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 .
Advisory Note
Following the CAFC decision mailed August 26, 2025, the examiner contacted Applicants attorney, Kevin Davis, on March 11, 2026 to propose claim amendments (see Misc. communication mailed 8/30/2021) and request Terminal Disclaimers that would place the claims in condition for allowance in the interest of compact prosecution. Applicant declined and requested an Office action, therefore this Office action is being mailed.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on February 12, 2020 has been entered.
Status of Claims
Claims 1-19 are currently pending. Claims 11-19 are withdrawn as being drawn to a non-elected invention. Claims 1-10 are examined on their merits.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Double Patenting
In light of the filing and approval of the terminal disclaimer to the claims of the U.S. Patent Appn. No. 15/167099 (PGPUB 2016/0367676), the provisional rejections of claims 1-10 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 16-42 of copending U.S. Patent Appn. No. 15/167099 (PGPUB 2016/0367676) in view of Leung et al US 2014/0276493 (3/15/2013), Sutcliffe et al. US 2010/0226983 (9/9/2010) and DiLeva 2009/0162304 (6/25/2009) is withdrawn.
In light of the filing and approval of the terminal disclaimer the provisional rejections of claims 1-10 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 26-29, 31-34, 36-43, 45-46 and 52-55 of copending U.S. Patent Appn. No. 15/167044 (PGPUB 2016/0367504) in view of Sutcliffe et al. US 2010/0226983 (9/9/2010) and DiLeva 2009/0162304 (6/25/2009) is withdrawn.
New Grounds of Rejections
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, 3 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. US 2009/0281013 (11/12/2009) in view of Sutcliffe et al. US 2010/0226983 (9/9/2010).
Patel et al. (Patel) teaches a composition that is emulsifier free and is a suspension that comprises water, petrolatum and an active ingredient. (See Abstract, [0001-0002], [0006], Patel claim 1). This reads on a petrolatum-based composition comprising petrolatum and an active ingredient whereby the composition contains no added emulsifier as called for in claim 1. The composition comprises water as called for in claim 1 and an active ingredient. Patel teaches that active agents deposit with greater substantivity from its composition than from those that contain surfactants. (See Abstract).
Patel teaches that its water-soluble active ingredient is present in an amount of from 0 to 25%. (See [0049]). Patel also teaches a polar solvent, which is water as called for in claim 1.
Patel does not teach an anionic biocide or nanodroplets. These deficiencies are made up for with the teachings of Sutcliffe et al.
Sutcliffe et al. (Sutcliffe) teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Anionic biocides are called for in claim 3. With the second active ingredient as triclosan, no cationic biocides would be included, so anionic biocide are all that are disclosed in Sutcliffe as called for in instant claims 1 and 3. Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract).
Sutcliffe teaches that its composition can contain nanodroplets that have a size of less than 3 microns. (See [0013]). Less than 3 microns overlaps with the diameter of from about 10 nm to about 10,000 nm as called for in instant claim 1. Sutcliffe teaches that the nanodroplets deliver the active ingredient biocide to the pilosebaceous gland, so antibiotic (biocide) is what is suspended in the nanodroplet which reads on the nanodroplets having a diameter of less than 3 microns from about 10 nm to about 10,000 nm called for in instant claim 1. Sutcliffe also teaches that nanodroplets containing the antibiotic (biocide) permeate into the pilosebaceous unit where they kill of inhibit the growth of P. acnes, the primary bacteria responsible for acne. (See [0032]).
Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]). Hydrocortisone is called for in instant claim 9, it is a steroid as called for in instant claim 8 and it is an additional active ingredient as called for in instant claim 7. Sutcliffe teaches that its composition can be prepared into a bandage which reads on the topical dressing as called for in instant claim 10. (See [0016]).
It would have been prima facie obvious for one of ordinary skill in the art making the Patel composition to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
It would have been prima facie obvious for one of ordinary skill in the art making the Patel composition to use triclosan and hydrocortisone as taught by Sutcliffe and to make the Patel composition containing these ingredients into a bandage which is a topical dressing in order to have a bandage that can effectively treat acne as taught by Sutcliffe.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. US 2009/0281013 (11/12/2009) in view of Leung et al US 2014/0276493 (3/15/2013) and Sutcliffe et al. US 2010/0226983 (9/9/2010).
