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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 June 2026 has been entered.
The Examiner acknowledges the amendments to claims 15 and 15, the cancelation of claim 24, and addition of new claims 26-29. Claims 15-22 and 25-29 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” is used to designate both the device and the outer tube [referred to as outer tube 210 in ¶0055 of Applicant’s Specification] in Fig. 4B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 15, 18-21, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green (US-20020019611-A1, previously presented) in view of Burkholz (US-20190321590-A1, previously presented) and Macors (US-5086783-A).
Regarding claim 15, Green teaches
A fluid collection device comprising:
a syringe barrel having a proximal end, a distal end, and a sidewall therebetween defining an interior [first cylinder 4 (Green ¶0054, Figs. 1-3)] configured to receive a fluid sample [The needle 2 is sharp and can penetrate the septum 13 of the bottle 14 to withdraw the medicine 14 (Green ¶0054), wherein the Examiner notes that the needle 2 being configured to reside within first cylinder 4 is considered to read on the syringe barrel being configured to receive a liquid sample];
a collection tube slidably received within the syringe barrel interior, the collection tube comprising a proximal end, a distal end having one or more openings therein, and a sidewall therebetween defining a collection tube interior in fluid communication with the interior of the syringe barrel [needle 2 (Green ¶0054, Figs. 1-3), wherein the needle 2 being positioned entirely within the first cylinder 4 (syringe barrel) is considered to define the needle 2 as being in fluid communication with the first cylinder 4] and configured to receive fluid therein when the distal end of the collection tube is positioned in a fluid source [To fill the second cylinder 5 from a vile 12 with a rubber septum 13, the cannula 3 is retracted and the needle 2 is extended (see FIG. 3). The needle 2 is sharp and can penetrate the septum 13 of the bottle 14 to withdraw the medicine 14 (Green ¶0054, Figs. 2-3)];
a tube plunger comprising a proximal end, a distal end, and a sidewall therebetween [second cylinder 5 (Green ¶0054, Figs. 1-3)], the tube plunger being slidably received within the interior of the syringe barrel and coupled with the collection tube [a needle 2 connected to the second cylinder 5. The second cylinder 5 travels within a first cylinder 4 (Green ¶0054)]; and
a sample plunger slidably received within the interior of the syringe barrel [plunger 6 (Green ¶0054, Figs. 1-3), wherein as depicted in Figs. 1-3, the plunger is slidably disposed within second cylinder 5, which is slidably disposed in the first cylinder 4 (syringe barrel), such that the plunger 6 is slidably disposed within the first cylinder 4] and configured to draw fluid into the collection tube interior through the distal end of the collection tube [a plunger 6 travelling in the second cylinder 5… Once the medicine has been withdrawn into the second cylinder 5 by deploying (extending) the plunger 6 (Green ¶0054)]].
