Prosecution Insights
Last updated: April 18, 2026
Application No. 17/437,477

Culture Method for Head and Neck Organoids

Final Rejection §102§103§DP
Filed
Sep 09, 2021
Examiner
DUTT, ADITI
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Koninklijke Nederlandse Akademie Van Wetenschappen
OA Round
2 (Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
4y 4m
To Grant
95%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
178 granted / 377 resolved
-12.8% vs TC avg
Strong +48% interview lift
Without
With
+47.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
22 currently pending
Career history
399
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
34.4%
-5.6% vs TC avg
§102
19.4%
-20.6% vs TC avg
§112
24.0%
-16.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 377 resolved cases

Office Action

§102 §103 §DP
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 . DETAILED ACTION Status of Application, Amendments and/or Claims 2. Applicant’s response dated 1/21/2026 is considered and entered into record. Claims 1-3, 5 and 14 have been amended. Claim 19 is canceled. Claims 1-3, 5, 8, 10, 12-16, 18, 20-24 and 30-33 are pending. 3. Claims 21-24 and 30-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2 June 2025. 4. Claims 1-3, 5, 8, 10, 12-16, 18 and 20, drawn to a method for culturing epithelial stem cells derived from oral mucosa, gingiva, mandibula, tongue, larynx or pharynx, are considered for examination in the instant application. Objections/Rejections withdrawn 5. Upon consideration of the drawing corrections, the objection to drawings is withdrawn. 6. Upon consideration of appropriate corrections of the listed informalities in the specification, the objection is withdrawn. 7. Upon consideration of amendment of claim 1, the rejections under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 are withdrawn. 8. Upon consideration of amendment of claim 1, the rejections under obviousness double patenting are withdrawn. New Rejections – as necessitated by current amendment Claim Rejections - 35 USC § 102 9. 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. 10. Claims 1-3, 8, 10, 12-13, 16, 18 and 20 are rejected under AIA 35 U.S.C. 102(a)(1) as being anticipated by Ortega et al WO2015/173425 (IDS), 11/19/2015, as evidenced by Salivary gland (<Salivary gland - Wikipedia> downloaded on 3/23/2026, 11 pages) and Ornitz et al (WIREs Dev Biol 4: 215-266, 2015). 11. The claims are directed to a method for culturing an epithelial stem cell or a population of such cells derived from oral mucosa, gingiva, mandibula, tongue, larynx or pharynx, comprising culturing the cells in contact with an extracellular matrix (ECM) in the presence of an expansion medium comprising a basal medium for animal or human cells, and further comprising mitogenic growth factor (GF) comprising: a factor that binds to EGFR; an FGF binding to FGFR or FGFR4; and an FGF binding to all of FGFR1, FGFR2, FGFR3 and FGFR4; TGF-beta inhibitor; prostaglandin (PG) signaling pathway activator; one or more Wnt agonist and a GSK-3 inhibitor; cAMP pathway activator; BMP inhibitor and nicotinamide (claim 1), selected from those in claim 2; and wherein: the medium further comprises B27 and/or N-acetyl-L-cysteine (claim 13); and the epithelial stem cell/s is part of or isolated from an organoid, or are tumour cells (claim 16). Claim 18 recites that the method further comprises culturing the expanded epithelial stem cells in a differentiation medium, and claim 20 recites that the culturing is done for a sufficient number of days to obtain an organoid. The claims also recite that GSK-3 inhibitor is CHIR-99021 (claim 3); prostaglandin signaling pathway activator is PGE2 (claim 8); cAMP pathway activator is forskolin (claim 10); and nicotinamide concentration is between 1 and 100 mM (claim 12). 12. Ortega et al teach a culture method comprising expanding epithelial stem cells and obtaining organoids (Abstract). The reference teaches that the method comprises culturing one or more epithelial stem cells derived from salivary gland (page 4, lines 8-9) in contact with an extracellular matrix in the presence of an expansion medium which comprises a basal medium for human or animal cells, wherein the medium comprises receptor tyrosine kinase ligands (mitogenic growth factors) comprising EGF (that binds to EGFR) and FGF; a TGF-beta inhibitor like ALK4, ALK 5, ALK7 or A83-01; an activator of prostaglandin (PG) signaling pathway like arachidonic acid or PGE2 (page 19, lines 24-26; page 20, lines 1-3; page 24, lines 1-2, 7-8); one or more Wnt agonist that is a Lgr5 agonist like Rspondin (R-spondin) selected from R-spondin (1-4) and a GSK inhibitor such as CHIR99021 (or