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 .
Applicants’ arguments, filed 12/15/2025, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1) Claims 1-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ignon et al. (US 2018 / 0318568 A1, publication date 09/08/2018) and Sakai et al. (JPH11116436A, publication date 04/27/1999; citing English machine translation) in view of Lim et al. (Scientific Reports, 2018, issue 8, article 16154).
Ignon concerns a device and method of treating skin [title]. The device used in the methods comprises a one or more abrasive features to exfoliate the skin [0053], a rollerball to facilitate the delivery of one or more fluids [0057], and a vacuum or suction source (i.e., hydradermabrasion device according to instant specification at para. 38; instant claim 5, 6, 16 and 18) [0062]. Fluids administered by the device may include salicylic acid and anti-acne agents (i.e., to treat acne/treatment to improve skin texture; instant claim 2 and 14) [0056]. According to Ignon salicylic acid is an exfoliating agent (i.e., instant claim 4) [p. 11, Table 1, line 1].
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In one embodiment, illustrated by figure 4 [p.4], Ignon discloses a device which comprises an abrasive tip 422 [0072] coupled to a vacuum source [0071]. When the vacuum of suction is activated, “skin located within an interior of the peripheral lip 424 of the tip 420 can be at least partially drawn into toward the assembly to facilitate and / or enhance contact between the rollerball 444 and the skin surface. Also, as noted herein, such embodiments that utilize suction can help deliver or enhance the delivery of fluids from the cartridge or other fluid source 440 to the tip. Further, as discussed in greater detail herein, the peripheral lip 424 and / or any other member (e.g., one or more interior members or portion of the tip, such as, posts, other cylindrical members, spiral members, abrasive pads and / or the like) can be used to at least partially abrade skin tissue as the tip is moved relative to a targeted skin surface” [0071]. In other words, the suction draws the skin into contact with the roller ball (i.e., fluid delivery mechanism) and the surface of 422 (i.e., abrasive exfoliant), thereby administering the steps of exfoliating, suction and fluid delivery simultaneously (i.e., instant claims 3 and 15). Additionally, Ignon discloses that in some embodiments the vacuum or suction source assists in drawing waste, such as exfoliated skin and other debris, away from the skin surface during a treatment procedure (i.e., cleansing the skin by suction; instant claim 1 and 13) [0083]. Finally, Ignon discloses a method of treating a skin surface which comprises treatment using a handpiece (device) disclosed by Ignon [p. 16, claim 1).
Ignon does not discloses administering a topical formulation comprising erythritol and zinc.
Sakai discloses a composition useful in the treatment of acne with excellent pimple treatment effect comprising erythritol, an anti-inflammatory component (i.e., instant claims 12 and 19), and antimicrobial agent and additional compounds, such as salicylic acid (i.e., instant claims 11 and 20) and zinc [abstract].
Sakai does not disclose an erythritol:zinc ratio of 3:1.
Lim relates to the antibacterial activity of zinc in combination with erythritol and discloses practical applications such as toothpastes (i.e., topical cosmetic composition) [p. 4, Discussion, first paragraph]. Specifically, Lim discloses that zinc chloride and erythritol complexes, at a molar ratio of 1:3, are able to penetrate biofilms and kill bacteria [p. 4, Discussion, first paragraph] and this combination may have great potential to be extensively used in a variety of practical application [p. 4, Discussion, first paragraph].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the anti-acne composition of Sakai with the device and methods of Ignon, because Ignon desires an anti-acne agent. One would have been motivated to combined these prior art elements to provide the excellent pimple treatment effect of Sakai in the anti-acne liquid called for by Ignon. One would have had an expectation of success because the Ignon specifically calls for an anti-acne fluid comprising a combination of components.
With respect to molar ratio of erythritol and zinc, one would have been motivated to provide the erythritol and zinc of Sakai in a 3:1 molar ratio to achieve the antibacterial affects disclosed by Lim, thereby achieving the antimicrobial activity Sakai desires. One would have had an expectation of success because Lim and Sakai both relate to topical cosmetic compositions.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have it reached a method of both treating a skin condition (acne) or improving appearance of skin (skin texture) by applying a salicylic acid (chemical exfoliant) and simultaneously mechanically rubbing the skin to exfoliate an area, cleansing the area with suction and applying a topical formulation comprising erythritol and zinc at a molar ratio of 3:1 to the area. Furthermore, it would have been obvious to have performed the method with a hydradermbrasion device.
Regarding instant claims 7-10, in the example composition Sakai discloses the composition may comprise lanolin, glycerin, cetostearyl alcohol (i.e., cleansing ingredient according to instant claim 8; instant claims 7 and 8) [p. 8 last paragraph] as well as cetyl alcohol and propylene glycol (PG) (i.e., moisturizing ingredients according to instant claim 10; instant claims 9 and 10) [p. 9, first paragraph].