Patel et al. (Patel) teaches a composition that is emulsifier free and is a suspension that comprises water, petrolatum and an active ingredient. (See Abstract, [0001-0002], [0006], Patel claim 1). This reads on a petrolatum-based composition comprising petrolatum and an active ingredient whereby the composition contains no added emulsifier as called for in claim 1, especially in light of the indefiniteness of this claim. The composition comprises water as called for in claim 1 and an active ingredient. Patel teaches that active agents deposit with greater substantivity from its composition than from those that contain surfactants. (See Abstract).
Patel teaches that its water-soluble active ingredient is present in an amount of from 0 to 25%. (See [0049]). Patel also teaches a polar solvent, which is water as called for in claim 1.
Patel does not teach a cationic biocide or nanodroplets. These deficiencies are made up for with the teachings of Leung et al. and Sutcliffe.
Leung et al. (Leung) teaches a topical composition that can have the cationic biocides benzalkonium chloride and polyhexanide biguanide. (See Leung [0030]). Benzalkonium chloride is called for in instant claim 4. Leung teaches that the cationic biocides can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state. (See [0030]). Benzalkonium chloride and polyhexanide biguanide are called for in claim 5. Cationic biocides are called for in claim 2. Leung does not teach anionic biocides so the only ionic biocides are cationic biocides as called for in instant claim 1 and 2.
Sutcliffe teaches that its composition can contain nanodroplets that have a size of less than 3 microns. (See [0013]). Less than 3 microns overlaps with the diameter of from about 10 nm to about 10,000 nm as called for in instant claim 1. Sutcliffe teaches that the nanodroplets deliver the active ingredient biocide, triclosan, to the pilosebaceous gland, so antibiotic (biocide) is what is suspended in the nanodroplet which reads on the nanodroplets having a diameter of less than 3 microns from about 10 nm to about 10,000 nm called for in instant claim 1. Sutcliffe teaches that its composition containing an antibiotic (biocide) is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that nanodroplets containing an antibiotic (biocide) permeate into the pilosebaceous unit where they kill or inhibit the growth of P. acnes, the primary bacteria responsible for acne. (See [0032]).
It would have been prima facie obvious for one of ordinary skill in the art making the Patel composition to use benzalkonium chloride and polyhexanide biguanide as the active ingredient as taught by Leung and to have the benzalkonium chloride and polyhexanide biguanide as biocides contained in nanodroplets that are less than 3 microns as the only constituent of the nanodoplet as taught by Sutcliffe in order to have a topical composition that can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state is useful in promoting vascular development and repair as taught by Leung and also to have a composition that can assist with the treatment or prevention of acne as taught by Sutcliffe.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. US 2009/0281013 (11/12/2009) in view of Sutcliffe et al. US 2010/0226983 (9/9/2010) as applied to claims 1,3 and 7-10 and further in view of DiLeva 2009/0162304 (6/25/2009).
Patel in view of Sutcliffe is described supra. Patel in view of Sutcliffe does not teach tetracycline HCl. This deficiency is made up for with the teachings of DiLeva.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). Tetracycline hydrochloride is called for in instant claim 6.
It would have been prima facie obvious for one of ordinary skill in the art making the Patel in view of Sutcliffe composition to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Claims 1-5 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Selner US 2018/0036236 (priority 2/5/2015)(9/26/2018 IDS) in view of Sutcliffe et al. US 2010/0226983 (9/9/2010).
Selner teaches a stable suspension comprising water, petrolatum and at least one ionic biocide, wherein the suspension is emulsifier free and all ionic biocides are contained within nanovesicles with a diameter of 100 microns or less. (See Abstract and Selner claim 1.) This reads on a petrolatum-based composition comprising petrolatum and an active ingredient whereby the composition contains no added emulsifier as called for in claim 1. The composition comprises water as called for in claim 1 and an ionic biocide as called for in instant claim 1.