CHIR-99021); cAMP pathway activator like forskolin; BMP inhibitor like Noggin (page 21, line 19) and nicotinamide, the medium further comprising B27 and N-acetylcysteine (page 2, lines 24-29, 31-33; page 3, lines 2-6, 8, 11-14; page 14, lines 23-24, 27), wherein the epithelial stem cells can be from any mammalian tissue such as human or mouse (non-human mammal) (page 48, lines 19-21). The reference also teaches that FGF is selected from a FGF that binds to FGFR4, like FGF10 (page 3, lines 2-4), and FGF19 (page 3, lines 24-25). As evidenced by Ornitz et al (Figure 2; page 221, last 2 lines), FGF19 is known to have a receptor specificity for all four FGFRs (FGFR1, FGFR2, FGFR3, FGFR4). Also to be noted is that salivary glands are located within the oral mucosa or cavity, as evidenced by Salivary gland (page 1, para 5, 6; page 3, para 1) (instant claims 1, 2, 3, 8, 10, 13). Ortega et al teach that the method further comprises culturing the cells in a differentiation medium (page 3, lines 17-18) (instant claim 18). The reference teaches that the method of culturing epithelial stem cells comprises obtaining an organoid after culturing for required number of days in the expansion medium (page 4, lines 6-7; page 5, lines 31-32; page 8, lines 8-10; page 29, lines 3-4, 15-22; page 32, lines 15-25) (instant claim 20). The reference also teaches using cells derived from an organoid (page 40, lines 20-21), or that the epithelial stem cell is a cancer cell (tumour cell) i.e., can be derived from a tumour (page 34, lines 18-19) (instant claim 16). The reference further teaches the use of nicotinamide at 7-15 mM or about 10 mM (between 1 and 100 mM) (page 22, line 16) (instant claim 12). The reference therefore, anticipates the invention. Claim Rejections - 35 USC § 103 13. 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. 14. Claims 1-3, 5, 8, 10, 12-14, 16, 18 and 20 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Ortega et al (2015) in view of Ornitz et al (2015). 15. Claim 5 recites that the mitogenic growth factor comprises EGF, FGF10 and FGF2. Claim 14 lists additional specific components of the medium. 16. The teachings of Ortega et al are set forth above. Ortega et al teach all the components recited in claims 1-3 (as stated above). 17. Even though Ortega et al teach FGF19, the reference does not explicitly teach FGF2 (recited in claims 5 and 14). Ortega et al however, teach that the FGF can preferably bind to FGFR2 or FGFR4 (page 5, lines 10, 11). 18. Ornitz et al teach that FGF2 has a receptor specificity of FGFR1, FGFR2, FGFR3 and FGFR4 (Figure 2). 19. Because of similarity in binding properties between FGF19 and FGF2 (both binding to FGFR1, FGFR2, FGFR3 and FGFR4 (as required by claim 1(c)), and because both FGFs are known receptor tyrosine kinase ligands that are used in culture medium, it would have been obvious to one of ordinary skill in the art to have made a simple substitution of equivalent elements, i.e. the substitution of FGF19 for FGF2 with predictable results (MPEP 2143 (B)). 20. Ortega et al, do not teach the specific combination recited in claims 5 and 14. Nonetheless, since Ortega et al and Ornitz et al in combination, teach or suggest all recited components (of claims 5 and 14) of the claimed expansion medium (as stated above) as preferred embodiments of the genus recited in claim 1 (for example see Ortega et al, page 5, lines 24, 25), and also state the inclusion of “one or more” of said components recited in claim 14, the teachings of the references necessarily suggest that the recited combination could obviously be derived, absent evidence to the contrary. 21. It would have been, therefore, obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the culture method using the expansion medium taught by Ortega et al, wherein the medium comprises the components recited in claims 5 or 14, by including FGF2 in view of Ornitz et al. The person of ordinary skill in the art would have found it obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. The person of ordinary skill would have been motivated to use the medium composition of claim 14, as each of the factors were taught to be one or more of the preferred embodiments of the expansion medium taught by the prior art. The person of ordinary skill would have also been motivated to use FGF2 as it is a mitogenic growth factor that binds to all four FGFR receptors, and is commonly used in culture medium. The person of ordinary skill would have expected success because research involving the culturing of epithelial stem cells to obtain organoids was an active pursuit, before the effective filing date of the instant invention. 22. Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art. 23. Claims 1-3, 5, 8, 10, 12-16, 18 and 20 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Ortega et al (2015) in view of Ornitz et al (2015) as applied to claims 1-3, 5, 8, 10, 12-14, 16, 18 and 20 above, and further in view of Sato et al WO2010090513, 8/12/2010 (IDS) and Naujok et al (BMC Res Notes 7: 1-8, 2014). 24. Claim 15 recites the concentration of different components. 25. The teachings of Ortega et al and Ornitz et al are set forth above. 26. Ortega et al also teach the use of about 10 mM nicotinamide (page 22, line 16); about 50 ng/ml EGF (page 24, line 2); FGF10 at 25-100 ng/ml (page 24, lines 7-8); A83-01 between 10nM and 10µM (about 500nM) (page 19, lines 20-21); R-spondin at least 200 ng/ml (about 200 ng/ml) (page 14, lines 32-33); cAMP pathway activator (forskolin) at about 1 µM (page 9, line 28); PGE2 at least 50 nM (about 1 µM) (page 20, lines 5-7); and Noggin at least 25 ng/ml (i.e. about 100 ng/ml) (page 21, lines 19-22). 27. Neither Ortega nor Ornitz teach concentrations of FGF2, and CHIR-99021. 28. Sato et al teach a method of culturing epithelial stem cells comprising BMP inhibitor, mitogenic growth factor and Wnt agonist, and a culture medium comprising the same (Abstract), wherein the BMP inhibitor Noggin is added at a preferred concentration of approximately 100 ng/ml (page 8, lines 18, 20-21), and the mitogenic growth factor is selected from bFGF (FGF2), FGF10 and EGF (para spanning pages 10, 11). Sato et al also teach that a FGF is added at a concentration of 5 and 500 ng/ml or a preferred concentration of at least 10 ng/ml (page 11, lines 5-12; claim 2). 29. Ortega et al, Ornitz et al, or Sato et al do not teach the concentration of CHIR-99021. 30. Naujok et al teach that GSK3 inhibitors like CHIR-99021 activate the Wnt/beta-catenin pathway during differentiation of embryonic stem cells, wherein CHIR-99021 has the lowest toxicity and a high potency for Wnt pathway activation (Wnt agonist) (Abstract). The reference teaches that maximum viability of the stem cells was achieved after exposing cells at 1 or 2.5 µM of CHIR-99021 (Fig 1A). 31. Even though Ortega et al, Ornitz et al, Sato et al or Naujok et al teach the concentration which generally overlaps those recited for most of the constituents of claim 15, the references do not have the exact amounts as instantly claimed. 32. The differences between the claimed method and the prior art method appears to be one of optimization of culture parameters such as medium composition. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have optimized the concentration of each of the components to arrive at the culture medium recited in the claims. See MPEP 2144.05: A. Optimization Within Prior Art Conditions or Through Routine Experimentation. 33. Generally, differences in concentration of medium components will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Concentration ranges are results-effective variables which can be optimized. In the case of culturing stem cells, one of skill in the art would clearly recognize that amounts of the medium components could easily be optimized by a cell biologist having expertise in cell culture based on the needs of individual cell or stem cell types. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim is disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As medium optimization is routine in the art of cell culture, the claims are considered to be prima facie obvious. Applicant’s Remarks: 34. Emphasizing the amendment of independent claim 1 reciting epithelial stem cells from “oral mucosa, gingiva, …..pharynx tissue”, Applicant argues that Ortega does not teach the claimed features. Applicant therefore, requests withdrawal of the anticipation rejection. 35. Applicant asserts the advantages of using Medium E (as in Table 1 of Example 9 of specification), the components of which are instantly claimed, adding that Medium E “was surprisingly effective for generating organoids and for longer term culturing of said organoids”. Applicant argues that because the cited references alone or in combination do not teach or provide motivation to culture epithelial stem cells from the tissues recited in amended claim 1, the claims are non-obvious over the cited art. Applicant therefore, requests withdrawal of the obviousness rejection. 36. Applicant’s arguments are fully considered, and are found to be persuasive. As stated above, all previous rejections have been withdrawn and new rejections addressing the amendment of claim 1 have been presented. The Ortega teachings are still applicable for showing anticipation and obviousness for reasons provided in the rejections. It is noted that salivary glands (taught by Ortega et al) are part of the oral mucosa. Additionally, the newly presented cited art, in combination, teaches all elements of the medium as instantly claimed. 