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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/18/2026 has been entered.
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 Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/18/2026, with respect to the Office Action mailed 6/18/2026, 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 continue to argue similar statements presented in their last correspondence such that the definition of “variations in chain length” is limited to that of (b) in claim 3. The argument was 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 which include the compound at col. 12, line 21.
Applicants also once again 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 (e.g. absent of efficacy data, etc.). This again is found unpersuasive as MPEP 2143 states the following 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 and the language in MPEP regarding homologs. Therefore the prior art compound or even others in the document may serve as a “lead compound” and this argument is found unpersuasive.
Applicants also argue that “homologs” only refer to compounds differing by only one methylene group as this interpretation would not be applicable to the lower alkylated species of claim 8. This is found unpersuasive as MPEP clearly states that 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). The latter does not support Applicant’s claims that it is only limited to simply one methylene group. Thus this is found unpersuasive despite Applicant’s citation of In re Mills since the fact pattern in the instant case is different.
Lastly Applicants argue the concept of stereochemistry to those species of claim 5 and that the examiner had failed to address those limitations. Applicants are reminded that the prior art compound was shown to embrace various stereochemistry via the squiggly bonds and may encompass all stereoisomers as currently claimed. 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.
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
