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 .
Claim Objections
Claim 50 is objected to because of the following informalities: the claim recites options i)-vi); however, options i) and iv) do not limit the parent claim. While the claim as a whole is further limiting, the recitation creates the impression that any of its options could be selected as further limitations of the parent. Appropriate correction is required.
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.
Claims 48 and 61-63 are 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 claims are drawn to a method where an applicator is used to apply a plurality of silica microparticles, whose length is larger than their diameter, to skin. The microparticles puncture the stratum corneum at an angle within a particular range or to a depth within a particular range. The disclosure only details the puncturing of skin with microparticles at certain angles or depths in the claimed range when a specialized applicator is employed (see example 2). While application AU2012905650 is referenced as the source of an envisioned applicator, the design of the applicator is not described in the instant specification and no general discussion of applicators or application techniques that attain the recited angles and depths of penetration are detailed (see page 6 lines 10-18). The referenced application discusses several details about the topography of the skin facing surface of the applicator that facilitate orientation of the microparticles with respect to the skin/biological barrier. Specific geometries are detailed for surface features of the applicator as well. The concentration and volume of the applied composition is detailed, but the duration of rubbing is not detailed nor is the applied force. There is no discussion of what features are necessary in a applicator in order to be able to produce the penetration depth and angles that are recited. As a result, the disclosure does not connect the occurrence of the claimed function with the breadth of the method steps as recited such that it is clear how the application needs to occur in order to meet the claimed outcome. 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 61-62 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.
The claims recite that the microparticles penetrate the skin at a depth of 0-40 mm. This recitation is inconsistent with the parent claim that recites the microparticles puncture the stratum corneum of the skin. A microparticle must penetrate the skin in a non-zero amount in order to puncture the stratum corneum. Thus, either the term “penetrate” does not require penetration which makes the scope of the term unclear or the claims explicitly embrace embodiments that are impossible to practice.
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, 43, 48, 50, 53-54, and 61-63 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Udompataikul et al. view of Villani et al. (US PGPub No. 2004/0109872 – henceforth Villani B) as evidenced by Harrington (GB-2483708).
Udompataikul et al. teach a preparation of Spongilla lacustris spicules in a 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 (see instant claim 54). 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 in a circular motion into skin (biological barrier) and spicules are seen piercing the skin under magnification (see page S16 first column first full paragraph and second column second full paragraph; instant claims 44, 46 and 56). A spicule seen under magnification penetrates the biological barrier at an acute angle and reaches into the stratum basalis (see figure 2; instant claims 48 and 61-63). The figure appears to show a spicule whose length is about 80 mm, based on the scale bar, with about a quarter of its length protruding from the skin as a result of massaging the composition on the skin for 10 minutes. They do not discuss the particle size distribution within the taught range or an applicator.
Villani B teaches compositions that include needle-like (elongate) structures known as spicules that are composed of silica in a composition for skin resurfacing delivering and active compounds through the skin (see paragraphs 34-35, 40-42, and 52). The envisioned and claimed variety of spicules belong to the species Spongilla lacustris (see paragraph 41 and claims 6 and 13). The spicules are ground, sieved, and sized to be less than 200 mm which makes them microparticles (see paragraphs 93-94). They detail application of the spicules as a paste in a carrier with hydrogen peroxide (active compound) by massaging with fingertips, where protective gloves may be worn (see paragraphs 138-143). The composition is exemplified with 0.5 g/ml spicules in the hydrogen peroxide (see paragraph 99; instant claim 41). They apply the composition to the face in a circular motion for approximately 5 minutes, then leave it to dry (see paragraph 102). A protective glove is an applicator (see Harrington page 5 section 6; instant claim 41). Villani detail the sensation of sharp needles under the skin during application (see paragraph 143).
It would have been obvious to one of ordinary skill in the art at the time of the invention to sieve the particles of Udompataikul et al. such that they are less than 200 mm and are included in the applied composition at 0.5 g/mL, in light of the teachings of Villani B. These modifications would have been obvious because Villani B teaches the utility of this size of sponge spicules for delivering active compounds through skin and this concentration of sponge spicules for delivering hydrogen peroxide in particular. The result would be a method of delivering a compound through the skin with the elongate particles of Udompataikul et al. having a length between 150 and 200 mm at 0.5 g/ml. While the median of this particle size range is not detailed, the minimum size, 150 mm, is within 80% of the maximum size and vice versa. Therefore regardless of the median, the entire range is within 80% of its value. It additionally would have been obvious to follow the suggestion of Villani B and employ protective glove covered fingertips for the massaging, which meets the limitation of using an applicator to apply the composition. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Regarding the penetration angle, particles of Udompataikul et al. are shown penetrating the skin at acute angles. There is a 50:50 chance that any given fiber shaped particle will enter at an acute angle less than 45 degrees within this range, since the only options are between 0 and 90 degrees. In addition, the circular massaging motion would yield an array of angles at which force is applied to the ends of the microparticles. Thus, absent evidence to the contrary, it also would have been obvious to expect at least some particles to have a penetration angle between 7 and 25 degrees due to the way in which an applicator moving in a circle would be expected to contact the microparticles. Further, depending on the pressure applied and the rubbing duration, the penetration depth is likely to be more (via greater pressure or longer time) or less (via less pressure or shorter time) than that attained by Udompataikul et al. and a yield a range of penetration depths that overlaps those instantly claimed. This overlapping range would render the instantly claimed range obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Therefore claims 41, 43, 48, 50, 53-54, and 61-63 are obvious over Udompataikul et al. in view of Villani B as evidenced by Harrington.
