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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 10 in figure 22. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 50 is objected to because of the following informalities: the claim recites "the elongate microparticles" in part (vi); however, limitations (i)-(xii) are all alternatives and the microparticles being elongate microparticles is one of these alternative options. Therefore it would be clearer to explicitly recite the microparticles as elongate microparticles in part (vi) before reciting their maximum length. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 49-55 and 57-59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a composition comprising a plurality of microparticles having a geometry and strength sufficient to penetrate a biological barrier.
Claim 50 recites the microparticles to comprise silica. Microparticles that comprise silica and are capable of penetrating a biological barrier naturally occur in fresh water sponges. This judicial exception is not integrated into a practical application because claims 49-51 are directed to a product that does not require any additional elements. Reiswig et al. detail that fresh water sponges have skeletons composed of collagen that binds siliceous spicules into a rigid framework (see “Porifera” in Ecology and Classification of North American Freshwater Invertebrates ed. Thorp et al. London:Elsevier, 2010 91-123; page 91 second column first paragraph and page 94 second column last paragraph-page 95 first column). The spicules contain silica and are categorized in three main groups called 1) megascleres which are needle shaped and sized at 150 to 450 mm, 2) microscleres which are also needle shaped, but shorter in size than the megascleres, and 3) gemmoscleres which have a variety of shapes and are similar to the microscleres in size (see page 95 first column first-second full paragraphs). The Spongilla lacustris variety has spicules in these categories as shown in the figure below (see figure 4.25).
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Their megasclere (M) and microsclere (m) are smooth surfaced and span from 158-362 mm and 30-130 mm, respectively (see page 117 first column third paragraph-second column first partial paragraph). The gemmoscleres have rough surfaces and span from 18-130 mm (see page 117 first column third paragraph-second column first partial paragraph). The width of each variety is less than 50 mm. As shown, some microsclere spicules have convex ends while others have flat ends. Some microsclere spicules can also be seen to have an included angle of less than 20 degrees. Villani teaches elongate Spongilla lacustris spicules in a carrier, such as water, that is applied to skin via gentle rubbing with fingertips and the spicules penetrate this biological barrier (see US PGPub No. 2010/0080853 – see IDS, paragraphs 6-8, 31, and 36-37 and figures 2A-2B). Thus the naturally occurring Spongilla lacustris spicules provide a plurality of the claimed microparticles that comprise silica and have a geometry and strength sufficient to penetrate a biological barrier. Thus the claimed microparticles are not markedly different than their natural counterparts in the Spongilla lacustris. Lackner et al. teach that light touch with a finger is up to 1 N in force (see Experimental Brain Research 1999 126:459-456 – see IDS, abstract). Therefore the ability to withstand an applied force of at least 0.01 N, as the fingertips provide and as required in claim 51, also is not a marked difference from the natural spicules. Claim 55 parses the microparticles into a substantially uniform size grouping which does not yield a marked difference. Claim 52 includes an additional element in its recitation of a bioactive compound and claim 53 positions this compound as a coating; however the naturally occurring spicules are coated with the bioactive compound collagen. Thus the presence of a generic bioactive compound does not amount to significantly more than the naturally occurring components of the fresh water sponge. Claim 54 adds a carrier to the microparticles. Since this additional component can be water, it does not amount to significantly more than the naturally occurring spicules. Claim 57 recites a kit with the claimed microparticles and a compound for delivery across a biological barrier. The kit components are not required in combination and can be located/packaged separately in the kit. As such, the compound can be naturally occurring and its presence in the kit along with the microparticles also does not amount to significantly more than either the naturally occurring microparticles or a naturally occurring compound. Claim 58 further adds an applicator to the kit. An applicator of some sort for applying a composition to a biological barrier and for forcing microparticles in the composition through the barrier are well known and conventional. Thus the presence of an applicator does not yield a product that is markedly different than or significantly more than the naturally occurring plurality of microparticles and naturally occurring compound embraced by the kit. Therefore the claimed subject matter does not amount to significantly more than a natural phenomenon and is not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 56 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites “a method of sensing an analyte”, where the sole active step forces a plurality of microparticles to penetrate a biological barrier and is recited to “facilitate sensing analyte across the biological barrier”. The recited result of the active step does not achieve the recited intent of the method without additional action. The disclosure provides no discussion of any analyte to sense. The only action of the method claim yields the penetration of a plurality of microparticles into a biological barrier and this penetration is not recited or discussed to occur in the presence of any additional compound that acts as a sensor or indicator of an analyte. The compositional component(s) in the microparticles discussed by the disclosure are metals, semi-metals such as silicon, plastics, (e.g. biocompatible polymers,) cellulose derived materials or ceramic material where silica and glass wool are named (see instant specification page 4 lines 121-24 and example 1). There is no indication of which varieties of these compounds, if any, have the ability to act as an indicator or to sense the presence of an analyte. Sodium fluorescein is discussed in the specification as a test payload for delivery into a biological barrier (see instant example 3). Fluorescein is capable of binding some blood proteins which could be considered an analyte (see Vlasova et al. Journal of Molecular Structure 2009 936:220–227). However, it is not clear from this capability which analyte compounds were contemplated for assessment by the applicant nor which compounds should be included to act as indicators or sensors. The disclosure also has no examples of sensing an analyte. There is no clear structure-function correlation between a set of envisioned components and the function of sensing an analyte or the collection of active steps necessary to pair with the microparticles penetrating a biological barrier that would result in an analyte being sensed. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as claimed.
