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/EP2021/054071 filed on 02/18/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in UNITED KINGDOM on 02/19/2020. It is noted, however, that applicant has not filed a certified copy of the GB2002299.2 application as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-22 and 24-26) drawn to an agent for use in medicine, wherein the agent comprises a compound of formula (I), in the reply filed on March 3, 2036 is acknowledged. Applicant’s election without traverse of compound P2B-H having the following structure:
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, wherein B and B' are B-I, W/W' is quinuclidin-3-yl, Z is COOH, Y is -NHCO-, and L is cyclohexyl, as a species of a compound of formula (I) in the reply filed on March 3, 2036 is also acknowledged.
Claims 8, 11, 13 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Applicant’s elected species was not found in the prior art and thus the search has been expanded to include additional species.
Claims 1-7, 9, 10, 12, 14-22 and 24-26 are currently presented for examination.
Claim Objections
Claims 6, 7, 9-10, 14-22 and 24-26 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, for the sake of compact prosecution, claims 6, 9-10, 14-16 and 26 are being interpreted as being dependent upon claim 1 and claims 6, 7, 9-10, 14-22 and 24-26 have been further treated on the merits.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9, 10, 12, 14-22 and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 17, 22-26 and 28 of copending Application No. 17/904,393 (U.S. Publication No. 2023/0101069 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘393 are substantially overlapping in scope for the reasons detailed below.
Claims 1-7, 9, 10, 12, 14-22 and 24-26 of the instant application claim an agent for use in medicine, wherein the agent comprises a compound of formula (I) having the following structure B-L-B’ wherein B and B’ are
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; Z may be selected as -COOH; W is an alicyclic amine group having from 5-12 carbon atoms and at least one amine nitrogen atom; Y may be selected as -NHCO-; and L may be -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is aryl or heteroaryl.
The claims of copending ‘393 claim a compound of formula (I):
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wherein Ar is
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or
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wherein R is an optional substituent on the aryl ring.
Accordingly, the claims of ‘393 anticipate the cited claims of the instant application when Formula I is B-L-B’ and B and B’ are both
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; Z is -COOH; W is an alicyclic amine group having from 5-12 carbon atoms and at least one amine nitrogen atom (quinuclidine); Y is -NHCO-; and L is -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is aryl or heteroaryl.
With respect to the claimed intended use as claimed in claims 15-22 and 24-25 of the instant application, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus, since the compounds of copending ‘393 meet the limitations of a compound of Formula (I) as claimed in claim 1 of the instant application, said compounds of copending ‘393 are inherently capable of performing the claimed intended use since "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9, 10, 12, 14-22 and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 20 of copending Application No. 18/683,412 (U.S. Publication No. 2025/0154143 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘412 are substantially overlapping in scope for the reasons detailed below.
Claims 1-7, 9, 10, 12, 14-22 and 24-26 of the instant application claim an agent for use in medicine, wherein the agent comprises a compound of formula (I) having the following structure B-L-B’ wherein B and B’ are
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; Z may be selected as -COOH; W is an alicyclic amine group having from 5-12 carbon atoms and at least one amine nitrogen atom; Y may be selected as -NHCO-; and L may be -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is aryl or heteroaryl.
The claims of copending ‘412 claim a compound of formula (I):
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wherein R1 and R2 may be selected as -OR3 and R3 is H, Ar is
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or
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wherein R is an optional substituent on the aryl ring.
Accordingly, the claims of ‘412 anticipate the cited claims of the instant application when Formula I is B-L-B’ and B and B’ are both
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; Z is -COOH; W is an alicyclic amine group having from 5-12 carbon atoms and at least one amine nitrogen atom (quinuclidine); Y is -NHCO-; and L is -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is aryl or heteroaryl.