Claims 41, 43, 47-48, 50-51, 53-54, and 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Udompataikul et al. in view of Villani B as evidenced by Harrington as applied to claims 41, 43, 48, 50, 53-54, and 61-63 above, and further in view of Lackner et al. (previously cited).
Udompataikul et al. in view of Villani B as evidenced by Harrington render obvious the limitations of instant claims 41, 43, 48, 50, 53-54, and 61-63. While skin penetration occurs due to rubbing with fingertips, the force the spicules are able to withstand is not discussed.
Lackner et al. teach that a 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. in view of Villani B as evidenced by Harrington. 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, 43, 47-48, 50-51, 53-54, and 61-63 are obvious over Udompataikul et al. in view of Villani B and Lackner et al. as evidenced by Harrington.
Claims 41, 43, 48, 50, 53-55, and 61-63 are rejected under 35 U.S.C. 103 as obvious over Udompataikul et al. in view of Villani B as evidenced by Harrington as applied to claims 41, 43, 48, 50, 53-54, and 61-63 above, further as evidenced by Stoor et al. (US PGPub No. 2002/0114768) and Shergold (Transactions of ASMA 2005 127:838-848 – see IDS).
The modified teachings of Udompataikul et al. render obvious the limitations of instant claims 41, 43, 48, 50, 53-54, and 61-63. The spicules are predominantly composed of silica, a component that is soluble in vivo; thereby making the microparticles at least partially soluble in vivo (see Stoor et al. paragraph 3). While skin penetration occurs due to rubbing with fingertips, the force the spicules are able to withstand is not discussed.
Shergold et al. teach that the pressure induced upon a blunt tipped cylindrical punch and a sharp tipped cylindrical punch when penetrating skin is approximately 7.3 MPa and 67 MPa, respectively (see figure 20; instant claim 55).
Given that the fiber shaped particles of Udompataikul et al. in view of Villani B as evidenced by Harrington penetrate the skin, they must be able to withstand the yield stress of skin. Since the ends of the particles fall within the spectrum between sharp tipped and flat ended, the pressure they were able to withstand would also fall between 7.3 MPa and 67 MPa, overlapping with the range instantly claimed, thereby rendering it obvious (see MPEP 2144.05). Therefore claims 41, 43, 48, 50, 53-55, and 61-63 are obvious over Udompataikul et al. in view of Villani B as evidenced by Harrington, Stoor et al. and Shergold et al.
Claims 41, 43, 50, 53-54 and 59 are rejected under 35 U.S.C. 103 as obvious over Villani (US PGPub No. 2010/0080853 - previously cited) in view of Udompataikul et al. and Villani B as evidence by Harrington.
Villani teaches 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 claim 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 claim 41). 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 53 and 54). Villani goes on to teach that the Spongilla spicules are ground and sieved such that their size is not more than 200 mm and is uniform (see paragraphs 20 and 26-27). 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). They teach a ratio of spicules to carrier of 1:2 which corresponds to about 300 mg/ml (see example 1; instant claim 41). 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. They do not discuss the particle size distribution within the taught range or an applicator.
Udompataikul et al. teach a preparation of Spongilla lacustris spicules in a 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 (see instant claim 54). 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 in a circular motion into skin (biological barrier) and spicules are seen piercing the skin under magnification (see page S16 first column first full paragraph and second column second full paragraph; instant claims 44, 46 and 56).
Villani B teaches compositions that include needle-like (elongate) structures known as spicules that are composed of silica in a composition for skin resurfacing delivering and active compounds through the skin (see paragraphs 34-35, 40-42, and 52). The envisioned and claimed variety of spicules belong to the species Spongilla lacustris (see paragraph 41 and claims 6 and 13). The spicules are ground, sieved, and sized to be less than 200 mm which makes them microparticles (see paragraphs 93-94). They detail application of the spicules as a paste in a carrier with hydrogen peroxide (active compound) by massaging with fingertips, where protective gloves may be worn (see paragraphs 138-143). The composition is exemplified with 0.5 g/ml spicules in the hydrogen peroxide (see paragraph 99; instant claim 41). They apply the composition to the face in a circular motion for approximately 5 minutes, then leave it to dry (see paragraph 102). A protective glove is an applicator (see Harrington page 5 section 6; instant claim 41). Villani detail the sensation of sharp needles under the skin during application (see paragraph 143).
