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 .
Response to Amendment
The Amendment filed 08/18/2025 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 05/30/2025. Applicant’s claims have been amended in the following manner: independent claims 8 and 11 reorders some of the limitations of the claim and makes minor, but scope changing edits to the claim language (e.g., introduction of the term “sunlight”), where the change in scope prompts a new ground of rejection. Overall, the scope of the claim set remains similar to what has been presented in the previous amendment, and much of the thrust of rejection remains consistent from the non-final action except addressing the term “sunlight” by modifying the rejection.
The Examiner further acknowledges the following:
Claims 8 and 11-21 are pending.
Claims 8 and 11-21 are presented for examination and rejected as set forth below.
New 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.
Claims 8 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Momoko (WO2018004006A1 – cited on IDS, 10/4/2021; machine translation provided), and in further view of Ertekin (WO2019/032059A1 - cited on IDS, 09/28/2023).
Applicant’s claims are directed to a method of applying a composition comprising a skin cell activator to the skin of a human subject, where the skin cell activator is selected from a group of substances, and exposing that composition with sunlight containing ultraviolet (UV) light (instant claim 8). Furthermore, Applicant claims a method of exposing the skin of a human subject to sunlight containing UV light through a product comprising a skin cell activator (instant claim 11).
It must be remembered that: “In determining the meaning of language present in a claim, and therefore the scope of the invention defined, the objective reach of the language of the claim presented is controlling. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the claim.”). Method claim limitations define steps or acts to be performed, product claims discrete physical structures or materials.” Thus, the preamble phrase “cosmetic method for activating skin of a human subject” doesn’t actually define a limitation beyond a method, and the method steps are as described above. Concerning the clause concerning “accelerating proliferation…of the human subject” in claims 8 and 11, remember that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).” Thus, the intended result of cell proliferation does not have weight with regard to the method claim. However, weight could be given to a method outcome in the event of unexpected results. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. The same rationale applies to newly added dependent method claims 16-17 that contain clauses that describe intended results.Momoko discloses a zinc oxide phosphor that can be used in a cosmetic, including on human skin (abstract; pg 11, lines 493-496 and pg 1, lines 20-25).
Regarding claims 8, 11, and 16-17: Momoko teaches a method of applying a composition comprising zinc oxide phosphor to skin and then exposing the skin with UV light in Use Example 1 (pg 23, lines 1026 to 1039; composition shown in Table 3). Thus, by the conditions of the prior art method, the UV light passes through the composition on the skin and continues further to reach the skin. Although the type of skin is not defined in the translation, it is obvious from the disclosure of Momoko that the zinc oxide phosphor is intended for use on human skin, since the invention seeks to solve the problem of removing impurities in zinc oxide phosphor to improve its safety for human skin application (pg 1, lines 20-25). Thus, a method of applying compositions to the human skin is a prima facie obvious use of the prior art compositions for the purpose they’ve been designed to provide. “Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.”
Furthermore, Momoko teaches that the zinc oxide phosphor is particularly suited for use in sunscreens (pg 11-12, lines 493-513), and thus, exposure of the cosmetic when topically applied to skin will then be exposed to “sunlight containing UV light.” A PHOSITA would understand that the cosmetics protect from UV light contained within sunlight. Thus, a method of applying these compositions to the skin to protect the skin from sunlight containing UV light is a prima facie obvious use of the prior art compositions for the purpose they’ve been designed to provide. “Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.”
Regarding claims 12-15: Momoko teaches a zinc oxide phosphor as part of a cosmetic preparation (Momoko – claim 6) that emits light with a longer peak wavelength (500 to 520 nm) than the incident UV light peak wavelength (365 nm) (description, pg 10, lines 436-443).
In summary, Momoko teaches a zinc oxide phosphor safe for use in a cosmetic (pg 1, lines 32-43), and a method of applying said composition on human skin for UV shielding (pg 2-3, lines 80-888) and further dosing the material while on the skin with UV light. However, Momoko does not explicitly teach sunlight comprising UV light (instant claims 8 and 11), and does not teach sunlight containing the instant UV light wavelengths (instant claims 12-15).
