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 .
Response to Amendment
This office action is responsive to the amendment filed on 7/28/2025. As directed by the amendment: claims 1 has been amended and claim 18 has been cancelled. Thus, claims 1-16 and 19-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 7/28/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the prior art of Dillani’s teachings applied to the former claim 18 and presently amended claim 1, particularly the position limited member teachings, 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.
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable. See examiner's rejection as necessitated by the amendment, below, for the prior art which discloses/teaches the dependent claims.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Regarding claim 1:
The claim recites “a control module, connected to the power module, controlling the power module…”, emphasis added to highlight the claim limitation in question.
Regarding claim 16:
The claim recites “auxiliary driving unit which is connected to and cooperated with the first driving unit or the second driving unit, and the first driving unit and the second driving unit cooperate with each other through the auxiliary driving unit”, emphasis added to highlight the claim limitation in question.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding claim 1:
control module
From applicant’s specification: "The control module101 is used to control the driving power output by the power module to control drug infusion. The control module101 may also establish wireless communication with a remote device (not shown). In one embodiment of the present invention, the control module101 further includes a power supply (not shown)." "The control module (not shown) is connected to the power module."
Accordingly, the control module does not have corresponding structure outside of the connections it has to other -claimed and not claimed- elements in the specification.
Regarding claim 16:
auxiliary driving unit
From applicant’s specification: "auxiliary driving unit 1000 is a gear." "the driving module further includes one or more auxiliary driving units connected to the first driving unit or the second driving unit, and the first driving unit and the second driving unit may not be in direct contact or connected directly. The auxiliary driving unit transmits the operating manner or operating mode of the first driving unit to the second driving unit, thereby making the second driving unit implement the operating manner or operating mode associated with the first driving unit. "
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20030199824 A1, henceforth written as Mahoney, in view of US 20120165734 A1, henceforth written as Auld, and further in view of US 5020643 A, henceforth written as Redenbarger.
Regarding Claim 1,
Mahoney’s present embodiment discloses:
A drug infusion device with multiple infusion modes, comprising:
(fluid delivery device 10 of the embodiment of fig 12-13; fig 2 best illustrates the invention as a whole)
a reservoir
(reservoir 30; fig 3),
a piston
(plunger 204; fig 3)
and a screw,
(screw 202; fig 3+12)
wherein the piston, connected with the screw, is arranged in the reservoir;
(paragraph 72-74; plunger 204 is within reservoir 30 and connected to screw 202; fig 3)
a driving module comprising a first driving unit and a second driving unit that cooperate with each other,
(paragraph 102; driving module comprises cage 364 interacting with gears 314a 314b; fig 12-13)
wherein the second driving unit drives the screw forward;
(paragraph 75+101; rotation of gears 314a 314b causes rotation of the lead screw 202; fig 12)
a power module connected to the first driving unit;
(paragraph 104; shape memory element 350 connects to cage 364; fig 12-13)
a control module, connected to the power module,
(paragraph 79-84; processor 50 connects to shape memory element 350; fig 12-13)
controlling the power module to apply different driving powers to the first driving unit,
(paragraph 79+104; processor 50 drives a movement of cage 364 by applying charge(s) to portions 356 358 of shape memory element 350; fig 12-13)
making the first driving unit have a variety of different operating modes, thereby making the infusion device have various different infusion increments or infusion rates and
(paragraph 84; processor 50 varies flow rate by adjust the time between charges administered to the portions of shape memory element 350)
a base on which the second driving unit is movably assembled, wherein the base and second driving unit are frictional fit,
(paragraph 75; gears and lead screw are mounted for rotation on fixed gear bracket 212, considered the claimed base; fig 3 best illustrates the fixed gear bracket of the invention)
wherein the second driving unit comprises at least one driving wheel provided with wheel teeth, --
(paragraph 102; gears 314a 314b have teeth; fig 13)
--the base does not separate from the at least one driving wheel,
(gear bracket 212 is fixed in place with the gears 314ab mounted for rotation therein, during such rotation the teeth of gears 314ab remain engaged with pawls 346 348 and do not displace along its axis of rotation, thus as the gears 314ab do not displace linearly within the gear bracket 212, they remain fixed relative to the sides of the bracket 212 upon being mounted therein, the claimed base can be considered to not separate from the claimed at least one driving wheel)
and the base does not contact the wheel teeth of the at least one driving wheel,
(fig 12-13 demonstrate that teeth of gears 314ab only mate with pawls 346 348)
wherein the at least one driving wheel of the second driving unit is rotatably disposed at the base, the at least one driving wheel rotates along an axis,--
(paragraph 75; gears and lead screw are mounted for rotation on fixed gear bracket 212)
--wherein the base is always not rotated with the at least one driving wheel.
