NON-FINAL REJECTION AFTER FILING RCE
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 .
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winston et al. U.S. Patent Application Publication No.: 2020/0022363 A1.
Winston et al. discloses process for forming controlled release antimicrobial salts that include a four-part mixture of (i) an antimicrobial cation, (ii) the anion of an organic acid, (iii) an ammonium, sodium or potassium cation and (iv) an anion such as a halide, acetate or gluconate, dissolved in a solvent so that a concentrate with dissociated controlled release antimicrobial ions is formed. Upon addition of water, controlled-release antimicrobial salt having a solubility in water at 20° C. of greater than about 0.001 (w/w) %, but less than about 1 (w/w) % are formed. Alternatively, a controlled release antimicrobial salt is formed in situ at a site of application containing moisture by addition of a concentrate having dissociated controlled release antimicrobial ions, see abstract.
Winston et al.’s compositions are directly disclosed to have various uses such as in dental applications and dental compositions, see paragraphs [0069] and [0073].
Applicant’s claims are deemed to be directly anticipated over at least the process of making the composition set forth in TABLE 2, see paragraphs [0081] and [0082]. Said process, see paragraph [0082], has the first process step of: while stirring, adding 3.1 wt. % of lauric acid to 84.98 wt. % of propylene glycol. Said concentration amounts are based on the final composition. Taking just the first composition which consists of only lauric acid and propylene glycol, the Examiner calculated concentration of the lauric acid in this said first composition is as followed: [(3.10 parts lauric acid)/(3.10 part lauric acid + 84.98 parts propylene glycol)] x 100 = 3.52 wt. % lauric acid which falls directly within the fatty acid concentration range as set forth in Applicant’s dependent claim 6.
Response to Arguments
Applicant’s arguments filed 9/16/26, with the RCE and amendment, with respect to claim(s) 1, 3-4 and 6-8, have been considered but do not place the claims in condition for allowance for the reasons set forth above. Additional examiner comments are set forth next.
Applicant argues the following: “The Examiner relies on an intermediate mixture temporarily formed during the preparation of the composition of Table 2. Specifically, paragraph [0082] describes adding 3.1 wt.% lauric acid to 84.98 wt.% propylene glycol as an initial step in preparing the Table 2 formulation. Winston does not identify this intermediate mixture as a separate composition. Rather, paragraph [0082] proceeds to add a separately prepared solution containing benzalkonium chloride and other components, followed by further ingredients, to obtain the formulation of Table 2.
Thus, the Examiner appears to isolate an intermediate state occurring during Winston's preparation process and treat that intermediate state as a composition separate from the composition actually prepared and disclosed in Table 2. The composition disclosed in Table 2, however, contains benzalkonium chloride and other components in addition to lauric acid and propylene glycol.”.
Examiner’s response. It is wholly irrelevant whether or not Winston et al. verbatimly identifies the intermediate mixture consisting of lauric acid and propylene glycol as a separate composition distinct from its subsequence use to make a four-component composition. The fact is, Winston et al.’s said mixture consists of lauric acid and propylene glycol, and said mixture IS a separate stable mixture that inherently meets the limitations of applicant’s independent claim 1.
Applicant further argues the following: “Moreover, the antimicrobial cation is not merely an incidental component of Winston's disclosed composition. Claim 1 of Winston requires a four-part mixture including, inter alia, "one or more antimicrobial cations," and the Table 2 composition relied upon by the Examiner contains benzalkonium chloride. Winston thus teaches the antimicrobial cation as an integral component of its controlled-release antimicrobial composition, rather than disclosing the lauric acid/propylene glycol intermediate as the composition ultimately prepared according to paragraph [0082].
In contrast, amended claim 1 recites a dental separation material consisting essentially of a fatty acid and water, a water-soluble solvent, or a mixture thereof. As described in paragraph [0019] of the present specification, the dental separation material may contain other components, such as a surfactant. Thus, the phrase "consisting essentially of" permits additional components that do not materially affect the basic and novel characteristics of the claimed composition.”.
Examiner’s response. Applicant seems to be of the opinion that applicant’s preamble claim language of: “A dental separation material consisting essentially of:” somehow positively excludes the further addition of benzalkonium chloride which is subsequently added to the lauric acid/propylene glycol base mixture. The examiner disagrees with applicant’s said argument. As applicant rightly argues: “Thus, the phrase "consisting essentially of" permits additional components that do not materially affect the basic and novel characteristics of the claimed composition.”. The Examiner holds that Winston et al.’s subsequent addition of benzalkonium chloride and sodium hydroxide to the lauric acid/propylene glycol base mixture, WOULD NOT materially affect the basic and novel characteristics of APPLICANT’S claimed composition. Applicant’s claimed invention is drawn to a composition that can be used in a dental process (e.g. dental separation material). Likewise, Winston et al.’s compositions are directly disclosed to have various uses such as in dental applications and dental compositions, see paragraphs [0069] and [0073].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH DAVID ANTHONY whose telephone number is (571)272-1117. The examiner can normally be reached M-F: 10:00AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie (Lanee) Reuther can be reached at 571-270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D ANTHONY/Primary Examiner, Art Unit 1764
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