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 .
Response to Amendment
Due to applicant’s amendment filed on January 20, 2026, the 112(b) rejections in the previous office action (dated 10/02/2025), are hereby withdrawn.
The status of the claim(s) is as follows:
Claims 1, 4, 7, 12-14 have been amended,
Claims 2-3, 5, 8-11 and 15 were previously presented,
Claim 6 was canceled,
Claims 16-17 were added
Therefore, claims 1-5 and 7-17 are currently pending in this application.
Drawings
The drawings were received on 01/20/2026. These drawings are accepted as applicant amend the drawing to correct one of the reference number 140 into 130 for the tray. However, the drawings are remain objected to under 37 CFR 1.83(a) because they fail to show reference number 190 indicate “a balloon catheter” as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7-11 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dacey (20170290634).
As to claim 1, Dacey discloses a packaging (250) for a medical device (252) comprising an outer packaging (258) defining an internal space; and a first and a second tray (254 and 256) configured to be arranged in the internal space (Figure 16A-C shows that the outer packaging folded to wrap around the tray 254 [0165]), wherein the second tray (256) comprises at least one protrusion (334A-D) on a bottom side (332) of the second tray, and wherein the first tray (254) comprises at least one recess (304A-D) on a top side of the first tray, the at least one recess being aligned with the at least one protrusion, wherein the second tray is configured to be arranged on the first tray so that the at least one protrusion engages with the at least one recess (the protrusion snap-fit into the 304A-D), at least one well (298) in the first tray, the at least one well in the first tray being shaped as a receptacle for a first component of the medical device (the well 298 is shape to accommodate the shaft of the medical device); and at least one well (336A, 335A, 336B, 335B) in the second tray (256) offset from the at least one well in the first tray (as shown in Figure 11, the wells are not align with each other), the at least one well in the second tray being shaped as a receptacle (the wells 3336A, 335A, 336B, 335B are form as a receptacle that is capable to hold a rectangular shape part of medical device). The medical device are not being claimed as the applicant use the intended use language “for a first component of the medical device” and “for a second component of the medical device”.
As to claim 3, Dacey further discloses that the at least one protrusion and the at least one recess are deep drawn into the tray (Figure 11, 12a-d and 13a-d shows that the protrusions and recesses are drawn into the tray).
As to claim 4, Dacey further discloses the at least one protrusion and the at least one recess are tapered so as to induce a press-fit when the at least one protrusion is inserted into the at least one recess and/or wherein the at least one protrusion and the at least one recess are configured to induce a snap fit upon insertion of the at least one protrusion into the at least one recess (as shown in Figure 13C and 13D, the protrusion (334 B-D are curved outward making the sidewall tapered and [0160] teaches that the protrusions are being snap-fit into the recesses of the bottom tray
As to claim 5, Dacey further discloses the second tray comprises a plurality of protrusions (334A-D, four protrusions) on the bottoms side of the second tray, and wherein the first tray comprises a corresponding plurality of recesses (304A-D, four recesses) on a top side of the first tray, each recess being aligned with one of the plurality of protrusions, wherein the second tray is configured to be arranged on the first tray so that each of the plurality of protrusions engages with a corresponding one of the plurality of recesses.
As to claim 7, Dacey further discloses the second tray comprises at least one holding element configured to hold the respective component in place, when the respective component is accommodated in the associated at least one well (355a-b teaches molded projections that engage the shaft top prevent lateral movement of the medical device in the channel 278 [0159]).
As to claim 8, Dacey further discloses an inner packaging in form of a sterile pouch (260), the sterile pouch being configured to hermetically enclose the first tray and the second tray when they are arranged in the internal space ([0147] teaches the pouch 260 with medical instrument inside for being sterilized and air-tight sealed).
As to claim 9, Dacey further discloses the outer packaging is a cardboard box (the sleeve being paperboard material [0161]).
As to claim 10, Dacey further discloses that the first tray (254) comprises a first material (high density polyethylene) , and wherein the second tray comprises a second material (polypropylene), the first and the second material having at least one different property from one another, wherein the at least one different property is density).
As to claim 11, Dacey further discloses the first tray (254) comprises a first material (high density polyethylene), and wherein the second tray comprises a second material (polypropylene). According to online website: Polypropylene vs. HDPE: Material Differences and Comparisons | Xometry. The hardness of polypropylene (PP) is higher than High density polyethylene (HDPE), which makes the first tray (254) softer than the second tray to form a cushion for the second tray with better shock resistance.
As to claim 16, Dacey further discloses the first tray and the second tray are differently shaped (as shown in Figure 11, the first tray 256 are in different shape in compare to the first tray) to accommodate different geometries of the first and second components of the medical device (medical device are not positively claimed, and the second tray have a well in the shape of elongated well that is shape to accommodate the shaft of the medical device and the least one well (336A, 335A, 336B, 335B) in the second tray (256) being shaped as a receptacle that can hold a rectangular shape part of medical device).
