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 18/693,708
Claims 1-19 are currently pending.
Priority
Instant application 18/693,708, filed 3/20/2024, claims priority as follows:
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Support for the instant claims is found in the provisional application.
Information Disclosure Statement
All references from the IDS’s submitted on 6/6/2024, 2/23/2026, 4/21/2026, and 5/13/2026 have been considered unless marked with a strikethrough.
Election/Restriction
Applicant’s election of Group I, claims 1-15, drawn to compositions comprising a non-triclosan antimicrobial agent, a calcium phosphate component, and a topical delivery vehicle, without traverse, in the reply filed 5/19/2026 is acknowledged. Applicant’s election of benzalkonium chloride as the non-triclosan antimicrobial agent and Ca10(PO4)6(OH)2 as the calcium phosphate component in the single disclosed species of composition in the same reply, is also acknowledged. The Examiner notes a topical delivery vehicle, as defined starting on page 12 of the instant specification, was not elected. In its place, a formulation type was provided, which was not a part of the Restriction/Election of Species Requirement dated 3/25/2026.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 102 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-15 read on the elected species. Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claim 1 recites the limitation, “topical delivery vehicle”, in reference to what the topical composition is comprised of. This limitation is currently being interpreted in accordance with the definition on page 12, lines 5-7 of the specification, which states that the topical delivery vehicle refers to that portion of the topical composition that is not the calcium phosphate particles or quaternary ammonium compound. Thus, the interpretation is consistent with additional ingredients of the composition, not the form of which the composition is in. If Applicants wish for the interpretation to align with a form of the composition such as lotion, cleanser, spray, etc., it is recommended to redraft the claims for clarity.
Claim 8 recites the limitation, “skin nourishing agents” as a component of the composition. This limitation is not defined in the instant specification or the claim, and is not known to one of ordinary skill in the art. On page 2, line 19 of the specification, botanical and herbal extracts are given as examples of skin nourishing agents and thus, the limitation is currently being interpreted as this definition.
Claim 13 recites the limitation, “is a cleanser”, in reference to the composition of claim 1, from which claim 13 depends. The claim does not contain additional structural limitations and the limitation “cleanser” is not defined in the claims or the specification. Stated differently, “cleanser” is considered an intended use because it is not what the composition is, but rather what the composition does, and the limitation is currently being interpreted as such.
Claim 15 recites the limitation, “is a lotion”, in reference to the composition of claim 1, from which claim 15 depends. Similar to above, the claim does not contain additional structural limitations and the limitation “lotion” is not defined in the claims or the specification. “Lotion” is considered an intended use because it is not what the composition is, but rather what the composition does. Furthermore, the broadest reasonable interpretation of lotion includes embodiments with a liquid base, and if the art teaches what could be construed as a lotion, then the broadest reasonable interpretation dictates that the prior art embodiment would be capable of the intended use.
Claim Objections
Claim 5 is objected to for a minor informality. Specifically, claim 5 recites, “the calcium phosphate particles by the molecular formula Ca10(PO4)6(OH)2”, but should read, “the calcium phosphate particles have the molecular formula Ca10(PO4)6(OH)2”, or something similar. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 13 and 15 recite the limitations “cleanser” and “lotion”, respectively, in reference to the composition as recited in claim 1. As stated in the claim interpretation section above, the limitations of claims 13 and 15 are merely intended uses of the compositions already recited by claim 1, and are not granted patentable weight. Dependent claim 14 does not resolve this issue by reciting the structural limitations of a “cleanser” and is therefore also rejected. Appropriate correction is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rohto Pharmaceutical Co., LTD (WO 2019/059023 A1, herein after “Rohto”) as evidenced by WebMD (https://www.webmd.com/oral-health/hydroxyapatite-toothpaste) and ACS (https://www.acs.org/molecule-of-the-week/archive/h/hydroxyapatite.html).
Regarding claims 1-3, 6, and 12-15, the reference Rohto discloses formulations comprising benzalkonium chloride, and specifically discloses Preparation Example 15 (page 17, translated document), which contains benzalkonium chloride and hydroxyapatite, in addition to multiple components that anticipate the limitation “topical delivery vehicle” according to the claim interpretation above, such as stearyl alcohol.
Regarding claim 4, the Examiner notes hydroxyapatite is a particle and is thus a calcium phosphate particle as evidenced by WebMD (https://www.webmd.com/oral-health/hydroxyapatite-toothpaste).
Furthermore, with respect to claim 5, the Examiner notes Ca10(PO4)6(OH)2 is the chemical formula of hydroxyapatite as evidenced by ACS (https://www.acs.org/molecule-of-the-week/archive/h/hydroxyapatite.html).
With respect to claims 7, 8, and 9, Preparation Example 15 discloses the compounds isononyl isononanoate, menthol, and isopropyl methyl phenol in the composition, which are an emollient, skin nourishing agent, and preservative, respectively, and thus anticipate the instant claims.
With respect to claims 10 and 11, Rohto discloses parabens and triclosan as examples of components of the composition (page 5, translated document). Though Preparation Example 15 does not contain an anticipatory species of a paraben or triclosan, a skilled artisan could at once envisage the addition of parabens or triclosan to the composition given the small number of examples provided.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rohto Pharmaceutical Co., LTD (WO 2019/059023 A1, herein after “Rohto”) as applied to claims 1-15 above as evidenced by WebMD (https://www.webmd.com/oral-health/hydroxyapatite-toothpaste) and ACS (https://www.acs.org/molecule-of-the-week/archive/h/hydroxyapatite.html).
Determining the scope and contents of the prior art
The reference Rohto teaches as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
Rohto fails to teach a working example of the elected composition comprising benzalkonium chloride and hydroxyapatite with a paraben or triclosan. Although, the Examiner’s position is that one skilled in the art could at once in visage these limitations, in the alternative the 103 is being made as well.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of non-triclosan containing compositions. An artisan possesses the technical knowledge necessary to make adjustments to the compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to non-triclosan containing compositions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Above, the Examiner took the position that a skilled artisan could at once envisage the combination given the small number of examples found in Rohto. In the alternative, applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine the benzalkonium chloride and hydroxyapatite containing composition with a paraben or triclosan because Rohto teaches a small number of examples, and one of ordinary skill in the art would expect the combination to be successful in generating skin compositions. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of compounds for the same purpose to improve the composition and would have readily predicted success in light of the teachings of Rohto.
Conclusion
Claims 1-15 are rejected. Claims 16-19 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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