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/EP2020/066182 filed on 06/11/2020.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in INDIA on 06/12/2019.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP on 08/27/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 8, 2026 has been entered.
Response to Amendment
Applicant’s amendments to the claims filed on March 16, 2026 amending claims 1, 7 and 10 has been entered. Claims 5, 8, 9 and 11-29 are withdrawn. Claims 1-4, 6, 7 and 10 are currently presented for examination.
Response to Arguments
Due to Applicant’s amendments to the claims filed on March 16, 2026, the previous rejection under 35 USC 103 over Redlich et al. in view of Patani et al. is hereby withdrawn. However, upon further search and consideration, new grounds of rejection are detailed below. This action is NON-final.
Claim Objections
Claim 1 is objected to because of the following informalities: the structure
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following “(a) the compound is not a compound of formula:” is unclear. Appropriate correction is required.
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 1-4, 6, 7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16 of U.S. Patent No. 11,059,850 (provided on IDS dated 01/02/2024). 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 ‘850 are mutually obvious for the following reasons.
Claims 1-4, 6, 7 and 10 of the instant application claim a compound of formula (A)
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such as the following compounds claimed in instant claim 10:
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Claims 15-16 of ‘850 claim a compound of Formula (XXX) having the following structure
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wherein Y is -O-, or CH2-; Rb is -OH; Ra is a hydroxyl protecting group such as C1-4 alkyl; and Rc1 and Rc2 taken together represent -C(C1-4 alkyl)2.
Thus, the only difference between the compounds of the instant claims and the compounds of ‘850 is the position of the -OH of Rb in ‘850.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and/or similar utilities. “An obviousness rejection based on similarity in chemical structure and/or function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991).
Structural similarities have been found to support a prima facie case of obviousness. 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).
Accordingly, the cited claims of the instant application are rendered obvious over the cited claims of ‘850.
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 1-4, 6 and 7 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 1-4, 6 and 7 claim a compound of formula (A)
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wherein when n is 1, R¹ is hydrogen and R² is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mC(O)ORᵃ, - (CH2)mC(O)NRᵃ₂, -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH₂)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group or =CRᵃ₂; or when n is 1, R² is hydrogen and R¹ is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mOPG, - (CH2)mC(O)ORᵃ, -(CH₂)mC(O)NR², -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH2)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group, -O-aryl or =CRᵃ₂; each Ra is, independently, hydrogen or C1-6 alkyl; each Rb is hydrogen or both Rb are taken together to form a boronic acid protecting group; RC is C1-6 alkyl or aryl; PG is a hydroxyl protecting group; m is 0 or 1; x is 0, 1 or 2; R4, R5 and R6 are each independently hydrogen or a hydroxyl protecting group; or R5 and R6 taken together are a diol protecting group; or R4 and R5 taken together are a diol protecting group.
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 breadth of the claims, the claims are drawn to an infinite number of compounds since they encompass a large number of possible substituents for R1, R2, R4, R5 and R6. As compared to the number of compounds claimed, only a fraction of those compounds are actually exemplified in the instant specification. For example, R1 and R2 as claimed may be any silyl group which is presumably any group containing Si; R1 and R2 as claimed may also include any hydroxyl protecting group or any boronic acid protecting group which includes a multitude of choices. In addition, R4, R5, and R6 as claimed may be individually selected as any hydroxyl protecting group or combined together to form any diol protecting group which also include a multitude of choices.
In the instant specification, Applicant describes a protecting group as any suitable hydroxyl protection group known in the art, for example, a hydroxyl protecting group may be a silyl group, C1-4alkyl, C1-4alkyl-O-C1-4alkyl, tetrahydropyranyl, allyl, benzyl, —CH2-naphthyl, or benzoyl, —C(═O)—C1-4alkyl, or —C(═O)-phenyl; wherein benzyl, -CH2-naphthyl, and benzoyl, are optionally substituted with one or two substituents each independently selected from —CH3 and —OCH3 [0069]. A diol protecting group may, for example, be —C(C1-4alkyl)2- (such as (-C(CH3)2)- [0071]. A boronic acid protecting group may, for example, be catechol borane, pinacol borane, N-methyliminodiacetic acid (MIDA) boronate, neopentylglycol borane, pinanediol borane, biscyclohexyldiol borane, or 1-(4-methoxyphenyl)-2-methylpropane-1,2-diol (MPMP-diol) borane [0072].
