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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/06/2026 has been entered.
Status of the Claims
Claims 1, 3, 9-14, and 17 are currently amended. Claims 4-5 are cancelled. Claims 1-3 and 6-17 are currently pending. Claims 1-3 and 6-17 are currently rejected.
Response to Arguments
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive.
Applicant argues that the previous combination of art applied to claim 4 does not teach the limitation:
“wherein the multiple different movement amplitudes include controlling a magnitude of a power output of the power unit for rotating the driving unit in a first direction to a first position or rotating the driving unit in the first direction to a second position, wherein the first position is different from the second position”.
However, as previously noted, Takada teaches limiting the movement of a driving unit to different positions. In doing so, the driving unit achieves different movement amplitudes, and thus also outputs a different amount of power. Thus, the power transferred through the power unit and driving unit changes depending on the movement amplitude of the driving unit.
In response to applicant's argument that the Dilanni and Yang cannot utilize the mechanism of Takada, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Takada is depended on to teach multiple different movement amplitudes, which would be obviously incorporated into the existing mechanism of Dilanni and Yang without importing all the other components of Takada.
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:
“drug storage unit” in claim 1
The drug storage unit is interpreted in light of instant specification fig. 2 and pg. 12 para. 3 having a side wall, capable of containing a drug for injection, and capable of being pressurized to push the drug out of the drug storage unit, such as a cartridge, vial or equivalent structure.
“power unit” in claim 1
The power unit is interpreted in light of the instant specification pg. 14 para. 2 to be one or more pieces of a shape memory alloy or equivalent.
“driving unit” in claim 1
The driving unit is interpreted in light of the instant specification pg. 11 para. 4 to have at least two driving arms.
“program unit” in claims 1 and 15-17
The program unit is interpreted in light of the instant specification to be a structure including at least a transmitter/receiver for sending signals, in light of pg. 12 para. 1, and a processor/controller in light of pg. 27 para. 3-4.
“detection unit” in claims 15-17
The detection unit is interpreted in light of the instant specification pg. 27 para 2 to be a continuous glucose monitor.
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.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 6-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al (CN 101208515 A; hereafter Dilanni) in view of Yang (CN 106139311 A; hereafter Yang) and further in view of Mahoney et al (US 20030199824 A1; hereafter Mahoney) and Takada et al (JP 2006132580 A; hereafter Takada). Text references for Dilanni, Yang, and Takada are made to the previously included Espacenet English translations.
Regarding claim 1, Dilanni discloses a bilaterally driven intelligent control infusion device, comprising:
an infusion unit, the infusion unit comprises a drug storage unit (see 112f interpretation above; fluid reservoir 230, fig. 11, [0037]), a piston (piston 236, fig. 2 and 3, [0037]) and a rigid screw (threaded drive rod 252, fig. 2 and 3, [0037]), the piston (236) is arranged in the drug storage unit (230) ([0037] plunger 236 is housed in the fluid reservoir 230, see fig. 10);
a driving wheel (drive wheel 256, fig. 2, [0037]), provided with wheel teeth (see fig. 2, fig. 5, [0038] drive wheel 256 includes first and second ratchet portions 258a, 258b; [0041] teeth present on the ratchet portions 258a, 258b), drives the rigid screw (252) to move by rotation, the rigid screw (252) advances the piston (236) to move ([0037] the drive wheel 256 is threadably engaged to the threaded drive rod 252 and imparts linear motion to the threaded drive rod 252 to advance the plunger 236 into the reservoir 230, see figs. 2 and 3);
a driving unit (rotatable drive engagement member 262, fig. 2 and fig. 5, [0039]; see 112f interpretation above, note that member 262 has two arms) cooperating with the driving wheel (256, see fig. 5 which shows cooperation, and fig. 13 which shows a detailed view of the contact);
a power unit (see 112f interpretation above; shape memory alloy wire with SMA wire portions 260a/b, fig. 2, [0039]), connected to the driving unit (262, see fig. 2 which shows connections), outputs forces in two different directions on the driving unit to lead driving unit (262, fig. 5) to pivot ([0043] SMA wire portion 260a causes the rotatable drive engagement member 262 to rotate in a first direction 20, see fig. 5; [0044] SMA wire portion 260b causes the rotatable drive engagement member 262 to rotate in a second direction 22, see fig. 5).
Dilanni is silent to a metal piece arranged on the piston, a position detector, and a program unit.
