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 .
The status of the claim(s) is as follows:
Claim 11 has been amended,
Claims 12-20 were previously presented, and
Claim 21 has been added.
Therefore, claims 11-21 are currently pending in this application.
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 11-12, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McClosky (4,398,634).
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As to claim 11, McClosky discloses a medication package (20) comprising an upper foil (28); and a lower foil (30);wherein the upper foil and the lower foil are connected to one another along a plurality of lines (as shown in Figure 3 and 4, the upper and lower foil are heat sealed around the periphery of the compartment and via peripheral seal zone 32), wherein a first group of compartments is provided (as shown in Figure 3 above, the upper two compartments are considered as a first group of compartment), the compartments of which are arranged one after the other along a longitudinal direction (the upper two compartment are arranged one after another in one longitudinal direction), wherein the respective compartment is limited at the top by a part of the upper foil and at the bottom by a part of the lower foil (Figure 5), wherein a front compartment is separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil (as shown in Figure 3, a upper left compartment 34 are completely separatable from the subsequent compartment, i.e., rear compartment, upper right compartment 34 via the peripheral seal zone 32), wherein at least one pill is arranged in at least one compartment of the first group (Figure 5 shows a single pill inside the compartment), wherein the package further comprises a second group of compartments (second group as the lower compartments as annotated in above Figure 3), the compartments of which are arranged one after the other in a longitudinal direction (the lower two compartment are arranged one after another in one direction), the respective compartment being limited at the top by a part of the upper foil and at the bottom by a part of the lower foil, a front compartment being separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil, wherein at least one pill is arranged in at least one compartment of the second group (Figure 5 shows a single pill inside the compartment), wherein the upper foil and the lower foil are flexible foils (column 4, line 6 teaches that the planar plastic sheet 28 and 30 are heat seal with each other, and the plastic material is flexible material).
As to claim 12, McClosky further discloses the longitudinal direction (as shown in Figure 3 as annotated above) along which the compartments of the first group are arranged runs parallel to the longitudinal direction along which the compartments of the second group are arranged.
As to claims 19-20, McClosky further discloses the upper foil and the lower foil consist of the same material (Figure 5 shows the same material marking, and column 3, lines 60-68 which the packaging system provide opposed planar plastic sheet 28 and 30 which can be made of tear resistance plastic material such as Mylar), the upper foil and the lower foil are welded to one another along a plurality of lines (heat sealed).
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.
The factual inquiries 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over McClosky (4,398,634) in view of Dressel et al (5,511,665).
As to claim 21, McClosky discloses a medication package (20) comprising an upper foil (28); and a lower foil (30);wherein the upper foil and the lower foil are connected to one another along a plurality of lines (as shown in Figure 3 and 4, the upper and lower foil are heat sealed around the periphery of the compartment and via peripheral seal zone 32), wherein a first group of compartments is provided (as shown in Figure 3 above, the upper two compartments are considered as a first group of compartment), the compartments of which are arranged one after the other along a longitudinal direction (the upper two compartment are arranged one after another in one longitudinal direction), wherein the respective compartment is limited at the top by a part of the upper foil and at the bottom by a part of the lower foil (Figure 5), wherein a front compartment is separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil (as shown in Figure 3, a upper left compartment 34 are completely separatable from the subsequent compartment, i.e., rear compartment, upper right compartment 34 via the peripheral seal zone 32), wherein at least one pill is arranged in at least one compartment of the first group (Figure 5 shows a single pill inside the compartment), wherein the package further comprises a second group of compartments (second group as the lower compartments as annotated in above Figure 3), the compartments of which are arranged one after the other in a longitudinal direction (the lower two compartment are arranged one after another in one direction), the respective compartment being limited at the top by a part of the upper foil and at the bottom by a part of the lower foil, a front compartment being separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil, wherein at least one pill is arranged in at least one compartment of the second group (Figure 5 shows a single pill inside the compartment). McClosky further discloses the flexible foil are made of Mylar material which is a polyester film made from stretched PET, but does not specifically disclose the upper foil and the lower foil are low-density polyethylene material foils. Nevertheless, Dressel discloses a child-resistant package for medication comprises upper and lower foils (12 and 13), the upper foil and the lower foil are low-density polyethylene material foils (column 6, lines 47-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the foil material of McClosky with additional layers such as LDPE and metal foil as taught by Dressel to form a greater strength medical package that is tear-resistant to the infant. Furthermore, it would also be obvious to one skill in the art to replace the molten polyethylene adhesive layer with LDPE sheet as adhesive layer since a sheet of LDPE is easier to handle when process the package.
Claims 11-14, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over by Khawaja (2006/0070895) in view of Hall et al (4,158,411).