Thus, the scope of the claims is extremely broad and encompasses an infinite number of compounds.
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.
Despite the broad scope of the claims and the infinite number of compounds claimed, only a fraction of the compounds claimed have been described in the specification to demonstrate Applicant was in possession of these compounds. For example, the only protecting groups shown on the compounds exemplified in the instant specification are C(CH3)2, methyl, ethyl, tert-butyl diphenyl silyl (TBDPS), pivaloyl (Piv), benzyl (Bn), CH2-naphthyl, benzoyl (Bz), acetyl, and tert-butyl dimethyl silyl. Moreover, despite the many choices for R1 and R2 as claimed, the exemplified compounds only contain R1 or R2 as
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or
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or (CH2)mC(O)ORa wherein m is 0 and Ra is hydrogen, methyl or ethyl; or (CH2)mO wherein m is 0 or 1 and the O is attached to hydrogen or one of the protecting groups as detailed above. There is no disclosure of any other compounds made having any other substituent as claimed and thus the instant specification does not provide any evidence that Applicant was in possession of the full scope of the claimed compounds prior to the effective filing date 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, it would be highly unpredictable for an ordinary skilled artisan to be able to synthesize all of the claimed compounds which is inclusive of predicting the suitable reagents and suitable reaction conditions to produce the compounds, with a reasonable expectation of producing a claimed compound which retains the suitable properties against PRMT5 as disclosed in the instant specification.
Thus, since Applicant has not described in adequate detail compounds containing the broad scope of substituents as claimed and furthermore have not provided any evidence that such compounds exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided sufficient evidence that Applicant was in possession of the full scope of the claimed compounds prior to the effective filing date of the instant application. Thus, in view of the aforementioned, 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.
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 the limitations "
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" and “
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”. There is insufficient antecedent basis for this limitation in the claim since claim 10 depends from claim 1 and claim 1 claims a compound of formula (A)
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wherein when n is 1, R¹ is hydrogen and R² is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mC(O)ORᵃ, - (CH2)mC(O)NRᵃ₂, -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH₂)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group or =CRᵃ₂; or when n is 1, R² is hydrogen and R¹ is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mOPG, - (CH2)mC(O)ORᵃ, -(CH₂)mC(O)NR², -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH2)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group, -O-aryl or =CRᵃ₂. Claim 1 does not claim that when n is 1, R1 or R2 is =O as in the compounds as detailed above in claim 10.
Claim 10 recites the limitations "
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". There is insufficient antecedent basis for this limitation in the claim since claim 10 depends from claim 1 and claim 1 claims a compound of formula (A)
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wherein when n is 1, R¹ is hydrogen and R² is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mC(O)ORᵃ, - (CH2)mC(O)NRᵃ₂, -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH₂)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group or =CRᵃ₂; or when n is 1, R² is hydrogen and R¹ is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mOPG, - (CH2)mC(O)ORᵃ, -(CH₂)mC(O)NR², -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH2)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group, -O-aryl or =CRᵃ₂. Claim 1 does not claim that when n is 1 and R1 is hydrogen, R2 is -(CH₂)mOPG as in the compounds as detailed above in claim 10.
