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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/9/2026 has been entered.
Election/Restrictions
Newly submitted claim 17 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features.
Group I (claims 1-16 as filed on 3/9/2021) and group II (claim 17 filed on 3/9/2026 lack unity of invention because even though the inventions of these groups require the technical feature of an arrangement for the implementation of in vitro biocompatibility tests, comprising: at least one sample is disposed on a surface of a base plate or in which the at least one sample forms a surface or a surface region of the base plate and a receiving element having at least one through-hole can be placed on the at least one sample such that a first opening which is disposed pointing in the direction of the base plate the at least one through-hole is disposed in the region of the at least one sample, the at least one through-hole with its hollow space and the sample forming a cavity, the receiving element being formed from or with an elastically deformable material; and a cover element placed and fixed on the receiving element such that a pressure force acts on the receiving element, which leads to an at least partial deformation of the receiving element and the fluid-impermeable closure of the first opening, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Frederickson (provided below).
Fredrickson teaches an arrangement for the implementation of in vitro biocompatibility tests (Fredrickson; Abstract), in which at least one sample is disposed on a surface of a base plate or in which the at least one sample forms a surface or a surface region of the base plate (Fredrickson; Fig. 3; para [47]; The frame 156 defines a recessed portion 159 having a counter surface 158 that is configured to receive multiple specimens 134) and a receiving element having at least one through-hole can be placed on the at least one sample such that a first opening (Fredrickson; Fig. 3; para [48]; the gasket 140 disposed on the frame 156 over the specimens 134. The gasket 140 defines multiple openings 162), which is disposed pointing in the direction of the base plate (Fredrickson; Fig. 3, 6; examiner notes that the opening is over the base plate), of the at least one through-hole is disposed in the region of the at least one sample (Fredrickson; Fig. 6; para [48]; the gasket 140 disposed on the frame 156 over the specimens 134), the at least one through-hole with its hollow space and the sample forming a cavity (Fredrickson; Fig. 6; examiner notes that the space in the through-hole is hollow thus holding the sample as seen in Fig. 6), the receiving element being formed from or with an elastically deformable material (Fredrickson; Fig. 1; para [44]; the gasket 40 can each be formed with various materials, preferably materials that can be sterilized for repeated use, such as silicone rubber; examiner notes that the gasket 40 shown in Fig. 1, is the general principles of the invention and later discussed as gasket 140); a cover element (Fredrickson; Fig. 3; para [46]; top plate 128) placed and fixed on the receiving element such that a pressure force acts on the receiving element, which leads to an at least partial deformation of the receiving element and the fluid-impermeable closure of the first opening, which is disposed pointing in the direction of the base plate, of the at least one through-hole (Fredrickson; Fig. 4, 5, 6; para [48, 49]; the gasket 140 provides a sealing fit between the top plate 128 and the specimens 134… A nut 154 can be threaded on to each pin 152 to couple the top plate 128 to the base 122, sandwiching the gasket 140 and the specimens 134 there between; examiner notes that the receiving element is partially deformed upon screwing of the nut because material of the gasket is silicone rubber), the base plate and the cover element being connected together on one side by at least one joint (Fredrickson; Fig. 2, 3, 8; para [49]; the coupling mechanism by which the top plate 128 is removably coupled to the base 122 includes a set of pins 152); the at least one joint and closing elements being arranged at oppositely-disposed sides of the arrangement (Fredrickson; Fig. 3, 7; para [49]; A nut 154 can be threaded on to each pin 152 to couple the top plate 128 to the base 122).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 17 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The amendments and remarks, filed on 3/9/2026, has been entered. The previous prior art rejection stands.
Claim Status
Claims 1-5 and 9-17 are pending with claims 1-5 and 9-16 being examined and claim 17 is withdrawn.
Claim Rejections - 35 USC § 102
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 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 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.
