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 Invention I, claims 1-12, in the reply filed on 3/5/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/5/2024, 3/14/2024, and 6/24/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 11 is objected to because of the following informalities: it is recommended that "the insertion pipes have an average aperture . Appropriate correction is required.
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:
"driving mechanism. configured to drive the culture medium" in claim 1.
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.
Claims 1-12 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.
Claim 1 recites the limitation "the " in line 11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the phrase "plate-like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 9, the phrase "plate-like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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.
Claims 1-4, 6, 8-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2010/0029000 A1) (already of record) in view of Kim et al. (WO 2021/215894 A1) (machine translated).
Regarding claim 1, Zhong et al. discloses a culture device for culturing a plurality of bioparticles (abstract “multiwell plate… cell culture”), the 3D culture device comprising: a plurality of accommodating wells (wells 40) each having a surrounding wall, wherein the surrounding wall of each of the accommodating wells defines a culture space therein for accommodating at least one of the bioparticles (wells 40; para. 0038 “culture cells on the bottom of well 40”);
a cover (lid 10) including a communication portion (skirt 22) and a plurality of insertion pipes (outlets 50) that are connected to the communication portion, wherein the insertion pipes are in spatial communication with each other through the communication portion, and wherein the insertion pipes are respectively inserted into the culture spaces of the accommodating wells, and each of the insertion pipes is in spatial communication with the corresponding culture space through the filtering bottom structure of the corresponding accommodating well (outlets 50);
a culture medium that is filled in the culture spaces of the accommodating wells, the communication portion of the cover, and the insertion pipes of the cover, so that the bioparticles respectively located in the culture spaces are immersed in the culture medium (para. 0039 “adding fresh medium to cell culture wells”); and
a driving mechanism assembled to the cover (Fig. 7 external pump 100 connected to lid 10), wherein the driving mechanism is configured to drive the culture medium in the cover so as to allow the culture medium to flow into or out of each of the culture spaces for controlling volume of the culture medium in each of the culture spaces (para. 0016 “medium flow is driven by an external pump which can control flow rate”; para. 0037 “fresh medium is driven by an external pump 100 into the compartment 25 of lid 10 through the inlet 60 of the upper section 26 of the lid 10 and then is distributed into wells 40”).
Zhong et al. does not teach wells with a filtering bottom structure. However, Kim et al. teaches a micro pattern on the bottom of wells (micro pattern 230) to reduce the contact area between the cell and the culture groove so cells can grow into three-dimensional spheroids having uniform size (para. 0077). It would have been obvious to a person of ordinary skill in the art to use the Kim et al. configuration of a micropattern on the bottom of wells in Zhong et al.’s device with a reasonable expectation that it would reduce the contact area between the cell and the bottom of the well so cells can grow into three-dimensional spheroids having uniform size. This method for improving Zhong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhong et al. and Kim et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Zhong et al. discloses a culture device wherein the cover encloses each of the accommodating wells (Figs. 1 lid 10 covers wells 40), so that the culture space of each of the accommodating wells is only in spatial communication with at least one of the insertion pipes arranged therein (Fig. 7 one outlet 50 inserted into each well 40).
Regarding claim 3, Zhong et al. discloses a culture device wherein the culture device allows the culture medium to flow among the culture spaces through the cover of the accommodating wells (para. 0037 “fresh medium is driven by an external pump 100 into the compartment 25 of lid 10 through the inlet 60 of the upper section 26 of the lid 10 and then is distributed into wells 40”).
Regarding the limitation “culture medium is capable of transmitting biological information generated from the bioparticles respectively located in the culture spaces”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Zhong et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to pump culture medium into the wells and release spend medium from the wells (para. 0037) and would be structurally capable of transmitting biological information generated from the bioparticles absent clear evidence otherwise.
Zhong et al. does not teach wells with a filtering bottom structure. However, Kim et al. teaches a micro pattern on the bottom of wells (micro pattern 230) to reduce the contact area between the cell and the culture groove so cells can grow into three-dimensional spheroids having uniform size (para. 0077). It would have been obvious to a person of ordinary skill in the art to use the Kim et al. configuration of a micropattern on the bottom of wells in Zhong et al.’s device with a reasonable expectation that it would reduce the contact area between the cell and the bottom of the well so cells can grow into three-dimensional spheroids having uniform size. This method for improving Zhong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhong et al. and Kim et al. to obtain the invention as specified in claim 3.
