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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-19 and 24-28) and Species 1 (Figure 1) in the reply filed on 12/10/2025 is acknowledged. In the reply, Applicant indicated that all claims are generic to elected species 1. Claims 20-23 are withdrawn from consideration as being directed to non-elected Group II.
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.
Claims 1-19 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Giovannone (US 5,379,572) in view of Patel (US 2016/0132658).
Regarding claim 1, Giovannone discloses a blister card (formed by elements 12/50 – See “finished package” at the right side of Fig. 1) for packaging pharmaceuticals (at 14 in Fig. 1) comprising: a blister sheet (at 12 in Fig. 1 – Fig. 1 labeled below) including a blister compartments (See compartment in 12 wherein 14 is accommodated) defining a recess configured to receive medications (as shown in Fig. 1); a label sheet (at 50 in Fig. 1 – See Fig. 1 labeled below) configured to be placed over the blister sheet to cover the blister compartment (as shown in Fig. 1) and including a seal portion (portion of 50 that surrounds the perimeter of the recess in 12 in Fig. 1 for sealing to 12 – Fig. 1 labeled below) that aligns with and correspond to the blister compartment; and a plurality of seals including a first type of seal (cold seal formed at 34/36 in Fig. 1) and a second type of seal (heat seal formed at 24/26 in Fig. 1) configured to adhere the label sheet to the blister sheet, the second type of seal being different than the first type of seal (column 4, line 52 – column 5, line 10).
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Giovannone discloses the claimed invention except for the blister sheet including a plurality of blister compartments. However, Patel teaches a blister packaging (See Fig. 1) comprising a blister sheet including a plurality of blister compartments, each blister compartment defining a recess configured to receive medications, for the purpose of providing a sealed package for containing multiple doses of medication (See [0007] and [0052]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blister packaging of Giovannone to include a plurality of blister compartments as taught by Patel in order to conveniently provide the user with multiple doses of medication.
Regarding claim 2, Giovannone discloses the first type of seal is a cold seal (at 30/32) and the second type of seal is a hot seal (at 20/22).
Regarding claim 3, Giovannone discloses the plurality of seals is provided on the blister sheet and the label sheet prior to adhering the label sheet to the blister sheet (the adhering of the label sheet to the blister sheet is formed after advancing through both hot and cold sealing).
Regarding claim 4, Giovannone discloses when the blister sheet and the label sheet are adhered, the plurality of seals abuts both the blister sheet and the label sheet (column 1, line 55 – column 2, line 12).
Regarding claim 5, Giovannone-Patel discloses the plurality of seals includes a first subset of seals of the first type of seal and a second subset of seals of the second type of seal, wherein the first subset of seals is arranged along a perimeter of the blister card between the blister sheet and the label sheet (column 2, lines 48-55).
Regarding claim 6, Giovannone-Patel discloses the second subset of seals is provided adjacent (the term adjacent is relatively broad and is defined as in close proximity – e.g. on the same side of the blister packaging) the first subset of seals along the perimeter of the blister card.
Regarding claim 7, Giovannone discloses the claimed invention except for the specifics of the seals. However, Patel further teaches wherein the plurality of seals includes a first subset of seals of the first type of seal and a second subset of seals of the second type of seal, wherein the first subset of seals is arranged between the plurality of blister compartments (the sealed medication compartments are not connected by perforations, which upon separation from the multi-compartment dosage through cutting or tearing produce an independently compliant single compartment for split package administration, [0085]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the plurality of seals of Giovannone to include a first subset of seals arranged between the plurality of blister compartments, as taught by Patel, for the purpose of providing a sealed package containing multiple doses of medication such that single doses of medication can be opened without opening any other doses of medication on the same blister card.
Regarding claim 8, Giovannone-Patel discloses the second subset of seals is provided adjacent the first subset of seals between the plurality of blister compartments (the term adjacent is relatively broad and is defined as in close proximity – e.g. on the same side of the blister packaging).