However, while it is understood that the syringe barrel of Green being configured to receive a fluid sample by the collection tube [Green ¶0054], Green fails to explicitly disclose wherein the liquid sample is a blood sample; wherein the collection tube is configured to receive blood therein when the distal end of the collection tube is positioned in a blood vessel; and wherein the sample plunger is configured to draw blood into the collection tube interior through the distal end of the collection tube. Green further fails to explicitly disclose a septum positioned in the interior of the syringe barrel and at the distal end of the syringe barrel, wherein the collection tube extends through the septum with the tube plunger in each of a retracted position and an extended position, with the septum preventing blood from entering into the interior of the syringe barrel when blood is drawn into the collection tube interior
Burkholz discloses a blood collection device that is considered to function and operate similar to the fluid collection device of Green, wherein the device of Burkholz comprises a barrel [housing 14 of delivery device 10 (Burkholz Fig. 1B)] and a collection tube slidably received within an interior of the barrel configured to receive blood therein when the distal end of the collection tube is positioned in a blood vessel [catheter 12 (Burkholz Figs. 1B, 2B); the catheter 12 may allow the user to draw a blood sample (Burkholz ¶0060); delivery of the catheter 12 into the catheter system 50 and/or the vasculature of the patient (Burkholz ¶0061)], wherein the collection tube is coupled to a tube plunger slidably received within the interior of the barrel [catheter hub 26 (Burkholz Figs. 1B, 2B); In some embodiments, the catheter 12 may be secured to the catheter hub 26. In some embodiments, the proximal end 22 of the catheter 12 may be secured to the catheter hub 26, as illustrated, for example, in FIG. 1B. In some embodiments, a portion of the catheter hub 26 may extend through the slot 20 and may be moveable along the slot 20 to advance the catheter 12 in a distal direction and/or retract the catheter 12 in a proximal direction (Burkholz ¶0040, Figs. 1-2), wherein based on the plain definition of a plunger meaning a piece with a motion like that of a ram or piston (https://www.merriam-webster.com/dictionary/plunger), the catheter hub 26 is considered to be equivalent to a plunger]. Burkholz further discloses a septum positioned in the interior of the barrel and at a distal end of the barrel [the delivery device 10 may include a blood control septum 51, which may be disposed within a lumen of the delivery device 10. In some embodiments, the septum 51 may be disposed proximate or towards the distal end 16 of the delivery device 10 (Burkholz ¶0053, Figs. 1B, 2B)], wherein a collection tube extends through the septum in each of a retracted position and an extended position, with the septum preventing blood from entering into the interior of the barrel when blood is drawn into the collection tube interior [the septum 51 may prevent blood from travelling between the catheter 12 and an inner surface of the delivery device 10 such that blood may not enter at least a portion of the delivery device 10 (Burkholz ¶0053), wherein as depicted in each of Figs. 1B (retracted position) and 2B (extended position), the collection tube (catheter 12) extends through the septum in each of the retracted position and the extended position]. Burkholz also discloses a guidewire extending into the collection tube [catheter 12] while the collection tube extends through the septum in each of the retracted position and the extended position [see guidewire 36 in each of Burkholz Figs. 1B and 2B].
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 the device of Green to employ wherein the liquid sample is a blood sample; wherein the collection tube is configured to receive blood therein when the distal end of the collection tube is positioned in a blood vessel; and wherein the sample plunger is configured to draw blood into the collection tube interior through the distal end of the collection tube, as this modification would amount to merely applying a known technique [blood withdrawal] to a known device (method, or product) [device of Green] ready for improvement to yield predictable results [blood withdrawal using a syringe] [MPEP § 2143(I)(D)]. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Green in view of Burkholz to employ a septum positioned in the interior of the syringe barrel and at the distal end of the syringe barrel, wherein the collection tube extends through the septum in each of a retracted position and an extended position, with the septum preventing blood from entering into the interior of the syringe barrel when blood is drawn into the collection tube interior, so as to prevent blood from leaking into the syringe barrel during extension and after retraction of the collection tube. Based on the modification of Green in view of Burkholz, the tube plunger is considered to extend through the septum based on the extension and retraction of the collection tube, as extension and retraction of the tube plunger extends and retracts the collection tube, respectively [a needle 2 connected to the second cylinder 5. The second cylinder 5 travels within a first cylinder 4 (Green ¶0054)].
However, Green in view of Burkholz fails to explicitly disclose wherein the tube plunger comprises one or more air vents at the distal end thereof.
