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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “automated drug microinjection pump”, “smart injector”, “electrical components”, “electrical boards”, “battery”, “built-in cartridge magnet”, “metal ring” of claim 1; “two medical-grade plastic”, “one medical-grade metal ring”, “the electrical components”, “electrical boards (PCBs)” of claim 2; “built-in magnet diaphragm pump cartridge”, “the diaphragm pump” of claim 3; “a circle, oval, or square shape steel plate”, “a built-in magnet plate” of claim 4; “disposable cartridge” of claim 5; “latches, clamps, cam locks, screws, magnets, adhesive, and others” of claim 6; “the actuating button”, “the automated drug microinjection pump” of claim 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "10" and "16" have both been used to designate “support needle hub” in at least P[026].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claims 1-18 are directed to “Automated drug mircoinjeciton pump with wireless communication and method of use” however, the content of the claims appear to be directed to a device. Examiner suggests amending the preamble to read “An automated drug microinjection pump device” or similar to clarify claims 1-18 are directed to a device/apparatus.
Claim 19 is directed to “Automated drug mircoinjeciton pump with wireless communication and method of use” however, the content of the claims appear to be directed to a method of use. Examiner suggests amending the preamble to read “A method for using the device of claim 1” or similar to clarify claim 19 is directed to a method of use.
Claim 7 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot reference two sets of claims to different features (i.e. the device of claim 1 and the sealing method of claims 4, 5, and/or 6). See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Claims 8-16 recite the phrase “the capacity of X ml”, the phrase should be written as “a capacity of X ml”.
Appropriate correction is required.
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.
Claims 1-19 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 1 recites the limitation "a disposable diaphragm micropump technology" in lines 3-4. It is unclear what is being claimed due to the awkward phrasing. Further, it is unclear is the limitation is claiming a disposable diaphragm micropump, or, some unknown portion of, or all of a “technology” associated with a disposable diaphragm mircopump. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “a disposable diaphragm micropump”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
Claim 1 recites the limitation "tablet-shaped housing with perimeter, oval, circular and or semi-circular" in line 5. It is unclear what is being claimed due to the awkward phrasing. Further, it is unclear how the housing and/or perimeter can be oval circular and semi-circular shaped. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “tablet-shaped housing with a perimeter that is oval, circular or semi-circular”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
Claim 1 recites the limitations "the main part", “the second part”, “the disposable part”, “their components”, “these two parts” in lines 6-8, and “the invention” in the last line. There is insufficient antecedent basis for these limitation in the claim.
Claim 1 recites the limitation "it has a built-in rubber gasket" in lines 10-11. It unclear to what feature “it” refers, rendering the claim indefinite. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “the disposable part has a built-in rubber gasket”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
Regarding claim 1, the phrase "as an" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As such, it is not clear if “o-ring” is required as part of the claimed invention.
Claims 2-18 are also indefinite by virtue of their dependency on Claim 1.
Claim 2 recites the limitation "the main part (A) is a controller and includes two medical-grade plastic, one medical-grade metal ring" in lines 3-4. It is unclear what is being claimed due to the awkward phrasing. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “the main part (A) is a controller and includes medical-grade plastic, one medical-grade metal ring”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
Claim 2 recites the limitation "called main part (A) is autonomous…called main part (A) also comprises…" in lines 5-6. It is unclear what is being claimed due to the awkward phrasing. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “the main part (A) is autonomous…the main part (A) also comprises”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
Claim 2 recites the limitation "the connections" in line 8. There is insufficient antecedent basis for these limitation in the claim. Further, it is unclear the which connection the limitation is referring, rendering the claim indefinite.
Claim 3 recites the limitations "their respective actuating rods", and “the spring body” in the last two lines. There is insufficient antecedent basis for these limitation in the claim. Further, it is unclear to what feature “their” is referring to, rendering the claim indefinite.
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 contains the trademark/trade names “Bluetooth”, “Zigbee”, and “OpenThread”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a wireless communication protocol and, accordingly, the identification/description is indefinite.
The term “more secure communication” in claim 18 is a relative term which renders the claim indefinite. The term “more secure communication” 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.
Claim 19 recites the limitations "the device", “the actuating button”, “the needle”, “the automated drug microinjection pump”, and “the hand”. There is insufficient antecedent basis for these limitation in the claim.
Claim 19 recites the phrase “fingers/thumb/user” , “button/needle”, and “audible/visual” in the claim. It is unclear if the Markush grouping are intended to be “and/or”, “and” or “or” options, rendering the claim indefinite. For examination purposes, as best understood by the Examiner in view of the specification, the limitation will be interpreted as “fingers, thumb, and/or user”, “button and/or needle”, and “audible and/or visual”. Examiner suggest amending the limitation as such to overcome the indefiniteness issues.
