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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/21/2026 has been entered.
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 top side of the first tray (Figure 12A), 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 top side in the second tray (256) offset from the at least one well in the first tray (as shown in Figure 13, the wells 336A, 335A, 336B, 335B on the top side of the second tray are offset to the well 298 of the first tray 254), the at least one well in the top side 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 top side of the first tray is shaped to accommodate a part of medical device and the at least one well (336A, 335A, 336B, 335B) in the top side of 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.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Detruit e al (2005/0077197).
PNG
media_image1.png
550
560
media_image1.png
Greyscale
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 (5) comprises at least one recess (18) on a bottom side of the second tray (5), and wherein the first tray (3) comprises at least one protrusion (42) on a top side of the first tray (3), 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 (43) in the top side of the first tray (3), the at least one well in the top side of the first tray being shaped as a receptacle for a first component of the medical device (the well 43 is shape to accommodate the tube of the medical device 4); and at least one well (as shown in Figure 1 the well is form around the projection 20), in top side of the second tray (5) offset from the at least one well in the first tray (as shown in Figure 1, the well 43 at the first tray 3 is not aligned with the wells on the top side of the second tray 5), the at least one well in the second tray being shaped as a receptacle (the well as annotated above of the second tray 5 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”. However, Detruit does not disclose the second tray comprises at least one protrusion on a bottom side of the second tray and the first tray comprises at least one recess on a top side of the tray. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse to have the at least one protrusion on a bottom side of the second tray at least one recess on a top side of the tray. It has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. MPEP2144.04 (VI)(A).
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 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.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dacey (20170290634) in view of Cianci et al (4,595,102) or Dunsky (4,293,074).
As to claims 18-20, Dacey further discloses the at least one well (298) is the top side of the first tray (254) has a depth that accommodates the first component therein and the at least one well (336A, B and 335A,B) in the top side of the second tray (256) has a depth, a medical device having the first component, the first component is accommodated in the at least one well in the top side of the first tray, and the at least one protrusion (334A-D) is engaged with the at least one recess to hold the top of the first tray against the bottom of the second tray (snap fit into the recess 304A-D at the second tray). However, Dacey does not specifically disclose the at least one well in the top side of the second tray has a depth that accommodates the second component therein. Nevertheless, Cianci discloses a kit for performing a medical procedure, the kit comprises a top tray (24), a bottom tray (12), both the top side of the top tray and the top side of the bottom tray comprises wells (recesses 26 on the top side of the top tray and recesses 14 on the top side of the bottom tray) both have sufficient depth to accommodate various first and second component for the medical procedure with medical device (needles or catheter). Similarly with Dunsky, Dunsky discloses a kit for performing a dental procedure (Figure 2), the kit comprises a top tray (12), a bottom tray (14), both the top side of the top tray and the top side of the bottom tray comprises wells (recesses 63A, 64A, 65A…etc on the top side of the top tray and recesses 38A, 41A, 42A, 62A…etc on the top side of the bottom tray) both have sufficient depth to accommodate various first and second component for the medical procedure with medical device (dental surgical equipments)
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 at least one well in the top side of the second tray of Dacey with sufficient depth to hold additional medical device as taught by Cianci or Dunsky so the wells at the top side of the second tray can hold additional medical device/equipment’s
Conclusion
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.
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 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.
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.
/CHUN HOI CHEUNG/Primary Examiner, Art Unit 3736
Prosecution Insights