(paragraph 75; gears are mounted for rotation on fixed gear bracket 212, accordingly the gears rotate relative to, and not with, the gear bracket as it is fixed in place)
However, Mahoney’s present embodiment is silent on:
the base directly and constantly contacts the at least one driving wheel,--and the screw moves axially and linearly along the axis;
However, Auld teaches a drug delivery device with a ratchet engaging a screw to push a plunger to deliver a medium comprising:
a base on which [a gear] is movably assembled, wherein the base and [the gear] are frictional fit, the base directly and constantly contacts the [the gear], and the screw moves axially and linearly along the [gear’s axis of rotation] wherein the base is always not rotated with the [gear]
(paragraph 34-35+62-64; housing 826 supports the rotation of ratchet gear 818, as acted upon by pawls 838 840, to linearly displace lead screw 812 and likewise displace plunger 810, ; fig 14-19; examiner’s annotation of Auld’s fig 17 demonstrates what can be considered Auld’s base and the manner by which Auld’s base is in frictional fit and direct constant contact with the gear 818)
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Examiner further notes that Auld’s screw 812 is configured to engage with an advancement component 828 such that depending on the state of component 828 the screw 812 may displace in either linear direction to aspirate or eject fluid within/from cavity 808 in a manner governed by by a user manipulating a handle (not enumerated) at the end of screw 812, see fig 14-16, and not by the engagement of pawls 838 840 against the teeth of gear 818, see paragraph 38-40+62. Examiner notes that the structure of screw 812 and gear 818 which permits the linear displacement of screw 812 without rotating with gear 818 is not enumerated in the embodiment of fig 14-19, but is illustrated throughout. This structure is best illustrated/enumerated in fig 6 as a protrusion 122 which slides within a slot 124 of screw 112 and discussed in detail in paragraph 35, however in the embodiment of fig 14-19, particularly visible in fig 18, gear 818 as plural integrally formed protrusions which engage corresponding slots on screw 812.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Auld’s teachings of a ratchet gear support mechanism which enables independent displacement of a lead screw to the invention of Mahoney, by supporting Mahoney’s at least one driving wheel with Auld’s gear protrusion being supported by Auld’s base sleeve such that varying the position of Auld’s advancement component 828 permits an operator to manipulate Auld’s screw handle to linearly translate Mahoney’s screw 202 relative to Mahoney’s gears 314ab via the engagement of Auld’s protrusion on Mahoney’s gears 314ab against Audl’s slot on Mahoney’s screw 202, therein advantageously arriving at an invention which permits a user to initiate a manual aspiration of media into its chamber which may beneficial in loading the material to be later ejected by a precise actuation system, see paragraph 40 of Auld.