For the sake of compact prosecution, claim 1 is being interpreted as when n is 1, and R¹ is hydrogen, R² may be selected as -(CH₂)mOPG in addition to the other substituents cited and examined herewith as such.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 which depends upon claim 1 claims the following compounds
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and
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. However, claim 1 claims a compound of formula (A)
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wherein when n is 1, R¹ is hydrogen and R² is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mC(O)ORᵃ, - (CH2)mC(O)NRᵃ₂, -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH₂)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group or =CRᵃ₂; or when n is 1, R² is hydrogen and R¹ is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mOPG, - (CH2)mC(O)ORᵃ, -(CH₂)mC(O)NR², -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH2)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group, -O-aryl or =CRᵃ₂. Claim 1 does not claim that when n is 1 R1 or R2 is =O as in the compounds as detailed above that are claimed in claim 10. Thus claim 10 fails to further limit the subject matter of the claim upon which it depends.
Claim 10, which depends from claim 1, claims the following compounds:
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However, claim 1 claims a compound of formula (A)
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wherein when n is 1, R¹ is hydrogen and R² is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mC(O)ORᵃ, - (CH2)mC(O)NRᵃ₂, -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH₂)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group or =CRᵃ₂; or when n is 1, R² is hydrogen and R¹ is -(CH₂)mNRᵃ₂, -(CH₂)mORᵃ, -(CH₂)mOPG, - (CH2)mC(O)ORᵃ, -(CH₂)mC(O)NR², -(CH₂)mC(O)Rᵃ, -(CH2)mB(ORᵇ)₂, -(CH2)mS(O)xRᶜ, a silyl group, C1-6 alkyl substituted with a silyl group, -O-aryl or =CRᵃ₂. Claim 1 does not claim that when n is 1 and R1 is hydrogen, R2 is -(CH₂)mOPG as in the compounds as detailed above in claim 10. Thus claim 10 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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 1-4, 6 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Verhoeven WO 2019/110734 A1 (provided on IDS dated 12/8/2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 1-4, 6 and 10 of the instant application claim a compound of formula (A)
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such as the following compounds claimed in instant claim 10:
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. Claim 1 is being interpreted as when n is 1, and R¹ is hydrogen, R² may be selected as -(CH₂)mOPG in addition to the other substituents cited (see 112(b) rejection above).
Verhoeven specifically discloses the following compound
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which anticipates a compound of formula (A) as claimed when Y is O; n is 1; R1 is hydrogen; R2 is –(CH2)mOPG wherein m is 0 and PG is the hydroxyl protecting group benzoyl; R5 and R6 are the hydroxyl protecting group Piv; and R4 is the hydroxyl protecting group methyl (page 33).
Verhoeven teaches that Bz means benzoyl (−C(=O)−phenyl) and Piv means pivaloyl (page 32 line 16).
Thus, Verhoeven discloses the same compound as claimed in claim 10 of the instant application and therefore, the cited claims of the instant application are anticipated.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 7 and 10 are rejected under 35 U.S.C. 103 as being obvious over Verhoeven WO 2019/110734 A1 (provided on IDS dated 12/8/2022).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 1-4, 6, 7 and 10 of the instant application claim a compound of formula (A)
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such as the following compounds claimed in instant claim 10:
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Verhoeven teaches a compound of Formula (XXX) having the following structure:
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wherein Y is -O-, or CH2-; Rb is -OH; Ra is a hydroxyl protecting group such as C1-4 alkyl; and Rc1 and Rc2 taken together represent -C(C1-4 alkyl)2 (page 23 lines 10-26). Verhoeven discloses Formula (XXX-C)
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and specifically exemplifies Formula (II)
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(pages 26, 29 and 31).
Thus, the only difference between the compounds of the instant claims and the compounds of Verhoeven is the position of the -OH of Rb in Formula (XXX) of Verhoeven.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and/or similar utilities. “An obviousness rejection based on similarity in chemical structure and/or function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991).
Structural similarities have been found to support a prima facie case of obviousness. 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).
Accordingly, for these reasons, the cited claims of the instant application are rendered obvious over the teachings of Verhoeven.
Conclusion
Claims 1-4, 6, 7 and 10 are rejected. Claims 5, 8, 9 and 11-29 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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