Prosecution Insights
Last updated: May 29, 2026
Application No. 18/046,300

PD-1 SIGNAL INHIBITOR COMBINATION THERAPY

Final Rejection §103
Filed
Oct 13, 2022
Priority
Dec 07, 2015 — JP 2015-238511 +3 more
Examiner
DENT, ALANA HARRIS
Art Unit
1643
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kyoto University
OA Round
6 (Final)
45%
Grant Probability
Moderate
7-8
OA Rounds
1m
Est. Remaining
77%
With Interview

Examiner Intelligence

Grants 45% of resolved cases
45%
Career Allowance Rate
327 granted / 733 resolved
-15.4% vs TC avg
Strong +32% interview lift
Without
With
+32.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
47 currently pending
Career history
798
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
59.3%
+19.3% vs TC avg
§102
12.7%
-27.3% vs TC avg
§112
10.4%
-29.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 733 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 2. Claims 1, 4-10 and 21 and 22 are pending. Claims 11-20 have been cancelled. Claims 21 and 22 have been added. Claim 1 has been amended. Claims 1, 4-10, 21 and 22 are examined on the merits. Withdrawn Grounds of Rejection Claim Rejections - 35 USC § 103 3. The rejection of claim(s) 1, 4-10 and 19 under 35 U.S.C. 103 as being unpatentable over Prendergast, Patrick, US 2011/0142829 (published June 16, 2011) as evidenced by Suliman et al. (Current Pharmaceutical Design 20: 5653-5662, 2014), and further in view of Dimitrov et al. (Investigational New Drugs 10: 289-298, 1992) and Abdiche et al., US 2016/0159905 A1 (effective filing date December 9, 2014/ IDS reference AK submitted October 13, 2022) is withdrawn in light of the amendment to claim 1 deleting the compound, 4-methyl-5-(2-pyrazinyl)-3-dithiolethione (oltipraz) from the claim, see Amendments to the Claims/ Listing of the Claims submitted January 21, 2026. New and Maintained Grounds of Rejection Claim Rejections - 35 USC § 103 4. 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. 5. 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. 6. The rejection of claim(s) 1, 4-10 and new claim 21 under 35 U.S.C. 103 are rejected as being unpatentable over Grabacka et al. (Arch. Dermatol. Res. 296:54-58, published online 15 June 2004) as evidenced by Lee et al., US Patent 7,795,310 (issued September 14, 2010), and further in view Abdiche et al., US 2016/0159905 A1 (effective filing date December 9, 2014/ IDS reference AK submitted October 13, 2022) is maintained and made. Initially, Applicant asserts claim 1 has been “…amended to define the amount of the stub stance that regulates PGC-1a/transcription factor complex (e.g. bezafibrate) as between 10 mg/kg body weight – 2.5 mg/kg body weight” and the daily dosage cited in Grabacka, 25mg/kg “…falls well outside the scope of the amended range”, see Remarks submitted January 21, 2026, paragraph (para.) bridging pages 5 and 6. Applicant concludes arguments stating “[w]hile Lee may teach treatment of metabolic diseases using a combination of bezafibrate and diflunisal, at a dose of bezafibrate that overlaps with the range recited in the amended claims (10 µg/kg body weight - 2.5 mg/kg body weight), it must be recognized that Lee is directed to the treatment of metabolic diseases such as diabetes and obesity, conditions completely separate and unique from cancer and infection as recited in claim 1. It is asserted that one of ordinary skill in the art at the time of the invention would have lacked motivation to use the dosages for bezafibrate taught by Lee in the methods of treatment taught by Grabacka.”. see page 6, 1st para. Applicant’s amendment, points of view and arguments have been carefully considered, but are found unpersuasive. Applicant’s arguments in regard to Grabacka noting the prescribed dosage of 25mg/kg falls outside the scope of the range cited in amended claim 1, especially in light of the separate and unique conditions treated are not persuasive. First, "where 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). Hence, it would not be unreasonable for one of ordinary skill in the art to achieve the dosage range now reading on the upper limit of 2.5 mg/kg body weight. Notwithstanding, given the range of diseases and disorders of the treated population there is no evidence presented that would negate that this new dosage range would not be able to treat for instance ocular cancer, an infection caused by a parasite, hepatitis B with hepatocellular carcinoma. As noted in the last Action mailed November 12, 2025, the Examiner recognized claim 1 “[recite] a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent [as well as dosage] for another.”, see Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). These known therapeutic agents at the achieved dosages would inevitably render and achieve Applicant’s desired method endpoint of enhancing mitochondrial activation of T cells. This achieved synergistically effective amount of the combination of the substance that regulates