Prosecution Insights
Last updated: April 19, 2026
Application No. 18/561,470

PHARMACEUTICAL COMPOSITION COMPRISING HYALURONIC ACID COMPLEX FOR PREVENTION OR TREATMENT OF SKIN DISEASE

Non-Final OA §102§103§112§DP
Filed
Nov 16, 2023
Examiner
CREWS, JARET JAMES
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ajou University Industry-Academic Cooperation Foundation
OA Round
1 (Non-Final)
47%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
34 granted / 72 resolved
-12.8% vs TC avg
Strong +70% interview lift
Without
With
+69.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
67 currently pending
Career history
139
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
34.3%
-5.7% vs TC avg
§102
18.2%
-21.8% vs TC avg
§112
24.6%
-15.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 72 resolved cases

Office Action

§102 §103 §112 §DP
CTNF 18/561,470 CTNF 98164 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The Information Disclosure Statements (IDS) filed on 11/16/2023, 11/19/2024, 01/07/2025 and 07/02/2025 have been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English. Claim Status The preliminary amendment filed November 16, 2023 has been entered. Claims 9-11 are canceled. Thus, claims 1-8 as amended are examined on the merits herein. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. 07-31-03 AIA Claim s 1-8 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 treating atopic dermatitis, psoriasis, allergic dermatitis, seborrheic dermatitis, and contact dermatitis with a hyaluronic acid conjugate consisting of hyaluronic acid and either lithocholic acid; cholanic acid or cholesterol as the hydrophobic substance , does not reasonably provide enablement for treating or preventing any skin disease by administering a hyaluronic acid conjugate composed of hyaluronic acid and any hydrophobic substance . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As a result, substantiation of utility and its scope is required when utility is speculative, sufficiently unusual or not provided, and enablement must be commensurate with the scope of the claim language. As MPEP § 2164.08 states, “The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” As stated in MPEP § 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”.” The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), where the court set forth eight factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph. They are: (1) The nature of the invention; (2) The state of the prior art; (3) The level of skill in the art; (4) The predictability or lack thereof in the art; (5) The breadth of the claims; (6) The amount of direction or guidance present; (7) The presence or absence of working examples; and (8) The quantity of experimentation needed. It is noted that all of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. The nature of the invention: The claimed invention is drawn to treating or preventing any skin disease in a subject comprising administering a hyaluronic acid conjugate composed of hyaluronic acid and any hydrophobic substance as an active ingredient as required in claims 1-8, wherein the Examiner is reasonably interpreting the phrase “skin disease” to mean any skin disease. Therefore, in order to be enabled for the full scope of treatment or prevention of said skin disease, one skilled in the art must reasonably be able to ascertain which agents are effective, obtain said agents, and successfully use said agents for treating or preventing said skin disease. The Examiner respectfully notes the specification defines the phrase “hydrophobic substance” to refer to a compound containing a hydrophobic substituent which is a substance imparting hydrophobicity to hydrophilic hyaluronic acid (pg. 10, paragraph [0041]. Therefore, the Examiner reasonably interprets based on the definition of “hydrophobic substance” as disclosed by Applicant above, said hydrophobic substance is any hydrophobic substance. The Examiner further respectfully notes the specification does not explicitly define the phrase “skin disease”; rather the specification only exemplifies the skin disease as particular diseases as recited within paragraph [0076] of the specification (see pg. 18, paragraph [0076]). Therefore, the Examiner reasonably interprets based on the disclosure of the specification as a whole said skin disease is any skin disease. The state of the prior art: The state of the art does not recognize treating or preventing any skin disease with a hyaluronic acid conjugate composed of hyaluronic acid and a hydrophobic substance. Attention is drawn to Lee et al. (Published 14 November 2022, ACS Nano, Vol. 16, Issue 12, pp. 20057-20074, IDS filed 11/19/2024), Lee teaches hyaluronic acid nanoparticles as a topical agent for treating psoriasis, see pg. 20057, title. Lee teaches using amphiphilic HA-LCA conjugates, hydrophilic 60 kDa free HAs were chemically conjugated with hydrophobic lithocholic acid (LCA, Figure S1), see pg. 20059, left column, results and discussion, efficacy against psoriasis-like skin dermatitis, paragraph 1. Lee teaches the specific HA-LCA conjugate known as HALN-3 (also referred to as HALN) was administered via the subcutaneous route in psoriasis-like skin dermatitis. Lee concludes their results indicate that an empty self-assembled HALN itself is sufficient to protect animals against psoriasis-like skin dermatitis safely and effectively, see pg. 20059, right column, paragraph 2. Lee further tested a hyaluronic acid conjugate consisting of 10 kDa free HA and 5β-cholanic acid known as HACN, see pg. 20061, left column, paragraph 3; where HACN showed similar therapeutic efficacy to HALN psoriasis induced mice models, see pg. 20061, right column, paragraph 1. The relative skill in the art: The relative skill of those in the art is high. The predictability or lack thereof in the art: As discussed above, Lee teaches administering hyaluronic acid conjugates consisting of lithocholic acid or cholanic acid as a topical agent in treating psoriasis. However, Lee does not demonstrate the hyaluronic acid conjugates consisting of lithocholic acid or cholanic acid can treat the “skin disease” commensurate in scope as interpreted by the Examiner in the Nature of Invention section written above. As a result, at the time of the invention the use of hyaluronic acid conjugates as recited within claim 1 to treat or prevent any skin disease was limited. Therefore, at the time of the invention the field of therapeutic use in treating or preventing any skin disease with the hyaluronic acid conjugates as recited within claim 1 was relatively underdeveloped and unpredictable. The breadth of the claims: The claims are extremely board in that it encompasses a treatment of any skin disease in a subject using the instantly claimed method comprising administering a hyaluronic acid conjugate composed of hyaluronic acid and any hydrophobic substance as an active ingredient to the subject as discussed in the Nature of Invention section written above. The amount of direction or guidance present: Applicants provide general guidance that the hyaluronic acid conjugates of the claimed invention are self-assembling; have excellent resistance to hyaluronidase and transdermal permeability; have excellent effects on the protection and recovery of skin barrier function; inhibit expression of cell proliferation-related factors and inflammatory cytokines; inhibit M1 macrophage polarization; and block TLR4 signaling which may be used as an agent for treating various skin diseases. However, as discussed in the State of the Prior Art section above, Lee teaches administering hyaluronic acid conjugates consisting of lithocholic acid or cholanic acid as a topical agent in treating psoriasis. Furthermore, Applicants do not provide any direction or guidance on the proposed scope of hydrophobic substances to be used within the hyaluronic acid conjugates nor do Applicants provide any direction or guidance on the mechanism of action of the hyaluronic acid conjugates of claims 1-6 in treating any skin disease, which is particularly important in view of the Nature of Invention section as discussed above. The presence or absence of working examples: Applicants provide experimental examples using specific hyaluronic acid conjugates to treat psoriasis within the specification. Experimental Example 2 discloses psoriasis animal models were treated with hyaluronic acid conjugates HALN-1 to 3 injected subcutaneously at a dose of 20 mg/kg for 4 days, see specification, pg. 27, paragraph [00114]. The specification discloses Figs. 3 and 4 confirmed when HALN-1 to 3 were administered, erythema, scaling, and skin thickness were reduced compared to when PBS was administered. See pg. 28, paragraph [00118]. Experimental Example 5 discloses a concentration-dependent effect of transdermal administration of HALN-2 on treatment of psoriasis, see pg. 33, paragraphs [00143]-[00146] and Figs. 11-14. Experimental Example 9 discloses psoriasis animal models were treated with hyaluronic acid conjugate HACN via tail vein injection 2 hours before application of Aldara cream to induce the psoriasis skin disease model, see pp. 41-42, paragraph [00184]. Within Experimental Example 9, Figs. 19 to 21 confirm HACN reduced the PAI score and epidermal thickness and inhibited skin cell proliferation and inflammatory response, indicating HACN is effective in treating psoriasis, see pg. 41, paragraph [00185]. Finally, Experimental Example 12 discloses treatment effects of psoriasis-induced mice with various types of hyaluronic acid conjugates containing lithocholic acid (HALN); cholanic acid (HACN); or cholesterol (HACHN) at either a molecule weight of 10kDa or 60kDa, see pp. 48-49, paragraphs [00215]-[00222]. Experimental 12 discloses as shown in Figs. 25 to 26 the hyaluronic acid conjugates comprising different types of hydrophobic substances bound to hyaluronic acids reduced the PASI score, skin thickness, skin cell proliferation, and inflammatory response in the group to which each of the hyaluronic acid conjugates were applied, see pg. 50, paragraph [00228] and Figs. 25-26. However, the Examiner respectfully notes the specification does not test any other hydrophobic substance other than lithocholic