The terms “easy push motion”, “ergonomic and easy to do for all ages”, “small force required”, “strong position” and “comfortable for fingers/thumb/user” in claim 19 is a relative term which renders the claim indefinite. The terms are 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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 6, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 20090275896), hereinafter: “Kamen”.
In Regard to Claim 1
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the automated drug microinjection pump with wireless communication is an automatic device(Fig 11A; ; P[0162]-P[0165]) with a disposable diaphragm micropump technology(disposable housing 114, 404, 504, 804; P[0007], P[0139]-P[0141]; P[0328]-P[0346]; P[0356-P[0362]; Fig 1-4, 9, 16-23) wherein the device is an automatic smart injector(Fig 11A; ; P[0162]-P[0165]), it has a tablet-shaped housing with a perimeter, the perimeter being oval, circular and/or semi-circular(Fig 1-4, 16, 34A), this housing divided into two parts:
the main part(112,402,502,802) that includes electrical components(110,816), electrical boards(830), battery(832), and a diaphragm pump actuator(104, 812) and their components(P[0135]-P[0137]; P[0357]-P[0362]) and
the second part is the disposable part(114,404,504,804), wherein these two parts are attached together with one or more mechanisms, a built-in cartridge magnet and/or a metal ring that rotates 90 degrees to press and fix these two parts(P[0335]-P[0336]; P[0357]-P[0358]; P[0364]), and also, it has a built-in rubber gasket(150,970), as an o-ring(“o-ring”, P[0157],P[0335]), in order to make the invention sealed and waterproof(P[0157], P0335], P[0378]; Fig 3, 48).
In Regard to Claim 2
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 1(see rejection of claim 1 above), wherein the main part is a controller(112,402,502,802 includes electrical control assemblies 110,816; P[0135]-P[0136], P[0359], P[0360]) and includes medical-grade plastic(P[0134]), one medical- grade metal ring(P[0329]-P[0331]), the electrical components, electrical boards, battery, on-off switch(824; P[0361]) and diaphragm pump actuator;
wherein the main part is autonomous for three days and then is charged wirelessly or wired(P[0144], P[0313], P[0362]); wherein the main part also comprises a top part(806,318; Fig 3, 36) with an outer casing(820,122) and a bottom casing(120,818) to connect with a disposable part(114,404,504,804) through a main seal ring(150,970) that provides the connections as well as pressure for waterproofing(P[0157], P0335], P[0378]; Fig 3, 48).
In Regard to Claim 5
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 2(see rejection of claim 2 above), wherein the main seal ring securely attaches a disposable cartridge(114,404,504,804; P[0157], P0335], P[0378]; Fig 3, 48), an easy turning motion using thread has been deployed(interpreted as intended result; however, as a turning motion is indicated by 512 in Fig 16); this uses the principle of a ramp to apply large amounts of downward force on the gasket/waterproofing seal, with a small user force required(interpreted as intended result; however, a thread or “screw-on” connection uses the principle of a ramp to apply force; P[0336]).
The limitation “an easy turning motion using thread has been deployed; this uses the principle of a ramp to apply large amounts of downward force on the gasket/waterproofing seal, with a small user force required” is construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Additionally, the limitations “an easy turning motion using thread”, “ramp”, “downward force” and “user force” are not positively recited by the claim. Since, Kamen teaches all required structure for the claim, Kamen anticipates the claim as written.
In Regard to Claim 6
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 1(see rejection of claim 1 above), wherein the device is able to present other ways that could be used to generate the closing force to attach the reusable side of the unit with the disposable cartridge, these could be latches, clamps, cam locks, screws, magnets, adhesive, and others(the device is “able” to use a variety of closing configurations, including “screw-on”, “twist-lock”, “compression-fit”, P[0140],P[0157], P[0335], P[0364], P[0378]; Fig 3, 48).
Additionally, the limitations “latches, clamps, cam locks, screws, magnets, adhesive, and others” are not positively recited by the claim. Since, Kamen teaches all required structure for the claim, Kamen anticipates the claim as written.
In Regard to Claim 17
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 1(see rejection of claim 1 above), wherein the device holds: a wireless communication(P[0162]-P[0165]), using an NFC tag to establish wireless communication with the device by simply touching the device of claim 1.
The limitation “using an NFC tag to establish wireless communication with the device by simply touching the device of claim 1” is construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Additionally, the limitation “NFC tag” is not positively recited by the claim. Since, Kamen teaches all required structure for the claim, Kamen anticipates the claim as written.
