Prosecution Insights
Last updated: April 19, 2026
Application No. 17/266,502

PARN AS A BIOMARKER AND THERAPEUTIC TARGET

Final Rejection §101§103§112§DP
Filed
Feb 05, 2021
Examiner
TRAN, CHRISTINA L
Art Unit
1637
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of Colorado
OA Round
3 (Final)
43%
Grant Probability
Moderate
4-5
OA Rounds
4y 2m
To Grant
98%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allow Rate
19 granted / 44 resolved
-16.8% vs TC avg
Strong +54% interview lift
Without
With
+54.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
55 currently pending
Career history
99
Total Applications
across all art units

Statute-Specific Performance

§101
6.5%
-33.5% vs TC avg
§103
30.5%
-9.5% vs TC avg
§102
14.1%
-25.9% vs TC avg
§112
35.3%
-4.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 44 resolved cases

Office Action

§101 §103 §112 §DP
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 . DETAILED ACTION Applicant’s amendments and remarks filed on September 15, 2025 are acknowledged. Claims 2, 3, 6-18, 20-45, 48-52, and 54-101 have been canceled. Claims 1, 4, 5, 46, and 47 were amended. It is noted that the amendment to the claims filed on 9/15/2025 does not comply with the requirements of 37 CFR 1.121(c) because all amendments are not shown with markings relative to the immediate prior version of the claim. For example, claim 47 recites “[[a]] the control sample” without showing underline for “the.” However, in the interest of compact prosecution, the amendment to the claims has been entered. Claims 1, 4, 5, 19, 46, 47, and 53 are pending and are examined on the merits herein. Withdrawn Objections In view of Applicant’s amendments and response, the objection to claims 1 and 46 is withdrawn. Withdrawn Rejections In view of Applicant’s amendments and response, the 35 U.S.C 112(b), 35 U.S.C 112(d), and 35 U.S.C. 102 rejections are withdrawn. Specification The disclosure is objected to because of the following informalities: In the brief description of figures section, Figures 1A, 3A, 6, and 7 refer to colors. However, the application does not have colored drawings. Appropriate correction is required. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant’s remarks did not address the objection to the specification; therefore, the Examiner is maintaining the objection. Claim Objections Claims 1, 5, and 46 are objected to because of the following informalities: Claim 1 part b) recites i), iii), and iv) and should recite i), ii), and iii). Claim 1 part c) recites “monoclonal and antibody therapy” and should recite “and monoclonal antibody therapy”. Claim 5 recites “The method of claim 1, wherein the the level”. There should only be one instance of “the”. Claim 46 part (iii) recites “monoclonal and antibody therapy” and should recite “and monoclonal antibody therapy”. Appropriate correction is required. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. In the Office Action mailed on March 14, 2025, claim 1 part b) was objected to for reciting “iii)” twice. Applicant amended the second iteration of “iii)” to “iv)”. However, the first iteration of “iii)” should be “ii)” and “iv)” should be “iii)”. 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. Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, natural phenomenon, or an abstract idea) without significantly more. Claim 4 (reproduced below) includes all of the limitations of claim 1; however, claim 4 substitutes part c) of claim 1 with “wherein the level of PARN corresponds with: a) the absence of a cancer”. PNG media_image1.png 244 800 media_image1.png Greyscale As outlined below, this judicial exception is not integrated into a practical application, and does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Subject Matter Eligibility Test for Products and Processes – Claim 4 Step 1 – Is the claim to a Process, Machine, Manufacture or Composition of Matter? YES. Claim 4 is directed to the method of claim 1 wherein the level of PARN corresponds with: a) the absence of a cancer, or b) the presence of a cancer not involving loss or reduction in p53 function or p53 signaling and the method comprises identifying the subject as having the cancer involving loss or reduction in Liver Kinase B1 (LKB1) based on higher level of PARN in the test sample as compared to the reference value; therefore, the claim is directed to a statutory category. Step 2A, Prong One – Does the claim recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES. Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. MPEP 2106.04(c) outlines the markedly different characteristics analysis. Claim 4 recites in part “wherein the level of PARN corresponds with: a) the absence of a cancer” which is a natural law. Step 2A, Prong Two – Does the Claim recite Additional Elements that Integrate the Judicial Exception into a Practical Application? NO. The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. The phrase "integration into a practical application" requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. In the instant case, claim 4 includes the additional elements of parts a) and b) of claim 1. However, claim 4 encompasses an embodiment (claim 4 part a)) in which no treatment is required. Step 2B – Does the Claim recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO. The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to "significantly more" than the judicial exception(s) itself. The claim as a whole is evaluated as to whether it amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). Although claim 4 includes the additional elements of parts a) and b) of claim 1, determining the level of PARN and measuring the levels of PARN from a control sample are directed to steps for routine data gathering in order for one to make the comparison and does not add a meaningful limitation as they would be used by those of ordinary skill in the art. Thus, the limitations are directed to extra-solution activity that does not integrate the judicial exception into a practical application. Thus, claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a law of nature without significantly more. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant asserts that amending the independent claim to remove the negative limitation of withholding, or not providing a therapeutic invention, overcomes the 35 U.S.C. 101 rejection. Claim 4 depends on claim 1 which recites a method of treating a subject having a cancer involving loss or reduction in p53 function or p53 signaling. Claim 4 part a) as currently written recites in part the method of claim 1 wherein the level of PARN corresponds with the absence of a cancer; therefore, claim 4 part a) does not require treatment and thus there is no practical application. 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. Claims 1, 4, 5, and 19 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. Claim 1 is indefinite because the claim recites conflicting definitions for the phrase “the control sample”. Specifically, the claim recites PNG media_image2.png 242 678 media_image2.png Greyscale and the claim also recites PNG media_image3.png 162 602 media_image3.png Greyscale . Thus, it is unclear whether or not the control sample is limited to a subject known to have cancer or whether or not the second definition of “control sample” is redundant. In addition, it is also unclear whether or not all three options [parts b) i), b) iii), and b) iv)] are still included in the scope of the claim. Claims 4, 5, and 19 are indefinite because the claims depend from a rejected claim (claim 1) without addressing the issue in claim 1. Claims 4 and 5 are indefinite at the recitation of “the level of PARN”. Claims 4 and 5 depend on claim 1 and claim 1 sets forth a level of PARN for the test sample and the control sample. Therefore, it is unclear which level of PARN claims 4 and 5 is referring to. Claims 4 and 5 recite the limitation "the reference value". There is insufficient antecedent basis for this limitation in the claims. In addition, it is unclear what is meant by “reference value” and how a “reference value” is obtained. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant amended claims 4 and 5; however, the last line of claims 4 and 5 still recite the limitation “the reference value”. As indicated in the original 35 U.S.C. 112(b) rejection, there is insufficient antecedent basis for this limitation in the claims. In addition, it is unclear what is meant by “reference value” and how a “reference value” is obtained. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 4, 5, and 53 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites the following: PNG media_image4.png 236 818 media_image4.png Greyscale . However, claim 1 recites a method of treating a subject having a cancer involving loss or reduction in p53 function or p53 signaling. Claim 4 part a) recites that the level of PARN corresponds with the absence of a cancer and recites in part b) that the level of PARN corresponds with the presence of a cancer not involving loss or reduction in p53 function or p53 signaling (emphasis added). Therefore, limitations of the dependent claim are substituted with different limitations than the independent claim and are outside the scope of the independent claim. Claim 5 recites PNG media_image5.png 176 812 media_image5.png Greyscale and is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph because there is insufficient antecedent basis for the limitation ("the reference value") in the claim. However, the Examiner is interpreting the phrase “the reference value” in claim 5 to be the same as the phrase “the control sample” (as recited in claim 1 part b iv)) and thus claim 5 fails to further limit the claim which it depends on. If claim 1 is interpreted as being limited to PNG media_image6.png 206 742 media_image6.png Greyscale then the limitation of claim 5 is already present in claim 1. Thus, claim 5 does not add a further limitation to claim 1. Claim 53 recites the method of claim 47 wherein the control sample in step (v) is a noncancerous cell. Claim 47 was amended to refer to “the control sample” in part (v) which refers back to the control sample of claim 