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 .
Response to Amendment
The amendment filed February 3, 2026 has been entered.
Claims 1-6 and 8-15 remain pending in the application, with claims 1-6 and 8-9 being examined, and claims 10-15 deemed withdrawn. Claim 7 is canceled.
Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed November 3, 2025. However, new 112(b) rejections have been raised, as detailed in the Claim Rejections-35 USC 112 section of the instant Office Action.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Objections
Claim 9 is objected to because of the following informalities:
Regarding claim 9, Lns. 2-3 recite, “for maintaining and/or adjusting temperature, gas atmosphere”, which is grammatically incorrect. It appears that the above limitation should recites, “for maintaining and/or adjusting temperature, and/or gas atmosphere”, to be grammatically correct.
Appropriate correction is required.
Claim Interpretation
The term “a supply and/or removal system” has been examined as any system or apparatus capable of supplying and removing materials to/from cultivation vessels, such as pumps.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “switching means for providing a switch between a first optical path for determining a physico-chemical parameter and a second optical path for imaging the morphology of cells” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-6 and 8-9 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.
Regarding claim 1, the clause e) recites, “wherein the physico-chemical parameter is selected from physico-chemical parameters indicative for the metabolic condition of cells, including pH, oxygen content, and optionally at least one further parameter”. However, it is unclear if the physico-chemical parameter must include pH and oxygen content, or if these are merely intended to be examples of physico-chemical parameters that may be selected. Therefore, the scope of the limitation is unclear. For purposes of compact prosecution, the above limitation has been examined as requiring at least one of pH and oxygen content to be measured as a physico-chemical parameter, and that additional physico-chemical parameters may optionally be selected.
Claims 2-6 and 8-9 are rejected at least as depending on a rejected claim.
Regarding claim 8, Lns. 7-8 recite, “the optical path”. However, claim 8 recites a first optical path and a second optical path. Therefore, it is unclear if “the optical path” is referring to either of the first optical path or the second optical path, or a different optical path entirely. Further clarification is needed.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lob et al., “Automated live cell screening system based on a 24-well-microplate with integrated micro fluidics”, 2007, Medical & Biological Engineering & Computing, Vol. 45, Pgs. 1023-1028 (hereinafter Lob; already of record).
Regarding claim 1, Lob discloses a device for analysis of cultured cells (see Figs. 1-2). The device comprises:
a) a plurality of cultivation vessels adapted for culturing cells, wherein the plurality of cultivation vessels are located at a stationary position in the device throughout a measurement cycle (see Figs. 1-2. The stage for micro-well plates is static. See also Pg. 1025 Col. 2 Ln. 13-Pg. 1026 Col. 1 Ln. 14).
b) a climatic chamber in which the plurality of cultivation vessels are positioned (Pg. 1024 Col. 1 Lns. 42-50).
c) a supply and/or removal system for supplying and/or removing materials, including cultivation media and/or test compounds to or from the plurality of cultivation vessels, and optionally at least one reservoir for supply materials and for waste (Figs. 1-2, the integrated microfluidics acts as a supply and/or removal system).
d) a light source for transmitting radiation to the plurality of cultivation vessels (Pg. 1025 Col. 1 Lns. 14-18, see Figs. 1-2).
e) at least one optical sensor which is responsive to a physico-chemical parameter in a cultivation vessel of the plurality of cultivation vessels, wherein the physico-chemical parameter is selected from physico-chemical parameters indicative for the metabolic condition of cells, including pH, oxygen content, and optionally at least one further parameter (Pg. 1024 Col. 2 Lns. 2-4, Fig. 3. See also Fig. 2, and Pg. 1025 Col. 1 Lns. 14-18, which shows that the optic microscope can be used to detect fluorescence signals from oxygen/pH sensors, and Pg. 1025 Col. 2 Lns. 5-12, which states that the filter changers are integrated into a microscopic building block, and the filter changers are necessary for fluorescence microscopy).
f) at least one electrode for measuring the impedance of cells in a cultivation vessel of the plurality of cultivation vessels (Pg. 1024 Col. 2 Lns. 8-11).
