DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-2, 5 and 15-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194) and Tonrey (US 4,196,809) and further in view of Mason (US 4,372,098).
Regarding claim 1, Klatt (figs. 3-4) discloses a packaging 5 for holding a plurality of oral medications, the packaging comprising:
a body including a plurality of compartments 11 each being configured to hold at least one of the plurality of oral medications, the body including an outer perimeter, one or more outer corner regions, a shoulder extending about the outer perimeter, a center region, and a plurality of strips, the one or more outer corner regions, the shoulder, the center region, and the plurality of strips defining a top surface of the body, wherein the one or more outer corner regions are arranged between the shoulder and the outer perimeter of the body, wherein the body includes four outer corner regions to provide the body with a square geometrical shape; and a
cover.
Klatt fails to disclose:
the plurality of strips extending radially from the center region of the body to the shoulder;
at least two of the four corner regions include surface-area reducing features;
the cover adhesively bonded to the top surface of the body for confining the plurality of oral medications in the compartments, the cover being at least partially detachable from the body to access all of the compartments and the oral medications positioned in the compartments; and
a corner pull tab formed as a portion of the cover, the corner pull tab being formable at one or more outer corner regions including the surface-area reducing features, the corner pull tab being configured to at least partially detach the adhesive attachment of the cover from the top surface of the body.
However, Gervais teaches a blister pack with a plurality of strips extending radially from a center region of the body to a shoulder (fig. 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have rearranged the compartments of Klatt to have a plurality of strips extending radially from the center region, as taught by Gervais, to facilitate sequential dosing and improved user guidance without altering the underlying blister structure.
Further Torney teaches:
a cover 17 adhesively bonded to a top surface of a body 16 for confining a plurality of oral medications in the compartments, the cover 17 being at least partially detachable from the body to access the oral medications; and
corner pull tabs 20a formed as a portion of the cover, the corner pull tabs being formable at one or more outer corner regions, the corner pull tabs 20a being configured to at least partially detach the adhesive attachment 33 of the cover 17 from the top surface of the body (figs. 1-8 and col. 2, lines 59-65).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, to have adhesively bonded the cover of the modified Klatt to the entire top surface of the body, and provided a pulling area in the corner, to provide a child resistant packaging, which permits opening by adults without undue difficulty, and presents substantial obstacles to being opened by children as taught by Tonrey in col. 1, lines 5-11.
Further Mason teaches:
one or more outer corner regions of a package including non-planar structures 22 defining surface-area reducing features on the body 12 (figs. 1-3, col. 3, lines 24-26).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, to have provided the at least one corner region of the modified device of Klatt, a non-planar structure, for providing easy gripping, as taught by Mason in col. 3, lines 24-26.
Regarding claim 2, the modified Klatt further discloses the surface-area reducing features ( of Mason) comprise non- planar structures formed into the top surface of the body (figs. 1-3, col. 3, lines 24-26 of Mason).
Regarding claim 5, the modified Klatt further discloses the cover being adhesively bonded to the entirety of the top surface of the body (figs. 1-8 and col. 2, lines 59-65 of Tonrey).
Regarding claim 15, Klatt further disclose the body and the cover being free of score lines or lines of weakening (fig. 3).
Regarding claim 16, the modified Klatt further discloses the shoulder being disposed between the outer perimeter of the body and the compartments, and each of the strips being disposed between an adjacent pair of the compartments (fig. 1 of Gervais).
Regarding claim 17, Klatt further discloses a carton, the carton comprising:
an outer casing that defines an interior space configured to hold a plurality of packagings 5 in a vertical stack, wherein the plurality of packagings 5 each contain the same amount and type of oral medications such that every packaging in the carton contains the same amount and type of oral medications (fig. 3).
Claims 6-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194), Tonrey (US 4,196,809) and Mason (US 4,372,098) as applied to claim 1 above, further in view of Margulies (US 4,294,361).
Regarding claims 6-10, the modified Klatt discloses all elements of the claimed invention as applied to claim 1 above, but fails to disclose:
the body includes an indexing feature configured to permit establishment of a rotational orientation of the body;
wherein the indexing feature is formed in the top surface of the body;
wherein the indexing feature projects away from a plane defined by the top surface of the body;
wherein the entirety of indexing feature is spaced from the outer perimeter of the body; and
wherein the indexing feature is located at one of the one or more outer corner regions of the body.
However, Margulies teaches separating a pull tab of a blister package by pushing a feature 18 formed on a top surface of the body (fig. 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have provided the feature 18 of Margulies near the pull tab of the modified Klatt, to easily start separating the pull tab without having to fold the corner. It has been held that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result. KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1395 (citing United States v. Adams, 383 U.S. 50-51, 148 USPQ 479, 483 (1966)).
Also, it is noted that the feature 18 of Margulies is capable of being used as an indexing feature.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194), Tonrey (US 4,196,809) and Mason (US 4,372,098) as applied to claim 1 above, further in view of Lucas (US 4,053,054).
Regarding claim 11, the modified Klatt discloses all elements of the claimed invention except for each of the plurality of compartments includes a first side wall, a second side wall, and a third side wall that form a triangular opening that narrows from the first side wall in a direction toward the center region of the body.
