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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Drawings
The drawings are objected to because the drawing Figures 4-6 comprise a gray scale shading to show structure of the disclosed embodiment wherein, pertinent structure of the invention is difficult to visualize and specific structural elements are difficult to discern. Furthermore, gray scale shading reproduction of copies yields dark reproductions. It is suggested the applicant provide drawings with the grayscale shading removed and all critical structure clearly distinguishable. Appropriate action is required.
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 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 1,2,411 and 13-19 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.
Claims 1,2,411 and 13-19 recite the limitations “a treatment protocol that includes” in line 2, “a computing device that includes” in line 4, “a pill tracking dispenser that is” in line 6 and further “a gate that permits a pill” in line 19. Applicant recites an element of the dispenser and follows the named element by reciting that, it is not clear as to whether the limitations “that” is referring to the said element or a different element. The limitations as recited are narrative. It is suggested the Applicant positively recited the claimed structure for example as follows:
“a treatment protocol includes” in line 2, “a computing device includes” in line 4, “a pill tracking dispenser” in line 6 and further “a gate permits a pill” in line 19.
Similar issues pertaining to the use of the limitations “that” exist throughout claim 1,2,411 and 13-19. It is suggested the Applicant positively recited the claimed structure as cited in the example above.
Claim 1 recites the limitations “reports to the mobile computing device the number of times the oral medication is consumed by the patient” in line 9. It is unclear as to how the mobile computing device detects the consumption of the medication by the patient. As best construed the mobile computing device detects the dispensing of the oral medication and not the consumption of the medication. Appropriate clarification is required.
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 1,2,4-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Howieson (US 2018/0247704 A1) in view of Blum (US 2017/0193191 A1).
Referring to claim 1. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]), the system comprising:
a mobile computing device (smartphone, step 218; Figure 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]) that includes an application program to record the periodic consumption of oral medication by the patient (application software updates consumption of dispensed medication); and
a pill tracking dispenser (100; as shown in Figure 1A) that is connected to the mobile computing device (smartphone, step 218) through a wireless network (Figure 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]), wherein the pill tracking dispenser (100; as shown in Figure 1A) reports to the mobile computing device (smartphone) the number of times the oral medication is consumed by the patient (Figure 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser (400; as shown in Figure 4A) comprises:
a first portion (402; Figure 4A), wherein the first portion comprises;
a pill chamber (interior of 402; Figure 4A) configured to contain a plurality of pills (110); and
a second portion (406; Figure 4A) that is removable from the first portion (402; Figure 4A), wherein the second portion (406; Figure 4A) comprises:
a pill release mechanism (420; Figure 4A), wherein the pill release mechanism (420; Figure 4A) includes:
a gate (412; Figure 4A) that permits a pill to be released from the pill chamber when the gate is opened (Figure 4A, 4B and 5; Para [0021],[0025]); and
a trigger (422) connected to the gate (412; Figure 4A), wherein the trigger (422) can be manipulated (can be actuated) by the patient to move the gate into an open position (Figure 4A,4B and 5; Para. [0021],[0025]); and
wherein the first portion (402; Figure 4A) can be separated (portion 402 can be removed from 406) from the second portion (406; Figure 4A) when the pill chamber (interior of 402) is empty.
Howieson does not disclose a first portion comprising a battery.
Blum discloses a method for authorizing and accessing medication consisting of a dispenser (100; Figure 1) wherein a first portion (200) comprises a battery (250; Figure 5A).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Howieson to include the first portion comprising a battery as taught by Blum because the dispenser can be loaded with a new battery every time the dispenser is refilled thus assuring the dispenser comprises a full power source.
Referring to claim 2. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the system further comprises a clinician computer system that is connected to the mobile computing device (smartphone, step 218) through an internet connection (see Para [102]; Turning to FIG. 2, there is shown schematically the system 200 of how a dispensing container as shown in FIGS. 1A-1C is configured to interact with a remote database. A doctor (or healthcare professional) 202 provides a prescription-dose regime 204 which includes a unique 1D code. The prescription 204 is given to the patient 206 who in turn passes it to a pharmacist 208 who provides the dispensing container which contains the required pharmaceutical tablets; If desired, the database 216 could be stored on a cloud based server or a hosted server with a secure network connection.).
Referring to claim 4. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser (100; as shown in Figure 1A) further comprises a safety latch mechanism that is configured to prevent the unintentional release of medication from the pill chamber, (para [0015], [0016], [0067], [0073], [0104],[0105],[0106] and [0123]).
