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 .
Election/Restrictions
Applicant's election with traverse of claim(s) 15-25 in the reply filed on 12 August 2025 is acknowledged. The traversal is on the ground(s) that the Applicant asserts that comparing the differences between the claims to determine whether there is overlap is an improper analysis and insufficient to support a restriction under 35 U.S.C. § 121, and further notes that the Examiner has not demonstrated that a serious search and/or examination burden exist(s) beyond generalized statements about “materially different designs” and the need for separate CPC classification searches, wherein the Applicant submits that when searching and examining Invention I, the Examiner will also encounter subject matter of inventions II-III. This is not found persuasive because as the Examiner notes that the “generalized statements” about materially different designs analyzes the different structures that are mutually exclusive to each invention, which would result in a serious search burden, as art that may structurally or functionally read on one invention may not read on another invention due to the mutually exclusive designs. Furthermore, the Examiner notes that a proper analysis has been performed under MPEP § 806.05(j), as the Examiner has identified how each invention as claimed does not overlap in scope, each invention as claimed are not obvious variants, and each invention as claimed have materially different designs, thus providing a serious examination and search burden as noted..
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 1-14 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the proximal end of the syringe is configured to reversibly couple to an indwelling catheter” and “wherein the proximal end of the syringe barrel comprises a luer connection”, of claims 16-17 respectively, must be shown or the feature(s) canceled from the claim(s) [the Examiner notes that Figs. 5A-E are considered to depict the disclosed feature for reversible coupling at distal end 314 and not at proximal end 312 based on the disclosure of ¶0058 of the Applicant’s Specification]. No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “proximal end 341” [Applicant’s Specification ¶¶0058, 0060], “sidewall 343” [¶¶0058-0059], “collection tube interior 344” [¶¶0058-0059, 0061], “one or more openings 345” [¶¶0059, 0061].
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim(s) 16 is/are objected to because of the following informalities:
Claim 16 should read “syringe barrel” [line 2].
Appropriate correction is required.
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 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green (US-20020019611-A1) in view of Hyde (US-20150374930-A1).
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.
Hyde discloses a blood collection device comprising a concentric syringes and a collection tube [see Hyde ¶¶0065-0067] configured for withdrawing blood from a subject [For example, the second initiator can be actuated with upward pressure to aspirate a captured sample, e.g., blood, tissue, marrow, or cerebral spinal fluid, into the lumen defined by the second hollow cylinder and into the second fluid reservoir portion (Hyde ¶0070)].
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)].
Regarding claim 18, Green in view of Hyde 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 Hyde 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 Hyde 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 Hyde 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 the syringe barrel interior [Green ¶0054].
Regarding claim 22, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde as presently modified 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 Hyde to employ a plurality of openings at a distal end of a collection tube to facilitate fluid flow into the collection tube.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Hyde, as applied to claim 15 above, in further view of Bullington (US-20180353117-A1).
Regarding claim 16, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde fails to explicitly disclose wherein the proximal end of the syringe 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 Hyde 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 [wherein the Examiner notes that “proximal” and “distal” are considered to be relative, such that any portion of the claimed syringe barrel may define a split between a “proximal end” and a “distal end”, such that the fluid inlet side of the first cylinder 4 (syringe barrel; see Figs. 1-3 of Green) may still include the “proximal end” of the first cylinder 4].
Regarding claim 17, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde fails to explicitly disclose wherein the proximal 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 Hyde 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 [wherein the Examiner notes that “proximal” and “distal” are considered to be relative, such that any portion of the claimed syringe barrel may define a split between a “proximal end” and a “distal end”, such that the fluid inlet side of the first cylinder 4 (syringe barrel; see Figs. 1-3 of Green) may still include the “proximal end” of the first cylinder 4].
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Hyde, as applied to claim 15 above, in further view of Stocking (US-5704914-A).
Regarding claim 23, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde fail to explicitly disclose the device further comprising a septum at the distal end of the syringe barrel.
Stocking discloses a device comprising a hollow cylinder body [body 18 (Stocking Figs. 3-4)] with a collection tube disposed therein [needle 27 (Stocking Figs. 3-4)], wherein the hollow cylinder body comprises a septum at a distal end [A liquid sealing means, preferably in the form of a flexible, resilient diaphragm or septum 34, through which a hypodermic needle such as the needle 27 can be passed, and which may include a deformable slit, encloses the proximal end of the hub 14 in a liquid tight manner when in an unpenetrated condition insofar as the needle 27 is concerned as shown in FIGS. 4-5 (Stocking Col 4:24-30, Figs. 3-5)].
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 Hyde to employ a septum at the distal end of the syringe barrel, in order to maintain sterility of the collection tube prior to fluid collection.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Hyde, as applied to claim 15 above, in further view of Lineback (US-4936315-A).
Regarding claim 24, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde fails to explicitly disclose wherein the tube plunger comprises one or more air vents at the distal end thereof.
Lineback discloses a blood collection device comprising a syringe barrel [distal syringe barrel 16 (Lineback Figs. 1-2)], a collection tube [flow-through adapter 22 (Lineback Figs. 1-2)], a tube plunger [proximal syringe 12 (Lineback Figs. 1-2)], and a sample plunger [plunger shaft 20 (Lineback Figs. 1-2)]; wherein Lineback generally discloses the use of vented plungers [If the blood is to be obtained directly from a patient's artery, then plunger 18 of the proximal syringe 12 is preferably vented. A vented plunger 18 allows air within both syringes 12 and 16 to escape as the syringe fills with blood (Lineback Col 6:64-68); Upon puncturing an artery, both syringe barrels fill with blood under the arterial blood pressure. As blood fills the syringe barrels, the air within the syringe barrels is vented through the vented plunger 18. In this manner, air bubbles within the arterial blood gas sample are minimized (Lineback Col 7:6-11)].
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 Hyde to employ wherein the tube plunger comprises one or more air vents at the distal end thereof, so as to allow for air to vent out of the device as fluid is collected.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green in view of Hyde, as applied to claim 15 above, in further view of Weinrib (US-4706671-A).
Regarding claim 25, Green in view of Hyde teaches
The blood collection device of claim 15.
However, Green in view of Hyde fails to explicitly disclose wherein the collection tube comprises a coil arranged at the distal end thereof.
Weinrib discloses a blood collection device, wherein the device comprises a tube with a coil arranged at a distal end of the tube [the needle end 13a of the catheter 10 is used to penetrate the vessel 17 and the wire member 20 will be extended as shown in FIG. 1 to uncoil the coils 42 or 42a leaving a straight end portion for threading through the vessel (Col 5:62-66, Fig. 1); When the embolism material is adjacent the catheter body end 13a, the wire member 41 may be pushed forwardly causing the coil section to lenthen and contract in diameter. The clot material may now be removed manually through the needle or be sucked through the needle by suction forces (Col 6:17-23), wherein the coils 42/42a are considered to be “arranged” at a distal end of the needle end 13a of catheter 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 Hyde to employ wherein the collection tube comprises a coil arranged at the distal end thereof, so as to facilitate clot removal.
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