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 .
Information Disclosure Statement
Three information disclosure statement (IDS) submitted: one on 11/29/2023; one on 02/05/2024; and one on 06/16/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The use of the term GraphPad Prism®, etc. which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
While the Examiner has made every attempt to check the Specification for trade mark compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding trade mark use compliance.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Bicyclic Pyrimidinones as MASP-2 inhibitors”.
Status of the Claims
Claims 1-2, 4-6, 9-10, 12, 16, 18, 22, 36, 40, 45, 48, 52, 56, 61-62, 74, 117, 119-120, and 124 are pending in this application. Claims 3, 7-8, 11, 13-15, 17, 19-21, 23-35, 37-39, 41-44, 46-47, 49-51, 54-55, 57-60, 63-73, 75-116, 118, 121-123, and 125-161 have been cancelled by Applicant.
Claim Interpretation
Claim 40 shows divalent heteroaryl groups with two possible points of attachment (e.g.
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). Since claim 40 depends from claim 1, where Cy1 is shown as a monovalent group, for the purposes of applying art, it will be assumed that Applicant intended for either of the indicated points of attachment to correspond to the bond between Cy1 and -CR5R6-, and for the other point of attachment to correspond to an additional substitution, OR for the divalent Cy1 to form a fused bicyclic system with either R5 or R6 and the carbon to which they are attached.
Claim Objections
Claim 61 is objected to because of the following informalities:
Some of the structures of claim 61 are blurry and bonds are difficult to see. See examples below: New clear structures are required.
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Examiner Notes
Claims 12, 61, and 74 are free of the prior art, but stand rejected over a provisional non-statutory double patenting rejection, and/or formal matters.
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.
Claim 124 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inhibiting MASP-2 in a subject, does not reasonably provide enablement for treatment or prevention of diseases mediated MASP-2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the examples; and (8) the quantity of experimentation necessary.
Breadth of Claims
Claim 124 broadly encompasses a method of treating or preventing any disease or disorder treatable by inhibiting MASP-2 (see extensive list of conditions on pages 119-120 of the specification, which include Glycogen storage disease type 1 and syphilis, among many others), in any subject in need thereof, comprising administration of any of the compounds of Formula I, a stereoisomer, tautomer, or pharmaceutically acceptable salt thereof.
The term “subject” is defined to include “all mammals, including without limitation, humans, non- human primates, dogs, cats, horses, sheep, goats, cows, rabbits, pigs, and rodents.” (page 8 of the spec).
The term "disease," is defined as a pathological condition of an organ, a body part, or a system, resulting from various causes such as infection, genetic defect, or environmental stress that is characterized by an identifiable group of symptoms (page 8 of spec.; see list of specific diseases and conditions on page 120 of the spec.).
The term “treatment” is defined as: (a) preventing a disease not yet diagnosed; (b) inhibiting the disease or condition; (c) relieving or ameliorating the disease or condition, or symptoms thereof.
The term “prevention” is not defined in the specification. The Oxford English Dictionary (2024) defines “prevent” as to “preclude the occurrence” and thus claim 124 encompasses embodiments in which the claimed compounds can preclude the many diseases mediated by MASP-2. See definition II.9.a. Obtained from oed.com [retrieved on 2025-03-05] URL:httos://www.oed.convdictionary/prevent_y?t=true).
Nature of the invention/ State of the Prior Art/ Predictability in the Art
The Cleveland Clinic discloses no way to prevent glycogen storage disease type 1, since this is a genetic condition (see Prevention, page 4). (Obtained from my.clevelandclinic.org [retrieved on 04/02/2026] <URL: https://my.clevelandclinic.org/health/diseases/15553-glycogen-storage-disease-gsd>) Last reviewed: 06/26/2023.
The CDC discloses no chemotherapeutic method for preventing syphilis, only the use of prophylactics during sexual encounters, such as condoms (see Prevention, page 3). (Obtained from cdc.gov [retrieved on 04/02/2026] <URL: https://www.cdc.gov/syphilis/about/index.html>). Pub. Date: Jan. 30th, 2025.
Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”).
Level of One of Ordinary Skill
The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying metabolic disorders and viral/ bacterial infections). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”).
