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.
Priority
Receipt is acknowledged of certified copies of papers (JAPAN 2020-212308 12/22/2020) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 9/8/2023; 11/5/2025; and 5/21/2025 have been considered and made of record.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“attachment/detachment portion” in claim 1;
“a sealing member” in claim 1;
“a transfer mechanism” in claim 1;
“a pressure application portion” in claim 2;
“a pressure application portion” in claim 3; and
“a medium management unit” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
As discussed above, the claim element “transfer mechanism” is considered to invoke 35 USC 112(f). Review of the disclosure fails to clearly identify the specific structure that corresponds with this claim element. Specifically, reference to “transfer mechanism” can only be found in the abstract and claims along with a reference in paragraph [0006] of the specification which do not identify any corresponding structure. While claims 2 and 3 appear to correlate some structure to this claim element, it is not clear how parts of previously recited claim elements can constitute the separate claim element of “a transfer mechanism”. Clarification and/or correction is requested.
Claims 2-9 are also considered indefinite because these claims depend from indefinite claim 1 and fail to cure the deficiencies of the claim from which they depend.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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. As described above in the rejection under 35 USC 112(b), the disclosure fails to clear identify any corresponding structure that performs the function related to the “transfer mechanism” claim element of claim 1. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claims 2-9 are included in this rejection because they depend from rejected claim 1 and fail to cure the deficiencies of claim 1.
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.
Claims 1, 3-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Katayama et al. (US 2019/0382703) in view of Nozaki et al. (US 2015/0231628).
With respect to claim 1, the reference of Katayama et al. discloses:
A cell culture container (Figs. 1, 2 and 9) comprising:
an insert member (cell culture insert) (2) having a membrane (porous membrane)(3) on which a cell (epithelial cells)(6) is seeded, the insert member defining a first inner space that functions as an anaerobic chamber (anaerobic environment)(Fig. 1);
a container (culture tank)(1) having an attachment/detachment portion (top wall of culture tank (1) which includes opening (1a)) to and from which the insert member is attachable and detachable, the container defining a second inner space that functions as an aerobic chamber (aerobic environment)(Fig. 1); and
a sealing member (sealing agent/gasket)(4) that closes an opening of the aerobic chamber between the attachment/detachment portion and the insert member with the insert member being attached to the attachment/detachment portion.
As discussed previously, it is noted that the claim elements “attachment/detachment portion” and “a sealing member” are considered to invoke 35 USC 112(f).
With respect to “attachment/detachment portion”, the top wall of culture tank (1) which includes opening (1a) is considered a structural and functional equivalent to the top wall structure (12) of the container (10) with opening (12c) as shown in Fig. 1 of the instant application.
With respect to “a sealing member”, the sealing agent/gasket (4) is considered a structural and functional equivalent to the sealing gasket/o-ring (50) of the instant application.
Claim 1 differs by reciting that the culture container includes:
a transfer mechanism that transfers force to the sealing member, wherein
the sealing member closes the opening in response to an input of the force from the transfer mechanism, and allows the insert member to be detached from the container when application of the force from the transfer mechanism is released.
The reference of Nozaki et al. discloses that it is known in the art to provide a culture container (Figs. 1-3) that includes a container (105) and an insert member (113) with a transfer mechanism (115, 102 and 108) for transferring force to a sealing member (103), wherein the sealing member (103) closes the opening in structure (109) in response to an input of the force from the transfer mechanism (115, 102 and 108), and allows the insert member (113) to be detached from the container (105) when application of the force from the transfer mechanism is released.
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 modify the device of Katayama et al. to include a transfer mechanism as suggested by the reference of Nozaki et al. for the known and expected result of providing an art recognized means for maintaining the structural integrity of the seal between the culture container and the culture insert while allowing the insert device to be easily removed from the culture container.
As discussed previously, it is noted that the claim element “a transfer mechanism” is considered to invoke 35 USC 112(f).
With respect to “a transfer mechanism”, elements (103, 115 and 108) are considered to be structural and functional equivalents to the elements (60, 40 and 61b) of the instant application.
With respect to claim 3, the structure encompassed by the combination of the references as discussed above with respect to claim 1 would include a first cover (115) wherein the sealing member is an o-ring (103) that covers the opening and the transfer mechanism has a pressure application portion (102) that is provided at the first cover (115) and that is pressed against the o-ring when the first cover (115) is fixed to the container (105).
With respect to claim 4, the reference of Katayama et al. discloses that the container (1) is provided with a through hole (1a) (Fig. 9) that communicates the second inner space (aerobic chamber) with outside of the container.
With respect to claim 5, while the reference of Katayama et al. discloses the use of an elastic member (4)(Fig. 9) that closes the through hole (1a)(Fig. 9), the reference does not disclose that it is attached to the first cover. However, as discussed in the rejection of claim 1, it would have been obvious to one of ordinary skill in the art to provide the elastic member between the first cover and the opening for the known and expected result of providing an art recognized means for maintaining the structural integrity of the seal between the elastic member and the sealed opening while allowing the opening to be easily uncovered after removal of the lid.
With respect to claim 9, the reference of Katayama et al. discloses the use of intestinal epithelial cells (¶[0081]-[0082]). With respect to the recited medium management unit, the reference of Nozaki et al. disclose that it is known in the art to provide the culture device with flow channel tubes (211-214) (Fig. 2A) for adding and/or removing fluids with respect to the chambers which would be a functional and structural equivalent to the recited “a medium management unit”.
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 device of the primary reference with a medium management unit that suctions and discharges a medium accommodated in at least one of the chambers as is conventional in the art as evidenced by the reference of Nozaki et al.
Allowable Subject Matter
Claims 2 and 6-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 2, the prior art of record fails to teach or fairly suggest a cell culture container, in the claimed environment or scope of claim, that includes a cover fixable to the container and includes a pressure application portion that presses a loop-shaped member against an o-ring positioned on a tapered portion of the attachment/detachment portion of the container.
With respect to claims 6 and 7, the prior art of record fails to teach or fairly suggest a cell culture container, in the claimed environment or scope of claim, that includes a second cover fixable to the container as required of claim 6.
With respect to claim 8, the prior art of record fails to teach or fairly suggest a cell culture container, in the claimed environment or scope of claim, wherein the upper wall of the container includes a standing wall protruding from the upper wall to support a flange portion of the insert member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Knebel et al. (US 2010/0129850) and Wilkes et al. (US 2007/0166817) are cited as prior art which pertains to cell culture containers that include cell culture inserts.
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.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB