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 .
Claim Status
This Office action is in response to the amendments filed 8/20/2025. Claims 37-60 are currently pending. Claims 1-36 have been previously canceled. Claims 44-60 are newly added.
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.
Claims 37, 42, 48, 51, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Kuwata (US 549166 A).
Regarding claim 37, Kuwata discloses a method of preparing at least one separate medical device component of at least one medical device packaged with a packaging system for medical use, comprising: selecting the packaging system comprising a thin, planar sheet of material (Fig. 1) that is foldable to have a base (24 – Fig. 3) and at least three sidewalls (4, 5, 6, 7 – Fig. 3) in a final packaging configuration (see Fig. 3), at least one of the sidewalls serving as a mounting sidewall (4, 6 – Fig. 3), at least one mounting feature (14’ and 33, 23’ and 34 – Fig. 3) being defined on at least the mounting sidewall to secure the at least one separate medical device component (see Fig. 3, 14’ and 33 are defined on 4 and 23’ and 34 are defined on 6 – Fig. 3), wherein the at least one separate medical device component (D – Fig. 4) is mountable onto at least the mounting sidewall (see Fig. 4); mounting the at least one separate medical device component onto at least the mounting sidewall (see Fig. 4); and engaging at least one feature (37 – Fig. 3) to secure at least one unfolding sidewall (7 – Fig. 3) in an unfolding direction (about 12 – Fig. 3) of the packaging system to close a display layout wherein a plurality of separate medical device components are arranged in a selected order (col. 9, lines 32-42 and see Figs. 3-4), wherein the at least one unfolding sidewall is at least one of the at least three sidewall (the at least 3 sidewalls are 4, 5, 6, 7 – Fig. 3, hence 7 is one of the at least three sidewalls). Note that the wall indicated by 7 is interpreted to be a sidewall because the top is interpreted to be a side.
However, Kuwata does not expressly disclose placing the packaging system on a working surface and disengaging at the at least one feature.
In this case, the Examiner takes the position that since Kuwata teaches engaging the at least one feature of the packaging system to close a display layout wherein a plurality of separate medical device components are arranged in a selected order, it would have been obvious to have disengaged the at least one feature in order to open the packaging system and access the medical device components. It would have been obvious because one of ordinary skill in the art would have the necessary experience opening packaging systems to understand that the at least one feature would need to be disengaged to access the medical device components. When the at least one feature is disengaged, the top of the packaging system would open to reveal a display layout wherein a plurality of separate medical device components are arranged in a selected order. Regarding the limitation “placing the packaging system on a working surface,” the Examiner again takes the position that it would have been obvious to one of ordinary skill in the art to have preceded the step of disengaging the at least one feature with this step since it is common to support a packaging system on a working surface while opening a packaging system.
Regarding claim 42, Kuwata further discloses the at least one separate medical device component (D – Fig. 4) includes at least one separate NPWT device component (a syringe is capable of being used for NPWT), wherein at least of first separate component (one of the syringes) of the plurality of separate medical device components is attachable to at least a second separate component (a second of the syringes) of the plurality of separate medical device components (the claim only requires the two components be capable of being attached to each other, in this case it is possible to attach a first syringe to a second syringe by many means, including using an adhesive), and wherein the at least one separate NPWT device component includes at least the first separate component (since a syringe is interpreted to be a NPWT component, the first separate component, the NPWT device includes the first separate component).
However, Kuwata does not expressly disclose that the first separate component has a different size and shape than the second separate component.
In this case, the examiner takes the position that since it is possible to place many different types of syringes within the packaging system of Kuwata, it would have been obvious to have two different size and shapes of components within the packaging system.
Regarding claim 48, Kuwata discloses essentially all of the elements of the claimed invention in claim 42.
However, Kuwata does not expressly disclose that the NPWT device component incudes at least one sterile component.
In this case, the examiner takes Official Notice that it is old and well-known in the art to provide sterile syringes.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have made the NPWT device component and sterile component since it is old and well-known in the art to provide sterile syringes. Note that this would result in the sterile syringe having at least one sterile component since all of the components of the syringe would be sterile. One of ordinary skill in the art would have been motivate to make this modification in order to reduce the change of infection during use.
Regarding claim 51, Kuwata further discloses that each sidewall is defined by a top edge, a bottom edge, and two opposite side edges (note that each sidewall has four edges, hence there is a top, bottom, and two opposite side edges) in the final packaging configuration and wherein at least one of the at least one mounting feature (14’ and 33, 23’ and 34 – Fig. 3) defined on at least the mounting sidewall (4, 6 – Fig. 3) is integral with the mounting sidewall (see Fig. 3, 14’ is integral with 4) and includes at least one fold in the mounting sidewall in the final packaging configuration (there is a fold between 14’ and 4 – Fig. 3).
Regarding claim 55, Kuwata further discloses at least one lip feature (one of the horizontal extensions of 14’ – Fig. 3) is defined on at least a portion of the top edge of at least one sidewall in the final packaging configuration (see Fig. 3, 14’ is disposed at a top edge of 4), and wherein any lip feature defined on at least a portion of the top edge of any sidewall in the final packaging configuration covers less than a majority of the base (based on Fig. 3, is it clear that one of the horizontal extensions of 14’ does not cover a majority of the base).
Claims 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kuwata (US 5494166 A) in view of Lavelle (US 2014/0027330 A1).
Regarding claim 38, Kuwata discloses essentially all of the elements of the claimed invention in claim 38.
However, Kuwata does not disclose that the packaging system includes a sheet of material placed around the planar sheet after folding.
