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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “an actuation arm coupled at a first end of the actuation arm to the barrel” causes the meaning of the claim to be unclear as a lack of clarity arises as to how and where “an actuation arm is coupled to a first end of the actuation arm”. Does applicant mean to say that the actuation arm is coupled to a first end of a barrel or something else?
Claim 7 is rejected by virtue of dependence on claim 6 and because it inherits and does not remedy the deficiencies of claim 6.
Claim 12 recites “the second fluid inlet valve” in the last limitation of the claim. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations is interpreted as referring to “a second one-way valve”.
Claims 13-14 are rejected by virtue of dependence on claim 12 and because they inherit and do not remedy the deficiencies of claim 12.
Claim 14 recites “the initial vessel retention arm”. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear as to which earlier recited element (if any) the limitations reference. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
Claim Rejections - 35 USC § 102
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 1-5 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopkins (US 20170360342 A1).
With respect to claim 1, Hopkins discloses a fluid sampling apparatus (see paragraph 0121 and Fig. 27-35: syringe-based transfer device #310) comprising:
a primary fluid chamber configured to receive a fluid therein (see paragraph 0122: housing #312; and see paragraph 0053: housing defines a pathway for withdrawing and/or conveying bodily-fluid from a patient to a transfer device), the primary fluid chamber defined by a barrel and a plunger (see paragraph 0122, 0126 and 0135: housing #312 is syringe like barrel where a movable second member #336 and plunger seal #354 defines variable second fluid reservoir #318), wherein the plunger is arranged at least partially within the barrel such that the movement of the plunger through the barrel varies the volume of the primary fluid chamber (see paragraph 0124, 0128, 0134-0135: second member #336 moves within housing #312 where proximal movement increases reservoir #318 volume), wherein:
a first end of the barrel comprises a fluid inlet port wherein the fluid inlet port is couplable to a fluid inlet tube (see paragraph 0122-0123, 0129: distal port #320 attached to housing #312 is coupled to a CVC/PICC line, butterfly needle or other lumen device which is interpreted to be a fluid inlet tube), wherein the fluid inlet port includes a first one-way valve (see paragraph 0122 and 0100: distal value #321 in port #320 is a one way check valve permitting inward flow and blocking distal expulsion) and wherein the fluid inlet port and the first one-way valve are configured to provide for fluid communication between a coupled fluid inlet tube and the primary fluid chamber (see paragraph 0135-0136: drawing plunger seal #354 pulls bodily fluid through port #320 and distal valve #321 into reservoir #318);
the plunger comprises a plunger channel therethrough including a second one-way valve (see paragraph 0126-0127: plunger assembly #336 has seal channel #356, proximal plunger tube #353 and one way valve #360 within channel #356 which permits distal to proximal flow), the plunger channel and second one-way valve are configured to provide for fluid communication between the primary fluid chamber at a first end of the plunger and a second end of the plunger wherein the first end of the plunger defines an inner surface of the primary fluid chamber and the second end of the plunger opposes the first end of the plunger (see paragraph 0126-0127, 0138: channel #356 and proximal cannula assembly #355 fluidically connect reservoir #318 to the proximal/rear end when valve #360 opens); and
wherein the second end of the plunger is configured to engage with a sample vessel for receiving a fluid from the plunger channel (see paragraph 0137-0138 and Fig. 33-35: evacuated sample device #399 couples to cannula assembly #355 after pre-sample vessel #338 is removed and receives the second reservoir fluid).
With respect to claim 2, all limitations of claim 1 apply in which Hopkins further discloses wherein the second end of the plunger is configured to be interchangeably couplable between each of an initial vessel and a sample vessel (see paragraph 0124, 0130, 0137-0138: initial evacuated vessel #338 is coupled to cannula #355 and is removed and later evacuated sample vessel #399 couples at the same rear assembly).
With respect to claim 3, all limitations of claim 1 apply in which Hopkins further discloses wherein the plunger is moveable between a first position and a second position (see paragraph 0102, 0107, 0114-0115: main second member #236 moves between distal and proximal positions) wherein, in the first position, the fluid inlet port is in fluid communication with the plunger channel such that fluid does not flow into the primary fluid chamber (see paragraph 0109-0111 and Fig. 20: initial blood passes port #220, valve #221 and channel #256/valve #260 to pre-sample syringe while reservoir remains unexpanded) and in the second position, the primary fluid chamber has a predefined volume (see paragraph 0107: radial projection #264 and housing protrusion #266 limit movement at a pre-set fill volume of reservoir #218) and the fluid inlet port is in fluid communication with the primary fluid chamber such that fluid flowing into the fluid inlet port enters the primary fluid chamber (see paragraph 0114-0116 and Fig. 21: main plunger withdrawal draws later blood via distal valve #221 into reservoir #218).
With respect to claim 4, all limitations of claim 3 apply in which Hopkins further discloses further comprising a sample vessel adapter arranged at the second end of the plunger (see paragraph 0118-0119: transfer adapter #270 threads into the proximal end of valve #260 after first member #234 is detached) configured to at least partially engage with the sample vessel when the sample vessel is fluidly coupled to the primary fluid chamber via the plunger channel (see paragraph 0119-0120 and Fig. 24: housing/needle assembly #274 of adapter #270 receives evacuated collection device #299 in fluid communication with reservoir #218).
