DETAILED ACTION
Notice of AIA Status
The present application, filed on 1/29/24, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-17 are pending.
Claims 1-3 and 10-17 are rejected.
Claims 4-9 are objected to.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim 1 “a safety mechanism actuatable from a first safety mechanism configuration to a second safety mechanism configuration, wherein the safety mechanism is configured to conceal the liquid storage container interface when the safety mechanism is in the first safety mechanism configuration, and wherein the safety mechanism is configured to reveal the liquid storage container interface when the safety mechanism in the second safety mechanism configuration”. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) , the limitation is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure in the instant specification includes an aperture in the form of a central cylindrical portion 702 described in [0119].
In addition, claim 4 recites “a release mechanism configured to engage a portion of the receptacle when the safety mechanism is in the first safety mechanism configuration”. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) , the limitation is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure in the instant specification includes the at least two clips described in [0013], two end ribs 714 in [0130] and the U-shaped section 722 described in [0131].
In addition, claim 7 recites the “blocking element configured to: prevent actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a first orientation; and permit actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a second orientation different to the first orientation”. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) , the limitation is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure in the instant specification includes the spherical blocking element 718 cooperating with the arcuate channels 716, lower flange section 704, recess 740 and angled shoulder 710 (see instant specification [0128] and [0164] and Fig. 11 where the spherical blocking element 718 moves within the arcuate channel 716 and selectively engages the lower flange section 704, recess 740 and angled shoulder depending upon the device orientation to prevent or permit actuation of the safety mechanism.
In addition, claim 10 recites “a liquid extraction mechanism actuatable from a first liquid extraction mechanism configuration to a second liquid extraction mechanism configuration, wherein the liquid extraction mechanism is configured to provide a pressure difference between a volume of gas in the liquid storage container and the liquid extraction outlet, when the liquid extraction mechanism is actuated from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration”. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) , the limitation is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure in the instant specification includes the piston 204 movably disposed within the cylinder 202 including a seal 208 on the piston 204 and a vent 212 in the cylinder as described in [0065]-[0066].
If applicant does not intend to have the limitations interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed functions so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 10-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation “the liquid extraction outlet”. There is insufficient antecedent basis for this limitation in the claim.
Claims 11-15 dependent on claim 10 rejected under 35 U.S.C. §112(b) are also rejected under 35 U.S.C §112(b) because any claim in dependent form is construed under 35 U.S.C. §112(d) to incorporate by reference all the limitations of the claim to which it refers.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Veraitch (US20230028474).
With respect to claim 1, Veraitch teaches a liquid extraction device (which corresponds to connector 100 in [0374] and second container 300 in [0382], see Fig. 4) for extracting liquid (fluid 202 in [0387]) (see also [0278], which recites “fluid is used to describe gas and liquids”) from a liquid storage container (first container 200 in [0381]), the liquid extraction device (connector 100 and second container 300) comprising:
a receptacle (connector 100 in [0374]) configured to receive a portion of the liquid storage container (first container 200) (see [0382], which recites “the first container 200 may be detachably coupled, or permanently coupled, to the distal end 104 of the connector 100. …, the first container 200 includes a threaded portion 208 that threadedly engages with the threaded portion 107 at the distal end 104 of the housing 102 of the connector 100”) (see Fig. 7);
a liquid storage container interface (hollow needle 112 in [0376]) housed within the receptacle (connector 100) (see Fig. 2), wherein the liquid storage container interface (hollow needle 112) is configured to provide a fluidic connection to a volume of liquid within the liquid storage container (first container 200) when the liquid storage container (first container 200) is connected to the liquid storage container interface (first container 200) (see [0469], which recites “the hollow needle 112 is as described in FIGS. 72(a) to 72(c), but the port 1013 extends through the hollow needle 112 so as to form a pair of diametrically opposed openings 1013 a, 1013 b. This allows fluid to drain out of each of the openings, so as to mitigate blockage of the hollow needle 112 during use. The hollow needle further includes a longitudinally extending slot 1017 extending from the open end 1015 toward the collar 118. This allows the fluid to more easily drain from a connected container into the bore of the hollow needle 112”) (see also [0415], which recites “shown in FIGS. 28 to 30 , there is provided another embodiment of a connector 800 for connecting two volumes of fluid. The connector 800 is the same construction as connector 100”) (see also [0421], which recites “As shown in FIG. 30(c), continual axial translation of the upper housing portion 102 a causes compression of the spring 802 so as to allow the upper housing portion 102 a to collapse further and thus cause the hollow needle 112 to pierce the first septum seal 108 at its first end 114. Thus, the volumes of fluid connected at each end of the connector 800 are fluidly connected by the hollow needle 112”); and
