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 of Group II, claims 9-11, and 14-18, drawn to a multi-chamber biochip in the reply filed on 04/13/2026 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)). Further, non-elected claims 1-8 and 12-13, are not being examined due to applicant not elected said claims.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/28/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
Claims 9-11, and 14-18 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. More specifically, claim 9 is rejected under 112(b) because on lines 17 and 19 of the claim, it is unclear what applicant is attempting to claim referring to the term “ambient”, as it appears the claim limitation is incomplete. Claims 10-11 and 14-18 are also rejected under 112(b), since they depend on claim 9 of the instant application.
Claim Rejections - 35 USC § 102
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.
Claims 9-11 and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10,731,119 B2-Mosig et al (hereinafter “Mosig”).
Regarding claim 9, Mosig discloses a multi-chamber biochip (an invention relating to in vitro production and arrangement of cell layers by which cell layers can be arranged, cultured and studied in a predetermined manner, col. 2, lines 7-10; the devices according to the invention can also be constructed as a chip, also known as a biochip, col. 5, lines 40-41) comprising: a base element (base plate 1, col. 8, line 43, Fig. 1) formed from a single workpiece (Fig. 1 shows base plate 1 as a single workpiece; col. 14, line 13) and including: a bottom having a frame disposed thereon (Fig. 2 shows a bottom having a frame, also shown in annotated Fig. 2 below); said frame having an elevation (edges 13 elevate the frame, show in Figs. 1 and 2) and having a side facing away from said bottom and being open on said side facing away from said bottom (side facing away from the bottom, shown in annotated Fig. 2 is disposed on the other side, shown in Fig. 1, and is open, shown in Fig. 1 and facing away from the bottom or opposite side); said frame having an interior space (interior space of frame, previously discussed above, is encompassed by edges 13, Fig. 1, col. 8, lines 50-51);
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“a first web seated inside said interior space on said bottom and surrounding a first surface; said first web defining a first support surface and a first lateral surface having an elevation less than said elevation of said frame;”: Mosig discloses a first web or a step portion of an inside of the interior space, shown below in annotated Fig. 1; a first support surface defined by the first web and a first lateral surface having an elevation or step portion, less than the elevation of the frame is shown in annotated Fig. 1 below).
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“a lower preliminary culture chamber (Mosig discloses sixth well 2.6 is shown on a bottom region in Fig. 7, enclosed by the first surface of the web or step portion, previously discussed above) conjointly enclosed by said first surface surrounded by said first web and said first lateral surface; said frame having an upper side (an upper portion of the frame of the device shown in Figs. 1 and 2); an upper preliminary culture chamber (Mosig discloses first well 2.1, col. 8, line 21, Fig. 7, where well 2.1 is shown in Fig. 7 being formed on an upper side of the device and thus, the previously discussed first support) being formed between said upper side and said first support surface;”
“a first channel opening on an outer side of said base element (Mosig discloses opening 4.1, a first fluid flow 12.1, col. 11, 36-37, Fig. 7, shown disposed on an outer side of base element 1) and configured to connect said lower preliminary culture chamber to an ambient (Mosig discloses a providing a first well which is closed off from its environment except for an inlet opening, col. 2, lines 18-19; further, Fig. 7 depicts a channel opening 4.1 connected to a lower culture chamber—well 2.6);”
“a second channel opening (Mosig discloses opening 5.1 disposed on an outer side of base element 1, Fig. 7) on an outer side of said base element and configured to connect said upper preliminary culture chamber (Mosig discloses well 2.1, Fig. 7) to the ambient (Mosig discloses a providing a first well which is closed off from its environment except for an inlet opening, col. 2, lines 18-19);”
“a second web extending within said interior space around a second surface; said second web having an elevation less than said elevation of said frame and greater than said elevation of said first web; said second web having a second lateral surface;
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“a middle preliminary culture chamber (well 2.5, disposed in a middle region of the device, col. 10, line 5, Fig. 7) enclosed by said second lateral surface of said second web and said surface enclosing said second web (shown above in annotated Fig. 1); a third channel opening (opening 5.6, col. 11, line 2, Fig. 7, shown disposed on an outer region of the device of Fig. 7 of base 1) on an outer side of said base element and being configured to connect said middle preliminary (connects to middle chamber—well 2.5, Fig. 7) culture chamber to the ambient (Mosig discloses a providing a first well which is closed off from its environment except for an inlet opening, col. 2, lines 18-19);”
