Prosecution Insights
Last updated: April 19, 2026
Application No. 16/321,265

DIFFERENTIATED CELL PRODUCTION METHOD AND CULTURE BAG USED THEREFOR

Final Rejection §103§112§DP
Filed
Jan 28, 2019
Examiner
ZHU, JIANJIAN
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kyoto University
OA Round
8 (Final)
62%
Grant Probability
Moderate
9-10
OA Rounds
3y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
46 granted / 74 resolved
+2.2% vs TC avg
Strong +82% interview lift
Without
With
+82.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
70 currently pending
Career history
144
Total Applications
across all art units

Statute-Specific Performance

§101
3.3%
-36.7% vs TC avg
§103
32.9%
-7.1% vs TC avg
§102
18.0%
-22.0% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 74 resolved cases

Office Action

§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 Amendments In the reply filed 10/09/2025, Applicant has amended claims 1, 2 and 10, and canceled claim 9. Claim Status Claims 1-2, 5-8 and 10 are pending. Claims 6-8 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/17/2022. Claims 1-2, 5 and 10 are considered on the merits. Withdrawn Claim Rejections - 35 USC § 112 The prior rejection of claims 1, 5 and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for insufficient antecedent basis is withdrawn in light of Applicant’s amendment to claims 1 and 10. Withdrawn Claim Rejections - 35 USC § 103 The prior rejection of claims 1-2, 5 and 10 under 35 U.S.C. 103 set forth in the prior Office action mailed on 07/09/2025 has been withdrawn in light of Applicant’s amendment to claims 1 and 2 to recite a new numerical range of a total number of non-fluorinated group terminals and a new numerical range of a total number of non-fluorinated group terminals and -CF2H group terminals. New 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 1-2, 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al., (Nature. 2008; 451: 141-146, Method page and Supplemental p. 1-3. Prior art of record) in view of Otsuji et al., (Stem Cell Reports. 2014;2:734-745 and suppl p. 1-12. Prior art of record), Clark et al (US PGPub 20160177247A1. Published 06/23/2016. Cited in IDS 08/30/2021) and Chapman et al. (US PGPub 2004/0127651. Prior art of record). With respect to independent claim 1 and independent claim 2, Park teaches a method for producing differentiated cells from induced pluripotent stem cells and a method for inducing differentiation of induced pluripotent stem cells by an embryoid body method (Method page, right col, section “Haematopoietic colony-forming assays”). In regard to step (1) culturing iPSCs in a culture liquid to form an embryoid body in claims 1 and 2, Park teaches “to form embryoid bodies, confluent undifferentiated iPS cells were mechanically scraped into strips and transferred to 6-well, low-attachment plates in differentiation medium consisting of knockout DMEM supplemented with 20% FBS” and other amino acids (Method page, left col, end of “Cell culture”, also see Method page, right col, section “Haematopoietic colony-forming assays”), thus teaches culturing iPSCs in a culture liquid to form an embryoid body in step (1). In regard to step (2) inducing differentiation of the iPSCs contained in the embryoid body to obtain differentiated cells in claim 1 or to obtain hematopoietic progenitor cells in claim 2, Park teaches embryoid bodies were dissociated and plated with hematopoietic growth factors to differentiate into hematopoietic progenitor cells (Method page, right col, section “Haematopoietic colony-forming assays” and see Fig S8 in Supplemental p. 2 for an example of burst-forming unit erythroid (BFU-E) colonies differentiated from iPSCs), thus teaches step (2) in claims 1 and 2. However, Park teaches culturing iPSCs by using low-attachment plates (Method page, left col, end of “Cell culture”), but is silent on using a culture bag as recited in step (1) in claims 1 and 2. Otsuji compares culturing iPSCs to form an embryoid body in different containers such as low-attachment culture dishes (equivalent to the low-attachment plates used by Park), test tubes, and culturing bags that were made of a gas-permeable membrane (p. 742, right col, section “3D sphere culture”, see Fig 5 for all three containers, see Fig 6 for culture bag and culture dish, and see Fig S6G for embryoid body formation assay related to Fig 5). Otsuji teaches the iPSCs are cultured in a culture liquid consisting of mTeSR medium with 0.3% methylcellulose and 0.01%–0.02% low-acyl gellan gum (p. 742, right col, section “3D sphere culture”) which shows no sign of gelation or significantly increased viscosity (p. 739, right col). Otsuji teaches iPSCs cultured in a gas-permeable culture bag has much higher expansion than those cultured in test tubes due to sufficient gas exchange (p. 740, 1st full para, see Fig 5B), and teaches a culture bag enables a larger-scale 3D sphere culture than a culture dish (p. 740, right col, section “scaling up of 3D sphere culture”, see Fig 6). Thus, Otsuji teaches using a gas-permeable culture bag to culture iPS cells to form an embryoid body in claims 1 and 2. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for producing differentiated cells from iPSCs and for inducing differentiation of iPSCs comprising culturing iPSCs by using a low attachment plate disclosed by Park, by substituting the low attachment plate with a gas-permeable culture bag as taught by Otsuji with a reasonable expectation of success. Since Otsuji teaches culturing iPSCs in a culture bag enables a larger-scale 3D sphere culture than using a culture dish and achieves high expansion (p. 740, right col, section “scaling up of 3D sphere culture”, see Fig 6), one of ordinary skill in the art would have had a reason to substitute the low attachment plate of Park with a gas-permeable cell culture bag of Otsuji in order to achieve high expansion and a large-scale culture of iPSCs. However, Park and Otsuji are silent on the material of its inner surface of the culture bag having a perfluoropolymer in claim 2 or a perfluoropolymer of a tetrafluoroethylene-hexafluoropropylene-perfluoroalkyl vinyl ether copolymer in claim 1, nor teach the perfluoropolymer has a total number of non-fluorinated group terminals being 13 to 35 per 1 x 106 carbon atoms and a total number of non-fluorinated group terminals and -CF2H group terminals being 13 to 35 per 1 x 106 carbon atoms in claims 1 and 2, or the perfluoropolymer does not contain -CF2H group terminals in claim 10. In regard to the material of the inner surface of a culture bag, Clark teaches a cell culture bag constructed by a gas permeable fluoropolymer on its inner surface (abstract, e.g., [0017], [0023]) and teaches the fluoropolymer includes copolymers of tetrafluoroethylene (TFE) with non-functional monomers including hexafluoropropylene (HFP) and perfluoroalkyl vinyl ether (such as PEVE, PMVE and PPVE) (e.g., [0083]). Thus, Clark suggests a cell culture bag having a perfluoropolymer including a copolymer of tetrafluoroethylene (TFE)-hexafluoropropylene (HFP)-perfluoroalkyl vinyl ether (such as PEVE, PMVE and PPVE) on its inner surface, related to claim 1 and claim 2. Clark teaches “fluoropolymer films have desirable characteristics that make them a popular choice for culture bags … fluoropolymer films are more biologically, chemically and immunologically inert, as well as being hydrophobic” ([0012]). In regard to group terminals in perfluoropolymer, Chapman teaches perfluoropolymers may have unstable end groups (equivalent to the claimed non-fluorinated group terminals) such as -COOH, -COF, -CF=CF2, -CONH2 that are thermally unstable or hydrolytically unstable ([0002]). Chapman teaches although -CF2H end groups are more stable (e.g. [0004]), the perfluorinated end group -CF3 is of greatest stability (e.g., [0003] and [0007]). Chapman teaches an improved fluorination method to convert the unstable end groups and non-perfluorinated end groups to the perfluorinated end group -CF3 (see e.g., [0031] reaction (iv) and [0051] the sum of the unstable end groups being less than 30 per 1 x 106 carbon atoms, related to claims 1 and 2). Chapman teaches in working examples that fluorination treatment of a copolymer of tetrafluoroethylene (TFE) with hexafluoropropylene (HFP) and perfluoroethyl vinyl ether (PEVE), a copolymer suggested by Clark and recited in claim 1, results in the polymer end groups consisting of 0 -CF2H end groups, 7 -COOH end groups, 2 -COF end groups, and 1 -CONH2 end groups (Example 10, e.g., [0089]). Thus, Chapman teaches a perfluoropolymer, specifically a TFE-HFP-PEVE copolymer suggested by Clark and recited in claim 1, has a total number of non-fluorinated group terminals being 10 per 1 x 106 carbon atoms and a total number of non-fluorinated group terminals and -CF2H group terminals being 10 per 1 x 106 carbon atoms, close to the recited range of 13 to 35 per 1 x 106 carbon atoms in claims 1 and 2, and does not contain -CF2H group terminals in claim 10. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method comprising culturing iPSCs by using a gas permeable culture bag suggested by Park and Otsuji, by choosing a gas permeable perfluoropolymer such as a tetrafluoroethylene-hexafluoropropylene-perfluoroalkyl vinyl ether (TFE-HFP-PAVE) copolymer on its inner surface of the culture bag as suggested by Clark and further choosing a fluorination-treated perfluoropolymer, such as a fluorination-treated TFE-HFP-PEVE copolymer having a total number of non-fluorinated group terminals being close to the recited range and not containing -CF2H group terminals as suggested by Chapman with a reasonable expectation of success. Since Clark teaches fluoropolymer films have desirable characteristics such as being more biologically, chemically and immunologically inert, as well as being hydrophobic, that make them a popular choice for culture bags ([0012]), and since Chapman teaches fluorination-treated perfluoropolymer such as a fluorination-treated TFE-HFP-PEVE copolymer is very low or absent of the thermally and hydrolytically unstable group terminals and contains the perfluorinated -CF3 end group that has the greatest stability (see Example 10 [0089], and also see [0002-0003], [0007]), one of ordinary skill in the art would have had a reason to choose the perfluoropolymer such as the fluorination-treated TFE-HFP-PEVE copolymer in order to obtain culture bags having highly stable perfluoropolymer on the inner surface to take advantage of their desirable characteristics of being more biologically, chemically and immunologically inert, as well as being hydrophobic as taught by Clark and Chapman. In addition, regarding the claimed total number of non-fluorinated group terminals, MPEP 2144.05(I) teaches “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Thus, “approaching, similar or close range” is obvious in the absence of any showing of unexpected results or criticality. With respect to claim 5 directed to the induced pluripotent stem cells being differentiated into progenitor cells, as stated supra, Park teaches embryoid bodies were dissociated and plated with hematopoietic growth factors to differentiate the iPSCs into hematopoietic progenitor cells (Method page, right col, section “Haematopoietic colony-forming assays” and see Fig S8 in Supplemental p. 2 for an example of burst-forming unit erythroid (BFU-E) colonies differentiated from iPSCs), thus teaches claim 5. Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary. Response to Traversal: Applicant’s argument filed on 10/09/2025 are acknowledged. Applicant argues that the entire disclosure of Chapman does not teach the recited total number of non-fluorinated group terminals and -CF2H group terminals (including Chapman Examples 2 and 4), thus a person of ordinary skill in the art would not have been motivated to adjust the numbers to the claimed “13 to 35” with a reasonable expectation of success (Remarks, p. 6-7). Applicant’s arguments have been fully considered and they are persuasive because the prior rejection as written does not address the newly recited range in the amended claims. Therefore, the prior rejections have been withdrawn. However, as necessitated by amendment, prior art Chapman has been reapplied to make obvious the claimed range. Specifically, Chapman teaches in Example 10 that a fluorination-treated perfluoropolymer (specifically, a fluorination-treated TFE-HFP-PEVE copolymer as recited in claim 1) has a total number of non-fluorinated group terminals being 10 per 1 x 106 carbon atoms and a total number of non-fluorinated group terminals and -CF2H group terminals being 10 per 1 x 106 carbon atoms, that is close to the recited range of 13 to 35 per 1 x 106 carbon atoms in claims 1 and 2, and does not contain -CF2H group terminals in claim 10. Thus, the claimed range that is “approaching, similar or close” to the range of Chapman is made obvious by Chapman in the absence of any showing of unexpected results or criticality. See MPEP 2144.05(I). Applicant is invited to provide factually supported objective evidence (i.e., comparative side-by-side data) to show unexpected results or criticality of the claimed range of the total number of non-fluorinated group terminals (and -CF2H group terminals). Withdrawn Double Patenting Rejections The prior rejection of claims 1-2, 5 and 10 on the ground of nonstatutory double patenting set forth in the prior Office action mailed on 07/09/2025 has been withdrawn in light of Applicant’s amendment to claims 1 and 2 to recite a new numerical range of non-fluorinated terminal groups. New Double Patenting Rejections 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-2, 5 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US Patent No. 10,961,493 in view of Park et al., (Nature. 2008; 451: 141-146, Method page and Supplemental p. 1-3. Prior art of record), Otsuji et al., (Stem Cell Reports. 