Macors discloses a blood collection device comprising a syringe barrel [tube holder 14 (Macors Fig. 1)], a tube plunger slidably received within the interior of the syringe barrel [wherein the arterial blood gas syringe 12 as coupled to the stopper assembly 10, as depicted in at least Macors Figs. 5-7, is considered to define a tube plunger; Next, the nurse or technician inserts the stopper assembly 10 and arterial blood gas syringe 12 combination into the proximal end 62 of the blood collection tube holder 14 (Macors Col 6:1-4), wherein the stopper assembly 10 as coupled to arterial blood gas syringe 10 is disclosed as a combined structure], and a sample plunger slidably received within the tube plunger [plunger rod 50 (Macors Figs. 1, 5-7)]; wherein Macors discloses that a distal end of the tube plunger comprises one or more air vents [wherein the portions of second section 28 in between each rib 30 is considered to define an air vent (see Macors Figs. 3-4); As shown in FIG. 2, the second section 28 of the proximal housing section 18 includes a plurality of evenly spaced and longitudinally aligned positioning ribs 30 extending radially outwardly from the circumference of the second section 28 (Macors Col 4:2-6, Figs. 3-4); Because the outer circumference of the stopper assembly 10, as measured around the positioning ribs, 30 and 38, is only slightly smaller than the inner circumference of the blood collection tube holder 14 and is larger than the outer circumference of the arterial blood gas syringe 12, the alignment of the proximal needle section 72 with the central openings 32 and 24 of the stopper assembly 10 is ensured as the stopper assembly 10 is moved distally in the blood collection tube holder 14. The relative size of the stopper assembly 10 with respect to the inner circumference of the blood collection tube holder 14 ensures that the proximal needle section 72 of the needle will be aligned to pierce the diaphragm member 22 and enter a portion of the luer extension 48 as the stopper assembly 10 and arterial blood gas syringe 12 are inserted distally into the blood collection tube holder 14. The use of the positioning ribs, 30 and 38, on the stopper assembly 10 allows any air that is displaced in the blood collection tube holder 14 to flow around the sides of the stopper assembly and out of the proximal end 62 of the blood collection tube holder 14 (Macors Col 6:4-25, Figs. 3-4)].
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 the device of Green in view of Burkholz to employ wherein the tube plunger comprises one or more air vents at the distal end thereof, so as to allow for any air displaced by movement of the tube plunger to flow around the tube plunger.
Regarding claim 18, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15, wherein the tube plunger is coupled to the proximal end of the collection tube [Green ¶0054].
Regarding claim 19, Green in view of Burkholz and Macors teaches
The blood collection tube of claim 15, wherein the collection tube and tube plunger are configured such that displacement of the tube plunger in a distal direction displaces the collection tube distally a corresponding distance [Green ¶0054].
Regarding claim 20, Green in view of Burkholz and Macors teaches
The blood collection tube of claim 15, wherein the sample plunger is slidably received within the tube plunger interior [Green ¶0054].
Regarding claim 21, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15, wherein the sample plunger is configured such that displacement of the sample plunger in a proximal direction causes blood to be drawn through the collection tube into an interior of the tube plunger [Green ¶0054].
Regarding claim 29, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15, wherein the one or more air vents comprise one or more cut-outs or openings formed in the distal end of the tube plunger [See § 103 modification of claim 15 above; Macors Figs. 3-4].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Burkholz and Macors, as applied to claim 15 above, in further view of Bullington (US-20180353117-A1, previously presented).
Regarding claim 16, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15.
However, Green in view of Burkholz and Macors fails to explicitly disclose wherein the distal end of the syringe barrel is configured to reversibly couple to an indwelling catheter.
Bullington discloses a syringe in fluid communication with a fluid source, wherein the syringe is configured to be coupled to an indwelling catheter [The inlet 132 of the control device 100 is configured to be placed in fluid communication with a bodily fluid source. In some embodiments, the inlet 112 can be coupled to and/or can include an inlet device such as, for example,… a syringe… the inlet can be a port, a valve, and/or the like such as, for example, a Luer Lok® or any other suitable coupler. In some embodiments, the inlet (e.g., port or coupler) can be configured to couple to an access or inlet device in fluid communication with a patient (e.g., a placed or indwelling IV catheter or needle) or other bodily fluid source (Bullington ¶0057)].