Ertekin teaches sunlight comprising UV light, and that topical phosphor-based compositions can protect skin from sunlight containing UV light (pg 1-2, ‘field of invention’ and ‘background of invention’). Ertekin teaches a method that when a phosphor-based sunscreen composition (reads on cosmetic) (pg 1; field of the invention; Ertekin – claim 1) is applied to skin (pg 11, line 22), the phosphor-based active ingredients convert UV radiation (such as from sunlight; pg 1, ‘background of invention’) such as between 390-490 nm (pg 8, lines 25-28) into red wavelengths such as 550-850 nm (RED region) (pg 10, lines 24-28) that are beneficial to the skin (pg 1, lines 5-9). With regard to the claimed wavelength range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). The resulting emitted light can benefit the skin (i.e., this reads on “activating skin”), including stimulation of collage and/or elastin, enhancement of DNA synthesis, improving skin texture, and repair and rejuvenation of the scars on the skin (pg 10, lines 24-35). Ertekin teaches sunlight comprising UV light, and that topical phosphor-based compositions can protect skin from sunlight comprising UV light (pg 1-2, ‘field of invention’ and ‘background of invention’).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Momoko’s method to exposing a composition on a human subject with UV light because Ertekin teaches that topical phosphor-based compositions can protect skin from sunlight containing UV light (pg 1, ‘field of invention’ and ‘background of invention’) (i.e., especially, as Ertekin teaches phosphor-based active ingredients that convert UV radiation such as between 390-490 nm into red wavelengths such as 550-850 nm (RED region) which is beneficial to the skin), and Momoko teaches zinc phosphor incorporation into sunscreens, where Momoko teaches zinc oxide phosphor as part of a cosmetic preparation (Momoko – claim 6) that emits light with a longer peak wavelength (500 to 520 nm) than the incident UV light peak wavelength (365 nm) (description, pg 10, lines 436-443).
Claims 8 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Momoko (WO2018004006A1 – cited on IDS, 10/4/2021; machine translation provided) and Ertekin (WO2019/032059A1 - cited on IDS, 09/28/2023), as applied to claims 8 and 11-17, in further view of Vinck (Lasers Med Sci, 2003).
As discussed above, Momoko teaches a zinc oxide phosphor safe for use in a cosmetic (pg 1, lines 32-43), and a method of applying said composition on human skin for UV shielding (pg 2-3, lines 80-888) and further dosing the material while on the skin with UV light, as framed in the use of sunlight exposure. However, Momoko does not teach the UV dose amount applied in the method (instant claims 18-21).
Vinck teaches that LED lights emitting 570 nm and 660 nm result in increased fibroblast production (abstract). Vinck teaches that lights of these wavelengths have possible stimulatory effects on wound healing in vivo (abstract). Vinck finally teaches that UV light of a dose of 0.53 J/cm2 (corresponds to 530 J/cm2) (red beam) and 0.1 J/cm2 (corresponds to 100 mJ/cm2) (green beam) are applied in the treatments of the study (pg 96, ‘exposure regime’). Furthermore, the used radiant exposures reach the tissue interaction threshold of 0.01 J/cm2 (corresponds to 10 mJ/cm2) (pg 97, paragraph 7).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Momoko’s method to use the UV dose described by Vinck because Vinck describes the positive effect on cell proliferation based on the reported UV doses. Momoko is only silent to the amount of UV dose provided but based on the teachings of Vinck, a dose between 10 (minimum dose for tissue interaction) and 100 mJ/cm2 (positive effects of cell proliferation appear) appears appropriate for possible stimulatory effects to improve wound healing, as taught by Vinck.
Claims 8 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ertekin (WO2019/032059A1 - cited on IDS, 09/28/2023), in further view of Momoko (WO2018004006A1) and Vinck (Lasers Med Sci, 2003).
Ertekin teaches a phosphor-based sunscreen composition that converts UV radiation to red wavelengths (i.e., RED light) which is beneficial to the skin (pg 1; field of the invention, abstract). Ertekin’s teaches topical phosphor-based compositions can protect skin from sunlight containing UV light (pg 1-2, ‘field of invention’ and ‘background of invention’).
Regarding claims 8 and 11-15: Ertekin teaches a method that when a phosphor-based sunscreen composition (reads on cosmetic) (pg 1; field of the invention; Ertekin – claim 1) is applied to skin (pg 11, line 22), the phosphor-based active ingredients convert UV radiation (such as from sunlight; pg 1, ‘background of invention’) such as between 390-490 nm (pg 8, lines 25-28) into red wavelengths such as 550-850 nm (RED region) (pg 10, lines 24-28) that are beneficial to the skin (pg 1, lines 5-9). With regard to the claimed wavelength range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). The resulting emitted light can benefit the skin (i.e., this reads on “activating skin”), including stimulation of collage and/or elastin, enhancement of DNA synthesis, improving skin texture, and repair and rejuvenation of the scars on the skin (pg 10, lines 24-35). Ertekin teaches sunlight comprising UV light, and that topical phosphor-based compositions can protect skin from sunlight comprising UV light (pg 1-2, ‘field of invention’ and ‘background of invention’).