g) a detector or detector system for receiving radiation from a cultivation vessel of the plurality of cultivation vessels, wherein the detector or detector system is adapted for (i) determining a physico-chemical parameter in said cultivation vessel of the plurality of cultivation vessels and (ii) imaging the morphology of cells in said cultivation vessel of the plurality of cultivation vessels (see Fig. 2 at CCD camera 4, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22).
h) a microscope for providing an optical path between a cultivation vessel of the plurality of cultivation vessels and the detector or detector system, wherein the microscope is adapted to be moved between a plurality of positions within the device, wherein an individual microscope position is attributed to an individual cultivation vessel of the plurality of cultivation vessels, and wherein the microscope comprises switching means for providing a switch between a first optical path for determining a physico-chemical parameter and a second optical path for imaging the morphology of cells (see Fig. 2, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22, which teaches that the microscope can be switched between multiple modes of microscopic techniques, which means that a switching means must intrinsically be present to switch between different modes. See also Pg. 1025 Col. 2 Lns. 1-12, which teach that the objective carousel (used for imaging), and the filter changer(s) (used for fluorescence microscopy) are integrated into the microscope). The microscope is mounted on a stage that allows movement in x- and y- directions, thereby being movable between the plurality of cultivation vessels (see Fig. 2, where the microscope moves via a moving base in x and y directions).
The device is configured to perform the measurement cycle by moving the microscope to said cultivation vessel to capture both the physico-chemical parameter and the morphology of cells from said cultivation vessel without moving the cells therein (see Fig. 2, where the microscope moves via a moving base in x and y directions, and the stage for the micro-well plates is static, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22, and Pg. 1025 Col. 2 Lns. 1-12).
Note: The instant Claims contain a large amount of functional language (ex: “adapted for culturing cells…”, “for supplying and/or removing materials…”, “for transmitting radiation…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 2, Lob discloses the device of claim 1, which is adapted for performing the measurement cycle comprising the steps of: (i) determining one or more physico-chemical parameters and imaging the morphology of cells in a first cultivation vessel (a); (ii) determining one or more physico-chemical parameters and imaging the morphology of cells in a second cultivation vessel (a); and (iii) repeating step (ii) for one or more other cultivation vessels (a); wherein the sequence of steps (i), (ii) and (iii) may be repeated at least once until the measurement cycle is performed (the device of Lob is identical to the instantly claimed device, and is capable of determining one or more physico-chemical parameters, imaging the morphology of cells, and moving in x-y directions to focus on different cultivation vessels in a microwell plate, see Fig. 2, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22. The device of Lob is therefore capable of performing the above claimed measurement cycle).
Regarding claim 3, Lob discloses the device of claim 1, wherein the switching means is adapted for substantially simultaneously determining a physico-chemical parameter and imaging of cell morphology (the device of Lob is identical to the instantly claimed device, and is therefore capable of performing substantially simultaneous determining of parameters and cell morphology imaging).
Regarding claim 5, Lob discloses the device of claim 1, which is adapted for performing the measurement cycle comprising the steps of: (i) determining a physico-chemical parameter in a plurality of cultivation vessels by moving the microscope between a plurality of positions and (ii) imaging the morphology of cells in a plurality of cultivation vessels by moving the microscope between a plurality of positions; wherein steps (i) and (ii) may be performed in any order (the device of Lob is identical to the instantly claimed device, and is capable of determining one or more physico-chemical parameters, imaging the morphology of cells, and moving in x-y directions to focus on different cultivation vessels in a microwell plate, see Fig. 2, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22. The device of Lob is therefore capable of performing the above claimed measurement cycle).
Regarding claim 6, Lob discloses the device of claim 5, which is adapted for performing the measurement cycle comprising the of: steps (ia) determining a first physico-chemical parameter in a plurality of cultivation vessels by moving the microscope between a plurality of positions; (ib) determining a second physico-chemical parameter in a plurality of cultivation vessels by moving the microscope between a plurality of positions; and (ii) imaging the morphology of cells in a plurality of cultivation vessels by moving the microscope between a plurality of positions; wherein steps (ia), (ib) and (ii) may be performed in any order (the device of Lob is identical to the instantly claimed device, and is capable of determining multiple physico-chemical parameters, imaging the morphology of cells, and moving in x-y directions to focus on different cultivation vessels in a microwell plate, see Fig. 2, Fig. 3, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22. The device of Lob is therefore capable of performing the above claimed measurement cycle).