However, Mahoney in view of Auld remains silent regarding:
a position limited member which is movably assembled on the base to limit a position of the second driving unit, wherein the position limited member and the second driving unit are frictional fit, wherein the position limited member and the at least one driving wheel are different elements and independent from each other, the position limited member includes a contact surface contacting the at least one driving wheel to provide friction for the at least one driving wheel,--
However, Redenbarger teaches a brake system for a rotating disc
a position limited member which is movably assembled on the base to limit a position of the [wheel],
(col 1 line 65 to col 3 line 55; caliper member 20, inclusive of its backing members 26 27 which are considered the claimed position limited member, is attached to axle housing 10, considered the claimed base, via a yoke 13; backing members 26 27 can be considered movably assembled on housing 10 in the manner by which they translate to engage pads 37 against rotor 12 to stop its rotation; fig 1-8)
wherein the position limited member and the [wheel] are frictional fit, wherein the position limited member and the [wheel] are different elements and independent from each other, the position limited member includes a contact surface contacting the [wheel] to provide friction for the [wheel],--
(braking pad 37, the claimed contact surface, engages rotor 12 to provide friction against rotor 12 and cease rotor 12’s rotation; fig 1-8)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Redenbarger’s teachings of providing a clamping brake mechanism on a base which supports the rotation of an object in order to slow/stop the rotation of that object to the base and rotating gears of the modified invention of Mahoney in view of Auld, by attaching Redenbarger’s brake mechanism via its yoke 13 to Mahoney’s modified base such that Redenbarger’s pads 37 engage sides of Mahoney’s gears 314ab, in order to arrive at an invention which can selectively slow/stop the rotation of the gears by the action of an operator and thus advantageously reduce risks associated with over rotation of the gears, such as over delivery of medication which may lead to overdose of drugs and death.
Regarding claim 2, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 1, wherein, an operating manner of the first driving unit comprises unidirectional movement or reciprocating movement.
Mahoney: (paragraph 100-102; cage 364 is linearly moved via portions 356 358 of shape memory element 350 in a uni-directional and reciprocating manner; fig 12-13)
Regarding claim 3, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 2, wherein, one of the variety of different operating modes of the first driving unit comprises a movement rate,
Mahoney: (paragraph 84, "Various flow rates are achieved by adjusting the time between charges. To give a fixed volume or bolus, multiple charges are given in rapid succession until the bolus volume is reached.")
therefore the variety of different operating modes of the first driving unit comprise various different movement rates.
Mahoney: (paragraph 84+102-104, "Various flow rates are achieved by adjusting the time between charges [resulting in actuation of pawls 346 348 interacting with gears 314a 314b]. To give a fixed volume or bolus, multiple charges are given in rapid succession until the bolus volume is reached.")
Regarding claim 4, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 3, wherein, the power module applies different forces in linear directions to the first driving unit.
Mahoney: (paragraph 104; portions 356 358 of shape memory element 350 move cage 364 linearly to induce a movement of pawls 346 348; fig 12-13)
Regarding claim 5, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 4, wherein, the power module comprises a first power unit
Mahoney: (second portion 358 of shape memory element 350; fig 12)
and a second power unit
Mahoney: (first portion 356 of shape memory element 350; fig 12) respectively connected to the first driving unit. (paragraph 104; portions 356 358 are connected via cage 364; fig 12)
Regarding claim 6, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 5, wherein, the first power unit comprises an electrically driven linear actuator or an electrically heated linear actuator,
Mahoney: (paragraph 76+98; second portion 358 of shape memory element 350 are actuated by application of an electrical charge resulting in a heating of the material and consequent linear shape change; fig 12;)
and the second power unit comprises an electrically driven linear actuator, an electrically heated linear actuator or an elastic member,
Mahoney: (paragraph 98; first portion 356 of shape memory element 350 are actuated by application of an electrical charge resulting in a heating of the material and consequent linear shape change; fig 12)
and the control module, through controlling an output frequency of a driving power output by the first power unit or the second power unit (paragraph 71+79+84+104; processor 50 distributes a charge to members 352 354 which results in a linear contraction/expansion of portions of shape memory element 350; fig 1+12+13), controls the movement rate of the first driving unit.
