DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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 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.
Application Status
This office action is in response to the claims filed 6/26/2025.
Claims 1-15 are currently pending and being examined.
Information Disclosure Statement
The IDS filed on 6/26/2025 has been considered. See the attached PTO 1449 forms.
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 1-15 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 pre-AIA the applicant regards as the invention.
Regarding claims 1-15:
In independent claims 1 and 9, lines 4-5, “the automatic medicament dispensing unit” lacks antecedent basis. For examination purposes this is being treated as “the automated medicament packaging system”.
Regarding claim 9:
In step (d) of claim 9, there should be a semicolon immediately after “dispensed in step (b)” to avoid the claim reading as “dispensed in step (b) and (e)”, which is currently indefinite.
Claims 2-8 and 10-15 are rejected as depending from rejected claims.
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, 3-4, 7, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmes US 2013/0318931.
Regarding claim 1:
Holmes teaches a method of dispensing medicaments into packages, comprising the steps of:
(a) providing an automated medicament packaging system (FIGS. 5-9, unit 110) comprising a plurality of medicament storage and dispensing units (storage cassettes 122), the plurality of medicament storage and dispensing units residing in individual storage locations in the automated medicament packaging system (see FIG. 5);
(b) dispensing medicaments from one or more of the storage locations ([0021]);
(c) selecting either (i) a first packaging unit (118) configured to package medicaments into a first package type ([0042], e.g., pouch) or (ii) a second packaging unit (the other 118) configured to package medicaments into a second packaging type that differs from the first packaging type ([0045], last sentence, e.g., blister card);
(d) transferring the dispensed medicaments from the storage locations into a package in the selected first packaging unit or second packaging unit (via chute 138).
Regarding claim 3:
Holmes teaches the method defined in claim 1, as discussed above, wherein the automated packaging system includes a diverter (130) for diverting medicaments dispensed in step (b) to the second packaging unit based on the selection in step (c) ([0047]-[0048]).
Regarding claim 4:
Holmes teaches the method defined in claim 1, as discussed above, further comprising the step of capturing an image of the medicaments after the dispensing step ([0042]-[0043]).
Regarding claim 7:
Holmes teaches the method defined in claim 6, as discussed above, further comprising the step of capturing an image of the medicaments after the dispensing step ([0042]-[0043]).
Regarding claim 9:
Holmes teaches a method of dispensing medicaments into packages, comprising the steps of:
(a) providing an automated medicament packaging system (FIGS. 5-9, unit 110) comprising a plurality of medicament storage and dispensing units (storage cassettes 122), the plurality of medicament storage and dispensing units residing in individual storage locations in the automated medicament packaging system (see FIG. 5);
(b) dispensing medicaments from one or more of the storage locations ([0021]);
(c) selecting either (i) a first packaging unit (118) configured to package medicaments into a first package type ([0042], e.g., pouch) or (ii) a second packaging unit (the other 118) configured to package medicaments into a second packaging type that differs from the first packaging type ([0045], last sentence, e.g., blister card);
(d) with an inspection unit, inspecting medicaments dispensed in step (b) ([0042]-[0043]) and
(e) transferring medicaments dispensed from the plurality of medicament storage and dispensing units into a package in the selected first packaging unit or second packaging unit (via chute 138).
Regarding claim 11:
Holmes teaches the method defined in claim 9, as discussed above, wherein the automated packaging system includes a diverter (130) for diverting medicaments dispensed in step (b) to the second packaging unit based on the selection in step (c) ([0047]-[0048]).
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 5-6, 8, 10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Holmes, as applied above.
Regarding claims 2 and 10:
Holmes teaches the method defined in claim 1, as discussed above, wherein the first packaging unit is a pouch packaging unit which receives medicaments from the storage and dispensing units and packages the medicaments in pouch packages ([0042]), and wherein the second packaging unit is a blister package packaging unit which receives medicaments from the storage and dispensing units and packages the medicaments in blister packages ([0045], last sentence).
Holmes does not explicitly teach the blister package packaging unit configured to load the medicaments into one or more specific cells of a blister package.
However, Examiner takes official notice that blister package packaging units are old and well-known in the art to be configured to load the medicaments into one or more specific cells of a blister package, and it would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the blister package packaging unit to ensure it is configured to load the medicaments into one or more specific cells of the blister package, as is old and well-known in the art to keep doses preserved until the time of consumption.
Regarding claims 5-6, 8, and 12-15:
Holmes teaches the method defined in claim 10, as discussed above, but does not explicitly teach further comprising the step of sealing the blister package after the inspecting/imaging step and after the transferring step; and conveying a blister package to the blister package packaging unit prior to step (e).
However, it would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Holmes by ensuring the sealing of the blister package happens after the inspecting/imaging step and after the transferring step; and conveying a blister package to the blister package packaging unit prior to step (e), such that erroneous packages are not sealed and finalized until after they’re transferred and inspected, and so that a blister package will be at the ready each time medications are transferred to the blister packaging unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARIUSH SEIF whose telephone number is (408)918-7542. The examiner can normally be reached Monday-Friday 9:30 AM-6:00 PM PST.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731