DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed August 15, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-21 are pending.
4. The declaration of Dimitrios Tsakouridis, filed August 15, 2025, has been received and considered.
Election/Restrictions
5. In the reply filed on November 13, 2024, applicant elected Group I, now claims 1-13 and 15-21, and species (i) a composition of peanut oil, olive oil, castor oil, and lanolin without traverse.
6. Claims 3 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. It is noted that applicant requests the search and examination of claim 3. However, claim 3 is withdrawn because it requires the presence the non-elected species rose oil and phytosterols. MPEP section 802.03 states “The prior art search will not be extended unnecessarily to cover all nonelected species.” Since claim 3 requires non-elected species, the search would need to be extended to cover these nonelected species which is directly in contrast with the guidance of the MPEP.
7. Claims 1, 2, 4-13, and 15-21 are examined on the merits solely in regards to the elected species.
Claim Rejections - 35 USC § 112
8. Claims 1, 2, 4-13, and 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because the scope of the claim is unclear. Claim 1 states that it is drawn to a composition of “natural substances consisting of…”. This phrasing implies that other ingredients can be included in the composition as long as they are not “natural” substances. This interpretation of the claimed scope appears to be the most consistent with dependent claims 6, 8, and 9 which require the composition of claim 1 to be formulated into topical formulations such as creams, ointments, gels and plasters that would need the inclusion of additional ingredients such as emulsifiers, gelling agents, or bandages to achieve these forms. However, claim 5 states that the castor or olive oil can be ozonated which is defined by applicant in claims 20 and 21 as being non-natural forms of these oils. Thus, the intended scope of the claims is unclear because it is unclear if non-naturally occurring ingredients are included in the composition. Since this appears to be the interpretation consistent with the majority of the dependent claims, this interpretation will be used for examination.
Claim Rejections - 35 USC § 101
9. Claim 1, 2, 4-8, 10-13, 20 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more for the reasons set forth in the previous Office action.
All of applicant’s arguments regarding this ground of rejection have been fully considered but are not persuasive. Applicant argues that the claimed invention is directed to patent eligible subject matter due to the presence of markedly distinct characteristics. Applicant argues that the claimed composition “is shelf stable for up to 24 months without preservatives and is clinically proven to be effective in treating psoriasis…”. Applicant argues that the specification and the declaration of Dimitrios Tsakouridis provide evidence to support these assertions of markedly distinct characteristics. However, the compositions stated in the specification and in the declaration to have these characteristics are not of the same scope as the claimed invention. The declaration states that the composition which demonstrates the markedly distinct characteristics contains peanut oil, castor, oil, olive oil, avocado oil, lanolin, phytosterol, and rose oil in specific amounts. In addition, the specification states that the compositions at Tables 1-6 display these characteristics. Table 1 requires peanut oil, castor oil, olive oil, avocado oil, lanolin, and phytosterol in specific amounts. Table 2 is the same embodiment as in the declaration. Table 3 requires peanut oil, ozonated castor oil, ozonated olive oil, lanolin, avocado oil, and phytosterol in specific amounts. Table 4 requires peanut oil, castor oil, olive oil, lanolin, and rose oil in specific amounts. Table 5 requires peanut oil, castor oil, olive oil, lanolin, and rose water in specific amounts. Table 6 requires peanut oil, ozonated castor oil, ozonated olive oil, lanolin, avocado oil, phytosterol, and rose oil in specific amounts. Each of these embodiment requires ingredients which are not required in the claims. The claims only require the presence of peanut oil, castor oil, olive oil, and lanolin. All other ingredients are optional. In addition, the claims are not limited to the amounts used in the embodiments. Thus, any showing of markedly distinct characteristics is not of the same scope as the currently claimed invention. Therefore, applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 102
10. Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lipi (US 6,383,499).
Lipi teaches a composition which comprises castor oil, peanut oil, olive oil and lanolin (see claims). The reference teaches that the ingredients are natural (see column 1, line 66-column 2, line 1).
Claim Rejections - 35 USC § 103
11. Claim(s) 1, 2, 4-13, 15-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiba (US 4,325,965).
As discussed above in paragraph 8, claim 1 is considered to be open to the inclusion of non-natural ingredients.
Chiba teaches a topical composition for the treatment of psoriasis. The reference teaches that the active ingredient is delta-tocopherol and is combined with carriers that can be olive oil, peanut oil, castor oil, and lanolin. The reference specifically states that while delta-tocopherol is a required ingredient, the delta-tocopherol is preferably synthetic (see column 2, lines 10-11 and 30-46). Thus, the required delta-tocopherol is not considered to be excluded by the scope of claim 1.
The reference teaches that the composition can be in the form of a cream or ointment (see column 2, lines 30-46). The composition is applied to the skin and then covered with a wrap (see column 3, lines 43-45). This is considered to read on a “medicinal plaster”.
The reference does not explicitly teach an embodiment with peanut oil, olive oil, castor oil, and lanolin. However, as discussed above, the reference does teach that these ingredients are suitable for use in the composition. Therefore, an artisan of ordinary skill would reasonably expect that a combination of these four ingredients would be useful in formulating the composition taught by the reference. This reasonable expectation of success would have motivated the artisan to modify the reference to include a formulation with peanut oil, olive oil, castor oil, and lanolin.
The reference does not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The reference teaches the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The reference does not teach that the ingredients are obtained as claimed by applicant in claim 4. However, regarding product-by-process claims, note that MPEP § 2113 states that:
[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate…A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)… Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
The prior art ingredients appear to be the same as the claimed ingredients. Furthermore, peanut, olive, and castor oils are typically obtained by mechanical pressing of the source material.
The reference does not teach that the composition is applied two or three time a day. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Response to Arguments
All of applicant’s arguments regarding Chiba have been fully considered but are not persuasive. Applicant argues that delta-tocopherol as required by Chiba is excluded from the claims. However, as discussed above, non-natural ingredients are not considered to be excluded. Chiba specifically states that the preferred delta-tocopherol is synthetic. Thus, the reference is still considered to teach the claimed invention.
12. Claim(s) 1, 2, 4, 6-13, and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Body Beautiful Massage Lotion” (https://web.archive.org/web/20170312192612/http://www.baar.com/body-beautiful-massage-lotion - web archived version from March 12, 2017) in view of “Using Castor Oil for Massage Benefits” (balancespaboca.com/2014/05/06/using-castor-oil-for-massage-benefits/ - May 6, 2014).
“Body Beautiful Massage Lotion” teaches a lotion composition consisting of peanut oil, olive oil, and lanolin. The reference teaches that the composition is useful for massage therapy and improving the moisturization of the skin. The reference does not teach including castor oil in the composition.
However, “Using Castor Oil for Massage Benefits” teaches that castor oil is useful as a lotion for massage therapy and improving the moisturization of the skin. The reference teaches that the castor oil is cold-pressed and can be covered with a wrap (i.e. a ‘medicinal plaster’).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that are useful for massage therapy and improving the moisturization of the skin. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions that are useful for massage therapy and improving the moisturization of the skin, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions that are useful for massage therapy and improving the moisturization of the skin. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” Varying the concentration of ingredients within a topical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
The references do not teach that the ingredients are obtained as claimed by applicant in claim 4. However, regarding product-by-process claims, note that MPEP § 2113 states that:
[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate…A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)… Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
The prior art ingredients appear to be the same as the claimed ingredients. Furthermore, peanut, olive, and castor oils are typically obtained by mechanical pressing of the source material.
The references do not teach that the composition is used for all of the same purposes as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
13. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655