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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 has been entered.
Status of the Claims
The amendment filed 12/16/2025 has been entered. Claims 1-33 and 35-43 remain pending in the application and claims 37-43 remain withdrawn.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/2/2025, 12/16/2025, 1/5/2026, and 2/2/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant argues on pp. 9-12 of Remarks that Wade does not teach or suggest a configuration in which bottles are received in the receptacle neck-in, as required by independent claim 1, and the Examiner agrees. Wade discloses a configuration such that the bottle is received with the neck facing outward from the carousel. However, Mi et al. (US 2015/0299642 A1) teaches that a bottle receptacle is configured to receive a bottle neck-first is known in the art, which will be discussed in further detail in the 35 USC § 103 section below.
Applicant argues on p. 12 of Remarks that the previous Office Action did not explain why one skilled in the art would replace measuring electrodes in the culture bottles of Wade with the sensor technology described in Bishop et al. and how to adapt this technology into Wade’s structure. This is not persuasive as it has been held that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements; the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole (MPEP § 2145 III). As for motivation, Bishop et al. teaches that the positive indicator light turns on and alerts the user when a container is detected as positive for microbial growth (Col. 31, lines 17-21), and one of ordinary skill in the art would be motivated to combine the teachings of Wade and Bishop et al. to be notified when a container is detected as positive for microbial growth.
As to the argument that the previous Office Action did not describe how to adapt the technology described in Bishop et al. into Wade’s device, prima facie obviousness under 35 USC § 103 does not require a detailed explanation of how the modification would be achieved, but rather only requires that the examiner set forth the relevant teachings of the prior art relied upon, the difference in the claim over the applied reference(s), the proposed modification of the applied reference(s) necessary to arrive at the claimed subject matter, and an explanation as to why the claimed invention would have been obvious to one of ordinary skill in the art (MPEP § 2142). Additionally, it has been held that “the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference… Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art” and that “combining the teachings of references does not involve an ability to combine their specific structures” (MPEP § 2145 III). Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wade with the teachings of Bishop et al. to arrive at the invention as specified in claim 1 without a detailed explanation of how the technology of Bishop et al. may be bodily incorporated into the structure of Wade.
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 1-12, 15-16, 21, 24, 27, 33, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1).
Regarding claim 1, Wade teaches an apparatus for storing and monitoring blood culture bottles (abstract), the apparatus comprising a drum (Fig. 2 12 carousel) having an exterior perimeter (Fig. 2 82 cylindrical shroud) and an interior perimeter (Fig. 2 78 central circular opening), the exterior perimeter having a diameter in excess of a diameter of the interior perimeter (Fig. 2), the drum having a plurality of receptacles (Fig. 2 22 receptacles), the receptacles having a proximal end at the exterior perimeter and a distal end at the interior perimeter (Fig. 2), each receptacle configured to receive a blood culture bottle (Fig. 7 24 culture bottle), the blood culture bottle comprising a bottom portion (Col. 4, lines 19-20 “rear surface”) and a neck portion (Fig. 7 46 neck), wherein the bottle can be received by the receptacle such that the bottom portion is received at the distal end of the receptacle (Fig. 7); wherein the drum perimeters are disposed about an axis of rotation of the drum (Fig. 2); wherein the plurality of receptacles are disposed in the drum as an array of receptacles (Fig. 2 22 receptacles), the array having receptacles disposed both vertically and horizontally (Fig. 2 22 receptacles); measurement electronics (Fig. 7 44 electrodes) for interrogating the blood culture bottles to determine if the blood culture bottles are positive or negative for microbial growth and culture bottle indicator electronics (Fig. 7 62 electrical contact members, 64 lead wires, Fig. 5 39 edge connector, 42 multiplexer; Col. 4 line 67-Col. 5 line 1); and the drum defining an interior space within the interior perimeter (Fig. 3) wherein at least a portion of drum electronics are disposed in the interior perimeter of the drum (Fig. 7 39 edge connector, 42 multiplexer, 68 interconnect cable, 70 cable).
Wade teaches measurement electronics (Fig. 7 44 electrodes), but does not teach that the measurement electronics comprise at least one light source. However, Bishop et al. teaches at least one light source (Fig. 1 190 positive indicator). Bishop et al. teaches that the positive indicator light turns on and alerts the user when a container is detected as positive for microbial growth (Col. 31, lines 17-21).
