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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 13-14 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 13 recites “a plunger rod” in line 4, which is unclear because claim 10 already introduced a plunger rod, and claim 13 previously referred to “the plunger rod”. It will be assumed that line 4 was intended to refer to the same plunger rod.
Claim 14 is rejected as it depends from claim 13.
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 of this title, 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.
Claim(s) 1-4, 10-13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura et al. (US 2015/0367068 A1, hereafter “Kawamura”) in view of Hunter et al. (US 2015/0122338 A1, hereafter “Hunter”), and further in view of Keenan (US 2007/0197954 A1).
As to claim 1, Kawamura discloses a syringe assembly (Fig. 22), comprising:
a syringe (46);
an infusion pump (20) configured to draw fluid from the syringe with vacuum pressure (para 0238-0239).
Kawamura is silent to a vibrator configured to vibrate at at least one frequency, wherein the vibrator is attached to the syringe and at least one pressure sensor configured to determine a vacuum pressure during fluid draw from the syringe by an infusion pump, wherein the vibrator is configured to vibrate based on the determined vacuum pressure.
Hunter discloses a vibrator (actuator 210) configured to vibrate at at least one frequency, wherein the vibrator is attached to the syringe (para 0031, 0042, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have attached a vibrator to the syringe of Kawamura, the vibrator being configured to vibrate at at least one frequency. One would have been motivated to do so to prevent static friction or stiction from affecting movement of the piston of the syringe (see para 0042 of Hunter).
Kawamura/Hunter are silent to at least one pressure sensor configured to determine a vacuum pressure during fluid draw from the syringe by the infusion pump, wherein the vibrator is configured to vibrate based on the determined vacuum pressure. Keenan discloses at least one pressure sensor (10) configured to determine a pressure of fluid exiting a syringe (19) (see para 0080, 0097, 0103, 0109, 0119). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kawamura further to include at least one pressure sensor configured to determine a vacuum pressure during fluid draw from the syringe by the infusion pump, as well additional components such as trigger controls configured to adjust flow rate. One would have been motivated to do so as a way to monitor and control pressure of the fluid as it leaves the syringe (see para 0080, 0097, 0103, 0109, 0119 of Keenan).
The examiner further points out that while Kawamura/Hunter/Keena does not explicitly mention wherein the vibrator is configured to vibrate based on the determined vacuum pressure, the claim is silent to any direct link between any direct between the vibrator and the at least one pressure sensor. In other words, in the modified version of Kawamura, any adjustment by a user that is in response to the at least one pressure sensor could be used to alter vibration of the vibrator, and therefore it can be said that the vibrator is configured to vibrate based on the determined vacuum pressure. The examiner recommends amending the claim to be more specific to how the vibrator and the at least one pressure sensor are linked, e.g. by claiming a controller that changes a behavior of the vibrator based on sensor feedback, for example with language from paragraph [0076] of the instant specification.
As to claim 2, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Further, Hunter teaches that its vibrator can be a piezoelectric drive or an inductive drive (see para 0007, 0040). Therefore, when modifying Kawamura as noted above, it would have been further obvious to use a piezoelectric drive or an inductive drive as Hunter teaches these as suitable drives for operating syringe (see para 0007, 0040 of Hunter).
As to claim 3, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. While Kawamura/Hunter/Keenan do not expressly recite wherein the vibrator is configured to vibrate at a natural frequency of the syringe assembly, Hunter does teach “The oscillating force may have a frequency between 50 Hz and 500 Hz. In some embodiments the oscillating force has a frequency below a cutoff frequency of the piston and syringe when containing the volume of liquid. The frequency of the oscillating force may be below an ultrasonic frequency” (para 0007, also see para 0011, 0052). Since Hunter teaches adjustment over a wide range of frequencies and it has been held that “[W]here 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 experimentation” (see MPEP 2144.05 ), operating the vibrator at a particular frequency that is optimal for operation of the syringe is considered to be a matter of obvious optimization.
As to claim 4, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Further, Hunter teaches that its vibrator is configured to vibrate at a plurality of different frequencies (see para 0007, 0011, 0052 of Hunter).
As to claim 10, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Kawamura further discloses wherein the syringe comprises a plunger rod (48) and a syringe barrel (47), but is silent to wherein the vibrator is attached to the plunger rod. However, Hunter teaches wherein its vibrator (210) is attached to the plunger rod (101) (see Figs. 2A, 2B). Therefore, when modifying Kawamura, it would have been further obvious to do so such that the vibrator is attached to the plunger rod to cause the vibration of the plunger rod (see para 0039, 0040 of Hunter).
As to claim 11, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 10 as described above. Kawamura further discloses wherein the syringe barrel extends between a proximal end and a distal end (see Fig. 22 of Kawamura), wherein the proximal end of the syringe barrel is configured to receive a distal end of the plunger rod (Fig. 22 of Kawamura), but does not expressly recite wherein the vibrator is attached to a proximal end of the plunger rod. Hunter teaches its vibrator (210) attached to a proximal end of its plunger rod (101) (see Fig. 2A, 2B and para 0039, 0040 of Hunter). Therefore, when modifying Kawamura, it would have been further obvious to do so such that the vibrator is attached to a proximal end of the plunger rod to cause the vibration of the plunger rod (see para 0039, 0040 of Hunter).
As to claim 12, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 11 as described above, and further wherein the vibrator is configured to impute motion to the plunger rod in an axial direction of the syringe barrel (see para 0039, 0040, Fig. 2A of Hunter which was used to modify Kawamura as noted above).
