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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 03/12/2026 is acknowledged. Claims 2 and 3 have been canceled and claims 5-17 have been withdrawn. Claims 1, 4, 18-20 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 03/12/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 102(a)(1) rejection of claims 1, 4, and 18-20 over Vogt et al. (US 2004/0137065 A1) and 35 U.S.C. 103(a) rejection of claims 1, 2, 4, and 18-20 over Vogt et al. (US 2004/0137065 A1), Edwards (US 3,818,076), and Crochet (Guide for crystallization, (https://share.google/ml6ce3FQrCtCrCcg6, 04/02/2022) from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections
Upon reconsideration the examiner is hereby applying the following new ground of rejections.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myers et al. (US 2018/0043190 A1).
Myers et al. meet all of the limitations of claims 1, 4, and 18-20.
Myers et al. disclose a combination of chlorhexidine (CHX) digluconate and sodium lauryl sulfate (SLS) (table 1 in paragraph 180).
CHX digluconate and SLS forms crystalline chlorhexidine lauryl sulfate upon contacting each other in situ according to withdrawn claim 8 which depends from withdrawn claim 5 which depends from the instant claim 1 and example 1 (paragraph 39 and 41) and example 3 (paragraph 54) in the instant specification. Thus, the combination of CHX digluconate and SLS disclosed by Myers et al. results in crystalline chlorhexidine lauryl sulfate and thus is solid (the instant claim 1).
Given the ionic chlorhexidine having 2+ charge and ionic dodecyl sulfate having 1- charge, the chlorhexidine to lauryl sulfate molar ratio would be 1:2, i.e., 1 chlorhexidine2+ and 2 lauryl sulfate1- form a salt with balanced total charge (the instant claims 4 and 20).
Chlorhexidine lauryl sulfate disclosed by Myers et al. is the same compound as the claimed;
thus, chlorhexidine lauryl sulfate disclosed by Myers et al., under the same ionization method, would have the same fragmentation pattern and thus the same mass spectrometry peaks as claimed (the instant claim 18) and
thus, chlorhexidine lauryl sulfate disclosed by Myers et al. has the same functional groups as the functional groups of the claimed compound and, with the same Fourier Transform (mathematical process for converting the raw data into spectrum), would have the same infrared (IR) spectrometry peaks as claimed (the instant claim 19).
Claims 1, 4, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pilgaonkar et al. (US 2011/0229569 A1).
Pilgaonkar et al. meet all of the limitations of claims 1, 4, and 18-20.
Pilgaonkar et al. disclose a combination of chlorhexidine (CHX) as an active (paragraph 45) and sodium lauryl sulfate (SLS) as a solubilizer (paragraph 53).
CHX digluconate and SLS forms crystalline chlorhexidine lauryl sulfate upon contacting each other in situ according to withdrawn claim 8 which depends from withdrawn claim 5 which depends from the instant claim 1 and example 1 (paragraph 39 and 41) and example 3 (paragraph 54) in the instant specification. Thus, the combination of CHX digluconate and SLS disclosed by Pilgaonkar et al. results in crystalline chlorhexidine lauryl sulfate and thus is solid (the instant claim 1).
Given the ionic chlorhexidine having 2+ charge and ionic dodecyl sulfate having 1- charge, the chlorhexidine to lauryl sulfate molar ratio would be 1:2, i.e., 1 chlorhexidine2+ and 2 lauryl sulfate1- form a salt with balanced total charge (the instant claims 4 and 20).
Chlorhexidine lauryl sulfate disclosed by Pilgaonkar et al. is the same compound as the claimed;
thus, chlorhexidine lauryl sulfate disclosed by Pilgaonkar et al., under the same ionization method, would have the same fragmentation pattern and thus the same mass spectrometry peaks as claimed (the instant claim 18) and
thus, chlorhexidine lauryl sulfate disclosed by Pilgaonkar et al. has the same functional groups as the functional groups of the claimed compound and, with the same Fourier Transform (mathematical process for converting the raw data into spectrum), would have the same infrared (IR) spectrometry peaks as claimed (the instant claim 19).
Response to Arguments
Applicant’s arguments, filed on 03/12/2026, have been fully considered but they are moot in view of new ground of rejections.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 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, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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