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 Amendments
Applicant’s amendments to the claims of March 30, 2026, in response to the Office Action of December 31, 2025, are acknowledged.
Response to Arguments
Applicant argues that the claims do not tie up any nature-based product and therefore the analysis should end. Applicant argues that the concentrations of components when viewed as a whole are self-evident, thereby concluding the eligibility analysis. Applicant cites M.P.E.P. 2106.06.
The examiner finds these arguments persuasive and withdraws the § 101 rejection.
With regard to the traversal of the § 103 rejection, the examiner responds.
The primary reference provides each of the claimed components with the exception of beta-glucan and water. As noted below, the examiner believes that a POSA would understand the primary reference to include embodiments comprising water. Beta-glucan is taught to treat wounds and burns, among other conditions, in a secondary reference. The examiner’s rejection is expounded on below in the context of Applicant’s traversal. The examiner notes that a prima facie showing is established and unexpected results have not been alleged and shown.
Applicant argues that the prior art does not teach or suggest at least 50% water. Applicant also argues that the concentration of vitamin D3 claimed is higher than that taught.
The examiner notes that each of the cited prior art references include forms that are known include at least about 50% water, such as a cream. As evidenced by Barnes et al., “Vehicles for Drug Delivery and Cosmetic Moisturizers: Review and Comparison,” Pharmaceutics 2021, 13, 2012: lotions generally contain 75-85% water, creams include 45-80% water. Further, according to McDonald, “What's The Difference Between An Ointment, A Cream And A Lotion?,” Vanderbilt University Medical Center, December 22, 2008, the following was explained:
Answer: Ointments, creams and lotions are different ways to formulate over-the-counter products or medicines. An ointment is 80 percent oil and 20 percent water. A cream is 50 percent oil and 50 percent water. A lotion is similar to a cream but it's an even lighter or less thick formulation. Any of these can be used with different over-the-counter products or drugs, depending on whether your skin is dry or oily. And so you want to ask your dermatologist if you have a prescription medication, which of these formulations is best for you.
While there may be some nuance with regard to the exact percentage of water required in a cream, lotion, ointment, or even a gel, it appears clear from the prior art that the use of a cream and lotion and other forms that contemplate a concentration of water that includes about 50 to 80% is contemplated. Martinsen describes gels, creams, lotions, and ointments; Kurhts contemplates creams, gels, solutions, and ointments; and Klein describes creams, gels, and lotions. Consistent with the above, Klein teaches a cream that can have at least about 50% water content.
Moreover, Martinsen does teach non-aqueous vehicles can be used. Martinsen also teaches the use of any pharmaceutical or standard carrier, including buffered solutions at physiologic pH are also taught. Further, food grade and pharmaceutical grade carriers, diluents and others can also be used. See par. 58. In context, the reference to gels, lotions, ointments, and creams and the ability to use any food or pharmaceutical carrier or diluent would be interpreted by a POSA to include substantial concentrations of water as is traditionally the case for creams, lotions, gels, e.g. Even further, DHA and EPA as well as other claimed components are taught for use in aqueous formulations by secondary references.
The examiner also notes that while the concentration of vitamin D3 taught by the prior art is lower than that claimed, the instant claims include 0.005% vitamin D3, which is also a trace amount of vitamin D3. Thus, both compositions comprise substantially less than 1/10th of one percent of vitamin D3. Additionally, vitamin D3 is a result-effective variable that can be optimized through routine experimentation. A deviation of less than 1% is not considered a critical distinction without a showing of a criticality.
Applicant argues that Kuhrts describes 0.1 to 94.9% water in a solution form and not a cream or lotion. Applicant argues that creams, ointments, and lotions are less satisfactory to consumers and this is a teaching away. Applicant argues that the claimed combination is non-obvious and not taught together.
The examiner notes that Kuhrts teaches formulations for delivery as an emulsion, cream, lotion, or ointment, and in other forms. See par. 58. Kurhts does not provide a teaching away of forms that are specifically contemplated. Further, Kurhts teaches using broad concentrations of water with a purpose being to increase the water solubility of EPA and DHA. Klein teaches the claimed concentration of water in the form of a cream or gel for topical administration. For a cream, the water content is 50%-70%. For a gel, the water content is above 80%. See prior art claim 15. Klein teaches topical compositions in form of a cream for application to the skin to cleans, moisturize, sooth and treat injuries (including wounds and burns), wherein the composition comprises 0.5 to 15% beta-glucan. In one example a cream is described with 0.5 to 15% beta-glucan and at least 50% water. See col. 4, line 63.
Martinsen also teaches treating burns, sores, wounds, skin damage, and numerous conditions while Klein teaches treating burns and wounds of the skin and mucosa. Thus, beta-glucan and water are each taught at claimed percentages and would be considered usable for a same purpose and combined with a composition having a similar/identical use. According to M.P.E.P. § 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
With regard to new claim 70, there is no requirement in any of the references that propylene glycol be included. Martinsen mentions propylene glycol in one instance as one of a number of usable vehicles. Propylene glycol is mentioned in Kurhts and Klein as an optionally usable vehicle.
