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 .
Claims Status
Applicant's election with traverse of Group V, claims 9 and 11-12 directed to a liquid composition comprising an oil in water emulsion (claim 11) in the reply filed on 11/03/2025 is acknowledged. Examiner notes that upon further consideration of the instant claims with the election including claim 11 which is directed to a liquid water in oil emulsion, the invention of group I (claims 1-3 and 16) and II (claims 4-6 and 17) are hereby rejoined with Group V to the extent of the elected liquid formulation including water in oil emulsions.
The traversal is on the ground(s) that there is existing technical relationship between a composition and method its use.
This is not found persuasive because as set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art." A lack of unity of invention determination begins with a consideration of the claims in light of the description and drawings. Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art.
The common technical feature of Groups I-VIII is a cationic polymer having a charge density higher than 2.0 meq/g. From claim 16 this cationic polymer can comprise polydiallyldimethylammonium chloride.
In the restriction requirement mailed 09/04/2024 it was noted that Gentle et al. (United States Patent 9265248-see IDS filed 10/13/2023) teaches antimicrobial compositions which comprise polydiallyldimethylammonium chloride (DADMAC), see column 8, line 41 and column 9, lines 1-5. Gentle does not teach the charge density, however as evidenced by Liu et al. DADMAC has a charge density of 6.2 meq/g, thus the charge density of the DADMAC of Gentle is 6.2meq/g., see materials section 2.1 of Liu. Therefore, based on the prior art, the common technical feature of the instant claims lacks novelty over the prior art. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posteriori and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d).
Applicant's election with traverse of the species: a) specific ingredients with the composition: polydiallyldimethylammonium chloride (PDADMAC cationic polymer) and soap anionic surfactant, with petrolatum as the hydrophobic base, smectite clay in the reply filed on 11/03/2025 is acknowledged. Examiner notes that emulsifier will be rejoined with the elected species. The traversal is on the ground(s) that the claims are directed to more than one species of the generic invention and lacks a single general inventive concept and that Applicant has presented a reasonable number of species for examination. This is not found persuasive because the instant claims contain species that are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: the species represent distinct characteristics. Gentle et al. (United States Patent 9265248-see IDS filed 10/13/2023) teaches antimicrobial compositions which comprise polydiallyldimethylammonium chloride (DADMAC), see column 8, line 41 and column 9, lines 1-5. Gentle does not teach the charge density, however as evidenced by Liu et al. DADMAC has a charge density of 6.2 meq/g, thus the charge density of the DADMAC of Gentle is 6.2meq/g., see materials section 2.1 of Liu
Claims 7-8, and 13-15 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/03/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5, 9, 11-12 and 16-17 are under current examination as being directed to the elected invention of a liquid composition comprising: polydiallyldimethylammonium chloride (PDADMAC cationic polymer) and soap anionic surfactant, with petrolatum as the hydrophobic base, and smectite clay, and emulsifier.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 10/13/2023 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
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.
(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 1-3 and 16-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Agarkhed et al. (WO2021/099471-filed 11/2020).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The instant claims recite that the composition and cationic polymer (e.g. polydialyllyl dimethyl ammonium chloride) is “for preventing reinfection against germs” which is being interpreted as a recitation of the intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the charge density of the cationic polymer of higher than 2 meq/g (instant claims 1 and 9) or higher than 3.5 (meq/g (instant claim 3), and the nitrogen content being higher than 5% by weight (instant claim 2), the instant specification discloses that polydimethyl ammonium chloride (PDADMAC) is preferably the polymer that has higher than 3.5 meq/g and a nitrogen content of higher than 5%, such as Polyquaternium-6 (Merquat-100) see page 2, lines 16-25; page 3, lines 17-20; page 5, line 20; and page 24, lines 4-7 and page 6, lines 15-27. Polyquaternium-6 contains an 8.7% nitrogen content, see page 7, lines 20-23. Therefore, polyquaternium-6 polymer necessarily has a meq/g greater than 3.5 and a nitrogen content of higher than 5% by weight and a teaching of polyquaternium-6 in the prior art meets the claim.
Agarkhed et al. disclose a porous clay particle including smectite having a water capacity from 10-50% by weight that is coated with a water soluble benefit agent and then further coated with petroleum or wax, see claims 1-6 and page 4, lines 1-8. The composition is used for disinfecting surfaces such as the hand, thus is capable of performing the intended use of preventing reinfection against germs. The benefit agent includes polyquaternium 6 (poly diallyl dimethyl ammonium chloride cationic polymer) and the charge density is higher than 2meq/g, see page 7, lines 5. As noted above, polyquaternium-6 necessarily has a meg/g of greater than 3.5 and a nitrogen content of higher than 5% by weight. The composition is used to delivery antimicrobial benefit thus is capable of performing the intended use of being configured to prevent reinfection against germs, see page 2, lines 16-25. The composition can be diluted with water to a solution (i.e. liquid) or dispersion, see page 5, lines 21-22 and page 9, lines 20-21.
Claims 1-5 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ananthasubramanian et al. (WO2021013546-published 01/28/2021).
