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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
Applicant’s amendment filed July 11, 2025 is acknowledged. Claim 8 is canceled. Claims 2-4 and 7 are amended. Claims 9-14 are newly added. Claims 1-7 and new claims 9-14 are pending in this application. Claims 1, 4-7 and 9-14 are withdrawn without traverse (filed 10/18/22) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 18, 2022.
Newly submitted claims 9-14 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 9-14 are directed to a method of treating spinal cord injuries, which was withdrawn from consideration without traverse filed in the reply filed on October 18, 2022.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9-14 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
4. Claims 2-3 are under examination in this office action.
5. Applicant’s arguments filed on July 11, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
6. The rejection of claims 2-3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims.
Claim Rejections/Objections Maintained
In view of the amendment filed on July 11, 2025, the following rejections are maintained.
Claim Rejections - 35 USC § 102
7. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-3 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (Stem Cell. Res. 2016; 7:2. DOI:10.1186/s13287-015-0264-1). The rejection is maintained for the reasons of record and the reasons set forth below.
Claim 2 as amended is drawn to a -secretase inhibitor-treated neurosphere derived from human pluripotent stem cells (hPSCs) for chronic phase spinal cord injury treatment, wherein a neurosphere is cultured in a culture medium comprising a -secretase inhibitor at 10mM for a period of 20-24hrs, and wherein the hPSCs are ESCs or iPSCs.
Claim 3 as amended is drawn to a -secretase inhibitor-treated neurosphere derived from hPSCs for chronic phase spinal cord injury treatment, wherein a neurosphere is cultured in a culture medium comprising a -secretase inhibitor at 10 mM for allowing the -secretase inhibitor to act on the neurosphere for 20-24 hours, in which phosphorylation of p38 MAPK is enhanced as compared to a control, wherein the control is a neurosphere that has not been contacted with a -secretase inhibitor, or neurons obtained by inducing differentiation from a neurosphere that has not been contacted with 10mM of a - secretase inhibitor, and wherein hPSCs are ESCs or iPSCs.
Response to Arguments
On p. 1-2 of the response, Applicant argues that: i) Chen does not disclose a -secretase inhibitor-treated neurosphere derived from human pluripotent stem cells (hPSCs) for a treatment of chronic phase spinal cord injury; ii) Chen’s product treated with a -secretase inhibitor are differentiated neuronal cells whereas the claimed product treated with a -secretase inhibitor are neurospheres, not differentiated; iii) Chen’s cells are not transplanted into a spinal cord injury site; iv) Chen does not teach phosphorylation of p38 MAPK.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2131, Chen does teach the claimed neurosphere derived from human pluripotent stem cells (hPSCs) because:
i. Instant claims are directed to a product, not a method of making or using the claimed -secretase inhibitor-treated neurospheres for chronic phase spinal cord injury treatment.
ii. The DAPT-treated neurospheres disclosed by Chen are derived from human induced pluripotent stem cells (hiPSCs), and wherein neurosphere are cultured in a medium comprising 10uM DAPT for 5 days to facilitate formation of neurospheres from iPSCs (p. ), which are -secretase inhibitor-treated neurospheres derived from hiPSCs. The neurospheres cultured in a RGC differentiation medium containing fresh 10uM DAPT which was provided every other day (i.e. a period of 24hr), are also -secretase inhibitor-treated neurosphere derived from hPSCs (see p. 3, 1st col., 1st paragraph, lines 7-14).
iii. The limitation “wherein a neurosphere is cultured in a culture medium comprising a -secretase inhibitor at 10mM for a period of 20-24hrs” recited in instant claims is a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. Note that the determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP2113.
iv. The limitation “for chronic phase spinal cord injury treatment” recited in the claims is merely to state the purpose or intended use of the invention. The intended use is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir.1999). Also See Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir.1997).
