Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 38-54, in the reply filed on 20 April 2026 is acknowledged.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Kingdom of Denmark on 20 June 2022. It is noted, however, that applicant has not filed a certified copy of the DK2022 00590 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 19 June 2023, 19 October 2023, and 15 February 2024 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because the following reference characters have been used to designate more than one part;
“83” has been used to designate both “second spring element” and “second electrical connector” (see page 26).
“84” has been used to designate both “second electrical connector” and “third electrical connector” (see page 26).
“131” has been used to designate both “docking station” and “first electrode” (see page 32).
“161” has been used to designate both “first electrode” and “pin body” (see page 24).
“166” has been used to designate both “first electrode” and “second electrode” (see page 34).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 52’’
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 38 – 40, 42, 45, and 48 – 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todd (US 20210293739 A1, cited on the IDS provided 16 October 2023).
With regards to claim 38, Todd teaches;
The claimed “a docking station” has been read on the taught ([0032], “The support arrangement may comprise multiple zones comprising a support arrangement array.”; The support arrangement array reads on a docking station.);
The claimed “a docking arrangement comprising at least one movable element” has been read on the taught ([0033], “In an embodiment there may further be provided means to agitate the receptacle. This causes the test sample to be mixed during testing…”; Means to agitate the receptacle reads on a movable element);
The claimed “a docking site for a container” has been read on the taught ([0027], “The apparatus preferably further comprises a support arrangement for supporting the receptacle…”; The support arrangement reads on a docking site);
The claimed “a set of electrical connectors adapted for connecting the respective electrodes to analyser” has been read on the taught ([0083], “The measuring arrangement 16 further comprises apparatus to measure the current through the circuit 18 passing through the test sample via the first electrode pair and also the voltage across the second electrode pair 10a, 10b via circuit 20.”; Circuits 18 and 20 read on a set of electrical connectors);
The claimed “a set of electrodes comprising at least two electrodes” and “wherein the docking arrangement is adapted for temporarily holding a container in location relative to the set of electrodes, to provide the respective electrode to be in physical contact with an outer surface of said container at respective preselected locations” has been read on the taught ([0027], “…the support arrangement carries the first and second electrode pair to define a zone wherein the first and second electrode pair contact the receptacle when supported by the support arrangement.”; [0008], “…the receptacle wall contacts both the first and second electrode pairs…”);
The claimed “wherein the electrodes are physically separated from each other” has been read on the taught ([0041], “The barrier contact surface area of at least one of the first electrode pair and the sensing surface area of at least one of the second electrode pair are separated from each other.”);
The claimed “wherein the docking site comprises a bottom structure comprising at least one electrode of the set of electrodes” has been read on the taught ([0034], “The support arrangement may comprise a platform for receipt of the receptacle. The electrodes are preferably positioned such that the receptacle sits onto the electrodes.”);
The claimed “wherein the docking arrangement is connected to or is connectable to the docking station” has been read on the taught ([0032], “The support arrangement may comprise multiple zones comprising a support arrangement array. Thus, multiple receptacles may be received for testing multiple test samples.”).
With regards to claim 39, the system of claim 38 is anticipated by Todd.
The claimed “wherein at least one of the electrodes of the set of electrodes are stationary in the docking station at a docking site to provide that the electrode comes into physical contact with the outer surface of a container when located at the docking site in the docking station, wherein the stationary electrode forms part of a bottom structure of the docking site” has been read on the taught ([0034], “The support arrangement may comprise a platform for receipt of the receptacle. The electrodes are preferably positioned such that the receptacle sits onto the electrodes. Therefore, in an operative position the receptacle may sit onto the electrodes.”).
With regards to claim 40, the system of claim 38 is anticipated by Todd.
The claimed “wherein the docking arrangement is correlated to or engaged with at least one of the electrodes of the set of electrodes, to provide the physical contact between the container outer surface and the electrode” has been read on the taught ([0031], “The support arrangement beneficially contains the electrodes of the first and second electrode pair.”);
The claimed “wherein the at least one movable element of the docking arrangement has a first position where at least one of the electrodes of the set of electrodes is detached from the outer surface of the container and a second position where the at least one electrode of the set of electrodes is held in physical contact with the outer surface of the container” has been read on the taught ([0033], “In an embodiment there may further be provided means to agitate the receptacle. This causes the test sample to be mixed during testing…”; [0046], “The first and second electrode pairs may mountable and demountable to the receptacle.”; The electrode being mountable during testing, and the agitator being activated during testing reads on a second position where at least one electrode is held in contact with the outer surface of the container. The electrode being demountable and the agitator being turned off outside of testing reads on a first position where the electrodes are detached.).