As to claim 11, Khawaja discloses a medication package (10) comprising an upper foil (the back sheet made of paper); and a lower foil (the sheet formed blister container 12); wherein the upper foil and the lower foil are connected to one another along a plurality of lines (the upper and lower foil are heat sealed around the periphery of the compartment, [0021]), wherein a first group of compartments is provided (as shown in Figure 1, the first group is considered as the row , “Morning”) which are arranged one after the other along a longitudinal direction (Figure 1), wherein the respective compartment is limited at the top by a part of the upper foil and at the bottom by a part of the lower foil (the definition of blister), wherein a front compartment is separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil (as shown in Figure 1, the compartment labeled matrix with Sunday morning is completely separate from the subsequent compartment in longitudinal direction), wherein at least one pill is arranged in at least one compartment of the first group ([0018] with the pill container contains the medication, the medication place in container is considered as pill), which the structure is , wherein the package further comprises a second group of compartments (second group as with the name Noon), the compartments of which are arranged one after the other in a longitudinal direction, the respective compartment being limited at the top by a part of the upper foil and at the bottom by a part of the lower foil, a front compartment being separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil, wherein at least one pill is arranged in at least one compartment of the second group ([0018] with the pill container contains the medication place in container is considered as pill). However, Khawaja does not specifically disclose that the upper foil and lower foil are flexible foil. Nevertheless, Hall discloses a blister package comprises an upper foil (cover portion 12 with paper layer and aluminum foil); and a lower foil (thin sheet of flexible plastic material 26), the upper and lower foil are flexible foil (the paper layer with aluminum foil and the thin sheet of flexible plastic material are both flexible foils). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container 12 formed from a sheet of molded plastic material of Khawaja with the container portion form with flexible sheet of material as taught by Hall in order to able to push the medication out of the container portion for easy access of the medication from the container portion.
As to claim 12, Khawaja as modified further discloses the longitudinal direction (Morning row) along which the compartments of the first group are arranged runs parallel to the longitudinal direction (Noon row) along which the compartments of the second group are arranged.
As to claim 13, Khawaja as modified further discloses at least one further group of compartments, the compartments of which are arranged one after the other in a longitudinal direction (Evening row), wherein the respective compartment is limited at the top by a part of the upper foil and at the bottom by a part of the lower foil, wherein a front compartment is separated from a compartment directly subsequent to it in the longitudinal direction by one of the lines connecting the upper foil to the lower foil, wherein at least one pill is arranged in at least one compartment of the further group.
As to claim 14, Khawaja as modified further discloses the first group contains seven compartments and/or the second group contains seven compartments (as shown in Figure 1, morning and noon row each comprises 7 compartments).
As to claim 16, Khawaja as modified further discloses a weakening of the material or a partial material breakthrough (perforation 16) is provided in the upper foil and the lower foil in the area of at least one line to form a separating aid ([0021] teaches the perforations that can separate the pill container into individual sealed pill containers).
As to claims 17-18, Khawaja as modified further discloses a print is provided on the upper side of the upper foil (a print of the differential marking, 18, 20, 22, 24) on each of the upper side of the upper foil, i.e., the back sheet) and comprising a frame (frame with Sunday-Saturday and Morning-night that can be completely separate from each compartment via perforation 16) that runs around the compartments present and to which the upper foil is directly connected to the lower foil.
As to claim 20, Khawaja further discloses the upper foil and the lower foil are glued to one another (via adhesive) along a plurality of lines ([0021]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Khawaja (2006/0070895) and Hall et al (4,158,411) in view of Wick (5,014,851).
As to claim 15, Khawaja as modified does not specifically disclose two pills are arranged in at least one compartment. Nevertheless, Wick discloses a similar blister package with upper back sheet (22) and lower blister sheet (11), the blister sheet comprises plurality of compartments (recess 23) and each other compartments holds plurality of pills in the at least one compartments (Figure 2 and 4 shows multiple pills 13 in each compartment).
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive.
Applicant argues that McClosky fails to teach or suggest a first group and a second group where each group is comprised of compartments arranged sequentially in a longitudinal direction such as rows A1 and A2. Such argument is not found persuasive. McClosky clearly discloses a two-by-two medication package. The top two compartments are arranged sequentially in one direction and the lower two compartments are also arranged sequentially in the same direction. The fact that applicant use the phrase “longitudinal”, examiner change the orientation of the medication package as shown in Figure 3 above as annotated which read on applicant’s claim language. With regarding to “creating a specific "tubular blister" sequence that allows for specific access to different dosage timings within a single, unified medication package” (page 9 of argument), which applicant claiming a functional language and not specifically claiming in claim 11. The structure of McClosky recites the top two compartments can also function as to take one in the morning and second sequent compartment for night time use.
Furthermore, applicant’s argues that “resent claim 11 is fundamentally distinct from the separable units disclosed in McClosky. The McClosky reference does not disclose a sequential longitudinal grouping of compartments where at least one pill is arranged in both a first and second group for the purpose of managing distinct medication intervals. Rather, McClosky describes identical, separable packages with placement of tear lines relative to pockets to avoid roughened bridge areas. McClosky lacks the specific "front" and "rear" longitudinal sequencing of multiple dosage groups.” (page 9 last paragraph). Upon further review of the claim 11, claim 11 does not explicitly claiming the limitation as applicant argues. Although these elements are found as examples or embodiments in the specification, they were not claimed explicitly. Nor were the words that are used in the claims defined in the specification to require these limitations. A reading of the specification provides no evidence to indicate that these limitations must be imported into the claims to give meaning to disputed terms. Constant v. Advanced Micro-Devices, Inc., 7 USPQ2d 1064.
Applicant’s arguments with respect to claims 11-21 to the primary reference Khawaja have been considered but are moot because the new ground of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles can be reached at (571)270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736
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