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
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 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.
Election/Restrictions
Applicant’s election of Group VIII, claims 29-33 and the species election of the 15th recited structure of claim 30 for formula (1) in the reply filed on May 11, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Based on the results of the search, the species election requirement between the species of the 15th recited compound and the 18th recited compound of claim 30 has been withdrawn.
Claims 1, 2, 6, 9, 11-17, 19, 21, and 29-33 remain pending in the current application, claims 1, 2, 6, 9, 11-17, 19, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 29-33 have been considered on the merits.
Status of the Claims
Claims 1, 2, 6, 9, 11-17, 19, 21, and 29-33 are currently pending.
Claims 1-2, 6, 11-12,14-15, 17, and 29 are amended.
Claims 1, 2, 6, 9, 11-17, 19, and 21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 3-5, 7-8, 10, 18, 20, 22-28 are cancelled.
Claims 31-33 are new
Claims 29-33 have been considered on the merits.
Drawings
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: there is description of color in the Specification of Fig. 4A in 0018; Fig. 5C in 0019 and the various colors cannot be distinguished from each other since the figures are in black and white.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms Neurobasal™ in 0005-0006, 0059, 00488-00489, 00494; N2 B-27™ Supplement in 0017, 00513-00514; Bio-Gel® P100 in 00492; StemCyte® in 00493; StemExpress® in 00493; FACS-Aria™ II in 00497-00498; Histopaque® 1119 in 00498; eBioscience® in 00500; BioLegend® in 00500; FlowJo® software in 00500 and Table 1; Diva® software in Table 1; Illumina NextSeq® in 00502; Illumina HiSeq® in 00502; Cell Ranger™ in 00503; Ready-SET-GO!® Elisa kits in 00508; Zeiss® LSM-780 in 00508, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities: minor grammatical error in claims.
Claim 31 is objected to because of the following informalities: The periods after the roman numerals denoting the different components need to be replaced with a parenthesis. For example, in claim 31 "i." should be corrected to "i)" in line 2. In other words, a claim should only contain one period. Please see MPEP 608.01(m).
Appropriate correction is appreciated.
Claim Rejections - 35 USC § 102
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 29 and 30 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cho et al. (US 2009/0131336 A1) .
With respect to claims 29 and 30, Cho teaches a cell culture medium containing a compound, 4-pyrimidin-2-yl-piperazin-1-yl)-(5-thiophen-2-yl-isoxazol-3-yl)-methanone or derivative 39 having the same structure as the 15th recited compound of Formula 1 in claim 30 (Table 6, 0293 and 00393).
PNG
media_image1.png
200
400
media_image1.png
Greyscale
PNG
media_image2.png
200
400
media_image2.png
Greyscale
Derivative 39 15th recited structure
Therefore, the reference anticipates the claimed subject matter.
Claims 29-30 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ying et al. (WO 2020/076739 A1, published Apr. 16, 2020) (ref. of record) as evidenced by Selleckchem.com (“SKL2001, Wnt/β-catenin Agonist” product data sheet, accessed online Jul. 8, 2026, copyright 2013).
With respect to claims 29 and 31, Ying teaches a cell culture medium for granulocyte/macrophage progenitors (GMPs) containing a growth factor, a B-Raf kinase inhibitor and a Wnt activator and/or a GSK-3 inhibitor (0005). With respect to claims 29 and 30, Ying teaches the Wnt activator is SKL 2001 which has the same structure as the 18th recited compound of Formula 1 in claim 30 (0051) as evidenced by Selleckchem.com (pg. 1) and the first structure of Fig. 1 of the instant application.
PNG
media_image3.png
200
400
media_image3.png
Greyscale
PNG
media_image4.png
200
400
media_image4.png
Greyscale
SKL 2001 18th recited structure
Therefore, the reference anticipates the claimed subject matter.
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 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (WO 2020/076739 A1, published Apr. 16, 2020) as evidenced by Selleckchem.com (“SKL2001, Wnt/β-catenin Agonist” product data sheet, accessed online Jul. 8, 2026, copyright 2013) in view of Webster et al. (US 2016/0303124 A1).