If the claimed -secretase inhibitor-treated neurosphere cultured in a medium comprising a -secretase inhibitor at 10mM can be used for chronic phase spinal cord injury treatment, the same neurospheres cultured in a differentiation medium comprising DAPT, a -secretase inhibitor at 10uM can also be used for chronic phase spinal cord injury.
v. If phosphorylation of p38 MAPK in the claimed -secretase inhibitor-treated neurospheres in claim 3 is enhanced as compared to a control with no treatment with a -secretase inhibitor (i.e. DAPT), the DAPT-treated neurospheres disclosed by Chen’2016 also express an enhanced level of as compared to neurospheres with no DAPT treatment because the neurospheres and the -secretase inhibitor (i.e. DAPT) disclosed by Chen’2016 are identical to those recited in instant claims. Thus, claims 2-3 are anticipated by Chen’2016.
Accordingly, the rejection of claims 2-3 under 35 U.S.C. 102(a)(1) as being anticipated by Chen is maintained.
Claim Rejections - 35 USC § 102
8. Claims 2-3 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okubo et al. (Stem Cell. Rep. 2016; 7:649-663). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 2-3 of the response, Applicant argues that i) Okubo does not disclose a -secretase inhibitor-treated neurosphere derived from human pluripotent stem cells (hPSCs) for a treatment of chronic phase spinal cord injury; ii) Okubo does not teach that the neurospheres in which phosphorylation of p38 MAPK is enhanced as compared to a control; iii) Okubo teaches transplanting a -secretase inhibitor-treated neurosphere into subacute spinal cord injury in moue models that were shown to enhance motor function and reduce tumor-like growth.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2131, Okubo does teach the claimed neurosphere derived from human pluripotent stem cells (hPSCs) because:
i. instant claims are directed to a product, not a method of making or using the claimed -secretase inhibitor-treated neurospheres for chronic phase spinal cord injury treatment.
ii. Okubo teaches human induced pluripotent stem cells (hiPSCs)-derived neurospheres (i.e. aggregates of 253G1 and 201B7 hiPSC-NS/PCs) cultured in a medium comprising a -secretase inhibitor including DAPT at 10uM for 1 day (24 hours) for treatment of spinal cord injury and transplantation, which meet the limitations recited in claims 2 and 3 (see p. 649 results to p.651, 1st col., 2nd paragraph, p. 650, figure 1A-1B; p. 655-660; p. 659, 2nd col. section: Experimental Procedures to p.661, 1st col.; p. 672, Supplemental Experimental Procedures).
Okubo teaches that -secretase inhibitor -treated hiPSC-derived neurospheres are differentiated more mature neuronal cell types (p.651, 1st col.) and transplantation of -secretase inhibitor-treated hiPSCs-derived neurospheres maintained and enhanced motor functional recovery after spinal cord injury (p. 653, 2nd col., last paragraph to p. 655, 1st col.; p. 655-p. 659).
iii. The limitation “for chronic phase spinal cord injury treatment” recited in the claims is merely to state the purpose or intended use of the invention. The intended use is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc.v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir.1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir.1997).
If the claimed neurosphere cultured in a medium comprising a -secretase inhibitor at 10mM for a period of 20-24 hrs for allowing the -secretase inhibitor to act on the neurosphere can be used for chronic phase spinal cord injury treatment, the same neurospheres cultured in a medium comprising a -secretase inhibitor including DAPT at 10uM for 1 day (24hrs) can also be used for chronic phase spinal cord injury treatment.
iv. If phosphorylation of p38 MAPK in the claimed neurospheres recited in claim 3 is enhanced as compared to a control with no treatment with a -secretase inhibitor, (i.e.DAPT), the DAPT-treated neurospheres disclosed by Okubo will also express an enhanced level of phosphorylation of p38 MAPK as compared to neurospheres with no DAPT treatment because the neurospheres and the -secretase inhibitor (i.e. DAPT) disclosed by Okubo are identical to those recited in the claims. Thus, claims 2-3 are anticipated by Okubo.
Accordingly, the rejection of claims 2-3 under 35 U.S.C. 102(a)(1) as being anticipated by Okubo is maintained.
