DETAILED ACTION
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.
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.
Claims 2, 4, 7, 8, 9, 10, 13, 14, 15, 16, 17, 18, 19, 20, and 21, are rejected under 35 U.S.C. 103 as being unpatentable over Tedham (U.S. Publication 2004/0188313) in further view of Bourque (U.S. Publication 2010/0319304).
Regarding claim 2, Tedham teaches a cartridge (shown in figures 11, 12, and 13, blister pack item 18) comprising: a frame having a face and defining a series of chambers therein (figure 12 item 18 is considered having the shape of a face, pockets items 12 and bubbles items 28 are considered reading on chambers), an opening to each chamber intersecting the face (items 22 and 28 are formed on item 18 and considered intersecting a surface of item 18), each chamber sized to receive one or more supplements therein (paragraph 99 teaches items 22 are filled with product and considered capable of containing supplements, the material being stored in the cartridge is considered intended use); and a membrane affixed in surface-to-surface relationship to the face of the frame and aligned therewith (frangible membrane 24), the membrane extending over and sealingly covering the series of chambers (paragraph 96 pockets 22 are covered by frangible membrane 24), wherein the membrane is puncturable such that the membrane is configured to be ruptured over each chamber in order to extract the one or more supplements therefrom (paragraph 96 teaches the membrane 24 is frangible and considered capable of being ruptured to extract a supplement); wherein the membrane further comprises a series of marker zones each marker zone associated with a respective one of the series of chambers (zones, which is interpreted as an area, can be delineated around each pocket 22), and each marker zone configured to be ruptured to indicate that the associated chamber has been opened (membrane 24 is considered capable of being ruptured at item 22, once ruptured open, clearly being visible that it has been opened); and information printed on the cartridge, indicia of data associated with one or more supplements contained within the cartridge (paragraph 108 teaches the blister pack having information printed thereon including the day of the week, which is considered reading on data associated with one or more supplements contained within the cartridge). Regarding claim 2, Tedham is silent to the marker zone of the membrane comprising ink provided on the membrane. Regarding claim 2, Bourque teaches a marker zone on a membrane (figure 6 item 50 is considered reading on the membrane, lines 62 and 60 are considered defining marker zones for each pill receptacle) comprising ink provided on the membrane (see printing on sheet 50 proximate each pill opening, paragraph 86 teaches using ink-jet printers to print information which is considered using ink to print). Regarding claim 2, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the membrane of Tedham with the ink printing provided on the membrane of Bourque in order to provide specific information to the patient by the doctor (see paragraph 86).
Regarding claim 4, Tedham teaches a supplement cartridge (shown in figures 11, 12, and 13, blister pack item 18, the materials being worked upon are considered intended use) comprising: a frame having a face and defining a series of chambers therein (figure 12 item 18 is considered having the shape of a face, pockets items 12 and bubbles items 28 are considered reading on chambers), an opening to each chamber intersecting the face (items 22 and 28 are formed on item 18 and considered intersecting a surface of item 18), each chamber sized to receive one or more supplements therein (paragraph 99 teaches items 22 are filled with product and considered capable of containing supplements, the material being stored in the cartridge is considered intended use); and a membrane affixed in surface-to-surface relationship to the face of the frame and aligned therewith (frangible membrane 24), the membrane extending over and sealingly covering the series of chambers (paragraph 96 pockets 22 are covered by frangible membrane 24), wherein the membrane is puncturable such that the membrane is configured to be ruptured over each chamber in order to extract the one or more supplements therefrom (paragraph 96 teaches the membrane 24 is frangible and considered capable of being ruptured to extract a supplement); wherein the membrane further comprises a series of marker zones each marker zone associated with a respective one of the series of chambers (zones, which is interpreted as an area, can be delineated around each pocket 22), and each marker zone configured to be ruptured to indicate that the associated chamber has been opened (membrane 24 is considered capable of being ruptured at item 22, once ruptured open, clearly being visible that it has been opened).Regarding claim 4, Tedham is silent to wherein the membrane is considered to be ruptured in the marker zone to indicate the associated chamber has been opened and wherein the marker zone further comprises ink provided on the membrane. Regarding claim 4, Bourque teaches wherein the membrane (figure 6 item 50) is considered to be ruptured in the marker zone to indicate the associated chamber has been opened (marker zones indicated by lines 60 and 62) and wherein the marker zone further comprises ink provided on the membrane (see printing on sheet 50 proximate each pill opening, paragraph 86 teaches using ink-jet printers to print information which is considered using ink to print). Regarding claim 4, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the membrane of Tedham with the ink printing provided on the membrane of Bourque in order to provide specific information to the patient by the doctor (see paragraph 86).
Regarding claim 7, Tedham teaches wherein each marker zone is aligned with an associated serving chamber (a marker zone is considered an area that can be delineated around each chamber item 22).
Regarding claim 8, Tedham teaches wherein each marker zone is disposed within an annular region of the membrane (a marker zone is considered an area that can be delineated within the annular region shown proximate item 26).
Regarding claim 9, Tedham teaches wherein each marker zone is spaced apart from an adjacent marker zone (areas can be drawn around each of item 22 that are spaced apart from adjacent areas of items 22).
Tedham is silent to the language of claim 10. Regarding claim 10, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the membrane of Tedham with the ink printing provided on the membrane of Bourque in order to provide specific information to the patient by the doctor (see paragraph 86). Regarding claim 10, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective fling date to modify the location of the printing in order to allow a user to more easily view the contents of the cartridge while inserting it into the dispenser since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 13, Tedham teaches wherein the indicia is indicative of data associated with the one or more supplements contained within the supplement cartridge (paragraph 108 teaches the blister pack having information printed thereon including the day of the week, which is considered reading on data associated with one or more supplements contained within the cartridge).
Regarding claim 14, Tedham teaches wherein the indicia further comprises a starter queue indicia indicative of a first chamber to be opened from the at least one chamber (paragraph 108 teaches the day of the week inherently indicating an order to in which the chambers are to be opened).
Regarding claim 15, Tedham teaches further comprising an adhesive connecting the membrane to the face of the frame and cooperating with the membrane to seal each chamber (paragraph 99 teaches using laminating the membrane which would inherently require an adhesive, and paragraph 99 additionally teaches the sealing configuration).
Regarding claim 16, Tedham teaches wherein the face of the frame is annular from an interior hole to an outer peripheral edge (see central aperture item 26 formed in item 18 which forms the annular configuration).
Regarding claim 17, Tedham teaches wherein the membrane defines an inner hole extending therethrough, the inner hole sized to align with the interior hole of the frame (figure 13 teaches an annular hub item 30 and shows the membrane item 24).
Regarding claim 18, Tedham teaches an annular shape in the frame interior hole (see items 26 and 30). Tedham is silent to the shape of claim 18. Regarding claim 10, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the membrane of Tedham with the ink printing provided on the membrane of Bourque in order to provide specific information to the patient by the doctor (see paragraph 86). Regarding claim 18, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the shape of cartridge to fit a corresponding shape of a dispenser it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Regarding claim 19, Tedham teaches wherein at least one layer of the membrane comprises a foil-like material, a plastic material, or a paper-based material (paragraph 96 teaches foil).
Regarding claim 20, Tedham teaches a pharmaceutical product (paragraph 4 teaches pharmaceutical products).
Regarding claim 21, Tedham teaches a membrane for a supplement cartridge (paragraph 96 membrane, item 24 ), the membrane comprising an outer face and an inner face (the outer face is facing the atmosphere, the inner face is facing items 22), wherein the indicia is indicative of data associated with one or more supplements contained within the cartridge (paragraph 108 teaches the blister pack having information printed thereon including the day of the week, which is considered reading on data associated with one or more supplements contained within the cartridge), wherein the inner face is configured to be affixed to a face of a frame of the cartridge to seal one or more chambers defined therein (item 24 is positioned on the face of item 18), wherein the membrane is puncturable to extract the one or more supplements from within each chamber (paragraph 96 teaches a frangible membrane); and wherein the membrane comprises a series of marker zones, each marker zone associated with each chamber and configured to be ruptured to indicate that the associated chamber has been opened (paragraph 96 teaches the membrane 24 is frangible and considered capable of being ruptured to extract a supplement). Regarding claim 21, Tedham is silent to the location of the printing being on the membrane and specifically being on the marker zones wherein the membrane is configured to be ruptured in the marker zone to indicate that the associated chamber has been opened and wherein the marker zone of the membrane comprises ink provided on the membrane. Regarding claim 21, Bourque teaches wherein the membrane (figure 6 item 50) is configured to be ruptured in the marker zone to indicate that the associated chamber has been opened (marker zones defined by lines 60 and 62, ruptured in the center to access the pills below) and wherein the marker zone of the membrane comprises ink provided on the membrane (paragraph 86 teaches an ink-jet printer which is considered using ink to print on the membrane). Regarding claim 21, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the membrane of Tedham with the ink printing provided on the membrane of Bourque in order to provide specific information to the patient by the doctor (see paragraph 86). Regarding claim 21, absent any unexpected results, it would have been obvious to one of ordinary skill in the art prior to the effective fling date of the claimed invention to modify the location of the printing in order to allow a user to more easily view the contents of the cartridge while inserting it into the dispenser since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tedham (U.S. Publication 2004/0188313) in view of Bourque (U.S. Publication 2010/0319304) in further view of Estabrook (U.S. Publication 2012/0321756).
Regarding claim 11, Tedham is silent to the language of claim 11. Regarding claim 11, Estabrook teaches wherein machine-readable binary code indicia (paragraph 52 teaches machine readable indicia including serial number or alphanumeric text string which is considered including binary code). It would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the cartridge indicia of Tedham in view of Bourque with the indicia of Estabrook in order to allow for specific information for the controller (see Estabrook paragraph 52).
Regarding claim 12, Tedham is silent to the language of claim 12. Regarding claim 12, Estabrook teaches indicia including a barcode (paragraph 52). would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the cartridge indicia of Tedham in view of Bourque with the indicia of Estabrook in order to allow for specific information for the controller (see Estabrook paragraph 52).
Response to Arguments
The remarks mailed 10/302/2025 regarding the 35 U.S.C. 102 (a)(1) rejection of claim 4 and the 35 U.S.C. 103 rejection of claims 3 and 21 have been considered and are persuasive in light of the amendments to claims 3, 4, and 21. A new ground of rejection is provided, necessitated by amendment.
The cancelation of claims 3, 5, and 6, is acknowledged.
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 ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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, Claire Wang can be reached at (571)270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANSHU BHATIA/Primary Examiner, Art Unit 1774