It would have been obvious to a person of ordinary skill in the art to use the Bishop et al. configuration of at least one light source in Wade’s device with a reasonable expectation that the light source would turn on and alert the user when a container is detected as positive for microbial growth. This method for improving Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Bishop 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 Wade and Bishop et al. to obtain the invention as specified in claim 1.
Regarding the limitation “the bottle can be received by the receptacle such that the bottom portion is received at the proximal end of the receptacle and the neck portion is received at the distal end of the receptacle”, Wade teaches a receptacle that receives a bottle such that the neck portion is received at the proximal end (facing outward from the carousel) and the bottom is received at the distal end (towards the interior of the carousel) (Fig. 7). However, Mi et al. teaches that a bottle receptacle configured to receive a bottle neck-first is known in the art (Fig. 3). Though Wade does not explicitly teach a receptacle configured to receive a bottle neck-first, it would have been obvious to a person of ordinary skill in the art to use this configuration (of Mi et al.) because the substitution of one known element for another would have predictably resulted in a carousel that holds bottles, with reasonable expectation of success. 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 Wade with the teachings of Mi et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein a drum is disposed in a housing (Fig. 2 2 main housing), but does not teach a plurality of drums. Nonetheless, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 VI). Modifying the device of Wade such that there is a plurality of drums instead of one drum would amount to merely duplication of parts, as such a modification would predictably result in an apparatus for storing and monitoring blood culture bottles comprising a plurality of receptacles for the bottles.
Regarding claim 3, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the housing has a door to access each drum disposed in the housing (Fig. 1 10 doors).
Regarding claim 4, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising an interface unit (Fig. 4 36 interface unit). Wade does not teach a touch screen; however, Bishop et al. teaches a touch screen (Col. 31, lines 29-30 “touch screen display”).
It would have been obvious to a person of ordinary skill in the art to use the Bishop et al. configuration of a touch screen in Wade’s device with a reasonable expectation that it would provide an operator with status information regarding the containers in the detection system (Col. 31, lines 26-28). This method for improving Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Bishop 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 Wade and Bishop et al. to obtain the invention as specified in claim 4.
Regarding claim 5, Wade teaches an apparatus for storing and monitoring blood culture bottles. Wade does not teach a rack for receiving culture bottles to be placed in or removed from the apparatus. However, Bishop et al. teaches a rack for receiving culture bottles to be placed in or removed from the apparatus (Fig. 1 202 loading station). Bishop et al. teaches that a user can place multiple specimen containers at the loading station at a time (Col. 7, lines 24-26).
It would have been obvious to a person of ordinary skill in the art to use the Bishop et al. configuration of a rack in Wade’s device with a reasonable expectation that it would allow a user to place multiple specimen containers at the loading station at a time. This method for improving Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Bishop 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 Wade and Bishop et al. to obtain the invention as specified in claim 5.
Regarding claim 6, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the drum has a plurality of panels that define vertical drum sectors (Fig. 7 50 sidewalls seen in Fig. 2).
Regarding claim 7, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein each vertical drum sector has an approximately equal horizontal span (Fig. 2) and each span is such that the horizontal span of one vertical drum sector is approximately the same as a horizontal span of the door (Fig. 3 10 door, 22 receptacle).
Regarding claim 8, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the apparatus further comprises a drive motor for rotating the drum disposed in the housing (Fig. 3 30 drive motor).
Regarding claim 9, Wade does not teach that the measurement electronics (44 electrodes/light source) themselves are disposed within the interior space defined by the interior perimeter of the drum, but does teach that measurement electronics are connected to electronics disposed within the interior space defined by the interior perimeter of the drum (Fig. 7 44 electrodes connected to 62 electrical contact members, 64 lead wires, Fig. 5 39 edge connector, 42 multiplexer; Col. 4 line 67-Col. 5 line 1). Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Wade such that the measurement electronics are disposed within the interior space defined by the interior perimeter of the drum instead of connected to additional electronics which are disposed in the interior perimeter of the drum would amount to merely rearrangement of parts, as such a modification would predictably result in a device that can measure each culture bottle in the receptacles as the device rotates.
