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 Status
Applicants’ amendments and arguments filed 04/15/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 3, 7, 11, 13, and 15 are canceled.
Claims 1-2 are amended.
Claims 8-10 and 16-19 remain withdrawn.
Claims 1-2, 4-6, 12, and 14 are examined on the merits.
Claim Interpretation
In regards to claims 1 and 2, as to the limitations of ‘adapted for the transport of a dissolved active agent into hair follicles’ and ‘adapted for transporting a dissolved pharmacologically active therapeutical and/or prophylactic agent into hair follicles’, it is noted that the instant claims are composition claims and future intended use, such as transport of an active to a hair follicle, is not given patentable weight. Thus any composition comprising an active agent dissolved in a topical dispersion medium and a submicron particle will meet this limitation in claim 1 and any composition comprising an active pharmaceutical/therapeutic or a prophylactic agent dissolved in a topical dispersion medium and a submicron particle will meet this limitation in claim 2.
In regards to claim 2, as to the limitation of ‘The composition according to claim 1, in the form of a pharmaceutical composition’, it is noted that the instant claims are composition claims and future intended use, such as in a pharmaceutical composition, is not given patentable weight. Thus any composition comprising an active pharmaceutical/therapeutic or a prophylactic agent dissolved in a topical dispersion medium and a submicron particle will meet this limitation.
In regards to claim 12, as to the limitation of ‘wherein the composition is a cosmetic composition' it is noted that the instant claims are composition claims and future intended use, such as in a cosmetic composition, is not given patentable weight. Thus any composition comprising an active agent dissolved in a topical dispersion medium and a submicron particle will meet this limitation.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-2, 4-6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lando et al. (US20200338360A1, published 10/29/2020, hereafter Lando) in view of Huang et al. (Huang Y, Yu F, Park YS, Wang J, Shin MC, Chung HS, Yang VC. Co-administration of protein drugs with gold nanoparticles to enable percutaneous delivery. Biomaterials. 2010 Dec;31(34):9086-91. doi: 10.1016/j.biomaterials.2010.08.046. Epub 2010 Sep 9. PMID: 20828812; PMCID: PMC2949472., hereafter Huang), in view of Plastic Surgery Key (The increasing importance of the hair follicle route in dermal and transdermal drug delivery - plastic surgery keyplastic surgery key. Plastic Surgery Key. (2017, July 8). https://plasticsurgerykey.com/the-increasing-importance-of-the-hair-follicle-route-in-dermal-and-transdermal-drug-delivery/, hereafter Plastic), and as evidenced by Fan et al. (Fan, Yuchen, Maria Marioli, and Kelly Zhang. "Analytical characterization of liposomes and other lipid nanoparticles for drug delivery." Journal of pharmaceutical and biomedical analysis 192 (January, 5th, 2021): 113642., hereafter Fan).
As evidenced by Fan, lipid nanoparticles, especially liposomes, have shown great success in the pharmaceutical industry (abstract).
Lando claims a method of treating a skin disease by topically applying a formulation comprising a sub-micron particle, specifically for facilitating delivery of said material into a hair follicle (claim 1 and [0161]; according to the claim limitations of the instant claim 1). Lando teaches the liquid dosage forms of the composition include emulsions, microemulsions, solutions, creams, lotions, ointments, suspensions, and syrups ([0143] and claim 15; according to the claim limitations of the instant claim 4). Furthermore, Lando teaches the composition comprises one or more of ethanol, isopropyl alcohol, propylene glycol, a surfactant, and/or isopropyl adipate; comprises hydroxypropylcellulose (HPC) and carboxymethyl cellulose (CMC); comprises any one or more of water, ethanol, propylene glycol, polysorbate 80, diisopropyl adipate, phospholipon, and thickening agent (claim 15; according to the claim limitations of the instant claims 1-2, 4, and 14). Lando teaches the addition of an active compound, specifically an active ingredient in a liquid dosage form with a diluent ([0087] and [0143]; according to the claim limitations of the instant claims 1, 4, and 14). Lando teaches the particulates in suspension can be used with small dissolved molecules such as pharmaceutical drugs, photodynamic therapy (PDT) pro-drugs, or PDT drugs ([0133]; according to the claim limitations of the instant claim 2). Lando teaches the operation and use of a delivery device is one part of a multi-part therapy, and in one specific example of a multiple part therapy is the use of the delivery system to deliver a fluid, a formulation particles, shells, pharmaceuticals, liposomes, other treatment agents or pharmacologic materials onto, into or within a structure within a treatment or delivery site followed by a further treatment of the delivery or treatment site ([0197]; according to the claim limitatoins of the instant claims 1-2, and 4). Lando teaches the invention can be a kit which