Selner teaches that its ionic biocides can be all cationic biocide or all anionic biocides. (See Selner claims 2 and 3). All cationic biocides are called for in instant claim 2 and all anionic biocides are called for in instant claim 3. Selner teaches that examples of suitable ionic biocides are polyhexamethylene biguanide (PHMB) and benzalkonium chloride. (See [0013]). Selner teaches that the more preferred embodiment is a combination of PHMB and benzalkonium chloride. (See [0013])
PHMB is called for in instant claim 4 and the combination of PHMB and benzalkonium chloride is called for in instant claim 5. Selner teaches its composition can also comprise an additional active that is a steroid. This steroid can be cortisone. (See Selner [0025] and claims 8-9)
Selner teaches that its composition can contain nanodroplets that have a diameter of 100 microns or less. (See [0008]). 100 microns or less overlaps with the diameter of from about 10 nm to about 10,000 nm as called for in instant claim 1. Selner teaches that the biocide is contained in the nanovesicles as called for in instant claim 1.
Selner teaches a steroid that is cortisone but does not teach hydrocortisone. Selner does not teach a topical dressing. These deficiencies are made up for with the teachings of Sutcliffe.
Sutcliffe et al. (Sutcliffe) teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract).
Sutcliff et al. (Sutcliff) teaches that its composition can contain nanodroplets that have a size of less than 3 microns. (See [0013]). Sutcliffe teaches that the nanodroplets deliver the active ingredient biocide to the pilosebaceous gland, so antibiotic (biocide) is what is suspended in the nanodroplet. Sutcliffe also teaches that nanodroplets containing the antibiotic (biocide) permeate into the pilosebaceous unit where they kill of inhibit the growth of P. acnes, the primary bacteria responsible for acne. (See [0032]).
Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]). Hydrocortisone is called for in instant claim 9, it is a steroid as called for in instant claim 8 and it is an additional active ingredient as called for in instant claim 7. Sutcliffe teaches that its composition can be prepared into a bandage which reads on the topical dressing as called for in instant claim 10. (See [0016]).
It would have been prima facie obvious for one of ordinary skill in the art making the Selner petrolatum, ionic biocide nanovesicle suspension to add tetracycline hydrochloride to use hydrocortisone as taught by Sutcliffe and to make the place the suspension in a bandage in order to have a bandage that can effectively treat acne as taught by Sutcliffe.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Selner US 2018/0036236 (priority 2/5/2015) (9/26/2018 IDS) in view of Sutcliffe et al. US 2010/0226983 (9/9/2010) as applied to claims 1-5 and 7-10 and further in view of DiLeva 2009/0162304 (6/25/2009).
Selner is described supra. Selner does not teach tetracycline HCl. This deficiency is made up for with the teachings of DiLeva.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). Tetracycline hydrochloride is called for in instant claim 6.
It would have been prima facie obvious for one of ordinary skill in the art making the Selner in view of Sutcliff petrolatum, ionic biocide and cortisone nanovesicle suspension in a bandage to add tetracycline hydrochloride as taught by DiLeva in order to have a dressing that can treat skin diseases as taught by DiLeva.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-10 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12290599 in view of Leung et al US 2014/0276493 (3/15/2013), Sutcliffe et al. US 2010/0226983 (9/9/2010), DiLeva 2009/0162304 (6/25/2009) and Patel et al. US 2009/0281013 (11/12/2009).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an emulsifier free petrolatum based composition comprising at least one cationic or anionic biocide dissolved in a polar solvent and dispersed throughout the petrolatum in nanodroplets.
Claims 1-18 of U.S. Patent No. 12290599 are also directed to a greater than about 60 wt% petrolatum based composition comprising antimicrobial agents dissolved in a polar solvent and powdered collagen.
The composition claimed in U.S. Patent No. 12290599 differs from that of the instant claims in that it does not require an anionic biocide or a mixture of cationic biocides benzalkonium chloride and polyhexanide biguanide, an additional active of hydrocortisone, or the composition to be free of emulsifier. This deficiency is made up for with the teachings of Leung et al., Sutfliffe, DiLeva and Patel et al.