Regarding claim 10, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the culture bottle indicator electronics are disposed within the interior space defined by the perimeter of the drum (Fig. 7 62 electrical contact members, 64 lead wires, Fig. 5 39 edge connector, 42 multiplexer; Col. 4 line 67-Col. 5 line 1).
Regarding claim 11, Wade teaches an apparatus for storing and monitoring blood culture bottles further comprising a heater disposed in the housing outside the exterior perimeter of the drum (Fig. 2 90 fan and heater structure).
Regarding claim 12, Wade teaches an apparatus for storing and monitoring blood culture bottles further comprising a blower disposed in the housing outside the exterior perimeter of the drum (Fig. 2 90 fan and heater structure).
Regarding claim 15, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the drum is assembled in layers, each layer being at least a portion of an entire row of receptacles and each layer having the interior perimeter and the exterior perimeter of the drum (four layers of receptacles seen in Fig. 2).
Regarding claim 16, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the drum is assembled in column segments, each column segment defining only a portion of the interior perimeter and the exterior perimeter of the drum (four column segments seen in Fig. 2 separated by radial arms 28).
Regarding claim 21, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein each receptacle comprises a bottle stop (Fig. 7 52 rear wall) and a segmented retention portion spaced apart from the bottle stop (Fig. 7 54 bottom, 56 recess, 58 forward lip).
Regarding the limitation “the plurality of receptacles each receive the neck portion at the distal end” and “to permit a cap disposed on the neck portion of the bottle to pass into the segmented retention portion and proceed to rest against the bottle stop, whereby the segmented retention portion releases tension and secures the culture bottle in the receptacle”, 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 Wade would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of receiving the neck portion at the distal end and permitting a cap disposed on the neck portion of the bottle to pass into the segmented retention portion and proceed to rest against the bottle stop, whereby the segmented retention portion releases tension and secures the culture bottle in the receptacle.
Regarding claim 24, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein each receptacle comprises a bottle stop (Fig. 7 52 rear wall) and a plurality of resilient wings extending from the bottle stop (Fig. 7 50 pair of side walls).
Regarding the limitation “the plurality of receptacles each receive the neck portion at the distal end” and “to permit a cap disposed on the neck portion of the bottle to pass past a flange portion of the wings and proceed to rest against the bottle stop, whereby the wings release tension and the flange portion secures the culture bottle in the receptacle”, 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 Wade would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of receiving the neck portion at the distal end and permitting a cap disposed on the neck portion of the bottle to pass past a flange portion of the wings and proceed to rest against the bottle stop, whereby the wings release tension and the flange portion secures the culture bottle in the receptacle.
Regarding claim 27, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the plurality of receptacles each further comprises a tray portion on which the culture bottle is placed (Fig. 7 54 bottom), the tray portion comprising a tab for securing the bottom of the culture bottle in the tray (Fig. 7 58 forward lip) the receptacle further comprising a stop portion, wherein the stop portion places the culture bottle in a predetermined fixed position within the receptacle (Fig. 7 52 rear wall).
Regarding claim 33, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the tray (Fig. 7 54 bottom) comprises a keyhole element (Fig. 7 56 recess), but does not teach wherein the bottle stop (Fig. 7 52 rear wall) comprises a keyhole element. Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Wade such that the rear wall comprises a keyhole element instead of the bottom of the receptacle would amount to merely rearrangement of parts, as such a modification would predictably result in a receptacle that holds the bottle firmly in the receptacle (Col. 4, line 50).
Regarding claim 35, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the exterior perimeter of the drum and the interior perimeter of the drum are circular (Fig. 2).
Regarding claim 36, Wade teaches an apparatus for storing and monitoring blood culture bottles wherein the exterior perimeter of the drum and the interior of the drum are faceted (Fig. 2).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Lee (US 4,377,639) (already of record).
Regarding claim 13, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising an axle (Fig. 3 29 shaft), but does not teach a bearing. However, Lee teaches a bearing (Fig. 4 49 ring bearing) which rigidly secures the shaft to the support means (Col. 3, lines 32-33).