includes a pharmaceutical pack comprising an effective amount of a light/energy absorbing material (e.g. a nanoshell having a silica core and a gold shell (150nm) ([0150]; according to the claim limitations of the instant claims 1-2, and 5). Furthermore, Lando teaches the invention is in the form of a kit containing a therapeutic or prophylactic composition ([0150]; according to the claim limitations of the instant claim 2). Furthermore, Lando teaches the invention provides a composition comprising a cosmetically acceptable carrier and a plurality of plasmonic nanoparticles in an amount effective to induce thermomodulation in a target tissue region with which the composition is topically contacted ([0053]; according to the claim limitations of the instant claims 1, 6, and 12). Lando claims the substantial amount of the sub-micron particles present in the formulation comprise geometrically-tuned nanostructures (claim 12; according to the claim limitations of the instant claim 6). Further, Lando claims the sub-micron particle is in a liposome (claim 17; according to the claim limitations of the instant claim 6). Claim 18 of Lando claims the nanoparticle has a diameter of about 50 to about 250 nm (according to the claim limitations of the instant claim 5).
Lando is silent about the particles and active agent relationship and doesn’t teach the active agent and submicron particles are coupled as in instant claim 1.
Huang teaches the co-administration of protein drugs with gold nanoparticles to enable percutaneous delivery (title). Huang teaches skin permeable metal nanoparticles may be used for transdermal drug delivery by modifying the surface with polymer and drug molecules (page 9090, paragraph 3). Furthermore, Huang teaches that cross-linking of drugs onto the surface of particles may significantly change their unique physiochemical properties (page 9090, paragraph 3). Huang teaches that protein loading efficiency onto rigid nanoparticles via chemical conjugation is relatively low and these chemical processes often cause loss in protein drug activity (page 9090, paragraph 4). Huang furthers this by saying in contract, the co-delivery method shows significant advantage over traditional use of nanoparticles in drug delivery by eliminating the complicated and costly processes of integrating drugs into a delivery platform and possibility of compromising in protein stability (page 9090, paragraph 4). Huang concludes that compromise in activity can be minimized for both protein drugs and nanoparticles because of the exclusion of complicated drug-loading processes (page 9090, conclusion, paragraph 6). Furthermore, Huang teaches the interaction between the nanoparticles and skin barrier leases to increase of skin permeability and effectively prompts percutaneous absorption of the co-administered proteins (page 9090, paragraph 6).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a composition comprising an active agent in a topical dispersion medium and a submicron particle as outlined by Lando by addition of the active agent and the submicron particle being chemically uncoupled to eachother as outlined by Huang under TSM, see MPEP 2143(G). As outlined by Huang, when the active agent – protein drug and nanoparticle are co-delivered without chemical conjugation, it increases protein drug activity, protein stability, and lowers costs, which would motivate someone skilled in the art to advantageously combine ammonium sulfate with the composition of Lando as it would have a reasonable expectation of success.
Both Lando and Huang fail to teach the particle size diameter as claimed by instant claim 1.
Plastic teaches the increasing importance of the hair follicle route in dermal and transdermal drug delivery (title). Plastic further teaches in comparison to intercellular penetration process, topical drug delivery via the hair follicles provides additional features such as fast delivery into the systemic circulation (page 1, paragraph 1). Plastic teaches in the last years, particulates, such as liposomes and micro-and nanoparticles have attracted attention as a result of their capacity to improve penetration into the hair follicle (page 2, paragraph 1). Plastic further teaches that the optimum size for particles to penetrate deeply into the hair follicle was determined to be in the range of 400-700nm, whereas larger and smaller particles reached significantly lower depths (page 2, paragraph 1).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a topical skin formulation comprising a sub-micron particle, specifically for facilitating delivery of said material into a hair follicle as outlined by Lando in view of Huang by adjusting the size of the submicron particle to 400-700nm as outlined by Plastic under TSM, see MPEP 2143(G). As outlined by Plastic, the optimum size for particles to penetrate deeply into the hair follicle was determined to be in the range of 400-700nm, whereas larger and smaller particles reached significantly lower depths which would motivate someone skilled in the art to advantageously adjust the size of the submicron particle with the composition of Lando in view of Huang as it would have a reasonable expectation of success.
