DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 5/12/2026 has been entered. Claims 1, 2, 4, 7-14 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 3/19/2026.
Claim Objections
Claim 13 is objected to because of the following informalities:
Regarding claim 13, line 3, applicant is requested to amend the claim to positively recite the features “microprocessor … beeper” if applicant intends to positively claim these features as a part of claimed invention. Currently, the claim, as presented, is not clearly indicating if these features are being positively claimed as a part of claimed invention.
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.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, lines 2-5, the recitation “the compression device comprises … roller on the flexible reservoir” renders the claim indefinite because the claim is unclear if these features are additional or same as feature being recited in claim 1. It appears that claim could overcome 112b rejection if claim 11 is amended to remove repeated limitations.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilmot et al. (US 2013/0324933 A1).
Regarding claim 1, Wilmot teaches an automatic medical injection device 100 (figure 2A with element 106) comprising:
a flexible reservoir 108 (figure 7) prefilled with a medical solution 110, the flexible reservoir 108 comprising a needle 144 for injecting the medical solution into a patient’s body, and
a body (body of element 100) removably (paragraph 0116, lines 4-7) enclosing the flexible reservoir 108, the body comprising:
a lower surface (see “LS” in figure 20B-B below) adapted to be applied against the patient’s skin (skin of element 101, hereinafter referred as “101”) during an injection of the medical solution (figure 20B-B), said lower surface comprising a throughhole (hole formed by elements 106, 107 coming together as shown in figure 17) adapted for a passage of the needle 144, and
an upper surface (see “US” in figure 20B-B below) opposite to the lower surface,
a compression device (device formed by all the components shown in figure 10 except for elements 102 and 104 or device shows in figure 33A) configured for compressing the flexible reservoir 108 to expel the medical solution through the needle 144, wherein the compression device comprises a support plate (plate of element 206 upon which element 108 rests) supporting the flexible reservoir 108, a roller 210 arranged for compressing the flexible reservoir 108 (paragraph 0159), at least one pinion rack 250 and at least one pinion 252 connected to the roller 210 (connected indirectly via different components in between) so that a rotational movement of the pinion (paragraph 0170, lines 12-22, due to movement of element 252, the spring 226 gets stretched which later on provokes a translational movement of the roller 210 as explained in paragraphs 0174, 0177 and thus element 252 is indirectly provoking translational movement of element 210) on the pinion rack provokes a translational movement of the roller 210 on the flexible reservoir 108, and
an activation button 270 (paragraph 0174, lines 1-6, paragraph 0177, lines 1-7, paragraph 0238, the component that allows current application from element 646) configured to trigger the compression device upon activation by a user.
wherein the support plate (plate of element 206 upon which element 108 rests is tiltable with respect to element 104 along an axis along which element 206 tilts with respect to element 104) is tiltable around a horizontal tilting axis (axis along which element 206 tilts with respect to element 104 is horizontal) between:
a storage position (position shown in figure 16B-B) wherein the injection needle 144 is maintained inside the body (element 144 is located inside the body of element 100), and an injection position (position shown in figure 20B-B) wherein the injection needle 144 is protruding from the body for penetrating the patient’s skin, the body comprising a blocking system 244, 246 (a force is needed to pivot the element 104 and begin the sequential events of moving the needle) configured for selectively maintaining the support plate in the storage position or the injection position
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Claim Rejections - 35 USC § 103
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.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wilmot et al. (US 2013/0324933 A1).
Regarding claim 2, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot further discloses wherein the flexible reservoir 108 has an oblong portion (see element 108 in figure 7 where element 108 has an oblong shape) along a longitudinal axis (axis extending along length of element 108) and is connected to the needle 144 but is silent regarding a tapered portion extending from a distal portion of the oblong portion, and wherein the needle is arranged in a distal tip of the tapered portion in one embodiment.
However, Wilmot teaches in a different embodiment (figure 1B) a tapered portion (see “TP” in figure 1B below) extending from a distal portion (portion of element 16 from where element “TP” extends) of the oblong portion (see “OP” in figure 1B below), and wherein the needle 26 is arranged in a distal tip (tip of “TP” in figure 1B below closest to element 26, element 26 is arranged via element 46) of the tapered portion in one embodiment for the purpose of using a well-known alternative shape of the flexible reservoir to deliver the medication to the patient’s body (paragraph 0106).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the shape of the flexible reservoir of one embodiment of Wilmot to incorporate a tapered portion extending from a distal portion of the oblong portion, and wherein the needle is arranged in a distal tip of the tapered portion as taught by different embodiment of Wilmot for the purpose of using a well-known alternative shape of the flexible reservoir to deliver the medication to the patient’s body (paragraph 0106).