In summary, Ertekin teaches a method of applying UV light through a phosphor-based composition applied to the skin that converts the UV light to longer wavelength light, which has benefits to the skin. However, Ertekin does not specifically teach the wavelength conversion substances of the instant claims (instant claims 8 and 11), and the UV dose applied in the method (instant claims 18-21).
Momoko teaches a zinc oxide phosphor as part of a cosmetic preparation (Momoko – claim 6) that emits light with a longer wavelength (480-540 nm) than the incident UV light (365 nm) (description, pg 10, lines 436-443). Momoko teaches application of a zinc oxide phosphor composition to the skin and exposure to UV light (365 nm) in Example 1 (pg 23, lines 1026 to 1039; composition shown in Table 3). The emission spectra of phosphors A and G from Examples 1 and 5 are seen in Figure 4 and show that emission from about 450-650 nm.
Vinck teaches that LED lights emitting 570 nm and 660 nm result in increased fibroblast production (abstract). Vinck teaches that lights of these wavelengths have possible stimulatory effects on wound healing in vivo (abstract). Vinck finally teaches that UV light of a dose of 0.53 J/cm2 (corresponds to 530 J/cm2) (red beam) and 0.1 J/cm2 (corresponds to 100 mJ/cm2) (green beam) are applied in the treatments of the study (pg 96, ‘exposure regime’). Furthermore, the used radiant exposures reach the tissue interaction threshold of 0.01 J/cm2 (corresponds to 10 mJ/cm2) (pg 97, paragraph 7).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ertekin’s method of converting UV light to longer wavelength light to benefit the skin by using Momoko’s zinc oxide phosphor composition and applying it toward a method of fibroblast growth (using the UV dose of the method) as described by Vinck because the emission wavelengths of Momoko’s compositions (phosphor A from example 1 emits about 450-650 nm per Figure 4) would result in increased fibroblast production (when exposed to 570 nm light) as demonstrated by Vinck and have possible stimulatory effects on wound healing in vivo. The selection of fibroblast production as an outcome of the method is simply a different beneficial skin result that parallels the skin benefits taught by Ertekin through the application of a phosphor-based composition to convert UV light to the RED region (defined as 550-850 nm by Ertekin). Ertekin is only silent to the amount of UV dose provided but based on the teachings of Vinck, a dose between 10 (minimum dose for tissue interaction) and 100 mJ/cm2 (positive effects of cell proliferation appear) appears appropriate for possible stimulatory effects to improve wound healing, as taught by Vinck.
The selection of Momoko’s zinc oxide phosphor as substance that converts light wavelength is simply the selection of a component known to be useful as the generic component taught by the primary reference of Ertekin, who teaches phosphor-based compositions. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because Ertekin teaches generically phosphors that convert wavelength light for use in sunscreen compositions (Ertekin – claim 1), it would be obvious to a person of ordinary skill in the art to substitute the zinc oxide phosphor composition, as described by Momoko, which is taught to convert light wavelength in the same way and is useful in topical cosmetics.
Maintained/Modified 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 8 and 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the Claims below and in further view of Ertekin (WO2019/032059A1 - cited on IDS, 09/28/2023) and Vinck (Lasers Med Sci, 2003):
Claims 1, 4, 9-13, 15-16 of copending Application No. 17601252 (reference application)
Claims 12, 14, and 17-19 of copending Application No. 17601262 (reference application)
Claims 1, 3, 5, 6, and 10-14 of copending Application No. 17601317 (reference application)
Claims 1-2, 4, 7-10, 13, and 15 of copending Application No. 17601331 (reference application)
Claims 1, 3, 5, 6, 9, 12-15, and 21-22 of copending Application No. 17601333 (reference application)
Claims 1-2, 4, and 12-14 of copending Application No. 17601347 (reference application)
Claims 1, 3, 5-6, and 9-13 of copending Application No. 17601704 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending applications teach wavelength conversion substances in combination with other components in the form of various cosmetic compositions. The copending applications do not teach a method of applying the wavelength conversion substance for a skin benefit (instant claims 8 and 11).
Ertekin teaches a method that when a phosphor-based sunscreen composition for use against UV radiation of the sun (pg 1; field of the invention) is applied to skin (pg 11, line 22), the phosphor-based active ingredients convert UV radiation such as between 390 and 490 nm (pg 8, lines 25-28) into red wavelengths such as 550-850 nm (pg 10, lines 24-28) that are beneficial to the skin (pg 1, lines 5-9). With regard to the claimed wavelength range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). The resulting emitted light can benefit the skin (i.e., this reads on “activating skin”), including stimulation of collage and/or elastin, enhancement of DNA synthesis, improving skin texture, and repair and rejuvenation of the scars on the skin (pg 10, lines 24-35).
