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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2019/0015585 A1) in view of Touchman (US 3,735,165).
As to claim 18, Smith discloses a device (100; see Figs. 1A-9E) comprising:
a means for containing medicament (reservoir 336);
a means for dispensing medicament from the medicament-containing means (plunger 335 + lead screw 334 + gear train 332; see para 0075); and
a means for actuating the medicament-dispensing means, the actuating means comprising
a rotor (331) operably coupled to the medicament-dispensing means and configured to rotate the rotor to cause medicament to be dispensed from the medicament-containing means (para 0070, 0071, 0075).
Smith does not expressly recite rotation of the rotor in a first direction less than a full rotation and the rotor being configured to rotate in a second, opposite direction for a second rotational amount more than the first rotational amount, wherein rotation in the second direction causes medicament to be dispensed from the medicament-containing means.
Touchman discloses a permanent magnet type torsional stepping motor and teaches “If the rotor 30 (FIG. 2) has been rotated approximately 71/2 degree. clockwise with respect to rotor 71 in latch assembly 14 at assembly (by rotating the end plate 18 and adjusting and tightening the screws 92 in slots 95 at the left hand end of the motor), the spring 67 will store energy therein by the torsional effect…. Albeit the amount of increase or decrease is small, the energy stored in a relatively short spring is sufficient to effect movement of the rotor in a very fast stepping action” (see para beginning line 37 col. 4).
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 Smith by substituting the motor design of Smith with that of Touchman, the resulting design being such that the rotor is configured for rotation of the rotor in a first direction less than a full rotation and the rotor being configured to rotate in a second, opposite direction for a second rotational amount more than the first rotational amount, wherein rotation in the second direction causes medicament to be dispensed from the medicament-containing means. One would have been motivated to do so for improved rotation of the gear train/lead screw of Smith by using stored energy of a spring as described by Touchman (see abstract, and paragraphs beginning line 5 col. 2, line 27 col. 2, line 37 col. 4).
As to claim 21, Smith in view of Touchman teaches the device of claim 18, wherein the medicament-dispensing means comprises a plunger (335; see para 0051 of Smith).
Allowable Subject Matter
Claims 1-17 are allowed.
Claims 19-20 and 22 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 1:
Smith discloses a method for driving a medicament infusion device (100; see Figs. 1A-9E) via an electromagnetic motor (motor described in at least para 0051, 0054, 0065, 0068) the method comprising:
supplying signals to a stator (“coil assembly 224 (which functions as a motor stator)”) of the electromagnetic motor to rotate a rotor (331) drive medicament out of the device (controller, such as microprocessor 223, controls operation of the device, which indicates the presence of signals sent to motor – see para 0061, 0062, 0068, 0073, 0075, 0078).
Smith is silent to supplying a first signal to a stator of the electromagnetic motor, thereby rotating a rotor of the electromagnetic motor from an initial static position in a first direction for a first rotational amount less than a full rotation to a windup position; and
after rotating the rotor of the electromagnetic motor in the first direction to the windup position, supplying a second signal to the stator, thereby rotating the rotor from the windup position in a second, opposite direction for a second rotational amount greater than the first rotational amount to drive medicament out of the infusion device.
While there is prior art, such as Pederson et al. (US 4,251,758), which teaches “A modulating circuit is provided which causes the rotor to be "wound-up" in the reverse direction during starting so that the rotor will gain a substantial starting momentum in the driving direction upon termination of the wind-up and the initiation of the normal running control signals” (abstract; also see claim 1), both Smith/Pederson are silent to the specifics of a method step of supplying a first signal to a stator of the electromagnetic motor, thereby rotating a rotor of the electromagnetic motor from an initial static position in a first direction for a first rotational amount less than a full rotation to a windup position, and after rotating the rotor of the electromagnetic motor in the first direction to the windup position, supplying a second signal to the stator, thereby rotating the rotor from the windup position in a second, opposite direction for a second rotational amount greater than the first rotational amount to drive medicament out of the infusion device.
Claims 2-8 depend from claim 1.
Claim 9, albeit drawn to an infusion device, requires a controller configured to perform steps similar to those in claim 1, and is therefore considered allowable for the same reasons as above.
Claims 10-27 depend from claim 9.
As to claim 19, while Smith in view of Touchman teaches the device of claim 18 as described above, and further a means for sensing rotation of the rotor (see sensors described in para 0073 of Smith and para beginning line 22 col. 5 of Touchman), each are silent to wherein the device is configured to initiate rotation of the rotor in the second direction based on one or more signals from the rotation-sensing means.
Claim 20 depends from claim 19.
As to claim 22, while Smith in view of Touchman teaches the device of claim 18 as described above, and further wherein the actuating means comprises an electromagnetic motor comprising a stator having a plurality of coil windings surrounding a central opening (see Fig. 10E, para 0088 of Smith, also see Figs. 1-4, para beginning line 39 col. 3 of Touchman), each are silent to the rotor comprising a permanent magnet removably disposed within the central opening.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jones et al. (US 2009/0157003 A1) – “the accumulator 112 is a mechanical energy accumulator but can be configured to accept any type of energy input whether such input energy is electrical, mechanical, chemical, etc. so long as the accumulator 112 outputs the stored energy in a mechanical form that drives the effector 108 in a manner that causes pressure pulses to be produced in the liquid 28 in the catheter 30 downstream of the cartridge 34. In a preferred embodiment, the accumulator 112 is a mechanical energy accumulator that accepts rotary or linear input motion from the drive 106a during an energy storage phase of accumulator operation. Such an accumulator 112 preferably has a mechanical energy storage mechanism (not shown) disposed within its housing 138 with its housing 138 fixed to part of the pump, such as the pump housing 48. Where separate from pump 22, the accumulator 112 can be anchored elsewhere, such as to part of a housing 141 of the apparatus 26a” – see para 0065-0067).
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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/James D Ponton/Primary Examiner, Art Unit 3783
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