Leung teaches a topical composition that can have the cationic biocides benzalkonium chloride and polyhexanide biguanide. (See Leung [0030]). Leung teaches that the cationic biocides can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state. (See [0030]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12290599 to use benzalkonium chloride and polyhexanide biguanide as the active ingredient as taught by Leung in order to have a topical composition that can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state is useful in promoting vascular development and repair as taught by Leung.
Sutcliffe teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12290599 to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12290599 to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Patel teaches a composition that is substantially surfactant free but has enhanced deposition of benefit agents. (See [0004] and [0006]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12290599 to have the composition be surfactant free in order to have a composition that can enhance deposition benefit agents as taught by Patel.
Claims 1-10 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. 12433856 in view of Leung et al US 2014/0276493 (3/15/2013), Sutcliffe et al. US 2010/0226983 (9/9/2010), DiLeva 2009/0162304 (6/25/2009) and Patel et al. US 2009/0281013 (11/12/2009).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an emulsifier free petrolatum based composition comprising at least one cationic or anionic biocide dissolved in a polar solvent and dispersed throughout the petrolatum in nanodroplets.
Claim 1 of U.S. Patent No. 12433856 are also directed to a greater than about 90 wt% petrolatum based composition that is a stable suspension comprising anti-fungal agent terbafine HCl dissolved in a polar solvent.
The composition claimed in U.S. Patent No. 12433856 differs from that of the instant claims in that it does not require an anionic biocide or a mixture of cationic biocides benzalkonium chloride and polyhexanide biguanide, an additional active of hydrocortisone, tetracycline HCl or the composition to be free of emulsifier. This deficiency is made up for with the teachings of Leung et al., Sutfliffe, DiLeva and Patel et al.
Leung teaches a topical composition that can have the cationic biocides benzalkonium chloride and polyhexanide biguanide. (See Leung [0030]). Leung teaches that the cationic biocides can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state. (See [0030]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12433856 to use benzalkonium chloride and polyhexanide biguanide as the active ingredient as taught by Leung in order to have a topical composition that can act to counter any bacterial protease activity that may hamper the healing environment, which allows a tissue site to progress towards an optimal healing state is useful in promoting vascular development and repair as taught by Leung.
Sutcliffe teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12433856 to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12433856 to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Patel teaches a composition that is substantially surfactant free but has enhanced deposition of benefit agents. (See [0004] and [0006]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12433856 to have the composition be surfactant free in order to have a composition that can enhance deposition benefit agents as taught by Patel.
Claims 1-10 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10874608 in view of Sutcliffe et al. US 2010/0226983 (9/9/2010) and DiLeva 2009/0162304 (6/25/2009).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an emulsifier free petrolatum based composition comprising at least one cationic or anionic biocide dissolved in a polar solvent and dispersed throughout the petrolatum in nanodroplets.
Claims 1-6 of U.S. Patent No. 10874608 are directed to an emulsifier free stable composition comprising greater than about 80 wt% petrolatum based comprising benzalkonium chloride and benzalkonium chloride antimicrobial agents dissolved in a polar solvent in nanodroplets.
The composition claimed in U.S. Patent No. 10874608 differs from that of the instant claims in that it does not require an additional active of hydrocortisone. This deficiency is made up for with the teachings of Leung et al., Sutfliffe, DiLeva and Patel et al.
Sutcliffe teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 10874608 to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 1111071 to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Claims 1-10 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claim 1-8 of U.S. Patent No. 12083221 in view of Leung et al US 2014/0276493 (3/15/2013), Sutcliffe et al. US 2010/0226983 (9/9/2010), DiLeva 2009/0162304 (6/25/2009) and Patel et al. US 2009/0281013 (11/12/2009).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an emulsifier free petrolatum based composition comprising at least one cationic or anionic biocide dissolved in a polar solvent and dispersed throughout the petrolatum in nanodroplets.