In Regard to Claim 18
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 1(see rejection of claim 1 above), wherein the device, for more secure communication an end-to-end encryption method has been applied for transferring data (Fig 11A; P[0162]-P[0165]).
The limitations “for more secure communication” and “for transferring data” are construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
In Regard to Claim 19
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method for using the device, wherein the actuating button(506; P[0335]-P[0338]) and activation method to insert the needle for the automated drug microinjection pump with wireless communication, comprises: a button with easy push motion(506; P[0335]-P[0338]), with an ergonomic and easy to do for all ages squeeze/push motion where there is a small force required, as it is a strong position for the hand, and is comfortable for fingers/thumb/user, the motion does not interrupt waterproofing, still is waterproof before and after activation due to two o-rings on the button activation rods(P[0335]), having a lock to hold button/needle in place until to release and an audible/visual sign to user that it is activated correctly, or warning if is not activated(P[0305]-P[0308]); after activated by the button the needle is spring loaded with one motion by the user to press the button, the needle will be inserted automatically(P[0345]-P[0350]).
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.
Claim(s) 3-4 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen et al. (US 20120209199), hereinafter: “Kamen ‘199”.
In Regard to Claim 3
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 1(see rejection of claim 1 above), wherein the second part is the disposable part(114,404,504,804; Fig 34A-34B) that includes a built-in magnet diaphragm pump cartridge(P[0335]-P[0336]; P[0357]-P[0358]; P[0364]) comprises a drug container(118,908) which is made of medical-grade silicone(P[0142]), micro-needle(13; P[0158]) made of medical grade stainless steel or silicone and a support needle hub(136; P[0146]) made of medical-grade plastic, called micro-needle connected to the drug container by a medicine/drug tube(140), made of medical-grade stainless steel or silicone, and a medical-grade stainless steel tubing, including an input tubing(Fig 21) and an output tubing(Fig 21) which connects the diaphragm pump to the needle hub(Fig 21) and the medical-grade silicone drug container(Fig 21);
Kamen fails to teach:
called needle hub support actuator comprises a double side torsion spring with their respective actuating rods located in the spring body
Kamen ‘199 teaches:
An analogous automated drug microinjection pump having a needle hub support actuator(5100) comprising a double sided torsion spring(5360,5390) with respective actuating rods(5330,5380) located in the spring body(Fig 91A-91C).
It is obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143(A). The MPEP states the prior art must: (1) teach each claimed element (a method or apparatus that will be modified), (2) show that one of ordinary skill in the art could have combined the elements by known methods and that the combination doesn’t change the function of the elements, and (3) show that one of ordinary skill would have recognized that applying the known technique to the base device would yield predictable results. See MPEP 2143(A).
In this case, Kamen teaches all elements except the “needle hub support actuator comprises a double side torsion spring with their respective actuating rods located in the spring body”. Kamen ‘199 teaches a needle hub support actuator comprising a double sided torsion spring with respective actuating rods located in the spring body, which has the function of providing the force necessary for insertion of an infusion device. When combined into Kamen at the support needle hub, it maintains its function of providing the force necessary for insertion of the infusion device. One of ordinary skill would expect predictable results because both references pertain to automated drug microinjection device that function in the same manner in the environment of drug delivery systems.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kamen in view of the teachings of Kamen ‘199 because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Kamen in view of Kamen’-199 fails to explicitly teach:
The micro-needle made of medical grade stainless steel or silicone;
a support needle hub made of medical-grade plastic;
a medicine/drug tube made of medical-grade stainless steel or silicone; and
a medical-grade stainless steel tubing
Official Notice is taken that constructing various components of automated drug microinjection systems of medical grade stainless steel, silicone and/or plastic is old and well established in the business of drug delivery systems and is asserted to be a well-known expedient or common knowledge by those of skill in drug delivery system art for their use in maintaining biocompatibility, sterilizability and/or chemical resistance. Further, use of which is capable of instant and unquestionable demonstration as being well-known so as to defy dispute as demonstrated by the art of record. MPEP 2144. It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to provide a micro-needle made of medical grade stainless steel or silicone; a support needle hub made of medical-grade plastic; a medicine/drug tube made of medical-grade stainless steel or silicone; and a medical-grade stainless steel tubing for the purposes of maintaining biocompatibility, sterilizability and/or chemical resistance.