Yang, in the field of drug delivery systems, teaches a metal piece (metal key 6’, fig. 5, [0042]) arranged on the piston (piston 3, fig. 5, [0042]), fixedly connected to the rigid screw (screw rod 4, fig. 5, [0039] screw rod 4 is directly connected to the piston 3 and drives it to advance in the drug storage cartridge 2);
a position detector (five position sensors 5a, 5b, 5c, 5d, and 5e form a sensor array; fig. 5, [0042]), interacting with the metal piece (6’) to generate a signal ([0042] the position sensors 5a-e sense the changes in electric field due to the movement of the metal piece 6’),
and converts the signal into a position information of the piston ([0042] the position sensors 5a-e sense the changes in electric field due to the movement of the metal piece 6’ to calculate the position of the piston 3).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Dilanni to include the piston position monitoring taught by Yang since both references deal with fluid injection via a screw rod advancing a piston through a reservoir. One would have been motivated to make the modification because, as taught by Yang [0016], monitoring the position of the piston in real-time can help detect infusion abnormalities.
Dilanni and Yang are silent to a program unit. Examiner notes that Dilanni [0034] does mention a circuit board 290 having control circuits for controlling the device and [0033] notes a variable flow rate.
Mahoney, in the art of a dispenser for patient infusion, teaches a program unit (local processor 50, fig. 2, [0059]; see 112f interpretation above note [0059] discloses the processor 50 sending and receiving signals), connected to the infusion unit (dispenser 40, reservoir 30, and exit port assembly 70, fig. 2, [0059]), and controls the driving unit (dispenser 40, fig. 2, [0059]) to operate with a different infusion rate according to requirements ([0059] local processor 50 is programmed to cause a flow of fluid to the exit port assembly 70 based on flow instructions from a separate, remote control device 100; [0060] local processor 50 includes an adjustable programmed flow rate),
wherein the driving unit perform a multiple-mode operation, making the infusion device have multiple infusion increments or infusion rates ([0084] Various flow rates are achieved by adjusting the time between charges),
wherein the multiple-mode operation of the driving unit includes multiple different movement rates in a unit time ([0084] Various flow rates are achieved by adjusting the time between charges; Examiner notes that more frequent charges would cause more frequent oscillation and thus an overall faster movement rate over a period of time.)
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the program unit of Mahoney to the device of Dilanni and Yang, and to have the program unit do the signal conversion taught by Yang, since Dilanni, Yang, and Mahoney all deal with infusion systems with electronic components. One would have been motivated to make the modification because controlling the flow rate allows for more specialized treatment for each patient/situation. Additionally, it would have been obvious to have the program unit of Mahoney perform the signal conversion taught by Yang since the sensors of Yang would need to be connected to a processor of some sort to be useful, and one would have been motivated to make this modification because it would allow the program unit to not only control but also verify the piston movement, ensuring successful infusion or error recognition.
Dilanni, Yang, and Mahoney are silent to the multiple-mode operation of the driving unit including different movement amplitudes in a unit time, wherein the multiple different movement amplitudes include controlling a magnitude of a power output of the power unit for rotating the driving unit in a first direction to a first position or rotating the driving unit in the first direction to a second position, wherein the first position is different from the second position.
Takada, in the art of ratchets driven by pawls, teaches wherein the multiple-mode operation of the driving unit (swing arm 2b, fig. 4, [0071]) includes multiple different movement amplitudes ([0071] forward swing limit position of the swing arm 2b can also be adjusted by the eccentric shaft 29b) in a unit time (Examiner notes that the adjustment must take place in a unit of time, and no specific unit or range of time is specified by the claim language.), wherein the multiple different movement amplitudes include controlling a magnitude of a power output of the power unit for rotating the driving unit in a first direction to a first position or rotating the driving unit in the first direction to a second position, wherein the first position is different from the second position ([0033] Eccentric shafts 29a and 29b are provided on the frame 5 as stoppers for restricting the limit positions of the forward swing of the swing arms 2a and 2b (see FIG. 4).; note that moving the limit position would change the movement amplitude from moving to a first position to moving to a second, different position; Examiner further notes that the magnitude of power output by the power unit would depend on the movement amplitude, and thus Takada teaches this limitation.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Dilanni modified by Yang and Mahoney to include the adjustable stoppers limiting rotational motion of the driving unit as taught by Takada since Takada also deals with a driving mechanism using pawls to push a ratchet wheel forward. One would have been motivated to make the modification because the adjustable stoppers of Takada allow for the drive system to be tuned specifically to achieve the correct extent of motion, even if other parts may be replaced later, thus improving the versatility and possible uses of the device.
