DETAILED ACTION
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 .
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.
Claim Status
Applicant’s arguments, affidavit, and amendments filed 3/2/26 have been received and entered in the application.
Claims 1, 4-12 are currently pending and examined on the merits.
Claim 8 is currently amended.
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163.
Claim 12 contains the limitation “wherein the hybrid neurovascular spheroid is an antagonist-treated hybrid neurovascular spheroid”. Claim 12 contains no limitations on what type of antagonist may be used to treat the spheroid. The specification as originally filed is limited to treating the spheroids with a CXCR4 antagonist ([0011], [0061]). Therefore, it is not clear that applicants had full possession of the invention as currently presented.
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.
Claim(s) 1, 3-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song, Liqing. “Modelling 3-D brain-like tissues using human stem cell-derived vascular spheroids, cortical spheroids and microglia-like cells.” (2018). Florida State University Dissertation (cited on IDS dated 2/10/23, hereinafter Song).
Regarding claim 1, Song discloses methods of making brain organoids using human induced pluripotent stem cell (hiPSC)-derived neural progenitor cells (NPCs), endothelial cells (ECs), and mesenchymal stem cells (MSCs) (Section 5.1). Song discloses preparing NPC spheroids, EC spheroids, MSC spheroids, and fusing together (Abstract)
Regarding claims 2-3, 13, Song discloses that inclusion of MSC spheroids in the fused spheroid results in upregulation of VEGF-A, PGE2, TBF-β1, increased expression of TBR1, Nkx2.1, MMP2, MMP3, Notch-1, GLUT-1, CD31, and ZO-1 (Abstract, 4.3.3, 4.3.4, 5.3.2, 5.3.3, Fig. 4.6).
Regarding claims 4, 7-9, Song discloses that undifferentiated hiPSCs are also seeded in ultra-low-attachment plates under conditions such that cortical induced neural progenitor cell (iNPC) spheroids form (5.2.3.2).
Regarding claims 5, 7, 9, Song discloses that the endothelial cell spheroids are derived from human iPSCs (5.2.1, 5.2.3.1).
Regarding claim 6, 8-9 Song discloses that the MSCs are human MSCs (5.2.2).
Regarding claim 10, the cells may be present at ratios of iNPC:iEC:MSC of 4:2:0, 3:2:1, 2:2:2, or 1:2:3 (5.2.4.2).
Regarding claim 11, the combined spheroids may be further cultured on hyaluronic acid (HA) or GelTrexTM for 7 days to promote spheroid fusion (5.2.5; GelTrexTM is interpreted as a basement membrane consistent with applicant’s specification at ¶ [0044]).
Regarding claim 12, the hybrid spheroids may also be cultured in a media containing the CXCR4 inhibitor AMD3100 for 10 days (5.2.11).
Therefore every limitation of claims 1, 3-12 is present in Song, and the subject matter is anticipated.
Response to Arguments
Applicant's arguments and affidavit dated 3/2/26 have been fully considered but are not persuasive as explained in detail below.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Applicant argues that the rejection should be withdrawn in view of the amendments to claim 12 (Response p4).
In response, claim 12 is not currently amended. Therefore, the rejection is maintained and made final.
Claim(s) 1, 3-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song.
Applicant argues that the Declaration of inventor Yan Li dated 11/1/22 under 37 C.F.R § 1.130(a) disqualifies the Song reference as prior art (Response p5).
Under MPEP § 717.01 to disqualify a reference as prior art under the 102(b)(1) (A) exception (the “grace period disclosure” by inventor or obtained from inventor), the applicant must demonstrate that the prior art reference falls within the one year grace period. The declaration as filed fails to contain any information regarding the publication date of the Song reference beyond the year 2018. As applicants have not provided any evidence that the Song reference falls within the one year grace period, the rejection has not been overcome and Song is considered prior art.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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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.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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