Vinck teaches that LED lights emitting 570 nm and 660 nm result in increased fibroblast production (abstract). Vinck teaches that lights of these wavelengths have possible stimulatory effects on wound healing in vivo (abstract). Vinck also teaches that UV light of a dose of 0.53 J/cm2 (corresponds to 530 J/cm2) (red beam) and 0.1 J/cm2 (corresponds to 100 mJ/cm2) (green beam) are applied in the treatments of the study (pg 96, ‘exposure regime’). Furthermore, the used radiant exposures reach the tissue interaction threshold of 0.01 J/cm2 (corresponds to 10 mJ/cm2) (pg 97, paragraph 7).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply Ertekin’s and Vinck’s cosmetic method to the teachings of the copending application compositions. One of ordinary skill in the art would have been motivated to apply this method to provide beneficial effects to the skin (i.e., stimulate fibroblast growth). Thus, the claims of the copending applications listed above render the instant invention obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 8 and 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the Claims below and in further view of Vinck (Lasers Med Sci, 2003):
Claims 1-8 and 11-19 of copending Application No. 17/796,577 (reference application)
Claims 1-8 and 11-19 of copending Application No. 17/796,578 (reference application)
Claims 1-10 and 14-22 of copending Application No. 17/796,580 (reference application)
Claims 1-8 and 11-19 of copending Application No. 17/796,577 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending applications teach a method for applying wavelength conversion substance compositions to the skin to benefit the skin. The copending applications do not teach an increase in fibroblast and/or keratinocytes proliferation.
Vinck teaches that LED lights emitting 570 nm and 660 nm result in increased fibroblast production (abstract). Vinck teaches that lights of these wavelengths have possible stimulatory effects on wound healing in vivo (abstract). Vinck also teaches that UV light of a dose of 0.53 J/cm2 (corresponds to 530 J/cm2) (red beam) and 0.1 J/cm2 (corresponds to 100 mJ/cm2) (green beam) are applied in the treatments of the study (pg 96, ‘exposure regime’). Furthermore, the used radiant exposures reach the tissue interaction threshold of 0.01 J/cm2 (corresponds to 10 mJ/cm2) (pg 97, paragraph 7).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply Vinck’s cosmetic method to the methods of the copending applications. One of ordinary skill in the art would have been motivated to apply this method because the copending application wavelength conversion substance compositions emit in the range that would promote fibroblast production. Thus, the claims of the copending applications listed above render the instant invention obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants arguments, see pg 5-9, filed 08/18/2025, with respect to the 103 rejection of claims 8 and 11-21 under rejection have been fully considered and are not persuasive. The 103 rejection has been modified with respect to minor amendments made to the claim set.
On page 5, Applicant references US20200308482 (an English equivalent of Momoko to provide a more accurate English translation). The Examiner acknowledges this translation of the reference, but reiterates the establishment of the publication date of 1/4/2018 for Momoko (WO2018004006; published 1/4/2018) prior to the EFD of the instant application.
On page 5-7, Applicant argues that Momoko nor Ertekin teach “accelerating proliferation of skin fibroblasts and/or keratinocytes in the skin of the human subject.” The Examiner is interpreting this argument to suggest that the results of method are unexpected, since only in this context is a method outcome/result given patentable weight (refer to language in claim interpretation section of the 103). The Examiner acknowledges the results that demonstrate the method outcome (e.g., Figure 6, shows a zinc oxide film where there is a modest increase in cellular activity (80 au vs. 90 au fluorescence), that may be caused by the protective effect of the zinc oxide and/or the conversion of UV light to red light by zinc oxide, which appears a predictable outcome based on the art, as discussed below). The Examiner will clarify the interpretation for the record.
In this case, the transformation of UV light to red light is inherent to phosphor-based compositions, as taught by Momoko and Ertekin. Thus, the prior art teaches a method of applying a phosphor-based composition to the skin (which is taught to transform UV light to redder light that has skin beneficial effects), wherein the composition applied to the skin is exposed to UV light (in which sunlight is taught to comprise UV light). The positive effects of red/green light on fibroblast growth are demonstrated in Vinck. Proper rationale is provided to combine Vinck with Momoko and Ertekin. Thus, the beneficial effects of providing light of a certain wavelength are expected: note that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Consequently, we must determine whether the results obtained in the closest prior art and those set forth by Applicants are sufficiently different in kind, and not merely in degree, so as to be unexpected by a person of ordinary skill in the art at the time of invention. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (Unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree from the results of the prior art") (citation omitted).