“said multi-chamber biochip further including: a first separation membrane placed on said first web (Mosig discloses first membrane 11.1 is shown disposed on first web or step portion shown in Fig. 1) and connected thereto;”
“a lower culture chamber being provided by said first web and said first separation membrane (membrane 11.1 shown in Fig. 1 disposed on a lower culture membrane—well 2.6, which is encompassed by membrane 11.1); a second separation membrane (second membrane 11.2, shown in Fig. 1 disposed on a second web or step portion, shown above in annotated Fig. 1) optionally placed on said second web and connected thereto;
“a middle culture chamber (Mosig discloses well 2.5, Fig. 7, is depicted being disposed between a first membrane—membrane 11.1 and second membrane—membrane 11.2 ) being provided between said first separation membrane and said second separation membrane; an upper closure membrane (bonding foil 3, col. 9, line 26, Fig. 1, shown disposed on an upper side of the frame of the device; and thus connected) placed on said upper side of said frame and being connected thereto;”
“and, an upper culture chamber (well 2.5, Fig. 7) being provided in accordance with one of the following: a) between said upper closure membrane and said first separation membrane (upper chamber—well 2.5 is shown disposed between an upper closure membrane—bonding foil 3, Fig. 7 and between a first separation membrane—first membrane 11.1, also shown in Fig. 7); or, b) between said upper closure membrane and said second separation membrane.”
Regarding claim 10, Mosig discloses wherein said bottom has a lateral surface facing away from said frame (the underside of base plate 1, shown in Fig. 2); and, said multi-chamber biochip further comprises a lower closure membrane (bonding foil 3, shown in Fig. 2; shown on a lateral surface of base plate1; that is, on the bottom of the device shown in Fig. 2) on said lateral surface of said bottom and is connected thereto.
Regarding claim 11, Mosig discloses wherein at least one of said separation membranes has microcavities (porous membrane with two lateral surfaces, col. 4, line 39).
Regarding claim 14, Mosig discloses a set for a multi-chamber biochip of claim 9, the set comprising: said base element (base plate 1, Fig. 1); at least one first separation membrane (first membrane 11.1, Fig. 1) which serves for placement onto the first web (shown above in annotated Fig. 1) and closing off the lower culture chamber (membrane 11.1 is shown closing off a lower chamber—well 2.6, Fig. 7, where membrane 11.1, closes off well 2.6, as shown in Fig. 7); optionally, at least one second separation membrane (membrane 11.2, Fig. 7, can be a placement for a second web or step portion as shown above in annotated Fig. 1) which serves for placement onto the second web and closing off the middle culture chamber (membrane 11); and, an upper closure membrane (bonding foil 3, shown in Fig. 7 is shown on a frame of base plate 1, and thus, closing off the upper chamber—well 2.5, shown in Fig. 7) and shown closing off a middle chamber—well 2.5) which serves for placement onto the frame and closing off the upper culture chamber.
Regarding claim 15, Mosig discloses wherein an additional closure membrane (bonding foil 3, shown in Fig. 2 disposed on a bottom surface of base plate 1 and on a lateral surface) which is intended for placement on the lateral surface, facing away from the frame, of the bottom.
Regarding claim 16, Mosig discloses a method for culturing cells, comprising the steps of: selecting and providing a multi-chamber biochip according to claim 9 (abstract, lines 11-15; device of claim 9, discussed above); and, introducing media and cells into the existing culture chambers (methods according to the invention in that a first fluid flow is guided through the first chamber and a second fluid flow is guided through the second chamber , wherein the first fluid flow and the second fluid flow contain nutrients, col. 3, lines 52-55; the fluids can be cell suspensions and/or nutritive media, col. 4, line 50).
Regarding claim 17, Mosig discloses wherein a hydrogel is introduced into at least one of the culture chambers (cell substrates may have a coating such as polymers, col. 2, lines 50-53, where hydrogels are known in the art to comprise polymers).
Regarding claim 18, Mosig discloses wherein spheroids and/or organoids are produced and/or cultured in at least one of the culture chambers (a tissue or an organoid can be provided in a well or in a device according to the invention having two or more wells, col. 6, lines 42-44), by colonizing them in microcavities of at least one of the separation membranes (abstract, lines 8-11).
Therefore, the reference of Mosig meet the limitation of claims 9-11 and 14-18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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