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 filed on 01/12/2024, is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/IB2022/056761, filed on 07/21/2022, which claimed the benefit of U.S. Provisional Patent Application No. 63/225,044 filed on 07/23/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/10/2024, and 05/14/2026, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of Claims
Applicant preliminary amendments filed on 07/08/2026 that amended claims 3 and 6, and cancelled claims 14-16, 18, 20-22, 24 and 26-27.
Claims 1-13, 17, 19, 23, 25, and 28-30 are pending.
Election/Restriction
Applicant’s response filed on 07/08/2026 to Restriction/Election Requirement filed on 05/21/2026, is acknowledged. Applicant elected with traverse Group I drawn to an antimicrobial composition comprising an octenidine salt; carnitine tartrate; and water. Claims 1-13, 17 and 19 read on the elected Group. Claims 23, 25, 28 and 29-30 of Group II-V are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Thus, claims 1-13, 17, 19, 23, 25 and 28-30 are pending with claims 23, 25 and 28-30 are withdrawn from further consideration, and claims 1-13, 17 and 19 are under consideration.
Response to Arguments
Applicant respectfully traverses the Unity of Invention Requirement for at least the following reasons. the Examiner's "Lack of Unity of Invention" analysis addresses only Groups I and V. The Examiner does not provide any analysis as to why Groups II, III, and IV lack unity of invention with Group I or with each other. Under 37 C.F.R. § 1.475(a), the requirement of unity of invention is fulfilled when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The Examiner has not set forth any reasoning as to why the shared technical feature linking Groups II, III, and IV to Group I is not a special technical feature with respect to those groups. Accordingly, the restriction of Groups II, III, and IV has not been properly established. Applicant respectfully requests that the Examiner withdraw the restriction requirement as to Groups II, III, and IV, or in the alternative, provide a complete analysis of the lack of unity for each group as required under PCT Rule 13.2 and 37 C.F.R. § 1.475.
Examiner response:
Applicant’s arguments have been fully considered but are not persuasive. Groups I-V1 lack unity of invention because the shared technical feature of octenidine salt, carnitine tartrate and water does not make contribution over the prior art. The groups, I-V required the antimicrobial composition of claim 1, octenidine salt, carnitine tartrate and water, and as explained in the previous communication, and herein below in the 103 Rejection, the combination of Bodkhe and Guth or Bodkhe and Xu renders the claimed antimicrobial composition obvious, see the 103 rejection below.
Claim Rejections - 35 USC § 103
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.
§ 103 Rejection over
Claims 1-13, 17 and 19 rejected under 35 U.S.C. 103 as being unpatentable over R. Bodkhe et al. (WO2020136552A1, 07/02/2020, “Bodkhe” cited in the IDS dated 04/10/2024) in view of D. Sedlock et al. (ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Dec. 1985, p. 786-790, cited in the PTO-892), and Zhao Xu (CN 108913373A, 11/30/2018, “Xu” cited in the PTO-892).
Bodkhe teaches an antimicrobial compositions comprising octenidine salt. [Title]. Bodkhe teaches that the composition comprises:
octenidine salt (having a concentration of at least about 0.04% by weight;
a polycarboxylic acid chelator having a concentration of at least about 0.05 M;
a (C8-C12) 1,2 alkane diol; and
water,
wherein the composition has a pH that is greater than or equal to 3.5 and less than 5.5, wherein the water is present in the composition at a greater weight percent than each of the component, wherein octenidine salt is octenidine dihydrohalide. [[00131]-[00131], and claim 1].
Bodkhe teaches that the "effective amount" of the active components in the composition provides antimicrobial activity, wherein the amount is a level low enough not to cause clinical symptoms and is desirably a non-detectable level, and this amount of the components, when considered separately, may not kill to an acceptable level, or may not kill as broad a spectrum of undesired microorganisms, or may not kill as fast; however, when used together such components provide an enhanced antimicrobial activity (as compared to the same components used alone under the same conditions). [0018]. Bodkhe teaches
the composition may additionally employ adjunct antimicrobial conventionally found in pharmaceutical compositions in their art-established fashion and at their art-established levels, wherein the additional antimicrobials employed for combination therapy. [0085]. Bodkhe teaches that the active agent of the composition is quaternary amine antiseptic component, with nonlimiting examples of quaternary amine antiseptics can be use in the antimicrobial composition including octenidine salt, di-(C8-C16) alkyldimethyl ammonium salt, a polyquatemary amine salt compound, or any combination of the quaternary amine antiseptic components. [0059]. The antimicrobial components, the quaternary amine antiseptic component, the 1,2-alkanediol can be used in combination, or with other antiseptics in order to effectively kill microorganisms on tissue. [0061].
Sedlock teaches the antimicrobial activity of octenidine hydrochloride. Sedlock teaches that octenidine hydrochloride has a broad-spectrum anti-bacterial activity as shown in greater than 99% activity against multiple bacteria. Sedlock teaches that octenidine hydrochloride reduced resident microflora populations from 90 to 99.98%. Sedlock teaches that Octenidine in a surfactant-based vehicle exhibited significantly better skin-degerming activity. [Abstract, Whole document]
However, while Bodkhe teaches that the antimicrobial composition is enhanced by additional active agents e.g., quaternary amine, Bodkhe does not teach that the other antimicrobial agent is carnitine tartrate.
Xu teaches anti-bacterial compositions comprising 10-14 parts of monoethanolamine, 10-18 parts of L-carnitine-L-tartrate, and 40-68 parts of water, [Translated document, Abstract, page 2 line 15]. Xu teaches that the carnitine-L-tartrate effectively enhance the antimicrobial effect, sterilizing rate and bacteria killing rate, preferable Bactericidal effect, [Translated document, page 2, page 10-7 from the bottom]. Xu teaches comparative example 2 of the composition prepared without carnitine tartrate, wherein Table 1 shows that the sterilizing rate and bacteria killing rate decrease significantly in comparative example 2 compared to compositions 1-5 comprising carnitine-L-tartrate. [original patent, page 4].
In view of the teaching of Xu, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to add carnitine tartrate (quaternary amine) to the Bodkhe’s antimicrobial composition to enhance the antimicrobial effect. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because:
Sedlock teaches that octenidine hydrochloride is very effective antimicrobial with greater than 99% broad spectrum antibacterial activity;
Bodkhe teaches an antimicrobial compositions comprising octenidine salt administered at an effective amount that is low enough not to cause clinical symptoms and is desirably a non-detectable level, however, Bodkhe teaches that this amount, when considered separately, may not kill to an acceptable level, or may not kill as broad a spectrum of undesired microorganisms, or may not kill as fast [0018];
Bodkhe teaches that combining octenidine with other antimicrobial agents provide an enhanced antimicrobial activity (as compared to the same components used alone under the same conditions). [0018];
Bodkhe teaches the composition may additionally employ adjunct antimicrobial conventionally found in pharmaceutical compositions in their art-established fashion and at their art-established levels [0085];
Bodkhe teaches that the active agent of the composition is quaternary amine antiseptic component, with nonlimiting examples of quaternary amine antiseptics can be use in the antimicrobial composition [0059];
and Xu teaches that adding carnitine tartrate to an antimicrobial composition effectively enhance the antimicrobial agent strength and the composition antimicrobial effect, sterilizing rate and bacteria killing rate, [Translated document, page 2, page 10-7 from the bottom]; Xu teaches that antimicrobial composition prepared with carnitine tartrate (example/embodiment 1) shows significant increase in the sterilizing rate and bacteria killing rate compared to composition without carnitine tartrate (comparative example 2), [original patent, page 4, Table 1]. Thus, one of ordinary skill in the art would have reasonable expectation of success selecting carnitine tartrate as the quaternary amine for Bodkhe’s antimicrobial composition to enhance the effect of the composition and prepare an effective antimicrobial composition with low level of active ingredients. Therefore, the combination of Bodkhe and Xu meat each and every limitation of claim 1.
With regard to claim 2, Bodkhe teaches that the octenidine salt is octenidine dihydrochloride. [00131].
With regard to claim 3, Bodkhe teaches that the octenidine salt concentration is at least about 0.05 wt. %, preferably equal to 10 wt.%, or more preferably less than or equal to 5 wt.%. [0060].
With regard to claim 4, Xu teaches that the concentration of carnitine tartrate in Example 1 (embodiment 1), is 10%. [Translation document, page 2, last line].
With regard to claim 5, the amount of octenidine salt taught by Bodkhe is equal to 5% [0060], Xu teaches 10% in example 1, and combining Bodkhe with Xu is established above. Thus, 5% octenidine: 10% carnitine tartrate is equivalent to 1:2 which read on claim 5 ration of 1:10.
With regard to claim 6, Bodkhe teaches example 1, wherein the amount of water is 85.22%. [00150], Table 2.
With regard to claims 7, 8, 9 and 10, Bodkhe teaches the preferred composition contains an effective amount of (C8-12) 1,2-alkanediol to rapidly kill or inactivate microorganisms, wherein the (C8-12) 1,2-alkanediol is 1,2-octanediol, wherein the 1,2octanediol is present at a concentration of at least about 0.05% by weight, or at least about 2% by weight. [0048]. Bodkhe teaches that the 1,2-octanediol is present at a concentration of about 0.05% by weight to about 3% by weight. [00140], [00141].
With regard to claim 11, Bodkhe’s amount of octenidine salt of 5 wt.% to 1.2-octanediol of 2% is equivalent to octenidine: 1,2-octanediol of 2.5: 1, which read on claim 11 ratio of 1:10- 10:1.
With regard to claims 12, 13 and 17, Bodkhe teaches that the composition comprises emulsifying the antimicrobial components into an emulsion comprising a discrete phase of a hydrophobic component and a continuous phase that includes water and optionally one or more polar hydrophilic carrier(s) as well as salts, surfactants, water-soluble or water-swellable polymers. [0055]. In certain preferred embodiments, the hydrophilic is selected from the group consisting of glycols, and in particular glycerin and propylene glycol, and mixtures thereof, [0077], particularly preferred are polyethylene glycols (PEGs), glycols, and combinations thereof, [0095], wherein the composition comprises cellulose derivative, [0099], wherein cellulose derivative of Example 1 is hydroxyethyl cellulose (250 HHX). [00150], Table 1].
With regard to claim 19, Bodkhe teaches that the antimicrobial composition is a solution, gel, or suspension, [00108], wherein the composition has a pH that is greater than or equal to 3.5 and less than 5.5. [00130].
Conclusion
Claims 1-13, 17, and 19 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
1 The Requirement for Restriction/Election mailed on 05/21/2026 stated groups I and V, which should be groups I-V.
Prosecution Insights