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 .
Drawings
The drawings in Figs. 1, 3, 6-16 are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
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Note: the quality of the drawings is very blurry and confusing to permit examination. For example, as seen in Fig. 1 above, #120 defines as inner access housing lumen, however, it is unclear to Examiner that the lumen 120 is being covered by a tube/ampoule/tubing lumen being connected to a housing head portion 116, or the lumen 120 is as an open channel/lumen. If the lumen 120 is similar to a tubing lumen, does fluid pass through the lumen 120? Is the first tube end 160 being connected to a proximal end of the lumen 120? It does not show clear that the first tube end 160 being connected to the housing lumen 120.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claim Objections
Claim 11 is objected to because of the following informalities: “a body” should be changed to --- the body ---. Note: the limitation “body” has been mentioned in the claim 7 above. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: Claim 21 is missing. Appropriate correction is required.
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 7, 11-12 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.
The limitation “body” is vague. It is unclear to Examiner that the limitation “body” is being referred to which element, i.e., a tube body, a body of the access assembly, a body of the aspiration assembly...
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.
Claim(s) 1-3, 7, 11-13, 17, 19-20 & 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riopelle et al. (US 2011/0152836).
Regarding claims 1 & 22, Riopelle discloses an access device, comprising:
an access assembly 70 & 80 for percutaneously accessing an anatomical space 62 in a patient;
an aspiration assembly 25 selectively operable to generate negative pressure in a fluidic channel (e.g., including a lumen of a needle 80, #50, 20 & 25) of the device, the fluidic channel placing the access assembly in fluid connection with the aspiration assembly; and
a fluid tube 20 (at Y-branch) having a first tube end 10 connected to the access assembly, a second tube end (at a proximal end of the tube 20 is being connected to a nose of a syringe 25) connected to the aspiration assembly, and
a tube body 20 extending between the first and second tube ends, the tube having a tube lumen (a fluid passage of the tube body 20) that extends between the first and second tube ends and at least partially defines the fluidic channel between the access assembly and the aspiration assembly, the tube body 20 defining a manometer tube portion (portions A & B, see marked up figure below) spaced apart from both the first and second tube ends, the manometer tube portion A & B selectively acting as at least part of a manometer (e.g. the first and second manometer tubes are in different directions and formed in an angle);
Note: with regarding to the limitation, i.e., manometer tube portion, the application does not define the term “manometer” such as to measure and indicate the pressure of the liquid in the tube portion. The application states in para [0039] that: The term “inflection point” is used herein to indicate an area of the manometer tube portion 168 wherein a change of extension direction of at least 45° occurs. Therefore, with broadest interpretation, the term “manometer tube portion” is defined as a tube is bent at least 45° or in U-shaped as shown in Fig. 4. In this case, the tube portion 20 in Riopelle is bent at 45°. Therefore, the tube portion 20 is fair enough to call as “manometer tube portion”.
when the device is selectively in a manometer mode (e.g., when the fluid channel is flow in different levels in between the portions A, B & fluid channel in portion 15), the manometer tube portion A & B having first and second manometer tube ends and an inflection point changing the extension direction (angle C, about 45 degrees) of the manometer tube portion at a location spaced apart from both the first and second manometer tube ends.
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Regarding claim 2, further comprising a trigger (a plunger flange located at proximal end of a plunger rod) operatively connected to the aspiration assembly, wherein selective manipulation of the trigger operates the aspiration assembly to generate the negative pressure (retracting the plunger rod).
Regarding claim 3, wherein the aspiration assembly includes an aspiration body 25 and a plunger having a plunger head in the aspiration body, the aspiration body and plunger head collectively defining an aspiration chamber (inside the syringe body 25), the aspiration chamber being fluidically connected to the tube lumen 20 and forming a portion of the fluidic channel, the trigger/plunger flange being operatively connected to the plunger such that the selective manipulation of the trigger moves the plunger relative to the aspiration body to generate the negative pressure.
Regarding claim 7, as best as understood, further comprising a body (a syringe body 25, or a body 5 of the device) to which the access assembly, the aspiration assembly, and the trigger are connected.
Regarding claim 11, as best as understood, the body 25 (or the body 5) to which the access assembly and the aspiration assembly are connected; and a guidewire introducer assembly 40, the guidewire introducer assembly including a guidewire introducer assembly connector 49 for connecting the guidewire introducer assembly to the body 5;
a guidewire housing 45 connected to the guidewire introducer assembly connector 49 (at a proximal end of the guidewire housing 45), the guidewire housing 45 being configured to selectively receive a proximal end 47 of a guidewire; and a guidewire introducer head (47 & 49 at a distal end of the guidewire housing 45) connected to the guidewire introducer assembly connector 49 (at the proximal end of the guidewire housing 45), the guidewire introducer head 47 & 49 (at the distal end of the guidewire housing 45) being separate from the access assembly, see Fig. 1; wherein the guidewire 40 is selectively advanced through the guidewire introducer head 32 into the anatomical space of the patient, see Fig. 1.
