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 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.
Claim 93 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.
The term “substantially” in line 2 is indefinite. There is no definition in the specification that provides for the metes and bounds of “substantially”. For example, what mesh size would be substantially uniform and what size particles. Additionally, by size does it mean length, diameter, or aspect ratio and does substantially qualify one or all of these sizes?
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 87-112, 118-120 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claim(s) recite(s) a kit comprising two natural components a (1) Spongilla composition and (2) a fluidizing agent (water – see claim 118). This judicial exception is not integrated into a practical application because there is no required application in a kit claim. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional components, or the additional components are routine and conventional.
The claims recite a kit comprising a first composition comprising Spongilla and a second composition comprising one or more fluidizing agents. The specification defines Spongilla as a freshwater sponge genus and states that Spongilla materials may include components “that are part of the naturally occurring Spongilla.” See specification [00021]-[00022]. Thus, the first composition encompasses a natural product.
Claim 118 recites that the fluidizing agent (second composition) may be water, which is also a natural product. The remaining fluidizing agents, including saline and hydrogen peroxide solution, are routine excipients/fluidizing agents. See specification ¶¶ [0002], [0007]-[0008], [00049], [00098].
The claims do not recite markedly different characteristics from naturally occurring Spongilla. Limitations such as powder form, particle size, moisture content, microbial limits, packaging, heating, gamma irradiation, hydrogen peroxide concentration/amounts, and solution/gel/powder forms are routine processing, formulation, or packaging features. The specification describes obtaining, processing, drying, packaging, testing, heating, irradiating, grinding, and sieving Spongilla by methods known to those of ordinary skill in the art. See specification ¶¶ [00025], [00060]-[00072].
The claims also do not integrate the natural product into a practical application. Claims 88-91 merely recite intended use for treating acne vulgaris and do not require any actual treatment step or structural change to the kit.
The additional elements, individually and as an ordered combination, amount only to placing a natural product in a conventional kit with routine fluidizing agents and routine processing/packaging features. These limitations do not add significantly more than the judicial exception. Evidence of routine and conventional is seen in the below prior art rejections.
The claimed combination does not exhibit any markedly different characteristics from the natural components themselves, because the only alleged therapeutic property—improvement of acne—is attributed in the specification to the naturally occurring properties of Spongilla and its natural components, rather than to any non-natural structural or functional change resulting from the claimed kit combination.
Accordingly, claims 87-112 and 118-120 are directed to non-statutory subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 3, 87-94, 98-105, 109-112, and 118-120 are rejected under 35 U.S.C. 102(a1)/a2 as being anticipated by Villani (US 2015/0079624 A1).
Initial claim interpretation – It is the office’s position that the reference of treatment in the kit claims are not limiting as the structure of the kit is limiting and the way it can be used is not limiting. For the sake of compact prosecution, the examiner will still cite the treatment used for the Kit.
Regarding claim Claim 3: Villani discloses “Spongilla-based therapeutic compositions for treating and preventing skin diseases,” including “acne vulgaris” (Abstract), “a method of treating skin conditions comprising applying to the skin of an individual a therapeutic composition consisting of a substantially pure powder of Spongilla lacustris, and at least one pharmaceutically acceptable excipient” (¶ [0051]), compositions compounded with “water” and “hydrogen peroxide” (¶¶ [0050], [0151]), and a topical acne therapeutic comprising “1.0 grams of Spongilla powder… and 2.0 milliliter of 3% hydrogen peroxide,” wherein “[t]he therapeutic is then applied to the entire face” (¶ [0227]); Villani further discloses that “the topical therapeutic was formulated as a topical acne therapeutic comprising of 1.0 grams of Spongilla powder and 2.0 milliliter of 3% hydrogen peroxide mixed prior to use” and “applied to the entire face” (¶ [0288]).