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 the device of Green in view of Burkholz and Macors to employ wherein the proximal end of the syringe is configured to reversibly couple to an indwelling catheter, as an indwelling catheter is considered to be a known fluid source for withdrawing fluids from.
Regarding claim 17, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15.
However, Green in view of Burkholz and Macors fails to explicitly disclose wherein the distal end of the syringe barrel comprises a luer connection.
Bullington discloses a syringe in fluid communication with a fluid source, wherein the syringe is configured to be coupled to a fluid source via a luer connection [Bullington ¶0057].
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 the device of Green in view of Burkholz and Macors to employ wherein the proximal end of the syringe barrel comprises a luer connection, as a luer connection is a known coupler for coupling a syringe to a fluid source.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Burkholz and Macors, as applied to claim 15 above, in further view of Hyde (US-20150374930-A1, previously presented).
Regarding claim 22, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15.
However, Green in view of Burkholz and Macors fails to explicitly disclose wherein the collection tube comprises a plurality of openings at the distal end thereof.
Hyde discloses a plurality of openings at a distal end of a collection tube [the systems and devices including a plurality of pores distributed along the length of a penetrating portion of the systems and devices, the plurality of pores in fluid communication with a fluid reservoir, the fluid reservoir configured to hold a fluid composition, wherein the fluid composition flows laterally out of the plurality of pores to aide in the injection process (Hyde ¶0064, Fig. 1)].
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 the device of Green in view of Burkholz and Macors to employ a plurality of openings at a distal end of a collection tube to facilitate fluid flow into the collection tube.
Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Burkholz and Macors, as applied to claim 15 above, in further view of Stice (US-20140031741-A1).
Regarding claim 25, Green in view of Burkholz and Macors teaches
The blood collection device of claim 15.
However, Green in view of Burkholz and Macors fails to explicitly disclose wherein the collection tube comprises a coil arranged at the distal end thereof, with the coil wrapped around the distal end of the collection tube.
Stice discloses a blood collection device comprising a collection tube comprising a coil arranged at the distal end thereof, with the coil wrapped around the distal end of the collection tube [Self-introducing catheter 400 is defined, at least in part, by catheter body 402, macroporous coil 122, longitudinally extending lumen 406, and end piece 418 at distal end 410 of catheter 400. As illustrated, distal region 408 of catheter 400 includes macroporous section 404 having an effective length 430 along which fluid and/or material is aspired or infused at a tissue site. Macroporous section 404 is defined, at least in part, by distal region 450 of catheter body 402 longitudinally circumscribed by macroporous coil 122. Distal region 450 of catheter body 402 includes a plurality of openings 446 such as slots or perforations through wall 448 of catheter body 402… during the aspiration mode of operation, fluid and/or material in the area (not shown) surrounding macroporous section 404 of catheter 400 flows through the porous wall of macroporous coil 122, through openings 446 into lumen 406, and suctioned out through the proximal end of catheter 400 (Stice ¶0101, Fig. 10)].
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 the device of Green in view of Burkholz and Macors to employ wherein the collection tube comprises a coil arranged at the distal end thereof, with the coil wrapped around the distal end of the collection tube, so as to provide an amount of rigidity and support to the distal end of the collection tube, and as this modification would amount to mere simple substitution of one known element for another with similar expected results [collection to configured to allow for fluid aspiration therethrough] [MPEP § 2143(I)(D)].
Regarding claim 26, Green in view of Burkholz, Macors, and Stice teaches
The blood collection device of claim 25, wherein the coil does not extend out past the distal end of the collection tube [See § 103 modification of claim 25; Stice Fig. 10].
Regarding claim 27, Green in view of Burkholz, Macors, and Stice teaches
The blood collection device of claim 25, wherein an outer diameter of the collection tube is the same or approximately the same as an outer diameter of the coil [See § 103 modification of claim 25; Stice Fig. 10].