As to claim 17, Dacey further discloses that the at least one well (298) in the first tray is shaped to accommodate a part of medical device and the at least one well (336A, 335A, 336B, 335B) in the second tray (256) being shaped as a receptacle that can hold a rectangular shape part of medical device). Note: applicant does not properly claimed the combination of the balloon catheter and dilatation catheter and the packaging together. Therefore, the medical device is not positively being claimed.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Detruit e al (2005/0077197).
As to claim 1, Detruit discloses a packaging (Figure 2) for a medical device (4) comprising an outer packaging (7 and 8) defining an internal space (11); and a first and a second tray (3 and 5) configured to be arranged in the internal space (Figure 3), wherein the second tray (3) comprises at least one protrusion (42) on a bottom side of the second tray (3, as the tray and cover rotated, and first tray 5 is place on top of the second tray 3 and the protrusion 42 is protruded from the bottom side of the tray 3), and wherein the first tray (5) comprises at least one recess (18) on a top side of the first tray as the tray and cover rotated, and second tray 3 is place at the bottom side and recess 18 is form on the top side), the at least one recess being aligned with the at least one protrusion, wherein the second tray is configured to be arranged on the first tray so that the at least one protrusion engages with the at least one recess ([0048]), at least one well (20) in the first tray (5), the at least one well in the first tray being shaped as a receptacle for a first component of the medical device (the well 20 is shape to accommodate the tube of the medical device); and at least one well (the underside of the raise central zone 41) in the second tray (3) offset from the at least one well in the first tray (as shown in Figure 2, the wells are not align with each other), the at least one well in the second tray being shaped as a receptacle (the underside of the raise central zone are form as a receptacle that is capable of accommodating the parietal reinforcement. The medical device are not being claimed as the applicant use the intended use language “for a first component of the medical device” and “for a second component of the medical device”.
As to claim 2, Detruit further discloses the at least one protrusion comprises a base portion forming a spacer (raise central zone 41) and an engaging portion (42) protruding from the base portion, the engaging portion being configured to be inserted into the at least one recess (18) so that a face side of the base portion rests on the top side of the first tray.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dacey (20170290634) in view of Baker (5,489,022).
As to claim 12, Dacey does not disclose the second tray comprises a light absorbing dye and/or comprises a light stopping material, such that a light sensitive component of the medical device arranged on the first tray can be protected from overexposure to UV radiation. Nevertheless, Baker discloses a Baker discloses a medical packaging comprising a pair of thermoplastic sheets and at least one of which having a transparent portion that is capable of absorbing ultraviolet light with ultra-light absorbing material (14) laminate to the thermoplastic sheet (11) to prevent oxidation and consequential deterioration when exposed to ultraviolet light. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray and lid of Dacey with light absorbing/stopping material (12) as taught by Baker in order to protect the medical instrument inside the tray from oxidation and deuteriation when exposed to harmful ultraviolet light during UV sterilization.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dacey (20170290634) in view of Gordon et al (3,967,728).
As to claim 13, Dacey does not disclose the first and/or the second tray comprises a heat insulating component and/or a heat insulating material, such that a heat sensitive component of the medical device present in a space formed between the first and second tray can be protected from overexposure to heat or can stably maintain an inner temperature relative to an external temperature. Nevertheless, Gordon discloses a package (Figure 6) comprises a pair of multilayer film construction, the multilayer film construction comprises Mylar film layer, the Mylar film layer to act as a thermal insulation layer form on the outer surface of the layer in order to reduce heat transfer during steam sterilization to protect the article store within the package from heat breakdown or degradation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray and lid of Dacey with thermal insulation layer as taught by Gordon in order to protect the medical instrument inside the tray from breakdown or degradation when under steam sterilization.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dacey (20170290634) in view of Colombo (7,175,021).
As to claim 14, Dacey further discloses that the material of the first and second material being high density polyethylene and polypropylene. However, Dacey does not disclose the first and/or the second tray comprise a permeation regulating component and/or a permeation regulating material such that a permeation sensitive component of the medical device present in a space formed between the first and second tray can be protected from a gas and/or a liquid, or wherein the first and/or the second tray comprise a semipermeable material to permit accelerated transport of a gas, across the first and second trays. Nevertheless, Colombo discloses a package tray (32) made of a gas permeable solid resin, such as polypropylene, polystyrene, low-density polyethylene, amorphous poly(ethylene terephthalate), high-density polyethylene, and suitable mixtures thereof (column 9, lines 66-67 to column 10, lines 1-3) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray and lid of Dacey material made of gas permeable polypropylene or high-density polyethylene as taught by Colombo in order to provide the gas permeable characteristic to the package. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dacey (20170290634) in view of Hasegawa et al (6,228,324).
As to claim 15, Dacey further discloses the tray and lid being thermoformed. However, Dacey does not disclose the first and or second tray is formed by a deep drawing process. Nevertheless, Hasegawa discloses medical package comprises a container body (2) and a cover (3), the container body is made of PET film with a deep drawing method (column 5, line 45). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray and lid of Dacey with deep drawing process as taught by Hasegawa in order to have one piece construction with versatile shape.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the 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 CHUN HOI CHEUNG whose telephone number is (571)270-5702. The examiner can normally be reached Monday to Friday 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E Aviles 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.
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/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736