Regarding claim 87: Villani discloses “A kit comprising a first composition comprising Spongilla, and a second composition comprising one or more fluidizing agents.” Villani discloses a “pre-weighed package containing substantially pure Spongilla” powder, with the pre-weighed amount “sufficient for one application to the face” (¶ [0282]), and further instructs to “[m]easure out two milliliters of 3% hydrogen peroxide” and “[p]our the warmed peroxide solution into the pre-weighed container of Spongilla powder” (¶ [0285]); Villani also discloses compositions compounded with excipients including “water,” “saline,” and “hydrogen peroxide” (¶ [0151]), thereby disclosing a first Spongilla composition and a second fluidizing composition used together.
Regarding claim 88: Villani discloses “The kit according to claim 87 for use in the treatment of acne vulgaris in the subject.” Villani discloses that treatable skin conditions include “acne vulgaris” (Abstract), that “[d]isclosed herein is an anti-acne vulgaris therapeutic” (¶ [0081]), and that the topical acne therapeutic comprises “Spongilla powder” and “3% hydrogen peroxide” (¶ [0227]).
Regarding claim 89: Villani discloses “The kit according to claim 88, wherein said acne vulgaris is moderate acne vulgaris or severe acne vulgaris.” Villani discloses that “acne is described as mild, moderate, or severe” (¶ [0012]) and that the disclosed compositions are effective in treating dermatologic conditions including “mild, moderate, and severe acne” (¶ [0090]).
Regarding claim 90: Villani discloses “The kit according to claim 88, wherein said acne vulgaris is facial acne vulgaris.” Villani discloses that acne commonly involves “the face” (¶ [0005]), that the therapeutic is “applied to the entire face” (¶ [0227]), that a pre-weighed amount of Spongilla powder is “sufficient for one application to the face” (¶ [0282]), and that the topical composition was “applied to the entire face” (¶ [0288]).
Regarding claim 91: Villani discloses “The kit according to claim 88, wherein said facial acne vulgaris is moderate facial acne vulgaris or severe facial acne vulgaris.” Villani discloses that acne is “mild, moderate, or severe” (¶ [0012]), that the disclosed compositions treat “mild, moderate, and severe acne” (¶ [0090]), and that the acne therapeutic is applied to “the entire face” (¶¶ [0227], [0288]).
Regarding claim 92: Villani discloses “The kit according to claim 87, wherein the first composition comprises Spongilla in the form of a powder.” Villani discloses “processed Spongilla powder” (Abstract), “a substantially pure powder of S. lacustris” (¶ [0049]), that the processed material is referred to as “Spongilla powder” (¶ [0147]), and that the topical acne therapeutic comprises “Spongilla powder” (¶ [0227]).
Regarding claim 93: Villani discloses “The kit according to claim 87, wherein the Spongilla is in the form of a powder comprising particles that are substantially uniform in size.” Villani discloses grinding and sieving dried Spongilla to form powder, including “grinding and sieving… to form a particle size less than 2 mm and repeating the grinding and sieving process to form a substantially pure Spongilla powder having an average particle size of less than 0.2 mm” (¶ [0042]), and further discloses passing ground S. lacustris through “a series of sieves with progressively smaller apertures wherein the last aperture is about 0.2 mm” (¶ [0047]), thereby providing size-controlled particles.
Regarding Claim 94: Villani discloses “The kit according to claim 93, wherein not less than 50% of the particles comprising the Spongilla powder pass through a US 70-mesh screen.” Villani discloses sieving the Spongilla powder with progressively smaller apertures including a final aperture of “about 0.2 mm” (¶ [0047-0049]) and reducing average particle size to “no more than about 0.2 mm” (¶ [0142]); because a US 70-mesh screen has openings of approximately 212 µm, Villani’s particles sized to about 0.2 mm, i.e., about 200 µm, would pass through a US 70-mesh screen.
In paragraph 0049 of Villali all the particles are less than .2 m meaning that the would pass through a US 70 mesh screen.
Regarding claim 98: Villani discloses that dried S. lacustris has “a residual moisture content of about 0.1% to about 10%” (¶ [0046]) and that “[t]he sponge mass is dried until residual moisture content is less than about 10%” (¶ [0133]).