Mahoney: (paragraph 84, "Various flow rates are achieved by adjusting the time between charges. To give a fixed volume or bolus, multiple charges are given in rapid succession until the bolus volume is reached.")
Regarding claim 7, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 6, wherein, the first driving unit comprises at least one driving end
Mahoney: (pawl 346 348; fig 13),
and the at least one driving end pushes the wheel teeth forward to rotate the at least one driving wheel.
Mahoney: (paragraph 102, teeth of the gear are shaped and oriented such that the first pawl rotates the gear; fig 12-13)
Regarding claim 8, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 7, wherein, the first power unit is an advancing member,
Mahoney: (second portion 358 of shape memory element 350 pulls; fig 12)
while the second power unit is a reset member,
Mahoney: (first portion 356 of shape memory element 350; fig 12 )
and during operation, the advancing member applies driving power to the first driving unit to drive the at least one driving end to advance the wheel teeth, while the reset member applies driving power to the first driving unit to reset the at least one driving end.
Mahoney: (paragraph 98+100+108; alternating charges are applied to portions 356 358 of shape memory element 350 to induce an advancing and resetting of pawls 346 348 with respect to gears 314a 314b, as demonstrated by the steps in fig 11)
Regarding claim 9, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 8, wherein, the at least one driving wheel is a ratchet wheel and the wheel teeth are ratchet teeth.
Mahoney: (paragraph 102; gears 314a 314b with teeth, constitute a ratchet wheel with ratchet teeth)
Regarding claim 10, the modified invention of Mahoney in view of Auld and Redenbarger discloses:
The drug infusion device with multiple infusion modes of claim 9, wherein, the at least one driving end comprises a linearly reciprocating pawl
Mahoney: (pawls 348 348; fig 12-13)
which pushes the ratchet teeth to rotate the ratchet wheel intermittently.
Mahoney: (paragraph 102, teeth of the gear are shaped and oriented such that the first pawl rotates the gear; fig 12-13)
Claim 11-15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney in view of Auld and Redenbarger as applied to claim 1 above, and further in view of US 20050238507 A1, henceforth written as Dilanni.
Regarding Claim 11,
Mahoney in view of Auld and Redenbarger discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Mahoney in view of Auld and Redenbarger is silent regarding:
The drug infusion device with multiple infusion modes of claim 9, wherein, the driving module further comprises at least one rotating shaft, the first driving unit comprises at least one driving member provided with the at least one driving end, and during operation, the driving member reciprocatingly rotates around the at least one rotating shaft, driving the at least one driving end to reciprocate to make the at least one driving wheel rotate intermittently.
However, Dilanni further teaches a drug delivery device
the driving module (paragraph 36; driving module comprising drive engaging member 262 and wheel 258a 258b; fig 4-5) further comprises at least one rotating shaft, (paragraph 36; pivot point 162; fig 4)
the first driving unit comprises at least one driving member provided with the at least one driving end,
(paragraph 36-38; drive engaging member 262 has arms 264a 264b, where the tip engages a tooth of wheel 258a 258b; fig 4-5
and during operation, the driving member reciprocatingly rotates around the rotating shaft, driving the at least one driving end to reciprocate to make the at least one driving wheel rotate intermittently.
(paragraph 36-38; drive engaging member 262, and its arms 264a 264b, incrementally rotate about the pivot point 162 in directions 20 22; fig 4-5)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the rotating driving member teachings of Dilanni to the driving module of Mahoney in view of Auld and Redenbarger in order to provide a control method for incrementally dispensing fluid out of the device (i.e. one pre-determined size unit at a time) while preventing counter-rotation of the 2nd driving unit, see paragraph 36-38 of Dilanni.
Regarding claim 12,
Mahoney in view of Auld, Redenbarger, and Dilanni discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Mahoney in view of Auld, Redenbarger, and Dilanni is silent on:
The drug infusion device with multiple infusion modes of claim 11, wherein, the at least one driving end comprises two driving ends, the driving member comprises the two driving ends which cooperate with the at least one driving wheel.