46. Claim 53 substitutes the control sample of claim 47 with a different control sample; therefore, claim 53 no longer includes all of the limitations of the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. Written Description Claims 1, 4, 5, and 19 are 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. Claims 1, 4, 5, and 19 are drawn to the genus of levels of PARN that indicate the presence or absence of a cancer involving loss or reduction in p53 function and thus embrace methods of identifying a subject as having any type of cancer involving loss or reduction in p53 function based on any level of PARN in the test sample. Applicant is referred to MPEP 2163(II)(A)(3)(a)(i and ii), which indicates that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure indicates that the patentee has invented species sufficient to constitute the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. The instant specification discloses on page 18 that the amount of PARN protein in the cytoplasm or the nuclease of a cell may be measured as well as the total amount of phosphorylated PARN protein. The relative increase in total phosphorylated PARN protein or phosphorylated PARN protein may be compared to a non-cancerous cell or a cell that has not been exposed to a genotoxic agent. The relative decrease in total phosphorylated PARN protein or phosphorylated PARN protein may be compared to a cancer cell or a cell that has been exposed to a genotoxic agent [page 19, first full paragraph]. The instant specification also discloses on page 34 that a patient that is measured as having cells with one or more features of PARN activity and, optionally, one or more features of p53 pathway activity, is diagnosed as having a chemotherapy-resistant cancer. On the other hand, a patient that is measured as having cells with one or more features of PARN inactivity and, optionally, one or more features of p53 pathway activity, is diagnosed as having a chemotherapy-sensitive cancer. However, the specification does not provide any correlation between any level of PARN and any type of cancer. Maragozidis et al. (Molecular Cancer 2015) discloses that the overall survival in squamous cell lung cancer patients overexpressing PARN was seven months longer than in patients that underexpress the same enzyme [Figure 3]. Therefore, it is unclear what level of PARN indicates the presence or absence of a cancer, such as one involving loss or reduction in p53 function. In view of the potential breadth of genus of levels of PARN that indicate the presence or absence of a cancer involving loss or reduction in p53 function embraced by the claims and the lack of reduction to practice of species embraced by the claims, there is a failure to satisfy the written description requirement. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant asserts that the claims have been amended to address the concerns related to the levels of the biomarkers to be measured and compared to a control sample; however, the claims stand rejected under 35 U.S.C. 112(a) for the reasons of record. 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. Claims 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yaffee et al. (US 2012/0252737; reference cited by Applicant). Regarding claims 1 and 19, Yaffee et al. teaches methods of treating a cancer patient diagnosed as having a chemotherapy-resistant cancer requiring the step of administering to the patient one or more MK2 inhibitor(s) and may further include administering one or more chemotherapeutic agent(s) [0027]. In addition, Yaffee et al. teaches methods of treating a cancer patient diagnosed as having a chemotherapy-sensitive cancer comprising the step of administering to the patient one or more chemotherapeutic agent(s) [0028]. In additional embodiments of the provided kits, the one or more reagent(s) in (a) are selected from the group of an antibody that binds to phosphorylated, nonphosphorylated, or total PARN and the one or more reagent(s) in (b) are selected from the group of: an antibody binding to p53 protein; an oligonucleotide containing a sequence complementary to a nucleic acid sequence encoding a wild type p53 protein; one or more nucleic acid primer(s) complementary to a nucleic acid sequence encoding a wild type p53 protein; an oligonucleotide containing a sequence complementary to a nucleic acid sequence encoding a mutant or truncated p53 protein; one or more nucleic acid primer(s) complementary to a nucleic acid sequence encoding a mutant or truncated p53 protein; and an antibody that binds to p21 [0033]. Further, the kits that provide reagents for diagnosing a chemotherapy-resistant cancer or a chemotherapy-sensitive cancer in a subject may contain for example one or more reagent(s) capable of measuring one or more feature(s) in a cancer cell(s) from a patient selected from the group of levels of phosphorylated PARN and one or more reagents capable of measuring one or more feature(s) in a cancer cell(s) from said patient selected from the group consisting of: tumor protein-53 (p53) mRNA or protein levels and