With regards to claim 42, the system of claim 38 is anticipated by Todd.
The claimed “wherein at least one of the electrodes of the set of electrodes is substantially plane and/or wherein at least one of the electrodes of the set of electrodes is circular, disc or ring shaped and/or wherein at least one of the electrodes of the set of electrodes is shaped to at least partially encircling a container located at a docking site of the docking station” has been read on the taught ([0089], “As an illustrative embodiment only, the electrode dimensions 8a and 8b is 50 mm×100 mm with a width of 10 mm.”; 50mm x 100mm with a width of 10mm reads on the electrodes being substantially planar.).
With regards to claim 45, the system of claim 38 is anticipated by Todd.
The claimed “wherein an electrical connector of the set of connectors is connected to or connectable to at least one electrode of the set of electrodes and wherein said electrical connector is at least partially located at said docking arrangement” has been read on the taught ([0083], “The measuring arrangement 16 further comprises apparatus to measure the current through the circuit 18 passing through the test sample via the first electrode pair and also the voltage across the second electrode pair 10a, 10b via circuit 20.”; [0088] and Figure 6 further show the connections of the circuit to the docking arrangement.).
With regards to claim 48, the system of claim 38 is anticipated by Todd.
The claimed “wherein the docking arrangement comprises at least one constraining element adapted for holding the container in a temporarily fixed condition” has been read on the taught ([0062], “The support arrangement is beneficially arranged to receive a test sample carrying receptacle. The support arrangement may cradle a test sample carrying receptacle.”; Cradling a receptacle reads on a constraining element adapted for holding the container.).
With regards to claim 49, the system of claim 38 is anticipated by Todd.
The claimed “wherein the system further comprises at least one electrically conductive guard adapted for shielding at least one of the electrodes of the set of electrodes” has been read on the taught ([0044], “One or more shielding arrangements are preferably provided for shielding each of the respective second electrodes from charge resulting from the application of the excitation current by the first electrode pair.”).
With regards to claim 50, the system of claim 38 is anticipated by Todd.
The claimed “wherein the system is adapted for electrochemical detection of growth of microorganisms in two or more containers” has been read on the taught ([0032], “Thus, multiple receptacles may be received for testing multiple test samples.”);
The claimed “wherein the docking arrangement is adapted for temporarily holding said containers in location relative to respective sets of electrodes, to provide the respective electrode of the sets of electrodes to be in physical contact with the outer surface of said respective containers at respective preselected locations” has been read on the taught ([0035], “The support arrangement may comprise a base and sidewalls defining a cavity forming the zone for receipt of the receptacle. The electrodes of each electrode pair are preferably positioned on the sidewalls having exposed electrode surfaces in the cavity. This means that a receptacle containing the test sample may be located into the cavity and the receptacle will be in direct contact with the electrodes.”);
The claimed “wherein the electrodes of respective sets of electrodes are physically separated from each other” has been read on the taught ([0041], “The barrier contact surface area of at least one of the first electrode pair and the sensing surface area of at least one of the second electrode pair are separated from each other.”).
With regards to claim 51, the system of claim 38 is anticipated by Todd.
The claimed “wherein the system further comprises at least one container, wherein the at least one container comprises one or more container wall sections, which are of non-conductive material and thereby provides insulated wall sections” has been read on the taught ([0011], “…a receptacle for receipt of the test sample, where the receptacle comprises a receptacle wall that forms a barrier between the first and second electrode pair and the test sample…”; [0025], “The receptacle is beneficially non-conductive.”).
With regards to claim 52, the system of claim 51 is anticipated by Todd.
The claimed “wherein the electrodes of the set of electrodes are adapted to be in physical contact with the outer surface of said container wall at locations of the container wall which comprises said insulated wall sections” has been read on the taught ([0025], “The receptacle is beneficially non-conductive.”; [0027], “…the support arrangement carries the first and second electrode pair to define a zone wherein the first and second electrode pair contact the receptacle when supported by the support arrangement.”).
With regards to claim 53, the system of claim 38 is anticipated by Todd.
The claimed “wherein the system comprises a foil with a pressure sensitive adhesive adapted for being attached to the outer surface of the container” has been read on the taught ([0045], “The electrodes may comprise an adhesive material.”).