Regarding claim 2, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 1, as described above. Dilanni further discloses wherein the rigid screw (252, fig. 2) is a metal screw ([0038] drive rod 252 is preferably made of metal or plastic). Dilanni modified by Yang and Mahoney, as applied to claim 1 above, disclose the metal piece (Yang: metal key 6’, fig. 5) is electrically connected with the metal screw (Yang: screw rod 4, fig. 5; Dilanni: [0038] drive rod 252 is metal; Examiner notes that since the screw and piece are in contact and both metal, they are electrically connected.), so that the metal piece (Yang: 6’) and the position detector (Yang: note sensors 5a-3, fig. 5) constitute a capacitor (Yang: [0042] the position sensor is a capacitive sensor), and a linear movement of the metal piece causes a change in capacitance making the position detector generate a signal, wherein the signal is an electrical signal (Yang: [0042] displacement of piston and metal key 6’ causes changes in electric field which the position sensors sense and then calculate the actual displacement of the piston 3; note that as modified the program unit of Mahoney does the calculation).
Regarding claim 3, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 1, as described above.
Dilanni and Mahoney are silent to the metal piece being magnetic and the position detectors being magnetic induction detectors.
Yang further teaches an alternate embodiment wherein the metal piece is a magnetic metal piece ([0039] magnet sheet 6 is embedded in a groove on the piston 3), and the position detector is a magnetic induction detector ([0039] position sensors 5a and 5b are magnetic sensors), a linear movement of the magnetic metal piece causes a change in a magnetic field around the position detector making the position detector generate the signal, wherein the signal is a magnetic signal ([0039] each position sensor senses the change in the magnetic field caused by the displacement of the piston 3 and then calculates the actual displacement of the piston 3).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to substitute the magnetic metal and the magnetic sensors taught by Yang since this would be a simple substitution of one known, equivalent element for another to obtain predictable results, as shown by Yang which presents the capacitive and inductive sensors as alternatives in [0042].
Regarding claim 6, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 1, as described above. Dilanni further discloses further comprising: a pivot shaft (pivot point 162, fig. 4, [0041]), and the driving unit (rotatable drive engagement member 262, fig. 2 and fig. 5, [0039]) includes at least two driving arms ([0041] rotatable drive engagement member 262 includes arms 264a, 264b that engage teeth on the ratchet portions 258a, 258b), and the driving unit (262) pivots around the pivot shaft (162) to drive the driving arms (264a/b) to move ([0043] driving arms 264a/b move when driving unit 262 is rotated).
Regarding claim 7, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 6, as described above. Dilanni further discloses wherein the driving wheel (drive wheel 256; see fig. 2, fig. 5) includes at least two sub-wheels ([0038] drive wheel 256 includes first and second ratchet portions 258a, 258b), and the driving arms (264a/b, fig. 5) rotate the driving wheel (256) by engaging the wheel teeth ([0041] arms 264a, 264b that engage teeth on the ratchet portions 258a, 258b and progressively rotate the drive wheel 256 as the rotatable drive engagement member 262 is rotated).
Regarding claim 8, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 7, as described above. Dilanni further discloses wherein the pivot shaft (pivot point 162, fig. 4) is disposed between the two sub-wheels (see fig. 4 which shows pivot point 162 between the two arms 264a/b; see fig. 5 which shows that each arm lines up with one of the two sub wheels 258a/b), one or more of the driving arms (264a/b, fig. 5) are respectively disposed on both sides of the driving unit (262, fig. 2 and fig. 5; fig. 5 shows that at least one driving arm 264a/b is on each side of the driving unit 262), and each sub-wheel (258a/b) cooperates with at least one driving arm (264a/b) ([0043] the arm 264a engages the teeth on the ratchet portion 258a; [0044] arm 264b engages the teeth on the ratchet portion 258b).