It would have been obvious to a person of ordinary skill in the art to use the Lee configuration of a bearing in modified Wade’s device with a reasonable expectation that it would rigidly secure the shaft to the support means. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Lee. 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 Wade and Lee to obtain the invention as specified in claim 13.
Regarding claim 14, Wade teaches an apparatus for storing and monitoring blood culture bottles, but does not teach a ring bearing. However, Lee teaches a ring bearing (Fig. 4 49 ring bearing) which rigidly secures the shaft to the support means (Col. 3, lines 32-33).
It would have been obvious to a person of ordinary skill in the art to use the Lee configuration of a ring bearing in modified Wade’s device with a reasonable expectation that it would rigidly secure the shaft to the support means. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Lee. 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 Wade and Lee to obtain the invention as specified in claim 14.
Claims 17 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Noda et al. (US 2016/0334431 A1).
Regarding claim 17, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles, but does not teach wherein the plurality of receptacles each have a respective elastomeric insert. However, Noda et al. teaches an elastomeric insert (para. 0078 “the container holding member 605 is formed of an elastic body such as rubber”) which is compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position (para. 0027).
It would have been obvious to a person of ordinary skill in the art to use the Noda et al. configuration of an elastomeric insert in modified Wade’s device with a reasonable expectation that it would be compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Noda 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 modified Wade and Noda et al. to obtain the invention as specified in claim 17.
Regarding claim 29, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a stop portion (Fig. 7 52 rear wall), but does not teach wherein the stop portion comprises a deformable material. However, Noda et al. teaches a deformable material (para. 0078 “the container holding member 605 is formed of an elastic body such as rubber”) which is compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position (para. 0027).
It would have been obvious to a person of ordinary skill in the art to use the Noda et al. configuration of a deformable material in modified Wade’s device with a reasonable expectation that it would be compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Noda 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 modified Wade and Noda et al. to obtain the invention as specified in claim 29.
Regarding claim 30, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a stop portion (Fig. 7 52 rear wall), but does not teach a pivoting arm that pivots in response to the culture bottle being advanced into the receptacle, thereby securing the culture bottle in the receptacle. However, Noda et al. discloses an opening/closing arm (para. 0027) which suppresses vibration and centers the container (para. 0027).
It would have been obvious to a person of ordinary skill in the art to use the Noda et al. configuration of pivoting arm in modified Wade’s device with a reasonable expectation that it would suppress vibration and center the container. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Noda 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 modified Wade and Noda et al. to obtain the invention as specified in claim 30.
Regarding claim 31, Wade teaches an apparatus for storing and monitoring blood culture bottles, but does not explicitly teach a resilient material selected from one or elastomeric flexible tubing, elastomeric materials, or foam materials. However, Noda et al. teaches an elastomeric material (para. 0078 “the container holding member 605 is formed of an elastic body such as rubber”) which is compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position (para. 0027).
It would have been obvious to a person of ordinary skill in the art to use the Noda et al. configuration of an elastomeric material in modified Wade’s device with a reasonable expectation that it would be compressed when holding a container to push the container by the elastic body on both sides so that containers of different diameters are positioned at the same position. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Noda 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 modified Wade and Noda et al. to obtain the invention as specified in claim 31.
Claims 18 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Vivet et al. (US 2017/0341873 A1) (already of record).
Regarding claim 18, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a bottle stop (Fig. 7 52 rear wall), but does not teach a canted coil spring However, Vivet et al. teaches a canted coil spring (Fig. 27A 864 canted coil spring) which allows multiple points of contact with the container to contain the bottle in the rack well (para. 0154, lines 8-9).
It would have been obvious to a person of ordinary skill in the art to use the Vivet et al. configuration of a canted coil spring in modified Wade’s device with a reasonable expectation that it would allow multiple points of contact with the container to contain the bottle in the rack well. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Vivet 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 modified Wade and Vivet et al. to obtain the invention as specified in claim 18.
Regarding the limitation “the plurality of receptacles each receive the neck portion of the culture bottle at the distal end” and “to permit a cap disposed on the neck portion of the bottle to pass by the canted coil spring and proceed to rest against the bottle stop, whereby the canted coil spring releases tension and secures the culture bottle in the receptacle”, 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 Wade in view of Vivet et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of receiving the neck portion of the culture bottle at the distal end and permitting a cap disposed on the neck portion of the bottle to pass by the canted coil spring and proceed to rest against the bottle stop, whereby the canted coil spring releases tension and secures the culture bottle in the receptacle.