With respect to claim 5, all limitations of claim 2 apply in which Hopkins further discloses wherein the second end of the plunger further comprises a piercing member (see paragraph 0126: shrouded cannula assembly #355 projects from rear plunger tube #353) which is configured to pierce a cap of a sample vessel to direct the flow of fluid from the plunger channel to the sample vessel (see paragraph 0119, 0130-0131, 0138: cannula pierces stopper #357 of initial tube where assembly #355 functions like adapter needle taught in [0119] for penetrating evacuated sample vessel #399 where Figs. 33-34 show the coupling).
With respect to claim 12, Hopkins discloses a method of extracting a fluid using a fluid sampling apparatus of claim 1 (see claim 1 above), the method comprising:
coupling the fluid inlet port to a fluid inlet tube at a second end of the fluid inlet tube and wherein the fluid inlet tube is configured to receive a fluid at a first end of the fluid inlet tube (see paragraph 0123, 0129: connect port #320 to CVC/PICC or butterfly needle line);
coupling an initial vessel to the second end of the plunger such that fluid flows from the fluid inlet tube through the fluid sampling apparatus via the first and second one-way valves and into the initial vessel (see paragraph 0122,0126-0127,0130-0132: evacuated vessel #338 couples to cannula #355 where blood crosses distal valve #321 and plunger valve #360);
removing the initial vessel (see paragraph 0134-0137: draws the sample into chamber #318 first and only then removes initial vessel #338);
moving the plunger within the barrel such that the volume of the primary fluid chamber is increased, thereby creating a negative pressure in the primary fluid chamber and causing fluid to flow from the fluid inlet tube through the first one-way valve into the primary fluid chamber (see paragraph 0134-0137: pull main plunger #336 to expand reservoir #318 and draw blood through valve #321);
coupling a sample vessel to the second end of the plunger such that fluid flows from the primary fluid chamber into the sample vessel via the second fluid inlet valve (see paragraph 0137-0138: after initial vessel removal, sample vessel #399 couples and draws blood from reservoir #318 through valve #360).
With respect to claim 13, all limitations of claim 12 apply in which Hopkins further discloses wherein moving the plunger within the barrel such that the volume of the primary fluid chamber is increased comprises moving the barrel from the first position to the second position (see paragraph 0102, 0107, 0114-0115: main member #236 moves distal to proximal; see paragraph 0109-0111: first flow via port #220 and channel #256 without entering reservoir #218; and see paragraph 0107: projection #264/stop #266 sets reservoir #218 fill volume; and see paragraph 0114-0116: blood later enters reservoir #218; and see paragraph 0134-0136: moves plunger #336 relative to held housing #312 where holding plunger ad moving housing creates the same relative expansion).
Claim Rejections - 35 USC § 103
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 6-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hopkins in view of Bullington (US 20160361006 A1).
With respect to claim 6, all limitations of claim 4 apply in which Hopkins does not disclose comprising an actuation arm coupled at a first end of the actuation arm to the barrel and wherein a second, opposite, end of the actuation arm extends beyond the second end of the sample vessel adapter when the plunger is in the first position and when the plunger is in the second position, the second end of the actuation arm is in line with the second end of the sample vessel adapter.
Bullington teaches an actuation arm coupled to a first end of a barrel (see paragraph 0097-0107 and Figs. 11-15: actuator mechanism #420 with a lever #441 attached to housing #410) wherein a second, opposite, end of the actuation arm extends beyond the second end of the sample vessel adapter when the plunger is in the first position and when the plunger is in the second position, the second end of the actuation arm is in line with the second end of the sample vessel adapter (see Fig. 12-13 and paragraph 0097-0107: lever #441 extends when device moves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hopkins with the teachings of Bullington to have included an actuator arm because it would have resulted in the predictable result of transitioning a device between various positions (Bullington: [0101]-[0107]).
With respect to claim 7, all limitations of claim 6 apply in which Bullington further teaches wherein the second end of the actuation arm comprises a load bearing surface at the second end of the actuation arm (see paragraph 0101-0107: actuator lever #441 connected to rack #445) wherein the load bearing surface extends perpendicularly to the length of the actuation arm such that the load bearing surface is configured to provide a surface against which force can be distributed in order to reduce a pressure on a surface pressing against the second end of the actuation arm (see paragraph 0101-0107 and Fig. 11-12: rack #445 helps distribute force).
With respect to claim 8, all limitations of claim 2 apply in which Hopkins does not disclose an initial vessel retention arm wherein the initial vessel retention arm is movable between a first position and a second position wherein the initial vessel retention arm comprises an initial vessel retention aperture in which an initial vessel can be retained and wherein: when the initial vessel retention arm is in the first position, at least a portion of the initial vessel retention arm is configured to substantially align the initial vessel retention aperture with the piercing member such that an initial vessel retained within the initial vessel retention aperture is pierced by the piercing member and when the initial vessel retention arm is in the second position, the initial vessel retention aperture is not in line with the piercing member such that the initial vessel retention arm does not impede the coupling of a sample vessel to the piercing member.
