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 .
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.
Claims 1-11 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.
Claim 1 recites the limitation "the optical sensor" in 13. There is insufficient antecedent basis for this limitation in the claim. Did applicant intend to recite the optical sensor assembly?
Dependent claims 2-11 are rejected insofar as they depend from a rejected claim and thereby incorporate the deficiency due to their dependency.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8-10, 12-14, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helmer (WO 2023/036719 A1).
Regarding independent claim 1, Figures 1-12 discloses applicant’s claimed dose monitoring system for an injection pen (1), the dose monitoring system (100) comprising:
a dose detection assembly (100), comprising:
a housing (20) configured to be secured to a body (40, 42) of the injection pen over a dose display window (18) of the injection pen, and
an optical sensor assembly (25,29) configured to determine an amount of movement (pages 25-26) of a dose indicator surface within the dose display window (18);
an injection detection assembly, comprising:
a body (40, 42) configured to be secured to a dose knob (16) of the injection pen (1),
an injection sensor (14, 27) configured to detect a force or touch applied to the dose knob (16) of the injection pen (1), and
a transmitter (28) configured to communicate injection information when the injection sensor (27) detects the force or touch applied to the dose knob (top & bottom of page 26); and
a processor (24) in communication with the optical sensor (25,29) and the injection sensor (27) that is configured to determine an amount of medication injected based on the amount of movement of the dose indicator surface within the dose display window (18 when the force or touch is applied to the dose knob (16) as detected by the injection sensor (27).
Regarding claim 2, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the dose detection assembly comprises a securement device (96) configured to secure the dose detection assembly (100) to the body (40, 42) of the injection pen (1).
Regarding claim 3, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the dose detection assembly (100) is configured to determine a set dose based on an amount of movement of the dose indicator surface within the dose display window (18) as determined by the optical sensor assembly (25, 29) when no force or touch is detected by the injection sensor (27).
Regarding claim 4, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the dose detection assembly (100) further comprises a display (21) configured to display the set dose.
Regarding claim 5, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the dose detection assembly (100) is configured to determine that the set dose was fully injected when the amount of movement within the dose display (18) window when the force or touch is applied to the dose knob is equal to the amount of movement of the dose indicator surface (see pages 25-25) when no force or touch was applied to the dose knob (16).
Regarding claim 6, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the injection sensor of the injection detection assembly comprises a touch sensor (14).
Regarding claim 8, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the optical sensor assembly (25, 29) comprises a light source (LEDs 29) configured to direct light at the dose indicator surface of the injection pen.
Regarding claim 9, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the optical sensor assembly (25, 29) is configured to detect one or more edges (sensor/LEDs 25, 29 are fully capable of detecting edges of and within display window 18) of the dose display window (18).
Regarding claim 10, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features as recited in these claims, wherein the processor (24) is configured to detect relative movement of the dose detection assembly and the body of the injection pen based on detection of a position of the one or more edges of the dose display window (Helmer processor 24 is inherently fully capable of detecting relative movement due to camera of optical sensor 25).
Regarding independent claim 12, Figures 1-12 discloses applicant’s claimed method for detecting dose information by a dose monitoring system (100) coupled to an injection pen (1), the method comprising:
detecting movement of an indicator surface in a dose display window (18) of an injection pen (1) by an optical sensor assembly (25, 29) of a dose detection assembly of the dose monitoring system, wherein the dose detection assembly (100) is secured to a body (10) of the injection pen (1) over the dose display window (18) of the injection pen (1);
detecting a force or touch applied to an injection sensor (27) of an injection detection assembly of the dose monitoring system, wherein the injection detection assembly is secured to a dose knob (6) of the injection pen (1);
transmitting (28) injection information from the injection detection assembly to the dose detection assembly when the force or touch is applied to the injection sensor (27); and
determining, by a processor (24) of the dose monitoring system (100), an amount of movement of the indicator surface within the dose display window (18) when the force or touch is applied to the dose knob (16), wherein the amount of movement corresponds to an amount of medication injected.
Regarding claim 13, Helmer reference, presented above, discloses applicant’s claimed method 12 comprising all features recited therein, further comprising transmitting the amount of medication injected to a receiver in wireless communication (28) with the dose monitoring system.
Regarding claim 14, Helmer reference, presented above, discloses applicant’s claimed method 12 comprising all features recited therein, further comprising displaying dose information on a display (21) of the receiver.
Regarding claim 17, Helmer reference, presented above, discloses applicant’s claimed method 12 comprising all features recited therein, further comprising determining a set dose based on an amount of movement of the dose indicator surface (pages 25-26) when no force or touch is applied to the injection sensor (27).
Regarding claim 18, Helmer reference, presented above, discloses applicant’s claimed method 12 comprising all features recited therein, further comprising displaying the set dose on a display (21) of the dose detection assembly.
Regarding claim 19, Helmer reference, presented above, discloses applicant’s claimed method 12 comprising all features recited therein, further comprising detecting relative movement of the dose detection assembly and the body of the injection pen by detecting a change in a position of one or more edges (Helmer processor 24 is inherently fully capable of detecting relative movement due to camera of optical sensor 25) of the dose display window (18) by the optical sensor assembly (25, 26).
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 7, 11, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer (WO 2023/036719 A1), as applied to claim 1 above, and further in view of Rehbein et al (U.S. Patent Application Publication No. US 2019/0192778 A1).
Regarding claim 7, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features above including the optical sensor assembly (25, 29).
Helmer does not disclose the optical sensor assembly comprises an optical navigation sensor.
However, Rehbein teaches an analogous injection device (1), Figures 3-5 and 7 illustrates a light source (32) and an optical sensor (34) and an existence of reflective regions (paragraphs 0078, 0082, 0088, 0091) such that deemed an optical navigation sensor.
Therefore, it would have been obvious to one of ordinary skill in the art prior to applicant’s effective filing date to substitute Rehbein sensor in Helmer invention as such simplistic design and construction is enhanced reliability (paragraph 0079).
Regarding claims 11 and 15-16, Helmer reference, presented above, discloses applicant’s claimed dose monitoring system comprising all features above including the transmitter of the injection detection assembly.
Helmer dies not discloses the injection detection assembly comprises a low power mode and a full power mode, wherein the injection detection assembly is configured to transition to the full power mode when the injection sensor is pressed.
However, Rehbein teaches switch (53) providing “optional wake-up” mode and “wake-up” mode in conjunction with dose button (26) such that the switch (53) controls application power from power source (54) to power arrangement (50), paragraph 0102 specifically discloses that depressing button (26) triggers the wake-up electronics.
Therefore, it would have been obvious to one of ordinary skill in the art prior to applicant’s effective filing date to incorporate switch (53) in Helmer invention, taught by Rehbein, as such switch (53) is environmentally friendly, to conserve energy and to prolong the life of the device.
Allowable Subject Matter
Claim 20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAMTU TRAN NGUYEN whose telephone number is (571)272-4799. The examiner can normally be reached 9am-5pm, Monday-Friday.
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/CAMTU T NGUYEN/Examiner, Art Unit 3786
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