Given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art, at the time of filing, and following the teachings of Sakai to have selected and combined known components for their established functions with predictable results. MPEP 2143 and 2144.06(I). Therefore it, would have been obvious for one of ordinary skill in the art, at the time of filling, to have included a cleansing ingredient, such as lanolin, glycerin or cetostearyl alcohol, as well as a moisturizing ingredient such as cetyl alcohol or propylene glycol.
2) Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ignon et al. (US 2018 / 0318568 A1, publication date 09/08/2018) and Sakai et al. (JPH11116436A, publication date 04/27/1999; citing English machine translation) in view of Lim et al. (Scientific Reports, 2018, issue 8, article 16154) as applied to claims 1-16 and 18-20 above, and further in view of Saphire Advanced Aesthetics (Saphire) (Make The Most Of Your HydraFacial, 9/29/2020 [retrieved 6/6/25]. https://www.sapphireadvancedaesthetics.com/2019/01/25/make-the-most-of-your-hydrafacial/#:~:text=If%20you%20would%20like%20to,the%20temples%2C%20midface%20and%20jawline.) and Krause et al. (TW 201805008 A, publication date 02/16/2018; citing English machine translation).
Ignon, Sakai and Lim, which are taught above, differ from the instant claims insofar as they do not teach administering dermal filler comprising erythritol and zinc at a molar ration of 3:1.
Saphire discloses a method of brightening skin by removing skins cells that are responsible for dull complexion (i.e., improving appearance of skin according to instant claim 14) by a HydraFacial process (i.e., hydradermabrasion according to instant specification at paragraph 38) [p. 2, para. 3]. Saphire also discloses that anti-aging benefits of the HydraFacial are maximized by adding a dermal filler treatment [p. 3, para. 3].
Saphire does not disclose a dermal filler comprising erythritol and zinc.
Krause discloses a hyaluronic acid skin filler (i.e., dermal filler) composition [p. 3 first full paragraph] which may further comprise polyols and mineral salts such as zinc salts [p. 17, second to last paragraph]. According to Krause suitable polyols include erythritol in amounts from 0.1 – 25% v/v [p. 18, para. 2].
Krause does not disclose a molar ratio of 3:1 for erythritol and zinc.
Lim relates to the antibacterial activity of zinc in combination with erythritol [p. 4, Discussion, first paragraph]. Specifically, Lim discloses that zinc chloride and erythritol complexes, at a molar ratio of 1:3, are able to penetrate biofilms and kill bacteria [p. 4, Discussion, first paragraph] and that this combination may have great potential to be extensively used in a variety of practical application [p. 4, Discussion, first paragraph].
Lim is relevant prior art because Lim and the instant application both concern cosmetic compositions.
Firstly, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the hydradermabrasion methods disclosed by Ignon, Sakai and Lim with the method of administering a dermal filler because Saphire discloses it is advantageous to do so.
Secondly, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected the dermal filler disclosed by Krause because generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
Finally, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have provide the erythritol and zinc of Sakai in a 3:1 molar ratio to achieve the antibacterial affects disclosed by Lim. One would have been motivated to do so to obtain the desirable effect of anti-bacterial activity. One would have had an expectation of success because Krause discloses a broad range of acceptable concentrations of erythritol.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have to further administered a dermal filler comprising erythritol and zinc at a molar ratio of 3:1.
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.
Claims 1-9, 11-16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11517578 B1 in view of Ignon et al. (US 2018 / 0318568 A1, publication date 09/08/2018).
The claims of ‘578 disclose a method a ameliorating acne (i.e., improving skin texture) in a subject comprising administering a composition comprising erythritol and zinc at a molar ratio of 3:1 [claim 1; instant claims 1, 2, 13 and 14]. The composition may further comprise benzoyl peroxide [claim 3; instant claim 11 and 20]. The claims also disclose a composition comprising a moisturizer (instant claims 9 and 19), an emollient [claim 4; instant claims 12] and a fragrance (i.e., perfume; instant claims 7 and 9) [claim 8].
The claims of ‘578 do not disclose exfoliating or cleansing by suction.
Ignon discloses a method a treating an area of skin comprising abrasive features to exfoliate the skin (i.e., hydradermbrasion device according to instant specification at para. 38; instant claim 5, 6, 16 and 18) [0053], a rollerball to facilitate the delivery of one or more fluids [0057], and a vacuum or suction source [0062]. Fluids administered by the device may include salicylic acid and anti-acne agents (i.e., to treat acne/treatment to improve skin texture; instant claim 2 and 14) [0056].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. Therefore, it would have been obvious to have administered the treatment of Ignon with the composition of the claims of ‘578 because Ignon desires an anti-acne composition. Additionally, the claims of ‘578 teaches the components of the instantly recited topical composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment. However, given the disclosure of each component individually, it would have been prima facie obvious to combine them.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have it reached a method of treating a skin condition (acne) or improving appearance of skin (skin texture) by applying a salicylic acid (chemical exfoliant) and simultaneously mechanically rubbing the skin to exfoliate an area, cleansing the area with suction and applying a topical formulation comprising erythritol and zinc at a molar ratio of 3:1 to the area. Furthermore, it would have been obvious to perform the method with a hydradermbrasion device.
