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 .
Claims 35-52 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I and the species compound 104 in the reply filed on 9/30/2025 is acknowledged.
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Claims 36, 37, 41 and 43-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 35, 38-40 and 42 are under examination.
After a structure search the scope of invention was broadened to include all compounds of formula I(g).
Claim Rejections - 35 USC § 112
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 35, 38-40 and 42 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.
Claims 35 and 40 recite the "reverse amide analog, isotopic variant (e.g., deuterated analog)” which encompasses analogs and variants that have not all been identified in the specification. Therefore the metes and bounds of the terms “reverse amide analog, isotopic variant (e.g., deuterated analog)” cannot be deciphered.
Regarding claims 35 and 40, the phrase " (e.g., deuterated analog)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, with respect to R5, R10 and R multiple limitations recite examples which render the claim unclear, for example, with reference to the alkyl the claim recites “(e.g. methyl…-OCH3)”. Further limitations to the haloalkyl, R8-aryl, aryl and heteroaryl have the same issue.
Claims 38, 39 and 42 are rejected for depending on rejected base claims 35 and 42.
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 35, 38-40 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, 13 and 16 of copending Application No. 18/848,256 (herein ‘256). Although the claims at issue are not identical, they are not patentably distinct from each other because the present compound is 104, whereas the copending application claims a compound 118.
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The compounds are both herbicidal compounds only differ by a saturated bond. The compound in ‘256 is prima facie due to having very close structural similarity and one skilled in the art would have expected the compounds to have similar properties.
Additionally, claims 12 and 13 of copending application ‘256 further specify a substantially pure single stereoisomer of the compound that is SR, RS, RR or SS. Therefore, the present claims are prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 35, 38-40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Klofta et al. (WO 99/45771; published September 16, 1999).
Applicant claims the compound 6-amino-7-hydroxyoctanoic acid below.
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With respect to claims 35, 39 and 40, Klofta et al. teach and anhydrous lotion composition for killing viruses and bacteria (abstract). The antivirals that may be added to the lotions include organic acids that are saturated, unsaturated C1-C12 carboxylic acids possessing 1 to 4 carboxylic acid groups and with optional functional groups (i.e., amino and hydroxyl) substituted along the carbon chain, wherein the hydroxy group is substituted on carbon number C4 or above (page 16, paragraph 3 through page 17, paragraph 1).
Klofta et al. teach organic acids which encompass the claimed compound 6-amino-7-hydroxyoctanoic acid.
With respect to claims 38 and 42, Klofta et al. do not specify a mixture of stereoisomers or that the compound is a substantially pure SR, RS, RR, SS isomers. However, MPEP 2144.09 states that compounds of close similar structure include stereoisomers and there is a presumed expectation that such compounds possess similar properties. See Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007).
Therefore, it would have been prima facie obvious for one of ordinary skill to combine the teachings of Klofta et al. to include the compound 6-amino-7-hydroxyoctanoic acid with a reasonable expectation of success. One of ordinary skill would have been motivated to combine the teachings of Klofta et al. before the time of filing to include the compound 6-amino-7-hydroxyoctanoic acid because Klofta et al. teach antiviral organic acids that are unsaturated C1-C12 carboxylic acids possessing 1 carboxylic acid groups and an optional amino and hydroxy group substituted along the carbon chain wherein the hydroxy group is substituted on carbon number C4 or above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Muchowski et al. (US 4,410,526; October 18, 1983) discloses a compound of formula I(g) as an intermediate (C) which is produced while preparing oxazolidine-2-one prostaglandin compounds but compound (c) does not have any specific utility.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
Prosecution Insights