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 .
This office action is in response to applicant’s amendments received on August 19th, 2026.
The applicant has cancelled claims 14, 15, and 19. Claims 1-13, 16-18, and 20 are pending. Claims 16, 18, and 20 are withdrawn. Claims 1-13 and 17 were examined on the merits.
Any objections or rejections not reiterated below are hereby withdrawn.
Priority
The provisional application 63/455,558 for instant application 18/615,128 does not disclose liposomal encapsulation as recited in amended claim 1, from which all other pending claims depend; therefore, the priority date is the filing date of the instant application, March 25th, 2024.
Information Disclosure Statement
The information disclosure statement filed August 19th, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the citations do not correspond to the references provided; rather, the citations appear to mix information corresponding to different reference documents in the instant application. . It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Withdrawal of Objections and Rejections
Applicant’s arguments, filed August 19th, 2026, with respect to the objection to the specification have been fully considered and are persuasive. The applicant has amended the specification to correctly recite the term “Aquaphor”, a trademark. The objection to the specification has been withdrawn.
Applicant’s arguments, filed August 19th, 2026, with respect to the objection have been fully considered and are persuasive. The applicant has amended claims 6, 7, 10, and 11, for clarity, addressing the informalities pointed out by the examiner. The objection to claims 6, 7, 10, and 11 has been withdrawn.
Applicant’s arguments, filed August 19th, 2026, with respect to the objection have been fully considered and are persuasive. The applicant has amended claim 17 for clarity, addressing the informality pointed out by the examiner. The objection to claim has been withdrawn.
Applicant’s arguments, filed August 19th, 2026, with respect to the rejection of claims 1-7 on the ground of non-statutory double patenting over U.S. patent No. 12303585 have been fully considered and are persuasive. The applicant has filed a terminal disclaimer for the instant application over U.S. patent No. 12303585. This terminal disclaimer has been approved. The rejection of claims 1-7 on the ground of non-statutory double patenting over U.S. patent No. 12303585 has been withdrawn.
Applicant’s arguments, filed August 19th, 2026, with respect to the rejection of claims 1- have been fully considered and are persuasive. The applicant has filed a terminal disclaimer for the instant application over U.S. patent application No. 19186852. This terminal disclaimer has been approved. The provisional rejection of claims has been withdrawn.
The rejection of claim 14 on the ground of non-statutory double patenting over U.S. patent application No. 19186852 has been withdrawn, this claim having been cancelled by the applicant.
Applicant’s arguments, filed August 19th, 2026, with respect to the rejection of claim 17 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The applicant has amended claim 17, removing indefinite language. The rejection of claim 17 under 35 U.S.C. 112(b) has been withdrawn.
The rejection of claim 19 under 35 U.S.C. 112(b) has been withdrawn, this claim having been cancelled by the applicant.
The rejection of claims 14, 15, and 19 under 35 U.S.C. 101 is withdrawn, these claims having been cancelled by the applicant.
Applicant’s arguments, filed August 19th, 2026, with respect to the rejection of claims 1-13 and 17 under 35 U.S.C. 103 have been fully considered. Liposomal encapsulation of Chaga, Reishi, or Lion’s Mane mushrooms, claimed in amended claim 1, is not taught or suggested by the previously relied upon prior art references. Furthermore, there is unpredictability in the liposomal encapsulation of medicinal chemical components (see the rejection of claims 1-1 and 17 under 35 U.S.C. 112(a) below). The rejection of claims 1-13 and 17 under 35 U.S.C. 103 has been withdrawn.
The rejection of claims 14, 15, and 19 under 35 U.S.C. 103 is withdrawn, these claims having been cancelled by the applicant.
Pending Objections and Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-13, 16, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making a composition comprising mushroom extracts, aloe vera gel, vitamins, emollients, emulsifiers, stabilizers, and essential oils, does not reasonably provide enablement for making a topical aftercare for tattooed skin comprising any medicinal extracts of Chaga, Lion's Mane, and Reishi mushrooms, wherein the extracts are liposomally encapsulated. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a composition comprising liposomally encapsulated medicinal mushroom extracts, recited as a topical aftercare gel composition for tattooed skin. Thus, the claims taken together with the specification imply that a person of skill in the art could liposomally encapsulate any medicinal extracts of Chaga, Lion's Mane, and Reishi; to prepare aftercare gel composition for tattooed skin.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Lombardo and Kiselev (Pharmaceutics 2022, 14 (3), 543) recite variability in the drug loading techniques applied in liposome preparation, including the amount of drug loading depending on the chemical characteristics of the drugs.
"The main aim of the liposome formation process is to create nanoformulations dedicated to the efficient transport and delivery of lipophilic (within the lipid bilayer), hydrophilic (in the aqueous core), and amphiphilic (partitioned at the bilayers surface) drugs. The amount of drug loading depends not only on the method used for liposome preparation, but also on the drugs’ chemical characteristics and on the composition and physicochemical properties of the liposomes (such as lipids’ concentrations and charge characteristics, drug/lipid ratios).