Regarding claim 9, Giovannone discloses the first type of seal (cold seal) is configured to temporarily adhere the label sheet to the blister sheet and does not require heat to be activated.
Regarding claim 10, Giovannone discloses the first type of seal is activated by applying pressure (by plates 44/46) to the first type of seal.
Regarding claim 11, Giovannone discloses the second type of seal (heat/hot seal) is heat activated.
Regarding claims 1 and 12-14, Giovannone discloses a blister card (formed by elements 12/50 – See “finished package” at the right side of Fig. 1) for packaging pharmaceuticals (at 14 in Fig. 1) comprising: a blister sheet (at 12 in Fig. 1 – Fig. 1 labeled above) including a blister compartment (See compartment in 12 wherein 14 is accommodated) defining a recess configured to receive medications (see medication 14 within blister recess directly below element 50 in Fig. 1); a label sheet (at 50 in Fig. 1 – See Fig. 1 labeled above) configured to be placed over the blister sheet to cover the blister compartment (as shown in Fig. 1) and including a seal portion (portion of 50 that surrounds the perimeter of the recess in 12 in Fig. 1 – Fig. 1 labeled above) that aligns with and correspond to the blister compartment; and a plurality of seals including a first type of seal (heat seal formed at 24/26 in Fig. 1) and a second type of seal (cold seal formed at 34/36 in Fig. 1) configured to adhere the label sheet to the blister sheet, the second type of seal being different than the first type of seal (column 4, line 52 – column 5, line 10). Giovannone discloses the claimed invention except for the blister sheet including a plurality of blister compartments. However, Patel teaches a blister packaging (See Fig. 1) comprising a blister sheet including a plurality of blister compartments, each blister compartment defining a recess configured to receive medications, for the purpose of providing a sealed package for containing multiple doses of medication (See [0007] and [0052]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blister packaging of Giovannone to include a plurality of blister compartments as taught by Patel in order to conveniently provide the user with multiple doses of medication. Furthermore, Giovannone discloses the first type of seal has a higher adhesive strength (heat seal can be easily pulled apart) prior to activation compared to the second type of seal (cold press does not seal without heat prior heat activation), and wherein the second type of seal has a higher adhesive strength after activation compared to the first type of seal; the second type of seal has no adhesive strength prior to activation; and the first type of seal is a non-tamperproof seal and the second type of seal is a tamperproof seal.
Regarding claim 15, Giovannone discloses a blister card (formed by elements 12/50 – See “finished package” at the right side of Fig. 1) for packaging pharmaceuticals comprising: a blister sheet (at 12 in Fig. 1 – Fig. 1 labeled above) including a blister compartment (See compartment in 12 wherein 14 is accommodated – See Fig. 1 labeled above), the blister compartment defining a recess (See Fig. 1 labeled above) configured to receive medications; a label sheet (at 50 in Fig. 1 – See Fig. 1 labeled above) configured to be placed over the blister sheet; and a plurality of cold seals (formed by 44/46) and a plurality of hot seals (formed by 34/36) provided between the blister sheet and the label sheet and configured to adhere the label sheet to the blister sheet. Giovannone discloses the claimed invention except for the blister sheet including a plurality of blister compartments. However, Patel teaches a blister packaging (See Fig. 1) comprising a blister sheet including a plurality of blister compartments, each blister compartment defining a recess configured to receive medications, for the purpose of providing a sealed package for containing multiple doses of medication (See [0007] and [0052]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blister packaging of Giovannone to include a plurality of blister compartments as taught by Patel in order to conveniently provide the user with multiple doses of medication.
Regarding claim 16, Giovannone-Patel discloses the plurality of cold seals is arranged along a perimeter of the blister card between the blister sheet and the label sheet (the term adjacent is relatively broad and is defined as in close proximity – e.g. on the same side of the blister packaging)., and wherein the plurality of hot seals is provided adjacent each of the plurality of cold seals along the perimeter of the blister card (the term adjacent is relatively broad and is defined as in close proximity – e.g. on the same side of the blister packaging).