In Regard to Claim 4
Kamen teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 2(see rejection of claim 2 above), wherein in the device, a circle shape plate has been deployed in the main part(104,504,818 is a circular shaped plate; Fig 3); a built-in magnet plate deployed in the disposable part(P[0335]-P[0336]; P[0357]-P[0358]; P[0363]-P[0365]);
The limitations “using a built-in magnet and stainless-steel plates make parts (A) and (B) indivisible; in order to separate two parts (A) and (B), an external force should be applied” are construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Kamen fails to teach:
The plate being constructed of “steel”
Kamen ‘199 teaches:
An analogous automated drug microinjection pump having a housing made of steel(P[0382]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kamen to incorporate the teachings of Kamen ‘199 to use steel to construct the plate as Kamen ‘199 teaches the use of a “steel” is a known material suitable for making housing components in infusion devices. It would have been obvious to one having ordinary skill in the art at the time of the invention to have selected a “steel” because it is merely the selection of an art known material suitable for the construction of a plate for an infusion device. In further support of this position, the selection of a known material to make a plate prior to the invention was held to be obvious see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
In Regard to Claims 8-11
Kamen in view of Kamen ‘199 teaches:
An automated drug microinjection pump(100,300,500, 800) with wireless communication(Fig 11A; P[0162]-P[0165]) and method of use, the device according to claim 3(see rejection of claim 3 above),
wherein the drug container has the capacity of 1 ml(max capacity of 3mL; P[0383] of Kamen).
wherein the drug container has the capacity of 1.5 ml(max capacity of 3mL; P[0383] of Kamen).
wherein the drug container has the capacity of 2 ml(max capacity of 3mL; P[0383] of Kamen).
wherein the drug container has the capacity of 2.5 ml(max capacity of 3mL; P[0383] of Kamen).
wherein the drug container has the capacity of 3 ml(max capacity of 3mL; P[0383] of Kamen).
Kamen further teaches “reservoir 118 may be any size or shape and may be adapted to hold any amount of insulin or other infusible fluid” in P[0144].
Kamen in view of Kamen ‘199 fails to teach:
wherein the drug container has the capacity of 3.5 ml of claim 13
wherein the drug container has the capacity of 4 ml of claim 14
wherein the drug container has the capacity of 4.5 ml of claim 15
wherein the drug container has the capacity of 5 ml of claim 16
The overall capacity of the drug container would depend on the size of the housing, the size of the casing, and the size of the drug container itself. A larger capacity corresponds to a longer supply window for the user. The overall capacity may also depend on the type of infusible fluid in the drug container. Therefore the capacity of the drug container affects the number of days a sufficient supply of infusible fluid can be maintained. Further, the size of the of drug container affect the type of infusible fluid which may be suitable for use. A larger capacity results in a longer supply window and a broader range of infusible fluids suitable for use in the device.
The Court has held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Syst., Inc., 725 F.2d 1338 220 USPQ 777 (Fed. Cir. 1984), see MPEP §2144.04 IV A for further clarification).
In Gardner v TEC Syst., Inc., Gardner received a patent for an apparatus used to dry ink applied to high-gloss papers by supporting the paper with wet ink over a field of static air. The applied prior art taught the claimed apparatus except for dimensional limitations. The trial Court held the opinion that the dimensional limitations had no impact on the function of the apparatus and no evidence was shown that departing from the claimed dimensions would cause the apparatus to fail.
In the instant case, Kamen in view of Kamen ‘199 teaches a drug container max capacity of 3mL and notes the drug container may be any size or shape and may be adapted to hold any amount of insulin or other infusible fluid
The examiner notes that paragraphs 15, 17, 26 and 28 of the applicant’s specification refers to the various capacities of the drug container, however, there is not an explanation of criticality for any particular capacity or an explanation for the size and scale of the smart injector.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kamen in view of Kamen ‘199 to have a drug container with a capacity of 3.5, 4, 4.5 or 5 mL in view of case law for the purpose of being able extend the supply window and use a broader range of infusible fluids in the device depending on the size and scale of the smart injector and its components.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure
US 20110021993 A1
Bar-Haim; Avraham et al.
US 20140194819 A1
Maule; Susie E. et al.
US 8231609 B2
Pang; Changlin et al.
US 11324881 B2
Larson; Eric Allan et al.
US 11286921 B2
Gray; Larry B.
US 8267921 B2
Yodfat; Ofer et al.
US 12023465 B2
Constantineau; Cole et al.
US 8303574 B2
Gray; Larry B. et al.
The above references are cited for teaching smart injection devices similar to the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN P WOLCOTT whose telephone number is (571)272-9837. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Court D. Heinle can be reached at (571) 270-3508. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN P WOLCOTT/ Primary Examiner, Art Unit 3745