In the passive loading method, drugs are loaded during the liposomes’ preparation. This method can be performed by means of solvent dispersion, mechanical dispersion, and detergent removal methods [65,68]. For example, in the thin TFH method, the lipophilic drugs are incorporated (in large amounts) within the lipid bilayers during the first stages of the liposomes’ self-assembly process. On the contrary, the hydrophilic drugs, which are usually incorporated during the (aqueous buffer) hydration stage, present lower incorporation efficiencies, as only part of the drugs are present within the liposome core region, while part of them still remain in the hydration volume (outside the liposomes). For this reason, strategies can be developed to increase the aqueous phase within the core volume, by means of the different methods of liposome formation.
Active loading methods, which incorporate drugs after liposome preparation, generally exploit the diffusion properties of a gradient which is established across the surface of the liposomes (gradient loading) by involving the addition of suitable buffers. Active loading can be obtained with lyophilization, whereby the formed liposomes are generated by transfer of the lipids from organic to aqueous phases [65,80]. The use of active-loading approaches generally shows higher EE as compared to the passive methods. Particularly interesting is the (transmembrane) pH-gradients method, as it can be used to encapsulate a variety of active drugs (including anticancer, anti-anesthetics, antimalarials, etc.). Interestingly, several amine-functionalized drugs (including doxorubicin, daunorubicin, chlorpromazine, quinine, quinidine, dopamine, serotonin, and chloroquine) exhibit a pH-gradient effect after liposome preparations by accumulating protons in the vesicles’ interior (and exhibiting an acidic character in their internal region). In order to create a pH gradient across the liposome membrane, the pH of the exterior aqueous compartment can be increased through the incorporation of an alkylating agent (alkaline buffer) or by exchanging (by gel filtration or dialysis methods) the external media with the desired buffer. According to this approach, the liposomes are first hydrated with a given buffer (of a fixed pH), followed by dialysis in an excess of another buffer (with a different pH), in order to replace the buffer in the liposomes outside region (and to create a trans-membrane pH gradient). In this case, uncharged drugs entering the liposomes become charged inside the first buffer (of the liposome aqueous core) and remain entrapped in the liposomes (as the charged drugs cannot diffuse through the lipid layer) [65,68]" (Lombardo and Kiselev, heading 6, emphasis made by the examiner), where the term "EE" is an abbreviation for encapsulation efficiency (Lombardo and Kiselev, subheading 3.3.1, paragraph 4).
Since the process of loading of any medicinal compound into a liposome, in any amount, remains largely unsolved, means for liposomally encapsulating any medicinal extracts of Chaga, Lion's Mane, and Reishi, to prepare aftercare gel composition for tattooed skin is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. From the disclosure of Lombardo and Kiselev, persons of skill in the art can use a trans-membrane pH gradient to actively load a liposome with certain drugs. However, this type of method is not described as a solution to liposomally encapsulate any medicinal compound.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided a general statement about incorporating "liposomal encapsulation, which enhances the penetration of the mushroom extracts into deeper layers of the skin" (paragraph [0038]). However, the specification does not provide a process of liposomally encapsulating medicinal extracts of Chaga, Lion's Mane, and Reishi mushrooms, to prepare an aftercare gel composition for tattooed skin.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Lombardo and Kiselev and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to liposomally encapsulate medicinal extracts of Chaga, Lion's Mane, and Reishi mushrooms, to prepare an aftercare gel composition for tattooed skin.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The response filed 08/19/2026 has introduced NEW MATTER into the claims. Amended claim 16 recites the composition is free of petrolatum. The response did not point out where support for the embodiment recited in claim 16 could be found in the originally filed disclosure. Although specification paragraphs [0005] and [0006] recited motivation to exclude petrolatum, they do not recite an embodiment of the instantly claimed invention that is free of petrolatum. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Instant claim 16 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in amended claim 16, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 16 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13, 16, and 17 are rejected under 35 U.S.C. 101 because the claims are directed to a product of nature without significantly more. Applicant's arguments filed August 19th, 2026 have been fully considered but they are not persuasive. The applicant has pointed out structural differences between the claimed composition and the individual components of Chaga extract, Lion’s Mane extract, Reishi extract and aloe vera. The applicant pointed out Nature-Based Products Examples 2 and 3 published by the USPTO. However, Example 2 is drawn to a beverage product and in Example 3, the non-natural physical structure of a pharmaceutical composition, combining naturally occurring substances, results in different functional characteristics in vivo compared to the naturally occurring substances by themselves (Nature-Based Products, Example 3, Claim 5). The claims are drawn to a medicinal composition, so biological function is an appropriate characteristic for markedly different characteristics analysis. It is not clear that liposomally encapsulated Chaga, Lion's Mane, and Reishi mushroom extracts are functionally different from the extracellular vesicles made by the living cells of Chaga, Lion's Mane, and Reishi mushrooms. It is not clear that the aloe vera gel in the instantly claimed composition has functional characteristics that differentiate it from its naturally occurring source material, aloe vera gel in the aloe vera plant. The rejection of claims 1-13 and 17 under 35 U.S.C. 101 is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