Claim(s) 1-5, 9-12, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frederickson et al (US 20080293157 A1; hereinafter “Fredrickson”; already of record on IDS filed 8/31/2021).
Regarding claim 1, Fredrickson teaches an apparatus for the implementation of in vitro biocompatibility tests (Fredrickson; Abstract), said apparatus comprising:
at least one sample being disposed on a surface of a base plate or in which the at least one sample forms a surface or a surface region of the base plate (Fredrickson; Fig. 3; para [47]; The base 122 includes an upper face 124 (FIG. 3) to which the frame 156 is coupled…The frame 156 defines a recessed portion 159 having a counter surface 158 that is configured to receive multiple specimens 134; the examiner interprets the base plate to include both the frame and the base 122) and a receiving element having at least one through-hole having ends with a first and second openings placed on the at least one sample such that the first opening of the through-hole (Fredrickson; Fig. 3; para [48]; the gasket 140 disposed on the frame 156 over the specimens 134. The gasket 140 defines multiple openings 162; examiner interprets the through holes to the first opening as the end that is directed/faced towards the base/frame, and the second opening as the end that is directed/faced towards cover/top) is disposed pointing in a direction of the base plate (Fredrickson; Fig. 3, 6; examiner notes that the opening is over the base plate), and the at least one through-hole being disposed pointing on the at least one sample (Fredrickson; Fig. 6; para [48]; the gasket 140 disposed on the frame 156 over the specimens 134),
the at least one through-hole having a hollow space above the sample forming a cavity (Fredrickson; Fig. 6; examiner notes that the space in the through-hole is hollow thus holding the sample as seen in Fig. 6), and
the receiving element being formed solely from or with an elastically deformable material (Fredrickson; Fig. 1; para [44]; the gasket 40 can each be formed with various materials, preferably materials that can be sterilized for repeated use, such as silicone rubber; examiner notes that the gasket 40 shown in Fig. 1, is the general principles of the invention and later discussed as gasket 140);
a cover element (Fredrickson; Fig. 3; para [46]; top plate 128) being placed and fixed directly on the receiving element such that pressure force acts on the receiving element which creates a partial deformation of the receiving element and produces a fluid-impermeable closure of the first opening (Fredrickson; Fig. 4, 5, 6; para [48, 49]; the gasket 140 provides a sealing fit between the top plate 128 and the specimens 134… A nut 154 can be threaded on to each pin 152 to couple the top plate 128 to the base 122, sandwiching the gasket 140 and the specimens 134 there between; examiner notes that the receiving element is partially deformed upon screwing of the nut because material of the gasket is silicone rubber), and, a
on the base plate and on the cover element, closure elements being formed with which, when brought into engagement, a form fit connection of the base plate and the cover element, and the pressure force exertion on the receiving element are provided (Fredrickson; Fig. 3, 5, 7; para [35, 48, 49]; the test apparatus 20 can include a gasket 40 to provide a sealing fit between the top plate 28…the gasket 140 defines multiple openings 162 that align with, and correspond to, apertures 150 of the top plate 128 when the top plate 128 is coupled to the base 122…the top plate 128 is removably coupled to the base 122 includes a set of pins 152…the coupling mechanism by which the top plate 128 is removably coupled to the base 122 includes a set of pins 152). The examiner notes that the top plate is screwed onto the base through the pins, thus a force is exerted on the receiving element when the plate is secured.
Regarding claim 2, Fredrickson teaches the apparatus according to claim 1, wherein the elastically deformable receiving element is formed from a biocompatible and/or sterilisable material (Fredrickson; Fig. 1; para [44]; the gasket 40 can each be formed with various materials, preferably materials that can be sterilized for repeated use, such as silicone rubber).
