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 without traverse of Group I, claims 1-12 in the reply filed on April 30, 2026 is acknowledged.
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 claim 10; “a drive control unit” in claim 12; and, “an optical-image acquisition unit” in claim 18.
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 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.
Claim 12 is 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.
Claim 12 recites the limitation "at least a part of the culture sheet has any of a flat shape" in line 3. Independent claim 1 requires a deformed culture sheet by the die member such that the at least the part has a shape concave with respect to the culture surface or a shape convex with respect to the culture surface. Therefore, it is unclear whether the culture sheet need to have a flat shape or curved shape. Further clarification is required and appropriate correction is required.
Appropriate correction is required.
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 1-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakata (US 7,968,335).
Regarding claim 1, Nakata discloses a cell culture system comprising: a culture sheet which is deformable, and to which a cell is allowed to adhere (FIG. 7: culture C; col. 8, line 54 to col. 9, line 27), the culture sheet having a culture surface and a back surface opposite to the culture surface (FIG. 7: culture C; col. 8, line 54 to col. 9, line 27); a die member configured to be pressed against the back surface of the culture sheet to deform at least a part of the culture sheet such that the at least the part has a shape concave with respect to the culture surface or a shape convex with respect to the culture surface (FIG. 7: unit (51D) is coupled to a surface of the culture sheet; it is noted that the upper and lower surfaces of the culture sheet allow cells to adhere; see col. 8, ll. 60-63; col. 9, ll. 20-27); and a drive unit configured to move the die member and to press the die member against the back surface of the culture sheet (see col. 8, ll. 10-15; col. 9, ll. 28-31).
Regarding claim 2, Nakata further discloses a vessel for accommodating a culture medium and the culture sheet (FIG. 7: culture receptacle (3)).
Regarding claim 3, Nakata further discloses 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 the culture surface (FIG. 7: unit (31A); col. 8, line 54 to col. 9, line 27), and wherein the second die member is configured to be pressed against the back surface (FIG. 7: unit (51D) is coupled to a surface of the culture sheet; it is noted that the upper and lower surfaces of the culture sheet allow cells to adhere; see col. 8, ll. 60-63; col. 9, ll. 20-27).
Regarding claim 4, Nakata further discloses a vessel for accommodating a culture medium, wherein the culture sheet forms a part of the vessel (FIG. 7: culture receptacle(3) includes a culture sheet (C)).
Regarding claim 5, Nakata further discloses 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 the culture surface (FIG. 7: unit (31A); col. 8, line 54 to col. 9, line 27), and wherein the second die member is configured to be pressed against the back surface (FIG. 7: unit (51D) is coupled to a surface of the culture sheet; it is noted that the upper and lower surfaces of the culture sheet allow cells to adhere; see col. 8, ll. 60-63; col. 9, ll. 20-27).
Regarding claim 6, Nakata further discloses wherein the die member includes a plurality of parts (see FIG. 7: unit (51D) includes a first part (51C) and a second part (51D)).
Regarding claim 7, Nakata further discloses 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 the culture surface (see FIG. 7: unit (51D) is not in contact with one face of the culture sheet).
Regarding claim 8, Nakata further discloses wherein the drive unit includes an arm (see FIG. 7: upper portion coupled to pressure member (51C)).
Regarding claim 9, Nakata further discloses an outer vessel for accommodating at least the vessel, the culture sheet, the die member, and the drive unit (components of the system of Nakata is disposed within an incubator; see abstract; col. 9, ll. 33-44).
Regarding claim 12, Nakata further discloses a drive control unit (control computer (4) of Nakata is structurally the same as the instant drive control unit and thus considered to be fully capable to control the drive unit based on an optical image of the cell; col. 8, ll. 10-15) such that at least a part of the culture sheet has any of a flat shape, a shape concave with respect to the culture surface, and a shape convex with respect to the culture surface (see FIG. 7).
Therefore, Nakata meets and anticipates the limitations set forth in claims 1-9 and 12.
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 Nakata as applied to claims 1 and 4 above, and further in view of Suenaga et al (already of record, US 2019/0300835; hereinafter “Suenaga”).
Regarding claim 10, Nakata discloses the cell culture system according to claims 1 and 4. Nakata does not explicitly disclose an external-force applying unit that is distinct from the drive unit and is configured to cause a pressure difference in the vessel such that the culture sheet is pressed against the die member. Suenaga disclose a cell culture system comprising a culture sheet (FIG. 7: culture vessel FP; [0114), a die member (pressing member (4); [0117]), and an external-force applying unit (negative pressure generator ([0117]). 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 employed the negative pressure generator of Suenaga with the cell culture system of Nakata to arrive at the claimed inventio. One of ordinary skill in the art would have made said modification in order to aid in positioning the culture sheet on the die member (31A) as disclosed by Suenaga ([0117]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nakata as applied to claim 1 above, and further in view of Suenaga et al (US 2019/0300835; hereinafter “Suenaga”).
Regarding claim 18, Nakata discloses the cell culture system according to claim 1.
Nakata does not explicitly disclose an optical-image acquisition unit configured to acquire an optical image of the cell. Suenaga further discloses an observation unit adapted to configured to acquire an optical image of the cell (see, e.g., [0065]-[0066], [0095] and [0123]). 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 employed the optical-image acquisition unit with the cell culture system of Nakata to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to observe the cell culturing process in real time ([0095]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nakata as applied to claim 1 above.
Regarding claim 19, Nakata discloses the cell culture system according to claim 1. Nakata does not explicitly disclose wherein the die member has a projection or a recess on its pressing surface. 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 modified the shape of the die member of Nakata to have the claimed shape, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (see MPEP 2144.04 IV.B.). Further, one would have been motivated have modified the shape of the die member of Nakata to have the claimed shape for the purpose of producing cell culture sheet having projections or recesses.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 have been considered but are moot in view of the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fofonoff et al (US 5,882,929) disclose a vessel containing a culture sheet and a die member.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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) at http://www.uspto.gov/interviewpractice.
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
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