Guidance/Working Examples
The specification provides no working examples for treatment or prevention of any condition caused by MASP-2.
Tables 3-4, pages 222-224, show the results of a biological assay for inhibition of MASP-2 and Thrombin in vitro with the instant compounds. Table 5, page 225, shows inhibition of LPA with the instant compounds in vitro.
Degree of Experimentation
To practice the invention as claimed, the skilled artisan would have to screen each of the many compounds encompassed by instant Formula I in order to determine whether all the compounds meet the functional limitations of the claim for the treatment and prevention of any of the many compounds treatable by inhibition of MASP-2. In addition, the skilled artisan would need to determine which mammal subjects would benefit from treatment and prevention of these diseases (humans, non- human primates, dogs, cats, horses, sheep, goats, cows, rabbits, pigs, and rodents, etc.) by administering the instantly claimed compounds to a statistically significant pool of subjects from each species. Prevention the aforementioned conditions would require long-term monitoring of each patient for appearance of any of the many conditions treatable by MASP-2 inhibition. Thus, the quantity of experimentation in this area would be extremely large, since there are a significant number of parameters that would have to be studied beyond the preliminary in vitro studies provided. Furthermore, the ultimate outcome of such experimentation is completely unpredictable.
In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention.
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 1-2, 4-6, 9-10, 12, 16, 18, 22, 36, 40, 48, 52, 56, 117, 119-120, and 124 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.
Claim 1 is indefinite because, when L is H, it is unclear how Cy2 can be aryl, cycloalkyl, etc. Examiner suggests specifying that when L is H, Cy2 is absent.
Claims 1-2, 4-6, 9-10, 12, 16, 18, 22, 36, 40, 48, 52, 56, 117, 119-120, and 124 are cancelled for depending upon the limitations of claim 1 without curing the deficiencies of claim 1.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 9-10, 16, 45, and 48 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Glunz et al. (WO 2004/002406 A2 – cited in the IDS) (“Glunz”).
Regarding claims 1-2, 4-6, 9-10, 16, 45, 48, Glunz discloses the compounds 25c (page 62) which anticipates the instant compounds when: Cy1 is phenyl substituted with -C(NH)NHBoc (reading on claim 16 when Cy1 is phenyl substituted with -C(NH)NHC(O)OR8, wherein R8 can be C1-6 alkyl – reading on tBu from Boc); R2-7 are H; L is -CH2-; and Cy2 is phenyl substituted with -CF3 (reading on claim 48 when Cy2 is aryl substituted with C1-6 haloalkyl). Glunz’s 25c is not the compound of Structure (I) in the instant proviso.
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(25c)
Further regarding claim 9, Glunz’s compound anticipates the instant compounds of Formula I-A-3 and -4 when R6 is H.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 5-6, 9-10, 16, 18, 45, 48, 52-53, 56, 62, and 117 are rejected under 35 U.S.C. 103 as being unpatentable over Glunz et al. (WO 2004/002406 A2 – cited in the IDS) (“Glunz”); as applied to claims 1-2, 4-6, 9-10, 16, 45, and 48.
The teachings of Glunz are disclosed in the 102-section above and incorporated herein.
Regarding claims 1-2, 4, 5-6, 9-10, 16, 18, 45, 48, Glunz also discloses their compounds of Formula I and Ic below (pages 4 and 15) as selective inhibitors of serine protease enzymes thrombin, factor Xa, factor XIa, factor IXa, and/or factor VIIa. It is known in the art that serine proteases belonging to the coagulation system, such as thrombin and factor VIIa, etc., are able to activate the complement cascade, and that inhibitors of these proteases can regulate the complement cascade.1 Thus, Glunz discloses their compounds as regulators of the complement system, which is the same intended use as the instant claims.
Glunz’s preferred embodiments of Formula Ic read on the instant compounds when R2 (corresponding to instant -L-Cy2) is H or alkyl (corresponding to instant L) substituted with 0-3 R2b, wherein R2b is H, aryl, or 5–10-member heterocycle, all substituted with 0-3 R2c groups, wherein R2c can be halogen, etc. (corresponding to substituted Cy2); R4-5 (corresponding to instant R3-4) can be H, alkyl, etc. Thus, Glunz discloses a narrow subgenus, which is encompassed by the genus of the instant claims.