It would have been obvious to one of ordinary skill in the art at the time of the invention to size the sponge spicules of Villani such that their minimum is 150 mm as taught by Udompataikul et al. This modification would have been obvious because Udompataikul et al. indicates the size minimum as suitable for the desired delivery of active compounds through the skin by rubbing a composition of the active compound with the same variety of sponge spicules as Villani onto the skin. While the median of the resulting particle size range is not detailed, the minimum size, 150 mm, is within 80% of the maximum size and vice versa. Therefore regardless of the median, the entire range is within 80% of its value. In addition, it also would have been obvious to use a protective glove covered finger for the application, as taught by Villani B, so as to protect the fingers. Therefore claims 41, 43, 50, 53-54 and 59 are obvious over Villani in view of Udompataikul et al. and Villani B as evidence by Harrington.
Claims 41, 43, 47, 50-51, 53-54 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Villani in view of Udompataikul et al. and Villani B as evidence by Harrington as applied to claims 41, 43, 50, 53-54 and 59 above, and further in view of Lackner et al.
Villani in view of Udompataikul et al. and Villani B as evidence by Harrington render obvious the limitations of instant claims 41, 43, 50, 53-54 and 59. While skin penetration occurs due to rubbing with fingertips, the force the spicules are able to withstand is not discussed
Lackner et al. teach that a 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 in view of Udompataikul et al. and Villani B as evidence by Harrington. 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 penetrate the skin under gentle (mild) touch, then they are able to withstand this force (see instant claims 47 and 51). Therefore claims 41, 43, 47, 50-51, 53-54 and 59 are obvious over Villani in view of Udompataikul et al., Villani B, and Lackner et al. as evidence by Harrington.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 41, 43, 47-48, 50-51, and 61-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-55 of copending Application No. 19/407961 (reference application) in view of Udompataikul et al. and Villani B as evidence by Harrington.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of delivering a compound through the skin by applying a force to a composition comprising the compound and microparticles such that microparticles penetrate the skin. The penetration occurs into the stratum corneum The copending claims go on to recite the particles to withstand a force of up to 13 MPa and penetrate the skin at an angle of 7 to 25 degrees. The copending microparticles can be composed of silica and the compound may be a bioactive agent admixed with the microparticles along with a carrier. The copending claims recite a width of less than 20 mm and length of 20 to 500 mm. In addition, the copending claims recite application via applicator as well as via massaging. The copending claims do not detail a microparticle length distribution, the concentration of microparticles in the composition, or a penetration depth due to application.
Udompataikul et al. teach a preparation of Spongilla lacustris spicules in a 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 (see instant claim 54). 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 in a circular motion into skin (biological barrier) and spicules are seen piercing the skin under magnification (see page S16 first column first full paragraph and second column second full paragraph; instant claims 44, 46 and 56).
Villani B teaches compositions that include needle-like (elongate) structures known as spicules that are composed of silica in a composition for skin resurfacing delivering and active compounds through the skin (see paragraphs 34-35, 40-42, and 52). The envisioned and claimed variety of spicules belong to the species Spongilla lacustris (see paragraph 41 and claims 6 and 13). The spicules are ground, sieved, and sized to be less than 200 mm which makes them microparticles (see paragraphs 93-94). They detail application of the spicules as a paste in a carrier with hydrogen peroxide (active compound) by massaging with fingertips, where protective gloves may be worn (see paragraphs 138-143). The composition is exemplified with 0.5 g/ml spicules in the hydrogen peroxide (see paragraph 99; instant claim 41). They apply the composition to the face in a circular motion for approximately 5 minutes, then leave it to dry (see paragraph 102). A protective glove is an applicator (see Harrington page 5 section 6; instant claim 41). Villani detail the sensation of sharp needles under the skin during application (see paragraph 143).
