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 .
This Office Action acknowledges the applicant’s amendment filed on 3/13/2026. Claims 1-14, 19 and 21-25 are pending in the application. Claims 15-18 and 20 are cancelled. Claims 21-25 are new.
The text of those sections of Title 35, U.S. code not included in this action can be found in a prior Office Action.
Claim(s) 1, 3, 5-11, 13, 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. US 9,993,601 B2 in view of Lloyd et al. US 5,497,763.
With regards to claim 1, Jung (Fig. 4-5) discloses a blister package (3; Col 4:1-4), comprising: a base layer having a first side and a second side, the first side opposing the second side, at least one dome extending from the first side with each dome defining a cavity 3A that receives a liquid drug dose (2; Col 1:38-40); an intermediate layer (3D; Col 4:18-22, 28-40) extending over the second side of the base layer and covering each cavity, the intermediate layer including an integrally formed nozzle opening (3E; Col 4:18-22) aligned with each cavity; and a removable layer (10/10A; Col 10:32-42) extending over the intermediate layer and being releasable from the intermediate layer for uncovering each nozzle opening.
Jung recites in Col 1:41-57, the carrier can hold and disperse a variety of formulations including liquid, fluid, powder for medicinal and therapeutic purposes, therefore it is capable of delivering an ophthalmic drugs. Since such a limitation is considered an intended use.
Jung recites a nozzle but it does not specifically disclose an inner surface of each nozzle opening is hydrophobic in a manner that the liquid drug dose is unable to exit each nozzle opening when the removable layer is removed unless a force urges the dome substantially toward the intermediate layer.
However, Lloyd teaches it was known in the art to have a blister package 1 have an inner surface of each nozzle opening 14 is hydrophobic (Col 14:23).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of the nozzle opening in Jung by having it be hydrophobic as taught by Lloyd for the purposes of strengthening the integrity of the nozzle.
With regards to claim 3, Jung (Fig. 4-5) discloses the base layer 3B comprises at least one of polyvinylchloride (PVC). (Col 8:64-67)
With regards to claim 5, Jung (Fig. 4-5) discloses each nozzle opening 3E is patterned into the intermediate layer 3D. (Col 10:32-42)
With regards to claim 6, Jung (Fig. 4-5) appears to disclose each nozzle opening (3E) is etched into the intermediate layer 3D.
In accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. nozzle openings, does not depend on its method of production, i.e. etching. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
With regards to claim 7, Jung discloses nozzle openings but it does not specifically disclose each nozzle opening comprises an array of slits.
Jung recites in (Col 11:14-17) the openings may have any shape or form to deliver and dispense the article, therefore, to modify nozzle openings with slits as claimed would entail a mere change in shape of the openings and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). 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.
With regards to claim 8, Jung discloses nozzle openings but it does not specifically disclose slits extending parallel to one another.
Jung recites in (Col 11:14-17) the openings may have any shape or form to deliver and dispense the article, therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to the openings be in the form of a plurality of slits extending parallel to one another, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
With regards to claim 9, Jung (Fig. 4-5) discloses nozzle openings but it does not specifically disclose slits are between 10-200 µm wide.
It has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patentably distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
With regards to claim 10, Jung (Fig. 4-5) discloses the removable layer 10/10A provides a moisture barrier to each nozzle opening. (Col 11:31-35)
With regards to claim 11, Jung (Fig. 4-5) discloses the removable layer 10/10A includes a tab 10B for helping to separate the removable layer from the intermediate layer 3D.
With regards to claim 13, Jung (Fig. 4-5) discloses each nozzle opening 3E is aligned with the respective cavity 3A through a thickness of the base layer.
With regards to claim 19, Jung (Fig. 4-5) discloses the intermediate layer 3D is noncoplanar with the base layer 3B.
With regards to claim 21, Jung discloses nozzles formed on the blister package but it does not specifically disclose each nozzle opening is oriented and shaped to be configured to produce a fluid stream of the liquid drug dose in a direction substantially perpendicular to an outer surface of the intermediate layer, the outer surface of the intermediate layer facing in a same direction as the second side of the base layer, each nozzle opening configured to face in a direction of fluid delivery of the liquid drug dose to a patient, wherein no portion of the blister package or any structure coupled to the blister package is positioned directly above the intermediate layer when the removable layer is removed.