With respect to claims 29 and 31, Ying teaches a cell culture medium for granulocyte/macrophage progenitors (GMPs) containing a growth factor, a B-Raf kinase inhibitor and a Wnt activator and/or a GSK-3 inhibitor (0005). With respect to claims 29 and 30, Ying teaches the Wnt activator is SKL 2001 which has the same structure as the 18th recited compound of Formula 1 in claim 30 (0051) as evidenced by Selleckchem.com (pg. 1) and the first structure of Fig. 1 of the instant application.
PNG
media_image3.png
200
400
media_image3.png
Greyscale
PNG
media_image4.png
200
400
media_image4.png
Greyscale
SKL 2001 18th recited structure
With respect to claim 32, Ying teaches the growth factor is stem cell factor (SCF) (0005). With respect to claim 33, Ying teaches the B-raf kinase inhibitor is GDC-0879, PLX4032, GSK2118436, BMS-908662, LGX818, PLX3603, RAF265, RO5185426, vemurafenib, PLX8394, SB590885, and any combination thereof.
Ying does not teach the medium containing a mitogen-activated kinase interacting protein kinases 1 and 2 (Mnk1/2) inhibitor as recited in claim 31.
However, Webster teaches a composition of immune cells containing a Mnk1/2 inhibitor (0015 and 0074). Webster teaches the immune cells can be granulocytes and macrophages (0072 and 0228). In addition, Webster teaches that a MNK-specific inhibitor increases the activity of immune cells and enhances immune cell response (0015 and 0074).
One of ordinary skill in the art would have been motivated to modify the cell culture medium of Ying to include a Mnk1/2 inhibitor for the benefit of increasing the activity of the cells as taught by Webster. It would have been obvious to include additional components to the medium of Ying that are known to be beneficial to granulocytes such as a Mnk1/2 inhibitor for increasing the cell’s activity as taught by Webster. Additionally, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the cell culture medium taught by Ying, since Webster teaches MNK-specific promoters are beneficial in maintaining the activity of immune cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 29 and 30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 12,006,513 B2 as evidenced by Selleckchem.com (“SKL2001, Wnt/β-catenin Agonist” product data sheet, accessed online Jul. 8, 2026, copyright 2013). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the issue patent. In addition, both claim cell culture media.
With respect to instant claims 29 and 30, claims 1 and 14 of US Pat. No. 12,006,513 B2 recite the limitations of a cell culture medium containing the 18th recited structure of instant claim 30. Claim 14 recites that the Wnt activator is SKL 2001 which has the same structure as the 18th recited compound of Formula 1 in claim 30 as evidenced by Selleckchem.com (pg. 1) and the first structure of Fig. 1 of the instant application.
PNG
media_image3.png
200
400
media_image3.png
Greyscale
PNG
media_image4.png
200
400
media_image4.png
Greyscale
SKL 2001 18th recited structure
Claims 29 and 30 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11 and 19 of copending Application No. 18/660178 as evidenced by Selleckchem.com (“SKL2001, Wnt/β-catenin Agonist” product data sheet, accessed online Jul. 8, 2026, copyright 2013). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims encompass those of the copending patent application. In addition, both claim cell culture media. With respect to instant claims 29 and 30, claims 11 and 19 of Appl. No. 18/660178 recite the limitations of a cell culture medium containing the 18th recited structure of instant claim 30 as evidenced by Selleckchem.com (pg. 1) and the first structure of Fig. 1 of the instant application.
PNG
media_image3.png
200
400
media_image3.png
Greyscale
PNG
media_image4.png
200
400
media_image4.png
Greyscale
SKL 2001 18th recited structure
Conclusion
No claims are allowed.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanna et al. (US 2017/0275593 A1)
With respect to claims 31 and 32, Hanna teaches a cell culture medium for pluripotent stem cells containing growth factors including stem cell factor (SCF) and a B-Raf kinase inhibitor (0016, 0018, 0022, 0391, 0408). With respect to claim 33, Hanna teaches the B-Raf kinase inhibitor is SB590885 (0385-0386).
Wu et al. "Wnt10b promotes hair follicles growth and dermal papilla cells proliferation via Wnt/β-Catenin signaling pathway in Rex rabbits." Bioscience reports 40.2 (2020): BSR20191248.
With respect to claims 29 and 30, Wu teaches a cell culture medium containing the Wnt/β-Catenin Pathway inhibitor, XAV939 (pg. 2 para. 4).
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 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, Peter Paras can be reached on 571-272-4517. 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 http://pair-direct.uspto.gov. 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.
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
Prosecution Insights