molecule). This is true throughout the entire specification, and is especially pronounced in Table 1. It is kindly requested that the specification the updated to reflect compounds of better higher resolution two-dimensional images.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112 (a)
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 9-11 and 15-19 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 9-11 and 15-19 of the instant application are drawn to compounds having following substituents:
—R1— represents a C12-4-C10 alkylene group which may have one or more substituent groups selected from the group A, a C6-10 arylene group which may have one or more substituent groups selected from the group A, or a group represented by —R11—R12—,
A is halogen atom, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, and a C1-3 halogenoalkyl group;
—R11— represents a C6-10 arylene group which may have one or more substituent groups selected from the group A,
—R12— represents a C1-2C4 alkylene group which may have one or more substituent groups selected from the group A,
R2 represents a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R4 represents a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R5 represents a hydrogen atom, a halogen atom, a hydroxy group, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group, or R5 is taken together with —N—R1— to form a C5-7 heterocyclic amine which may have an asymmetric carbon atom,
R6 is a protecting group of an amino group, a C1-5 alkyl group or a hydrogen atom,
R7 is a protecting group of an amino group, a C1-5 alkyl group or a hydrogen atom,
R8 represents a hydrogen atom, a halogen atom, a hydroxy group, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, a C1-3 halogenoalkyl group or a group represented by —O—R13—,
R13— represents a protecting group of a carboxyl group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group,
R22 represents a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R24 represents a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
—R21— represents a C12-4-C10 alkylene group which may have one or more substituent groups selected from the group A, a C6-10 arylene group which may have one or more substituent groups selected from the group A, or a group represented by —R11—R12—,
R25 represents a hydrogen atom, a halogen atom, a hydroxy group, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group, or R25 is taken together with —N—R1— to form a C5-7 heterocyclic amine which may have an asymmetric carbon atom,
R26 is a protecting group of an amino group, a C1-5 alkyl group or a hydrogen atom,
R27 is a protecting group of an amino group, a C1-5 alkyl group or a hydrogen atom,
R28 represents a hydrogen atom, a halogen atom, a hydroxy group, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, a C1-3 halogenoalkyl group or a group represented by —O—R13—,
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 present case, the important factors leading to a conclusion of inadequate written description is the lack of a representative number of species that characterizes the entire claimed genus and accounts for variations between species of the genus.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
—R1— as a C1 or C5-C10 alkylene group which may have one or more substituent groups selected from the group A, a C6-10 arylene group which may have one or more substituent groups selected from the group A;
A as halogen atom, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, and a C1-3 halogenoalkyl group,
—R11— as C7-10 arylene group which may have one or more substituent groups selected from the group A,
—R12— as a C3-C4 alkylene group which may have one or more substituent groups selected from the group A,
R2as a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R4 as a hydrogen atom, a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R5 as a halogen atom, a hydroxy group, an amino group, a nitro group, a C2-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group;
R6 as a C1-5 alkyl group
R7 as a C1-5 alkyl group
R8 as a hydrogen atom, a halogen atom, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, a C1-3 halogenoalkyl ;
R13as a a C2-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group
will R22 as a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
R24 as a hydrogen atom, a tert-butoxycarbonyl group (Boc), a 9-fluorenylmethyloxycarbonyl group (Fmoc), a tosyl group (Tos), a nitro group (NO2), a 4-methoxy-2,3,6-trimethylbenzenesulfonyl group (Mtr), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc), benzyloxycarbonyl group (Z), a 2-chlorobenzyloxycarbonyl group (Cl-Z), a 3-nitro-2-pyridinesulfenyl group (Npys), a phenacyl group (Pac), a benzyloxymethyl group (Bom), a dinitrophenyl group (Dmp), a trityl group (Trt), a benzyl group (Bzl), a 4-methoxybenzyl group (MBzl), a 4-methylbenzyl group (4-MeBzl), a acetamidomethyl group (Acm), a tert-butylthio group (tBuS), a 2,6-dichlorobenzyl group (Cl2-Bzl), a formyl group (CHO), a benzyl ester group (OBzl), a tert-butyl ester group (OtBu), a cyclohexyl ester group (OcHex), a phenacyl ester group (OPac), and a xanthyl group (Xan),
—R21— as a C1 or C5-C10 alkylene group which may have one or more substituent groups selected from the group A, a C6-10 arylene group which may have one or more substituent groups selected from the group A;
R5 as a halogen atom, a hydroxy group, an amino group, a nitro group, a C2-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, or a C1-3 halogenoalkyl group;
R26 as a C1-5 alkyl group
R27 as a C1-5 alkyl group
R28 as a hydrogen atom, a halogen atom, an amino group, a nitro group, a C1-5 alkyl group, a C1-3 alkoxy group, a C1-3 alkylthio group, a C1-3 halogenoalkyl ;
The instant specification (pages 17-51) teaches compounds which are characterized as having only the following substituents:
—R1— is an unsubstituted C2-C10 alkylene group or a group represented by —R11—R12—
A is not exemplified
—R11— is an unsubstituted C6 arylene group
R12— is an unsubstituted C1-C2 alkylene group,
R2 is a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf),
R4 is hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc),
R5 is a hydrogen atom, a C1 alkyl group, or R5 is taken together with —N—R1— to form a C5-7 heterocyclic amine which may have an asymmetric carbon atom,
R6 represents a protecting group of an amino group or a hydrogen atom,
R7 represents a protecting group of an amino group or a hydrogen atom,
R8 is a hydroxy group or a group represented by —O—R13—,
R13— represents a protecting group of a carboxyl group, a C1 alkyl group,
R22 is a hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a 2,2,4,6,7-pentamethyl-2,3-dihydrobenzofuran-5-sulfonyl group (Pbf),
R24 is hydrogen atom or 10,11-dihydro-5H-dibenzo-[a,d][7]annulene-5-yl group (Sub), a diphenylmethyl group (Bzh), a 4-methoxyphenylmethyl group (PMB), a tert-butyl group (tBu), a 2,2,5,7,8-pentamethylchroman-6-sulfonyl group (Pmc),
—R21— is an unsubstituted C2-C10 alkylene group or a group represented by —R11—R12—
R25 is a hydrogen atom, a C1 alkyl group, or R25 is taken together with —N—R1— to form a C5-7 heterocyclic amine which may have an asymmetric carbon atom,
R26 is a protecting group of an amino group or a hydrogen atom,
R27 represents a protecting group of an amino group or a hydrogen atom,
R28 is a hydroxy group or a group represented by —O—R13—,
Therefore, the methods and compounds described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-18, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 37-54, above).
There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see substituents 19-36, above). Thus, the instant specification does not provide any evidence that Applicant was in possession full scope of the claimed prior to the effective filing of the instant application.
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 methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they 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 claimed invention prior to the effective filing of the instant application. Thus, claims 9-11 and 15-19 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Claim Rejections - 35 U.S.C. § 112 (b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 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.
Claim 10 recites wherein R2 and R4 may be cyclohexyl ester or phenacyl ester. These substituents are determined to be indefinite because a person of ordinary skill in the art would not be able to ascertain how the ester is connected to the nitrogen atoms of Formula (I). For example, the cyclohexyl ester may be connected to the core nitrogen as either -O-C(O)-C6H13 or as -C(O)-O-C6H13. It is unclear which of the two forms of cyclohexyl ester or phenacyl ester applicant has attended to claim. This is unlike the rest of the claim which specifically details the connectivity of the substituents (e.g., 2-chlorobenzyloxycarbonyl). As such, person of ordinary skill in the art would not be able to the meaning of the substituents outlined by claim 10.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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