Response to Arguments
1) On page 7 of their remarks, Applicant argues that none of the cited references teach or suggest “both (i) a hydradermabrasion-type delivery sequence
involving abrasion and suction, and (ii) a chemically defined formulation that is
specifically compatible with such delivery” and more specifically that the primary reference, Ignon, does not teach or suggest Applicant’s formulation.
This argument is not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, even though Ignon is directed to a hydradermbrasion device, Ignon nevertheless desires skin care and skin treatment compositions. From the disclosure of Ignon, these compositions are not particularly limited. See, for example Ignon at paragraph 56 (page 4):
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Furthermore, Ignon does not set forth specific requirements for formulations comprising the agents listed in paragraph 56. Thus, one of ordinary skill in the art would have understood the composition of Sakai for treating acne (Sakai at the abstract) to fall within the scope of the formulations desired by Ignon.
2) On page 8 of their remarks, Applicant argues that Lim is non-analogous art because a skill artisan would not reasonably look to oral biofilm research to solve problems associated with skin treatment following mechanical exfoliation and suction.
This argument is not persuasive. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Lim is relevant because it addresses the particular problem with which the inventor was concerned; penetrating the biofilm and ameliorating bacterial growth. See, for example the instant specification at paragraph 12: “There is a need for more effective reduction, negation, and elimination of biofilm. The compositions and methods described herein provide safe and effective means of penetrating biofilm and ameliorating bacterial growth. Accordingly, aspects of the invention include formulations and methods that utilize erythritol and zinc for reducing, negating and eliminating the formation of biofilm to treat skin conditions and improve the appearance of one’s skin” (emphasis added).
3) On pages 8-9 of their remarks, Applicant argues that the combination of references is based on impermissible hindsight. Specifically, applicant asserts that nothing in the prior art suggests that: zinc should be added to Sakai’s formulation, zinc should be added at a specific 3:1 erythritol:zinc molar ratio or such formulations would be compatible with the abrasion- and suction-based skin treatment.
This argument is not persuasive. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, Sakai suggests zinc [abstract] and desires an antibacterial component [0006]. Lim discloses the specific ratio of 3:1 erythritol:zinc demonstrates improved antibacterial effects [abstract & conclusion]. Ignon, discloses a device and desire anti-acne agents and materials [abstract & 0056]. Therefore, the combination of references does not rely on impermissible hindsight because it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made.
4) On page 9 of their remarks, Applicant asserts the 3:1 molar ratio of erythritol:zinc unexpectedly: enhances skin hydration following exfoliation and suction, reduces irritation and improves skin tolerance relative to zinc-rich formulations, maintains formulation stability during vacuum assisted delivery and improves anti-inflammatory performance in abraded skin. Applicant cites the attached declaration of John H. Joseph filed 12/15/2025 to support the assertion of unexpected results.
This argument is not persuasive. “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). In the present case the declaration is lacking in probative value insofar as it does not present evidence and/or data demonstrating that the inventions operates in an unexpected manner. See MPEP 716.01(C).
The closest support the Examiner is able to find for the alleged unexpected results in the declaration is at paragraphs 8-9, 15, 16 and 19-20. However, these paragraphs (and the declaration as a whole) do not disclose enhanced skin hydration following exfoliation and suction, reduced irritation and improves skin tolerance relative to zinc-rich formulations, formulation stability during vacuum assisted delivery and improves anti-inflammatory performance in abraded skin when the molar ratio of erythritol to zinc is 3:1, much less that these are unexpected results.
With respect to the specific claims of unexpected results:
With respect to the alleged unexpected result of enhanced skin hydration following exfoliation, the declaration discloses “[e]rythritol is included as one of many sugar alcohols. Sugar alcohols are often used in skincare formulations as hydrating and moisturizing agents. Sorbitol, for example, is commonly used as a thickener to improve the texture of formulations” [para. 16]. The declaration discloses erythritol is a sugar alcohol which are often used as hydrating agents, but does not disclos that the specific molar ratio of erythritol:zinc of the instant claims results in an unexpected improvement to the hydration.