Regarding claim 9, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 8, as described above, including wherein one of the multiple different movement amplitudes (Takada: [0033] Eccentric shafts 29a and 29b are provided on the frame 5 as stoppers for restricting the limit positions of the forward swing of the swing arms 2a and 2b (see FIG. 4); Dilanni: [0043] engagement of arm 264a with ratchet portion 258a causing the drive wheel 256 to rotate one increment) corresponds to one kind of pivot mode of the driving unit (Dilanni: [0043] rotation of drive unit 262 in the first direction 20), and the driving unit (Dilanni: 262, fig. 5), pivoting in various pivot modes (Dilanni: [0043] driving unit 262 is rotated in first direction 20; [0044] driving unit 262 is rotated in second direction 22, see fig. 5), drives the driving arm (Dilanni: 264a/b, fig. 5) to rotate the driving wheel (Dilanni: 256, fig. 5) to implement increment-adjustable infusion (Dilanni: [0043] When the rotatable drive engagement member 262 is rotated in the first direction 20, the arm 264a engages the teeth on the ratchet portion 258a, thereby causing the drive wheel 256 to rotate one increment.), and each increment-adjustable infusion corresponds to one of the multiple infusion increments (Dilanni: [0045] each increment of the drive wheel 256 causes the plunger in the reservoir 230 to be advanced to cause a respective amount of fluid to be dispensed).
Regarding claim 10, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 9, as described above. Dilanni further discloses wherein the various pivot modes of the driving unit (262, fig. 5) include: after pivoting one or more steps in the first direction (first direction 20, fig. 5) in a single time, the driving unit (262) starts pivoting one or more steps in a second direction (second direction 22, fig. 5) until the end of the pivot in the second direction, the driving unit completes an alternate pivot (Examiner notes that driving unit 262 alternates pivoting in the first and second directions.) in both of the first and second direction to perform multiple-mode driving on the driving wheel (256, fig. 5) ([0043] driving unit 262 rotates in first direction 20 and causes advancement of drive wheel 256; [0044] driving unit 262 rotates in second direction 22 and causes advancement of drive wheel 256).
Regarding claim 11, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 10, as described above. Dilanni further discloses wherein the wheel teeth are ratchet teeth ([0041] teeth are located on the ratchet portions 258a, 258b; Examiner notes that since the teeth are part of ratchet portions 258a/b, the teeth are ratchet teeth.).
Dilanni and Yang are silent to the driving unit pivoting and stopping multiple times while rotating in one direction.
Mahoney further teaches during a whole process of the driving unit pivoting in one of the first direction and the second direction, the driving unit (cam 274, fig. 14, [0107]) alternately pivots and stops for multiple times to drive the driving arms (first pawl 376 and second pawl 378, fig. 14, [0107]) to alternately engage and stop engaging the ratchet teeth ([0107] both pawls 376 and 378 rotate the gear 314 in the first rotational direction “C”, first and second pawls 376/378 have different lengths such that pivotal movement of the cam 374 in the first pivotal direction "A" produces less than a tooth pitch of gear 314 advancement), so that the driving wheel alternately rotates and stops rotation ([0111] fixed pawl assembly 380 prevents rotation opposite to the direction “C”) to perform the multiple-mode driving on the driving wheel ([0107] difference in the lengths of the first and the second pawls 376, 378 are less than a single tooth pitch of the gear 314; Examiner notes that the driving wheel is pushed by both first and second pawls 326/328, but not at the same time as seen in fig. 14 and known because the pawls differ by less than a single tooth pitch of the gear 314 as noted in [0107], and [0111] notes fixed pawl assembly 380 prevents reverse rotation by less than a single tooth pitch, so the wheel would rotate under the separate successive action of both pawls 376/378 and would stop in between, not advanced by either pawl but not allowed to reverse by pawl assembly 380).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device of Dilanni, Yang, Mahoney, and Takada to include the alternate motion in the same rotation direction as taught by Mahoney, using more than one pawl which differs by less than a tooth length, since Mahoney teaches this arrangement as an additional embodiment of a dispensing mechanism for a similar device. One would have been motivated to make the modification because using more than one pawl differing in length by less than a tooth length allows for very fine dispensing, allowing for even smaller increments of fluid to be delivered without needing a wheel with smaller teeth, which may, as noted in Mahoney [0094], increase the costs of the gear due to the small tolerances involved.
Regarding claim 12, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 11, as described above. Dilanni further discloses wherein when the driving unit (262, fig. 5) drives the driving wheel (256, fig. 5), at least one of the driving arms (264a/b, fig. 5) on one side of the driving unit (264a) engages the wheel teeth ([0043] When the rotatable drive engagement member 262 is rotated in the first direction 20, the arm 264a engages the teeth on the ratchet portion 258a), while the driving arm (264b) on a different side of the driving unit (262) slide on the wheel teeth ([0043] one of the arms 264a or 264b is always engaged by the toothed portion of the drive wheel; Examiner notes that when arm 264a pushes on the wheel tooth, the other arm 264b is not actively pushing the wheel tooth.).