2014;2:734-745 and suppl p. 1-12. Prior art of record) and Chapman et al. (US PGPub 2004/0127651. Prior art of record). Although the claims at issue are not identical, they are not patentably distinct from each other. Patented claims 1-12 recite a method of culturing a mammal cell comprising culturing the mammal cells within a container (patented claims 7 and 11), the container being a bag (patented claims 2, 6, 8 and 12), the mammal cell being an adhesive cell or being a mesenchymal stem cell (claims 3, 4, 9 and 10), the container having a surface in contact with the mammal cell being formed of a fluororesin having a total number of a non-fluorinated group terminal and a -CF2H group terminal in the fluororesin of 70 or less per 1x106 carbon atoms, the fluororesin being at least one fluororesin selected from a tetrafluoroethylene-hexafluoropropylene-based copolymer and a tetrafluoroethylene-perfluoroalkylvinyl ether-based copolymer (patented claims 1 and 7), or a surface of the container in contact with the mammal cell being formed of a fluororesin having one or more -CF3 terminal groups, wherein the fluororesin is at least one fluororesin selected from a tetrafluoroethylene-hexafluoropropylene-based copolymer and a tetrafluoroethylene-perfluoroalkylvinyl ether-based copolymer, wherein a surface of the container in contact with the mammal cell being formed of a fluororesin having a number of the non-fluorinated group terminals of 70 or less per 1×106 carbon atoms (patented claims 5 and 11). Thus, copending claims recite a method of culturing mammalian cells such as a mesenchymal stem cells in a culture bag having at least one perfluoropolymer (i.e., having one or more -CF3 terminal groups) of a tetrafluoroethylene-perfluoroalkylvinyl ether-based copolymer on its inner surface wherein a total number of non-fluorinated group terminals of 70 or less per 1×106 carbon atoms or a total number of a non-fluorinated group terminal and a -CF2H group terminal in the fluororesin of 70 or less per 1x106 carbon atoms, related to the instant claims 1 and 2. However, patented claims are silent on the cells being iPSCs to be cultured in a culture liquid and to be differentiated to progenitor cells or hematopoietic progenitor cells by an embryoid body method in instant claims 1-2 and 5, nor teach the fluororesin has non-fluorinated group terminals of 13 to 35 per 1×106 carbon atoms and does not contain -CF2H group terminals in instant claims 1-2 and 10. Otsuji teaches culturing iPSCs to form an embryoid body in different containers such as low-attachment culture dishes, test tubes, and culturing bags that were made of a gas-permeable membrane (p. 742, right col, section “3D sphere culture”, see Fig 5 for all three containers, see Fig 6 for culture bag and culture dish, and see Fig S6G for embryoid body formation assay related to Fig 5). Otsuji teaches the iPSCs are cultured in a culture liquid consisting of mTeSR medium with 0.3% methylcellulose and 0.01%–0.02% low-acyl gellan gum (p. 742, right col, section “3D sphere culture”) which shows no sign of gelation or significantly increased viscosity (p. 739, right col). Otsuji teaches iPSCs cultured in a gas-permeable culture bag has much higher expansion than those cultured in test tubes due to sufficient gas exchange (p. 740, 1st full para, see Fig 5B), and teaches a culture bag enables a larger-scale 3D sphere culture than a culture dish (p. 740, right col, section “scaling up of 3D sphere culture”, see Fig 6). Thus, Otsuji teaches using a gas-permeable culture bag to culture iPS cells to form an embryoid body in instant claims 1 and 2. Park teaches a method for producing differentiated cells from iPSCs and a method for inducing differentiation of iPSCs by an embryoid body method (Method page, right col, section “Haematopoietic colony-forming assays”), related to instant claims 1 and 2. Park teaches “to form embryoid bodies, confluent undifferentiated iPS cells were mechanically scraped into strips and transferred to 6-well, low-attachment plates in differentiation medium consisting of knockout DMEM supplemented with 20% FBS” and other amino acids (Method page, left col, end of “Cell culture”, also see Method page, right col, section “Haematopoietic colony-forming assays”). Park teaches embryoid bodies were differentiated into hematopoietic progenitor cells (related to instant claims 2 and 5, see “Method” page, right col, section “Haematopoietic colony-forming assays” and see Fig S8 in Supplemental p. 2 for an example of burst-forming unit erythroid (BFU-E) colonies differentiated from iPSCs). In regard to the group terminals of the material, Chapman teaches the unstable group terminals in fluoropolymers are thermally or hydrolytically unstable ([0002]), and the perfluorinated end group -CF3 is of greatest stability (e.g., [0003] and [0007]). Chapman teaches an improved fluorination method to convert the unstable end groups and non-perfluorinated end groups to the perfluorinated end group -CF3 (see e.g., [0031] reaction (iv) and [0051] the sum of the unstable end groups being less than 30 per 1 x 106 carbon atoms). Chapman teaches in working examples that fluorination treatment of a copolymer of