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Regarding claim 4, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot further discloses wherein the flexible reservoir 108 has an oblong portion (see element 108 in figure 7 where element 108 has an oblong shape) along a longitudinal axis (axis extending along length of element 108) and is connected to the needle 144 and wherein the direction of translational movement of the roller 210 is along the longitudinal axis but is silent regarding a tapered portion extending from a distal portion of the oblong portion, the needle being arranged in a distal tip of the tapered portion in one embodiment.
However, Wilmot teaches in a different embodiment (figure 1B) a tapered portion (see “TP” in figure 1B above) extending from a distal portion (portion of element 16 from where element “TP” extends) of the oblong portion (see “OP” in figure 1B above), wherein the needle 26 being arranged in a distal tip (tip of “TP” in figure 1B above closest to element 26, element 26 is arranged via element 46) of the tapered portion in one embodiment for the purpose of using a well-known alternative shape of the flexible reservoir to deliver the medication to the patient’s body (paragraph 0106).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the shape of the flexible reservoir of one embodiment of Wilmot to incorporate a tapered portion extending from a distal portion of the oblong portion, and wherein the needle being arranged in a distal tip of the tapered portion as taught by different embodiment of Wilmot for the purpose of using a well-known alternative shape of the flexible reservoir to deliver the medication to the patient’s body (paragraph 0106).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wilmot et al. (US 2013/0324933 A1) in view of Halaka (US 2010/0174237 A1).
Regarding claim 8, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot is silent regarding further comprising a Peltier element adapted for cooling the patient’s skin, said Peltier element surrounding the throughhole in the lower surface.
However, Halaka teaches a design of a skin cooling apparatus comprising a Peltier element 50 (figure 3) adapted for cooling (paragraph 0035) the patient’s skin, said Peltier element 50 surrounding the throughhole 40 in the lower surface 38 for the purpose of alleviating pain associated with the medical treatment being applied to the patient’s skin (paragraph 0001).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the automatic medical injection device of Wilmot to incorporate a Peltier element adapted for cooling the patient’s skin, said Peltier element surrounding the throughhole in the lower surface as taught by Halaka for the purpose of alleviating pain associated with the medical treatment being applied to the patient’s skin (paragraph 0001).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wilmot et al. (US 2013/0324933 A1) in view of Schiff et al. (US 11,504,470 B1).
Regarding claim 9, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot is silent regarding further comprising a beeper configured for emitting an acoustic signal at the end of an injection.
However, Schiff teaches a design of an automatic drug delivery device further comprising a beeper (column 4, lines 26-31) configured for emitting an acoustic signal at the end of an injection for the purpose of alerting the user to remove the device only after the completion of the drug delivery (column 4, lines 26-31).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the automatic medical injection device of Wilmot to incorporate further comprising a beeper configured for emitting an acoustic signal at then end of an injection as taught by Schiff for the purpose of alerting the user to remove the device only after completion of the drug delivery (column 4, lines 26-31).
Regarding claim 10, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot is silent regarding wherein the body comprises a microprocessor and a motor, the motor being arranged to drive the compression device so as to expel the medical solution through the needle, said motor being controlled by the microprocessor.
However, Schiff teaches wherein the body (body of element 110 in figure 5) comprises a microprocessor 115 (column 6, lines 28-31) and a motor 122, the motor 122 being arranged to drive the compression device 124 (column 10, lines 23-33) so as to expel the medical solution through the needle (column 6, lines 12-15), said motor 122 being controlled by the microprocessor (column 6, lines 28-38, column 10, lines 23-33) for the purpose using an alternative electronic control means to expel the medical solution through the needle (column 6, lines 28-38).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the automatic medical injection device of Wilmot to incorporate wherein the body comprises a microprocessor and a motor, the motor being arranged to drive the compression device so as to expel the medical solution through the needle, said motor being controlled by the microprocessor as taught by Schiff for the purpose using an alternative electronic control means to expel the medical solution through the needle (column 6, lines 28-38).
