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 .
Election/Restrictions
Applicant's election with traverse of the restriction in the reply filed on 7/20/2026 is acknowledged. The traversal is on the ground(s) that the International Searching Authority states that there is unity of invention. This is not found persuasive because the cited section does state that examination of a national stage application must adhere to the International Search Authority’s determination of unity. The section indicates that Examiners should consider the categories, wherein categories can be determined in MPEP 806.05. Since the Examiner established that there is no feature that links that groups, there is no unity of invention. For example, there is nothing to suggest that the claimed method is the only manner of making the organoid, nor is there any clear linking claim between the method of making the organoid and the method of making hematopoietic and/or stromal cells. While the methods do have overlapping biomolecules and method steps, a marrow organoid is interpreted differently than cells, per se. Finally, the kit of claim 38 is merely containers of well-known biomolecules and is not linked to the organoid, per se.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26, 36, and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/20/2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 36 and 37 of the instantly filed specification . Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 9 is objected to because of the following informalities: please place a space between “350-400” and “µm.” Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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 1-4, 9, 10, and 23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nakahata, et al (PGPub 2017/0130202 [IDS Reference]) and evidenced by Akl, et al (Oncotarget, 7, 44735-44762, 2016) and Claesson-Welsh, et al (Journal of Internal Medicine, 273, 114-127, 2012). Nakahata teaches a method of inducing pluripotent stem cells into a mesodermal lineage. Nakahata places these cells, as mesodermal cells, into a three-dimensional support. See paragraph [0016]. Nakahata indicates that the pluripotent stem cells can be induced pluripotent stem cells (IPSC). See paragraph [0024]. Nakahata teaches that the support is cultured in a medium containing BMP4, VEGF, bFGF, and SCF. See paragraph [0023] [0024] [0097]. Nakahata teaches a method of inducing pluripotent cells, which can include IPSCs, into bone marrow cells, using methods that are consistent with those claimed, including steps of including a suitable media for stem cell maintenance, that is supplemented with cytokines for generating bone marrow cells. Nakahata defines these cells as “showing bone marrow-like surface markers and morphology,” and as such, must be consistent with the claimed organoid. See paragraphs [0210]-[0215]. Nakahata teaches that the cells are embedded in a sponge made from collagen. See paragraph [0016]. Which is consistent with the claimed hydrogel. Nakahata, however, never defines the aggregate as a “bone marrow organoid.”
Since Nakahata never describes the construct as a “bone marrow organoid,” it is unclear if Nakahata anticipates the claimed method. However, since Nakahata’s method appears to anticipate every claimed step, Nakahata’s method must have resulted in the claimed bone marrow organoid. See MPEP 2112(III). Furthermore, the metes and bounds of “bone marrow organoid” are not explicitly defined in the instant specification, and as such, it can be reasoned that Nakahata anticipates the claimed organoid. If Nakahata does not anticipate the claimed invention, the claimed invention would have been obvious to the ordinary artisan, based upon Nakahata and the level of skill of the ordinary artisan; in this situation, the ordinary artisan possesses a Masters or PhD in a related field of biomedical engineering, and additionally possess ample applied experience. See MPEP 2141.03.
Nakahata teaches VEGF, not VEGFA. Claesson-Welsh indicates that these are synonymous. See page 114, “Introduction” section, 2nd paragraph. Nakahata teaches bFGF, not FGF2. Akl indicates that bFGF and FGF2 are synonymous. See page 44735, “Introduction” section, 1st paragraph.
With respect to claim 1, as described above, Nakahata appears to anticipate the claimed method, and although it is unclear if a “bone marrow organoid” resulted in the method, it appears as though this should be inherent. Additionally, as discussed above, Nakahata explicitly teaches methods of generating hematopoietic cells, which are bone marrow-based cells.
With respect to claim 2, Nakahata teaches the further addition of Ftl3L. See paragraph [0036].
With respect to claim 3, Nakahata teaches this step. See paragraph [0097].
With respect to claim 4, Nakahata teaches all of the claimed ranges. See paragraph [0103]-[106] [0128] [0130].
With respect to claims 9 and 10, Nakahata appears to teach a method that is consistent with that claimed. See paragraph [0103]-[106] [0128] [0129] [0130] [0131] [0166] [0167] [0169]-[0183].
With respect to claim 23, Nakahata teaches various forms of widely used fresh and conditioned media. See paragraph [0094]. While not explicitly teaching any types of media, Nakahata makes it clear that this choice would be obvious to the ordinary artisan.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Nakahata, et al (PGPub 2017/0130202 [IDS Reference]) and evidenced by Akl, et al (Oncotarget, 7, 44735-44762, 2016) and Claesson-Welsh, et al (Journal of Internal Medicine, 273, 114-127, 2012) and further evidenced by Bentley, et al (British Journal of Haematology, 48, 287-291, 1981). Nakahata teaches that the sponge is collagen, but does not state the type of collagen. Although Nakahata indicates that the sponge was acquired from “MedGEL44,” this particular product/company could not be found. However, the ordinary artisan would have been aware that bone marrow is a homogenous material, that includes collagen types I and IV. See Bentley, page 287, “Summary” section. Therefore, it would have been obvious to the ordinary artisan to use a sponge that is comprised of collagen type I, and/or type IV, since the ordinary artisan understands that an in vitro environment should mimic the in vivo environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
Prosecution Insights