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 41, 43-48, 50, 54-56, and 59-60 are 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 41 recites a method for delivering a compound through a biological barrier; however, the method steps do not recite the presence of this compound. Instead the method recites an active step of applying a force to a plurality of microparticles on the surface of a biological barrier so that at least some of the microparticles penetrate the biological barrier. Dependent claim 42, which should be a further limitation, recites the presence of the compound with the microparticles in its method. The scope of claim 41 is thus unclear as to when and where the compound is included in the method. For the sake of compact prosecution and the application of prior art, a method that applies a force to a plurality of microparticles on the surface of a biological barrier, where some subset of the microparticles penetrate the barrier as a result will be deemed sufficient to meet the limitations of “delivering a compound through a biological barrier” and “to facilitate delivery of the compound”. Clarification is still required.
Regarding claims 44, 47-48, 50, 54, and 59 the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 48, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 55 recites “at least some of the microparticle are configure to at least withstand pressure of up to 13MPa” [emphasis added]. The recitation “at least” implies a range that has a minimum and an unbounded maximum, while the recitation “up to” implies range that has a maximum and an unbounded minimum. The use of both recitations makes it unclear which level of pressure the microparticles must withstand.
Due to the lack of description about the analyte being sensed and how the analyte is to be sensed, beyond requiring a plurality of microparticles and mechanical properties that permit them to be able to penetrate a biological barrier, the scope of required components in claim 56 is unclear. In addition, the preamble of the claim recites a method of sensing, but the result recited in the body of the claim is “to facilitate sensing analyte across the biological barrier”. Thus it is unclear if sensing an analyte is actually a required part of the steps of the method. For the sake of compact prosecution and the application of prior art, a method that applies a force to a plurality of microparticles on the surface of a biological barrier, where some subset of the microparticles penetrate the barrier as a result will be deemed sufficient to meet the limitations of “sensing an analyte” and “facilitating sensing analyte across the biological barrier”. Clarification is still required.
Claims not explicitly elaborated upon are indefinite because they require the limitations of an indefinite claim, but do not add clarity.
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.
Claims 41-44, 46, 48-50, 52-54, and 56-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Udompataikul et al. (Journal of the Medical Association of Thailand 2012 95(Suppl 12): S15-S20 – see IDS).
Udompataikul et al. disclose a preparation of Spongilla lacustris spicules in 3% hydrogen peroxide (bioactive compound, pharmaceutical) solution to treat acne (see page S15 second column; instant claims 41-43 and 52-53). The liquid in which the hydrogen peroxide is dissolved meets the limitations of a carrier and the composition meets the limitations of a kit comprising a compound and a plurality of microparticles (see instant claims 54 and 57). A second preparation embodiment employs a saline solution (carrier) instead of a hydrogen peroxide solution with the Spongilla lacustris spicules (see page S15 second column last partial paragraph-page S16 first column first partial paragraph; instant claim 54). The spicules are rods (elongate) 150-300 mm in length and 10-20 mm in diameter with sharp (angled) ends, meeting the instant size limitations (see page S16 second column second full paragraph and figure 1; instant claim 50). The composition is massaged into skin (biological barrier) and spicules are seen piercing the skin under magnification (see page S16 second column second full paragraph; instant claims 44, 46 and 56). The spicule seen under magnification penetrates the biological barrier at an acute angle and reaches into the stratum basalis (see figure 2; instant claims 48-49). The method of Udompataikul et al. performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. Therefore claims 41-44, 46, 48-50, 52-54, and 56-57 are anticipated by Udompataikul et al.
Claims 41, 43, 45, 49-51, 55-56, 58, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitchell et al. (International Journal of Impact Engineering 2003 28:581-599 – see IDS).
