Prosecution Insights
Last updated: April 19, 2026
Application No. 18/504,742

WOUND DRESSING COMPRISING HYALURONIC ACID-CALCIUM AND POLYLYSINE AND MANUFACTURING METHOD THEREFOR

Non-Final OA §103§112
Filed
Nov 08, 2023
Examiner
SHIAO, YIH-HORNG
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Youreh Co. Ltd.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
683 granted / 942 resolved
+12.5% vs TC avg
Strong +76% interview lift
Without
With
+75.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
32 currently pending
Career history
974
Total Applications
across all art units

Statute-Specific Performance

§101
5.8%
-34.2% vs TC avg
§103
31.3%
-8.7% vs TC avg
§102
20.8%
-19.2% vs TC avg
§112
26.3%
-13.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 942 resolved cases

Office Action

§103 §112
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 11/08/2023 has been entered. Claims 1-11 are cancelled. Claims 1 2-22 are new, pending , and currently under examination. Priority This application is a DIV of 16/633,951 filed on 01/24/2020, now ABN, which is a 371 of PCT/KR2018/008397 filed on 07/25/2018 and claims foreign priority of KOREA, REPUBLIC OF 10-2017-0094693 filed on 07/26/2017 . Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/633,951 , filed on 01/24/2020 . Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Information Disclosure Statement T he information disclosure statement (IDS) filed on 11/08/2023 has been considered. Claim Objections Claim s 12, 15, 20, and 22 are objected to because of the following informalities: In claim s 12, 15, and 22 , insert the missing word “ salt ” immediately after the recitation “ hyaluronic acid-calcium ” (line s 2 , 3, and 6 of claim 12; line 2 of claims 15 and 22 ) to provide correct chemical name and to be consistent with the salt in claims 13 and 14 . In claim 20, change the grammatically incorrect recitation “ hyaluronic acid in the hyaluronic acid-calcium and polylysine have a ” (lines 1 to 2 of claim 20) to “ hyaluronic acid has a ". Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 12-22 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. Claims 13- 15 and 20- 22 depend from claim 12. Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 12 recites “ preparing a wound dressing ” in the preamble and step (2). Since steps (1) and (2) are required to achieve the preamble, the “ preparing a wound dressing ” in step 2 amounts to a gap between the necessary structural connections. Applicant is advised to change the recitation “ preparing a wound dressing ” in step (2) to “forming a wound dressing ”; and to replace the recitations “prepared” ( line 1 of claim 16) and “to prepare” (line 2 of claims 17-19) with “formed” and “to form”, respectively. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . 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. (I) Claim s 12-17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Karageozian et al. ( US 2009/0042834 , Feb. 12, 2009 , hereinafter referred to as Karageozian ‘834) . With regard to structural limitations “a method comprising: (1) mixing an aqueous hyaluronic acid-calcium salt at pH 8.4 or higher and an aqueous polylysine at pH 8.4 or higher (or the pH is respectively adjusted or adjusted to pH 8.4 to 9.0 prior to mixing ) in the ratio of hyaluronic acid-calcium salt to polylysine of 4:1 to 1:1.5 by weight; and (2) forming a wound dressing (or in a liquid type; or filled into a prefilled syringe ) from a mixed solution (or a uniform solution ) obtained in Step (1), wherein the wound dressing contains hyaluronic acid-calcium salt and polylysine which are not cross-linked (or not chemically cross-linked ; or the hyaluronic acid has a molecular weight of 2x 10 6 to 3x 10 6 Da ; or does not contain a crosslinking agent ) ” (claims 12-17 and 20-22): Karageozian ‘834 disclosed compositions that comprise a glycosaminoglycan (e.g., hyaluronic acid or a hyaluronic acid salt ) in combination with at least one agent selected from the group consisting of i ) polyglycols, ii) Hydroxy Polyanionic Polysaccharides, and iii) long chain Nitrogen containing polymers (e.g., Polylysine , Polyvinylpyrrolidone, and polyvinyl alcohol). Such compositions may be prepared in aqueous solution having a pH of from about 5.0 to about 9.0 . To prepare the buffer, 1 g of boric acid, 2.9 g of Sodium chloride, 0.7 g of potassium chloride, 0.1 g of calcium chloride dihydrate and 0.055 g magnesium chloride hexahydrate were dissolved in distilled water . To insure samples were thoroughly dissolved and well mixed, stock solutions of the polymers in borate buffer were prepared when possible. All stock solutions were vortex mixed and then placed on a shaker until clear and homogeneous (page 7/14, [0017] ; page 10/14, [0048 and 0049 ] ). A composition comprising: a first component selected from the group consisting of glycosaminoglycans ; and a second component selected from the group consisting of i ) polyglycols, ii) long chain hydroxy polyanionic polysaccharides and iii) long chain nitrogen containing polymers and iii) long chain Nitrogen containing polymers, wherein