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 .
DETAILED ACTION
Status of Claims
Claims 1, 2, 5-8,10,11, and 13-18 are pending in the instant application. Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1-2, 5-8, 10, and 11 is contained herein.
Status of Rejections
35 USC § 103
The rejection of claims 1, 2, 5-8, and 10-11 is maintained.
Applicant’s arguments, see Remarks, filed 5/20/2026, with respect to the Office Action mailed 2/20/2026, have been fully considered but are not found persuasive.
To reiterate the rejection of record, claims 1-2, 5-8, 10, and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over US Patent 9,073,884 (mentioned of record previously).
The instant claims may be drawn to compositions comprising the structure of formula I in a mouthwash or dentifrice (powder, paste, liquid) wherein R1 may be C2-C24 linear or branched alkyl. In particular lower alkyl derivatives such as those described below:
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.
Patent ‘884 teaches the following compound and compositions thereof (see col. 12, line 21, for compound and col. 13, claim 7 and col. 4 under pharmaceutical compositions for compositions):
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. The document teaches that the compositions are used as antibacterial agents (see col. 2, line 10) and are formulated in a manner to afford a therapeutic effect (see col. 4, lines 60-65). Additionally, the compositions may be formulated as mouthwash or dentifrice and weight amounts are described therein (see col. 3, lines 33-34 and col. 8, lines 20-30).
The only difference between these similar compounds stems from variable R1 (methyl versus lower alkyl) and are considered homologs. However, MPEP states the following:
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).
Additionally, patent ‘884 even suggests that analogues of the C1 alkyl fatty acid are also suitable (see col. 12, line 44) which would motivate one skilled in the art to make these modifications. Thus, formulations of these claimed fatty acids as mouthwash/dentrifice are well documented in the art and one skilled in the art would have arrived at the claimed compounds and compositions. Thus the claimed compositions are obvious.
Applicants now argue the concept of a “lead compound” where a person skilled in the art would not have selected the prior art compound as a starting point for exploration and derivatization. The examiner respectfully disagrees. In reference to MPEP 2143 as Applicants conveniently point out; the following guidance is also provided regarding the “lead compound” analysis:
The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: "Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound." Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Office personnel should recognize that a proper obviousness rejection of a claimed compound that is useful as a drug might be made beginning with an inactive compound, if, for example, the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be a lead compound by pharmaceutical chemists, but could potentially be used as such when considering obviousness.
Once again, “any known compound” may serve as a lead compound as long as there is provided some motivation to arrive at the claimed species. As in the present case, the examiner has provided at least two means of motivation ranging from the language cited at claim 3, col. 12 which suggests variations of chain length to those groups of (a) in the broadest reasonable interpretation. Also note that Applicant’s argument regarding the definition of “variations in chain length” is limited to that of (b) in claim 3 is found unpersuasive. As (b) is viewed as another optional embodiment falling under the scope of (a) and does not suggest that the variations of (a) is only defined to that of what is described in (b). The citations (a)-(e) are considered to be individual optional limitations for those compounds described in claim 1 generally.
Therefore the prior art compound or even others in the document may serve as a “lead compound” and this argument is found unpersuasive.
Furthermore, the examiner argued the readily recognized concept of homologs (which indeed the claim compounds are with respect to the prior art compound cited of record) which states the following:
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).
Applicants also argue that since the examiner had put forth an Improper Markush rejection in the office action 5/8/2024; it is inconsistent with the current obviousness rejection of record. The examiner does not comprehend this argument as the two rejections are different in context. The concept of obviousness in the instant case (methyl for other lower branched or unbranched alkyl groups) is not related to the claims embracing a proper Markush grouping. In fact, the claimed compounds and the compound applied as are art are very similar in structure and are considered cyclopropanated fatty acids. Thus the examiner could not possibly interpret how a rejection made previously centered around a proper Markush grouping could invalidate the current obviousness rejection of record based on methyl for a lower alkyl group. Thus the argument is found unpersuasive.
Thus, based on the preponderance of evidence submitted by the examiner the claimed compounds would have been considered obvious and the rejection is maintained.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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