Regarding claim 22, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles, a bottle stop, and a segmented retention portion, but does not teach a canted coil spring. However, Vivet et al. teaches a canted coil spring (Fig. 27A 864 canted coil spring) which allows multiple points of contact with the container to contain the bottle in the rack well (para. 0154, lines 8-9).
It would have been obvious to a person of ordinary skill in the art to use the Vivet et al. configuration of a canted coil spring in modified Wade’s device with a reasonable expectation that it would allow multiple points of contact with the container to contain the bottle in the rack well. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Vivet 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 modified Wade and Vivet et al. to obtain the invention as specified in claim 22.
Regarding claim 23, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles, a bottle stop, and a segmented retention portion, but is silent to resilient segments. However, Vivet et al. teaches an apparatus made of resilient material (para. 0089 “plastic, wood, or metal”). Vivet et al. teaches that these materials reduce instability (para. 0086).
It would have been obvious to a person of ordinary skill in the art to use the Vivet et al. configuration of resilient material in modified Wade’s device with a reasonable expectation that it would reduce instability. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Vivet 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 modified Wade and Vivet et al. to obtain the invention as specified in claim 23.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Pang et al. (US 6,060,022).
Regarding claim 19, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a bottle stop (Fig. 7 52 rear wall), but does not teach an O-ring. However, Pang et al. teaches an O-ring (Figs. 9A-9D O-ring member 609) which augments frictional engagement of containers (Col. 20, lines 14-15).
It would have been obvious to a person of ordinary skill in the art to use the Pang et al. configuration of an O-ring in modified Wade’s device with a reasonable expectation that it would augment frictional engagement of the containers. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Pang 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 modified Wade and Pang et al. to obtain the invention as specified in claim 19.
Regarding the limitation “to permit a cap disposed on the neck portion of the bottle to pass by the O-ring and proceed to rest against the bottle stop, whereby the O-ring releases tension and secures the culture bottle in the receptacle”, 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 Wade in view of Pang et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of receiving the neck portion of the culture bottle at the distal end and permitting a cap disposed on the neck portion of the bottle to pass by the O-ring and proceed to rest against the bottle stop, whereby the O-ring releases tension and secures the culture bottle in the receptacle.
Claims 20 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Tsumura et al. (US 2019/0119623 A1) (already of record).
Regarding claim 20, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a bottle stop (Fig. 7 52 rear wall), but does not teach a ball plunger. However, Tsuruma et al. teaches a ball plunger (para. 0113; Fig. 20 122 ball plunger) which restricts displacement (para. 0113).
It would have been obvious to a person of ordinary skill in the art to use the Tsuruma et al. configuration of a ball plunger in modified Wade’s device with a reasonable expectation that it would restrict displacement. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Tsuruma 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 modified Wade and Tsuruma et al. to obtain the invention as specified in claim 20.
Regarding the limitation “the plurality of receptacles each receive the neck portion of the culture bottle at the distal end” and “to permit a cap disposed on the neck portion of the bottle to pass by the ball plunger and proceed to rest against the bottle stop, whereby the ball plunger releases tension and secures the culture bottle in the receptacle”, 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 Wade in view of Tsuruma et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of receiving the neck portion of the culture bottle at the distal end and permitting a cap disposed on the neck portion of the bottle to pass by the ball plunger and proceed to rest against the bottle stop, whereby the ball plunger releases tension and secures the culture bottle in the receptacle.
Regarding claim 25, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles including notches (Fig. 7 56 recess) and a bottle stop (Fig. 7 50 pair of side walls), but does not teach a bottle stop comprising a notch. Nonetheless, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the device of Wade such that the bottle stop comprises a notch instead of the bottom of the receptacle would amount to merely rearrangement of parts, as such a modification would predictably result in a receptacle with a notch.
Wade does not teach a receptacle comprising a ball plunger, but does teach springlike members (Fig. 7 62 springlike electrical member). Wade teaches that the spring force causes the bottle to engage the lip and the recess, holding the bottle firmly in place (Col. 4, lines 47-50). However, Tsumura et al. teaches that a ball plunger is a known element in the art (para. 0113; Fig. 20 122 ball plunger) which restricts displacement (para. 0113).
