DETAILED ACTION
This application includes independent claims 1 and 14 and dependent claims 2-13 and 15-20.
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 Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(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.
Claim(s) 14-17, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Colson et al. (US 12,503,259).
Regarding independent claim 14, Colson discloses a method of filling a pharmaceutical order (see at least col. 28, lines 7-35) including one or more pharmaceuticals, the method comprising: determining a container volume for containing at least a portion of the one or more pharmaceuticals based on the one or more pharmaceuticals (see at least col. 5, line 53 – col. 6, line 16); forming a pharmaceutical container having the determined container volume (see at least col. 5, line 53 – col. 6, line 16); and filling the formed pharmaceutical container with said at least a portion of the one or more pharmaceuticals (see at least col. 28, lines 24-26).
Regarding dependent claims 15-17, 19, and 20, Colson discloses that the forming the pharmaceutical container includes forming the pharmaceutical container via additive manufacturing (see at least col. 2, lines 65-67). The forming the pharmaceutical container includes forming the pharmaceutical container via thermoforming (see at least col. 32, lines 25-57). Colson further discloses forming a patient label on the pharmaceutical container via additive manufacturing, the patient label including at least one of a patient name, a day indicia indicating a day said at least a portion of the one or more pharmaceuticals is to be taken, a day time indicia indicating a time of day said at least a portion of the one or more pharmaceuticals is to be taken, a prescription number, one or more names of the one or more pharmaceuticals, or a combination thereof (see at least col. 61, lines 35-46). Determining the container volume is based on one or more characteristics of the one or more pharmaceuticals, the one or more characteristics including at least one of a size of each pharmaceutical of the one or more pharmaceuticals, a shape of each pharmaceutical of the one or more pharmaceuticals, a stacking characteristic of each pharmaceutical of the one or more pharmaceuticals, a quantity of the one or more pharmaceuticals, or a combination thereof (see at least col. 5, line 53 – col. 6, line 16). The at least a portion of the one or more pharmaceuticals comprises is a first portion of the one or more pharmaceuticals, the container volume is a first container volume, and the pharmaceutical container is a first pharmaceutical container, the method further comprising: determining a second container volume for containing at a second portion of the one or more pharmaceuticals based on the one or more pharmaceuticals; forming a second pharmaceutical container having the determined second container volume; and filling the formed second pharmaceutical container with said second portion of the one or more pharmaceuticals (see at least col. 5, line 53 – col. 6, line 16).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 1, 3-5, 7, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colson et al. (US 12,503,259) in view of Terzini (US 8,392,020).
Regarding independent claim 1, Colson discloses a pharmaceutical order processing system (see at least col. 28, lines 7-35) comprising: an order processing device configured to receive a pharmaceutical order (see at least Fig. 8, 802 and col. 27, lines 55-65) including one or more pharmaceuticals (see at least col. 28,lines 7-35), the order processing device configured to determine a container volume for containing at least a portion of the one or more pharmaceuticals based on the one or more pharmaceuticals (see at least col. 5, line 53 – col. 6, line 16); and a container former communicatively coupled to the order processing device, the container former configured to form a pharmaceutical container having the container volume determined by the order processing device (see at least col. 5, line 53 – col. 6, line 16). Colson discloses all the limitations of the claims, but it does not explicitly disclose a pharmaceutical dispensing device communicatively coupled to an order processing device, the pharmaceutical dispensing device configured to dispense said at least a portion of the one or more pharmaceuticals into the pharmaceutical container formed by the container former. Rather, Colson discloses, “the container may be formed and the medicinal product may be counted and placed in the container (see col. 28, lines 24-26).” However, Terzini discloses a similar device which includes a pharmaceutical dispensing device communicatively coupled to an order processing device, the pharmaceutical dispensing device configured to dispense at least a portion of one or more pharmaceuticals into a pharmaceutical container (see col. 2, lines 40 – 65) for the purpose of counting and dispensing pharmaceuticals. It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the applicant’s invention to include a pharmaceutical dispensing device communicatively coupled to an order processing device, the pharmaceutical dispensing device configured to dispense said at least a portion of the one or more pharmaceuticals into the pharmaceutical container formed by the container former, as disclosed by Terzini, for the purpose of counting and dispensing pharmaceuticals.
