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 .
Claim Status
Applicants' response and amendments to the claims, filed 08/12/2025, are acknowledged and entered. Claims 1 and 3-10 have been cancelled and claims 11-21 newly added by Applicant.
Claims 2 and 11-21 are pending and under examination.
Duplicate Claims Warning
Applicant is advised that should claims 2 and 11-13 be found allowable, claims 14-21 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Here, claims 2, 14, and 18 recite identical compounds of formula (4). Claims dependent from claims 14 and 18 recite identical limitations as claims dependent from claim 2. The preambles of claims 14 and 18 are not afforded patentable weight and cannot be used to distinguish the claims from claim 2 because they merely recite purposes or intended uses of the compound of formula (4) recited therein. The fact remains, however, that claims 14-21 cover the same compound of formula (4) recited in claims 2 and 11-13.
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 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 2 and 11-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2006/080463 A1 (Published August 3, 2006) and WO 2015/018858 A1 (Published February 12, 2015).
Regarding claim 1, WO ‘463 teaches vitamin K hydroquinone carboxylic acid esters or salts thereof of general formula (I), wherein R1 and R2 each represent hydrogen, a carboxylic acid residue which has a nitrogenous substituent and is selected among residues of amino acids, N-acylamino acids, N-alkylamino acids, Ν,Ν-dialkylamino acids, pyridinecarboxylic acid, and hydrohalogenic acid salts, alkylsulfonic acid salts, and sugar acid salts of these, or a dicarboxylic acid residue selected among residues of dicarboxylic acids and alkali metal salts thereof, provided that at least either of R1 and R2 is a carboxylic acid residue having a nitrogenous substituent or a dicarboxylic acid residue; R3 represents hydrogen or a group represented by the general formula (II) or (ΠΙ); and n is an integer of 1-14.)
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(Abstract). More specifically, WO ‘463 teaches the following species of formula (I):
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([0030]-[0034]). WO ‘463 teaches a species wherein R1 and R2 are each -COCH2CH2COOH (Compound 29), which differs from the genus of general formula (4) only in that the R1 and R2 variables are a carboxylic acid, not an ester thereof, or in the number of methylene groups in the chain length of the R1 and R2 substituents.
WO ‘858 teaches compounds of formula (I) and formula (I’)
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wherein each R is independently hydrogen, a -P(R1)y group wherein y is 2 or 3, -SO2R4, -COOH, -CO(CH2)pAr, -COOC1-6alkyl, -CON(R2)2, COAr, -COC1-6 alkyl group; -CO(CH2)pCOOR3, CO(CH2)pCON(R2)2 or -CO(CHR6)pN(R5)2 wherein at least one R group is not hydrogen;
each R1 is independently OH, halo, C1-6-alkyl, OPh, Obenzyl, OC1-6-alkyl or oxo such that the valency of the P atom is 3 or 5;
each R2 group is independently hydrogen or C1-6-alkyl;
R3 is H, C1-6-alkyl, Ar, or (CH2)pAr;
R4 is OH, C1-6 alkyl, Ph, CF3, or tolyl;
each R5 is H, an amino protecting group such as Boc, or C1-6 alkyl;
each R6 is H or C1-6 alkyl;
any C1-6-alkyl group is optionally substituted by one or more groups selected from -OR2, N(R2)2 or COOR2;
each Ar is an optionally substituted phenyl or naphthyl group, said substituent being a C1-6 alkyl, CHalH2, CHal2H, CHal3, (where Hal is halide), OH, OC1-6-alkyl, COOR6;
each p is 1 to 4;
q is 2; and
n is 2 to 8 such as 3 to 8; or a salt or solvate thereof.
(p.4, l.1 to p.5, l.3).
The R1 and R2 variables in the claimed compounds of general formula (4) differ from the compounds taught in WO ‘483 only in that the R1 and R2 variables are carboxylic acid esters or in the number of methylene groups in the chain length of the R1 and R2 substituents when R1 and R2 are HOOCH2CH2CH2CO-. For example, WO ‘482 teaches the following species:
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This species differs from claims 2 and 11-21 when R1 and R2 are HOOCH2CH2CH2CO- only in the number of methylene groups in the carbon chain. It would have been obvious to a person of ordinary skill in the art before the filing date of the present claims to modify the dicarboxylic acid residue in the compounds taught in ‘483 by extending the methylene chain length and/or by making an alkyl ester thereof because WO ‘858 teaches vitamin K derivatives having substantially similar structures as those taught in WO ‘483 and teaches R1 and R2 can be -CO(CH2)pCOOR3, wherein R3 is H, C1-6-alkyl, Ar, or (CH2)pAr, and p is 1 to 4. They teach a compound having the same -COCH2CH2COOH substituent recited in Example 29 of WO ‘483:
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(Example 14). An alkyl ester thereof having a C1-6-alkyl group would have been prima facie obvious because WO ‘858 expressly teaches such carboxylic acid esters as an optional variable for R1 and R2 in vitamin K derivatives having the general formulas taught in WO ‘483 and WO ‘858 and recited in the instant claims. 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). Given the close structural similarity of the compounds taught in WO ‘483, WO ‘858, and the instant claims, i.e., they are disclosed to be vitamin K1 and K2 provitamins, they would be expected by those skilled in the art to have similar properties.
Response to Arguments
Applicants argue that neither WO '463 nor WO '858 teaches or suggests that, in Claim 2 of the present application, "in general formula (4), R1 and R2 are carboxylic acid residues selected from the group consisting of R4OOCCH2CH2CO- and R4OOCCH2CH2CH2CO-, where Ra is a C1-C3 alkyl group."
In response, these limitations were removed from claim 2. Regardless, the combined teachings of the cited prior art as discussed above suggest the claimed R1 and R2 carboxylic acid ester substituents for the reasons discussed in the rejection.
Conclusion
Claims 2 and 11-21 are rejected.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038