Claim Rejections - 35 USC § 103
9. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2-3 stand rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Stem Cell. Res. 2016; 7:2) in view of Okubo et al. (Stem Cell. Rep. 2016; 7:649-663) and Shin (US11566221). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 3-5 of the response, Applicant argues that: i) for the reasons set forth above, Chen does not the same product as instantly claimed and Shin and Okubo do not compensate the deficiencies of Chen; ii) Okubo does not disclose a -secretase inhibitor-treated neurosphere derived from hPSCs for treatment in a chronic phase of spinal cord injury nor that the neurosphere in which phosphorylation of p38 MAPK is enhanced as compared to a control; iii) Shhin does not disclose the claimed -secretase inhibitor-treated neurosphere in a chronic phase spinal cord injury. Shin teaches treating human iPSCs with GIBCO PSC neural induction medium to induce NSCs. The Shin’s product is a differentiated neuronal cell, not a neurosphere in which phosphorylation of p38 MAPK; iv) at the time filing, transplanting neural stem/progenitor cells during the chronic phase of spinal cord injury was less effective compared to transplantation during the acute or subacute phases. The present application demonstrates a -secretase inhibitor-treated neurosphere can be used for treating chronic phase spinal cord injury, and such neurosphere increased phosphorylation of p38MAPK, which is required to promote axonal regeneration.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Even if Chen’s neurosphere is not exactly identical to the claimed -secretase inhibitor-treated neurosphere wherein a neurosphere was treated with a -secretase inhibitor for 20-24hrs, Okubo and Shin teach these limitations and provide motivation and an expectation of success in generation of the claimed -secretase inhibitor-treated neurosphere wherein a neurosphere was treated with a -secretase inhibitor for 20-24hrs because:
i) Okubo teaches hiPSCs-derived neurospheres (i.e. aggregates of 253G1 and 201B7 hiPSC-NS/PCs) cultured in a medium comprising a -secretase inhibitor including DAPT at 10uM for 1 day (24 hours) differentiated into more mature neuronal cell types for better treatment of spinal cord injury and transplantation (p.651, 1st col.) and transplantation of such -secretase inhibitor-treated hiPSCs-derived neurospheres maintained and enhanced motor functional recovery after spinal cord injury (SCI) (p. 653, 2nd col., last paragraph to p. 655, 1st col.; p. 655-p. 659);
ii) Shin teaches a culture of human neural stem cells (hNSCs) derived from human pluripotent stem cells (hPSCs) (hPSCs-derived hNSCs) cultured in a culture medium comprising a -secretase inhibitor at a concentration of 0.1-80uM, 0.1-20uM, 0.2-10uM, 0.2-2uM, 0.2-1uM or 0.2-0.5uM, wherein the -secretase inhibitor includes Compound E, DAPT, YO-01027, LY411575 at a concentration of 0.01uM-20uM; and RO4929097, LY450139 (Semagacestat) or MK-0752 at a concentration of 0.8uM-80uM; wherein the hPSCs include human embryonic stem cells (hESCs) or hiPSCs, and the use of the hPSCs-derived hNSCs treated with -secretase inhibitor for treatment of neurodegenerative diseases including spinal cord injury (see col. 3, lines1-35; col. 6, line 38- col. 7, line 2; col. 8 line 59-col.10, line 2; col. 13-14, Examples 4-5, Table 1; claims 1-12).
A person of ordinary skill in the art would have recognized that selecting and applying the known neursopheres-derived from hiPSCs or hESCs cultured in a medium comprising a -secretase inhibitor at a dose of 10uM for 24hrs and the known technique disclosed by Okubo and Shin to the Chen’s neurosphere would have yielded the predictable result of a -secretase inhibitor-treated neurosphere derived from hESCs or hiPSC for chronic phase spinal cord injury treatment, wherein a neurosphere is cultured in a culture medium comprising a -secretase inhibitor at 10mM for a period of 20-24hrs, and resulted in an improved product for better treatment of chronic phase spinal cord injury using transplantation of -secretase inhibitor-treated neurospheres because -secretase inhibitor-treated neurospheres derived from hiPSCs or hESCs can differentiate into more mature neurons and enhance motor functional recovery after spinal cord injury. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known neursopheres-derived from hESCs or hiPSCs cultured in a medium comprising a -secretase inhibitor at a dose of 10uM for 20-24hrs disclosed by Okubo and Shin to the neurosphere of Chen and yield the predictable result of a neurosphere derived from hPSCs for treatment of neurodegenerative diseases including spinal cord injury.