However, patentable weight for a method of treatment (by applying a composition) can be differentiated by some other distinguishing limitation (i.e., a specific combination, range, patient or skin condition), as long as the scope is non-obvious or supported by unexpected results. Note that any amending of the method outcome with regards to additional limitations would require search/consideration. In the current form, the instant invention is obvious, the benefits of the invention are expected, and the method outcome an inherent result of applying a composition comprising the instant substance (e.g., zinc oxide phosphor).
On page 5-7, Applicant further discusses very detailed dosing effects and introduces arguments based on a new limitation based on “sunlight containing ultraviolet light.” However, Ertekin teaches sunlight comprising UV light, and that topical phosphor-based compositions can protect skin from sunlight comprising UV light (pg 1, ‘field of invention’ and ‘background of invention’). Ertekin makes obvious the relationship of topical phosphor-based compositions to protection of sunlight containing ultraviolet light, making the benefits of phosphor-based compositions directly related to sunlight-based ultraviolet light (abstract). Furthermore, Momoko teaches that the zinc oxide phosphor is particularly suited for use in sunscreens, and thus, exposure of the cosmetic when topically applied to skin will then be exposed to “sunlight containing UV light” (pg 11-12, lines 493-513) (which as evidenced by Ertekin, sunlight contains UV light (pg 1, ‘field of invention’ and ‘background of invention’)).
Additionally, the examiner notes that attacks against the teachings of the Art (especially, what Vinck teaches with respect to fibroblast acceleration translating to Applicant’s embodiment) is not supported by evidence. See, In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). Thus, the arguments are based on reasoning and principles and not fact.
Furthermore, Vinck’s dose levels (i.e., 1, 0.1, 0.53 J/cm2, or 1000, 100, and 530 mJ/cm2) overlap with the levels claimed in claims 18-21 (10-200 mJ/cm2). A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Beyond this, Applicant has not provided evidence that the levels of light dosing proposed by Vinck are different in nature from the Applicant’s light dose. Applicant points to page 97, where Vinck teaches lower irradiances are confirmed by other experiments to be more effective, which provides motivation for a PHOSITA to optimize light irradiation levels, and speaks to the obviousness of the claim limitations. Finally, Vinck teaches the used radiant exposures reach the tissue interaction threshold of 0.01 J/cm2 (corresponds to 10 mJ/cm2) (pg 97, paragraph 7). Thus, Vinck teaches the encompassing range of light dosing required to accelerate fibroblast proliferation (title, abstract).
On page 6-7, Applicant argues that Vinck teaches the need for further study to explain the mechanisms. This is not relevant to establishing patentability of a method. Methods could be patentable with no known knowledge of mechanism. Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310, 115 USPQ2d 2012, 2023 (Fed. Cir. 2015) ( "Only a sufficient description enabling a person of ordinary skill in the art to carry out an invention is needed.")." Furthermore, this statement does not invalidate Vinck’s own words and what they teach to a PHOSITA: “LED and LLL irradiation resulted in an increased fibroblast proliferation in vitro. This study therefore postulates possible stimulatory effects on wound healing in vivo at the applied dosimetric parameters” (abstract). In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The art does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner. Finally, Applicant appears to suggest that PHOSITA would not have a reasonable expectation of success in producing the instant invention. Note that “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).”
On page 7, Applicant argues importance of irradiance, and describes the relationship between irradiance and dose. Note that the dose levels recited by Vinck make the dose limitations of claims 18-21 obvious (see response to arguments regarding this and 103, above), regardless of the relationship between irradiance and dose.
On page 8, Applicant argues that Vinck requires a special device such as LED or LLL to achieve the effects demonstrated therein. This argument is not found convincing because it is the light dosing that leads to the effect (i.e., and not where the light originates from) that is important for the effect on cells. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. A PHOSITA would have recognized, at the time of filing, the red light shift of UV irradiation (as occurring by the sun/UV protection compositions of Momoko and Ertekin), and the fibroblast benefitting effects of light exposure in Vinck, and come to the same conclusions as explained by the Applicant.
On page 8-9, Applicant will address provisional rejects at a later time, which is acceptable.
Correspondence
Applicant's amendment necessitated the new ground 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 extension fee 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 date of this final action.
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/R.P./Examiner, Art Unit 1614 9/24/2025
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614