PCG-1a/transcription factor complex with the PD-1 signaling inhibitor at the designated amounts would be met given it is art known dosage range and their effects would naturally flow from the combination of prior art herein. The Examiner has provided articulated reasoning with rational underpinning supporting the legal conclusion of obviousness. For the reasons cited herein, the combination of therapeutic agents would expectedly and predictably render synergistic treatment effects to the treated subject. Hence, the rejection is maintained for the reasons of record and cited herein. Thus, the rejection is maintained and made for the reasons of record herein. Grabacka teaches inhibiting melanoma metastases and the observation of significantly fewer metastatic foci in the lungs with the administration of fenofibrate, see page 54, Title and Abstract. Metastases is art known to be cancer cells that spread from their primary tumor site to different locations within the body. As evidenced by Lee, fenofibrate is art known as a bezafibrate analog, see column 2, lines 54-56; and Bezafibrate beginning in column 23. Bezafibrate has the chemical name, 2-(4-{2-[(4-chlorobenzoyl)amino]ethyl }phenoxy)-2-methylpropanoic acid. Grabacka teaches “[m]icronized fenofibrate…was administered orally in daily doses of 25 mg/kg…after tumors had become palpable…”, see page 54, 1st column, 1st full paragraph (para.). There was a reduction in the number of Bomirski hamster melanotic Ma melanoma (BHM Ma) metastases to the lungs when animals were treated with fenofibrate, see Figures on page 56 and in particular Figure 2B. Grabacka does not teach fenofibrate is administered in the amount of 10 ug/kg body weight – 2.5 mg/kg body weight in combination with a PD-1 signaling antibody inhibitor in an amount of 0.1-100 mg/kg body weight and more specifically in an amount of 1-10 mg/kg body weight. Abdiche teaches treating cancer with programmed cell death protein 1 (PD- 1) antibodies, see sections 0025-0029, 0031-0034 on page 2; and 0072 on page 7. The dosage range of administration is about “any of 3 μg/kg to 30 μg/kg to 300 μg/kg to 3 mg/kg, to 30 mg/kg, to 100 mg/kg or more,”, see page 26, section 0225. The taught antibodies include monoclonal, humanized, chimeric, as well as fragments thereof (such as Fv, Fab, Fab’, F(ab’)2, or other antigen-binding subsequences of antibodies that contain minimal sequence derived from non-human immunoglobulin.”, see section 0052 on page 4. There are also “fragments including complementarity determining regions (CDRs), single chain variable fragment antibodies (scFv), maxibodies, minibodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv, and polypeptides that contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide.”, see page 3, section 0047. The PD-1 antibodies can be administered with other therapeutic agents can “be used in conjunction with, or administered separately, simultaneously, or sequentially with other agents that serve to enhance and/or complement the effectiveness of the agents”, see page 25, sections 0214, 0219 and 0220. “[T]he anti-PD-1 antibody may precede or follow [another] agent treatment by intervals ranging from minutes to weeks”, see page 26, section 0230; and page 28, sections 0233-0235. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references in order to effectively treat the cancer, see all references. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both references combinatorial treatment may improve anti-tumor activity and may result in a synergistic effect and enhance one another, see Grabacka page 56, 2nd column, 2nd sentence; page 8 of Abdiche, section 0086, section 0214 on page 25; section 0229, page 26. Furthermore, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the listed teachings in the Abidche, as well as in the art that studies have been facilitated using different dosage amounts and implementing a range of said dosages is routine in experimentation. "[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). 7. The rejection of claim(s) 1, 4-10 and new claim 21 under 35 U.S.C. 103 are rejected as being unpatentable over Liu et al. (Journal of Cancer 6: 1214-1221, published 2015.09.20), and further in view of Lee et al., US Patent 7,795,310 (issued September 14, 2010) and Abdiche et al., US 2016/0159905 A1 (effective filing date December 9, 2014/ IDS reference AK submitted October 13, 2022) is maintained and made. Initially, Applicant asserts claim 1 has been “…amended to define the amount of the stub stance that regulates PGC-1a/transcription factor complex (e.g. bezafibrate) as between 10 mg/kg body weight – 2.5 mg/kg body weight”, see Remarks submitted January 21, 2026, page 7, 1st paragraph (para.). Applicant’s argues Lee teaches “…treatment of metabolic diseases such as diabetes and obesity” opposed to the cancer, infection or a combination thereof recited in the instant claims. Applicant further argues “…that one of ordinary skill