However, Lucas teaches a package for medications having compartments 2 with triangular-shaped openings (figs. 1-2).
It would have been obvious to one of ordinary skill in the art at the time of the invention, to have made the compartments of the modified Klatt, triangular-shaped, as taught by Lucas, to use the space of the package more effectively.
Further, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194), Tonrey (US 4,196,809), Mason (US 4,372,098) and Lucas (US 4,053,054) as applied to claim 11 above, further in view of Ward (US 3,615,039).
Regarding claim 12, the modified Klatt discloses all elements of the claimed invention as applied to claim 11 above, but fails to disclose each of the plurality of compartments includes a denesting feature that projects from the first side wall into an interior space of the compartment.
However, Ward teaches containers having denesting lugs 18 (fig. 1 and col. 2, lines 40-44).
It would have been obvious to one of ordinary skill in the art at the time the invention was made, to have provided the compartments of the modified Klatt, denesting lugs, as taught by Ward, for easily pulling apart stacked packagings that have not been filled yet. It is also noted that one of ordinary skill in the art would have provided each of the compartments of the modified Klatt, denesting lugs (taught by Ward) to provide better balance and provide a more stable stack. Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 13-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194), Tonrey (US 4,196,809) and Mason (US 4,372,098) as applied to claim 1 above, further in view of Heath (US 6,588,180).
Regarding claim 13, the modified Klatt discloses all elements of the claimed invention except for the body including a plurality of indicia, with each of the indicia marked on one of the compartments such that each of the compartments is uniquely identified by a respective one of the indicia, and wherein each of the indicia is legible from an exterior of the packaging.
However, Heath teaches compartments of a blister pack having indicia 20 (figs. 1-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to add indicia to the compartments of the modified Klatt, in order to provide the user with information regarding the contents of each compartment, thereby improving identification and proper use.
Regarding claim 14, Klatt further discloses the cover including a first surface, a second surface between the first surface and the compartments. However, the modified Klatt fails to disclose a data field on the first surface, the data field comprised of human-readable text that correlates one of the indicia with an alphanumeric identifier of the oral medication in each of the compartments.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to add printed matter on the blister cover to indicate the compartments contents, as this is a routing, way to improve user convenience without altering the compartment’s function. Further, it has been held that when the claimed printed matter is not functionally related to the substrate it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the substrate may render the device more convenient by providing an individual with a specific type of information does not alter the functional relationship. Mere support by the substrate for the printed matter is not the kind of functional relationship necessary for patentability.
Claims 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klatt (US 6,988,619) in view of Gervais (US 2005/0112194), Tonrey (US 4,196,809) and Mason (US 4,372,098) as applied to claim 17 above, further in view of Toinet (US D321,134).
Regarding claims 18-20, Klatt further discloses the carton including a slot 8 formable in the outer casing to provide access to the interior space for removing the packagings (fig. 3). However, the modified Klatt fails to disclose:
a removable slot cover disposed over the slot;
wherein the removable slot cover includes perforations and is separable from the outer casing of the carton along the perforations to form the slot; and
wherein the removable slot cover includes an opening configured to receive a finger for separating the removable slot cover from the outer casing of the carton.
However, Toinet teaches a removable slot cover disposed over a slot;
wherein the removable slot cover includes perforations and is separable from the outer casing of the carton along the perforations to form the slot; and
wherein the removable slot cover includes an opening configured to receive a finger for separating the removable slot cover from the outer casing of the carton (figs. 1-2 and 8).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have provided the slot 8 of the modified Klatt, a cover and an opening to receive a finger, as taught by Toinet, to prevent accidental loss of the blister packages during shipment and for easy removal of the cover when a user is ready to use the medicines.
Response to Arguments
Applicant's arguments filed 7/17/26 have been fully considered but they are not persuasive.
Applicant argues that the examiner has not established that Klatt discloses a body having square geometrical shape. However, fig. 4 of Klatt depicts the body as having a generally square configuration including four outer corner regions. Furthermore, to the extent that the depicted configuration is not considered to be square, modifying the shape of the body would have been obvious since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
In response to applicant's arguments against the Tonrey and Mason references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Tonrey teaches the four outer corner regions and Mason teaches that at the time the invention was filed, it was well known to provide corner gripping regions, surface-area reducing features for providing easy gripping.
Further, applicant argues that nothing in Mason teaches or suggests providing knurling, at two or more corner regions. However, the two or more corner regions are taught by Tonrey and not Mason.
Applicant further argues that the combination is improper because further modifying Klatt in view of Mason would undermine the very reason the examiner provides for relying on Tonrey. However, the mere provision of a gripping region does not establish that a child would identify, grasp, and use the gripping region to open the package.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. 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 BLAINE GIRMA NEWAY whose telephone number is (571)270-5275. The examiner can normally be reached Monday - Friday 9:00 AM- 5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at 571-272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLAINE G NEWAY/Examiner, Art Unit 3735
/Anthony D Stashick/Supervisory Patent Examiner, Art Unit 3735
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