37. Applicant’s argument that the claimed medium was surprisingly effective for generating organoids is considered. Applicant seems to be asserting unexpected results. However, the cited art in combination teaches culturing epithelial stem cells from oral mucosa (salivary gland) and obtaining an organoid, using a medium comprising all elements as instantly claimed. Applicant’s assertion of surprising (unexpected) results is therefore, not persuasive. The combination of the above references proves that the knowledge and expertise for the claimed method comprising culturing an epithelial stem cell derived from oral mucosa was known in the art and the results were expected to be successful. The prima facie obviousness of the claimed invention in view of the combined references, therefore, provides sufficient reasoning, and nullifies Applicant’s allegations of the improper teachings in the individual references. Applicant’s assertion of unexpected results does not overcome the rejection because of obvious expected properties taught in the prior art, either explicitly or implicitly. “Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness”. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). Double Patenting Non-Statutory 38. 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). 39. 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). 40. 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. 41. 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. 42. Claims 1-3, 5, 8, 10, 12-16, 18, 20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 5-8, 10-12, 14, 16-17, 28-30, 34 of co-pending application number 17/611,561, in view of Ortega et al (2015). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to culturing an epithelial stem cell derived (selected) from pharynx, larynx, salivary gland (oral mucosa), the method comprising culturing in a medium suitable for the cells for a sufficient number of days, wherein the cells are in contact with an ECM, and the medium comprises Wnt agonist, BMP inhibitor and TGF-beta inhibitor and a mitogenic growth factor. Note that previously rejected claim 19 is now canceled. Also, with regards to the '561 application, claim 27 has been canceled and claim 34 has been newly added. The only differences between the two sets of claims are: (i) Claims 12, 29, 30 of ‘561 application recite synthetic matrix, feeder-cell free method and culturing in a suspended state respectively, while instant claims do not have these limitations. However, instant claims are to a genus of ECM, used for a method of culturing of epithelial stem cells recited in both sets of claims. Besides, instant specification contemplates a synthetic ECM (page 23, line 3), feeder cell free (page 33, lines 36, 37) and suspended state of culture (page 23, line 21). (ii) ‘561 claims recite that the medium is supplemented with an integrin agonist, which is absent in instant claims. However, this would be obvious as integrins are cellular membrane proteins that would inherently be present and be required for interaction with the ECM to mimic a cellular niche for culturing epithelial stem cells, based upon the teaching in the instant specification (page 21, para 3; page 23, lines 10, 11). Additionally, instant claim 1 recites that the method “comprises”. “Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. [MPEP 2111.03(I)] (iii) Instant claims recite the inclusion of nicotinamide, forskolin, A83.01, and PGE2, while ‘561 claims do not recite these components. However, both sets of claims recite a method of culturing epithelial stem cells from the same source, therefore, it would be obvious to include the same components at the recited concentrations in view of the teachings of Ortega et al, for reasons stated above. 43. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. 44. Claims 1-3, 5, 8, 10, 12-16, 18, 20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 35, 37, 65-72, 75, 79, 83-84, 91 of co-pending application number 14/124,884 in view of Ortega et al (2015), Naujok et al (2014), Sato et al (2010), and Yee et al (Stem Cells 31: 992-1000, 2013). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to culturing an epithelial stem cell and obtaining an organoid, the method comprising culturing in a medium, wherein the cells are in contact with an ECM, and the medium comprises Wnt agonist, BMP and TGF-beta inhibitors, mitogenic GFs (tyrosine kinase ligands), nicotinamide, and PG signaling pathway activator. It is noted that previously rejected claim 19 is now canceled. The only differences between the two sets of claims are: (i) Instant claims recite cAMP pathway activator in the medium, while the ‘884 claims do not recite this factor. However, the addition of exendin-4 (for increasing intracellular cAMP) in the culture medium is contemplated in the ‘884 specification (para 0125). (ii) Claim 35 of the ‘884 application recites the use of Lgr5+ epithelial stem cells, while instant claims do not have this limitation. However, this would be obvious in view of Yee et al, teaching that Lgr5 marks adult stem cells of the tongue (Abstract). Additionally, the instant specification teaches that lgr5 is expressed on epithelial stem cells from the oral cavity (page 13, lines 17-18; page 24, line 17; page 25, lines 29-32). (iii) Instant claims recite the inclusion of forskolin, and PGE2, while ‘884 claims do not recite these components, and the combination as recited in claims 14 and 15. However, this would be obvious in view of the teachings of Ortega et al, Sato et al, and Naujok et al for reasons stated above. 45. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented. 46. Claims 1-3, 5, 8, 10, 12-16, 18, 20, are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4-11, 14, 20-27, 30-31 and 33-34, of US Patent 10,597,633 in view of Ortega et al (2015), Naujok et al (2014) and Sato et al (2010). Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to culturing an epithelial stem cell derived (selected) from tissues like salivary gland (oral mucosa), the method comprising culturing in an expansion medium comprising a basal medium, wherein the cells are in contact with an ECM, and the medium comprising Wnt agonist, BMP and TGF-beta inhibitors, mitogenic GF (tyrosine kinase ligands), nicotinamide, B27, N-acetylcysteine and cAMP pathway activator, and further culturing the cells in a differentiation medium. It is noted that previously rejected claim 19 is now canceled. The only differences between the 2 sets of claims are: i) Instant claims recite the inclusion of prostaglandin signaling pathway activator in the expansion medium, while the ‘633 claims do not recite this factor. However, the use of prostaglandin pathway activator would be obvious as the ‘633 specification teaches that the expansion medium is supplemented with a PG pathway activator (col 15, last para). (ii) Instant claims 14 and 15 recite the components and the combination of the expansion medium, while the ‘633 claims do not have these limitations. However, this would be obvious in view of the teachings of Ortega et al, Naujok et al and Sato et al, for reasons stated above. 47. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,597,633. Applicant’s remarks 48. Applicant argues that the rejections be held in abeyance until indication of allowability. Applicant also argues that based upon the later filing date of the '561 application, if the provisional double patenting rejection is the only remaining rejection, it should be withdrawn. 49. Applicant’s arguments are fully considered, however, are not found to be persuasive. Since the instant claims are not yet allowable, and the provisional double patenting rejection over the ‘561 claims is not the only remaining rejection in the current application, consideration of the filing date of the ‘561 application is moot. The response requests the rejections be held in abeyance. The rejection has not been overcome by amendment or the filing of an approved terminal disclaimer. Thus, the rejections are modified and restated, as necessitated by amendment. Conclusion 50. No claims are allowed. 51. Applicant’s amendment necessitated the new ground(s) of rejection presented in the 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). 52. 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 extension fee 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. 53. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm. 54. 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. 55. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 56. 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. /A. D./ Examiner, Art Unit 1675 29 March 2026 /KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
Read full office action

Prosecution Timeline

Sep 09, 2021
Application Filed
Sep 09, 2021
Response after Non-Final Action
Jul 12, 2025
Non-Final Rejection — §102, §103, §DP
Jan 21, 2026
Response Filed
Mar 30, 2026
Final Rejection — §102, §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
47%
Grant Probability
95%
With Interview (+47.5%)
4y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 377 resolved cases by this examiner. Grant probability derived from career allow rate.

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