expression of a mutant or truncated p53 with decreased expression or activity [0155]. MK2 pathway inactivation or MK2 pathway activation and p53 pathway inactivation may be performed using a sample of cells from a patient (e.g., a biopsy sample or blood sample) or a cellular lysate prepared from cells from a patient. A patient that is measured as having cells with one or more features of MK2 pathway activation and, optionally, one or more features of p53 pathway inactivation, is diagnosed as having a chemotherapy-resistant cancer (e.g., a patient that may benefit from the administration of one or more MK2 inhibitor(s) or the combination of one or more MK2 inhibitor(s) and one or more chemotherapeutic agent(s)). A patient that is measured as having cells with one or more features of MK2 pathway inactivation and, optionally, one or more features of p53 pathway inactivation, is diagnosed as having a chemotherapy-sensitive cancer (e.g., a patient that may benefit from administration of one or more chemotherapeutic agent(s)) [0161]. Yaffee et al. teaches a kit for diagnosing a chemotherapy-resistant or chemotherapy-sensitive cancer in a patient comprising: one or more reagent(s) capable of measuring one or more feature(s) in a cancer cell(s) from said patient selected from the group consisting of: levels of phosphorylated poly(A)-specific ribonuclease (PARN) and b) instructions for using the reagents of (a) to determine the presence of a chemotherapy-resistant or chemotherapy-sensitive cancer in said patient [claim 71]. Yaffee et al. also teaches the kit of claim 71, wherein said one or more reagent(s) in (a) are selected from the group consisting of: an antibody that binds to phosphorylated, nonphosphorylated, or total PARN [claim 73]. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to determine that any change in the amount of phospho-PARN is not solely due to degradation of total PARN instead of an effect on the phosphorylation reaction and thus it would be helpful to measure the total PARN through the use of the total PARN antibody in the kit. Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant asserts that amending claim 1 to include the limitations of claim 3 overcomes the 35 U.S.C. 103 rejection. However, for the purposes of examination, claim 1 is interpreted as wherein the control sample is obtained from: PNG media_image7.png 238 742 media_image7.png Greyscale . See rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph above. Therefore, amending claim 1 to include the limitations of claim 3 does not overcome the 35 U.S.C. 103 rejection. 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, 4, 5, 19, 46, 47, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/794,630 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims overlap in scope. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. PNG media_image8.png 642 584 media_image8.png Greyscale PNG media_image9.png 773 591 media_image9.png Greyscale PNG media_image10.png 784 586 media_image10.png Greyscale PNG media_image11.png 172 586 media_image11.png Greyscale Response to Arguments Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant indicates that a Terminal Disclaimer was concurrently filed with Applicant’s response; however, the Terminal Disclaimer filed was disapproved. The Terminal disclaimer was disapproved for the following reasons: 1. The applicant is not cited on the TD. The applicant cited on the TD must be cited exactly as it is cited on the ADS and/or filing receipt and also in its entirety. If more space for the applicant section is required, please use smaller font or submit an attachment page to the TD. 2. This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b). Please file a POA that gives power to the attorney who is signing the TD, along with another copy of the TD, or file a TD that is signed by the applicant. The TD may be resubmitted without a new fee payment. Therefore, the Examiner is maintaining the nonstatutory double patenting rejection. Conclusion No claims are allowed. THIS ACTION IS MADE FINAL. 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 CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm. 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, Jennifer Dunston can be reached on (571) 272-2916. 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. /C.T./ Examiner, Art Unit 1637 /Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637
Read full office action

Prosecution Timeline

Feb 05, 2021
Application Filed
Jan 22, 2024
Non-Final Rejection — §101, §103, §112
Oct 07, 2024
Response after Non-Final Action
Dec 04, 2024
Response Filed
Mar 04, 2025
Non-Final Rejection — §101, §103, §112
Sep 15, 2025
Response Filed
Oct 23, 2025
Final Rejection — §101, §103, §112 (current)

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Prosecution Projections

4-5
Expected OA Rounds
43%
Grant Probability
98%
With Interview (+54.4%)
4y 2m
Median Time to Grant
High
PTA Risk
Based on 44 resolved cases by this examiner. Grant probability derived from career allow rate.

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