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 .
Election/Restrictions
Applicant's election with traverse of Group I, 1-6, 12, and 14-15 in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that groups I and III have substantial overlap as to the special technical features, namely common dependency on claim 1. Furthermore, Applicant makes reference to 35 U.S.C. 121, MPEP 802.01, and 808.02 which Applicant further argues that the two groups are not distinct and that restriction requires separate classification, separate status in the art, or different field of search. Applicant specifies this argument by stating the Examiner has failed to identify any classification, difference as to the status of the are or a different field search.
In response to Applicant’s arguments, Applicant is reminded that the instant case is a 371 of a PCT and thus subject to restriction under PCT rule 13.1, as the examiner provided prior art and broke unity showing the technical feature of the instant claims is ‘common’ and not special (see page 4 of the restriction for the explanation made of Lando et al).
Per Annex B Unity of Invention, (b) technical feature, Rule 13.2 states:
The expression "special technical features" is defined in Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art.
As stated in the restriction/election requirement, the groups lack unity of invention because even though the inventions of these groups require the same technical feature, this technical feature is not a special technical feature as it does not make a contribution over the prior art. Therefore, the groups lack unity of invention.
Overall, Applicant’s argument is not found persuasive because unity was broken based off of the originally filed claims. Furthermore, over Lando as evidenced by Fan and Lando in view of Huang as evidenced by Fan, the prior art below in the USC 103 rejections teaches the same issue with the claims, thus unity remains broken. Thus, the requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/20/2023 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is unclear as to whether the claim requires all of the listed components first due to the fact that ‘active agent’ from instant claim 1 is not mentioned but rather claim 2 which depends from claim 1 now and 2 claims in the ‘and/or’ “pharmacologically active therapeutic” with “prophylactic agent”. Are these species of the ‘active agent’ in claim 1 or is just one of the components individually meeting the limitation or is a combination of the all components required? And further are these meant to limit the ‘active’ of claim 1 or are they required in addition to the active of claim 1? As there is more than 1 interpretation the claim is thereby rendered indefinite.
Therefore, the claim 2 will be broadly interpreted by the examiner to mean the claims require just one of the components individually (i.e. an active agent which is a prophylactic agent).
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 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lando et al. (US20200338360A1, published 10/29/2020, hereafter Lando) 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 (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 claimlimitatoins 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 claims 5 and 15).
Lando does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Lando with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claim 3 is 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), 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 outlined above, Lando as evidenced by Fan teaches a composition comprising an active agent in a topical dispersion medium and a submicron particle. Although Lando doesn’t teach the active agent and submicron particles are coupled, it also does not explicitly teach the active agent is not chemically coupled to the submicron particles as in instant claim 3.
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 Yu as it would have a reasonable expectation of success.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611