Regarding claim 11, Wilmot discloses the claimed invention substantially as claimed as set forth above in claim 1. Wilmot further discloses wherein the compression device comprises a support plate (plate of element 206 upon which element 108 rests) supporting the flexible reservoir 108, a roller 210 arranged for compressing the flexible reservoir 108 (paragraph 0159), at least one pinion rack 250 and at least one pinion 252 connected to the roller 210 (connected indirectly via different components in between) so that a rotational movement of the pinion (paragraph 0170, lines 12-22, due to movement of element 252, the spring 226 gets stretched which later on provokes a translational movement of the roller 210 as explained in paragraphs 0174, 0177 and thus element 252 is indirectly provoking translational movement of element 210) on the pinion rack provokes a translational movement of the roller 210 on the flexible reservoir 108 but is silent regarding wherein the motor is configured to drive the pinion to roll on the pinion rack.
However, Schiff teaches wherein the motor 122 is configured to drive the compression element 124 for the purpose using an alternative electronic control means to expel the medical solution through the needle (column 6, lines 28-38).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the compression device of Wilmot to incorporate a motor as taught by Schiff for the purpose using an alternative electronic control means to expel the medical solution through the needle (column 6, lines 28-38). Wilmot modified in view of Schiff would result in having the motor is configured to drive the pinion to roll on the pinion rack because Wilmot in view of Schiff is being modified to use motor as means to provide power to drive the pinion on the pinion rack instead of spring.
Regarding claim 12, Wilmot discloses the claimed invention as claimed, as set forth above in claim 1. Wilmot is silent regarding wherein the activation button is configured for starting and/or stopping the motor and/or controlling a speed of the motor.
However, Schiff teaches wherein the activation button (column 6, line 64-column 7, line 3) is configured for starting and/or stopping the motor and/or controlling a speed of the motor for the purpose of starting the medical procedure when needed (column 6, line 64-column 7, line 3).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wilmot et al. (US 2013/0324933 A1) in view of Armbruster et al. (US 5,322,511).
Regarding claim 13, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot is discloses further comprising a battery 646 (figure 33A) adapted for supplying electrical power to at least one of a microprocessor, a motor, a Peltier element and a beeper (element 646 will be able to provide electrical power to any of the listed components) but is silent regarding further comprising a rechargeable battery, the body further comprising an electrical connector arranged through a wall of the body and configured to connect an electrical power source for recharging the rechargeable battery.
However, Armbruster teaches a design of an injector 10 (figure 1) comprising a rechargeable battery 40 (figure 2), the body further comprising an electrical connector 42 arranged through a wall of the body (body of element 10) and configured to connect an electrical power source 14 for recharging the rechargeable battery (column 5, lines 53-56) for the purpose of using a well-known alternative energy source to operate the components of the device using rechargeable the batteries (column 5, lines 53-56).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the battery and the body of Wilmot to incorporate further comprising a rechargeable battery, the body further comprising an electrical connector arranged through a wall of the body and configured to connect an electrical power source for recharging the rechargeable battery as taught by Armbruster for the purpose of using a well-known alternative energy source to operate the components of the device using rechargeable the batteries (column 5, lines 53-56).
Regarding claim 14, Wilmot discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilmot is silent regarding wherein the electrical connector is further configured to connect an external electronic device to the microprocessor.
However, Armbruster teaches wherein the electrical connector 42 is further configured to connect an external electronic device 14 to the microprocessor (element 14 could be connected to a microprocessor via element 42 if present in the device) for the purpose of using an external charging system to recharge the battery (column 5, lines 53-56).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Wilmot to incorporate wherein the electrical connector is further configured to connect an external electronic device to the microprocessor as taught by Armbruster for the purpose of using an external charging system to recharge the battery (column 5, lines 53-56).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Wilmot et al. (US 2013/0324933 A1) is silent regarding further comprising at least one holding flap protruding from a lateral side of the body and configured to bend and extend upward around the upper surface of the body, said at least one holding flap being configured for at least partially surrounding a hand of the user during injection in combination with other claimed limitations of claim 7.
Response to Arguments
Applicant's arguments filed 5/12/2026 have been fully considered but they are not persuasive.
Applicant argues on page 7, line 19 – page 8, line 16 that Wilmot fails to disclose at least “wherein the support plate is tiltable around a horizontal tilting axis between a storage position … and, an injection position …” and therefore applicant argues that the amended claim overcomes the prior art of record. Examiner respectfully disagrees. The claim does not recite any reference with respect to which the supporting plate tilts. The axis along which the element 206 rotates with respect to element 104 is a horizontal tilting axis. Therefore, claim needs to further clarify the tilting movement in order to overcome the prior art of record.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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