Mitchell et al. disclose the penetration of a series of different sized spherical polymer, metal, and ceramic microparticles into mucosa (see abstract, page 583 second full paragraph, and table 2). Polystyrene particle populations sized at 99, 200, or 400mm as well as gold (biocompatible) are passed into the tissue with a light gas gun or contoured shock tube that provides a pressure force to drive the particles into the tissue (see section 3, table 2, and figure 9-10). The light gas gun and contoured shock tube meet the limitations of applicators (see instant claim 58). The lowest yield strength the microparticles overcome in order to penetrate the tissue is the 1 MPa yield strength representing the extracellular failure (see page 593 second-third full paragraphs). The largest particle would experience the least force and at most, the surface area experiencing the force would be that of the entire 400mm spherical microparticle. This then corresponds to an experienced force upon impact of 0.5 N (as calculated by the examiner; instant claim 51). The method of Mitchell et al. performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. While a compound is not included with the microparticles, their penetration through the biological barrier could facilitate delivery of a later applied compound due to the tissue disruption the penetration caused (see instant claim 43). Therefore claims 41, 43, 45, 49-51, 55-56, 58, and 60 are unpatentable over Mitchell et al.
Claims 41, 43, 45-46, 49-51, and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raju et al. (Vaccine 2006 24:4644-4647 – see IDS).
Raju et al. disclose a contoured shock tube that delivers gold (biocompatible) microparticles through skin (see page 4644 first column first full paragraph-page 4645 first column; instant claims 41 and 49-50). The delivered microparticles are noted in the stratum corneum (see page 4645 second column; instant claim 46). The device is an applicator that has a 4mm diameter delivery area and provides a maximum of 1.1 MPa of peak gas pressure on the target along with the microparticles (see page 4645 first column; instant claim 45). As a result, the microparticles that reach the target also are subjected to this pressure. The pressure at the target corresponds to 13,827 N and the microparticles are able to withstand it and penetrate into the tissue (see figure 3; as calculated by the examiner; instant claim 51). The method of Raju et al. performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. While a compound is not included with the microparticles, their penetration through the biological barrier could facilitate delivery of a later applied compound due to the tissue disruption the penetration caused (see instant claim 43). Therefore claims 41, 43, 45-46, 49-51, and 56 are unpatentable over Raju et al.
Claims 41-43, 45-46, 49-53, and 55-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (Journal of Virology 2001 75(23):11630-11640 – see IDS) as evidenced by Fuller et al. (US PGPub No. 2003/0124718 -see IDS).
Chen et al. disclose the delivery of flu vaccine coated gold microparticles through the epidermis (which includes the stratum corneum) of test subjects with a powder delivery device (see page 11631 first column second and fourth full paragraphs and figure 1; instant claims 41-43, 46, 49-50, 52-53, and 57). The particles are sized at 1.5 to 2.5m (substantially uniform) (see page 11631 first column fourth full paragraph; instant claim 55). This apparatus (applicator) applies a pressure force of to the microparticles to force them through the skin (see Fuller et al. paragraph 179; instant claim 45). The coated particles together with the powder delivery device yield a kit (see instant claims 57-58). Therefore claims 41-43, 45-46, 49-53, and 55-58 are unpatentable over Chen et al. in view of Fuller et al.
Claim Rejections - 35 USC § 102/103
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.
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 41-44, 46, 49-50, 52-57, and 59 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Villani.
Villani discloses compositions composed of needle-like (elongate) structures known as spicules that are composed of silica in a dermabrasion composition (see paragraphs 14 and 29 and table 1; instant claims 49 and 50). The envisioned and claimed variety of spicules belong to the species Spongilla lacustris and are sized at less than 200 mm which makes them microparticles (see paragraph 15 and claims 2 and 4). Envisioned spicules are pictured below:
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As shown, some spicules have convex ends while others have flat ends (see instant claim 50). Some spicules can also be seen to have a tapered end with an included angle of less than 20 degrees (see largest spicule in figure 2B; instant claim 59). Upon massaging Spongilla spicules in a carrier into the skin, the spicules penetrate the epidermis which includes the skin’s outmost layer, the stratum corneum (see paragraphs 31 and 36-37; instant specification page 9 line 27-page 10 line 8; instant claims 41 and 46). Villani further teach that the penetrating spicules aid in the delivery of bioactive compounds to the dermis (see paragraph 33). Anesthetic is an envisioned pharmaceutical excipient compounded with the spicules along with a saline carrier (see paragraph 29; instant claims 42-43, 52-54, and 57). Villani goes on to teach that the Spongilla spicules are ground and sieved such that their average particle size is not more than 200 mm and is uniform (see paragraphs 20 and 26; instant claims 50 and 55). An example is provided where Spongilla spicules are blended with a carrier and gently massaged into the skin with fingertips (manually), where a resulting tingling sensation was indicative of the spicules penetrating the skin (see example 1; instant claims 44 and 57). The inclusion of a bioactive compound, envisioned as an anesthetic, with the spicules and carrier is disclosed by Villani via their teaching of their presence or alternatively would have been obvious to one of ordinary skill in the art at the time of the invention to include due to the teaching of Villani. This composition meets the limitation of a kit (see instant claims 52-53 and 57). The method of Villani performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. Therefore claims 41-44, 46, 49-50, 52-57, and 59 are anticipated by, or alternatively are obvious over Villani
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 41-44, 46-54, and 56-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Udompataikul et al. view of Lackner et al. (Experimental Brain Research 1999 126:459-456 – see IDS).