Regarding claim 3, Fredrickson teaches the apparatus according to claim 1, wherein the receiving element is formed from or with the elastically deformable material has a Shore hardness in the range of 30 to 50 (Fredrickson; Fig. 1; para [44]; the gasket 40 can each be formed with various materials, preferably materials that can be sterilized for repeated use, such as silicone rubber). While Fredrickson does not address a Shore hardness in the range of 30 to 50, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the receiving element can consist for example of silicone. Absent persuasive evidence that the receiving element of the instant claims and the gasket made of silicone rubber of Fredrickson are different, the prior art is considered to have the same properties with respect to Shore hardness in the range of 30 to 50 as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 4, Fredrickson teaches the apparatus according claim 1, wherein the at least one sample is fixed in a form-fit area on the surface of the base plate (Fredrickson; Fig. 6; para [47]; the frame 156 with specimens 134 disposed within the recessed portion 159).
Regarding claim 5, Fredrickson teaches the apparatus according claim 1, wherein at least one opening located in the cover element (Fredrickson; Fig. 3; para [46]; the top plate 128 includes an upper face 130, a lower face 132, and defines multiple apertures 150 extending from the upper face 130 to the lower face 132) connecting at least partially to the second opening of a respective through-hole of the receiving element which second opening is disposed in a direction of the cover element (Fredrickson; Fig. 3, 6; para [48]; The gasket 140 defines multiple openings 162 that align with, and correspond to, apertures 150 of the top plate 128). As previously noted, the examiner interprets the side which contact/face the top plate as the second opening of the through hole, thus partially connecting the receiving element and the cover element.
Regarding claim 9, Fredrickson teaches the apparatus according claim 1, wherein corresponding to cavities in cell culture research (Fredrickson; para [61]; the sample material can be, for example, a biological material, a non-biological material, a fluid, a dye, a cell), the cover element and the receiving element adapted thereto are modularly exchangeable (Fredrickson; para [35]; the gasket 40 can be removably disposed between the frame 56 and the top plate 28). Examiner notes that the cover element and receiving element are capable of being adapted modularly as both structures may be removed or provided without the other.
Regarding claim 10, Fredrickson teaches the apparatus according claim 1, wherein the at least one sample is inserted in a receiving space configured in the base plate (Fredrickson; Fig. 3; para [47]; the frame 156 defines a recessed portion 159 having a counter surface 158 that is configured to receive multiple specimens 134), and after placing the receiving element with the first opening of one or more through-holes on the sample, the respective sample does not contact an inner wall of an adjacent through-hole of the receiving element (Fredrickson; Fig. 6; para [48]; When the top plate 128 is coupled to the base 122, multiple wells 164 are defined by the apertures 150 of the top plate 128 and each of the specimens 134. Thus, each specimen 134 is associated with multiple different apertures 150. The gasket 140 provides a sealing fit between the top plate 128 and the specimens 134, providing a seal at a bottom portion of the wells 164).
Regarding claim 11, Fredrickson teaches the apparatus according claim 1, wherein a plurality of the through-holes are configured or disposed in assigned groups (Fredrickson; Fig. 6). The through-hole can be grouped based on the row/column of the top plate.
Regarding claim 12, Fredrickson teaches the apparatus according claim 1, wherein the receiving element is retained in a form-fit with the base plate or the cover element (Fredrickson; Fig. 2, 5, 6; para [48]; the gasket 140 provides a sealing fit between the top plate 128 and the specimens 134).
Regarding claim 14, Fredrickson teaches the apparatus according claim 1, wherein on the base plate, at least one opening is present for guiding objects in and out (Fredrickson; para [43]; a recessed portion similar to the frame 56 such that the specimens 34 can be placed within the reader tray 46…transporting the specimens 34 from, for example, the test apparatus 20 to a spectrophotometer or other device for further evaluation).
Regarding claim 15, Fredrickson teaches the apparatus according claim 1, wherein the cover element and/or a closing cover which allow a gas exchange with an ambient atmosphere are present on the cover element or on a closing cover (Fredrickson; Fig. 6; para [46]; The top plate 128 includes an upper face 130, a lower face 132, and defines multiple apertures 150). The system is an open system comprising apertures on the top plate which allows for gases from the ambient atmosphere to be present/exchanged.