Regarding claim 99: Villani discloses microbiological testing for “pathogens, coliform organisms, bioburden” (¶ [0135]) and Table 3 specifies “Total Colony Count (Aerobic and Anaerobic)” as “Not more than about 5 x 10³ Colony forming units (CFU)” (¶ [0137], Table 3), which is below the claimed maximum of about 25×104 CFU/g.
Regarding Claim 100: Villani discloses microbiological testing and Table 3 specifies “Yeast and Mold — Absent” (¶ [0137], Table 3), which is below the claimed maximum of about 25×10^4 CFU/g.
Regarding Claim 101: Villani discloses microbiological testing for “coliform organisms” (¶ [0135]) and Table 3 specifies “Coli forms — Absent” (¶ [0137], Table 3), which is below the claimed maximum of about 25×10^4 CFU/g.
Regarding Claim 102: Villani discloses microbiological testing and Table 3 specifies “Salmonella — Absent” (¶ [0137], Table 3), which is below the claimed maximum of about 25×104 CFU/g.
Regarding claim 103: Villani discloses microbiological testing for “pathogens” and “bioburden” (¶ [0135]) and Table 3 limits the “Total Colony Count (Aerobic and Anaerobic)” to “Not more than about 5 x 10³” CFU (¶ [0137], Table 3), which necessarily includes any aerobic bacterial content within the total colony count and is below the claimed maximum of about 25×10^4 CFU/g.
Regarding claim 104: Villani discloses microbiological testing for “pathogens” and “bioburden” (¶ [0135]) and Table 3 limits the “Total Colony Count (Aerobic and Anaerobic)” to “Not more than about 5 x 10³” CFU (¶ [0137], Table 3), which necessarily includes any aerobic bacterial content within the total colony count and is below the claimed maximum of about 25×104 CFU/g.
Regarding claim 105: Villani discloses that, after final grinding and sizing, “the dried sponge material is immediately packaged in bulk… in airtight moisture-proof storage bags” (¶ [0145]), that storage bags/containers are labeled with product information (¶ [0146]), and that “[a] pre-weighed package containing substantially pure Spongilla” powder is provided for use (¶ [0282]).
Regarding claim 109-110: Villani discloses that the therapeutic compositions can include pharmaceutically acceptable excipients including “water” and “hydrogen peroxide” (¶ [0151]), and specifically discloses a topical acne therapeutic comprising “1.0 grams of Spongilla powder (active ingredient) and 2.0 milliliter of 3% hydrogen peroxide (vehicle),” wherein “[t]he ingredients are combined and mixed together” (¶ [0227]); Villani further discloses pouring “the warmed peroxide solution into the pre-weighed container of Spongilla powder” and stirring “to obtain a thin paste” (¶ [0285]), thereby disclosing a Spongilla composition further comprising an aqueous hydrogen peroxide solution.
Regarding claim 111: Villani discloses topical acne compositions comprising “1.0 grams of Spongilla powder … and 2.0 milliliter of 3% hydrogen peroxide” (¶ [0227]) and “1.5 grams of Spongilla powder, 1.0 milliliter of 3% hydrogen peroxide, and 3.0 milliliters of 5% boric acid” (¶ [0228]); Villani also generally discloses therapeutic compositions comprising “from 0.8 to 1.5 grams of substantially pure Spongilla powder” and “from 0.5 mL to 5 mL of 0.1% to 10% hydrogen peroxide” (¶ [0152]). However, Villani does not appear to expressly disclose the specific combination of “about 2 grams of Spongilla” and “about 6 mL of 3% hydrogen peroxide solution.” Claims 109-110 cover the hydrogen peroxide amount.
Examiner interprets about 2 grams to encompass 1.5 grams.
Regarding claim 112: Villani methods involving freshwater species of genus Spongilla and specifically “Spongilla lacustris” (Abstract), and further discloses “a therapeutic composition … consisting of a substantially pure powder of … S. lacustris” (¶ [0049]); Villani also states that the “present inventor has developed therapeutic compositions derived form the fresh water sponge species Spongilla lacustris” (¶ [0080]).