Udompataikul et al. disclose a preparation of Spongilla lacustris spicules in 3% hydrogen peroxide (bioactive compound, pharmaceutical) solution to treat acne (see page S15 second column; instant claims 41-43 and 52-53). The liquid in which the hydrogen peroxide is dissolved meets the limitations of a carrier and the composition meets the limitations of a kit comprising a compound and a plurality of microparticles (see instant claims 54 and 57). A second preparation embodiment employs a saline solution (carrier) instead of a hydrogen peroxide solution with the Spongilla lacustris spicules (see page S15 second column last partial paragraph-page S16 first column first partial paragraph; instant claim 54). The spicules are rods (elongate) 150-300 mm in length and 10-20 mm in diameter with sharp (angled) ends, meeting the instant size limitations (see page S16 second column second full paragraph and figure 1; instant claim 50). The composition is massaged into skin (biological barrier) and spicules are seen piercing the skin under magnification (see page S16 second column second full paragraph; instant claims 44, 46 and 56). The spicule seen under magnification penetrates the biological barrier at an acute angle and reaches into the stratum basalis (see figure 2; instant claims 48-49). The method of Udompataikul et al. performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. A specific force employed by the massage application is not recited.
Lackner et al. teach that light touch with a finger is up to 1 N in force (see abstract; instant claims 47 and 51).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply a 1N force with the fingertip massage employed to the composition of Udompataikul et al. Such a force would have been obvious because Lackner et al. teach that it was known to be that imposed by gentle touch as is desired by Udompataikul et al. for their application techniques. Since the spicules of Udompataikul et al. penetrate the skin under gentle (mild) touch, then they are able to withstand this force (see instant claims 47 and 51). Therefore claims 41-44, 46-54, and 56-57 are obvious over Udompataikul et al. in view of Lackner et al.
Claims 41-44, 46-47, 49-57, and 59 are rejected under 35 U.S.C. 103 as obvious over Villani in view of Lackner et al.
Villani discloses compositions composed of needle-like (elongate) structures known as spicules that are composed of silica in a dermabrasion composition (see paragraphs 14 and 29 and table 1; instant claims 49 and 50). The envisioned and claimed variety of spicules belong to the species Spongilla lacustris and are sized at less than 200 mm which makes them microparticles (see paragraph 15 and claims 2 and 4). Envisioned spicules are pictured below:
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As shown, some spicules have convex ends while others have flat ends (see instant claim 50). Some spicules can also be seen to have a tapered end with an included angle of less than 20 degrees (see largest spicule in figure 2B; instant claim 59). Upon massaging a powder of the Spongilla in a carrier into the skin, the spicules penetrate the epidermis which includes the skin’s outmost layer, the stratum corneum (see paragraphs 31 and 36-37; instant specification page 9 line 27-page 10 line 8; instant claims 41 and 46). Villani further teach that the penetrating spicules aid in the delivery of bioactive compounds to the dermis (see paragraph 33). Anesthetic is an envisioned pharmaceutical excipient compounded with the spicules along with a saline carrier (see paragraph 29; instant claims 42-43, 52-54, and 57). Villani goes on to teach that the Spongilla spicules are ground and sieved such that their average particle size is not more than 200 mm and is uniform (see paragraphs 20 and 26; instant claims 50 and 55). An example is provided where Spongilla spicules are blended with a carrier and gently massaged into the skin with fingertips (manually), where a resulting tingling sensation was indicative of the spicules penetrating the skin (see example 1; instant claims 44 and 57). The inclusion of a bioactive compound, envisioned as an anesthetic, with the spicules and carrier is disclosed by Villani via their teaching of their presence. This composition meets the limitation of a kit (see instant claims 52-53 and 57). The method of Villani performs the step recited by claim 56, where a force is applied to a plurality of microparticles on the surface of a biological barrier and at least a subset of the microparticles penetrate the barrier. A specific force employed by the gentle massage application is not recited.
Lackner et al. teach that light touch with a finger is up to 1 N in force (see abstract; instant claims 47 and 51).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply a 1N force with the fingertip massage employed to the composition of Villani. Such a force would have been obvious because Lackner et al. teach that it was known to be that imposed by gentle touch as is desired by Villani for their application techniques. Since the spicules of Villani et al. penetrate the skin under gentle (mild) touch, then they are able to withstand this force (see instant claims 47 and 51). The inclusion of an anesthetic with the spicules also would have been obvious due to the suggestion to do so by Villani. Therefore claims 41-44, 46-47, 49-57, and 59 are obvious over Villani in view of Lackner et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615