Regarding claim 16, Fredrickson teaches the apparatus according claim 1, wherein a plurality of different samples are disposed on a surface of a base plate or various sample respectively form a surface or a surface region on the base plate (Fredrickson; Fig. 6; para [50]; one or more test or sample materials 142 can be disposed within one or more of the wells 164 to test the effects of the sample material(s) 142 on the specimen(s) 134). Regarding claim 16, these limitations are directed to the intended use of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Fredrickson and the apparatus of Fredrickson is capable of “various sample respectively form a surface or a surface region of the base plate”. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Fredrickson (see MPEP §2114).
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 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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fredrickson in view of Mainquist et al (US 20040141887 A1; hereinafter “Mainquist”; already of record).
Regarding claim 13, Fredrickson teaches the apparatus according claim 1, with the closing element.
Fredrickson does not teach further comprising a closing cover is located on the cover element, the closing cover allowing a gas exchange with an environment, for a defined prescribable positioning or orientation on a surface of the closing cover or the cover element, with at least one construction element being present for a form-fit orientation.
However, Mainquist teaches an analogous art of an apparatus for fluidily separating substrate surface (Mainquist; Abstract) comprising a closing cover (Mainquist; Fig. 1B, 9A; para [99]; sealing member 126) is located on the cover element (Mainquist; Fig. 1B; para [71]; sealing member 126 is mated with, e.g., separating member 102, and when substrates 108 are supported by supporting member 106) the closing cover allowing a gas exchange with an environment, (Mainquist; Fig. 9A; para [99]; sealing member 126 includes recessed grooves 130; The system is an open system comprising grooves on the sealing member 126 which allows for gases from the ambient atmosphere to be present/exchanged), for a defined prescribable positioning or orientation on a surface of the closing cover or the cover element (Mainquist; Fig. 9A; para [101]; sealing member 126 of FIG. 9A includes alignment features 154 that align sealing member 126 with, e.g., separating member 102), with at least one construction element being present for a form-fit orientation (Mainquist; para [99]; an apparatus of the invention further includes at least one sealing component (e.g., a gasket or the like) disposed between sealing and separating members). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the apparatus of Fredrickson to comprise the closing cover as taught by Mainquist, because Mainquist teaches that the sealing member seals the apparatus (Mainquist; para [71]) and minimizes evaporation and the risk of contamination during processes or storage (Mainquist; para [102]).
Response to Arguments
Applicant’s arguments filed, 3/9/2026, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 8-9, the Applicant argues Frederickson fails to teach the limitation “on the base plate and on the cover element, closure elements being formed with which, when brought into engagement, a form fit connection of the base plate and the cover element, and the pressure force exertion on the receiving element are provided”. Specifically, the Applicant argues the “screwing” of the top plate and the base does not teach “the closure elements [being] formed by the base plate and the cover elements”, because the nuts are neither part of the base and the frame. The examiner respectfully disagrees. The closure elements are not limited to only the nuts which screw on. Specifically, the nut is “screwed” onto the set of pins. Thus, the closure elements which would be interpreted as comprising both the pins and nuts meets the claim limitation. Specifically, the base plate and cover element are brought into engagement and form the “fit connection” by mating the opening of the top plate with the pins of the base. The nut applies the pressure force onto the receiving element. The examiner suggests reciting structural elements such as the lower edge and edge described in paragraph [57] and depicted in Fig. 2 and 4.
In response to Applicant's argument, on page 10-11, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a connection that requires no individually manageable connection elements) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the Applicant’s arguments, on page 11-12, the arguments regarding the dependent claim 13 merely refer back to the teachings of the references not meeting independent claim 1. However, the arguments regarding claim 1 are addressed above. Further, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Mainquist teaches that the cover minimizes evaporation and the risk of contamination during processes or storage (para [102]). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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