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Therefore, regarding claims 1-2, 4, 5-6, 9-10, 16, 18, 45, 48, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Glunz’s disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of serine protease inhibitors disclosed by Glunz. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Further regarding claim 9, Glunz’s compounds read on all I-A-1 through -4. With respect to stereoisomerism, Applicant is advised that, in Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007), the court also relied on the settled principle that in chemical cases, structural similarity can provide the necessary reason to modify prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an explicitly stated prior art-based motivation, explaining that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular utility. The Federal Circuit cautioned that requiring such a clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to the Supreme Court' s decision in KSR. The court stated: [r]equiring an explicit teaching to purify the 5(S)-stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM test that was criticized in KSR. Id. at 1301 (See MPEP 2143).
Further regarding claims 16 and 18, Glunz reads on the instant compounds when their group corresponding to instant Cy1 is
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(C6 aryl substituted with -C(NR9)NR10R11, wherein R9-11 are H).
Regarding claims 22, 36, and 40, Glunz discloses their compounds of Formula I, wherein X (corresponding to instant -C(O)NH(CR5R6)Cy1) is -C(O)NH(CR16R16)nR8, wherein n can be 1, R16 can be H or Me, etc., and R8 can be phenyl or a 5-6 membered heteroaryl substituted with alkyl, halogen, -OH, -NH2, -C(NH)NH2, etc., and further optionally substituted with a halogen, alkyl, etc. (see [0035]-[0038]). Glunz discloses that preferred 5-6 membered heterocycles include pyridinyl, furanyl, etc. [0167]. Thus, in view of Glunz’s preferred embodiments and disclosure, the instant compounds wherein the group corresponding to instant Cy1 is
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or
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are particularly obvious.
Regarding claim 52, Glunz discloses their compounds of Formula Ic, wherein R2 can be methyl substituted with R2b, wherein R2b (corresponding to instant Cy2) can be phenyl (as in their preferred embodiment 25c shown above) substituted with 0-3 R2c, wherein R2c can be H, F, Cl, -CN, -Me, -OMe, etc. ([0112]-[0115]), thus rendering the instant compounds obvious when Cy2 is
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,
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, or
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, etc.
Regarding claim 53, Glunz discloses their compounds of Formula Ic wherein R2 can be cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl ([0112]), reading on the instant compounds when L is -CH2- and Cy2 is an unsubstituted C3-6 cycloalkyl. Applicant is advised that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Regarding claim 56, Glunz discloses their compounds of Formula I, wherein R2 can be C1 alkyl substituted with R2b, wherein R2b (corresponding to instant Cy2) can be a 5-10 membered heterocycle (see [0020]-[0024]). Glunz discloses that heterocycles include pyridinyl, furanyl, etc. [0164]-[0165]. Thus, Glunz renders the instant compounds obvious when Cy2 is a heterocycle.
Regarding claim 62, as stated above, Glunz discloses their compounds of Formula I, wherein X (corresponding to instant -C(O)NH(CR5R6)Cy1) is -C(O)NH(CR16R16)nR8, wherein n can be 1, R16 can be H or Me, etc., and R8 a 5-6 membered heteroaryl substituted with alkyl, halogen, -OH, -NH2, -C(NH)NH2, etc. (see [0035]-[0038]). Glunz discloses that preferred 5-6 membered heterocycles include pyridinyl, etc. [0167]. Thus, in view of Glunz’s preferred embodiments and disclosure, the instant compounds wherein the group corresponding to instant Cy1 is
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or
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are particularly obvious. Glunz also discloses their preferred embodiments of Formula Ic, in which the group corresponding to instant Cy2 is phenyl (as in their preferred embodiment 25c shown above) substituted with 0-3 R2c, wherein R2c can be H, F, Cl, -CN, -Me, -OMe, etc. ([0112]-[0115]). Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Glunz’s disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of serine protease inhibitors disclosed by Glunz. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding claim 117, Glunz discloses their imidamide compounds are prepared after Boc group removal under acidic conditions, with TFA ([0267]; and Scheme 25, page 61) to afford a TFA salt. Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a TFA salt of the instant compounds in view of Glunz.
Regarding claim 119, Glunz claims pharmaceutical compositions comprising their compounds and acceptable carriers (Glunz’s claim 7).
Claims 120 and 124 are rejected under 35 U.S.C. 103 as being unpatentable over Glunz et al. (WO 2004/002406 A2 – cited in the IDS) (“Glunz”); as applied to claims 1-2, 4, 5-6, 9-10, 16, 18, 45, 48, 52-53, 56, 62, and 117; in view of Amara et al. (Adv Exp Med Biol. 2008 ; 632: 71–79) (“Amara”).
The teachings of Glunz are disclosed in the 102- and 103-sections above and incorporated herein.
Glunz also discloses their compounds as selective inhibitors of serine protease enzymes thrombin, factor Xa, factor XIa, factor IXa, and/or factor VIIa (page 1).
While Glunz does not specifically teach their compounds as inhibitors of MASP-2 for the treatment of disorders related to MASP-2; the teachings of Amara are relied upon for these disclosures.
Amara the complement system as a main column of innate immunity and the coagulation system as a main column in hemostasis undergo massive activation early after injury, however, interactions between the two are still in the dark (abstract). Amara teaches that various serine proteases belonging to the coagulation system are able to activate the complement cascade independently of the established pathways. Moreover, functional C5a and C3a are generated, both of which are known to be crucially involved in the inflammatory response (abstract). Amara suggests, it is tempting to speculate that these significant interactions between the coagulation and complement system may play an important role after trauma and for subsequent inflammatory reactions and complications (last para. Of intro.). Amara discloses: “to ameliorate the inflammatory response, various immune modulators have been examined, some of which revealed regulatory effects on both the complement and the coagulation system” (page 4, para. 1); and discloses that a C1-esterase inhibitor, which curbs not only complement components of all three pathways (C1r/s, MASP-2, and C3b) but also the endogenous coagulation cascade (kallikrein, Factor XIIa), evinced a cross-talk between both systems. Thus, Amara suggests that serine protease inhibitors may be able to activate the complement system, modulating inflammatory response in conditions like posttraumatic organ failure, etc. – reading on disorders treatable by inhibiting MASP-2.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Glunz’s selective protease inhibitors to inhibit MASP-2 in a subject, or for the treatment of a condition mediated by MASP-2 in a subject, in view of Amara. One of ordinary skill would have been motivated to do so because Glunz discloses their selective protease inhibitors and pharmaceutical compositions thereof for the treatment of cardiovascular and thromboembolic disorders (see Glunz’s claims 9-10); further because Amara suggests significant interactions between the coagulation and complement system may play an important role after trauma and for subsequent inflammatory reactions and complications. One of ordinary skill would have had a reasonable expectation of success because Amara discloses various immune modulators have been examined, some of which revealed regulatory effects on both the complement and the coagulation system (page 4, para. 1), further because of their disclosure that a C1-esterase inhibitor curbs MASP-2 and also the endogenous coagulation cascade, suggesting a cross-talk between both systems.
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 1-2, 4-6, 9-10, 12, 16, 18, 22, 36, 40, 45, 48, 52, 56, 61-62, 74, 117, 119-120, and 124 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 13, 19, 25, 27, 38, 42, 48, 58, 74, 78, 93, 107, 109, 110-111, 114, and 154 of copending Application No. 18/907,356 (Copending ‘356). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-2, 4-6, 9-10, 12, 16, 18, 22, 36, 40, 45, 48, 52, 56, 61-62, 74, 117, 119-120, and 124, Copending ‘356 claims the compounds of Formulae I and I-B, for example, and pharmaceutical compositions thereof. These compounds differ only in the position of a nitrogen on the pyrimidinone, and therefore render the instant compounds obvious.
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Specifically, regarding claim 74, Copending ‘356 claims the compound below, which anticipates one of the instant compounds (Copending ‘356’s claim 109).
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(instant compound)
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(copending ‘356’s compound)
Applicant is advised that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding instant claims 120 and 124, Copending ‘356 claims methods of inhibiting MASP-2 and methods of treating MASP-2 related conditions comprising administration of their compounds (Copending ‘356’s claims 114 and 154).
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
1 Amara et al.; Adv Exp Med Biol. 2008; 632: 71–79. (abstract).
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