Claim 1 of U.S. Patent No. 12083221 are directed to a greater than about 80 wt% petrolatum based composition that is a stable suspension comprising a benzalkonium chloride and polyhexanide biguanide dissolved in a polar solvent and collagen.
The composition claimed in U.S. Patent No. 12083221 differs from that of the instant claims in that it does not require an additional active of hydrocortisone or tetracycline hydrochloride or the composition to be free of emulsifier. This deficiency is made up for with the teachings of Sutfcliffe, DiLeva and Patel et al.
Sutcliffe teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12083221 to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12083221 to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Patel teaches a composition that is substantially surfactant free but has enhanced deposition of benefit agents. (See [0004] and [0006]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12083221 to have the composition be surfactant free in order to have a composition that can enhance deposition benefit agents as taught by Patel.
Claims 1-10 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 7-14 of U.S. Patent No. 12171901 in view of Sutcliffe et al. US 2010/0226983 (9/9/2010) and DiLeva 2009/0162304 (6/25/2009).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an emulsifier free petrolatum based composition comprising at least one cationic or anionic biocide dissolved in a polar solvent and dispersed throughout the petrolatum in nanodroplets.
Claims 1 and 7-14 of U.S. Patent No. 12171901 are directed to an emulsifier free greater than about 80 wt% petrolatum based composition that is a stable suspension comprising a benzalkonium chloride and polyhexanide biguanide dissolved in a polar solvent and collagen.
The composition claimed in U.S. Patent No. 12171901 differs from that of the instant claims in that it does not require an additional active of hydrocortisone or tetracycline hydrochloride. This deficiency is made up for with the teachings of Sutfcliffe and DiLeva.
Sutcliffe teaches a topical composition that can be a suspension that can contain the anionic biocide triclosan as a second active ingredient. (See Abstract, [0083], [0121]). Sutcliffe teaches that its composition containing a biocide is very effective when applied topically at treating acne. (See Abstract). Sutcliffe also teaches that its composition can contain an additional active ingredient that is preferably hydrocortisone. (See [0014]).
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12171901 to use triclosan and hydrocortisone as taught by Sutcliffe in order to have a topical composition that can effectively treat acne as taught by Sutcliffe.
DiLeva teaches a composition that can treat skin diseases that comprises tetracycline hydrochloride.(See [0047]). It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12171901 to add tetracycline hydrochloride as taught by DiLeva in order to have a composition that can treat skin diseases as taught by DiLeva.
Response to Arguments
Applicants’ comments on March 25, 2019 and February 12, 2020 have been fully considered and are not found to be only partly persuasive for the reasons described below.
Applicants argue in their March 25, 2019 comments that Patel does disclose the use of emulsifiers as they are described in the specification of the instant application. These include clays and mica, etc. which assist in stabilizing the composition. The instant invention is directed to a composition with a large amount of petrolatum that is stabilized without the use of such emulsifiers. Applicants request that the provisional double patenting rejections be held in abeyance.
Applicants assert in their February 12, 2020 comments that a terminal disclaimer was filed that obviates the provisional obviousness-type double patenting rejections. These provisional obviousness-type double patenting rejections have been withdrawn above.
Upon further consideration Applicants’ arguments regarding the prior art are not found to be persuasive. While Patel does disclose the use of components which are described as emulsifiers in the specification of the instant application, these components are not required to be part of the composition. (See [0022] and [0025]). Patel teaches that its compositions have substantially no emulsifier or surfactant. (See [0025]. Furthermore, the Patel compositions are described as stable without emulsifier or surfactant. (See [0025] and [0027]). Applicants’ argument that their invention requires a large amount of petrolatum is noted, but it is not found to be persuasive because there is no actual claim limitation directed to the amount of petrolatum in any of the present claims.
Upon further consideration and the passage of the considerable amount of time in the instant application and the filing of many additional applications during that time, new obviousness-type double patenting rejections have been necessitated in the instant application. The Examiner is cognizant of potential amendments to the claims which have been discussed in the instant application but notes that due to the passage of time in the instant application due to the derivation proceeding, these amendments have not yet been filed.
Conclusion
No claims are allowed.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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