a safety mechanism (actuating mechanism 132 in [0380] and outer sleeve 134 in [0389]) (see Figs. 2-3 which illustrates cylindrical shape) actuatable from a first safety mechanism configuration (see Fig. 27 a, hollow needle concealed within the outer sleeve of the connector in a retracted state) to a second safety mechanism configuration (see Fig. 27 b, hollow needle exposed beyond the outer sleeve 134) (see [0062], which recites “actuating mechanism may be configured such that it is only operable once the connector has engaged with both the first receptacle and the second receptacle. That is, in some embodiments the actuating mechanism may only be operable once the first receptacle is connected to the distal end of the housing, and when the second receptacle is connected to the proximal end of the housing”) (see also [0063],which recites “the actuating mechanism may include one or more engagement portions configured to engage with a corresponding portion of a receptacle, such that, upon engagement of the or each engagement portion with the corresponding portion, the actuating mechanism is operable”) (see also [0064], which recites “this provides the advantage that needlestick injuries are avoided, as the hollow needle can only be actuated once connected to respective first and second receptacles”), wherein the safety mechanism (actuating mechanism 132 and outer sleeve 134) is configured to conceal the liquid storage container interface (hollow needle 112) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) is in the first safety mechanism configuration (see Fig. 27 a), and wherein the safety mechanism (actuating mechanism 132 and outer sleeve 134) is configured to reveal the liquid storage container interface (hollow needle 112) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) in the second safety mechanism configuration (see Fig. 27 b) (see [0389], which recites “the outer sleeve 134 is rotated in the opposite direction, such that the hollow needle 112 is retracted firstly from the first container 200 and the first septum seal 108, and then from the second container 300 and the second septum seal 110”).
With respect to claim 2, Veraitch teaches a liquid extraction device according to claim 1, wherein the liquid storage container interface (hollow needle 112) comprises at least one needle (hollow needle 112 in [0385]) configured to provide the fluidic connection to the volume of liquid within the liquid storage container (first container 200) (see [0469], which recites “the hollow needle 112 is as described in FIGS. 72(a) to 72(c), but the port 1013 extends through the hollow needle 112 so as to form a pair of diametrically opposed openings 1013 a, 1013 b. This allows fluid to drain out of each of the openings, so as to mitigate blockage of the hollow needle 112 during use. The hollow needle further includes a longitudinally extending slot 1017 extending from the open end 1015 toward the collar 118. This allows the fluid to more easily drain from a connected container into the bore of the hollow needle 112”).
With respect to claim 3, Veraitch teaches a liquid extraction device according to claim 1, further comprising a resiliently deformable element (first helical spring 120 in [0379], which recites “helical springs 120, 122 may be resilient … a deformable material or another type of spring may be provided”) configured to be deformed when the safety mechanism (actuating mechanism 132 and outer sleeve 134) is actuated from the first safety mechanism configuration (needle concealed within the outer sleeve of the connector in a retracted state, see Fig. 27 a,) to a second safety mechanism configuration (hollow needle exposed beyond the outer sleeve 134, see Fig. 27 b);
wherein the resiliently deformable element (first helical spring 120) is configured to bias the safety mechanism (actuating mechanism 132 and outer sleeve 134) away from the second safety mechanism configuration (hollow needle exposed beyond the outer sleeve 134, see Fig. 27 b) towards the first safety mechanism configuration (hollow needle concealed within the outer sleeve of the connector in a retracted state, see Fig. 27 a) (see [0034], which recites “the first biasing mechanism comprises a spring”) (the operational sequence shown in the Figs 27 a-e, the first helical spring is compressed as the safety mechanism transitions from the first safety configuration to the second safety configuration and, upon reversal of engagement operation, the spring biases the safety mechanism toward the first safety mechanism configuration such that the hollow needle retracts).
With respect to claim 16, Veraitch teaches a liquid extraction device according to claim 1, wherein the safety mechanism (actuating mechanism 132 and outer sleeve 134) comprises an aperture (defined at the distal end of outer sleeve 134, see Fig. 2) (see also Fig. 7 which illustrates the distal outer sleeve 134 defining the aperture adjacent to the septum seal 304 of container 300);
wherein the liquid storage container interface (hollow needle 112) does not extend through the aperture (opening at a distal end of outer sleeve 134) in the safety mechanism (actuating mechanism 132 and outer sleeve 134) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) is in the first safety mechanism configuration (hollow needle concealed within the outer sleeve of the connector in a retracted state, see Fig. 27 a); and
wherein the liquid storage container interface (hollow needle 112) extends through the aperture in the safety mechanism (opening at a distal end of outer sleeve 134) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) is in the second safety mechanism configuration (hollow needle exposed beyond the outer sleeve 134, see Fig. 27 b).
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Close (US20210154402) in view of Veraitch (US20230028474).