in the art at the time of the invention would have lacked motivation to use the dosages for bezafibrate taught in Lee in the methods of treatment taught by Liu”, see page 7, 2nd para. Applicant concludes arguments stating, “[w]hile Lee may teach treatment of metabolic diseases using a combination of bezafibrate and diflunisal, at a dose of bezafibrate that overlaps with the range recited in the amended claims (10 µg/kg body weight - 2.5 mg/kg body weight), it must be recognized that Lee is directed to the treatment of metabolic diseases such as diabetes and obesity, conditions completely separate and unique from cancer and infection as recited in claim 1. It is asserted that one of ordinary skill in the art at the time of the invention would have lacked motivation to use the dosages for bezafibrate taught by Lee in the methods of treatment taught by Liu.”. see page 7, 2nd para. Applicant’s amendment, points of view and arguments have been carefully considered, but are found unpersuasive. First, "where 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). Hence, it would not be unreasonable for one of ordinary skill in the art to achieve the dosage range now reading on the upper limit of 2.5 mg/kg body weight. Notwithstanding, given the range of diseases and disorders of the treated population and no limiting, nor specific disorder/disease cited within the claims, there is no evidence presented that would negate that this new dosage range would not be able to treat for instance ocular cancer, an infection caused by a parasite, hepatitis B with hepatocellular carcinoma. As noted in the last Action mailed November 12, 2025, the Examiner recognized claim 1 “[recite] a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent [as well as dosage] for another.”, see Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). These known therapeutic agents at the achieved dosages would inevitably render and achieve Applicant’s desired method endpoint of enhancing mitochondrial activation of T cells. This achieved synergistically effective amount of the combination of the substance that regulates PCG-1a/transcription factor complex with the PD-1 signaling inhibitor at the designated amounts would be met given it is art known dosage range and their effects would naturally flow from the combination of prior art herein. Utilizing the knowledge known in the art regarding the ease at which bezafibrate and its analogs can be implemented in combination with additional therapeutic agents would not dissuade one of ordinary skill in the art from practicing the claimed invention. Furthermore, after arriving at the designated dose with art known technology there is no evidence the synergistic combination of fenofibrate at the designated amount with the PD-1 signaling inhibitor at the designated amount would not be achieved. These known therapeutic agents at the achieved dosages would inevitably render and achieve Applicant’s desired method endpoint of enhancing mitochondrial activation of T cells. And "where 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). The Examiner has provided articulated reasoning with rational underpinning supporting the legal conclusion of obviousness. For the reasons cited herein, the combination of therapeutic agents would expectedly and predictably render synergistic treatment effects to the treated subject. Hence, the rejection is maintained for the reasons of record and cited herein. Thus, the rejection is maintained and made for the reasons of record herein. Liu teaches “[u]sing a nude mice xenograft model, we also found that bezafibrate could inhibit tumor growth of lung [lung adenocarcinoma] AC in vivo.”, see Abstract on page 1214; paragraph bridging both columns on page 1216; Bezafibrate…segment on page 1218; Figure 3 on page 1219; and page 1220, column 1, lines 5-11. Liu does not teach bezafibrate is administered in the amount of 10 ug/kg body weight – 2.5 mg/kg body weight combination with a PD-1 signaling antibody inhibitor in an amount of 0.1-100 mg/kg body weight. However, Lee teaches bezafibrate with chemical name, 2-(4-{2-[(4- chlorobenzoyl)amino]ethyl }phenoxy)-2-methylpropanoic acid can be administered at dosages ranging from 0.001 mg (1 ug) to 2000 mg, as well in combination with additional therapeutic agents, see Bezafibrate segment spanning columns 23-25; Dosages in column 43, lines 48-56; Additional Therapeutic Agents beginning in column 29; and Additional Applications beginning in column 43. This dosage range overlaps with that noted in independent claim 1. Abdiche teaches treating cancer with programmed cell death protein 1 (PD- 1) antibodies, see sections 0025-0029, 0031-0034 on page 2; and 0072 on page 7. The dosage range of administration is about “any of 3 μg/kg to 30 μg/kg to 300 μg/kg to 3 mg/kg, to 30 mg/kg, to 100 mg/kg or more,”, see page 26, section 0225. The taught antibodies include monoclonal, humanized, chimeric, as well as fragments thereof (such as Fv, Fab, Fab’, F(ab’)2, or other antigen-binding subsequences of antibodies that contain minimal sequence derived from non-human immunoglobulin.”, see section 0052 on page 4. There are also “fragments including complementarity determining regions (CDRs), single chain variable fragment antibodies (scFv), maxibodies, minibodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv, and polypeptides that contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide.”, see page 3, section 0047. The PD-1 antibodies can be administered with other therapeutic agents can “be used in conjunction with, or administered separately, simultaneously, or sequentially with other agents that serve to enhance and/or complement the effectiveness of the agents”, see page 25, sections 0214, 0219 and 0220. “[T]he anti-PD-1 antibody may precede or follow [another] agent treatment by intervals ranging from minutes to weeks”, see page 26, section 0230; and page 28, sections 0233-0235. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references in order to effectively treat the cancer, see both references. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both references combinatorial treatment may improve anti-tumor activity and may result in a synergistic effect and enhance one another, see Liu, page 1220, column 1, lines 16-18; page 8 of Abdiche, section 0086, section 0214 on page 25; and section 0229, page 26. Furthermore, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the listed teachings in Liu, Lee and Abidche, as well as in the art that studies have been facilitated using different dosage amounts and implementing a range of said dosages is routine in experimentation. "[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). 8. Claim(s) 1, 4-10 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bianco et al., (The Journal of Biological Chemistry 284(35): 23286-2392, August 28, 2009), and further in view of Casaburi et al. (Oncotarget 6(28): 25135-25148, published July 29, 2015) and Abdiche et al., US 2016/0159905 A1 (effective filing date December 9, 2014/ IDS reference AK submitted October 13, 2022). Bianco teaches XCT790 (3-[4-(2,4-bis-trifluoromethylbenzyl oxy)-3-methoxyphenyl]-2-cyano-N-(5-trifluoromethyl-[1,34] thiadiazol-2-yl)-acrylamide results in reduced tumorgenicity and “…delayed tumorigenicity of MCF7cells in Nude mice”, see page 23286, abstract and 2nd column (col.), 1st full paragraph (para.); Figure 1E on page 23288; and para. bridging the columns on page 23290. The synthetic compound was used at the concentration of 5uM except for dose-response experiment, see page 23287, 1st col., last sentence before Proliferation…subtitle. Bianco does not teach XCT790 is administered in the amount of 10 ug/kg body weight – 2.5 mg/kg body weight in combination with a PD-1 signaling antibody inhibitor in an amount of 0.1-100 mg/kg body weight. However, Casaburi teaches animals with H295R adrenocortical carcinoma (ACC) cell xenograft tumors were injected with XCT790 at a dose of 2.5 mg/Kg, see page 25136, 2nd col., 2nd para.; Figure 2A and Figure 2B on page 25138; and page 25145, col. 1, Xenograft…segment, 2nd para. Abdiche teaches treating cancer with programmed cell death protein 1 (PD- 1) antibodies, see sections 0025-0029, 0031-0034 on page 2; and 0072 on page 7. The dosage range of administration is about “any of 3 μg/kg to 30 μg/kg to 300 μg/kg to 3 mg/kg, to 30 mg/kg, to 100 mg/kg or more,”, see page 26, section 0225. The taught antibodies include monoclonal, humanized, chimeric, as well as fragments thereof (such as Fv, Fab, Fab’, F(ab’)2), or other antigen-binding subsequences of antibodies that contain minimal sequence derived from non-human immunoglobulin.”, see section 0052 on page 4. There are also “fragments including complementarity determining regions (CDRs), single chain variable fragment antibodies (scFv), maxibodies, minibodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv, and polypeptides that contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide.”, see page 3, section 0047. The PD-1 antibodies can be administered with other therapeutic agents can “be used in conjunction with, or administered separately, simultaneously, or sequentially with other agents that serve to enhance and/or complement the effectiveness of the agents”, see page 25, sections 0214, 0219 and 0220. “[T]he anti-PD-1 antibody may precede or follow [another] agent treatment by intervals ranging from minutes to weeks”, see page 26, section 0230; and page 28, sections 0233-0235. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references in order to effectively treat the cancer. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in the references combinatorial treatment may improve anti-tumor activity and may result in a synergistic effect and enhance one another, see page 8 of Abdiche, section 0086, section 0214 on page 25; and section 0229, page 26. Furthermore, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the listed teachings in Bianco, Casaburi and Abidche, as well as in the art that studies have been facilitated using different dosage amounts and implementing a range of said dosages is routine in experimentation. "[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). 