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 .
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on October 14, 2025 is acknowledged.
Claims 15, 16, 19, 26-28, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 7, 9-13, and 25 are being examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) submitted October 3, 2022, December 13, 2024, January 3, 2025, and September 4, 2025 is/are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, lines 1-2 recite “the intermediate positions” which should be changed to “the one or more intermediate positions” to be consistent with claim 1.
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, 7, 9-13, and 25 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, line 10 introduces “a second position”, however line 5 previously introduced “first and second positions” for the “member” that is movable. It is unclear if line 10 is referring to the same “second position” or an alternative “second position”. If these are the same feature, then line 10 should be amended to recite “the second position”. For the purpose of examination, line 10 will be treated as reciting “the second position”.
Claim 1, line 14 introduces “a specific volume” however line 6 previously introduced “a specific volume” and it is unclear whether these are the same feature or separate features. For the purpose of examination, line 14 will be treated as referring to “the specific feature”.
Claim 9, line 2 introduces “a first chamber” of the member, however claim 9 depends from claim 1 which previously introduced “a first chamber” for the member. It is unclear whether claim 9 is referring to the same “first chamber” or an alternative “first chamber”. For the purpose of examination, claim 9 will be treated as referring to “the first chamber”.
Claim 9, line 3 similarly introduces “a second, separate chamber” however claim 1 previously introduced “a second chamber” for the member and it is unclear if this is the same “second chamber” or a separate feature. For the purpose of examination, claim 9 will be treated as referring to the same “second chamber”.
Claim 11, line 2 introduces “a first chamber” and “a second, separate chamber” for the cartridge, however claim 11 depends from claim 1 which previously stated the cartridge had “one or more chambers”. It is unclear whether the “first chamber” and “second, separate chamber” are part of the “one or more chambers” or are separate features. For the purpose of examination, the respective first and second chambers will be treated as being part of the “one or more chambers”.
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.
Claim(s) 1, 9-13, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,667,097 to Joyce.
In Reference to Claim 1#
Joyce teaches:
A device for dispensing an oral dosage form (pills 1), comprising:
a cartridge (20) comprising one or more chambers (25) for containing an oral dosage form, wherein each of the one or more chambers comprises at least one outlet (bottom of 2, see Figure 6) for dispensing the oral dosage form from the chamber;
a member (30) that is movable between first (initial position 31, see Figure 8) and second (release position 32, see Figure 8) positions, wherein in the first position the member is configured to receive and hold a specific volume (one pill) of the oral dosage form from one of the chambers of the cartridge via one of the outlets,
wherein the member is movable to one or more intermediate positions (any position between 31 and 32 in Figure 8) in which the specific volume of the oral dosage form is held and retained within the movable member such that the oral dosage form cannot be dispensed therefrom, and the member is movable from the intermediate position(s) to the second position in which the oral dosage form held within the movable member can be dispensed therefrom,
wherein:
the movable member is a rotatable disc (Figures 5, 6, and 8 embodiment of housing 30) comprising at least one chamber (multiple instances of 35, see Figure 8) for holding and retaining the specific volume of the oral dosage form as aforesaid;
the at least one chamber of the movable member comprises a first chamber (35) and a second chamber (also 35, see Figure 8); and
the device is configured such that when the device is in use, the one or more chambers of the cartridge are disposed above the rotatable disc and the rotatable disc is disposed generally horizontally (see column 5, lines 5-30 and Figures 5-9).
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In Reference to Claim 9#
Joyce teaches:
The device as claimed in claim 1, wherein the at least one chamber of the member comprises the first chamber configured to receive and hold a first volume (circular instance of 35 in Figure 8) of the oral dosage form from the cartridge, and the separate, second chamber configured to receive and hold a second volume (racetrack instance of 35 in Figure 8) of the oral dosage form from the cartridge.
In Reference to Claim 10#
Joyce teaches:
The device as claimed in claim 9, wherein the first volume of oral dosage form is different to the second volume of oral dosage form. The circular and racetrack shapes hold differently sized pills (see Figure 8) and therefore the volumes of the oral dosage form are different.
In Reference to Claim 11#
Joyce teaches:
The device as claimed in claim 9, wherein the cartridge comprises a first chamber (circular instance of 25 in Figure 7) of the one or more chambers and a second, separate chamber (racetrack instance of 25 in Figure 7) of the one or more chambers, wherein each of the first and second chambers of the cartridge are configured such that the oral dosage form in one chamber does not intermix with the oral dosage form in the other chamber, wherein each chamber of the cartridge comprises a separate outlet (bottom of respective passages 25) for dispensing the oral dosage form from the respective chamber.
In Reference to Claim 12#
Joyce teaches:
The device as claimed in claim 11, wherein the first chamber of the movable member is configured in the first position thereof to receive and hold the first volume of oral dosage form from one of the first and second chambers of the cartridge via its respective outlet, and the second chamber of the movable member is configured in the first position thereof to receive and hold the second volume of oral dosage form from the other of the first and second chambers of the cartridge via its respective outlet (column 4, lines 41-46).
In Reference to Claim 13#
Joyce teaches:
The device as claimed in claim 9, wherein in the first position of the member the first and second chambers thereof are both configured to receive and hold a separate volume of oral dosage form from the cartridge at the same time (each chamber receives a pill, column 4, lines 41-46), wherein in the second position of the member the first and second chambers thereof are both configured to dispense their respective volumes of oral dosage form therefrom (column 4, lines 50-55).
In Reference to Claim 25#
Joyce teaches:
The device as claimed in claim 1, wherein the device comprises one or more outlet passages (45) configured to receive the oral dosage form dispensed from the movable member in the second position thereof (column 5, lines 26-30).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,667,097 to Joyce as applied to claim 1 above, and further in view of WO 2019/115832 to Axelsson.
In Reference to Claim 7
Joyce teaches:
The device as claimed in claim 1, comprising the one or more intermediate positions of the at least one chamber of the movable member.
Joyce fails to teach:
In the one or more intermediate positions, the at least one chamber is sealed and isolated from the one or more chambers of the cartridge.
Axelsson teaches:
A device (100) for dispensing an oral dosage form (drug or medicament in pellet form, page 9, lines 19-21) comprising a cartridge (200) having one or more chambers (220) and a movable member (250) having at least one chamber (groove in screw section 240), wherein the at least one chamber is sealed and isolated from the one or more chambers (seal is not shown, but mentioned in page 10, line 12, “suitable seal”) (see page 10, lines 8-15 and Figure 2).
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 Joyce by adding a seal to the one or more chambers of the cartridge as taught by Axelsson for the purpose of sealing the outlet of the cartridge to prevent air and moisture from entering the cartridge (page 10, lines 17-18 of Axelsson).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 9,636,279 to Song et al teaches a device which delivers oral dosage form which comprises a cartridge and movable member. US 7,896,195 to Limback teaches a device comprising a cartridge and movable member. US 7,377,401 to Humphrey teaches a device comprising a cartridge and movable member. US 4,150,766 to Westendorf teaches a device comprising a cartridge and movable member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON GREGORY DAVIS whose telephone number is (571)270-3289. The examiner can normally be reached M-Th: 8:00-5:00, F: 8:00-12:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Wiehe can be reached at (571) 272-8648. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON G DAVIS/Examiner, Art Unit 3745
/NATHANIEL E WIEHE/Supervisory Patent Examiner, Art Unit 3745