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 8/18/2025. As directed by the amendment: Claim 1 has been amended, thus, claims 1-5 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 8/18/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the independent claims on page 6-9:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"wherein when the power unit pulls the driving unit with force, the driving unit rotates in the driving direction around the rotating shaft, at this time, the rebound unit is pressed by the driving unit to generate a gradually increasing elastic force, when the power unit stops providing power and under the action of the elastic force, the driving unit rotates around the rotating shaft in the returning direction, at this time, the driving wheel stops rotating, the driving portions slide on the surface of the wheel teeth synchronously, and driving direction and the returning direction are reverse."
Applicant's arguments particularly regard the claimed rebound unit, its functions, and its interactions with other claimed structures and the manner by which a shape memory alloy of the prior art of Dilanni and Mahoney cannot be considered a rebound unit in the presently amended claims.
See examiner's rejection as necessitated by the amendment which details the prior art not previously relied upon which discloses/teaches the claimed rebound unit.
Regarding applicant’s argument regarding dependent claims on page 9:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner’s discussion above, and examiner's rejection as necessitated by the amendment, below, detailing the prior art relied upon with discloses/teaches the limitations of the presently amended claims.
Claim Interpretation
Regarding claim 1:
“power unit…[cooperates with rebound unit] to apply force to the driving unit to rotate the driving unit”, emphasis added to highlight the claim limitation in question.
“rebound unit …[cooperates with rebound unit] to apply force to the driving unit to rotate the 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:
power unit
From applicant’s specification: "The power unit 180 is a linear actuator. In the embodiment of the present invention, the power unit 180 is an electrically driven linear actuator or an electrically heated linear actuator…. the power unit 180 may be other types, eg. mini-airbag, etc.."
rebound unit
From applicant’s specification: "In the embodiment of the present invention, the rebound unit 170 is a spring. In other embodiments of the present invention, the rebound unit 170 can also be an elastic piece, an elastic plate, an elastic rod, etc. The type and material selection of the rebound unit 170 are not specifically limited herein, as long as it can satisfy the condition of making the driving unit 150 rotate in the return direction. "
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 § 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.
Claim 1-5 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.
Regarding claim 1
The term “gradually increasing” in claim 1 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, the rate at which elastic force is increased by the driving unit pressing on the rebound unit is rendered indefinite.
Regarding claims 2-5
The aforementioned claims are at least rejected for being dependent upon the rejected indefinite independent claim 1.
Claim Rejections - 35 USC § 103
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20050238507 A1, henceforth written as Dilanni, in view of CN 106139311 A, henceforth written as Yang, US 20030199824 A1, henceforth written as Mahoney, Machinery’s Handbook 27th edition’s chapter on Ratchet Gearing, henceforth written as Machinery’s Handbook, and US 20030199825 A1, henceforth written as Flaherty.
Regarding Claim 1,
Dilanni discloses:
A miniature patch-type intelligent control infusion device, comprising an infusion unit, comprising:
(fluid delivery device 200; fig 1)
a drug storage unit, --
(reservoir 230; fig 1)
--a piston
(plunger 236; fig 2+5)
and a rigid screw,
(paragraph 33; threaded drive rod 252 ; fig 2+5)
wherein the piston is arranged in the drug storage unit; --
(paragraph 32)
--a rotating shaft,
(pivot point 162; fig 4 )
a driving unit
(rotatable drive engaging member 262; fig 4-5)
and a driving wheel provided with wheel teeth,
(paragraph 36; first ratchet wheel 258a has teeth (not enumerated) ; fig 1-5)
wherein the driving unit comprises a driving portion,