However, Mahoney further teaches a drug delivery device
wherein, the at least one driving end comprises two driving ends, (pawls 376 378 ; fig 14)
the driving member comprises the two driving ends which cooperate with the at least one driving wheel. (paragraph 107; pawls 376 378 interacting with a single gear 314; fig 14)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multiple driving ends corresponding to a single driving wheel teachings of Mahoney’s further embodiment to the present embodiment of Mahoney in view of Auld, Redenbarger, and Dilanni in order to arrive at a dispensing mechanism which can rotate the gear by less than a tooth pitch and therein improve accuracy of the device by providing less than one "pulse volume", see paragraph 107+84 of Mahoney.
Regarding Claim 13,
Mahoney in view of Auld and Redenbarger discloses all of the elements of the current invention which the present claim is dependent upon, as described above, and the following limitations of the present claim.
The drug infusion device with multiple infusion modes of claim 7, wherein, the at least one driving end comprises at least two driving ends,
Mahoney: (pawls 346 348 ; fig 12-13)
and the at least one driving wheel comprises two driving wheels fixedly connected,
Mahoney: (paragraph 101, "first and second gears 314a, 314b coaxially secured to the lead screw 202 for rotation therewith"; fig 12-13)
and each of the driving wheels at least cooperates with one of the at least one driving ends.
Mahoney: (fig 12-13, show interaction of pawls with gears to advance drug delivery)
However, Mahoney in view of Auld, and Redenbarger is silent regarding:
the driving module further comprises a rotating shaft,
However, Dilanni further teaches a drug delivery device
the driving module further comprises a rotating shaft,
(paragraph 36-38; drive engaging member 262, and its arms 264a 264b, incrementally rotate about the pivot point 162 in directions 20 22 to actuate wheel 258a 258b; fig 4-5)
the at least one driving end comprises at least two driving ends, (arms 264a 264b; fig 4-5)
and the at least one driving wheel comprises two driving wheels fixedly connected,
(paragraph 36+38; wheel 258a 258b are fixed to drive wheel 256 such that a rotation of wheel 258a or 258b has a consequent movement of drive wheel 256; fig 2)
and each of the driving wheels at least cooperates with one of the at least one driving ends.
(paragraph 38; arms 264a 264b individually cooperate with wheel 258a 258b respectively; fig 5)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the rotating driving member teachings of Dilanni to the driving module of Mahoney in view of Auld and Redenbarger in order to provide a control method for incrementally dispensing fluid out of the device (i.e. one pre-determined size unit at a time) while preventing counter-rotation of the 2nd driving unit, see paragraph 36-38 of Dilanni.
Regarding claim 14, Mahoney in view of Auld, Redenbarger, and Dilanni discloses
The drug infusion device with multiple infusion modes of claim 13, wherein, the first driving unit is disposed between the two driving wheels,
Mahoney: (fig 12, show cage 364 arching between gears 314a 314b)
and during operation, the first power unit and the second power unit alternately apply driving power to the first driving unit, making the first driving unit, in two directions of its reciprocating rotation, drive the driving wheels to rotate intermittently.
Mahoney: (paragraph 98+100+108; alternating charges are applied to portions 356 358 of shape memory element 350 to induce an advancing and resetting of pawls 346 348 with respect to gears 314a 314b, as demonstrated by the steps in fig 11, resulting in intermittent rotation of gears 314a 314b)
Examiner notes, that Dilanni similarly teaches the above claim limitations with its position of drive engaging member 262, wheel 258a 258b, and operation of SMA wire portions 260a 260b pulling drive engaging member 262 in direction 20 22, see Dilanni’s paragraph 34-36 & fig 4-5. Accordingly, the incorporation of Dilanni’s teachings in claim 13 above, continues to support the original disclosure of Mahoney relied upon for the above claim limitations.