Bullington teaches an initial vessel retention arm wherein the initial vessel retention arm is movable between a first position and a second position wherein the initial vessel retention arm comprises an initial vessel retention aperture in which an initial vessel can be retained (see paragraph 0101,0107, 0139-0145, 0151-0159: lever #41 pivots and operators rack #445 where adapter #250,750 receives a sampling vessel and needle #253 pierces a vessel in adapter #250) and wherein: when the initial vessel retention arm is in the first position, at least a portion of the initial vessel retention arm is configured to substantially align the initial vessel retention aperture with the piercing member such that an initial vessel retained within the initial vessel retention aperture is pierced by the piercing member (see paragraph 0059: needle #252 pierces a vessel in adapter #250) and when the initial vessel retention arm is in the second position, the initial vessel retention aperture is not in line with the piercing member such that the initial vessel retention arm does not impede the coupling of a sample vessel to the piercing member (see Figs. 25-29 and see paragraph 0141,0151, adapter #750 translates along transverse housing branch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hopkins with the teaching of Bullington because it would have resulted in the predictable result of placing a needle in fluidic communication with a patient (Bullington: see [0032]) to conduct tests of fluid (Bullington: see [0072]).
With respect to claim 9, all limitations of claim 8 apply in which Bullington further teaches wherein the initial vessel retention arm comprises:
a first initial vessel retention sub-arm, wherein the first initial vessel retentions sub-arm is coupled to one of the barrel, the plunger or the sample vessel adapter (see Fig. 11-15 and paragraph 0097-0107: actuator lever #441 has a bottom end that is coupled to housing #410); and
a second initial vessel retention sub-arm wherein the second initial vessel retentions sub-arm comprises the initial vessel retention aperture (see Fig. 11-15 and paragraph 0097-0107: actuator lever #441 has top end where has an aperture), and
wherein the first initial vessel retention sub-arm is coupled to the second initial vessel retention sub-arm by an articulated joint and wherein, in its first position, the second initial vessel retention sub-arm extends perpendicularly to the first initial vessel retention sub-arm (see Fig. 11-15 and paragraph 0097-0107: actuator lever #441 is movable coupled to housing #410 and extends perpendicular when moving from a first to second position as seen best in Fig. 13).
With respect to claim 10, all limitations of claim 9 apply in which Bullington further teaches wherein in the second position, the second initial vessel retention sub-arm extends parallelly to the first initial vessel retention sub-arm (see Fig. 14).
With respect to claim 11, all limitations of claim 8 apply in which Bullington further teaches wherein the first initial vessel retention sub-arm is coupled to the barrel and the initial vessel retention sub-arm is the actuation arm (see paragraph 0101,0107, 0139-0145, 0151-0159: lever #41 pivots and operators rack #445 where adapter #250,750 receives a sampling vessel).
With respect to claim 14, all limitations of claim 13 apply in which Hopkins does not disclose wherein: the step of coupling an initial vessel to the second end of the plunger comprises moving the initial vessel retention arm into the first position and retaining the initial vessel within the initial vessel retention aperture; and the step of removing the initial vessel comprises removing the initial vessel retention arm from the initial vessel retention aperture and moving the initial vessel retention arm into the second position.
Bullington teaches the step of coupling an initial vessel to the second end of the plunger comprises moving the initial vessel retention arm into the first position and retaining the initial vessel within the initial vessel retention aperture (see Fig. 13-14; and see paragraph 0101,0107, 0139-0145, 0151-0159: lever #41 pivots and operators rack #445 where adapter #250,750 receives a sampling vessel and needle #253 pierces a vessel in adapter #250); and the step of removing the initial vessel comprises removing the initial vessel retention arm from the initial vessel retention aperture and moving the initial vessel retention arm into the second position (see Fig. 13-14; and see Figs. 25-29 and see paragraph 0141,0151, adapter #750 translates along transverse housing branch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hopkins with the teaching of Bullington because it would have resulted in the predictable result of placing a needle in fluidic communication with a patient (Bullington: see [0032]) to conduct tests of fluid (Bullington: see [0072]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hopkins in view of Bullington-2 (US 20180353117 A1).
With respect to claim 15, Hopkins discloses a fluid sampling apparatus of claim 1 (see claim 1 above).
Hopkins does not specifically disclose a kit of parts comprising a fluid sampling apparatus, an initial vessel, a sample vessel, and a fluid inlet tube.
Bullington-2 discloses a fluid sampling apparatus, an initial vessel, a sample vessel and a fluid inlet tube (see paragraph 0280: a kit having any suitable combination of components including fluid collection device, inlet device, lumen containing device and fluid control device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hopkins with the teachings of Bullington-2 to have a kit comprising parts because it would have resulted in the predictable result of allowing a user to open a packaging containing all the parts needed to use a device (Bullington-2: see [0280]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
