Prosecution Insights
Last updated: April 19, 2026
Application No. 18/345,895

DISINFECTANTS WITH IODINE AND COPPER COMPLEXES FOR BIOFILM ERADICATION AND PREVENTION

Non-Final OA §102§112§DP
Filed
Jun 30, 2023
Examiner
PARK, HAEJIN S
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Clyra Medical Technologies Inc.
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 3m
To Grant
94%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
392 granted / 705 resolved
-4.4% vs TC avg
Strong +38% interview lift
Without
With
+38.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
57 currently pending
Career history
762
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
42.4%
+2.4% vs TC avg
§102
14.8%
-25.2% vs TC avg
§112
21.9%
-18.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 705 resolved cases

Office Action

§102 §112 §DP
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 . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on February 18, 2026 is acknowledged. Claims 31-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 18, 2026mkm5. Claim Objections Claim 9 is objected to because of the following informalities: for consistency “ .0625%” needs a zero preceding the period. 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 applicant regards as his invention. Claim 14 is 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. The term “significant” in claim 14 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure has been reviewed; however no illustrative discussion or data supports a determination of the requisite degree of “significant precipitation, discoloration or loss of antimicrobial efficacy”. For the purposes of examination now this claim term is construed as “stable” as recited in claim 1, i.e., “wherein the composition maintains a pH of from about 4.0 to about 7.0 without discoloration or solid iodine precipitation for at least 6 months”. (See Opinion, p.4 second-last para., US Application 16/874,525, February 16, 2022.) Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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 – (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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Rhodes (US 2018/0228837). Rhodes teaches a liquid or gel antimicrobial solution (title; abstract; paras. 0005-06, 0008, 0011-12, 0056-66, 0086, 0088, 0098). The following are Findings of Fact from the opinion issued in parent application 16/874,525. PNG media_image1.png 770 555 media_image1.png Greyscale PNG media_image2.png 471 540 media_image2.png Greyscale (Opinion, pp.8-9, US Application 16/874,525, February 16, 2022.) Instant claim 1, limitations (a) through (e), and claims 2-11, 13, and 14 read on ClyraTM 4 and C4 shown above. Rhodes does not expressly disclose whether ClyraTM 4 and C4 meet claim 1’s limitation (f), and claim 12’s “effective antimicrobial activity of at least three days”. However the following are also from the Opinion. PNG media_image3.png 482 510 media_image3.png Greyscale PNG media_image4.png 93 535 media_image4.png Greyscale (Opinion, pp.10-11, US Application 16/874,525, February 16, 2022.) The Board proceeded to rely on “Clyra 501(k)”; however it further stated as follows. PNG media_image5.png 153 523 media_image5.png Greyscale PNG media_image6.png 297 539 media_image6.png Greyscale (Opinion, pp.11-12.) Footnote number 7 in the above quote is as follows. PNG media_image7.png 157 538 media_image7.png Greyscale (Opinion, p.12.) As the Board noted, for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Furthermore a “chemical composition and its properties are inseparable”. MPEP § 2112.01(II). Therefore ClyraTM 4 and C4 are presumed to have the properties in claim 1 limitation (f) and claim 12. Furthermore the Board stated the Applicant, “as real party in interest of Rhodes and the instant application, is better placed than most to determine whether …the ClyraᵀM 4 disinfectant solution …solution satisfies the requirements of claim” 1, limitation (f), and claim 12. Applicant may file relevant data in response hereto. 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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11744249. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a stable liquid antimicrobial disinfectant composition comprising: a. at least 95.0% of total weight of a carrier liquid; b. potassium iodide at a first effective concentration by weight; c. copper sulfate at a second effective concentration by weight; d. wherein a mixture of the first concentration of potassium iodide and the second concentration of copper sulfate generates an amount of free iodine in the composition of from about 100 ppm to about 330 ppm; e. wherein the carrier liquid does not include any metallo-peptides, acidifying agents, buffers or surfactants; and f. wherein the composition maintains a pH of from about 4.0 to about 7.0 without discoloration or solid iodine precipitation for at least 6 months. The difference is that the ‘249 patent’s claims further require the composition be “against coronavirus”, which is narrowing. Therefore the present claims are anticipated. Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11457632. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a stable liquid antimicrobial disinfectant composition comprising: a. at least 95% of total weight of a carrier liquid; b. potassium iodide at a first effective concentration by weight; c. copper sulfate at a second effective concentration by weight; d. wherein a mixture of the first concentration of potassium iodide and the second concentration of copper sulfate generates an amount of free iodine in the composition of from about 100 ppm to about 330 ppm; e. wherein the carrier liquid does not include any metallo-peptides, acidifying agents, buffers or surfactants; and f. wherein the composition maintains a pH of from about 4.0 to about 7.0 without discoloration or solid iodine precipitation for at least 6 months. The difference is that the ‘632 patent’s claims recite a method of providing the stable liquid antimicrobial disinfectant composition. However the ‘632 patent does not recite steps that render the method distinct from the composition recited. The ‘632 patent’s claims also recite that the composition be “against coronavirus”; however this is narrowing. Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12156524. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a stable liquid antimicrobial disinfectant composition comprising: a. at least 95% of total weight of a carrier liquid; b. potassium iodide at a first effective concentration by weight; c. copper sulfate at a second effective concentration by weight; d. wherein a mixture of the first concentration of potassium iodide and the second concentration of copper sulfate generates an amount of free iodine in the composition of from about 100 ppm to about 330 ppm; e. wherein the carrier liquid does not include any metallo-peptides, acidifying agents, buffers or surfactants; and f. wherein the composition maintains a pH of from about 4.0 to about 7.0 without discoloration or solid iodine precipitation for at least 6 months. The difference is that the ‘524 patent’s claims recite a method of providing the stable liquid antimicrobial disinfectant composition. However the ‘524 patent does not recite steps that render the method distinct from the composition recited. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays. 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, Ali Soroush can be reached at (571)272-9925. 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. /H. SARAH PARK/Primary Examiner, Art Unit 1614
Read full office action

Prosecution Timeline

Jun 30, 2023
Application Filed
Mar 07, 2026
Non-Final Rejection — §102, §112, §DP (current)

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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
56%
Grant Probability
94%
With Interview (+38.3%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 705 resolved cases by this examiner. Grant probability derived from career allow rate.

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