With regards to claim 54, the system of claim 38 is anticipated by Todd.
The claimed “wherein the system further comprises or is adapted to be connected to an analyser, wherein said respective electrical connectors are or are adapted for providing electrical contact with said analyser, wherein the analyser is an electrochemical analyser” have been read on the taught ([0083], “The measuring arrangement 16 further comprises apparatus to measure the current through the circuit 18 passing through the test sample via the first electrode pair and also the voltage across the second electrode pair 10a, 10b via circuit 20.”; Measuring the current reads on an electrochemical analyser. Circuits 18 and 20 read on the electrical connectors providing contact with the analyser.).
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 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Todd (US 20210293739 A1, cited on the IDS provided 16 October 2023).
With regards to claim 43, the system of claim 38 is anticipated by Todd.
Todd additionally teaches;
“Wherein an electrode is associated to the docking arrangement, to provide that the electrode is detached from the outer surface of the container when the docking arrangement is in a first position and is contacting the outer surface of the container when the docking arrangement is in a second position” has been read on the taught ([0046], “The first and second electrode pairs may mountable and demountable to the receptacle.”; [0045], “The electrodes may comprise an adhesive material.”).
However, Todd et al does not explicitly disclose wherein at least one electrode of the set of electrodes comprises a strip shaped electrode adapted for encircling and contacting the outer surface of the container.
Regarding “wherein at least one electrode of the set of electrodes comprises a strip shaped electrode adapted for encircling and contacting the outer surface of the container,” this limitation describes a change in shape and rearrangement of parts, which does not modify the operation of the device and would have been obvious to one of ordinary skill in the art. Please see MPEP 2144 (IV)(B) and 2144(VI)(C), as well as In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Todd with the strip shaped electrode for the predictable benefit of strong contact between the electrode and the container.
With regards to claim 44, the system of claim 38 is anticipated by Todd.
Regarding “wherein at least one electrode of the set of electrodes comprises a strip shaped electrode adapted for encircling and contacting the outer surface of the container,” this limitation describes a change in shape and rearrangement of parts, which does not modify the operation of the device and would have been obvious to one of ordinary skill in the art. Please see MPEP 2144.04(IV)(B) and 2144.04(VI)(C), as well as In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Regarding “wherein the docking arrangement comprises an adjustment arrangement arranged for adjusting the diameter of the ring element between a first diameter at a first position and a second diameter at a second position, wherein the second diameter is larger than the first diameter” this limitation describes making a device adjustable. Per MPEP 2144.04(V)(D), making parts adjustable may be prima facie obvious; please see In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the device of Todd with the strip shaped electrode having an adjustable diameter for the predictable benefit of strong contact between the electrode and the container, while allowing removal of the container.
Claims 41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Todd (US 20210293739 A1, cited on the IDS provided 16 October 2023) in view of Gougis et al (US 20220299497 A1, effectively filed 22 August 2019).
With regards to claim 41, the system of claim 40 is anticipated by Todd.
However, Todd does not explicitly disclose wherein the at least one movable element of the docking arrangement in the second position is adapted to establish a pressure between the at least one electrode of the set of electrodes and the outer surface of the container and wherein the at least one movable element of the docking arrangement in the second position is establishing and maintaining a pressure between the at least one electrode of the set of electrodes and the outer surface of the container for a period of at least 1 minute.
In the analogous art of analyzers for detection of microbial growth, Gougis et al teaches;
A docking arrangement with a docking site for receiving a container, as has been read on the taught ([0069], “…the system comprises an enclosure 2 intended to receive the vial for analysis.”);
The docking site including electrodes, as has been read on the taught ([0079], “…the two electrical contacts 241, 251 of the enclosure 2 may take the form of two conductive metal rings…”);
The docking arrangement including a movable element, and the claimed “wherein the at least one movable element of the docking arrangement in the second position is adapted to establish a pressure between the at least one electrode of the set of electrodes and the outer surface of the container” have been read on the taught ([0081], “The vial 1 is intended to be placed in the internal space of the enclosure. The enclosure 2 and the vial 1 may interact with each other to ensure a contact pressure is exerted between the electrical contacts 141, 151 of the vial and the electrical contacts 241, 251 of the enclosure. A spring 29 may be attached to the lid 21 and bear against the vial 1 when the lid 21 is closed on the receptacle 20, so as to press the vial against the bottom of the enclosure 2.”; A spring 29 reads on a movable element.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer device of Todd with the movable element as taught by Gougis et al, for the predictable benefit of ensuring strong contact between the container and the electrical contacts of the device (Gougis et al, [0081], “A spring 29 may be attached to the lid 21 and bear against the vial 1 when the lid 21 is closed on the receptacle 20, so as to press the vial against the bottom of the enclosure 2.”).