However, Lloyd further teaches each nozzle opening 14 is oriented and shaped to be configured to produce a fluid stream of the liquid drug dose in a direction substantially perpendicular to an outer surface of the intermediate layer. The combination with Jung would inherently disclose the outer surface of the intermediate layer facing in a same direction as the second side of the base layer, each nozzle opening configured to face in a direction of fluid delivery of the liquid drug dose to a patient, wherein no portion of the blister package or any structure coupled to the blister package is positioned directly above the intermediate layer when the removable layer is removed.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the blister package in Jung by providing the nozzle openings as arranged above as taught by Lloyd for the purposes of allowing the dispensing of the articles from the blister.
Claim(s) 2, 4, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. US 9,993,601 B2 in view of Lloyd et al. US 5,497,763 and further in view of Kurowski et al. US 8,795,607 B2.
With regards to claim 2, Jung discloses the claimed invention (removable layer) as stated above but it does not specifically disclose the removable layer comprises a blister foil composite including an aluminum core.
However, Kurowski (Fig. 3) teaches that it was known in the art to have a removable layer 3/7 comprise a blister foil composite including an aluminum core. (Col 9:1-3)
The inventions of Jung and Kurowski are both drawn to the field of containers (blisters) that are capable of holding items such as medicinal articles. Each container includes a blister tray, an intermediate layer and removable layer. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the removable layer in Jung by providing the removable layer with a blister foil composite including an aluminum core as taught by Kurowski for the purposes of providing a fluid-tight closure to the cavity.
With regards to claim 4, Jung discloses removable layer (10/10A), but does not specify the material comprised in the removable layer. However, Kurowski further teaches the removable layer 3/7 comprises at least one of polyvinylchloride (PVC). (Claim 9). In addition, in Column 3, starting in line 21 Kurowski describes how using plastics would allow the film to tear while the plastic film undergoes only an elastic and/or plastic deformation. Therefore, it would have been obvious to one of ordinary skill in the art to have further modified the invention of Jung and have the removable layer to comprise at least PVC, as it has been held that the selection of a known material based on its suitability of its intended use supports a prima facie obviousness – See MPEP 2144.07.
With regards to claim 12, Jung (Fig. 4-5) discloses a dome but it does not specifically disclose the dome is configured to buckle in response to a force urging the dome towards the intermediate layer to cause the liquid drug dose to be pushed through the nozzle opening.
Kurowski teaches it was known in the art to have a dome 1 configured to buckle in response to a force urging the dome towards the intermediate layer 13 to cause the liquid drug dose to be pushed through the nozzle opening 6.
Jung recites the blister 3 is formed of a flexible material, therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the dome in Jung by configuring the dome to buckle in response to a force urging the dome towards the intermediate layer as taught by Kurowski for the purposes of providing a way of dispensing the article from the blister.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. US 9,993,601 B2 in view of Lloyd et al. US 5,497,763 and further view of Kurowski et al. US 8,795,607 B2.
With regards to claim 14, Jung discloses a blister package comprising: a polymer base layer (3B; Col 8:64-67) having a first side and a second side, the first side opposing the second side, wherein domes (3A; plurality of receptacles Col 4:6,8:64-67) extend from the first side with each dome defining a cavity that receives a liquid drug dose (2; Col 1:38-40); a polymer intermediate layer (3D; Col 4:18-22, 28-40) extending over the second side of the base layer and covering each cavity, the intermediate layer including an integrally formed nozzle (3E; Col 4:18-22) aligned with each cavity and comprising openings extending entirely through the intermediate layer; and a peelable layer (10/10A; Col 10:32-42) extending over the intermediate layer and being releasable from the intermediate layer for uncovering each nozzle.
Jung recites in Col 1:41-57, the carrier can hold and disperse a variety of formulations including liquid, fluid, powder for medicinal and therapeutic purposes, therefore it is capable of delivering an ophthalmic drugs. Since such a limitation is considered an intended use.
Jung discloses domes to form the cavities of the blisters but it does not specifically disclose hemispherical domes.
However, Kurowski (Fig. 3) teaches that it was known in the art to have dome cavities be hemispherical domes. (Col 9:46-47)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the domes in Jung by having them be hemispherical domes as taught by Kurowski for the purposes of providing an alternative shape to the cavity, since it has been held that changes in shape is a matter of design choice which a person skilled in the art would have found obvious absent any persuasive evidence that the particular configuration of the claimed container was significant – see MPEP 2144.04-IV-B.
Jung discloses a peelable layer but it does not specifically disclose the peelable layer being a composite layer.
However, Kurowski teaches that it was known in the art to have a peelable layer 3/7 be a composite layer. (Col 11:11-13)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the peelable layer in Jung by providing the layer with a composite as taught by Kurowski for the purposes of providing a fluid-tight closure to the cavity.
Jung discloses nozzle openings but it does not specifically disclose each nozzle opening comprises an array of slits.
Jung recites in (Col 11:14-17) the openings may have any shape or form to deliver and dispense the article, therefore, to modify nozzle openings with slits as claimed would entail a mere change in shape of the openings and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). 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.
Jung recites a nozzle but it does not specifically disclose an inner surface of each nozzle opening is hydrophobic in a manner that the liquid drug dose is unable to exit each nozzle opening when the removable layer is removed unless a force urges the dome substantially toward the intermediate layer.
However, Lloyd teaches it was known in the art to have a blister package 1 have an inner surface of each nozzle opening 14 is hydrophobic (Col 14:23).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of the nozzle opening in Jung by having it be hydrophobic as taught by Lloyd for the purposes of strengthening the integrity of the nozzle.
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung et al. US 9,993,601 B2.
With regards to claim 22, Jung discloses a blister package (3; Col 4:1-4), comprising: a base layer having a first side and a second side, the first side opposing the second side, at least one dome extending from the first side with each dome defining a cavity 3A that receives an liquid drug dose (2; Col 1:38-40); an intermediate layer (3D; Col 4:18-22, 28-40) extending over the second side of the base layer and covering each cavity, the intermediate layer including an integrally formed nozzle opening (3E; Col 4:18-22) aligned with each cavity, each nozzle opening configured to deliver the liquid drug dose; and a removable layer configured to seal the liquid drug dose within the cavity, the removable layer (10/10A; Col 10:32-42) extending over the intermediate layer and being releasable from the intermediate layer for uncovering each nozzle opening to allow for the delivery of the liquid drug dose.
Jung recites in Col 1:41-57, the carrier can hold and disperse a variety of formulations including liquid, fluid, powder for medicinal and therapeutic purposes, therefore it is capable of holding an ophthalmic drugs. Since such a limitation is considered an intended use.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. US 9,993,601 B2 in view of Kurowski et al. US 8,795,607 B2.
With regards to claim 23, treated as in claim 2 above.
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et al. US 9,993,601 B2.
With regards to claim 24, Jung discloses the nozzle, cavity, intermediate layer and base layer but it does not specifically disclose the nozzle and the cavity are micro-molded with the intermediate layer and the base layer, respectively.
In accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. nozzle, cavity, intermediate layer and base layer, does not depend on its method of production, i.e. micro-molding. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
With regards to claim 25, Jung discloses the nozzle, cavity, intermediate layer and base layer but it does not specifically disclose the nozzle and the cavity are stamped into the intermediate layer and the base layer, respectively.
In accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. nozzle, cavity, intermediate layer and base layer, does not depend on its method of production, i.e. stamped. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14, 19 and 21-25 have been considered but are moot because of a 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 JENINE SPICER whose telephone number is (313)446-4924. The examiner can normally be reached 9:00am-5:00pm, Monday-Thursday.
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, Orlando E. Avilés 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.
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.
/JENINE SPICER/Examiner, Art Unit 3736
/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736
Prosecution Insights