The instant claims recite that the composition and cationic polymer (e.g. polydialyllyl dimethyl ammonium chloride) is “for preventing reinfection against germs” which is being interpreted as a recitation of the intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the charge density of the cationic polymer of higher than 2 meq/g (instant claims 1 and 9) or higher than 3.5 (meq/g (instant claim 3), and the nitrogen content being higher than 5% by weight (instant claim 2), the instant specification discloses that polydimethyl ammonium chloride (PDADMAC) is preferably the polymer that has higher than 3.5 meq/g and a nitrogen content of higher than 5%, such as Polyquaternium-6 (Merquat-100) see page 2, lines 16-25; page 3, lines 17-20; page 5, line 20; and page 24, lines 4-7 and page 6, lines 15-27. Polyquaternium-6 contains an 8.7% nitrogen content, see page 7, lines 20-23. Therefore, polyquaternium-6 polymer necessarily has a meq/g greater than 3.5 and a nitrogen content of higher than 5% by weight and a teaching of polyquaternium-6 in the prior art meets the claim.
Ananthasubramanian et al. disclose cleaning compositions comprising water-in-oil emulsions, see page 2, lines 5-10.The aqueous phase comprises a skin benefit agent while the hydrophobic phase comprises petrolatum or wax, see page 3, lines 24-29 and claims 1-11. The hydrophobic phase comprises an emulsifier, see page 4, lines1-3. The composition contains anionic surfactant such as soap, see abstract and page 4, lines 8-10 and page 9, lines 31-33 to page 10, lines 1-3. The skin benefit agent is most preferably the cationic polymer of polydialyllyl dimethyl ammonium chloride including polyquaternium-6, see claims 7-8 and page 7, lines 1-10. As noted above, polyquaternium 6 necessarily has a meg/g of greater than 3.5 and a nitrogen content of higher than 5% by weight. The composition is used to delivery antimicrobial benefit thus is capable of performing the intended use of being configured to prevent reinfection against germs, see page 2, lines 16-25.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 9, 11, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ananthasubramanian (WO2021013546-published 01/2021) in view of Leslie et al. (GB2242358A).
The instant claims recite that the composition and cationic polymer (e.g. polydialyllyl dimethyl ammonium chloride) is “for preventing reinfection against germs” which is being interpreted as a recitation of the intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the charge density of the cationic polymer of higher than 2 meq/g (instant claims 1 and 9) or higher than 3.5 (meq/g (instant claim 3), and the nitrogen content being higher than 5% by weight (instant claim 2), the instant specification discloses that polydimethyl ammonium chloride (PDADMAC) is preferably the polymer that has higher than 3.5 meq/g and a nitrogen content of higher than 5%, such as Polyquaternium-6 (Merquat-100) see page 2, lines 16-25; page 3, lines 17-20; page 5, line 20; and page 24, lines 4-7 and page 6, lines 15-27. Polyquaternium-6 contains an 8.7% nitrogen content, see page 7, lines 20-23. Therefore, polyquaternium-6 polymer necessarily has a meq/g greater than 3.5 and a nitrogen content of higher than 5% by weight and a teaching of polyquaternium 6 in the prior art meets the claim.
Ananthasubramanian et al. teach cleaning compositions comprising water-in-oil emulsions, see page 2, lines 5-10. The aqueous phase comprises a skin benefit agent while the hydrophobic phase comprises petrolatum or wax, see page 3, lines 24-29 and claims 1-11. The hydrophobic phase comprises an emulsifier, see page 4, lines 1-3. The composition preferably contains anionic surfactant such as soap, see abstract and page 4, lines 8-10 and page 9, lines 31-33 to page 10, lines 1-3. The skin benefit agent is most preferably the cationic polymer of polydialyllyl dimethyl ammonium chloride including polyquaternium-6, see claims 7-8 and page 7, lines1-10. As noted above, polyquaternium-6 necessarily has a meg/g of greater than 3.5 and a nitrogen content of higher than 5% by weight. The composition is used to delivery antimicrobial benefit, thus is capable of performing the intended use of being configured to prevent reinfection against germs, see page 2, lines 16-25. The emulsion is preferably in the liquid state, see page 9 at lines 19-20.
Regarding instant claim 9, Ananthasubramanian et al. teach that water comprises from 40-60% by weight for the aqueous phase, see page 9, lines 15-16. A water content of 60% by weight is close to greater than 65% by weight. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Nevertheless, Ananthasubramanian et al. do not expressly teach greater than 65% by weight water (instant claim 9).
However, Leslie et al. teach water in oil emulsions for cosmetic products which comprise polyquaternium-6, see abstract and pages 2,5, and 7-8. The water can comprise from 10-90% by weight and formulations with high water content in the w/o emulsion are particularly advantageous because this provides for rapid mixing with the cosmetic carrier on application to a desired site giving rise to good cosmetic feel, see page 3 and 6. Additionally, high water content allows for the use of higher quantities of ionic compounds in the composition, see page 3 and 6.