As to claim 13, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 10 as described above. Kawamura further discloses wherein the syringe barrel extends between a proximal end and a distal end (see Fig. 22 of Kawamura), wherein the proximal end of the syringe barrel is configured to receive a distal end of the plunger rod (Fig. 22 of Kawamura), but does not expressly recite wherein the vibrator is attached between a proximal end and the distal end of a plunger rod. Hunter teaches its vibrator (210) attached between a proximal end and the distal end of a plunger rod (101) (see Fig. 2A, 2B and para 0039, 0040 of Hunter; at least a proximal portion of the plunger rod is contained in 210 and therefore the proximal end, as well as a portion between the proximal end and distal end is attached). Therefore, when modifying Kawamura, it would have been further obvious to do so such that wherein the vibrator is attached between a proximal end and the distal end of a plunger rod to cause the vibration of the plunger rod (see para 0039, 0040 of Hunter).
As to claim 20, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Kawamura further discloses wherein the syringe comprises a plunger rod (48) and a syringe barrel (47), wherein the syringe barrel extends between a proximal end and a distal end (Fig. 22), wherein the proximal end of the syringe barrel is configured to receive a distal end of the plunger rod (Fig. 22), and wherein the distal end of the syringe barrel is connected to the infusion pump via a fluid line (31) (see Fig. 22, para 0011, 0238-0239).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kawamura in view of Hunter and Keenan as applied to claim 1 above, and further in view of Frankhouser et al. (U.S. PGPUB 2012/0209303), hereinafter Frankhouser.
As to claim 9, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1. While Kawamura/Hunter/Keenan does not explicitly teach that the vibrator has a predetermined mass, this is inherent with regards to the device. Kawamura/Hunter.Keenan also fails to teach wherein the predetermined mass is configured to tune a natural frequency of the syringe assembly to a preselected natural frequency.
Frankhouser teaches that resonant properties (i.e. the natural frequency of the
device) may be optimized through mass of the device [Paragraph 0145].
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 vibrator to have a
predetermined mass configured to tune a natural frequency of the syringe assembly to a
preselected natural frequency, as taught by Frankhouser. Doing so would allow for
modification of the natural frequency of the syringe assembly as needed for optimization
by the user, as taught by Frankhouser [Paragraph 0145].
Claim(s) 15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura in view of Hunter and Keenan as applied to claim 1 above, and further in view of Marx et al. (US 2015/0283334 A1 hereafter “Marx”).
As to claim 15, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Kawamura further discloses wherein the syringe comprises a plunger rod (48) and a syringe barrel (47), but is silent to wherein the vibrator is attached to the syringe barrel.
Marx teaches a syringe (102) comprising a plunger rod and a syringe barrel (see Figs. 8a-11c), and wherein a vibrator is attached to the syringe barrel (see Figs. 6, 7, para 0057, 0069).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kawamura further such that the vibrator is attached to the syringe barrel. One would have been motivated to do so as one possible alternative for a location of the vibrator (see para 0016, 0057, 0069, Figs. 6-11c depicting multiple possible locations for mounting of the vibrator).
As to claim 17, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above, but is silent to wherein the vibrator is removably attached to the syringe.
However, Marx teaches a vibrator () is removably attached to a syringe (para 0069, 0075, 0128, 0130, 0158, claim 21; also see Figs. 8a-8b, 10a-12b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kawamura further such that the vibrator is removably attached to the syringe. One would have been motivated to do so so that the vibrator can be easily/securely attached and reattached to the syringe (see para 0069, 0075, 0128, 0130, 0158, claim 21; also see Figs. 8a-8b, 10a-12b of Marx).
As to claim 18, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above, but do not expressly recite wherein the vibrator is attached to the syringe by at least one of an adhesive connection, a mechanical connection, and a magnetic connection.
Marx teaches wherein a vibrator is attached to a syringe by a mechanical connection (see para 0069, 0075, 0128, 0130, 0158, claim 21; also see Figs. 8a-8b, 10a-12b of Marx).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kawamura further such that the vibrator is attached to the syringe by a mechanical connection. One would have been motivated to do so as a way to easily/securely attach the vibrator to the syringe (see para 0069, 0075, 0128, 0130, 0158, claim 21; also see Figs. 8a-8b, 10a-12b of Marx).
Allowable Subject Matter
Claims 5-8, 16, and 19 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to claim 5, Kawamura in view of Hunter and Keenan teach the syringe assembly according to claim 4 as described above. However, each are silent to at least one sensor configured to determine a natural frequency of the syringe assembly in combination with the limitations of claims 1 and 4.
Claims 6-7 depend from claim 5.
As to claim 14, while Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 13 as described above, each are silent to wherein the vibrator is configured to impute motion to the plunger rod in a direction transverse to an axial direction of the syringe barrel in combination with the limitations of claims 1, 10, and 13.
As to claim 16, while Kawamura in view of Hunter, Keenan, and Marx teaches the syringe assembly of claim 15 as described above, there does not appear to be an obvious teaching from the prior art to modify Kawamura such that wherein the vibrator is configured to impute motion to the syringe barrel in a direction transverse to an axial direction of the syringe barrel in combination with the limitations of claims 1 and 15.
As to claim 19, Kawamura in view of Hunter and Keenan teaches the syringe assembly of claim 1 as described above. Kawamura further discloses the infusion pump (20) configured to draw fluid from the syringe with a negative pressure (para 0238-0239), but is silent to wherein the vibrator receives a supply of power from the infusion pump, wherein during fluid draw from the syringe by the infusion pump, the vibrator is configured to vibrate one of continuously and periodically, and wherein the vibrator is connected to a housing of the infusion pump via a line in combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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