(paragraph 38; contact surface (not enumerated) of arm 264a for mating with teeth (not enumerated) of ratchet wheel 258a; fig 4)
the driving unit rotates around the rotating shaft in a driving direction and a returning direction,
(paragraph 36; member 262 reciprocally pivots about point 162, either toward direction 20 or toward direction 22; fig 4-5)
when rotating in the driving direction, one driving portion -- push the wheel teeth to rotate the driving wheel -- which engages the rigid screw to move forward in a non-rotating way, --
(paragraph 32-33+36-38; when member 262 is pulled in direction 20 its arm 264a drives ratchet wheel 258a to rotate drive wheel 256 and consequently advance drive rod 252; fig 1-4)
--and a power unit --
(SMA wire portion 260a; fig 5)
wherein the power unit -- apply force to the driving unit to rotate the driving unit; --
(paragraph 33-34+36-38; portion 260a is charged and consequently contracts to rotate member 262 toward direction 20; fig 5)
--an infusion needle, wherein one end of the infusion needle is in communication with an outlet of the drug storage unit, and the other end of the infusion needle pierces a skin surface to achieve drug infusion;--
(paragraph 31; transcutaneous access tool 272 fluidically communicates a pierced patient and reservoir 230; fig 1)
wherein the rotating shaft is perpendicular to a rotating axis of the driving wheel,
(fig 2-5 illustrates that pivot point 162 is perpendicular to a rotating axis of wheel 256)
wherein after a completion of the [driving portion rotating in the driving direction], the -- driving portion slides for a distance in the returning direction along the rotating shaft
(paragraph 36-38; arm 264a rotating in a returning direction disengages from wheel 258a, therein sliding in a return direction along axis of the pivot point 162; fig 2-5)
wherein when the power unit pulls the driving unit with force, the driving unit rotates in the driving direction around the rotating shaft, at this time-- when the power unit stops providing power --the driving unit rotates around the rotating shaft in the returning direction, at this time, the driving wheel stops rotating, the driving portions slide on the surface of the wheel teeth synchronously, and driving direction and the returning direction are reverse.
(paragraph 32-33+36-38; when portion 260a is charged it consequently contracts in length to pull member 262 toward direction 20 around pivot point 162 and have member 262’s arm 264a drive ratchet wheel 258a to rotate drive wheel 256; fig 1-4; paragraph 38, upon member 262 having rotated in this driving direction, its leg 268b contacts contact point 164b, which communicates a signal to the electronic controller that the charge applied to portion 260a should be disabled, consequently returning member 262 to a neutral home position, without allowing further rotation of ratchet wheel 258a, and thus rotating in a returning direction toward direction 22; examiner notes that rotating in a returning direction to the member 262’s home position does not necessitate the activation/charging of Dilanni’s additional second wire portion 260b)
Dilanni discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a metal piece, -- the metal piece, fixedly connected to the rigid screw, is arranged on the piston;-- at least one position detector, wherein the metal piece and the position detector interact to generate signals;
However, Yang teaches a drug delivery system with position detecting unit:
a metal piece, (magnet sheet 6; fig 1-2+4)
the metal piece, fixedly connected to the rigid screw, is arranged on the piston;
(magnet sheet 6 is embedded on the piston 3, and fixed to screw 4 such that a linear displacement of screw 4 has a consequent movement of detecting part 6; fig 1-2+4)
at least one position detector, (sensors 5a-b; fig 1-2+4)
wherein the metal piece and the position detector interact to generate signals;
(paragraph 34; linear movement of piston 3, to include magnet sheet 6, results in a change of magnetic field(s) around position sensor 5a-b and consequently a corresponding signal is produced tracking injection progress)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the piston position detection teachings of Yang to the disclosure of Dilanni in order to advantageously cooperate multiple sensors to determine a real piston displacement tracking injection progress in a more accurate and reliable manner, see paragraph 34 of Yang.