With respect to the claimed intended use as claimed in claims 15-22 and 24-25 of the instant application, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus, since the compounds of copending ‘393 meet the limitations of a compound of Formula (I) as claimed in claim 1 of the instant application, said compounds of copending ‘412 are inherently capable of performing the claimed intended use since "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 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 1-7, 9, 10, 12, 15-22 and 24-26 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 1-7, 9, 10, 12, 15-22 and 24-26 of the instant application claim an agent for use in medicine, wherein the agent comprises a compound of formula (I) having the following structure B-L-B’ wherein B and B’ are independently selected from groups of formula B-I
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wherein:
Z is selected from -COOH, -CH2COOH, -PO(OH)(OR1), or -CH2PO(OH)(OR1), wherein R1 is H or a phosphate protecting group;
W is an alicyclic amine group having from 5 to 12 carbon atoms and at least one amine nitrogen atom;
W' is H, or W' is linked to W to form said alicyclic amine group;
Y is selected from -NH-, -N(CH3)-, -CH2-, -NHCO-, -CH2CONH-, -CONH-, -CH2NHCO-, or -NHCH2-; and
L is a linker group selected from: a direct bond; a saturated or unsaturated chain of from 1 to 12 carbon atoms in which from 1 to 4 of the carbon atoms are optionally replaced by O or S, and wherein the chain is optionally substituted by one or more groups selected from halogen, C1-C6 alkyl, C2-C6 alkenyl, C6-C12 (hetero)aryl, C6-C12 (hetero)arylCl-C4alkyl, or C1-C6 alkoxy; or L is a group of formula -L1-Cy-L2- wherein Cy is a (hetero)aryl or (hetero)cycloalkyl group and L1 and L2 are independently selected from a direct bond or C1-C4 alkenyl groups in which one or two of the carbon atoms are optionally replaced by O or S, including individual stereoisomers thereof, stereoisomer mixtures thereof, and pharmaceutically acceptable salts, solvates, prodrugs or derivatives thereof.
In the present case, the important factors leading to a conclusion of inadequate written description is the breadth of the claims, the lack of sufficient working examples of the compounds as claimed, and the lack of predictability in the art.
With respect to the breath of the claims, the claims are overly broad as the claims are drawn to an infinite number of compounds compared to what is exemplified and prepared in the instant specification.
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); 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). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the instant case, despite the claims being drawn to an infinite number of compounds, the specification provides evidence that Applicant was in possession of only a fraction of the claimed compounds.
First, the only compounds disclosed in the instant specification are compounds wherein B and B’ are the same. There are no compounds exemplified wherein the B and B’ groups are different.
The only exemplified compounds found within the specification which demonstrates possession are those where Z is -COOH, -PO(OH)OBn; W is quinuclidine, piperidine, or pyrrolidine, W’ is H, or W together with W’ form quinuclidine; Y is -NH, -NHCO, -CONH, -NHCH2, or -CH2CONH; and the linker is a direct bond, phenyl, cyclohexyl, a saturated chain from 1 to 8 carbons, and the linkers as disclosed on pages 15-17 of the instant specification. There is no disclosure of any other compounds exemplified containing the various substituents as claimed and thus the instant specification does not provide sufficient evidence that Applicant was in possession of the claimed compounds except for those as detailed above 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. In the instant case, Applicant has not provided sufficient evidence to demonstrate that the compounds having the many various substituents as claimed will also have the activity as claimed and specifically demonstrated for the compounds as exemplified in the instant specification.
Thus since Applicant has not described in adequate detail compounds as claimed except for those as detailed above and 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 claimed compounds except for those as detailed above having the specific substituents as detailed above, prior to the effective filing of the instant application. Thus, the claimed compounds, except those as indicated above, 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(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.
Claims 1-7, 12, 15-22 and 24-26 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 15, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) 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 15 recites the broad recitation an IC₅₀ of about 200µM or less, and the claim also recites preferably about 50µM or less, more preferably about 20µM or less, still more preferably about 10µM or less, or about 5µM or less, or about 1 µM or less 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.
Claim 15 is further indefinite since it is unclear what “as described herein” refers to.
Regarding claim 12, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) 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 12 recites the broad recitation -CH2CH2- or -CH=CH-, and the claim also recites (preferably trans-CH=CH-) 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.