9. Claim(s) 1, 4-10 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casaburi et al. (Oncotarget 6(28): 25135-25148, published July 29, 2015), and further in view of Abdiche et al., US 2016/0159905 A1 (effective filing date December 9, 2014/ IDS reference AK submitted October 13, 2022). Casaburi teaches animals with H295R adrenocortical carcinoma (ACC) cell xenograft tumors were injected with XCT790 at a dose of 2.5 mg/Kg, see page 25136, 2nd column (col.), 2nd paragraph (para.); Figure 2A and Figure 2B on page 25138; and page 25145, col. 1, Xenograft…segment, 2nd para. Casaburi does not teach XCT790 is administered in the amount of the lower limit of the range, 10 ug/kg body weight – 2.5 mg/kg body weight in combination with a PD-1 signaling antibody inhibitor in an amount of 0.1-100 mg/kg body weight. However, Abdiche teaches treating cancer with programmed cell death protein 1 (PD- 1) antibodies, see sections 0025-0029, 0031-0034 on page 2; and 0072 on page 7. The dosage range of administration is about “any of 3 μg/kg to 30 μg/kg to 300 μg/kg to 3 mg/kg, to 30 mg/kg, to 100 mg/kg or more,”, see page 26, section 0225. The taught antibodies include monoclonal, humanized, chimeric, as well as fragments thereof (such as Fv, Fab, Fab’, F(ab’)2), or other antigen-binding subsequences of antibodies that contain minimal sequence derived from non-human immunoglobulin.”, see section 0052 on page 4. There are also “fragments including complementarity determining regions (CDRs), single chain variable fragment antibodies (scFv), maxibodies, minibodies, intrabodies, diabodies, triabodies, tetrabodies, v-NAR and bis-scFv, and polypeptides that contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide.”, see page 3, section 0047. The PD-1 antibodies can be administered with other therapeutic agents can “be used in conjunction with, or administered separately, simultaneously, or sequentially with other agents that serve to enhance and/or complement the effectiveness of the agents”, see page 25, sections 0214, 0219 and 0220. “[T]he anti-PD-1 antibody may precede or follow [another] agent treatment by intervals ranging from minutes to weeks”, see page 26, section 0230; and page 28, sections 0233-0235. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references in order to effectively treat the cancer, see Abidche. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in the references combinatorial treatment may improve anti-tumor activity and may result in a synergistic effect and enhance one another, see page 8 of Abdiche, section 0086, section 0214 on page 25; and section 0229, page 26. Furthermore, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the listed teachings in Casaburi and Abidche, as well as in the art that studies have been facilitated using different dosage amounts and implementing a range of said dosages is routine in experimentation. "[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). Conclusion 10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. 11. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached on 8AM-8PM, Monday through Friday and occasionally Saturday evening. 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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. ALANA HARRIS DENT Primary Examiner Art Unit 1643 23 April 2026 /Alana Harris Dent/Primary Examiner, Art Unit 1643
Read full office action

Prosecution Timeline

Show 15 earlier events
May 13, 2025
Response after Non-Final Action
Jul 29, 2025
Applicant Interview (Telephonic)
Aug 08, 2025
Request for Continued Examination
Aug 11, 2025
Response after Non-Final Action
Sep 15, 2025
Examiner Interview Summary
Nov 12, 2025
Non-Final Rejection mailed — §103
Jan 21, 2026
Response Filed
May 06, 2026
Final Rejection mailed — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12601742
METHODS AND MATERIALS FOR TREATING ENDOMETRIAL CANCER
3y 5m to grant Granted Apr 14, 2026
Patent 12594344
PRODUCTION OF EXOSOMES AND USES THEREOF
3y 4m to grant Granted Apr 07, 2026
Patent 12589165
METHODS FOR TREATING BLADDER TUMORS WITH VIRAL NANOPARTICLE CONJUGATES AND IMMUNE CHECKPOINT INHIBITORS.
4y 7m to grant Granted Mar 31, 2026
Patent 12589132
CD80 EXTRACELLULAR DOMAIN FC FUSION PROTEINS FOR TREATING PD-L1 NEGATIVE TUMORS
4y 7m to grant Granted Mar 31, 2026
Patent 12590964
MATERIALS AND METHODS FOR EXTRACELLULAR VESICLE DETECTION
3y 9m to grant Granted Mar 31, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

7-8
Expected OA Rounds
45%
Grant Probability
77%
With Interview (+32.4%)
3y 8m (~1m remaining)
Median Time to Grant
High
PTA Risk
Based on 733 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month