The modified device of Dilanni in view of Yang teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
wherein the driving unit comprises two driving portions, -- when rotating in the driving direction, one driving portion of the two driving portions or another one driving portion of the two driving portions to push the wheel teeth to rotate the driving wheel or both of the one driving portion and the another one driving portion to alternately push the wheel teeth to rotate the driving wheel which engages the rigid screw to move forward in a non-rotating way, when rotating in the returning direction, all of the driving portions of the driving unit slide synchronously on a surface of the wheel teeth; -- wherein vertical projections of front ends of any two of the two driving portions on the driving unit do not coincide, the driving unit is provided with the two driving portions, and the two driving portions are matched with the driving wheel, if the distance, in a pushing direction, between the vertical projections of the front ends of two adjacent ones of the driving portions is t1,and a tooth pitch is T,
wherein after a completion of the one or the another one of the two driving portions --pushing a tooth of the wheel teeth to rotate along the rotating axis --, the two driving portions slides for a distance in the returning direction
Notably, Mahoney teaches drive mechanism for a patient infusion device:
wherein the driving unit comprises two driving portions, --
(paragraph 107; cam 374 includes first pawl 376 and second pawl 378; fig 14)
--when rotating in the driving direction, one driving portion of the two driving portions or another one driving portion of the two driving portions to push the wheel teeth to rotate the driving wheel or both of the one driving portion and the another one driving portion to alternately push the wheel teeth to rotate the driving wheel which engages the rigid screw to move forward in a non-rotating way,
(paragraph 106-107; when pawls 376 378 move in direction A, they individually and alternately rotate the gear 314; fig 14)
when rotating in the returning direction, all of the driving portions of the driving unit slide synchronously on a surface of the wheel teeth;
(paragraph 107; when pawls 376 378 move in direction B, they do not rotate, therein sliding over synchronously, the gear 314; fig 14)
-- wherein vertical projections of front ends of any two of the two driving portions on the driving unit do not coincide,
(see fig 14)
the driving unit is provided with the two driving portions, and the two driving portions are matched with the driving wheel, if the distance, in a pushing direction, between the vertical projections of the front ends of two adjacent ones of the driving portions is t1,and a tooth pitch is T, then t1 is some proportion of T.
(paragraph 107; a difference in length of pawls 376 378 in the pushing direction A, is less than a single tooth pitch, such the claimed t1 is less than the claimed T; examiner further notes in paragraph 103 that a distinct embodiment’s pawls 346 348 gear engaging surfaces are out of phase, therein having a difference in a pushing direction, of a single tooth pitch, the claimed T.)
wherein after a completion of the one or the another one of the two driving portions --pushing a tooth of the wheel teeth to rotate along the rotating axis --, the two driving portions slides for a distance in the returning direction
(paragraph 107; after moving in direction A where 376 378 push the wheel teach, the pawls 376 378 move in direction B, the returning direction, and slide synchronously over the gear 314; fig 14)
Further, it would be similarly obvious to implement the multiple driving portions having different lengths for engaging a singular drive wheel’s teeth as taught by Mahoney to the driving portion of Dilanni, by duplicating each tip of arm 264a and 264b of Dilanni which engages with a respective wheel 258a 258b of Dilanni such that each tip is offset for engaging with the matched wheel in the manner taught by Mahoney, therein arriving at a pair of claimed driving portions engaging and disengaging with a Dilanni’s driving wheel, ratchet wheel 258a, in the claimed manner, in order to advantageously arrive at an injection gear drive which can provide a finer actuation cycle, and therein deliver finer amounts of media per actuation and consequently improve the accuracy and variability of the invention’s fluid injection rate, see paragraph 103+107 of Mahoney.
The modified device of Dilanni in view of Yang and Mahoney teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
if the distance, in a pushing direction, between the vertical projections of the front ends of two adjacent ones of the driving portions is t1,and a tooth pitch is T, then t1 = 3T/2
However, Machinery’s Handbook teaches result effective variables impacting the rotary relationship between pawls and gears on pages 2119-2120 that by positioning “a number of driving pawls side byside (mating with a ratchet wheel) and proportioning their lengths according to the pitch of the teeth, a very fine feed can be obtained”.
Examiner notes as taught by Machinery’s handbook, a multiple pawl to single gear system is not always limited to pawls having a distance therebetween less than a tooth pitch in order to achieve such a fine feed result. As an example, where there are four pawls, A, B, C, and D and each of their mating surfaces are separated by a half tooth pitch from the nearest pawl mating surface, the furthest separated pawls, e.g. A and D, will be separated by 1.5 tooth pitches and the pawl system will be capable of the same intermittent rotary motion as another pawl-gear system with only two pawls that are likewise separated by a half tooth pitch.
Further, it would be similarly obvious to routinely optimize the driving portion lengths of the modified device of Dilanni in view of Yang and Mahoney by incorporating Machinery’s Handbook’s teachings of varying different driving portion lengths relative to a tooth pitch to effect a gear rotation feed rate, in order to advantageously arrive at an injection gear drive which can provide a finer actuation cycle, and therein deliver finer amounts of media per actuation and consequently improve the accuracy and variability of the invention’s fluid injection rate, see page 2296-2297 of Machinery’s handbook.