Regarding claim 17, Giovannone-Patel discloses the plurality of cold seals is arranged between the plurality of blister compartments, and wherein the plurality of hot seals is provided adjacent each of the plurality of cold seals between the plurality of blister compartments (the term adjacent is relatively broad and is defined as in close proximity – e.g. on the same side of the blister packaging).
Regarding claim 18, Giovannone-Patel discloses the plurality of cold seals has higher adhesive strength compared to the plurality of hot seals prior to heat activation of the plurality of hot seals.
Regarding claim 19, Giovannone-Patel discloses the plurality of cold seals are non-tamperproof seals (until after pre-heating) and the plurality of hot seals are tamperproof seals (once cold seal pressed).
Regarding claim 24, Giovannone discloses a blister card (formed by elements 12/50 – See “finished package” at the right side of Fig. 1) for packaging pharmaceuticals comprising: a blister sheet (at 12 in Fig. 1 – Fig. 1 labeled above) including a blister compartment (See compartment in 12 wherein 14 is accommodated), the blister compartment defining a recess (See Fig. 1 labeled above) configured to receive medications; a label sheet (at 50 in Fig. 1 – See Fig. 1 labeled above) configured to be placed over the blister sheet to cover the plurality of blister compartments and including a plurality of seal portions (portion of 50 that surrounds the perimeter of the recess in 12 in Fig. 1 – Fig. 1 labeled above) that align with and correspond to the blister compartment; and a plurality of seals (seal formed at 34/36 and seal formed at 24/26) configured to adhere the label sheet to the blister sheet, the plurality of seals having a first adhesive strength when activated using a first activation technique (a preheat seal press station having a preheated press comprising an upper 20 and lower 22 platens with upper 24 and lower 26 working tools – column 4, lines 35-38) and having a second adhesive strength when activated using a second activation technique, wherein the first adhesive strength is a non-zero adhesive strength and the second adhesive strength is higher than the first adhesive strength (the plastic is heated substantially through the depth of the plastic film thickness, so that on cold bonding at the cold seal station the plastic material forms a deep, strong, cold-seal bond – column 4, lines 52-56). Giovannone discloses the claimed invention except for the blister sheet including a plurality of blister compartments. However, Patel teaches a blister packaging (See Fig. 1) comprising a blister sheet including a plurality of blister compartments, each blister compartment defining a recess configured to receive medications, for the purpose of providing a sealed package for containing multiple doses of medication (See [0007] and [0052]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blister packaging of Giovannone to include a plurality of blister compartments as taught by Patel in order to conveniently provide the user with multiple doses of medication.
Regarding claim 25, Giovannone discloses the plurality of seals form a non-tamperproof seal when activated using the first activation technique and form a tamperproof seal when activated using the second activation technique (column 4, lines 35-56).
Regarding claim 26, Giovannone discloses the plurality of seals is provided on the blister sheet and the label sheet prior to adhering the label sheet to the blister sheet (the adhering of the label sheet to the blister sheet is formed after advancing through both hot and cold sealing).
Regarding claim 27, Giovannone-Patel discloses when the blister sheet and the label sheet are adhered, the plurality of seals abuts both the blister sheet and the label sheet.
Regarding claim 28, Giovannone-Patel discloses the plurality of seals includes a first subset of seals and a second subset of seals, wherein the first subset of seals is arranged along a perimeter of the blister card between the blister sheet and the label sheet (column 2, lines 48-55). Giovannone does not disclose wherein the second subset of seals is arranged between the plurality of blister compartments. However, Patel further teaches wherein the second subset of seals is arranged between the plurality of blister compartments ([0085]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the plurality of seals of Giovannone to include a second subset of seals arranged between the plurality of blister compartments, as taught by Patel, for the purpose of providing a sealed package containing multiple doses of medication such that single doses of medication can be opened without opening any other doses of medication on the same blister card.
Conclusion
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735