Regarding claim 28, Green in view of Burkholz, Macors, and Stice teaches
The blood collection device of claim 25, wherein the collection tube tapers in a distal direction to an outer diameter that is the same or approximately the same as the outer diameter of the coil [See § 103 modification of claim 25; Stice Fig. 10].
However, Green in view of Burkholz, Macors, and Stice fails to explicitly disclose wherein the collection tube tapers from having an outer diameter larger than an outer diameter of the coil to an outer diameter that is the same or approximately the same as the outer diameter of the coil.
Stice does disclose that the diameter of the coil is variable and that the diameter of the coil is a result effective variable to optimize properties of the coil itself, as well as porosity and compatibility [In turn, those skilled in the art, given the present description, will appreciate the manner in which a macroporous region of this invention can be designed to any desired specifications, e.g., in terms of dimensions, tension, compression, torque, and pitch strength. So too can single, dual and triple layer tubes can be prepared as well, having desired flexibility and control, and providing suitable inner diameter, outer diameter, wire size, and filar diameter, filar number. For instance, a hollow helical strand can be provided with an inner diameter between about 0.02 mm to about 3.5 mm, an outer diameter between about 0.06 mm to about 5 mm, about 6 to about 18 filars, and a pitch selected from left, right, unidirectional, and reverse pitch. These and other characteristics, in turn, can be used to provide one or more macroporous regions having desired properties, particularly including size characteristics, porosity, and compatibility with the body (Stice ¶0017)].
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 the device of Green in view of Burkholz, Macors, and Stice to employ wherein the collection tube tapers from having an outer diameter larger than an outer diameter of the coil to an outer diameter that is the same or approximately the same as the outer diameter of the coil, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Green in view of Burkholz, Macors, and Stice would not operate differently with the claimed diameter of the coil relative to the collection tube. Therefore 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 the device of Green in view of Burkholz, Macors, and Stice to employ wherein the collection tube tapers from having an outer diameter larger than an outer diameter of the coil to an outer diameter that is the same or approximately the same as the outer diameter of the coil, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 18 June 2026, with respect to the previously presented drawing objection(s) have been fully considered and are persuasive. The drawing objection due to a reference character being used to designate different elements has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6-10, with respect to the rejection(s) of claim(s) 15 and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Green (US-20020019611-A1, previously presented) in view of Burkholz (US-20190321590-A1, previously presented) and Macors (US-5086783-A).
The Applicant asserts that the previously applied combination of Lineback with Green and Burkholz fails to teach or suggest what is called for in amended claim 15 regarding the claimed blood collection device including a tube plunger, wherein the tube plunger comprises one or more air vents at the distal end thereof, wherein the Applicant particularly notes that Lineback does not teach or suggest that a distal end of a “tube plunger” includes one or more air vents as amended and that Lineback only discloses that a distal end of a “sample plunger” [plunger shaft 20] may be configured as a vented component. The Applicant further notes that in the previously applied modification in view of Lineback, the Examiner’s assertion that it would have been obvious to modify Green in view of Burkholz in further view of Lineback mischaracterizes operation of the present invention and functionality of the air vent(s) provided in the tube plunger, as the claimed air vents do not function “to allow for air to vent out of the device as fluid is collected”, as fluid is only collected based on proximal retraction of the sample plunger, and is instead functions to allow air to pass from syringe barrel interior 318 to ambient environment during tube plunger displacement, such that the motivation applied for modifying the device(s) of Green and Burkholz in view of Lineback is not applicable. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Green (US-20020019611-A1, previously presented) in view of Burkholz (US-20190321590-A1, previously presented) as previously applied is further modified in view of Macors (US-5086783-A), wherein Macors is considered to disclose that a distal end of a tube plunger comprises one or more air vents [wherein the portions of second section 28 in between each rib 30 is considered to define an air vent (see Macors Figs. 3-4); Macors Col 4:2-6, 6:4-25, Figs. 3-4].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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