It would have been obvious to one of ordinary skill in the art at the time of the invention to size the microparticles of the copending claims like those of Udompataikul et al. and Villani B such that they are 150 mm to less than 200 mm and are included in the applied composition at 0.5 g/mL, in light of the teachings of Villani B. These modifications would have been obvious because Udompataikul et al. and Villani B teach the utility of this size of elongate particles for delivering active compounds through skin and Villani B teach this concentration for delivering a bioactive compound. The result would be a method of delivering a compound through the skin with the elongate particles of the copending claims having a length between 150 and 200 mm at 0.5 g/ml. While the median of this particle size range is not detailed, the minimum size, 150 mm, is within 80% of the maximum size and vice versa. Therefore regardless of the median, the entire range is within 80% of its value. It additionally would have been obvious to follow the suggestion of Villani B and employ protective glove covered fingertips for the massaging which meets the limitation of an applicator. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Further, depending on the pressure applied and the rubbing duration, the penetration depth is likely to be more (via greater pressure or longer time) or less (via less pressure or shorter time) than that attained by Udompataikul et al. and yield a range of pentation depths that overlaps those instantly claimed. This overlapping range would render the instantly claimed range obvious (see MPEP 2144.05). Therefore claims 41, 43, 47-48, 50-51, and 61-63 are obvious over claims 20-55 of copending Application No. 19/407961 in view of Udompataikul et al. and Villani B as evidence by Harrington.
Claims 41, 43, 47-48, 50-51, 59, and 61-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-55 of copending Application No. 19/407961 in view of Udompataikul et al. and Villani B as evidence by Harrington as applied to claims 41, 43, 47-48, 50-51, and 61-63 above, and further in view of Villani.
Claims 20-55 of copending Application No. 19/407961 in view of Udompataikul et al. and Villani B as evidence by Harrington render obvious the limitations of instant claims 41, 43, 47-48, 50-51, and 61-63. Microparticles with a tapered end as taught by Udompataikul et al., but not expressly recited in the copending claims.
Villani teaches 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 claim 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 claim 41).
It would have been obvious to one of ordinary skill in the art at the time of the invention to design or select the microparticles in the copending method to have a tapered end as exemplified by Udompataikul et al. and Villani because both teach it as a suitable end geometry for penetrating the skin when rubbed. Therefore claims 41, 43, 47-48, 50-51, 59, and 61-63 are obvious over claims 20-55 of copending Application No. 19/407961 in view of Udompataikul et al., Villani B, and Villani as evidence by Harrington.
Response to Arguments
Applicant's arguments filed May 18, 2026 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection and objection are withdrawn and new grounds of rejection and objection are detailed to address the new limitations.
Regarding rejections under 35 USC 103 over Villani in view of others:
The applicant argues that Villani relies on particles of different sizes for their method of dermabrasion which is different than the instantly claimed method. Villani does not make such a statement nor do they discuss heterogeneity is a desired or required attribute of the spicules they employ. More importantly, whether dermabrasion occurs in the cited prior art method is irrelevant because there are no claim limitations that require or disallow dermabrasion. The instantly claimed method delivers a compound through the skin via whatever happens when silica microparticles of the recited dimensions and concentration are applied with a generic applicator.
The applicant refers to the contents of an affidavit or declaration filed in the prior application. Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
The applicant argues that instantly claimed particle size distribution does not abrade the skin. There is no evidence that the scope of microparticles embraced by the claimed distribution do not abrade skin across the scope of the claimed methods. While the applicant’s tested embodiment of the recite microparticles may have performed in this manner, there is no evidence it is representative of the claimed scope of methods. Therefore limiting the minimum length to that employed by Udompataikul et al. in a method that also employs sponge spicules for the drug delivery across the skin would have been obvious and expected to yield delivery across the skin.
The applicant argues that Villani does not teach that their particles puncture the stratum corneum; however, the rejection notes the teaching by Villani that their particles penetrate the epidermis. The epidermis is the outer layer of the skin. The rejection also cited the instant specification and its discussion of applying the composition to the stratum corneum of the skin; implying it is the outer layer. Thus Villani teach that their particles puncture the stratum corneum.
Regarding rejections under 35 USC 103 over Villani in view of others:
The applicant argues that Udompataikul et al. teach a heterogenous particle size. This characterization does not appear to acknowledge their teaching of their particles being 150 to 300 mm in length and the breadth of the applicant’s recited distribution. Furthermore, the text of Udompataikul et al. is silent about the size distribution of their particles. Thus the text of the reference does not support the applicant’s argument.
The applicant again refers to the contents of an affidavit or declaration filed in the prior application which is not evidence of record in the current application. Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
The applicant asserts that the size distribution instantly claimed reduces abrasion, does not exfoliate the skin, and favors penetration over skin disruption. There is no evidence to support these assertions. Further, the specification states that the instant microparticles and low angle application “results in maximal disruption” (see page 13). Thus the disclosure appears to contradict the applicant’s argument.
In contrast to the applicant’s argument, Udompataikul et al. would have good reason, in light of Villani, to narrow their particle size because the latter teaches that the same type of particles with a lower maximum length are also suitable for their same purpose.
Conclusion
No claim is 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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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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