With respect to claim 17, Close teaches a liquid handling apparatus (infusion and blood collection device 100 in [0102], illustrated in Figs. 1-10) comprising:
a liquid handling device (fluidic system 101 in [0107]) comprising one or more conduits (blood collection channel 54 in [0107]); and
a liquid extraction device (see Fig. 1 and Fig. 4) for extracting liquid from a liquid storage container (blood collection tube 15 in [0124]), the liquid extraction device comprising:
a receptacle (tube holder 30 in [0116]) configured to receive a portion of the liquid storage container (blood collection tube 15);
a liquid storage container interface (draw needle 34 in [0116]) housed within the receptacle (tube holder 30) (see Fig. 1 and Fig. 4), wherein the liquid storage container interface (draw needle 34) is configured to provide a fluidic connection to a volume of liquid (blood) within the liquid storage container (blood collection tube 15) when the liquid storage container (blood collection tube 15) is connected to the liquid storage container interface (draw needle 34) wherein the liquid extraction device (see Fig. 1 and Fig. 4) is in fluidic communication with at least one of the one or more conduits (blood collection channel 54).
Close fails to teach a safety mechanism actuatable from a first safety mechanism configuration to a second safety mechanism configuration, wherein the safety mechanism is configured to conceal the liquid storage container interface when the safety mechanism is in the first safety mechanism configuration, and wherein the safety mechanism is configured to reveal the liquid storage container interface when the safety mechanism in the second safety mechanism configuration.
In the analogous art of liquid handling apparatus, Veraitch teaches a safety mechanism (actuating mechanism 132 in [0380] and outer sleeve 134 in [0389]) actuatable from a first safety mechanism configuration (see Fig. 27 a, hollow needle concealed within the outer sleeve of the connector in a retracted state) to a second safety mechanism configuration (see Fig. 27 b, hollow needle exposed beyond the outer sleeve 134) (see [0062], which recites “actuating mechanism may be configured such that it is only operable once the connector has engaged with both the first receptacle and the second receptacle. That is, in some embodiments the actuating mechanism may only be operable once the first receptacle is connected to the distal end of the housing, and when the second receptacle is connected to the proximal end of the housing”) (see also [0063],which recites “the actuating mechanism may include one or more engagement portions configured to engage with a corresponding portion of a receptacle, such that, upon engagement of the or each engagement portion with the corresponding portion, the actuating mechanism is operable”) (see also [0064], which recites “this provides the advantage that needlestick injuries are avoided, as the hollow needle can only be actuated once connected to respective first and second receptacles”), wherein the safety mechanism (actuating mechanism 132 and outer sleeve 134) is configured to conceal the liquid storage container interface (hollow needle 112) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) is in the first safety mechanism configuration (see Fig. 27 a), and wherein the safety mechanism (actuating mechanism 132 and outer sleeve 134) is configured to reveal the liquid storage container interface (hollow needle 112) when the safety mechanism (actuating mechanism 132 and outer sleeve 134) in the second safety mechanism configuration (see Fig. 27 b) (see [0389], which recites “the outer sleeve 134 is rotated in the opposite direction, such that the hollow needle 112 is retracted firstly from the first container 200 and the first septum seal 108, and then from the second container 300 and the second septum seal 110”)
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 liquid extraction device disclosed by Close by incorporating the safety mechanism disclosed by Veraitch around Close’s draw needle (which corresponds to the claimed liquid storage container interface) such that the liquid storage container interface is selectively concealed and exposed with a reasonable expectation of success for the benefit of reducing the likelihood of accidental needle stick injuries (see [0056]-[0055] of Veritch) while preserving Close’s intended blood collection functionality. The modification advantageous incorporates a safety feature around the needle and would not alter the liquid transfer function of Close.
Allowable Subject Matter
Claims 4-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claims 4 and claims 5-6 dependent on claim 4, Veraitch teaches a liquid extraction device according to claim 1.
Veraitch neither teaches nor suggests that the safety mechanism comprises a release mechanism configured to engage a portion of the receptacle when the safety mechanism is in the first safety mechanism configuration.
With respect to claim 7 and claims 8-9 dependent on claim 7, Veraitch teaches a liquid extraction device according to claim 1.
Veraitch neither teaches nor reasonably suggests a blocking element configured to:
prevent actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a first orientation; and
permit actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a second orientation different to the first orientation.
Claims 10-15 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
With respect to claim 10 and claims 11-15 dependent on claim 10, Veraitch teaches a liquid extraction device according to claim 1.
Veritch neither teaches nor reasonably suggests a liquid extraction mechanism actuatable from a first liquid extraction mechanism configuration to a second liquid extraction mechanism configuration, wherein the liquid extraction mechanism is configured to provide a pressure difference between a volume of gas in the liquid storage container and the liquid extraction outlet, when the liquid extraction mechanism is actuated from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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