DETAILED ACTION
Status
Claims 1-5,7, and 17-28 are pending. Claims 1-5,7 and 17-19 are amended. Claims 6 and 8-16 are cancelled. Claims 20-28 are new.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on the references as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claims have changed substantially which has necessitated the new grounds of rejection.
Regarding Examiner’s official notice with respect to claims 9 and 13, as Applicant has not adequately traversed examiner’s assertion of official notice, the examiner notes that the common knowledge or well-known in the art statement is taken to be admitted prior art in accordance with MPEP 2144.03. Examiner notes to adequately traverse a finding based on official notice, an applicant must specifically point out the supposed errors in the examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A mere request by the applicant that the examiner provide documentary evidence in support of an officially-noticed fact is not a proper traversal. As Applicant has failed to specifically point out the supposed errors or give reasons as to why the noticed fact is not considered to be common knowledge or well-known in the art the traversal is insufficient.
Election/Restrictions
Newly submitted claims 25 and 28 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 25 is directed to “A system comprising the automated drug microinjection pump device of claim 1” having additional features (“an external user device comprising a smartphone or smartwatch…includes software that uses artificial intelligence…”) not previously claimed whereas Claims 1-18, as originally filed, were directed to “Automated drug microinjection pump with wireless communication and method of use” wherein, the content of the claims were directed to a pump device/apparatus.
Claim 19 as originally filed was directed to “Automated drug microinjection pump with wireless communication and method of use” wherein, the content of the claim were directed to a method of use.
Claim 28 is directed to “A disposable cartridge (B) for use with an automated drug microinjection pump device” whereas Claims 1-18, as originally filed, were directed to “Automated drug microinjection pump with wireless communication and method of use” wherein, the content of the claims were directed to a pump device/apparatus.
Claim 19 as originally filed was directed to “Automated drug microinjection pump with wireless communication and method of use” wherein, the content of the claim were directed to a method of use.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 28 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The amendment filed 5/1/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
In Claims 1 and 19, “a single diaphragm pump actuator and devoid of additional pumps” is a negative limitation and is not sufficiently supported by the original disclosure.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, and 17-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 19 recite the limitation, “a single diaphragm pump actuator and devoid of additional pumps”.
The specification, however, is silent regarding the automated drug microinjection pump device having a single diaphragm pump actuator, and does not explicitly state the automated drug microinjection pump device is devoid of additional pumps. Therefore, the specification does not sufficiently support the limitation. Further, this limitation is a negative limitation. Any negative limitation or exclusionary provision must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i).
Therefore, the above amended limitations add new matter and fail to comply with the written description requirement, because there is no support in the disclosure as originally filed for the amended limitations.
Claims 2-5, 7, 17-18 and 20-27 also contain new matter by virtue of their dependency on Claims 1 or 19.
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, 17-18 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 20120209199), hereinafter: “Kamen”.
In Regard to Claim 1
Kamen teaches:
An automated drug microinjection pump device(10), the device comprising:
a device housing comprising a reusable main part (X; Fig 66, 77; P[0377]) and a disposable part (Y; Fig 66, 77; P[0377]) releasably attached to the reusable main part(P[0420]-P[0428]);
the reusable main part comprising:
a single diaphragm pump actuator(16; P[0014], P[0237]-P[0238]) and devoid of additional pumps(the reusable main part appears to be devoid of additional pumps); and
an actuating button(5110; P[0300]-P[0303]; P[0450]);
the disposable part comprising;
a drug container(20; P[0370]);
a microneedle(5010) disposed within the disposable part(Fig 64C-Fig 65A; Fig 67; Fig 77) and configured to be deployed through a bottom surface of the device housing(at 5030) directly into subcutaneous tissue of a user(P[0390-0398]); P[0420-0431]);
a support needle hub(5040, 5100) coupled to the microneedle(Fig 77), wherein the support needle hub includes a needle actuator(5100) fixedly integrated within the disposable part(via 5070), the needle actuator comprising:
a double-sided torsion spring(5360,5390) having associated actuating rods(5330,5380) located in a spring body(Fig 91A-91C), the needle actuator being configured to deploy the microneedle through the bottom surface of the device housing upon actuation by the actuating button(P[0450]);
a medicine tube(310) connecting the drug container to the microneedle(Fig 3; P[0238]);
an input tubing that fluidly connects the drug container to the diaphragm pump actuator(visually apparent in Fig 3); and
an output tubing that fluidly connects the diaphragm pump actuator to the microneedle via the medicine tube to define a fluid path extending from the drug container to the microneedle(visually apparent in Fig 3), the fluid path being entirely contained within the device housing(visually apparent in Fig 64D, 67F).