Regarding claim 15, Mahoney in view of Auld, Redenbarger, and Dilanni discloses
The drug infusion device with multiple infusion modes of claim 12, wherein, when the at least one driving wheel cooperates with the two driving ends, front ends of the two driving ends are not level, making the two driving ends push the wheel teeth asynchronously.
Mahoney: (paragraph 107; pawls 376 378 are not equal length so as to push the gear 314 in partial increments; fig 14-15)
Regarding claim 19,
Mahoney in view of Auld, Redenbarger, and Dilanni discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Mahoney in view of Auld, Redenbarger, and Dilanni is silent on:
The drug infusion device with multiple infusion modes of claim 13, wherein when one of the driving wheels cooperates with the two driving ends, front ends of the two driving ends are not level, making the two driving ends push the wheel teeth asynchronously.
However, Mahoney further teaches a drug delivery device
wherein when one of the driving wheels cooperates with the two driving ends,
(paragraph 107; pawls 376 378 interacting with a single gear 314; fig 14)
front ends of the two driving ends are not level, making the two driving ends push the wheel teeth asynchronously.
(paragraph 107; pawls 376 378 are not equal length so as to push the gear 314 in half increments; fig 14-15)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multiple driving ends corresponding to a single driving wheel teachings of Mahoney’s further embodiment to the present embodiment of in view of Dilanni in order to arrive at a dispensing mechanism which can rotate the gear by less than a tooth pitch and therein improve accuracy of the device by providing less than one "pulse volume", see paragraph 107+84 of Mahoney.
Regarding claim 20,
Mahoney in view of Auld, Redenbarger, and Dilanni discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Mahoney in view of Auld, Redenbarger, and Dilanni is silent on:
The drug infusion device with multiple infusion modes of claim 14, wherein when one of the driving wheels cooperates with the two driving ends, front ends of the two driving ends are not level, making the two driving ends push the wheel teeth asynchronously.
However, Mahoney further teaches a drug delivery device
wherein when one of the driving wheels cooperates with the two driving ends,
(paragraph 107; pawls 376 378 interacting with a single gear 314; fig 14)
front ends of the two driving ends are not level, making the two driving ends push the wheel teeth asynchronously.
(paragraph 107; pawls 376 378 are not equal length so as to push the gear 314 in half increments; fig 14-15)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multiple driving ends corresponding to a single driving wheel teachings of Mahoney’s further embodiment to the present embodiment of Mahoney in view of Dilanni in order to arrive at a dispensing mechanism which can rotate the gear by less than a tooth pitch and therein improve accuracy of the device by providing less than one "pulse volume", see paragraph 107+84 of Mahoney.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mahoney in view of Auld, and Redenbarger as applied to claim 1 above, and further in view of US 20180055995 A1, henceforth written as Hanson.
Regarding Claim 16,
Mahoney in view of Auld, and Redenbarger discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Mahoney in view of Auld, and Redenbarger is silent regarding:
The drug infusion device with multiple infusion modes of claim 1, wherein, the driving module further comprises at least one auxiliary driving unit which is connected to and cooperated with the first driving unit or the second driving unit, and the first driving unit and the second driving unit cooperate with each other through the at least one auxiliary driving unit.
However, Hanson teaches a drug delivery mechanism
the driving module further comprises at least one auxiliary driving unit (balance wheel 566; fig 4)
which is connected to and cooperated with the first driving unit (lever 564; fig 4) or the second driving unit (gear train 510; fig 4),
and the first driving unit and the second driving unit cooperate with each other through the at least one auxiliary driving unit (paragraph 68-71; balance wheel 566 cooperate with lever 564 and gear train 510; fig 4).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply the gear train teachings of Hanson to the driving module of Mahoney in view of Auld, and Redenbarger in order to better regulate the dose delivery cycle, see paragraph 71-72 of Hanson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783