DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/10/2025 has been entered.
Applicant’s amendments to the claims and arguments filed on September 10, 2025 have been received and entered. Claims 1 has been amended, while claim 7 has canceled. The Zhu’s declaration filed on May 13, 2025 have been considered. The declaration will be discussed below as it pertains to the rejection. Claims 1-6, 8 and 9 are pending in the instant application.
Election/Restrictions
Applicant’s election of species without traverse of a cardiomyocytes (a) in the reply filed on January 20, 2025 was acknowledged. Upon further consideration election of species requirement from each of the distinct species of cardiomyocyte, vascular endothelial cell, fibrinogen, collagen and auxiliary cells as set forth in (a) –(d) is hereby withdrawn and all the non-elected species are hereby rejoined with elected species.
Priority
This application is a continuation of PCT/CN2023/080957 03/11/2023, which claims priority from a foreign application 202310044224.1 filed 01/29/2023 in China.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Receipt is also acknowledged of a certified copy of an English language translation of a non-English language foreign application submitted together with a statement that the translation of the certified copy is accurate.
Claims 1-6, 8 and 9 are under consideration.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Applicant’s amendments to claim 1 obviates the basis of the rejection. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Withdrawn-Claim Rejections - 35 USC § 103
Claims 1-4, 6-9 were rejected under 35 U.S.C. 103 as being unpatentable over King et al (Cell Reports Methods 2, 100280, Aug. 2022, 1-12), as evidenced by Doung (Tissue Engineering, 15(7), 2009, 1865-1876) and Kaiser et al (ACS Biomater. Sci. Eng. 2019, 5, 887−899) / Gudapati et al (Soft Matter, 2020, 16, 10506—10517, IDS). Applicants’ cancellation of claim 6 renders their rejections moot. In view of Applicants’ amendment of base claim 1, introducing the limitation placing the cellular entity in the mixed culture medium at a static status with a flow rate of s 0 mm3/s for static culture for 6-8 days, wherein a preset pulsation frequency of the cellular entity after static culture is 28-35 beats/min, and then placing the cellular entity in the mixed culture medium at a flowing status with a flow rate of 120-600 mm3/s for dynamic culture to obtain an engineered microvessel entity, wherein the engineered microvessel entity includes a plurality of microvascular lumen structures with an inner diameter ranging from 100 pm to 1 mm, and the plurality of microvascular lumen structures are stable, non-collapsible, and perfusable, that is not taught by the combination of references, the previous rejection is rendered moot and hereby withdrawn. Further, applicant’s argument in conjunction with Zhu’s declaration stating culturing cellular entity statically for 6-8 days and the pulsation frequency of the cellular entity is 28-35 beats/min. and resulting three-dimensional physiological tensile stress produced in amended claim 1 can cooperate well with the fluid shear stress in dynamic culture so that a plurality of microvascular lumen structures with an inner diameter ranging from 100 µm to 1 mm are formed inside the cellular entity, and the microvascular lumen structures are stable, non-collapsible, and perfusable is found persuasive, therefore, previous rejection of claims are hereby withdrawn. Applicant’s argument pertaining to withdrawn rejection are hereby rendered moot.
Claims 1, 3-4 were rejected under 35 U.S.C. 103 as being unpatentable over King et al (Cell Reports Methods 2, 100280, Aug. 2022, 1-12), as evidenced by Doung (Tissue Engineering, 15(7), 2009, 1865-1876) and Kaiser et al (ACS Biomater. Sci. Eng. 2019, 5, 887−899) / Gudapati et al (Soft Matter, 2020, 16, 10506—10517, IDS) as applied above and further in view of Twardowski (Ann Biomed Eng. 2014 42(5): 1074–1084). The rejection is withdrawn for the reasons discussed above.
Claims 1 and 5 were rejected under 35 U.S.C. 103 as being unpatentable over King et al (Cell Reports Methods 2, 100280, Aug. 2022, 1-12), as evidenced by Doung (Tissue Engineering, 15(7), 2009, 1865-1876) and Kaiser et al (ACS Biomater. Sci. Eng. 2019, 5, 887−899) / Gudapati et al (Soft Matter, 2020, 16, 10506—10517, IDS) as applied above and further in view of Levenberg (US11045500, dated 06/29/201, filed on 2/13/2012). The rejection is withdrawn for the reasons discussed above.
New-Claim Rejections - 35 USC § 112 - necessitated by amendments
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.
Claims 1-6, 8 and 9 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the recitation of limitation “..placing the cellular entity in the mixed culture medium at a flowing status with a flow rate of 120-600 mm3/s for dynamic culture ” (claim 1) is considered new matter. Applicants point to paragraph 65 of the specification for the specific support of the claimed amendment. However, upon further review of the instant specification, examiner could not find support for flowing status with a flow rate of 120-600 mm3/s for dynamic culture. It is emphasized that instant specification provides explicit support for a flow rate of 5 mm/s (see para. 67 and 75 of the specification). There is no explicit or implicit support for a flow rate of 120-600 mm3/s or a linear speed of 5 mm/s for an artisan to calculate flow rate from the dimensions of the flow chamber. The specification fails to disclose linear speed of the culture medium to determine the linear rate 5-10 mm/s) x (width 8-12 mm) x (depth 3-5 mm). The difference between flow rate and flow speed in a microfluidic microchannel is further exemplified in Plecis et al (see Journal of Applied Physics, 2008, 1-6, page 124909-3, col. 1, last para.). In the instant case, the indicated support at best is directly to the dimensions of the flow chamber (see para. 65). In absence of any explicit or implicit support for a claimed for flow rate of 120-600 mm3/s for dynamic culture or linear flow speed of 5-10 mm/s , an Artisan of skill would not recognize from the disclosure that Applicant was in possession of a placing the cellular entity in the mixed culture medium at a flowing status with a flow rate of 120-600 mm3/s for dynamic culture, as claimed. In case if applicants have evidence to support otherwise, applicants are invited to indicate page and line number for the written support specifically for a flow rate of 120-600 mm3/s.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement”. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981) teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed…If a claim is amended to include subject matter, limitation or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. This is a new matter rejection.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ma et al (CN114591836, IDS) teaches vascular bed micro-fluidic chip design can culture larger scale of vascular network and can construct more complex vascular model to effectively simulate the in vivo vascular network nutrition supply of the tissue.
Tranquillo et al (WO/2005/003317, 1/13/2005, IDS).
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632