In Regard to Claim 17
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the device further comprises:
a wireless transceiver configured to communicate using at least one wireless communication protocol compliant with IEEE 802.15.1 or IEEE 802.15.4 wireless standards(Bluetooth is IEEE 802.15.1 compliant; P[0489]); and
a near-field communication(NFC) transceiver configured to establish a wireless communication link with an external user device upon proximity contact with the device(the communications transceiver is configured to establish a wireless communication link with an external device up to about 30 feet away; P[0489]).
The limitation “configured to communicate using at least one wireless communication protocol compliant with…” and “configured to establish a wireless communication link with…” 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 “at least one wireless communication protocol compliant with IEEE 802.15.1 or IEEE 802.15.4 wireless standards”, “a wireless communication link” and “an external device” 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 18
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the device employs end-to-end encryption
The limitation “employs end-to-end encryption
Additionally, the limitations “end-to-end encryption”, “wireless data transfer” and “an external user device” 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 21
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the diaphragm pump actuator is configured to meter and deliver a dose of medication from the drug container through the microneedle at a controlled rate(16; P[0014], P[0237]-P[0238]) determined by software running on at least one electrical board.
The limitation “determined by software running on at least one electrical board” 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 “software” and “at least one electrical board” 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 22
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the microneedle is spring-loaded by the double-sided torsion spring such that upon actuation, the microneedle is deployed through the bottom surface of the device housing for direct subcutaneous insertion into the user(P[0390-0398]); P[0420-0431]; P[0450]-P[0455]).
In Regard to Claim 23
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the device is configured to be worn on a user's body(via 3100; P[0392]), and the medication dosage is calculated by software embedded in an external user device that communicates wirelessly with the device(P[0481]), the device using artificial intelligence to optimize drug treatment based on the user's personal medication dosing ratios.
The limitation “the medication dosage is calculated by software embedded in an external user device that communicates wirelessly with the device, the device using artificial intelligence to optimize drug treatment based on the user's personal medication dosing ratios” 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 “the medication dosage”, “software”, “an external user device”, “artificial intelligence”, “drug treatment”, and “the user’s personal medication dosing ratios” are not positively recited by the claim. Since, Kamen teaches all required structure for the claim, Kamen anticipates the claim as written.
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) 2, 4, 5, 7, 20 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen et al. (US 20090275896), hereinafter: “Kamen ‘896”.
In Regard to Claim 2
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above), wherein the main part is a controller(501; P[0014], P[0022], P[0024], P[0041-0042], P[0240]) and is configured to operate autonomously on battery power and to be charged wirelessly or by wired connection(P[0014], P[0022], P[0024], P[0041-0042], P[0240]); and
the main part further comprises a top part with an outer casing(main part X has a top part/portion with an outer casing) and a bottom casing(main part X has a bottom part/portion with a casing that connects to the disposable part Y), the bottom casing being configured to connect with the disposable part(Fig 66, 77; P[0377])
Kamen fails to teach:
The bottom casing configured to connect with the disposable part through a main seal ring that provides both a structural connection and a pressure seal for waterproofing.
Kamen ‘896 teaches:
An analogous automated drug microinjection pump having a top part with a bottom casing configured to connect with the disposable part through a main seal ring(150,970) that provides both a structural connection and a pressure seal for waterproofing(P[0157]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kamen to incorporate the teachings of Kamen ‘896 to provide a main seal ring between the reusable housing and the disposable housing assemblies to enable the user to wear the device while swimming, bathing or exercising(P[0157]).
In Regard to Claim 4
Kamen in view of Kamen ‘896 teaches:
The device according to claim 2(see rejection of claim 2 above)
Kamen also fails to teach:
wherein medical-grade steel material of the reusable main part and built-in magnetic material of the disposable part cooperate to releasably hold the reusable main part and the disposable part together, such that an external force is required to separate the reusable main part from the disposable part
Kamen ‘896 also teaches:
An analogous automated drug microinjection pump having a reusable main part(102) and a disposable part(104) with built in magnetic material(844) cooperate to releasably hold the reusable main part and the disposable part together(P[0364]-P[0365]), such that an external force is required to separate the reusable main part from the disposable part(an external gripping/twisting force is required to separate 102 and 104; P[0364]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kamen to incorporate the teachings of Kamen ‘896 to provide magnetic material in the disposable part to help ensure the housings are properly engaged with one another and the device is in a closed position(P[0364]).
In Regard to Claim 5
Kamen in view of Kamen ‘896 teaches:
The device according to claim 2(see rejection of claim 2 above)
Kamen also fails to teach:
wherein the main seal ring
Kamen ‘896 teaches:
An analogous automated drug microinjection pump having a reusable main part(102) and a disposable part(104) wherein the main seal ring comprises a built-in rubber gasket(150,970; “o-ring”, P[0157],P[0335]) and securely attaches the disposable part to the reusable main part using threaded engagement that applies a downward compressive force on the built-in rubber gasket through a turning motion(a thread or “screw-on” connection uses the principle of a ramp to apply a downward compressive force on the built-in rubber gasket by turning 102 and 104 relative to one another; P[0336]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kamen to incorporate the teachings of Kamen ‘896 to provide a main seal ring with a built-in rubber gasket between the reusable housing and the disposable housing assemblies to provide a releasable waterproof seal(P[0335], P[0336]).