Claim 4 recites the limitation "wherein the alicyclic amine group W is pyrrolidine, piperazine, pyrimidine or morpholine" in the claim. There is insufficient antecedent basis for this limitation in the claim since claim 1 from which claim 4 depends claims the W is an alicyclic amine group having from 5 to 12 carbon atoms and at least one amine nitrogen atom. Pyrrolidine does not apply to the definition as recited in claim 1 since pyrrolidine is a five membered ring and only has 4 carbon atoms and one N ring atom. Piperazine also does not apply to the definition as recited in claim 1 since piperazine only has 4 carbon ring atoms and 2 nitrogen ring atoms. Pyrimidine also does not apply to the definition as recited in claim 1 since pyrimidine only has 4 carbon ring atoms and 2 nitrogen ring atoms. Morpholine also does not apply to the definition as recited in claim 1 since morpholine only has 4 carbon ring atoms, 1 oxygen ring atom and 1 nitrogen ring atom. Thus said rings do not have from 5 to 12 carbon atoms as defined in claim 1.
Claim 5 recites the limitation "wherein the alicyclic amine group W is N-methylpyrrolidine-3-yl" in the claim. There is insufficient antecedent basis for this limitation in the claim since claim 1 from which claim 5 depends claims the W is an alicyclic amine group having from 5 to 12 carbon atoms and at least one amine nitrogen atom. N-methylpyrrolidine-3-yl does not apply to the definition as recited in claim 1 since pyrrolidine is a five membered ring and only has 4 carbon atoms and one N ring atom. Thus said ring does not have from 5 to 12 carbon atoms as defined in claim 1.
Regarding claim 1, the use of parentheses surrounding hetero renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention or optional. See MPEP § 2173.05(d). It is unclear why hetero is in parentheses. It is unclear if hetero is optional or required in the claim. It is unclear if the claim should be interpreted as heteroaryl or aryl; or heterocycloalkyl or cycloalkyl. Thus claim 1 and claims dependent upon claim 1 (claims 2-7, 15-22 and 24-26) are rejected. For the sake of compact prosecution claim 1 is being interpreted as “C6-C12 heteroaryl, C6-C12 aryl, C6-C12 heteroarylC1-C4alkyl, C6-C12 arylC1-C4alkyl, or C1-C6 alkoxy; or L is a group of formula -L1-Cy-L2- wherein Cy is a heteroaryl, aryl, heterocycloalkyl or cycloalkyl group” and examined herewith as such.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 15-22 and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dorshow et al. WO 2016/183351 A1.
Claims 1-3, 15-22 and 24-26 of the instant application claim an agent for use in medicine, wherein the agent comprises a compound of formula (I) having the following structure B-L-B’ wherein B and B’ are
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; Z may be selected as -CH2COOH; W is an alicyclic amine group having from 5-12 carbon atoms and at least one amine nitrogen atom; Y may be selected as -NHCO-; and L may be -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is heteroaryl.
Dorshow et al. discloses the following structure:
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(page 68). This compound anticipates a compound of formula (I) as claimed when Z is selected as -CH2COOH; W is an alicyclic amine group having 5 carbon atoms and one nitrogen atom (pyridine); Y is -NHCO-; and L is -L1-Cy-L2 wherein L1 and L2 are direct bonds and Cy is heteroaryl (pyrazine). Since claim 1 does not recite that Cy is unsubstituted, the claim is interpreted as Cy is either substituted or unsubstituted heteroaryl. This compound is an agent for use in medicine as Dorshow et al. teaches compositions and method for assessing blood vessels and organs of the body (abstract and [002]).
With respect to the claimed intended use as claimed in claims 15-22 and 24-25 of the instant application, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Thus, since the compound of Dorshow et al. meets the limitations of a compound of Formula (I) as claimed in claim 1 of the instant application, said compound of Dorshow et al. is inherently capable of performing the claimed intended use since "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
Thus, the cited claims of the instant application are rejected.
Conclusion
Claims 1-7, 9-10, 12, 14-22 and 24-26 are rejected. Claims 8, 11, 13 and 23 are withdrawn. Claims 6, 7, 9-10, 14-22 and 24-26 are objected to. 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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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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