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 (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.
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-17, in the reply filed on 3/4/2026 is acknowledged. The traversal is on the ground(s) that the method expressly requires use of the specific structural system recited in the apparatus claims (page 2 of the response dated 3/4/2026). This is not found persuasive because, as stated in the restriction, the apparatus as claimed can be used to practice another and materially different process.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/4/2026.
Information Disclosure Statement
The information disclosure statement dated 10/31/2022 has been considered and made of record.
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.
Claims 1, 2, 4, 6, 9 and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higuchi et al. (US 2018/0171280) (IDS dated 10/31/2022).
With respect to claim 1, the reference of Higuchi et al. discloses:
A cell culture exposure system (CCES)(100)(Figs. 1, 6a and 6b) comprising:
at least one dilution manifold (103, 104, 105) including at least one inlet (102) for receiving a fluid flow;
at least one flow splitter (top plate)(113)(Figs. 1, 6a and 6b);
an exposure chamber (111) configured to receive a cell culture plate;
wherein the at least one flow splitter (top plate)(113) is disposed between the at least one dilution manifold (103, 104, 105) and the exposure chamber (111), and provides flow communication between the at least one dilution manifold (103, 104, 105) and a cell culture plate (¶[0035]) received in the exposure chamber.
With respect to claim 2, the dilution manifold (Fig. 1 reproduced below) includes:
at least one inlet cap (103) having the at least one inlet (102);
at least one inner diluter (104);
at least one exhaust dilutor (Fig. 1 below).
PNG
media_image1.png
335
555
media_image1.png
Greyscale
With respect to claims 4 and 6, in the absence of further positively recited structure, the at least one flow splitter (top plate)(113)(Figs. 1, 6a and 6b) is considered to be structurally capable of accommodating VOC or aerosol flows.
With respect to claim 9, the system (Figs. 1 and 5) includes:
a plenum plate (113);
an annular plate (Fig. 5);
a base configured to receive the cell culture plate (114);
wherein the annular plate is disposed between the plenum plate and the base.
With respect to claims 11 and 12, the system include a culture plate (¶[0035]) disposed within the system, wherein cell culture plate includes a plurality of wells, and the system is configured such that each well of the plurality of wells receives its own independent flow of the fluid flow from the at least one inlet.
With respect to claim 13, the reference of Higuchi et al. discloses:
A cell culture exposure system comprising:
a dilution manifold (103, 104, 105) having at least one inlet (102) for receiving a fluid flow;
an assembly of flow splitters (recesses in top plate)(113)(Figs. 1, 6a and 6b);
an exposure chamber (111) configured to receive a cell culture plate having a plurality of wells;
wherein the assembly of flow splitters is disposed between the dilution manifold (103, 104, 105) and the exposure chamber (111) and provides flow communication therebetween and the system is configured such that each well of the plurality of wells (¶[0035]) receives its own independent flow of the fluid flow downstream of the assembly of flow splitters.
With respect to claim 14, the dilution manifold (Fig. 1 reproduced above) includes:
at least one inner diluter (104);
at least one exhaust dilutor (Fig. 1 above).
With respect to claim 15, in the absence of further positively recited structure, the assembly of flow splitters (recesses in top plate)(113)(Figs. 1, 6a and 6b) are considered to be structurally capable of accommodating VOC or aerosol flows.
With respect to claim 16, the system (Figs. 1 and 5) includes:
a plenum plate (113);
an annular plate (Fig. 5);
a base configured to receive the cell culture plate (114);
wherein the annular plate is disposed between the plenum plate and the base.
With respect to claim 17, the system include a culture plate (¶[0035]) disposed within the system.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Higuchi et al. (US 2018/0171280) (IDS dated 10/31/2022) in view of Mohr et al. (US 2005/0170499) (IDS dated 10/31/2022).
The reference of Higuchi et al. has been discussed above with respect to claim 1.
Claim 10 differs by reciting that the system includes a heating element.
The reference of Mohr et al. discloses that it is known in the art to provide the base or lower part (2) of a cell culture exposure system (Fig. 1) with a heating element (coil)(¶[0040]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the cell culture exposure system of the reference of Higuchi et al. with a heating coil for the known and expected result of regulating the temperature of the culture chamber.
Allowable Subject Matter
Claims 3, 5, 7 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 3, the prior art of record fails to teach or fairly suggest a cell culture exposure system, in the claimed environment or scope of claim, that includes at least two inner diluters and the at least one dilution manifold further includes: a U-turn component disposed between the at least two inner diluters and providing flow communication therebetween.
With respect to claim 5, the prior art of record fails to teach or fairly suggest a cell culture exposure system, in the claimed environment or scope of claim, wherein the VOC flow splitter includes: a sampling port; a flow splitter body; at least one chamber adapter.
With respect to claims 7 and 8, the prior art of record fails to teach or fairly suggest a cell culture exposure system, in the claimed environment or scope of claim, wherein the aerosol flow splitter includes: an aerosol flow adapter; a flow splitter body; at least one chamber adapter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Zavala et al. (Inhal. Toxicol) is cited as prior art that pertains to a cell culture exposure system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB