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 Objections
Claim 1 is objected to because of the following informalities: Either (a) the phrase “the fluid reservoir” on line 3 should be amended to recite “the fluid reservoir” to ensure consistency of claim language. The text of lines 4-5 appears to be grammatically incorrect and should be amended to recite “to travel to an exit orifice of the needle”. The term “the” should be removed from the phrase “the longitudinal actuation” on line 7 since this is the first time that this feature is recited. The phrase “fixed to the dosing pen and” should be removed from line 10 since this is grammatically incorrect (in order for the feedback element to be a part of the dosing pen (as required by the format of the claim), it cannot be “fixed” to the dosing pen). Either (a) the phrase “the injection button” on line 11 should be amended to recite “the injection button” in order to ensure consistency of claim language. 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 1-8 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 “a feedback element fixed to the dosing pen and having dual states consisting of an operable state initiated in response to the depression of the injection button and for a period of time measured by a countdown timer triggered by the depression, and an inoperable state otherwise” on lines 10-13. The phrase “and for a period of time measured by a countdown timer” appears to be grammatically incorrect to the point that it is unclear as to how this limitation is intended to apply to the “operable state” or the “depression of the injection button”. Additionally, it is unclear as to what situation is being referred to by the term “otherwise”. For the sake of examination, lines 10-13 are interpreted as reciting “a feedback element fixed to the dosing pen and having dual states consisting of an operable state and an inoperable state, the operable state initiated in response to the depression of the injection button and lasting for a period of time measured by a countdown timer triggered by the depression”. Claims 2-8 are rejected due to their dependence on claim 1.
Claim 2 recites “a contact sensor disposed on the dosage knob coupled to a microelectronic state machine” on lines 1-2. It is unclear as to which feature – the “contact sensor” or the “dosage knob” – is coupled to the microelectronic state machine. For the sake of examination, the contact sensor is interpreted as being coupled to the state machine; accordingly, it is suggested to amend lines 1-2 to recite “a contact sensor disposed on the dosage knob and coupled to a microelectronic state machine”.
Allowable Subject Matter
Claims 1-8 would be allowable if rewritten or amended to overcome the objections and rejections under 35 U.S.C. 112(b) set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claim could not be found nor was suggested in the prior art of record.
Independent claim 1 requires a dosing pen comprising (a) a barrel adapted to house a fluid reservoir coupled to a piston plunger, (b) a needle assembly fit to a distal end of the barrel and including a needle, (c) a dosage knob calibrating the volume of the fluid to be forced through the needle upon actuation of the piston plunger, (d) an injection button configured to motivate the piston plunger upon depression, (e) a feedback element having an operable state and an inoperable state, the operable state initiated in response to the depression of the injection button and lasting for a period of time measured by a countdown timer triggered by the depression, and (f) a finger placement sensor at a top surface of the injection button that electrically actuates the feedback element when the feedback element has been latched in the operable state.
The closest prior art of record is US Pat 11,424,026 to Groeschke et al. which discloses a dosing pen 1 (Fig 1) comprising a barrel 10, a needle assembly 15, a dosage knob 12, an injection button 11, a feedback element 220 (Fig 2) having an operable state initiated in response to the depression of the injection button (Col 13, Line 66 - Col 14, Line 7) and an inoperable state otherwise (in which the LED 220 would not be turned on), a countdown timer triggered by the depression (“timer”, Col 13, Line 67 - Col 14, Line 1) and measuring a period of time that the feedback element is in an operable state (Col 5, Lines 16-21), and a finger placement sensor 2 at a top surface of the injection button (as seen in Fig 2) that electrically actuates the feedback element (Col 13, Line 66 – Col 14, Line 7). Since Groeschke discloses that the actuation of the feedback element 220 by the finger placement sensor 2 causes the feedback element to enter the operable state (in which the LED 220 is lit), Groeschke does not disclose that the feedback element is actuated “when the feedback element has been latched in the operable state” as claimed; in other words, the claim requires the feedback element to already be in the operable spate prior to the finger placement sensor actuating the feedback element, but Groeschke discloses that the feedback element only enters the operable state after the finger placement sensor has actuated the feedback element. Since the sensor’s purpose is to place the feedback element in the operable state, modifying Groeschke to include the feedback element in the operable state prior to the sensor actuating the feedback element would render the dosing pen inoperable for its intended purpose.
Other relevant prior art includes PG PUB 2024/0252757 to Bruegger (disclosing “the actuation of the operating means 4 can also be determined by means of touch sensors on a, for example, capacitive, resistive or piezoelectric basis or by means of an electromechanical switch”, Para 109), PG PUB 2021/0060260 to Ruiz-Valdepenas Marten De Almagro (disclosing “alarm means adapted to output an alarm if a further injection is detected in a predefined time period following the stored date and time of the injection” and “a patient is warned immediately if he or she attempts to inject a drug too early or too late such that an unnecessary injection can be avoided or at least the patient can be made aware of the fact that the second injection was too early “, Para 51), PG PUB 2019/0175841 to Sjolund et al. (disclosing monitoring use of an injection pen based on removal of a cap such that “if the pen cap is removed from the injection pen within a threshold period of time […] from a previous capping, the pen cap may provide a visual, audible, or vibrational notification to indicate that the user may have recently used the pen to administer insulin”, Para 37, and that the cap may include a “capacitive touch button”, Para 102), PG PUB 2016/0296716 to Cabiri et al. (disclosing a dosing pen and that “processor 426 may track elapsed time between events and/or issue alerts and/or error messages and/or place the device into an error sate when an expected even does not occur in the proper time period and/or when events occur in an improper time period”, Para 110), and PG PUB 2016/0012205 to Saint et al. (disclosing “the pen device is provided with a method to warn the user if a bolus has been recently take […] this is a safeguard against accidentally double dosing for a meal or taking long acting insulin twice in a day […] this alarm could be active if a second dose is initiated within a predefined period of time after the previous dose” and the alarm could be “audio, visual and/or tactile”, Para 64). However, none of these references alone or in combination teach all of the recited features of claim 1. Additionally, a dosing pen comprising all of the features recited in claim 1 was not suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783