Regarding claim 12, as best as understood, wherein the guidewire assembly further includes a protrusion 32 against which the guidewire is pressed concurrently with direction of the guidewire through the guidewire introducing head (47 & 49 at a distal end of the guidewire housing 45).
Regarding claim 13, wherein the access assembly includes an access housing 5 connected to the first tube end 10, the access housing 5 having an inner access housing lumen fluidically connected to the tube lumen 20, the inner access housing lumen forming a portion of the fluidic channel; and a hollow needle 80 connected to the access housing, see Fig. 1.
Regarding claim 17, as best as understood, further comprising a guidewire introducer assembly including a guidewire introducer assembly connector 49 (at a proximal end of the guidewire housing 45) for connecting the guidewire introducer assembly 40 to a body 5 of the device, the access assembly (70 & 80) and aspiration assembly 25 being connected to the body 5;
a guidewire housing 45 connected to the guidewire introducer assembly connector 49 (at a proximal end of the guidewire housing 45), the guidewire housing 45 being configured to selectively receive a proximal end 47 of a guidewire; and a guidewire introducer head (47 & 49 at a distal end of the guidewire housing 45) connected to the guidewire introducer assembly connector 49 (at the proximal end of the guidewire housing 45), the guidewire introducer head 47 & 49 (at the distal end of the guidewire housing 45) being separate from the access assembly, see Fig. 1; wherein the guidewire 40 is selectively advanced through the guidewire introducer head 32 into the anatomical space of the patient, see Fig. 1.
Regarding claim 19, Note: the claims 19-20 encompass the same scope of the invention as to that of device claim 1 except that they are drafted in method format instead of apparatus format. The claim(s) is/are therefore rejected for the same reason as set forth above. Examiner believes that device claim 1 and method claim 19-20 are not patentable distinguish from each other. In other words, if the device/apparatus claim (or method claim) is unpatentable and rejected over the prior art, the evidence or admission may be used in a rejection under method claim (or device/apparatus claim) as well. Therefore, claims 1 and 19-20 are examined together. However, if Applicant believes that the claims 1, 19-20 are patentable distinguishable, then the claims would be subject to further Election/Restriction.
Riopelle discloses a method for accessing an anatomical space in a patient, the method comprising: providing the device of claim 1;
inserting a portion of the access assembly into the patient, see Fig. 1;
operating the aspiration assembly to generate the negative pressure (by retracting the plunger rod); via the negative pressure, aspirating fluid from the patient into the manometer tube portion;
manipulating the device into the manometer operating mode (when retracting the plunger rod) such that the manometer tube portion acts as at least part of a manometer (e.g. the manometer tube portions are being located in different elevations); and with the device in the manometer operating mode, monitoring the fluid within the manometer tube portion to responsively determine whether the inserted portion of the access assembly is in a target anatomical space within the patient (e.g., the syringe 25 is used if negative pressure is desired through aspiration. A practitioner may desire to use aspiration to confirm that a vessel or cavity has been entered, para [0025]. At that point, the body fluid from the cavity body of a patient enters into the manometer tube portion and into the syringe 25).
Regarding claim 20, wherein the device includes a guidewire, the method further comprising: with the inserted portion of the access assembly maintained in the target anatomical space within the patient, directing the guidewire through at least a portion of the access assembly and into the target anatomical space to locate at least a portion of the guidewire in the target anatomical space.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-6, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Riopelle et al. (US 2011/0152836) in view of Oliver et al. (US 2012/0022447).
Regarding claims 4 & 24, Riopelle further discloses that wherein the aspiration body 25 is selectively openable to atmosphere, the device having an aspiration mode (when retracting the plunger rod) in which the plunger head is in a first, closed position in which the aspiration chamber is not open to atmosphere,
Riopelle does not disclose that wherein selective manipulation of the trigger generates the negative pressure when the device is in the aspiration mode, and the manometer mode in which the plunger head is in a second, open position in which the aspiration chamber is open to atmosphere and the manometer tube portion is configured to function as a manometer. In other words, the claimed invention requires that the aspiration body includes an aspiration body sidewall opening selectively opening the aspiration chamber to atmosphere.