The modified device of Dilanni in view of Yang, Mahoney, and Machinery’s Handbook teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
an adhesive patch, wherein the adhesive patch attaches the infusion unit to the skin surface,
However, Mahoney further teaches a patient infusion device including:
an adhesive patch, wherein the adhesive patch attaches the infusion unit to the skin surface,
(paragraph 70; device 10 provided with an adhesive layer (not enumerated/illustrated) on the housing 20)
Further, it would be similarly obvious to implement the adhesive patch taught by Mahoney to the modified invention in order to adhere the device to a patient, as it is an art recognized means for making the invention portable and therein improving a patient’s capacity to adhere to infusion recommendations while ambulating, see MPEP 2144.04(V)(A), paragraph 70 of Mahoney, and paragraph 4-6 of Dilanni.
The modified device of Dilanni in view of Yang, Mahoney, and Machinery’s Handbook teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
a rebound unit, --
wherein the power unit and the rebound unit cooperate with each other to apply force to the driving unit to rotate the driving unit; --
wherein when the power unit pulls the driving unit with force, the driving unit [moves] in the driving direction --the rebound unit is [biased] by the driving unit to generate a gradually increasing elastic force, when the power unit stops providing power and under the action of the elastic force, the driving unit [moves] in the returning direction, at this time, the driving wheel stops rotating
However, Flaherty further teaches a patient infusion device including:
a rebound unit,
(spring 248; fig 7-9)
wherein the power unit and the rebound unit cooperate with each other to apply force to the driving unit to rotate the driving unit; wherein when the power unit pulls the driving unit with force, the driving unit [moves] in the driving direction --the rebound unit is [biased] by the driving unit to generate a gradually increasing elastic force, when the power unit stops providing power and under the action of the elastic force, the driving unit [moves] in the returning direction, at this time, the driving wheel stops rotating, --and driving direction and the returning direction are reverse.
(paragraph 61-66; when shape memory element 246 is charged, it contracts to resist the bias of spring 248 and rotate wheel 244 in a first direction to advance screw 202 and dispense medicament, and when charge is removed from element 246 the spring 248 rotates wheel 244 in the opposing direction; fig 7-9)
Examiner also notes Flaherty also discloses an equivalent means for rotating a ratchet wheel comprising opposing shape memory elements 290 268 in fig 13-15, as opposed to a shape memory element opposing a spring as demonstrated in fig 7-9.
Further, it would be similarly obvious to apply Flaherty’s teachings of utilizing a spring to return a rotating body to a home position in an opposite direction as the direction of actuation by a charged/contracted shape memory wire acting on the rotating body to the presently modified invention, by disposing multiple of Flaherty’s spring 248 to be biased by the contraction of Dilanni’s shape memory portions 260ab and return member 262 to a home position after a charge of the shape memory element is removed and therein disposing Flaherty’s rebound unit in the claimed configuration with Dilanni’s drive unit and drive wheel, in order to advantageously arrive at an invention which combines linear actuator equivalents know for the same purpose of biasing a rotating member to and from a neutral rotation position, see MPEP 2144.06(I).
The modified device of Dilanni in view of Yang, Mahoney, Machinery’s Handbook, and Flaherty teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
the rebound unit is pressed by the driving unit to generate a gradually increasing elastic force
However, Flaherty further teaches a patient infusion device including:
the rebound unit is pressed by the driving unit to generate a gradually increasing elastic force
(paragraph 72-77; charging of shape memory element 308 contracts element 308 and likewise contracts spring 310, therein pressing rather than pulling on the spring, such that by disable the charge on element 308 permits spring 310 to bias an actuating body in a direction opposite the contraction direction of element 308; fig 16-19)
Further, it would be similarly obvious to apply Flaherty’s teachings of varying spring direction and type (i.e. compression vs tension) relative to a shape memory element to the rebound unit of the presently modified invention, by disposing Flaherty’s spring in a position that is pressed/compressed by the contraction of Dilanni’s shape memory portion being charged and therein arriving at the claimed invention, as a manner of substituting equivalent means known for the same purpose of biasing a rotating body with a spring against the contraction of a shape memory element, see MPEP 2144.06(II).