With regard to the traversal of the DP rejection over 11,903,978, the ‘978 patent is directed to a cream or lotion, which would be interpreted by a POSA to include at least about 50% water. Further vitamin D3, EPA and DHA at claimed ratios, melatonin up to 100 mg (claim 3), and a low percentage of fatty acid being as low as 15% is claimed. The instant claims require 14% fatty acids. In view of the cited prior art, a glucan at a claimed percentage would be included as it is an API that provides specific benefits when topically applied as a cream also for treating wounds, sores, and burns. The claims of the ‘978 patent also include a claimed ratio of EPA:DHA. While the claims of the ‘978 patent are more specific in some ways, they include DHA:EPA at claimed ratios, melatonin, vitamin D3, a claimed amount of water (i.e., a lotion, cream, ointment). Klein provides a motivation to include beta-glucan and the claimed amount of water.
With regard to the traversal of the provisional DP rejection over copending application 18/864,389, the examiner notes that the claims of the ‘389 patent and the instant claims include the same components with overlapping percentages. Applicant argues that this rejection can be withdrawn if it is the remaining rejection. At the moment, this is not the only remaining rejection.
As such, the Double Patenting Rejection is maintained.
Suggestions for Allowance:
The examiner encourages Applicant to reach out in an effort to further prosecution of the instant application. In particular, the incorporation of some specific components recited in the Example 1 provided in the Specification may be helpful.
Status of the Claims
Claims 1, 9, 18, 22, 25, 29, 30, 34, 35, 43, 45, 51-53, 56, 58-60, 62-64, 67, and 70 are pending. Claims 18, 22, 25, 29, 30, 35, 43, 45, 51-53, 56, 58-60, 62-64, and 67 are preliminarily withdrawn. Claims 1, 9, 34, and 70 are examined.
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.
Claims 1, 9, 34, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Martinsen et al., (EP3257506A1) (cited in ISR), in view of Kuhrts (US2011/0054029), and in view of Klein et al., (U.S. Pat. No. 5,980,918).
Martinsen teaches compositions comprising DHA and EPA in the forms of topical creams and ointments, e.g. See par. 23. The ratios of DHA:EPA include 2:1 to 1:2, which includes a 1:1 ratio. See par. 22. Further, the oils can come from a fish and can be purified. See par. 34. Omega-3 fatty acids can be in a concentration of 15 to 35%, including discrete amounts of 24% and 25%. See par. 45. Further, a vitamin including D3 can be used and it can be used in a concentration of 25 to 200 IU/ml oil. See par. 49. Even further, melatonin can be incorporated into the composition and it can be used in a concentration of as low as 0.1 mg to 100 mg. See par.’s 52 and 53. Other additives that can be used include beta-glucan. See par. 55.
Martinsen does not explicitly teach using 50-80% water.
Kuhrts teaches a formulation that can be administered topically, which comprises EPA, DHA, or a mixture thereof. See prior art claims 1, 5, and 13. The fatty acid concentration can be at least 20% or from 5 to 60%. See prior art claim 14. Further, the amount of water can be as high as 94.9% and almost no water is required. Water can range from 15 to 75%. See prior art claim 22. The fatty acid can be derived from a fish source. See prior art claim 15. Formulations can include emulsions, lotions, creams, and gels. See par. 58.
Kuhrts does not teach the percentage of beta-glucan.
Klein teaches topical compositions in form of a cream for application to the skin to cleans, moisturize, sooth and treat injuries, wherein the composition comprises 0.5 to 15% beta-glucan. See Abstract. The amount of water in the composition can be about 80%. See col. 2, line 27. In one example a cream is described with 0.5 to 15% beta-glucan and at least 50% water. See col. 4, line 63.
It would have been prima facie obvious to a person having ordinary skill the art prior to the filing of the instant application to combine the teachings of Martinsen, Kuhrts, and Klein. One would be motivated to do so because they each teach topical application of compositions comprising the claimed components at concentrations that overlap those claimed. Martinsen teaches a composition comprising the claimed components while Kuhrts teaches topical compositions comprising high concentrations of water including DHA and EPA derived from fish oils. Further, Klein teaches topical compositions comprising the claimed percentage of beta-glucan and a claimed percentage of water. Each of these references teach emulsions, creams, and/or lotions. As such, it would be obvious to arrive at the composition taught by Martinsen with the claimed concentrations of beta-glucan and water for use in topical application to a subject in a claimed form with a reasonable and predictable expectation of success. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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, 3, 7, 9, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Pat. No. 11,903,978, in view of Martinsen et al., (EP3257506A1) (cited in ISR), in view of Kuhrts (US2011/0054029), and in view of Klein et al., (U.S. Pat. No. 5,980,918).
The claims of the ‘978 patent are directed to a cream or lotion comprising melatonin, DHA, EPA, vitamin D3, and includes the claimed ratios of fatty acids and the use of fish as a source of oil. In view of the prior art cited above, the use of a claimed percentage of water and beta glucan would be contemplated. The prior art teaches the components claimed in the ‘978 patent including claimed concentrations of water and beta-glucan with all other components accounted for. As such, one would arrive at the instant claims in view of those of the 978’ patent and cited prior art.
Claims 1, 3, 7, 9, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 9-10, and 34 of copending Application No. 18/864,389.
The claims of the ‘389 application are directed to a composition comprising water, vitamin D3, melatonin, EPA, DHA, and beta-glucan. The percentages overlap and/or are similar. The distinction over the instant claims is a different concentration of components, which can be optimized through nothing more than routine experimentation. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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