acid; cholanic acid; or cholesterol within their hyaluronic acid conjugates. Nor does the specification test any other skin disease other than psoriasis with the hyaluronic acid conjugates consisting of lithocholic acid; cholanic acid; or cholesterol as the hydrophobic substance. Thus, the Examiner respectfully notes Applicant’s examples are not commensurate in scope with treating any skin disease with a hyaluronic acid conjugate composed of hyaluronic acid and any hydrophobic substance. Accordingly, the experimental examples discussed above do not support using the claimed hyaluronic acid conjugates of claim 1 in treating or preventing any skin disease. Furthermore, Applicant’s experimental examples only support the use of hyaluronic acid conjugates consisting of hyaluronic acid and either lithocholic acid; cholanic acid; or cholesterol as the hydrophobic substance in treating psoriasis. Note the lack of working examples is a critical factor to be considered, especially in a case involving the unpredictability of and underdeveloped art. The quantity of experimentation needed: In order to translate the suggestion in Applicant’s disclosure into an actual therapeutic model with the full range of all possible treatment methods beyond those known in the art, one skilled in the art would have to undertake a novel and extensive research program to show that a hyaluronic acid conjugate composed of hyaluronic acid and any hydrophobic substance could successfully treat or prevent any skin disease in a subject. Therefore, because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope beyond what is already known in the art, it would constitute an undue and unpredictable search and experimental burden. Genentech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Therefore, in view of the Wands factors, as discussed above, particularly the state of the art and the lack of guidance or working examples, Applicants fail to provide information sufficient to practice the claimed invention . Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-2, 4-6 and 8 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kim et al. (Published 01 August 2019, US-20190231898-A1, IDS filed 01/07/2025) . Regarding claims 1-2, 4-6 and 8, Kim teaches treating an inflammatory disease comprising administering hyaluronic acid nanoparticles represented by Formula (I) depicted as, PNG media_image1.png 499 890 media_image1.png Greyscale , see pg. 10, left column, claim #1. The Examiner respectfully notes Formula (I) depicts a hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid. Kim teaches the hyaluronic acid particles of Formula (1) may consist of hyaluronic acid and 5β-cholanic acid (e.g. the hyaluronic acid conjugate composed of hyaluronic acid and a hydrophobic substance as an active ingredient, required in claim 1, lines 3-4 ), see paragraph [0029]. Kim teaches the hyaluronic acid nanoparticles of Formula (I) may consist of hyaluronic acid and 5β-cholanic acid in a mass ratio of 1:0.05 to 1:0.30 (e.g. the mass ratio, required in claim 4 ), see paragraph [0030]. Kim teaches the hyaluronic acid conjugate of the hyaluronic acid nanoparticles of Formula (I) may be formed through self-assembly in an aqueous solution state (e.g. self-assembly, required in claim 5 ), see paragraph [0031]. Kim teaches the hyaluronic acid nanoparticles have a diameter of 100 nm to 500 nm (e.g. the diameter, required in claim 6 ), see pg. 10, left column, claim #5. Kim teaches the pharmaceutical composition is effective in treating an inflammatory disease, wherein the inflammatory disease may be selected from the group consisting of and including dermatitis (e.g. inflammatory skin disease, required in claim 8, line 4 ), see paragraph [0033]. Kim teaches the hyaluronic acid nanoparticles may be administered at a dose of 0.1 mg/kg (body weight) to 30 mg/kg (body weight) (e.g. a pharmaceutically effective amount, required in claim 1, line 4 ), see paragraph [0038]. Kim exemplifies administration to a patient (e.g. the subject in need thereof, required in claim 1, lines 4-5 ), see paragraph [0038]. With respect to the limitation “the hydrophobic substance has a partition coefficient (LogP) within a range of 2 to 10”, required in claim 2 ; the Examiner reasonably interprets this limitation as a physical limitation of the hydrophobic substance conjugated to the hyaluronic acid. Since Kim teaches a hyaluronic acid conjugate consisting of 5β-cholanic acid, the Examiner reasonably interprets the physical limitation as discussed above is met by the teachings of Kim as discussed above. Thus, the teachings of Kim as discussed above anticipate claims 1-2, 4-6 and 8 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-22-aia AIA Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Published 01 August 2019, US-20190231898-A1, IDS filed 01/07/2025) as applied to claim s 1-2, 4-6 and 8 above, and further in view of Yang et al. (Published 08 October 2020, WO-2020205937-A1, PTO-892) . Kim addresses claims 1-2, 4-6 and 8 as written above. Kim further teaches the pharmaceutical composition may be administered orally or parenterally (e.g. intravenously, subcutaneously, intraperitoneally, or topically), see paragraph [0038]. Although, Kim does not explicitly teach wherein the hyaluronic acid conjugate is administered transdermally, required in claim 7. However, in the same field of endeavor of administering a hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid, Yang exemplifies hyaluronic acid nanoparticles containing an anticancer agent, see abstract. Yang further exemplifies said nanoparticles are made up of hyaluronic acid conjugated to hydrophobic moieties, and wherein the hydrophobic moieties are steroid based compounds such as 5β-cholanic acid, see abstract. Yang teaches the particles can be administered by a variety of routes including the oral, transdermal , subcutaneous or intravenous routes, see pg. 18, lines 20-25. It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated wherein the hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid is administered transdermally as taught by Yang above into the method of administering the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as taught by Kim above as within the scope of the artisan as combining prior art elements according to known compounds and methods to yield predictable results. One of ordinary skill in the art would have been motivated to administer the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as taught by Kim as discussed above. One of ordinary skill in the art would have had a reasonably expectation of success to have incorporated the teachings of Yang into the method of Kim as discussed above, because both Yang and Kim are drawn to administering hyaluronic acid conjugate particles composed of hyaluronic acid conjugated to hydrophobic moieties, particularly 5β-cholanic acid as discussed above. Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art. Double Patenting 08-33 AIA 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. (I) Claims 1-2, 4-6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,806,800 B2 (Applicant: Ajou University Industry-Academic Cooperation Foundation, PTO-892) in view of Kim et al. (Published 01 August 2019, US-20190231898-A1, IDS filed 01/07/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to administering hyaluronic acid conjugates composed of hyaluronic acid and a hydrophobic substance in treating a skin disease, particularly an inflammatory skin disease. Reference claim 1 recites a method of treating an inflammatory disease comprising administering an effective amount of hyaluronic acid nanoparticles represented by Formula (1) depicted as, PNG media_image2.png 699 680 media_image2.png Greyscale , wherein the hyaluronic acid nanoparticles of Formula (I) consists of hyaluronic acid and 5β-cholanic acid in a mass ratio of 1:0.05 to 1:0.3; wherein the hyaluronic acid nanoparticles have a diameter of 107.5 nm to 224 nm, and wherein the inflammatory disease is selected from the group consisting of and including dermatitis. Reference claim 2 recites the hyaluronic acid nanoparticles are formed through self-assembly in an aqueous solution. Although, ‘800 does not recite the subject, required in instant claim 1, lines 4-5. However, in the same field of administering a hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid, Kim teaches treating an inflammatory disease comprising administering hyaluronic acid nanoparticles represented by Formula (I) depicted as, PNG media_image1.png 499 890 media_image1.png Greyscale , see pg. 10, left column, claim #1. The Examiner respectfully notes Formula (I) depicts a hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid. Kim teaches the hyaluronic acid particles of Formula (1) may consist of hyaluronic acid and 5β-cholanic acid, see paragraph [0029]. Kim exemplifies administration to a patient (e.g. the subject in need thereof, required in instant claim 1, lines 4-5 ), see paragraph [0038]. With respect to the limitation “the hydrophobic substance has a partition coefficient (LogP) within a range of 2 to 10”, required in instant claim 2 ; the Examiner reasonably interprets this limitation as a physical limitation of the hydrophobic substance conjugated to the hyaluronic acid. Since Kim teaches a hyaluronic acid conjugate consisting of 5β-cholanic acid, the Examiner reasonably interprets the physical limitation as discussed above is met by the teachings of Kim as discussed above. It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the patient as taught by Kim above into the method of administering the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as recited by ‘800 as discussed above as within the scope of the artisan as combining prior art elements according to known compounds and methods to yield predictable results. One of ordinary skill in the art would have been motivated to administer the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as recited by ‘800 as discussed above. One of ordinary skill in the art would have had a reasonably expectation of success to have incorporated the teachings of Kim into the method as recited by ‘800 as discussed above, because both ‘800 and Kim are drawn to administering hyaluronic acid conjugate nanoparticles consisting of hyaluronic acid conjugated to 5β-cholanic acid as discussed above. Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art. (II) Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,806,800 B2 (Applicant: Ajou University Industry-Academic Cooperation Foundation, PTO-892) in view of Kim et al. (Published 01 August 2019, US-20190231898-A1, IDS filed 01/07/2025) and Yang et al. (Published 08 October 2020, WO-2020205937-A1, PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to administering hyaluronic acid conjugates composed of hyaluronic acid and a hydrophobic substance in treating a skin disease, particularly an inflammatory skin disease. ‘800 and Kim address instant claims 1-2, 4-6 and 8 as written above. Although, ‘800 does not explicitly recite wherein the hyaluronic acid conjugate is administered transdermally, required in instant claim 7. However, in the same field of endeavor of administering a hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid, Yang exemplifies hyaluronic acid nanoparticles containing an anticancer agent, see abstract. Yang further exemplifies said nanoparticles are made up of hyaluronic acid conjugated to hydrophobic moieties, and wherein the hydrophobic moieties are steroid based compounds such as 5β-cholanic acid, see abstract. Yang teaches the particles can be administered by a variety of routes including the oral, transdermal , subcutaneous or intravenous routes, see pg. 18, lines 20-25. It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated wherein the hyaluronic acid conjugate composed of hyaluronic acid and 5β-cholanic acid is administered transdermally as taught by Yang above into the method of administering the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as recited by ‘800 above as within the scope of the artisan as combining prior art elements according to known compounds and methods to yield predictable results. One of ordinary skill in the art would have been motivated to administer the hyaluronic acid conjugate consisting of hyaluronic acid and 5β-cholanic acid in treating dermatitis as recited by ‘800 as discussed above. One of ordinary skill in the art would have had a reasonably expectation of success to have incorporated the teachings of Yang into the method recited by ‘800 as discussed above, because both Yang and ‘800 are drawn to administering hyaluronic acid conjugate particles composed of hyaluronic acid conjugated to hydrophobic moieties, particularly 5β-cholanic acid as discussed above. Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art. Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST. 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, Renee Claytor can be reached at (571) 272-8394. 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. /JARET J CREWS/Examiner, Art Unit 1691 /RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691 Application/Control Number: 18/561,470 Page 2 Art Unit: 1691 Application/Control Number: 18/561,470 Page 3 Art Unit: 1691 Application/Control Number: 18/561,470 Page 4 Art Unit: 1691 Application/Control Number: 18/561,470 Page 5 Art Unit: 1691 Application/Control Number: 18/561,470 Page 6 Art Unit: 1691 Application/Control Number: 18/561,470 Page 7 Art Unit: 1691 Application/Control Number: 18/561,470 Page 8 Art Unit: 1691 Application/Control Number: 18/561,470 Page 9 Art Unit: 1691 Application/Control Number: 18/561,470 Page 10 Art Unit: 1691 Application/Control Number: 18/561,470 Page 11 Art Unit: 1691 Application/Control Number: 18/561,470 Page 12 Art Unit: 1691 Application/Control Number: 18/561,470 Page 13 Art Unit: 1691 Application/Control Number: 18/561,470 Page 14 Art Unit: 1691 Application/Control Number: 18/561,470 Page 15 Art Unit: 1691 Application/Control Number: 18/561,470 Page 16 Art Unit: 1691 Application/Control Number: 18/561,470 Page 17 Art Unit: 1691 Application/Control Number: 18/561,470 Page 18 Art Unit: 1691 Application/Control Number: 18/561,470 Page 19 Art Unit: 1691 Application/Control Number: 18/561,470 Page 20 Art Unit: 1691
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Prosecution Timeline

Nov 16, 2023
Application Filed
Mar 23, 2026
Non-Final Rejection — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12565575
NEW CYCLODEXTRIN DIMERS AND THEIR USES THEREOF AS CHEMICAL SCAVENGERS
2y 5m to grant Granted Mar 03, 2026
Patent 12559512
METHOD FOR PRODUCING GLYCOSIDE COMPOUND
2y 5m to grant Granted Feb 24, 2026
Patent 12534542
COMPOSITIONS OF HYDROXYPROPYL-BETA-CYCLODEXTRIN AND METHODS OF PURIFYING THE SAME
2y 5m to grant Granted Jan 27, 2026
Patent 12509531
COMPOSITIONS OF HYDROXYPROPYL-BETA-CYCLODEXTRIN AND METHODS OF PURIFYING THE SAME
2y 5m to grant Granted Dec 30, 2025
Patent 12478637
METHOD FOR SUPPRESSING INTERVERTEBRAL DISC PAIN
2y 5m to grant Granted Nov 25, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
47%
Grant Probability
99%
With Interview (+69.8%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 72 resolved cases by this examiner. Grant probability derived from career allow rate.

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