Regarding claim 118: Villani discloses “that the Spongilla compositions can be compounded with pharmaceutically acceptable excipients including “water, saline… [and] hydrogen peroxide” (¶ [0151]); Villani further discloses topical acne compositions using “3% hydrogen peroxide” as the vehicle (¶ [0227]) and identifies “water” as an excipient used in the compositions (¶ [0152]).
Regarding claim 119: Villani discloses hydrogen peroxide solutions in the range of “from 0.5 mL to 5 mL of 0.1% to 10% hydrogen peroxide” as an excipient for therapeutic compositions (¶ [0152]), and specifically discloses “3% hydrogen peroxide” for topical acne treatment (¶¶ [0227], [0228], [0285]); the disclosed 3% hydrogen peroxide falls within the claimed range of about 0.5% to about 50% hydrogen peroxide.
Regarding Claim 120: Villani discloses that the compositions may include excipients including “water,” “saline,” “gels,” and “hydrogen peroxide” (¶ [0151]); Villani further discloses use of “3% hydrogen peroxide” as a liquid vehicle/solution mixed with Spongilla powder (¶¶ [0227], [0285]) and also discloses “enzyme gel” as an excipient, including “from 0.5 mL to 5 mL enzyme gel” (¶ [0152]). Thus, Villani discloses the second composition in the form of a solution, aqueous solution, or gel.
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.
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.
Claim(s) 95-97 are rejected under 35 U.S.C. 103 as being unpatentable over Villani (US 2015/0079624 A1) further in view of Lee (Spicule-New Technology for Collagen Induction Therapy).
Regarding claim 95, Villani discloses forming Spongilla powder having “an average particle size of less than 0.2 mm” (¶ [0042]) and reducing particle size to “no more than about 0.2 mm” (¶ [0142]), i.e., less than about 200 µm, which falls within the claimed range of about 50 µm to about 500 µm; Villani also depicts Spongilla spicules/particles with micrometer-scale dimensions in SEM figures (Figs. 11A-13; ¶¶ [0067]-[0069]).
Regarding claim 96, Villani discloses SEM images of S. lacustris “megascleres (spicules)” and “microcleres (spicules)” (¶¶ [0068]-[0069]; Figs. 12A-13) and describes the spicules as “slightly curved” and of “uniform size” (¶ [0136]); the micrometer-scale spicule diameters shown in Villani’s SEM figures fall within the claimed broad diameter range of about 5 µm to about 50 µm.
Regarding claim 97: Villani discloses elongated Spongilla spicules, including “megascleres (spicules)” and “microcleres (spicules)” shown in SEM images (¶¶ [0068]-[0069]; Figs. 12A-13), and describes the spicules as “slightly curved” with acerate-to-blunt tips (¶ [0136]), thereby describing elongated particles having an aspect ratio above 1.
With respect to claims 95-97, Villani does not expressly teach where the average length is exactly 0-500 microns, the average diameter is 5-50 microns, and the aspect ratio is 1-100.
However, Lee teaches that with Spongilla spicules a average 10 micron diameter and 180-250 micron length of spicules (Aspect ratio of 18 to 25) where known to be useful for dermatological applications. (See Lee Pages 2-3).
From the teachings of Villani and Lee it would have been obvious to those having the ordinary skill in the art to use spicules sized similarly to Lee in Villani’s methods and products to treat acne as those dimensions have been proven to apply a positive effect to human skin.
Claims 106-107 are rejected under 35 U.S.C. 103 as being unpatentable over Villani (US 2015/0079624 A1) further in view of Shi et al. (US 2007/0116851 A1).
Regarding Claim 106/107: Villani discloses that commercial dryers may be used to dehydrate the harvested sponge colonies (¶ [0129]) and that residual moisture measurements may be performed by exposing the sample to “a heat source such as a drying oven or heat lamp operated at a temperature sufficient to evaporate any remaining free or loosely bound water” (¶ [0133]); Villani further discloses that Spongilla material may be extracted at “60° C.” in Examples 2 and 3 (¶¶ [0197]-[0202]), but Villani does not appear to expressly state heating the first composition to at least about 70 °C prior to packaging. Villani discloses drying with heat sources such as drying ovens or heat lamps to remove residual moisture (¶ [0133]) and processing to achieve low residual moisture before packaging (¶¶ [0145]-[0146]); however, Villani does not appear to expressly disclose heating the first composition to at least about 70 °C for at least about 5 minutes prior to packaging.