Lavelle teaches a method comprising selecting a packaging system (Fig. 1) and placing the packaging system on a working surface (see Fig. 4, although unlabeled, the packaging system is clearly resting on a surface), wherein the packaging system includes a sheet of material (16 – Fig. 1) placed around a container (13 – Fig. 1) and placing the packaging system on the working surface includes configuring the sheet of material placed around the container to provide a barrier between the container and the working surface, such that the container does not contact the working surface after it is opened (see Fig. 4). One of ordinary skill in the art, upon reading the teaching of Lavelle, would have recognized that the container of Lavelle is
analogous to the planar sheet after folding of Kuwata since they are both containers for holding medical equipment.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have modified the method of Kuwata to include a sheet of material with the packaging system and to use it to provide a barrier as taught by Lavelle. One of ordinary skill in the art would have been motivated to make this modification in order to allow the container to be sterilized and reduce the probability of a contaminated medical device component.
Regarding claim 39, Kuwata, as modified by Lavelle, further teaches configuring of the sheet of material placed around the planar sheet after folding creates a sterile field (para. 0023, Lavelle).
Claims 40 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Kuwata (US 5494166 A) in view of Schluger (US RE33503 E) and Macinnes (US 2012/0145589 A1).
Regarding claim 40, Kuwata discloses essentially all of the elements of the claimed invention in claim 37 and further teaches that the planar sheet forms an enclosed volume in the final packaging configuration after folding (it is clear from Fig. 3 that rotating 37 downwards about 12 closes the packaging system).
However, Kuwata does not expressly disclose activating packaging instructions.
Schluger teaches a similar method comprising the step of disengaging at least one feature (36 – Fig. 1) of a packaging system (10 – Fig. 1) to activate packaging instructions (col. 2, lines 45-50; note that opening the packaging system provides access to the instructions, this is interpreted to be activating packaging instructions) on a sheet (the panel having the pocket, col. 2, lines 45-50) facing an enclosed volume (as can be seen from Figs. 1 and 3, when the panels are folded, they face an enclosed volume) in a final packaging configuration (the configuration of Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have modified the method of Kuwata such that the step of disengaging activates packaging instructions as taught by Schluger.
However, Schluger does not expressly teach that the instructions include at least one instruction for using at least one of at least one of the at least one separate medical device component and/or at least one of the at least one medical device.
Macinnes teaches a similar method comprising providing packaging instructions (1301 -Fig. 15, 1302 – Fig. 16, 1205 – Fig. 19), wherein the packaging instructions include at least one instruction for using the at least one medical device (as is clear from the legible instructions on 1301, 1302, and 1205).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention to have modified the method of Kuwata and Schluger such that the instructions include at least one instruction for using at least one of the at least one medical device. One of ordinary skill in the art would have been motivated to make this modification in order to improve that an end-user properly uses the at least one medical device and thereby improve safety.
Claim 54 is rejected in the same manner and noting that since each sidewall has four edges, each sidewall has a top edge, a bottom edge, and two side edges.
Allowable Subject Matter
Claims 41, 43, and 59 are allowed.
Claims 44-47, 49-50, 52-53, 56-58, and 60 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive.
Regarding claim 37, applicant argues that Kuwata does not disclose that disengaging involves disengaging a sidewall.
In response, it is noted that the new interpretation of Kuwata set forth above interprets the wall 7 to be a sidewall. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 37, applicant argues that it would not be obvious to disengaging after placing on a working surface since Kuwata discloses that the packaging systems may be placed on top of each other.
However, it is noted that any surface can be interpreted as a working surface, even the top of another packaging system. Furthermore, simply because Kuwata discloses that they may be overlaid does not mean that it would not be obvious to place them on some kind of working surface. Packaging systems are placed on working surfaces all the time. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 42, applicant argues that it is not obvious that a syringe is capable of being used for NPWT.
However, NPWT comprises many different steps and if the syringe is capable of being used in any of those steps, the it is capable of being used in NPWT. For example, the syringe is capable of holding a sterile gauze. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 42, applicant notes that it has been amended to include additional features of Kuwata does not disclose those features.
In response, it is noted that the examiner has modified the rejection. Please see the rejection of claim 42 above. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 38 applicant argues that Lavelle does not teaching placing the packaging system on a working surface such that the container does not contact the working surface after it is opened since Fig. 4 of Lavelle does not specify if the orientation of the working surface is before or after wrapping or that a barrier would be provided between the container and the working surface.
In response, it is noted that regardless of whether Fig. 4 depicts before or after wrapping, the arrangement would be the same. Unwrapping is simply the opposite of wrapping. Furthermore, the sheet clearly provides a barrier from the surface upon which the system is placed. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 39, applicant argues that after a tray is unwrapped the sterility of the wrap is compromised and cannot be used to create a sterile barrier.
However, when the sheet is wrapping around the tray and when modified to be included in the invention of Kuwata, around the packaging system, it provides a sterile barrier, consistent with the claim language. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 40, applicant argues that Schluger does not teach instructions on a sidewall.
However, it is noted that wall 7 is now interpreted to be a sidewall. Therefore, applicant’s arguments are found to be not persuasive.
Regarding claim 40, applicant argues that Schluger teaches removable instructions thus does not teach instructions on the packaging.
However, the claim language “on the planar sheet” can have the meaning of resting on top of. The instructions of Schluger rest on top of a planar sheet. Therefore, applicant’s arguments are found to be not persuasive.
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 THOMAS M WITTENSCHLAEGER whose telephone number is (571)272-7012. The examiner can normally be reached MON-FRI: 9:00-5:00.
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/THOMAS M WITTENSCHLAEGER/Primary Examiner, Art Unit 3731
11/6/2025