Dilanni and Yang are silent to the driving arm sliding on the wheel teeth.
Mahoney further teaches wherein the driving arm slides on the wheel teeth ([0087] the moveable pawl and the teeth are shaped to slide over each other as the moveable pawl 222 moves past the gear 214 in the second direction).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to have the driving arm, when not pushing the wheel teeth (moving in the first direction of Mahoney), slide over the wheel teeth (moving in the second direction of Mahoney) as taught by Mahoney since Mahoney teaches a drive mechanism for infusion using pawls and a shape memory element much like Dilanni. One would have been motivated to make the modification because allowing the pawls to slide along the wheel teeth ensures that close proximity to the wheel is maintained which may help to prevent unwanted back-rotation of the wheel.
Regarding claim 13, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 12, including wherein the driving wheel stops rotating when the driving arm is sliding on a surface of the wheel teeth (Mahoney, see [0107] and [0111]; Examiner notes that the driving wheel is pushed by both first and second pawls 326/328, but not at the same time as seen in fig. 14 and known because the pawls differ by less than a single tooth pitch of the gear 314 as noted in [0107], and [0111] notes fixed pawl assembly 380 prevents reverse rotation by less than a single tooth pitch, so the wheel would rotate under the separate successive action of both pawls 376/378 and would stop in between, not advanced by either pawl but not allowed to reverse by pawl assembly 380, due to the length difference of the first and second pawls 326/328).
Dilanni discloses further including a base (chassis 100, fig. 9, [0038]) on which the driving wheel (256, fig. 5) is movably assembled ([0038] driving wheel 256 is rotatably supported by the chassis 100), and the base (100) and the driving wheel (256) are frictionally fit ([0038] bearing surfaces 158a-c of chassis 100 support hub 254 of drive wheel 256; Examiner notes that since these are bearing surfaces, thus in contact with the hub 254, these pieces must be in frictional engagement and thus have a frictional fit.).
Regarding claim 14, Dilanni modified by Yang, Mahoney, and Takada discloses the bilaterally driven intelligent control infusion device of claim 13, as described above, including wherein the driving wheel stops rotating when all of the driving arms are sliding on the surface of the wheel teeth (Mahoney, see [0107] which discusses driving arms/pawls 326/328 and [0111] which discusses fixed pawl assembly 380; Examiner notes that the driving wheel is pushed by both first and second pawls 326/328, but not at the same time as seen in fig. 14 and known because the pawls differ by less than a single tooth pitch of the gear 314 as noted in [0107], and [0111] notes fixed pawl assembly 380 prevents reverse rotation by less than a single tooth pitch, so the wheel would rotate under the separate successive action of both pawls 376/378 and would stop in between, not advanced by either pawl but not allowed to reverse by pawl assembly 380, due to the length difference of the first and second pawls 326/328. When no arms are pushing the driving wheel forward, or arms are only sliding on the driving wheel, then the wheel would stop rotating.)
Dilanni discloses further including a position limited member (tilt nut 242, fig. 11a/b, [0053]) which is movably assembled ([0053] open/tilted potion shown in fig. 11a, closed position shown in fig. 11b, tilt nut 242 is movable between an open and closed position) on the base (chassis 100, fig. 9 and 10, fig. 12a-c shows that tilt nut 242 is assembled on base/chassis 100) to limit the position of the driving wheel (256, fig. 12a-c), and the position limited member (242, fig. 12b) and the driving wheel (256, fig. 12b) are frictionally fit ([0053] tilt nut 242 is held in the drive wheel 256 by part of the chassis and by a tilt nut clamp 1201, an exploded view of which is shown in fig. 12a; Since the tilt nut is contacts the drive wheel 256, the two have a frictional fit and the tilt nut 242 necessarily limits the position of the drive wheel 256.).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni modified by Yang, Mahoney, and Takada as applied to claim 1 above, and further in view of Moberg et al (US 20080051710 A1; hereafter Moberg) and O’Connor (US 20100081993 A1; O’Connor).
Regarding claim 15, Dilanni modified by Yang, Mahoney, and Takada discloses a closed-loop artificial pancreas, comprising: the bilaterally driven intelligent control infusion device according to claim 1 (see 103 rejection of claim 1 over Dilanni modified by Yang, Mahoney, and Takada as described above).