the second component comprises polylysine ; or wherein the glycosaminoglycan or hyaluronic acid has an average molecular weight in the range of about 2x10 5 to about 3x10 6 ; or wherein the weight ratio of the first component to the second component is from about 0.1:1 to about 10:1 ; or wherein the composition has a pH in the range of about 5.0 to about 9.5 . A system comprising a quantity of the above composition packaged in a syringe for injection into a human or animal s ubject (pages 13/14 to 14/14, para. #1, #9, #22, # 24, #25, #28, and #33) . One drawback of administering exogenous hyaluronic acid for therapeutic or other biomedical purposes is that hyaluronic acid degrades very rapidly and consequently loses its viscosity and its lubricity. This limits the many biomedical applications of the hyaluronic acid in tissue grafting, dermal wound healing, corneal wound healing , as a viscoelastic agent in cataract surgery, or as a drug delivery vehicle (page 9/14, [0044]). Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the generic hyaluronic acid salt with calcium salt of hyaluronic acid as taught by Karageozian ‘834 , followed by optimization of pH and/or weight ratio to obtain suitable viscosity and/or lubricity for wound healing because calcium is required in the composition, as described above . Th erefore , one of skill in the art would have a reasonable expectation that by substituting the generic hyaluronic acid salt with calcium salt of hyaluronic acid as taught by Karageozian ‘834 , followed by optimization of pH to obtain suitable viscosity and/or lubricity , one would achieve Applicant’s claims 12-17 and 20-22 . "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 214 3 [R- 0 1 .20 24 ] [I]. "[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). See MPEP § 2144.05 [R- 0 1 .20 24 ] [II.A]. (II) Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Karageozian et al. ( US 2009/0042834 , Feb. 12, 2009 , hereinafter referred to as Karageozian ‘834 ) , as applied to claims 12-17 and 20-22 , in view of Mousa et al. (US 2016/0206773 , Jul. 21, 2016 , hereinafter referred to as Mousa ‘ 773, also listed in IDS filed on 11/08/2023 ) . The teachings of Karageozian ‘834 are disclosed above and are incorporated by reference herein. The Karageozian ‘834 fails to teach the structural limitations “ the mixed solution obtained in Step (1) is freeze-dried to form a foam-type wound dressing (or is applied onto a substrate or poured into a mold, and then dried to prepare a film-type wound dressing ) ” , required by claims 18 and 19. Mousa ‘773 disclosed a hydrogel matrix comprising poly L-Lysine ionically bonded to both hyaluronic acid and alginic acid, or a hydrogel matrix comprising chitosan and poly L-Lysine ionically bonded to both hyaluronic acid and alginic acid, said hydrogel matrix encapsulating various compounds. The wound dressing is constructed from a non-mammalian material for the control of severe bleeding. The hydrogel may comprise tranexamic acid, calcium salt (e.g., calcium chloride: CaCl 2 ) . In one embodiment, a low density sponge is formed by compressing a sponge with an initial density of about less than 0.05 g/cm until the sponge reaches a density of about less than 0.08 g/cm. The sponge can be formed by a process other than freezing or freeze drying . Liquid bandage preparations are often used for covering and protecting minor lacerations and abrasions, friction blisters and paper cuts. When applied to the skin, the solution in a liquid bandage evaporates to form a protective film over the application area (page 19/29, [0036, 0038, 0049, 0050]; page 23/29, [0093]; page 18/29, [0025 ]). Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the generic type of wound healing composition as taught by Karageozian ‘834 with sponge-type or film-type wound dressing in view of Mousa ‘773 because both references teach a wound healing composition or matrix comprising hyaluronic acid, calcium salt, and polylysine , as described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the generic type of wound healing composition as taught by Karageozian ‘834 with sponge-type or film-type wound dressing in view of Mousa ‘773 , one would achieve Applicants' claims 18 and 19 . "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 214 3 [R- 0 1 .20 24 ] [I]. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT YIH-HORNG SHIAO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7135 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon- Thur , 08:30 am to 07:00 pm 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, FILLIN "SPE Name?" \* MERGEFORMAT Renee Claytor can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /YIH-HORNG SHIAO/ Primary Examiner, Art Unit 1691
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Prosecution Timeline

Nov 08, 2023
Application Filed
Feb 20, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+75.9%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 942 resolved cases by this examiner. Grant probability derived from career allow rate.

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