tetrafluoroethylene (TFE) with hexafluoropropylene (HFP) and perfluoroethyl vinyl ether (PEVE), a copolymer recited in patented claims 1&7 and instant claim 1, results in the polymer end groups consisting of 0 -CF2H end groups, 7 -COOH end groups, 2 -COF end groups, and 1 -CONH2 end groups (Example 10, e.g., [0089]). Thus, Chapman teaches a perfluoropolymer, specifically a TFE-HFP-PEVE copolymer recited in instant claim 1, has a total number of non-fluorinated group terminals being 10 per 1 x 106 carbon atoms and a total number of non-fluorinated group terminals and -CF2H group terminals being 10 per 1 x 106 carbon atoms, close to the recited range of 13 to 35 per 1 x 106 carbon atoms in instant claims 1 and 2, and does not contain -CF2H group terminals in instant claim 10. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of culturing mammalian cells using a culture bag having the claimed material in the inner surface recited in the patent, by choosing induced pluripotent stem cells to culture and differentiate into hematopoietic progenitor cells by an embryoid body method as suggested by Otsuji and Park, and further choosing a fluorination-treated fluoropolymer, i.e., perfluoropolymer having a total number of non-fluorinated group terminals in the recited range and not having -CF2H group terminals as suggested by Chapman with a reasonable expectation of success. Since Otsuji and Park suggest and reduce to practice a method of culturing and differentiating iPSCs into hematopoietic progenitor cells via an embryoid body method by using the culture bag which enables a large-scale culture, and since Chapman teaches the non-fluorinated group terminals are thermally or hydrolytically unstable while the perfluorinated end group -CF3 is of greatest stability and reduces to practice a method of fluorination treatment to obtain a total number of non-fluorinated group terminals close to the recited range, one of ordinary skill in the art would have had a reason to choose iPSCs to culture and differentiate into hematopoietic progenitor cells by an embryoid body method as suggested by Otsuji and Park in order to obtain a large-scale culture and differentiation of iPSCs into hematopoietic progenitor cells, and to choose fluorination-treated fluoropolymer, i.e., perfluoropolymer having the claimed number of non-fluorinated group terminals and not having -CF2H group terminals as suggested by Chapman in order to obtain a highly stable perfluoropolymer for making the culture bag. In addition, regarding the claimed total number of non-fluorinated group terminals, MPEP 2144.05(I) teaches “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Thus, “approaching, similar or close range” is obvious in the absence of any showing of unexpected results or criticality. Since the instant application claims are obvious over cited patent claims, in view of Otsuji, Park and Chapman, said claims are not patentably distinct. Response to Traversal: Applicant’s argument filed on 10/09/2025 (Remarks, p. 7-8) are acknowledged and have been discussed above. Conclusion 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 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 date of this final action. No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST). 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, James Douglas (Doug) Schultz can be reached on (571) 272-0763. 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. /JIANJIAN ZHU/Examiner, Art Unit 1631 /JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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Prosecution Timeline

Jan 28, 2019
Application Filed
Jul 15, 2022
Non-Final Rejection — §103, §112, §DP
Nov 25, 2022
Response Filed
Dec 10, 2022
Final Rejection — §103, §112, §DP
Apr 10, 2023
Examiner Interview Summary
Apr 10, 2023
Applicant Interview (Telephonic)
May 10, 2023
Request for Continued Examination
May 16, 2023
Response after Non-Final Action
Jun 05, 2023
Non-Final Rejection — §103, §112, §DP
Sep 13, 2023
Response Filed
Dec 01, 2023
Final Rejection — §103, §112, §DP
Mar 18, 2024
Response after Non-Final Action
May 17, 2024
Request for Continued Examination
May 20, 2024
Response after Non-Final Action
Jun 27, 2024
Non-Final Rejection — §103, §112, §DP
Oct 02, 2024
Response Filed
Oct 22, 2024
Final Rejection — §103, §112, §DP
Jan 27, 2025
Response after Non-Final Action
Mar 25, 2025
Request for Continued Examination
Mar 30, 2025
Response after Non-Final Action
Jul 05, 2025
Non-Final Rejection — §103, §112, §DP
Oct 09, 2025
Response Filed
Jan 12, 2026
Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

9-10
Expected OA Rounds
62%
Grant Probability
99%
With Interview (+82.0%)
3y 8m
Median Time to Grant
High
PTA Risk
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