Villani does not expressly teach heating above 70C for at least 5 minutes before packaging.
However, Shi teaches the need to heat (boiling - generally understood to be 100C or above) for up to an hour may be necessary to kill bacteria and improve the shelf life. (See paragraph 0031). It would have been obvious to combine Villani and Shi for the benefit of eliminating bacteria/moisture prior to packaging to maximize the effectiveness and shelf life of the product.
Claim 108 is rejected under 35 U.S.C. 103 as being unpatentable over Villani (US 2015/0079624 A1) further in view of Messenger (USP No. 6,290,976 B1).
Regarding claim 108: Villani quarantine and quality-control testing, including microbiological testing and bioburden testing (¶¶ [0135]-[0137]), and discloses sterilization/safety processing generally; however, the reproduced Villani text does not appear to expressly disclose treatment with gamma radiation prior to packaging.
However, Messenger teaches that in the same field of endeavor (applying skim improvement composition with a powder like material) that the powder should be sterilized with gamma radiation to perform microbe control. (See abstract).
It would have been obvious to use a known technique for sterilization to yield the predictable result of strelizing.
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over Villani (US 2015/0079624 A1.
Regarding claim 111: Villani discloses topical acne compositions comprising “1.0 grams of Spongilla powder … and 2.0 milliliter of 3% hydrogen peroxide” (¶ [0227]) and “1.5 grams of Spongilla powder, 1.0 milliliter of 3% hydrogen peroxide, and 3.0 milliliters of 5% boric acid” (¶ [0228]); Villani also generally discloses therapeutic compositions comprising “from 0.8 to 1.5 grams of substantially pure Spongilla powder” and “from 0.5 mL to 5 mL of 0.1% to 10% hydrogen peroxide” (¶ [0152]). However, Villani does not appear to expressly disclose the specific combination of “about 2 grams of Spongilla” and “about 6 mL of 3% hydrogen peroxide solution.” Claims 109-110 cover the hydrogen peroxide amount.
If it is determined that about 2 grams does not encompass 1.5 grams. It would have been obvious to those skilled in the art that the amount of Spongilla would be tunable to the desired dermatological use and desired effect.
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.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,208,123. Although the claims at issue are not identical, they are not patentably distinct from each other because they both use Spongilla with fluidizing agents to treat acne vulgaris.
Claims 3, 87-112, and 118-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,629,331 in combination with the prior art references used in the 102/103 above as the Vallari references uses Spongilla in the same way as the reference application (dermatological application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both use Spongilla with fluidizing agents to treat acne vulgaris.
Both the instant application and the patent use a kit with Spongilla particles and an excipient/fluidizing agent to treat skin related ailments.
Claims 3, 87-112, and 118-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of US Application # 18/954,103331 in combination with the prior art references used in the 102/103 above as the Vallari references uses Spongilla in the same way as the reference application (dermatological application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both use Spongilla to treat a skin ailment. The addition of a fluidizing agent such as water or cream to spread the treatment on skin is notoriously well known in the art and an obvious addition.
Claims 3, 87-112, and 118-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of US Application # 18/954,103331 in combination with the prior art references used in the 102/103 above as the Vallari references uses Spongilla in the same way as the reference application (dermatological application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both use Spongilla to treat a skin ailment. The addition of a fluidizing agent such as water or cream to spread the treatment on skin is notoriously well known in the art and an obvious addition.
Claims 3, 87-112, and 118-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 39, 69-70, 72, 76-81, 84, 86-87, 89-93 of US Application # 17/628,810331 in combination with the prior art references used in the 102/103 above as the Vallari references uses Spongilla in the same way as the reference application (dermatological application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both use Spongilla to treat a skin ailment with a fluidizing agent (dermal filler).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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