Though Wade does not teach a ball plunger, it would have been obvious to a person of ordinary skill in the art to use springlike members because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a receptacle that restricts displacement and holds the bottle firmly in place. 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 Wade with the teachings of Tsuruma et al. to obtain the invention as specified in claim 25.
Regarding the limitation “as the culture bottle advances into the bottle stop, the bottle stop is advanced further into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop in the receptacle”, 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 Wade in view of Tsuruma et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of advancing the culture bottle into the bottle stop until the ball plunger aligns with the notch, thereby securing the bottle stop in the receptacle.
Regarding claim 26, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles including notches (Fig. 7 56 recess) and a bottle stop (Fig. 7 50 pair of side walls). Wade does not teach a receptacle comprising a ball plunger, but does teach springlike members (Fig. 7 62 springlike electrical member). Wade teaches that the spring force causes the bottle to engage the lip and the recess, holding the bottle firmly in place (Col. 4, lines 47-50). However, Tsumura et al. teaches that a ball plunger is a known element in the art (para. 0113; Fig. 20 122 ball plunger) which restricts displacement (para. 0113).
Though Wade does not teach a ball plunger, it would have been obvious to a person of ordinary skill in the art to use springlike members because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a receptacle that restricts displacement and holds the bottle firmly in place. 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 Wade with the teachings of Tsuruma et al. to obtain the invention as specified in claim 26.
Regarding the limitation “as the culture bottle advances into the bottle stop, the bottle stop is advanced further into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop in the receptacle”, 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 Wade in view of Tsuruma et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for retaining bottles in the receptacles (claim 1) and would be structurally capable of advancing the culture bottle into the bottle stop until the ball plunger aligns with the notch, thereby securing the bottle stop in the receptacle.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 1 above, and further in view of Procyshyn et al. (US 2019/0056419 A1) (already of record).
Regarding claim 28, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising springlike members (Fig. 7 62 springlike electrical member), but does not teach a leaf spring. Wade teaches that the spring force causes the bottle to engage the lip and the recess, holding the bottle firmly in place (Col. 4, lines 47-50). However, Procyshyn et al. teaches that a leaf spring is a known element in the art (para. 0101, line 3) which ensures the implement is reliably sealed inside the sheath (para. 0101, lines 5-6).
Though Wade does not teach a leaf spring, it would have been obvious to a person of ordinary skill in the art to use springlike members because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a receptacle that holds the bottle firmly in place. 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 Wade with the teachings of Procyshyn et al. to obtain the invention as specified in claim 28.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Wade (US 4,250,266) (already of record) in view of Bishop et al. (US 8,709,344 B2) (already of record) and Mi et al. (US 2015/0299642 A1) as applied to claim 27 above, and further in view of Hogan et al. (US 2018/0051243 A1) (already of record).
Regarding claim 32, Wade teaches an apparatus for storing and monitoring blood culture bottles comprising receptacles and a tray portion (Fig. 7 54 bottom), but does not teach a light pipe. However, Hogan et al. teaches a light pipe (Fig. 5A 5030). Hogan et al. teaches that light emerging from the light pipe allows cell density in a culture to be measured (para. 0075).
It would have been obvious to a person of ordinary skill in the art to use the Hogan et al. configuration of a light pipe in modified Wade’s device with a reasonable expectation that it would allow cell density in a culture to be measured. This method for improving modified Wade’s device was within the ability of one of ordinary skill in the art based on the teachings of Hogan 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 modified Wade and Hogan et al. to obtain the invention as specified in claim 32.
Regarding the limitation “transmits a light signal from indicator LEDs disposed within the interior perimeter of the drum to a light detector positioned on the exterior of the drum”, 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 Wade in view of Hogan et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have signal lights (Fig. 1 14 signal light) and would be structurally capable of transmitting a light signal from indicator LEDs disposed within the interior perimeter of the drum to a light detector positioned on the exterior of the drum.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Berndt et al. (US 5,518,923) discloses a turntable for storing blood culture bottles; Shaw et al. (US 2006/0270027 A1) discloses an incubation device including a rotatable carousel.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799