Dilanni, Yang, Mahoney, and Takada are silent to a detection unit.
Moberg, in the art of infusion pumps secured to a user’s skin, teaches a detection unit (sensing device 14, fig. 1, fig. 2, fig. 7, [0072]; see 112f interpretation above), configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) detect blood glucose continuously ([0074] the sensing device 14 may include electronics and enzymes reactive to a biological condition, such as a blood glucose level), connected with the program unit (electronic circuitry 17, fig. 7; see 112f interpretation above; [0124] electronic circuitry 17 may control motor 84 to deliver a desired infusion program and may receive signals from external systems; Examiner notes that electronic circuitry 17 of Moberg meets the 112f limitations of processing and transmitting/receiving information, but Moberg’s electronic circuitry 17 is only being used to teach the relative location of the processor 50 of Dilanni, Yang, and Mahoney as applied to claim 1 above, not replace the processor 50) and infusion unit (drive device 80, fig. 7, fig. 5c) of the infusion device ([0123] the drive device 80 and electronic circuitry 17 are housed or contained within the durable housing 30).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Dilanni as modified to include the detection unit of Moberg, since Moberg also deals with an infusion unit. One would have been motivated to make the modification because monitoring the blood glucose of a patient increases the safety of the device by allowing the user to keep track of their current blood glucose and trends over time.
Dilanni, Yang, Mahoney, Takada, and Moberg are silent to the detection unit being a continuous glucose monitor (see 112f interpretation above).
O’Connor, in the art of wearable medical devices, teaches wherein a detection unit is a continuous glucose monitor ([0042] devices other than a blood glucose meter could be used, such as a continuous glucose monitor).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the detection unit of Dilanni as modified to be a continuous glucose monitor as taught by O’Connor since O’Connor is also in the art of wearable drug delivery devices and also teaches a pump communicating with a detection unit ([0042]). One would have been motivated to make the modification because continuously monitoring the glucose levels of the patient would help ensure that no potentially harmful hypo- or hyper-glycemic events go unaddressed.
Regarding claim 16, Dilanni modified by Yang, Mahoney, Takada, and Moberg discloses the closed-loop artificial pancreas of claim 15, as described above.
Moberg further teaches wherein any two of the detection unit (sensing device 14, fig. 2; see 112f interpretation above, note that as described in claim 15, the detection unit is modified to be a continuous glucose monitor as taught by O’Connor), the program unit (electronic circuitry 17, fig. 7; see 112f interpretation above) and the infusion unit (drive device 80, fig. 5c) are connected to each other configured to form a single structure ([0123] the drive device 80 and electronic circuitry 17 are housed or contained within the durable housing 30) whose attached position on a user’s skin is different from a remaining one of the detection unit, the program unit, and the infusion unit (sensing device 14, fig. 1) ([0074] sensing device 14 may be secured to the body 5 of the user 7 or embedded in the body 5 of the user 7 at a location that is remote from the location at which the delivery device 12 is secured to the body 5 of the user 7, see fig. 1 and 2 which show that the sensing device 14 is located at a different location than the device 12 which includes the durable housing 30).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to arrange the units as taught by Moberg, since Moberg teaches all three of a detection unit, program unit, and infusion unit. One would have been motivated to make the modification because locating the units separately since the program unit controls the infusion unit and locating the detection unit at an alternate location may help the blood glucose level recorded by the detection unit to not be overly influenced by any spikes in insulin level which may occur nearer to the infusion unit point.
Regarding claim 17, Dilanni modified by Yang, Mahoney, Takada, and Moberg discloses the closed-loop artificial pancreas of claim 15, wherein the detection unit (sensing device 14, fig. 2; see 112f interpretation above; note that as described in claim 15, the detection unit is modified to be a continuous glucose monitor as taught by O’Connor), the program unit (electronic circuitry 17, fig. 7; see 112f interpretation above) and the infusion unit (drive device 80, fig. 5c) are connected together configured to form a single structure which is attached on only one position on a user’s skin ([0074] the sensing device 14 may be incorporated within the delivery device 12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to arrange the units as taught by Moberg, since Moberg teaches all three of a detection unit, program unit, and infusion unit. One would have been motivated to make the modification to have all the units located together in the delivery device 12 because this would make the device less cumbersome for a patient since they would only have needles in one location, which would also decrease the area of skin which may be damaged by the needles.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/10/2026