With respect to the alleged unexpected result of reduced irritation and improved skin tolerance relative to zinc-rich formulations, the declaration discloses “[t]he safest approach is to use non-antibiotic antimicrobial and anti-inflammatory actives (e.g., erythritol-zinc). Moreover, nonantibiotic antimicrobials present several advantages (e.g., less irritation, fewer side effects, no resistance)” [para. 7]. In addition to lacking probative value, this does not appear to be unexpected in view of the prior art. Lim, for example, discloses “the results of this study identified a means of dramatically improving the efficacy of zinc chloride without increasing its toxicity. This was made possible by weakening the internal interactions between exopolysaccharides in biofilms, which are an obstacle to the action of zinc chloride, without directly improving bactericidal activity. This approach allowed us to avoid toxicological issues that would typically be concomitant with an increase in efficacy. Another important point is that because no chemical synthesis process is required, no additional toxicological problems can arise from by-products and residual reactants. Therefore, the results in this study can be applied to humans without concern for unpredictable toxicity. In conclusion, the described method for effectively removing mature biofilms using zinc chloride and erythritol may have great potential to be extensively used in a variety of practical applications” [p. 6, para. 2]. One of ordinary skill in the art would have understood that the 3:1 erythritol:zinc ratio of Lim allows for the reduction of zinc in composition with a concomitant reduction in toxicity (i.e., irritation) while maintaining the same level of antibacterial activity.
With respect to the alleged unexpected results of composition stability under vacuum, the closest support the Examiner is able to find in the declaration is at paragraphs 19-20:
“Lim's complexes are designed to adhere to oral biofilms, not to treat skin conditions. Lim is directed exclusively to oral-care biofilm disruption and to formulations such as toothpaste and mouthwash. Lim's surfactant and agent compatibilities are optimized for toothpaste vehicles, not dermal formulations. Moreover, oral and cutaneous biofilms differ in pH, hydration, enzymatic content, and structure.
One skilled in the art (e.g., a dermatologist or cosmetic health professional) would have no reason to apply an oral-care ratio to a dermatological hydradermabrasion system. As noted above, the present claims address topical skin treatment, acne and inflammation mitigation, and compatibility with hydradermabrasion devices, which are problems fundamentally different from those addressed in Lim.”
Here the declaration appears to argue that Lim is non-analogous art, which is addressed above, but does not directly address stability under vacuum. However, the declaration does appear to be asserting that one would not have expected the zinc:erythritol to be effective against C. acnes because Lim is exclusively directed to oral S. mutans, and cutaneous biofilms differ in pH, hydration, enzymatic content, and structure. In addition to lacking probative value, this assertion, in view of the prior art, does not appear to establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (MPEP 716.02(b)). Lim, for example, discloses “regardless of pH, the tendency for significantly increased antibiofilm activity when zinc was combined with erythritol was consistent” [p. 3, para. 1]. Additionally, Lim proposes that cationic complexes of zinc and erythritol “may have been transferred into biofilms containing anionic components, such as bacterial lipids, by electrostatic interactions. It is also presumed that zinc chloride and erythritol may accumulate in biofilms and efficiently act to weaken the cohesion of exopolysaccharides, allowing zinc chloride to penetrate biofilms and have an antimicrobial effect, even against mature biofilms” [p. 5, para. 6]. Finally, Lim discloses that “the described method for effectively removing mature biofilms using zinc chloride and erythritol may have great potential to be extensively used in a variety of practical applications” [p. 6, para. 2]. Therefore, one of ordinary skill in the art would have expected the erythritol:zinc of Lim to be effective against other biofilms because it is not impacted by pH and the proposed mechanism of action would not have been expected to be limited to only S. mutan biofilms.
With respect to the alleged unexpected result of improved anti-inflammatory performance in abraded skin, the declaration discloses “The present invention includes the use of a erythritol :zinc chloride mixture to at a specific ratio (3:1 of erythritol to zinc) in combination with microdermabrasion. Benefits include, for example, reductions in C. acnes, erythema, pustules, post inflammatory papules and inflammation/redness. The erythritol:zinc combination can be particularly beneficial to patients with (a) acne lesions that rupture during treatment, (b) oily or congested skin and (c) those prone to folliculitis” [para. 8]. The declaration also discloses “zinc in its various forms (i.e., salts), is commonly used in topical formulations. it has been used to proposed for treating infections, inflammatory dermatoses and pigment disorders. As noted above, it has some biocidal activity” [para. 17]. The declaration discloses the erythritol :zinc chloride mixture to at the molar ratio of 3:1 has benefits, including reductions in inflammation, but does not indicate such a benefit is an unexpected result of erythritol:zinc at a molar ratio of 3:1.
The paragraphs discussed above, and the declaration as a whole, do not disclose that the results are unexpected, nor do they provide objective evidence to support the assertion of unexpected results. Therefore, the Examiner respectfully disagrees with the assertion of unexpected results because the declaration is lacking in probative value, and the Examiner is unable to determine if the results are truly unexpected.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612