Regarding claim 2,
Dilanni in view of Yang, Mahoney, Machinery’s Handbook, and Flaherty 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:
wherein, the rigid screw is a metal screw,
(Dilanni: paragraph 33; rod 252 is made of metal)
However, Dilanni in view of Yang, Mahoney, Machinery’s Handbook and Flaherty is silent regarding:
the metal piece is electrically connected with the metal screw, so that the metal piece and the position detector constitute a capacitor, and an linear movement of the metal piece causes a change in capacitance making the position detector generate an electrical signal of the signals.
However, Yang further teaches an alternative embodiment of its drug delivery system with position detecting unit:
the metal piece (paragraph 37; metal key 6'; fig 5) is electrically connected with the metal screw (screw 4; fig 5),
Note, in present combination screw 4 of Yang is replaced by the rigid metal screw 202 of Mahoney, therein an electrically conductive screw. As metal key 6’ has an electrical charge, see paragraph 37 of Yang, the physical connection to screw 4 of Yang and like-wise to rigid metal screw 202 of Mahoney will constitute a type of electrical connection.
so that the metal piece and the position detector constitute a capacitor,
(paragraph 37; position sensor 5a-d is a capacitive sensor for detecting electric field of metal key 6'; fig 5)
and an linear movement of the metal piece causes a change in capacitance making the position detector generate an electrical signal of the signals.
(paragraph 37, "the metal key 6 has an associated electric field, electric field change caused by each position sensor sensing piston 3 displacement"; 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 replace the magnetic position detector of Yang with capacitance position detector further taught by Yang in order to arrive at a modified infusion device which is “more accurate and reliable” as it does not rely on common electrical fields which can face more interference phenomena, see paragraph 37 of Yang.
Regarding claim 3, Dilanni in view of Yang, Mahoney, Machinery’s Handbook and Flaherty teaches:
wherein, the metal piece is a magnetic metal piece,
Yang: (magnet sheet 6; fig 1-4)
the at least one position detector comprises position detectors,
Yang: (position sensors 5a-b; fig 1-4)
and each of the position detectors is magnetic induction detector,
Yang: (paragraph 34, "each position sensor sensing piston 3 displacement caused by the change of the magnetic field", consequently position sensors 5a-b detect magnetic inductance)
an linear movement of the magnetic metal piece causes a change in a magnetic field around each of the position detectors to make each of the position detectors generate a magnetic signal of the signals.
Yang: (paragraph 34; linear movement of piston 3, to include magnet sheet 6, results in a change of magnetic field(s) around position sensor 5a-b and consequently a corresponding signal is produced)
Regarding claim 4, Dilanni in view of Yang, Mahoney, Machinery’s Handbook and Flaherty discloses:
The miniature patch-type intelligent control infusion device of claim 1, wherein, the infusion unit further includes a clutch structure movably disposed on the driving wheel,
Dilanni: (fig 11, shows thread engaging mechanism 240 movably disposed on driving wheel 256)
the rigid screw passes through the clutch structure,
Dilanni: (fig 11 shows drive rod 252 passing through thread engaging mechanism 240)
and the clutch structure is provided with an internal thread that cooperates with the rigid screw,
Dilanni: (thread engaging mechanism 240 has threaded areas 244a-b engaging screw drive rod 252; fig 11)
the driving wheel drives the clutch structure to rotate which, with the internal thread, pushes the rigid screw to move forward in a non-rotating way.
Dilanni: (paragraph 47-49; O-shaped ring 501 provides enough anti-rotation friction which along with thread engaging mechanism cause drive rod 252 and plunger 236 to move forward, linearly, in reservoir 230 in a non-rotating manner; fig 5+11-12)
Regarding claim 5, Dilanni in view of Yang, Mahoney, Machinery’s Handbook and Flaherty discloses:
The miniature patch-type intelligent control infusion device of claim 1, wherein, the infusion unit further includes a blocking wall, and the driving unit stops rotating upon contacting the blocking wall.
Dilanni: (paragraph 36-37; points 164ab, therein a blocking wall, stop member 262 from rotating upon being contacted by its legs 268ab; fig 4)
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.
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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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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783