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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-12, drawn to a cell culture system, classified in C12M23/26.
Group II. Claims 13-17, drawn to a method, classified in C12N5/0062.
The inventions are independent or distinct, each from the other because:
Inventions Groups I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process such as a process of lysing cells.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Applicant’s representative, Jason Okun, on January 8, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-17 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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: “a drive unit” in claim 1; an external-force applying unit” in claims 10-11; “a drive control unit” in claim 12.
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.
Claims 10-11 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. Claim 10 recites the limitation "an external-force applying unit that is distinct from the drive unit and is configured to press the die member against the culture sheet," however, said limitation fails to comply with written description requirement. The instant specification, as originally filed, discloses an external-force applying unit (see [0056] and [0072]). However, the specification is silent as to the structure that comprise the claimed external-force applying unit. As such, said limitation fails to comply with the written description requirement. Claim 11 recites the limitation "wherein an external-force applying unit is configured to increase and reduce a pressure in the vessel," however, said limitation fails to comply with written description requirement. The instant specification, as originally filed, discloses an external-force applying unit (see [0056] and [0072]). However, the specification is silent as to the structure that comprise the claimed external-force applying unit. As such, said limitation fails to comply with the written description requirement.
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 10-11 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.
Regarding claims 10-11, claim limitation “an external-force applying unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The instant specification, as originally filed, discloses an external-force applying unit (see [0056] and [0072]). However, the specification is silent as to the structure that comprise the claimed external-force applying unit. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Appropriate correction is required.
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 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chesnut et al. (US 2009/0035857; hereinafter “Chesnut”) in view of Suenaga et al. (US 2019/0300835; hereinafter “Suenaga”).
Regarding claim 1, Chesnut discloses a cell culture system comprising: a culture sheet which is deformable, and to which a cell is allowed to adhere (FIG 25: cell culture layer (70); [0083]); a die member configured to be pressed against the culture sheet to deform the
culture sheet (cell culture processing tool (102); [0082]); and a drive unit configured to drive the die member (actuator (104); [0082]). Chesnut does not explicitly disclose an optical-image acquisition unit configured to acquire an optical image of the cell. Suenaga discloses a cell culture system comprising a pressing member (FIG. 1: member 4) for pressing cells in a culture vessel ([0057]). The system further includes an optical-image acquisition unit configured to acquire an optical image of the cell (FIG. 1: observation device 7; [0065]). In view of Suenaga, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the optical-image acquisition of Suenaga with the system of Chesnut for the purpose of observing the cells in real-time as disclosed by Suenaga ([0065]). One of ordinary skill in the art would have made said modification in order to maintain the cells in optimum culturing conditions.
Regarding claim 2, modified Chesnut further discloses a vessel for accommodating a culture medium and the culture sheet (FIG. 26: cell culture dish (74); [0083]).
Regarding claims 3 and 6, modified Chesnut further discloses the claimed die member but does not explicitly disclose wherein the die member wherein the die member includes two or more die members including a first die member and a second die member, wherein the first die member is configured to be pressed against a culture surface
of the culture sheet, wherein the second die member is configured to be pressed against a back surface opposite to the culture surface of the culture sheet, and wherein the die member includes a plurality of parts. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the die member of modified Chesnut to comprise two or more die members, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (see MPEP § 2144.04 VI. B.). One would have been motivated to duplicate the die member of modified Chesnut to comprise two or more die members for the purpose of pressing a plurality of sections on the culture sheet and thereby increasing the throughput of the system.
Regarding claim 7, it is noted that apparatus claims cover what a device is, not what a device does. Therefore, the limitation “wherein the die member is prevented from coming into contact with a part of an area to which the cell is allowed to adhere in a culture surface of the culture sheet” fail to define additional structural elements to the device (see § MPEP 2114).
Regarding claim 8, modified Chesnut further discloses wherein the drive unit includes an arm (FIGS. 25-26: support structure (108); [0082]).
Regarding claim 9, modified Chesnut does not explicitly disclose an outer vessel for accommodating at least the vessel, the culture sheet, the die member, and the
drive unit. However, Chesnut does disclose that it is well known in the art to culture cells in an incubator ([0069]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Chesnut such that components of the system are within an incubator to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to maintain the cells in optimum culturing conditions as suggested by Chesnut ([0069]).
Regarding claim 10, modified Chesnut further discloses wherein an external-force
applying unit that is distinct from the drive unit and is configured to press the die member against the culture sheet (movable carrier (110); [0082]).
Regarding claim 11, modified Chesnut further discloses wherein an external-force applying unit is configured to increase and reduce a pressure in the vessel (movable carrier (110) can increase a pressure in the vessel by pressing the culture sheet and thus the section of the vessel under the culture sheet; [0082]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Chesnut in view of Suenaga as applied to claim 1 above, and further in view of Kurosawa (JP 2003-079360-A; with English machine translation; hereinafter “Kurosawa”).
Regarding claim 4, modified Chesnut disclose the cell culture system according to claim 1. Modified Chesnut a vessel for accommodating a culture medium (FIG. 26: cell culture dish (74); [0083])., but does not explicitly disclose wherein the culture sheet forms a part of the vessel. Kurosawa discloses a culture vessel having a culture sheet forming a part of the culture vessel (sheet 14; FIG. 2a). Kurosawa further discloses, in another embodiment, wherein the culture sheet is arranged within the culture vessel (FIG. 2b). In view of Kurosawa, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vessel of modified Chesnut with the culture vessel of Kurosawa having a sheet forming a portion of the vessel. One of ordinary skill in the art would have made said modification because Kurosawa discloses that the sheet can be a part of the vessel or can be arranged within the vessel (see FIGS. 2a-2b of Kurosawa).
Regarding claim 5, modified Chesnut does not explicitly disclose an outer vessel for accommodating at least the vessel, the culture sheet, the die member, and the
drive unit. However, Chesnut does disclose that it is well known in the art to culture cells in an incubator ([0069]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Chesnut such that components of the system are within an incubator to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to maintain the cells in optimum culturing conditions as suggested by Chesnut ([0069]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chesnut in view of Suenaga as applied to claim 1 above, and further in view of Blanchard (US 2018/0087021).
Regarding claim 12, modified Chesnut disclose the cell culture system according to claim 1. Modified Chesnut further discloses a drive control unit configured to control the drive unit (FIG. 25: controller (106); [0081]-[0082]), and at least a part of the culture sheet has any of a flat shape, a shape concave with respect to a culture surface, and a shape convex with respect to the culture surface. Blanchard discloses a cell culture system comprising a cell culture vessel comprising cells, a manipulator, an imager and a controller ([0073]; FIG. 2A). Blanchard further discloses wherein the manipulator can be controlled by the control unit based on the images acquired by the imager ([0011]). In view of Blanchard, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Chesnut with the system of Blanchard. One of ordinary skill in the art would have made said modification for the purpose enhancing the operation of the driving unit of the die member by selectively manipulating the desired areas of the vessel containing cells, as suggested by Blanchard ([0011]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lau et al. (US 2021/0284969) disclose a vessel containing a culture sheet and a die member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799