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lob as applied to claims 1-3 and 5-6 above, and further in view of Kitagawa (Translation of JP Pub. No. 2000-97857; already of record).
Regarding claim 4, Lob discloses the device of claim 3, and all limitations recited therein. Lob further discloses that the switching means is adapted for providing a temporal offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 s or less, and/or for providing a spatial offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 mm or less (the invention of Lob is identical to the instantly claimed invention, and therefore is capable of providing the claimed temporal offset and/or spatial offset).
Further, even if Lob is not considered to disclose that the switching means is adapted for providing a temporal offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 s or less, and/or for providing a spatial offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 mm or less, Kitagawa, in the analogous field of optical scanning systems for measuring cells (Kitagawa Pg. 1 at 2nd Para.), teaches a switching means that is adapted for providing a temporal offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 s or less, and/or for providing a spatial offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 mm or less (Kitagawa; Pg. 4 7th to Last Para.-Pg. 6 2nd Para., see Fig. 1 at slide mechanisms 108, 112, 208, 212 for moving mirrors 106, 110, 206, and 210, respectively, into and out of optical path, see also Pg. 8 8th to Last-3rd to Last Paras. regarding automatically controlling the position of the mirrors using a controller, and simultaneously measuring a plurality of different fluorescences). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Lob with the teachings of Kitagawa so that the switching means is adapted for providing a temporal offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 s or less, and/or for providing a spatial offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 mm or less. The motivation would have been to provide a device that can quickly switch between various modes, thereby improving throughput, and/or a device that can measure a physico-chemical parameter and image cell morphology within a small area, thereby improving the resolution of data obtained by the device.
Further, even if modified Lob does not teach that the switching means is adapted for providing a temporal offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 s or less, and/or for providing a spatial offset between determining a physico-chemical parameter and imaging of cell morphology, which is about 2 mm or less, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a device having the claimed temporal offset and/or spatial offset. The motivation would have been to provide a device that can quickly switch between various modes, thereby improving throughput, and/or a device that can measure a physico-chemical parameter and image cell morphology within a small area, thereby improving the resolution of data obtained by the device.
Regarding claim 8, Lob discloses the device of claim 1. Lob further discloses that the microscope (h) comprises a first optical element, and a second optical element, and wherein the switching means is adapted for switching between the first optical path comprising the first optical element and the second optical path comprising the second optical element (see Fig. 2, see also Pg. 1024 Col. 2 Lns. 1-8, Pg. 1026 Col. 1 Lns. 15-22).
Lob fails to explicitly disclose that the switching means is adapted for moving the first optical element and the second optical element into or out from the optical path and wherein the first optical element and the second optical element are mounted on a movable sliding element.
However, Kitagawa teaches a switching means that is adapted for moving a first optical element and second optical element into or out from the optical path and that the first optical element and the second optical element are each mounted on movable sliding elements (Kitagawa; Pg. 4 7th to Last Para.-Pg. 6 2nd Para., see Fig. 1 at slide mechanisms 108, 112, 208, 212 for moving mirrors 106, 110, 206, and 210, respectively, into and out of optical path). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Lob with the teachings of Kitagawa so that the switching means is adapted for moving the first optical element and the second optical element into or out from the optical path and that the first optical element and the second optical element are each mounted on movable sliding elements, in order to switch between different modes in the microscope (Kitagawa Pg. 8 8th to Last-3rd to Last Paras.).
Further, even if Lob is not considered to teach that the switching means is adapted for switching between the first optical path comprising the first optical element and the second optical path comprising the second optical element, Kitagawa teaches a switching means adapted for switching between a first optical path comprising a first optical element and a second optical path comprising a second optical element (Kitagawa; Pg. 4 7th to Last Para.-Pg. 6 2nd Para., see Fig. 1 at slide mechanisms 108, 112, 208, 212 for moving mirrors 106, 110, 206, and 210, respectively, into and out of optical path). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Lob with the teachings of Kitagawa so that the switching means is adapted for switching between a first optical path comprising the first optical element and a second optical path comprising the second optical element, in order to switch between different modes in the microscope (Kitagawa Pg. 8 8th to Last-3rd to Last Paras.).
Modified Lob fails to explicitly disclose that the first optical element and the second optical element are mounted on a movable sliding element.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the first optical element and the second optical element be mounted on a movable sliding element, since the use of a one piece construction instead of the structure disclosed in the would be merely a matter of obvious engineering choice. See MPEP 2144.04(V)(B), and In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). The motivation for providing the first optical element and the second optical element on a movable sliding element would have been to simplify the construction of the device, and conserve space.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lob as applied to claims 1-3 and 5-6 above, in view of Oelschlager et al. (US Pub. No. 2016/0289621; hereinafter Oelschlager).
Regarding claim 9, Lob discloses the device of claim 1 wherein the climatic chamber (b) is provided with a control element adapted for maintaining and/or adjusting temperature, and/or gas atmosphere (Pg. 1024 Col. 1 Lns. 42-50).
Lob fails to explicitly disclose that the climatic chamber (b) is further provided with (i) a separation element, for physically separating the culture vessels from the supply and/or removal system (c) and/or from the microscope (h), and/or (ii) a ventilation filter element, and/or (iii) with a pressure control element.
Oelschlager is in the analogous field of bioreactors (Oelschlager [0002]). Oelschlager teaches a chamber that is provided with a pressure control element (Oelschlager; [0028], [0120]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Lob with the teachings of Oelschlager so that the climatic chamber is provided with a pressure control element, in order to prevent the climatic chamber from rupturing under pressure (Oelschlager; [0028], [0120]).
Response to Arguments
Applicant's arguments filed February 3, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 9-10 of their Remarks that Lob, the primary reference used in the Non-Final Office Action mailed 11/3/2025, does not teach a stationary multi-sensor platform, a movable microscope with switching means, parallel multi-parametric sensing, and a synergistic combination of stationary cultivation, a movable microscope, and an integrated optical switching mechanism. The Applicant argues that Lob instead employs two separate constructional systems in parallel, and that the sensor and imaging optics of Lob are discrete components of separate different system, and therefore Lob does not teach a switching means to toggle between a first optical path for determining a physico-chemical parameter, and a second optical path for imaging the morphology of cells. The Examiner respectfully disagrees. In Pg. 1025 Col. 2 Lns. 1-12, and Fig. 2 of Lob, Lob teaches that the objective carousel (used for imaging), and the filter changer(s) (used for florescence microscopy) are integrated into the microscope. Therefore, even if the components are part of different systems, both systems are integrated into a single microscope, and the microscope is capable of switching between the two components depending on what procedure is to be performed. Further, Pg. 1026 Col. 1 Lns. 15-22 of Lob teaches that the microscope can be switched between multiple modes of microscopic techniques, i.e. a switching means must intrinsically be present to switch between the different modes.
Applicant further argues on Pgs. 10-11 that Lob does not allow for the cells to remain stationary throughout the measurement cycle to avoid mechanical disturbances. The Examiner respectfully disagrees. Lob explicitly teaches in Fig. 2 and Pg. 1025 Col. 2 Ln. 13-Pg. 1026 Col. 1 Ln. 14 that the stage on which the micro-well plates are placed is static.
Applicant further argues on Pgs. 11-12 of their Remarks that Kitagawa does not disclose or suggest an integrated movable microscope with switching means to switch between an optical path for a physico-chemical sensor and an optical path for morphology. However, as previously stated, the Examiner’s position is that Lob does teach the above claimed limitation. Further, with regards to the dependent claims 4 and 8 that do rely upon Kitagawa’s teachings, the Examiner reminds the Applicant that it is not necessary that the inventions of the references be physically combinable to render obvious the invention under review, and that the teachings of references does not involve an ability to combine their specific structures. See MPEP 2145(III), In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983), and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973).
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 John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Examiner, Art Unit 1798