Referring to claim 5. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the safety latch mechanism comprises:
a locking tab that prevents the gate from opening when the locking tab is in a deployed position (Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]); and
a button connected to the locking tab, wherein the button can be manipulated by the patient to retract the locking tab from the deployed position to permit the gate to be opened by the patient (Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]).
Referring to claim 6. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser further comprises an electronics chamber that includes an onboard processing unit, wherein the onboard processing unit establishes a data connection with an oral medication compliance system that includes a mobile computing device that in turn connects to a computer system (Figure 2, 3-5, Para. [0002],[0036],[0037],[0068]-[0071],[0103],[0114],[0122]).
Referring to claim 7. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser further comprises a gate position sensor (Para. [0021], [0114], [0122]), wherein the gate position sensor detects the gate opening and provide the onboard processing unit with a signal that the gate was opened to permit the release of a pill (Para. [0021], [0114], [0122]).
Referring to claim 8. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser further comprises a pill release sensor detects the release of a pill from the pill chamber through the gate (Para. [0021], [0114], [0122]).
Referring to claim 9. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill release sensor comprises a light curtain that includes a light sensor and a light emitter that are activated when the gate is opened (Para. [0021], [0114], [0122]).
Referring to claim 10. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the pill tracking dispenser and the electronics chamber is contained within a second portion of the pill tracking dispenser (Figure 4A, 4B and 5; Para. [0021],[0025]) and the powered by the battery in the first portion (powered by battery 250 in the first portion 200; Blum).
Referring to claim 11. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the first portion of the pill tracking dispenser is removable from the second portion of the pill tracking dispenser (Figure 7A,7c and 9; Para. [0062], [0101], [0114]).
Referring to claim 13. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (see Figures 2,3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0103], [0114], [0122]),
wherein the application program advises the patient when it is time to consume the oral medication according to the treatment protocol (Para. [0103], [0113], [0122], [0123]).
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)(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.
Claims 14-19 are rejected under 35 U.S.C. 102(a)(b) as being clearly anticipated by Howieson (US 2018/0247704 A1).
Referring to claim 14. Howieson discloses a pill tracking dispenser (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071],[0103],[0114] and [0122]), the pill tracking dispenser comprising:
a pill chamber (interior of 402; Figure 4A) containing a plurality of pills (Figure 2, 3-5, Para. [0002],[0036],[0037],[0068]-[0071],[0103],[0114],[0122]);
a pill release mechanism, wherein the pill release mechanism includes a gate that permits a pill to be released from the pill chamber when the gate is opened (Figure 2, 3-5, Para. [0002],[0036],[0037],[0068]-[0071],[0403],[0114] and [0122]);
a trigger (422) connected to the gate (412; Figure 4A), wherein the trigger (422) can be manipulated (can be actuated) by the patient to move the gate into an open position (Figure 4A,4B and 5; Para. [0021],[0025]);
an electronics chamber (406) that includes an onboard processing unit, wherein the onboard processing unit establishes a data connection with an oral medication compliance system that includes a mobile computing device that is in turn connects to a computer system (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]);
a gate position sensor, wherein the gate position sensor detects the gate opening and provides the onboard processing unit with a signal that the gate was opened to permit the release of a pill (Para. [0021], [0114], [0122]);
a safety latch (420) that prevents the unintentional release of medication from the pill chamber (release cannot be actuated without actuating the safety latch mechanism), wherein the safety latch (420) comprises:
a locking tab (422) that prevents the gate (412) from opening when the locking tab (422) is in a deployed position (when actuated; Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]); and
a button (418) connected to the locking tab (422), wherein the button (418) can be manipulated by the patient (actuated by the user) to retract the locking tab (release 422) from the deployed position to permit the gate (412) to be opened by the patient (Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]); and
wherein the pill chamber (interior of 402; Figure 4A) can be separated from the electronic chamber (406) when the pill chamber is empty (see Figure 4A and 1A-1B).