Oliver discloses an aspiration assembly (a retractable syringe) comprising: an aspiration body 16 includes an aspiration body sidewall opening 38 selectively opening the aspiration chamber to atmosphere (Fig. 1);
wherein the aspiration body 16 is selectively openable to atmosphere (Fig. 1), the device having an aspiration mode in which the plunger head is in a first, closed position in which the aspiration chamber is not open to atmosphere, see Fig. 5 (e.g., the plunger head is located at the opening 38 and blocks the air in/out);
wherein selective manipulation of the trigger 30 generates the negative pressure when the device is in the aspiration mode, Figs. 2 & 4, and the manometer mode (i.e., fluid into the lumen of the syringe) in which the plunger head is in a second, open position (Figs. 2 & 4) in which the aspiration chamber 36 is open to atmosphere and the manometer tube portion is configured to function as a manometer.
Note: the opening 38 can be located anywhere on the sidewall of the syringe body and that considered as rearrangement part.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the aspiration assembly device of Riopelle with including an aspiration body sidewall opening being blocked by a plunger head in a first, closed position, and being unblocked by the plunger head in second, open position, as taught by Oliver, in order to allow the air being communicated to the aspiration chamber during aspiration to avoid the creation of vacuum/aspiration pressure.
Thus, Riopelle in view of Oliver discloses that in the manometer mode in which the plunger head is in a second, open position in which the aspiration chamber is open to open to atmosphere and the manometer tube portion is configured to function as a manometer.
Regarding claims 5-6, Riopelle in view of Oliver discloses all the claimed subject matter as required. Having said in the claim 4 above, Riopelle in view of Oliver discloses that wherein the aspiration body includes an aspiration body sidewall opening 38 (as modified by Oliver) selectively opening the aspiration chamber to atmosphere, the selective manipulation of the trigger longitudinally moving the plunger relative to the aspiration body, the device being in the aspiration mode as the plunger is moved longitudinally in a first direction toward the aspiration body sidewall opening, the device transitioning to the manometer mode responsive to movement of the plunger head longitudinally in the first direction beyond at least a portion of the aspiration body sidewall opening to open the aspiration chamber to atmosphere; wherein when the device is in the aspiration mode, the selective manipulation of the trigger to generate negative pressure draws fluid into the manometer tube portion to produce manometer fluid, when the device is in the manometer mode, the manometer fluid is visually accessible for pressure measuring.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Riopelle et al. (US 2011/0152836) in view of Vaillancourt (US 5,591,138).
Riopelle discloses all the claimed subject matter as required except for the limitation that the access housing includes a needle retraction mechanism for selectively moving the needle between deployed and retracted positions, a distal needle tip of the needle being outside the access housing when in the needle is in the deployed position, the distal needle tip being inside the access housing when the needle is in the retracted position.
Vaillancourt discloses a protected needle assembly comprising: a needle retraction mechanism (rotatable sleeve 13, guide slot 22 & projection 21) for selectively moving a needle 15 between deployed and retracted positions (Figs. 2-5), a distal needle tip of the needle being outside the access housing when in the needle is in the deployed position, see Fig. 2, the distal needle tip being inside the access housing when the needle is in the retracted position, see Figs. 5-6.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the access device or modify the access assembly of Riopelle with obtaining a needle retraction mechanism for selectively moving the needle between deployed and retracted positions, as taught by Vaillancourt, in order to prevent needle sticks.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Riopelle et al. (US 2011/0152836).
Regarding claim 18, Riopelle further discloses all the claimed subject matter as required. The limitation “the device is configured for one-hand operation by user” is a functional limitation and only requires performing a function. In this case, a person skilled in the art would recognize that the device can be used in one-hand operation. For example: after positioning or inserting the catheter and needle in stable position; wherein the portion #15 lies on a surface of the skin, then a user holds the syringe 25 to retract or push the plunger in backward or forward direction.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Riopelle et al. (US 2011/0152836) in view of Gillies et al. (US 2013/0096428).
Riopelle discloses all the claimed subject matter as required except for the limitation that the extension direction of the manometer tube portion substantially reverses at the inflection point. In other words, the manometer tube portion is in U-shaped configuration.
Gillies discloses an access assembly 13; a fluid tube 57 having a tube body defining an manometer tube portion 57 spaced apart of a first and second tube ends (adjacent to #35 & 55), the manometer tube portion having first and second manometer tube ends and an inflection point (at point #57 located in Fig. 2) changing the extension direction of the manometer tube portion at a location spaced apart from both the first and second manometer tube ends; wherein the manometer tube portion is U-shaped configuration; and the extension direction of the manometer tube portion substantially reverses at the inflection point.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the manometer tube device of Riopelle with obtaining a U-shaped configuration; wherein extension direction of the manometer tube portion substantially reverses at the inflection point, as taught by Gillies, in order to provide highly accurate pressure measurement by balancing the pressure of liquid in the tubing.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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