Prosecution Insights
Last updated: April 18, 2026
Application No. 18/037,119

STORING AND/OR TRANSPORTING EXTRACELLULAR NUCLEIC ACIDS

Non-Final OA §102§103§112
Filed
May 16, 2023
Examiner
VAN BUREN, LAUREN K
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Atelerix Limited
OA Round
1 (Non-Final)
39%
Grant Probability
At Risk
1-2
OA Rounds
4y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants only 39% of cases
39%
Career Allow Rate
158 granted / 407 resolved
-21.2% vs TC avg
Strong +57% interview lift
Without
With
+57.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 5m
Avg Prosecution
56 currently pending
Career history
463
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
47.5%
+7.5% vs TC avg
§102
11.0%
-29.0% vs TC avg
§112
23.0%
-17.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 407 resolved cases

Office Action

§102 §103 §112
DETAILED ACT I ON 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. Restriction/Election Applicant's election with traverse of Group II (Claims 12-14,21-22,24,26-27,and 30-31 ) in the reply filed on March 16, 2026 is acknowledged. The traversal is on the ground that the reference cited in the restriction (dated 01/12/2026) does not teach a reversibly cross-linked RNA-containing hydrogel. This argument is not found persuasive because the claims were ame nded to recite RNA after the initial restriction. Furthermore, the examiner has found additional art that teaches the new claim amendments. The requirement is still deemed proper and is therefore made FINAL. Claims 1-3,5, and 7-10 (Group I) are canceled. Claims 16,18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups III-V, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 12, 2026. Duplicate Claims Applicant is advised that should claim 26 be found allowable, claim 30 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). 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. Claim 31 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. Claim 31 recites limitations concerning the “cross-linked alginate.” There is not proper antecedent basis since there is no mention of a cross-linked alginate in the independent claim 12. Claim Rejections - 35 USC § 102 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. Claim s 12-14,24, 26, and 30 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chetverin (5,616,478) Chetverin discloses a method of preparing a sample comprising extracellular RNA for storage, the method comprising the steps of: i) contacting the sample with a hydrogel-forming polymer; and ii) polymerizing the polymer to form a reversibly cross-linked RNA-containing hydrogel (Columns 7,9-10 , Figure 2 and its brief description, Example 1 of Chetverin ) as in instant Claim 1 2 . Chetverin discloses mixing the extracellular RNA with an aqueous buffer prior to step (i) (Column 1, line 23-25 of Chetverin ) as in instant Claim 13 . Ch etverin discloses sealing the RNA-containing hydrogel into a receptable for storage (Column 8, ln 35-50 of Chetverin ) as in instant Claim 14 . Chetverin discloses an aqueous buffer (Column 1, line 20-30) as in instant Claim 24 . Chetverin discloses wherein the hydrogel comprises cross-linked calcium alginate (Column 9, last paragraph of Chetverin) as in instant Claim s 26 and 30 . The references anticipates the claim limitations. Claim s 12,21-22 , 26 , and 30 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Garver (US 6,916,490) Garver disclose s a method of preparing a sample comprising extracellular RNA for storage, the method comprising the step of: contacting the sample with a hydrogel-forming polymer; and polymerizing the polymer to form a reversibly cross-linked RNA containing hydrogel (Abstract ; Column 2, ln 55-67;Column 3, ln 15-20; Column 7, ln 15-20; Column 8, ln 10-20 ;Column 14, ln 1-28; Column 21, ln 58-65 of Garver ) as in instant Claim 12 . Garver discloses wherein the extracellular RNA is within a li pid capsule (Column 4, ln 2 of Garver ) as in instant Claim 21 . Garver discloses wherein the extracellular RNA is a viral vector or a viral particle ( Column 15, ln 1-5; Column 19 of Garver) as in instant Claim 22 . Garver discloses wherein the hydrogel comprises cross-linked calcium alginate (Column 14, ln 1-28 ; Claim 29, Clam 31 of Garver ) as in instant Claim 26 and 30 . The references anticipates the claim limitations. 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. Claim s 12-14, 24, 26-27 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Chetverin (5,616,478) in view of C.l Bucke “Cell Immobilization in Calcium Alginate” Methods in Enzymology, Volume 135, 1987, Pages 175-189. Chetverin applies as above to teach claims 12-14, 24, 26, and 30. Chetverin does not specifically teach the amount of calcium -alginate . However, the Chetverin reference does refer to the reference, Bucke “ Cell Immobilization in Calcium Alginate” Methods, Enzymol. 135, 175-189 when discussing calcium-alginate . Bucke teaches that the amount of calcium alginate in such a composition can be about 2.4 % (Page 18 8 , 4 th paragraph). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the amount of calcium -alginate taught by Bucke . An artisan would have been motivated to have used Bucke’s amount of c alcium alginate since it allows for the successful encapsulation of a biological specimen and preserves the activity of th at biological specimen ( Page 188, 4 th paragraph of Bucke ). Because that concentration of calcium alginate allows for the successful encapsulation of a biological specimen, there would have been a high expectation for success (Page 188, 4 th paragraph of Bucke ) as in instant Claim s and 27 and 31 . Chetverin teaches a hydrogel that comprises a cross-linked calcium alginate but does not teach the precise amount of calcium alginate. An artisan would have been motivated to have used the amount of calcium alginate taught by Bucke (2.4%) since it successfully preserves the activity of the encapsulated biological specimen. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention. All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ) . People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, and engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have pr actical knowledge in nucleic acid delivery systems. Therefore, the level of ordinary skill in the art is high. Claim s 12,21-22,26-27, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Garver (US 6,916,490) in view of C.l Bucke “Cell Immobilization in Calcium Alginate” Methods in Enzymology, Volume 135, 1987, Pages 175-189. Garver applies as above to teach claims 12,21-22, 26, and 30 . Garver does not teach the amount of calcium-alginate. Bucke teaches that the amount of calcium alginate in such a composition can be about 2.4% (Page 188, 4 th paragraph of Bucke ). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the amount of calcium-alginate taught by Bucke. An artisan would have been motivated to have used Bucke’s amount of calcium alginate solution since it allows for the successful encapsulation of a biological specimen and preserves the activity of the biological specimen (Page 188, 4 th paragraph of Bucke). Because that concentration of calcium alginate allows for the encapsulation of a biological specimen and preserves its activity , there would have been a high expectation for success (Page 188, 4 th paragraph of Bucke) as in instant Claim s and 27 and 31 . Garver teaches a hydrogel containing RNA that comprises a cross-linked calcium alginate but does not teach the precise amount of calcium alginate. An artisan would have been motivated to have used the amount of calcium alginate taught by Bucke (2.4%) since it successfully preserves the activity of the encapsulated biological specimen. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention. All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, and engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have practical knowledge in nucleic acid delivery systems. Therefore, the level of ordinary skill in the art is high. Conclusion All claims stand rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LAUREN K VAN BUREN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1025 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F:9:30am-5:40pm; 9:00-10:00pm . 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 Tracy Vivlemore can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2914 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT LAUREN K. VAN BUREN Examiner Art Unit 1638 /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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Prosecution Timeline

May 16, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §102, §103, §112 (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
39%
Grant Probability
96%
With Interview (+57.3%)
4y 5m
Median Time to Grant
Low
PTA Risk
Based on 407 resolved cases by this examiner. Grant probability derived from career allow rate.

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