The limitation “securely attaches the disposable part to the reusable main part using threaded engagement that applies a downward compressive force on the built-in rubber gasket through a turning motion” 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 “threaded engagement”, “downward compressive force” and “a turning motion” are not positively recited by the claim. Since, Kamen in view Kamen ‘896 teaches all required structure for the claim, the claim as written is obvious over Kamen in view of Kamen ‘896 for reasons stated above.
In Regard to Claim 7
Kamen in view of Kamen ‘896 teaches:
The device according to claim 5(see rejection of claim 2 above), wherein the built-in rubber gasket
Official Notice is taken that constructing an o-ring with a cross-sectional shape selected from the group consisting of: circle, triangle, oval and square is old and well established in the business of mechanical seals and is asserted to be a well-known expedient or common knowledge by those of skill in mechanical seal art for their use in sealing against oil, air, and/or water. 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 an o-ring with a circle, triangle, oval or square cross-section to seal against oil, air, and/or water.
In Regard to Claim 20
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above)
Kamen fails to teach:
wherein the drug container has a capacity in a range of 1 mL to 5 mL
Kamen ‘896 further teaches:
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 ‘896 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 ‘896 fails to teach:
wherein the drug container has the capacity of 3-5 ml
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 ‘896 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 ‘896 to have a drug container with a capacity of 1-5 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.
In Regard to Claim 24
Kamen in view of Kamen ‘896 teaches:
The device according to claim 5(see rejection of claim 2 above), wherein the turning motion comprises an approximately 90-degree rotation to engage the threaded connection between the reusable main part and the disposable part(a thread or “screw-on” connection is made by turning 102 and 104 relative to one another at least approximately 90 degrees to enable sufficient engagement of the threads; P[0336]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of AAPA (Applicant Admitted Prior Art).
In Regard to Claim 3
Kamen teaches:
The device according to claim 1(see rejection of claim 1 above),
Kamen fails to explicitly teach:
wherein the drug container is made of medical-grade silicone, the micro-needle is made of medical grade stainless steel or silicone, the support needle hub is made of medical-grade plastic, the medicine tube is made of medical-grade stainless steel or silicone, the input tubing and the output tubing are made of medical-grade stainless steel tubing.
However, Official Notice was taken (now AAPA, see response to arguments above) 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 drug container is made of medical-grade silicone, the micro-needle is made of medical grade stainless steel or silicone, the support needle hub is made of medical-grade plastic, the medicine tube is made of medical-grade stainless steel or silicone, the input tubing and the output tubing are made of medical-grade stainless steel tubing for the purposes of maintaining biocompatibility, sterilizability and/or chemical resistance.
Allowable Subject Matter
Claim 19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) and/or 112(b), set forth in this Office action.
Regarding Claim 19
Kamen teaches:
A method for operating an automated drug microinjection pump device(10), the device comprising a single diaphragm pump actuator(16; P[0014], P[0237]-P[0238]) and devoid of additional pumps(the reusable main part appears to be devoid of additional pumps), and wherein the method comprises:
releasably attaching(P[0420-P[0434]) a disposable part(Y; Fig 66, 77; P[0377]) of the device to a reusable main part(X; Fig 66, 77; P[0377]) of the device to define a fluid path(310; Fig 3; P[0238]) extending from a drug container(20; P[0370]) to a microneedle(5010), the fluid path being entirely contained within a device housing of the device(visually apparent in Fig 64D, 67F);
attaching the device to a user's body(via 3100; P[0392]); and
pressing an actuating button(5110; P[0300]-P[0303]; P[0450]) on the device in a single press motion to actuate a needle actuator(5100) fixedly integrated within the disposable part(via 5070), wherein actuating the needle actuator causes a double-sided torsion spring to deploy the microneedle through the bottom surface of the device housing and into the user's subcutaneous tissue(P[0390-0398]); P[0420-0431]; P[0450]-P[0455]),
wherein an audible or /visual indicator signals to the user whether actuation has occurred(P[0043], P[0207], P[0418]).
However, Kamen fails to teach the limitations requiring the needle actuator comprises activation rods sealed by o-rings that maintain a waterproof seal before and after actuation, and the actuating button is held in an engaged position by a locking mechanism after actuation and until release.
It is the Examiner’s opinion that one having ordinary skill in the art as of the effective filing date of the claimed invention would not have arrived at the invention of claim 19 without the benefit of Applicant’s disclosure.
Claims 26-27 would also be allowable by virtue of their dependency on Claim 19.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at 571-270-1775. 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 3711
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