It would have been prima facie obvious to adjust the water content of the water in oil emulsion of Ananthasubramanian et al. to greater than 65% by weight.
One of ordinary skill in the art would have been motivated to do so because water in oil emulsions having a higher water content including preferably 60-80% by weight have good skin feel and allow for the incorporation of higher quantities of ionic compounds. There would have been a reasonable expectation of success given Ananthasubramanian et al. and Leslie et al. both teach liquid water in oil compositions including soaps for cosmetic use on the hair (see page 7 of Leslie; abstract and page 9 at lines 19-20 of Ananthasubramanian et al.).
Claim 12 is rejected under 35 U.S.C. 103 as being obvious over Ananthasubramanian (WO2021013546-published 01/2021) in view of Leslie et al. (GB2242358A) as applied to claims 1-5, 9, 11, and 16-17 above, and further in view of Agarkhed et al. (WO2021/099471-filed 11/2020).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Ananthasubramanian in view of Leslie et al. do not teach a clay particle the elected smectite with a water holding capacity from 10-50% by weight having a coating of PDADMAC (polydialyllyl dimethyl ammonium chloride) and further coating of petrolatum.
However, Agarkhed et al. teach compositions which comprise clays such as smectite coated with PDADMAC and further coated with petrolatum, see abstract. The coatings provide sufficient delivery of water soluble cationic actives for a long time post washing on a skin surface, see field of invention. The clay has a water holing capacity from 10-50% by weight, see summary of invention.
It would have therefore been prima facie obvious to provide the water in oil composition of Ananthasubramanian with a coated smectite clay with PDADMAC (polydialyllyl dimethyl ammonium chloride) coated with petrolatum.
One of ordinary skill in the art would have been motivated to do so in order to provide enhanced delivery of PDADMAC to a skin surface for a longer period of time post washing.
There would have been a reasonable expectation of success given both Ananthasubramanian et al. and Agarkhed et al. teach antimicrobial cleansing compositions containing petrolatum and PDADMAC.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ananthasubramanian et al. (WO2021013546-published 01/2021) in view of Leslie et al. (GB2242358A) as applied to claims 1-5, 9, 11, and 16-17 and further in view of Nadolsky (United States Patent 5112603), Azorb (Common Desiccants and Substrates- Published 08/2020) and Ansari et al. (EP1082092).
Ananthasubramanian et al. in view of Leslie et al. do not teach a clay particle the elected smectite with a water holding capacity from 10-50% by weight having a coating of PDADMAC (polydialyllyl dimethyl ammonium chloride) and further coating of petrolatum.
Nadolsky et al. teach that the combination of polyquaternary compounds with smectite clays produces very useful thickening agents for use in aqueous systems and for thickening personal care formulations, see column 5 at lines 15-30. The use of polyquaternary compounds enables the smectite to swell and increase hydration of the clay, see column 6, lines 25-35 and column 9, lines 55-68. The thickening agents of the present invention may be employed in a wide variety of aqueous systems, see column 9, lines 55-56. Smectite clays are often used for such purposes, see column 9. The improved swelling enables smectite clays to be used as a replacement for untreated smectites in any situation wherein such improved swelling is useful, see column 9, lines 55-68. For example, together with an anionic, nonionic, amphoteric or cationic detergent, they may be employed in cleansing compositions, see column 9, lines 55-68. Examples of polyquaternium compounds include polyquaternium 6 (PDADMAC), see column 11 at line 48 and entire document. The smectite clay includes montmorillonite, see column 9, lines 18-22. Azorb teaches that montmorillonite is capable of absorbing 30% weight of water, thus has a water holding capacity of 30% by weight, see montmorillonite clay at page 2. Therefore, the montmorillonite which is a smectite clay of Nadolsky has a water holding capacity of at about 30% weight.
Noether Nadolsky or Azorb teach a further coating of petrolatum wax.
However, Ansari et al. tach that petrolatum is useful in inhibiting the attachment of bacteria to the skin surface, see abstract, and pages 2-3.
It would have been prima facie obvious to provide a PDADMAC (polydialyllyl dimethyl ammonium chloride) coating of smectite montmorillonite clay to the water in oil composition of Ananthasubramanian and to further provide a coating of petrolatum.
One of ordinary skill in the art would have been motivated to do so to thicken the liquid cleansing composition of Ananthasubramanian et al. One of ordinary skill in the art would have additionally been motivated to coat the PDADMAC based montmorillonite smectite clay composite with an outer layer of petrolatum in order to block bacteria from attaching to the surface of skin.
There would have been a reasonable expectation of success given Ananthasubramanian et al. already teaches petrolatum surrounding PDADMAC polymer and Ananthasubramanian et al., Nadolsky and Ansari et al. all teach application with cleansing compositions. The modification which includes montmorillonite as the smectite would necessarily have a water absorption capacity between 10-50% by weight given Nadolsky teaches smectite clay materials, and per the teachings of Azorb, montmorillonite has a water holding capacity of 30% weight.
Correspondence
Currently, no claims are allowed and all claims are rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619