Referring to claim 15. Howieson discloses a system for tracking patient compliance with a treatment protocol that includes periodic consumption of oral medication (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), the system comprising:
a mobile computing device that includes an application program that records the periodic consumption of oral medication by the patient (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]); and
a pill tracking dispenser that connects to the mobile computing device through a wireless network (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), wherein the pill tracking dispenser reports to the mobile computing device the number of times the oral medication is consumed by the patient (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]) and
wherein the pill tracking dispenser (100; as shown in Figure 1A) comprises:
a pill chamber (112; Figure 1B) containing a plurality of pills (110); and
a pill release mechanism (420; Figure 4A), wherein the pill release mechanism (420; Figure 4A) comprises
a gate (412; Figure 4A) that permits a pill to be released from the pill chamber when the gate is opened (Figure 4A, 4B and 5; Para [0021],[0025]); and
a safety latch (420) that prevents the unintentional release of medication from the pill chamber (release cannot be actuated without actuating the safety latch mechanism), wherein the safety latch (420) comprises:
a locking tab (422) that prevents the gate (412) from opening when the locking tab (422) is in a deployed position (when actuated; Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]); and
a button (418) connected to the locking tab (422), wherein the button (418) can be manipulated by the patient (actuated by the user) to retract the locking tab (release 422) from the deployed position to permit the gate (412) to be opened by the patient (Para. [0015], [0016], [0067], [0073], [0104], [0105] and [0106]); and
wherein the pill chamber (interior of 402; Figure 4A) can be separated from the electronic chamber (406) when the pill chamber is empty (see Figure 4A and 1A-1B).
Referring to claim 16. Howieson discloses a pill tracking dispenser for use within a system for tracking patient compliance with a treatment protocol that includes the periodic consumption of oral medication (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), the pill tracking dispenser comprising:
a pill chamber containing a plurality of pills;
a pill release mechanism (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), wherein the pill release mechanism includes:
a gate that permits a pill to be released from the pill chamber when the gate is opened (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]); and
a trigger connected to the gate, wherein the trigger can be manipulated by the patient to move the gate into an open position (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]); and
an onboard processing unit, wherein the onboard processing unit establishes a data connection with a mobile computing device that is in turn connects to a computer system used by a clinician in monitoring the patient's compliance with the treatment protocol (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]); and
wherein the pill chamber (interior of 402; Figure 4A) is contained within a disposable first portion (portion 402) of the pill tracking dispenser (400) and the onboard processing unit (418) is contained within a second portion (406) of the pill tracking dispenser (400), and wherein the disposable first portion (portion 402 can be disposed) of the pill tracking dispenser (400) is removable (can be removed) from the second portion (406) of the pill tracking dispenser (400).
Referring to claim 17. Howieson discloses a pill tracking dispenser configured for use within a system for tracking patient compliance with a treatment protocol that includes the periodic consumption of oral medication (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), the pill tracking dispenser comprising:
wherein the pill tracking dispenser further comprises a safety latch mechanism that prevents the unintentional release of medication from the pill chamber (Para. [0015], [0016], [0067], [0073], [0101], [0105],[0106)]).
Referring to claim 18. Howieson discloses a pill tracking dispenser configured for use within a system for tracking patient compliance with a treatment protocol that includes the periodic consumption of oral medication (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), the pill tracking dispenser comprising:
wherein the safety latch mechanism comprises:
a locking tab that prevents the gate from opening when the locking tab is in a deployed position (Para. [0015], [0016], [0067], [0073], [0101], [0105] and [0106]); and
a button connected to the locking tab, wherein the button can be manipulated by the patient to retract the locking tab from the deployed position to permit the gate to be opened by the patient (Para. [0015], [0016], [0067], [0073], [0101], [0105] and [0106]).
Referring to claim 19. Howieson discloses a pill tracking dispenser configured for use within a system for tracking patient compliance with a treatment protocol that includes the periodic consumption of oral medication (Figure 2, 3-5, Para. [0002], [0036], [0037], [0068]-[0071], [0403], [0114] and [0122]), the pill tracking dispenser comprising:
wherein the pill tracking dispenser further comprises a gate position sensor, wherein the gate position sensor detects the gate opening and provide the onboard processing unit with a signal that the gate was opened to permit the release of a pill (Para. [0021], [0114] and [0122]).
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
See modified rejections including all newly added limitations and specifically including the first portion can be separated from the second portion when the pill chamber is empty and the first portion comprising a battery rejected in combination of the secondary reference Blum (US 2017/0193191 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAKESH KUMAR whose telephone number is (571)272-8314. The examiner can normally be reached M-TH from 8AM-6:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gene Crawford can be reached at (571) 272-6911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RAKESH KUMAR/Primary Examiner, Art Unit 3651