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 .
Preliminary Remarks
The amendment filed on 03/03/2026 has been entered. Claims 1, 4, and 8 were amended, no claims have been canceled, no claims have been added, and claims 11-12 wire withdrawn from consideration.
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 use the word “means,” and are 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: “bonding means” in claims 4-6.
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
Applicant has amended claims 1, 4, and 8 to overcome the cited 112(b) rejection of said claims and therefore, the rejection cited in the Office Action mailed on 12/05/2025 is withdrawn.
Claim Rejections - 35 USC § 103
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 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/183875 A1-Kwon et al. (hereinafter “Kwon”, all citations are made to the machine English translation).
Regarding claim 1, Kwon discloses a cell culture test device (cell culture apparatus 100, page 4, paragraph 3, line 1, Fig. 1) comprising a plurality of well units (plurality of well units 110, page 4, paragraph 3, lines 1-2, Fig. 1), each of which comprises an inlet portion (opening of well unit 210, shown in Fig. 3, that is the opening of well unit 210) through which a first fluid and a second fluid are introduced (first fluid introduced and a second fluid introduced, page 4, paragraph 3, lines 2-3, Fig. 1) and a bottom portion comprising a first sub-well (first sub-well 120, page 4, paragraph 3, line 2, Fig. 1) comprising a first fluid-accommodating space (first sub-well 120 includes a space for receiving a first fluid, page 4, paragraph 3, line 2). However, Kwon does not explicitly teach an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid.
For claim 1, another embodiment of Kwon (referring to Fig. 5), teaches a first subwell 520 and a groove (micropatterned groove 522, page 6, paragraph 1, line 3), which reads on the instant claim limitation of an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid, as taught by a different embodiment, Fig 5 of Kwon, because Kwon teaches the groove, 522 allows for a sample to be fixed in a desired region due to a well having a groove (page 6, paragraph 1, lines 3-4).
Regarding claim 2, Kwon teaches the invention discussed above in claim 1. Further, Kwon teaches a second fluid, also discussed above. Kwon also teaches a barrier 140 prevents the first fluid from overflowing into the second sub-well so that contamination of the first fluid with the second sub-well including the solid bioactive agent can be prevented (col. 6, lines 54-58). However, Kwon does not teach an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid.
For claim 2, another embodiment of Kwon (referring to Fig. 5), teaches a first subwell 520 and a groove (micropatterned groove 522, page 6, paragraph 1, line 3), which reads on the instant claim limitation of an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid, as taught by a different embodiment, Fig 5 of Kwon, because Kwon teaches the groove, 522 allows for a sample to be fixed in a desired region due to a well having a groove (page 6, paragraph 1, lines 3-4).
Regarding claim 3, Kwon teaches the invention discussed above in claim 1. Also, Kwon teaches a groove—groove 322, which also, corresponds to groove 522, may have a depth or thickness of 200 µm, which is within the claimed range thickness of 1 to 2000 µm (page 5, paragraph 1, lines 7-8). Further, Kwon teaches an edge groove of a first subwell 520 and a different embodiment of Kwon, referring to Fig. 5, does teach an edge groove, 522, also discussed above. However, Kwon does not explicitly teach the groove having a thickness of 1 to 2000 µm and a width of 300 to 2000 µm.
For claim 3, another embodiment of Kwon (referring to Fig. 5), teaches a first subwell 520 and a groove (micropatterned groove 522, page 6, paragraph 1, line 3), which reads on the instant claim limitation of an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an edge groove formed along an outer circumference of a lower end of the first fluid-accommodating space to accommodate a portion of the first fluid, as taught by a different embodiment, Fig 5 of Kwon, because Kwon teaches the groove, 522 allows for a sample to be fixed in a desired region due to a well having a groove (page 6, paragraph 1, lines 3-4).
Regarding claim 4, Kwon teaches wherein the cell culture test device further comprises a bonding means disposed on a rear surface of the cell culture test device to prevent leakage of the first fluid (a thin film filling the concave portion 121 including the micropatterned groove 122 can be formed, page 5, paragraph 1, lines 11-13).
Regarding claim 5, Kwon teaches wherein the bonding means is an optically transparent film (since the solid thin film has a thickness in the above-described range, the biological material immobilized in the interior can be observed in a single cell or a single cell colony unit, page 6, paragraph 8, lines 7-9).
Regarding claim 6, Kwon teaches the invention discussed above in claim 4. Further, modified Kwon teaches a bonding means, a first fluid, and a first-fluid accommodating space and an edge groove. However, Kwon does not explicitly teach a pressure control channel.
For claim 6, a different embodiment of Kwon teaches microchannels of the bottom recess 321 (col. 6, lines 25-26, Figs. 3a-b), which reads on the instant claim limitation of a pressure control channel.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the cell culture test of Kwon and further include a pressure control channel as taught by a different embodiment of Kwon. Further, a different embodiment of Kwon teaches the shape and width of the recess are not limited as long as the largest possible amount of the mixture solution can be loaded while maintaining the dimensions and width, which facilitates accurate control over responses to the bioactive agent (col. 8, lines 39-44).
Regarding claim 7, Kwon discloses wherein the bottom portion comprises a second sub-well (second sub-well 130 is for receiving the second fluid, page 5, paragraph 2, line 1, Fig. 1) in which the second fluid is accommodated and an antibiotic (the second fluid may be a solution containing a physiologically active substance, page 4, paragraph 5, lines 3-4) is loaded at a specific location.
Regarding claim 8, Kwon discloses wherein each well unit includes a stepped portion that protrudes toward a center of the well unit along a circumference of an inner wall of the well unit such that the well unit has a lower portion whose inner width is smaller than that of an upper portion at the inlet portion side (Fig. 1 shows stepped regions of each well unit 210, also shown in annotated Fig. 2 below).
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Regarding claim 9, Kwon discloses wherein the stepped portion has an angle of 90° or more with respect to the advancing direction of the second fluid such that the introduced second fluid is prevented from advancing vertically from the bottom portion (a stepped portion of well unit 210 having an angle of 90° is shown in annotated Fig. 1 below).
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Regarding claim 10, Kwon discloses wherein the stepped portion has a continuous edge shape along the circumference of the inner wall (the stepped portion discussed above included a continuous edge shape along the circumference of the inner wall as shown below in annotated Fig. 1).
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Response to Arguments
Applicant’s arguments with respect to claim 1 and the dependent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the current rejection above pertains to new reference(s) relied upon to address the newly amended claim limitations; the arguments filed rely on the reference or combination of references not currently being used in the present Office Action. In particular, a different embodiment of the relied upon reference has been cited for the present rejection of the claims.
Additionally, regarding applicant’s argument “Kwon also fails to disclose the alternative ‘increases in diameter from upper end to lower end’ limitation” is also not found persuasive because as cited in claim 1 of the instant application, and acknowledged by applicant, it is merely an “alternative” feature, that is not required by the claim. Therefore, for the reasons discussed above in the rejection, claims 1-10 stand rejected.
Conclusion
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 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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