Regarding claim 4, Zhong et al. discloses a culture device comprising wells (wells 40), but does not disclose wherein, in each of the accommodating wells, a filtering bottom structure includes a base and a plurality of upright arms that are connected to the base and that are spaced apart from each other, and wherein, in the filtering bottom structure of each of the accommodating wells, any two of the upright arms adjacent to each other have a gap therebetween being smaller than a diameter of any one of the bioparticles. However, Kim et al. teaches a micro pattern on the bottom of wells (micro pattern 230) including a base (culture groove 220) and a plurality of upright arms spaced apart from each other (protrusions 231) wherein upright arms adjacent to each other have a gap therebetween smaller that a diameter of any one of the bioparticles (Figs. 2-8b). Kim et al. teaches that the micro pattern reduces the contact area between the cell and the culture groove so cells can grow into three-dimensional spheroids having uniform size (para. 0077). It would have been obvious to a person of ordinary skill in the art to use the Kim et al. configuration of a micropattern on the bottom of wells in Zhong et al.’s device with a reasonable expectation that it would reduce the contact area between the cell and the bottom of the well so cells can grow into three-dimensional spheroids having uniform size. This method for improving Zhong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhong et al. and Kim et al. to obtain the invention as specified in claim 4.
Regarding claim 6, Zhong et al. discloses a culture device further comprising: a carrier having a plate-like shape (plate 20); and a frame that is connected to the carrier to jointly form the accommodating wells, wherein the frame includes the surrounding walls that are spaced apart from each other (sidewalls 14).
Zhong et al. does not teach wells with a filtering bottom structure. However, Kim et al. teaches a micro pattern on the bottom of wells (micro pattern 230) to reduce the contact area between the cell and the culture groove so cells can grow into three-dimensional spheroids having uniform size (para. 0077). It would have been obvious to a person of ordinary skill in the art to use the Kim et al. configuration of a micropattern on the bottom of wells in Zhong et al.’s device with a reasonable expectation that it would reduce the contact area between the cell and the bottom of the well so cells can grow into three-dimensional spheroids having uniform size. This method for improving Zhong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhong et al. and Kim et al. to obtain the invention as specified in claim 6.
Regarding claim 8, Zhong et al. discloses a culture device wherein the frame has a top end surface connected to the surrounding walls (upper section 14A of sidewalls 14), and the communication portion of the cover abuts against the top end surface to enclose the accommodating wells (Fig. 1; para. 0031 “a skirt 22 surrounding the lower section defining a plurality of corners on the lid 10 and extending downwardly”).
Regarding claim 9, Zhong et al. discloses a culture device wherein the communication portion has a plate-like shape (Fig. 1 skirt 22), and the communication portion has a bottom side (lower section 24) and a top side that is opposite to the bottom side (upper section 26), where the insertion pipes are connected to the bottom side of the communication portion (Fig. 1 outlets 50 connected to lower section 24), wherein the cover includes an external pipe that is connected to the top side and that is in spatial communication with each of the insertion pipes through the communication portion (Fig. 1 inlet 60), and wherein the driving mechanism is assembled to the external pipe (Fig. 7 external pump 100 connected to inlet 60).
Regarding claim 10, Zhong et al. discloses a culture device wherein at least one of the insertion pipes has a plurality of filtering holes and is able to be in spatial communication with the corresponding culture space through the filtering holes (hole/slot/orifice 54; Fig. 3).
Regarding claim 12, Zhong et al. discloses a culture device wherein the filtering holes of the at least one of the insertion pipes (hole/slot/orifice 54; Fig. 3) are arranged adjacent to the corresponding wells and are immersed in the culture medium (Fig. 7 outlets 50 inserted into wells 40 with culture medium).
Zhong et al. does not teach wells with a filtering bottom structure. However, Kim et al. teaches a micro pattern on the bottom of wells (micro pattern 230) to reduce the contact area between the cell and the culture groove so cells can grow into three-dimensional spheroids having uniform size (para. 0077). It would have been obvious to a person of ordinary skill in the art to use the Kim et al. configuration of a micropattern on the bottom of wells in Zhong et al.’s device with a reasonable expectation that it would reduce the contact area between the cell and the bottom of the well so cells can grow into three-dimensional spheroids having uniform size. This method for improving Zhong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhong et al. and Kim et al. to obtain the invention as specified in claim 12.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2010/0029000 A1) (already of record) in view of Kim et al. (WO 2021/215894 A1) (machine translated) as applied to claim 4 above, and further in view of Takahashi et al. (US 2013/0323839 A1).
Regarding claim 5, modified Zhong et al. discloses a culture device comprising a filtering bottom structure comprising upright arms as Kim et al. discloses a micro pattern (230) comprising protrusions (231). Modified Zhong et al. does not disclose wherein a gap between adjacent upright arms/protrusions is less than or equal to 2 µm, or wherein the upright arms/protrusions have an average height being within a range from 5 µm to 15 µm. However, Takahashi et al. teaches a pillar pitch (para. 0061 “distance 107 from the center of the tip of the projection to the center of the tip of the adjacent projection”) ranging from 0.18 to 20 µm (para. 0109) and a pillar height of 1 µm (para. 0061) which control the adhesiveness and migration of cells so that uniformly-sized three-dimensional cell structures are formed (abstract).
Regarding the pillar pitch, it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range of a gap between adjacent upright arms is obvious in view of Takahashi et al. because Takahashi et al. discloses a range of 0.18 to 20 µm, which overlaps the claimed range of less than or equal to 2 µm. It would have been obvious to one of ordinary skill in the art to select the claimed range from the broader prior art range because one of ordinary skill in the art would reasonably expect that a pillar/upright arm gap within the range of 0.18 to 20 µm would help control the adhesiveness and migration of cells so that uniformly-sized three-dimensional cell structures are formed (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range to obtain the invention as specified in claim 5.
Regarding the pillar height, it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP 2144.05 I). The claimed range of 5 µm to 15 µm is obvious in view of Takahashi et al. because Takahashi et al. discloses a height of 1 µm which is close to the claimed range. It would have been obvious to one of ordinary skill in the art to select the claimed range from the close prior art range because one of ordinary skill in the art would reasonably expect that a pillar/upright arm height close to 1 µm would help control the adhesiveness and migration of cells so that uniformly-sized three-dimensional cell structures are formed (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Zhong et al. and Takahashi et al. to obtain the invention as specified in claim 5.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2010/0029000 A1) (already of record) in view of Kim et al. (WO 2021/215894 A1) (machine translated) as applied to claim 6 above, and further in view of Tipgunlakant et al. (US 2014/0273191 A1).
Regarding claim 7, Zhong et al. discloses a culture device comprising a carrier (plate 20), a frame (sidewalls 14), and a driving mechanism (external pump 100), but does not disclose wherein the carrier and the frame are a semiconductor chip, and the driving mechanism is a piezoelectric micro-controller. However, Tipgunlakant et al. teaches that a semiconductor cell plate (para. 0172) and a piezoelectric actuator (para. 0365) are known in the art. Though modified Zhong et al. does not explicitly teach a semiconductor cell plate or a piezoelectric actuator, it would have been obvious to a person of ordinary skill in the art to use a semiconductor cell plate and a piezoelectric actuator because the substitution of one known element for another would have predictably resulted in a microfluidic system that monitors the biological properties of cells (para. 0172) and has controllable valves suitable for microfluidic systems (para. 0365), with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of modified Zhong et al. with the teachings of Tipgunlakant et al. to obtain the invention as specified in claim 7.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2010/0029000 A1) (already of record) in view of Kim et al. (WO 2021/215894 A1) (machine translated) as applied to claim 10 above, and further in view of Nguyen et al. (US 2023/0080802 A1).
Regarding claim 11, Zhong et al. discloses a culture device comprising insertion pipes comprising filtering holes (hole/slot/orifice 54), but does not disclose wherein the filtering holes of the at least one of the insertion pipes have an average aperture being less than 1 µm. However, Nguyen et al. teaches a membrane with an average pore size within a range of 0.2 µm to 10 µm (para. 0042) which allows cells of different sizes to be studied (para. 0042). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range of an aperture less than 1 µm is obvious in view of Nguyen et al. because Nguyen et al. discloses a range of 0.2 µm to 10 µm, which overlaps the claimed range of less than 1 µm. It would have been obvious to one of ordinary skill in the art to select the claimed range from the broader prior art range because one of ordinary skill in the art would reasonably expect that a membrane with a pore size of 0.2 µm to 10 µm would allow cells of different sizes to be studied. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range to obtain the invention as specified in claim 11.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Costoya Puente et al. (US 2021/0222108 A1) (already of record) discloses a system for cell culture including a well plate and nozzles for each well; Li et al. (US 2021/0395669 A1) discloses a cell culture system including a well plate and a cover including tubes for pumping medium into the wells; Tsai et al. (US 2024/0228938 A1) discloses a liquid processing device including a well plate and a lid including tubes which insert into each well.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799