Accordingly, the rejection of claims 2-3 under 35 U.S.C. 103 as being unpatentable over Chen in view of Okubo and Shin is maintained.
Double Patenting
10. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-3 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of copending Application No. 18/561077. The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p.5 of the response, Applicant argues that the ‘077 Application does not teach or suggest the claimed composition because the claims of the ‘077 Application are directed to a method for producing a neurosphere for treatment of spinal cord injury, comprising using a neurite outgrowth promotion kit on a neurosphere derived from pluripotent stem cells, wherein the neurite outgrowth promotion kit comprises a g-secretase inhibitor or a GADD45G expression vector.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §804 and MPEP §2131, the neurospheres recited in claims 9-10 of the ‘077 Application anticipate the neurospheres recited in instant claims 2-3 because:
i. The neuropheres recited in claims 9-10 of the ‘077 Application are derived from pluripotent stem cells and treated with a g-secretase inhibitor including compound 34 or DAPT.
ii. The limitation “cultured in a culture medium comprising a g-secretase inhibitor at 10mM for a period of 20-24hours” recited in instant claims is a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. Note that the determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP2113.
Further, the period of neurospheres treated with a g-secretase inhibitor recited in the method of the ‘077 Application is 24hours (see p. 19, paragraph [0053]). Therefore, claims 2-3 of the instant Application are not patentably distinct from claims 9-10 of the ’077 Application because claims 2-3 of instant Application are anticipated by claims 9-10 of the ‘077 Application.
iii. The limitation “for chronic phase spinal cord injury treatment” recited in instant claims 2-3 is merely to state the purpose or intended use of the invention. The intended use is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc.v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir.1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir.1997).
If the claimed neurosphere cultured in a medium comprising a -secretase inhibitor at 10mM for a period of 20-24 hrs for allowing the -secretase inhibitor to act on the neurosphere can be used for chronic phase spinal cord injury treatment, the same neurospheres cultured in a medium comprising -secretase inhibitor including DAPT at 10uM for 1 day (24hrs) can also be used for chronic phase spinal cord injury treatment.
Accordingly, the provisional rejection of claims 2-3 on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of copending Application No. 18/561077 is maintained.
Conclusion
11. NO CLAIM IS ALLOWED.
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Theocharatos et al. (PLoS One, 2013; 8:e54809. doi:10.1371/journal.pone.0054809) teach human neurospheres cultured in a medium comprising DAPT, a -secretase inhibitor, at a concentration of 20uM, which meet the limitations recited in claims 2, 3 and 8 (see p.1, abstract; p. 3, col.1, paragraph 1; p. 4, col.1, paragraph 4 to col. 2, paragraph 2; p. 7, Figures 5-6).
Chen et al. (US9730975) teach glial-derived neural stem cells/neurospheres cultured in a culture medium comprising DAPT, a -secretase inhibitor at a concentration of 0.1 nmol in 2ml, or 5uM, or 0.01 nmol to about 100 nmol in 2ml (col. 13, lines 38-col. 14, line 59; col. 15, table 1; col.36, Example 9, claims 1-4).
Niapour et al. teach human dental pulp-derived neurospheres cultured in a medium comprising DAPT, a -secretase inhibitor, at a concentration of 0-100uM, 6.25uM, 12.5uM, 25uM, 50uM, 100uM (see p. 876, col.1, paragraph 2; p. 878, col.2, paragraphs 2-4, p. 881, Figures 3A-E).
13. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm 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, 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.
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Chang-Yu Wang
November 5, 2025
/CHANG-YU WANG/Primary Examiner, Art Unit 1675