Response to Applicant’s Arguments
Applicant’s arguments filed on 04/15/2026 have been considered by the examiner.
In regards to 35 USC § 103 rejections, Applicant argues that Lando as evidenced by Fan fails to teach the amended claim 1, specifically that Lando does not teach “the active agent is not directly coupled to the particles” as previously recited in claim 3. Applicant then again argues that Lando does not teach the active agent is not directly coupled to the active agent and further argues that Lando does not teach the active agent is not incorporated into the particles. Then Applicant argues that Lando does not teach the particle size having a diameter of 500-800nm, but instead teaches the submicron particles are about 0.1-1.0 micrometers or 0.05-0.25micrometers. Similarly, Applicant then argues that Huang does not teach the particle diameter of the instant claims. Further, Applicant argues that Lando does not disclose that the particles are used to transport active liquid agents into the hair follicles as the instant invention. Applicant then argues when combing Lando in view of Huang as evidenced by Fan, one would not arrive at the claimed invention. Applicant further this argument by stating the inventors unexpectedly discovered that submicron particles enable the delivery of active agents that are not coupled to particles, not incorporated in the particles, and are dissolved in a dispersion medium.
In regards to Applicant’s argument that Lando does not teach the active agent is not directly coupled to the particles and does not teach the active agent is not incorporated into the particle, it is first noted that claim 3 was not previously rejected under Lando as evidenced by Fan, but instead by Lando in view of Huang as evidenced by Fan. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In regards to Applicant’s argument that Lando and Huang do not teach the diameter of the particles as instant claim 1. It is noted that Lando and/or Lando in view of Huang is no longer rejected to solely, but instead in view of Plastic which provides motivation to use a bigger nanoparticles. Specifically, Plastic teaches the optimum size for particles to penetrate deeply into the hair follicle was determined to be in the range of 400-700nm, whereas larger and smaller particles reached significantly lower depths (page 2, paragraph 1) which as outlined above would motivate someone to adjust the particle size of Lando in view of Huang.
In regards to Applicant’s argument that Lando does not disclose the particles are used to transport active liquid agents into the hair follicles, it is noted that this is not currently a requirement of the instant claims which claim a “composition” generically. Further, it is again noted that the instant claims are composition claims and intended use, such as use to transport active liquid agents into the hair follicle is not given patentable weight. Further, it is noted that Lando claims a method of treating a skin disease by topically applying a formulation comprising a sub-micron particle, specifically for facilitating delivery of said material into a hair follicle (claim 1 and [0161]) and teaches multiple part therapy is the use of the delivery system to deliver a fluid, a formulation particles, shells, pharmaceuticals, liposomes, other treatment agents or pharmacologic materials onto, into or within a structure within a treatment or delivery site followed by a further treatment of the delivery or treatment site ([0197]). Therefore, Lando does teach a liquid transporting active agents into a hair follicle.
In regards to Applicant’s arguments against Lando in view of Huang as evidenced by Fan, it is first noted that Applicant has provided no reasoning as to why these should not be combined, nor has the Applicant provided addition reason as to why Lando in view of Huang would not exhibit the same properties as the instantly claimed invention. Furthermore, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed composition. Further, it is noted that Lando teaches the addition of an active compound, specifically an active ingredient in a liquid dosage form with a diluent ([0087] and [0143]) and Huang provides further motivation by teaching a co-delivery method shows significant advantage over traditional use of nanoparticles in drug delivery by eliminating the complicated and costly processes of integrating drugs into a delivery platform and possibility of compromising in protein stability (page 9090, paragraph 4). Additionally, as outlined above and reiterated here, Plastic teaches the optimum size for particles to penetrate deeply into the hair follicle was determined to be in the range of 400-700nm, whereas larger and smaller particles reached significantly lower depths (page 2, paragraph 1) which as outlined above would motivate someone to adjust the particle size of Lando in view of Huang. Therefore, Lando in view of Huang and Plastic teach the limitations of the instant claim 1.
In summary, the examiner is not persuaded by Applicant’s arguments. The rejections are maintained and updated to account for claim amendments.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611
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