With regards to the limitation, “wherein the at least one movable element of the docking arrangement in the second position is establishing and maintaining a pressure between the at least one electrode of the set of electrodes and the outer surface of the container for a period of at least 1 minute,” this is functional language describing the intended used of the device, and has been given the appropriate patentable weight. As Todd in view of Gougis et al teaches all of the structural limitations of claim 41, this additional limitation does not distinguish the instant application over the prior art.
With regards to claim 46, the system of claim 38 is anticipated by Todd.
Todd does not explicitly disclose wherein said docking arrangement comprises a spring element, wherein said spring element is adapted to establish a pressure between at least one of the electrodes of the set of electrodes and the outer surface of the container and wherein the docking arrangement is connected to or is connectable to the docking station, wherein the docking arrangement and the docking station is adapted for holding the container to provide that the spring element establish a pressure between the at least one electrode of the set of electrodes and the outer surface of the container.
In the analogous art of analyzers for detection of microbial growth, Gougis et al teaches;
The claimed “wherein said spring element is adapted to establish a pressure between at least one of the electrodes of the set of electrodes and the outer surface of the container and wherein the docking arrangement is connected to or is connectable to the docking station, wherein the docking arrangement and the docking station is adapted for holding the container to provide that the spring element establish a pressure between the at least one electrode of the set of electrodes and the outer surface of the container” has been read on the taught ([0081], “The vial 1 is intended to be placed in the internal space of the enclosure. The enclosure 2 and the vial 1 may interact with each other to ensure a contact pressure is exerted between the electrical contacts 141, 151 of the vial and the electrical contacts 241, 251 of the enclosure. A spring 29 may be attached to the lid 21 and bear against the vial 1 when the lid 21 is closed on the receptacle 20, so as to press the vial against the bottom of the enclosure 2.”; A spring 29 reads on a movable element.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer device of Todd with the movable element as taught by Gougis et al, for the predictable benefit of ensuring strong contact between the container and the electrical contacts of the device (Gougis et al, [0081], “A spring 29 may be attached to the lid 21 and bear against the vial 1 when the lid 21 is closed on the receptacle 20, so as to press the vial against the bottom of the enclosure 2.”).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Todd (US 20210293739 A1, cited on the IDS provided 16 October 2023) in view of Gougis et al (US 20220299497 A1, effectively filed 22 August 2019) as applied to claim 46 above, and further in view of Caiafa et al (US 20180237764 A1, cited on the IDS provided 19 June 2023).
With regards to claim 47, the system of claim 46 is obvious over Todd in view of Gougis et al.
Todd further teaches the claimed “wherein the electrode […] is adapted for being located at the outer surface of the container” as read on the taught ([0043], “The electrodes are preferably positioned such that the receptacle sits onto the electrodes.”).
However, Todd in view of Gougis et al does not explicitly disclose wherein the spring element is indirectly via a pin body engaged with the at least one electrode of the set of electrodes, wherein the electrode is located at the pin body or is adapted for being located at the outer surface of the container.
In the analogous art of electric analyzer devices, Caiafa et al teaches;
The claimed “wherein the spring element is directly engaged with the at least one electrode of the set of electrodes” has been read on the taught ([0035], “In some embodiments, the sample holder 26 may have a spring-loaded mechanism that pushes electrodes 16 and 18 of the sample holder 26 against electrodes 156A and 156B of the cuvette 152.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device with a container, a docking site, and a spring as taught by Todd in view of Gougis et al with the spring directly engaged with the electrode as taught by Caiafa et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Todd in view of Gougis et al teaches a “base” device. The prior art of Caiafa et al teaches a “comparable” device which has been improved in the same way as the claimed invention, with a spring directly engaged with electrodes. One of ordinary skill in the art could have applied this technique in the same way to the device of Todd in view of Gougis et al, for the predictable result of a device which securely engages a container with electrodes for analyzing a sample.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Godfrey et al (US 20090114044 A1) teaches a docking mechanism for a biological analyzer.
Fan et al (US 20100097374 A1) teaches a ring shaped electrode.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797