Regarding dependent claims 3-5, 7, and 10-11. Colson discloses said at least a portion of the one or more pharmaceuticals includes all of the one or more pharmaceuticals, the order processing device being configured to determine the container volume for containing said all of the one or more pharmaceuticals based on the one or more pharmaceuticals, and the pharmaceutical dispensing device configured to dispense said all of the one or more pharmaceuticals into the pharmaceutical container. The container former includes an additive manufacturing machine configured to form the pharmaceutical container (see at least col. 2, lines 65-67). The additive manufacturing machine is configured to form a patient label on the pharmaceutical container, the patient label including at least one of a patient name, a day indicia indicating a day said at least a portion of the one or more pharmaceuticals is to be taken, a day time indicia indicating a time of day said at least a portion of the one or more pharmaceuticals is to be taken, a prescription number, one or more names of the one or more pharmaceuticals, or a combination thereof (see at least col. 61, lines 35-46). The additive manufacturing machine comprises a 3-dimensional printer (see at least col. 2, lines 65-67). The container former includes a thermal forming machine (see at least col. 32, lines 25-57). The order processing device is configured to determine the container volume based on one or more characteristics of the one or more pharmaceuticals, the one or more characteristics including at least one of a size of each pharmaceutical of the one or more pharmaceuticals, a shape of each pharmaceutical of the one or more pharmaceuticals, a stacking characteristic of each pharmaceutical of the one or more pharmaceuticals, a quantity of the one or more pharmaceuticals, or a combination thereof (see at least col. 5, line 53 – col. 6, line 16). At least a portion of the one or more pharmaceuticals forms a pharmaceutical dose of the pharmaceutical order.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colson et al. (US 12,503,259) in view of Terzini (US 8,392,020) as applied to claim 1 above, and further in view of Stock et al. (US 2022/040818). The combination of Colson and Terzini discloses all the limitations of the claim, including forming a patient label on the pharmaceutical container, the patient label including at least one of a patient name, a day indicia indicating a day said at least a portion of the one or more pharmaceuticals is to be taken, a day time indicia indicating a time of day said at least a portion of the one or more pharmaceuticals is to be taken, a prescription number, one or more names of the one or more pharmaceuticals, or a combination thereof. However, it does not explicitly disclose a laser labeler. The combination is silent regarding how the label is applied to the container. Stock discloses a similar device which includes a laser labeler (see para. 0082) for the purpose of applying information to a container. It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the applicant’s invention to utilize a laser labeler, as disclosed by Stock, for the purpose of applying information to the container.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colson et al. (US 12,503,259) in view of Terzini (US 8,392,020) as applied to claim 1 above, and further in view of Marcus (US 4,376,090). The combination of Colson and Terzini discloses all the limitations of the claims, including forming the pharmaceutical container based on the container volume determined by the order processing device, but it does not disclose that the thermal forming machine includes an adjustable pharmaceutical container mold; or that the thermal forming machine includes a plurality of pharmaceutical container molds of different sizes for forming different sizes of pharmaceutical containers. However, Marcus discloses a similar device including a thermal forming machine including an adjustable pharmaceutical container mold and a plurality of pharmaceutical container molds of different sizes for forming different sizes of pharmaceutical containers for the purpose of necessitating only a single injection molding core (see col. 8, lines 45-50). It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the applicant’s invention, to have the thermal forming machine include an adjustable pharmaceutical container mold; and have the thermal forming machine include a plurality of pharmaceutical container molds of different sizes for forming different sizes of pharmaceutical containers, as disclosed by Marcus, for the purpose of necessitating only a single injection molding core.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colson et al. (US 12,503,259) in view of Terzini (US 8,392,020), as applied to claim 1 above, and further in view of Terzini (US 2011/0146835). The combination of Colson and Terzini (‘020) discloses all the limitations of the claims but it does not disclose a container transporter and a container sealer, the container sealer being configured to seal the pharmaceutical container with the one or more pharmaceuticals contained therein, the container transporter arranged to transport the pharmaceutical container from the pharmaceutical dispensing device to the container sealer; or a packager configured to package the pharmaceutical container for delivery, the container transporter arranged to transport the pharmaceutical container to the packager. However, Terizini (‘835) discloses a similar device which includes a container transporter (421) and a container sealer (335), the container sealer being configured to seal the pharmaceutical container with the one or more pharmaceuticals contained therein, the container transporter arranged to transport the pharmaceutical container from the pharmaceutical dispensing device to the container sealer; and a packager (600) configured to package the pharmaceutical container for delivery, the container transporter arranged to transport the pharmaceutical container to the packager for the purpose of sealing and shipping pharmaceutical containers. It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the applicant’s invention to include a container transporter and a container sealer, the container sealer being configured to seal the pharmaceutical container with the one or more pharmaceuticals contained therein, the container transporter arranged to transport the pharmaceutical container from the pharmaceutical dispensing device to the container sealer; and a packager configured to package the pharmaceutical container for delivery, the container transporter arranged to transport the pharmaceutical container to the packager as disclosed by Terzini (‘835), for the purpose of sealing and shipping pharmaceutical containers.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colson et al. (US 12,503,259) in view of Stock et al. (US 2022/0404818). Colson discloses all the limitations of the claim, including forming a patient label on the pharmaceutical container, the patient label including at least one of a patient name, a day indicia indicating a day said at least a portion of the one or more pharmaceuticals is to be taken, a day time indicia indicating a time of day said at least a portion of the one or more pharmaceuticals is to be taken, a prescription number, one or more names of the one or more pharmaceuticals, or a combination thereof (see rejection above). However, it does not explicitly disclose a laser labeler. The combination is silent regarding how the label is applied to the container. Stock discloses a similar method which includes a laser labeler (see para. 0082) for the purpose of applying information to a container. It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the applicant’s invention to utilize a laser labeler, as disclosed by Stock, for the purpose of applying information to the container.
Allowable Subject Matter
Claim 2 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gaffigan (US 2021/0252658) discloses a device for creating a dispensing attachment for a medicine dispenser using a 3d printer. McErlean et al. (US 7,386,965) discloses a system for automatic prescription fulfillment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK HEWEY MACKEY whose telephone number is (571)272-6916. The examiner can normally be reached M - F 9-5.
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/PATRICK H MACKEY/ Primary Examiner, Art Unit 3653