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 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, 5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wells (WO 2021/126676).
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Claim 1
Wells discloses a device (400) capable of supporting a plurality of medical containers, the device comprising a plate (402) having an upper surface, a lower surface, and a sidewall defining a perimeter of the plate and extending between the upper surface and the lower surface, the sidewall comprising four edges intersecting at corners, a longitudinal axis of the plate extending perpendicular to the upper surface, the plate defining a plurality of openings (412) extending through the plate from the upper surface to the lower surface (see figure 4b), each opening capable to retain a medical container therein, the plate being dimensioned to be disposed in a packaging (300) for transporting a plurality of medical containers such that a distance measured between opposing edges of the sidewall is less than a distance measured between opposing sidewalls of an interior surface of the packaging (see figures above); and at least two positioning elements (408) coupled at a first end thereof to the plate, each of the positioning elements having a second end opposite the first end detached from the plate, the first of the at least two positioning elements is at least partly disposed on a first edge of the four edges, the second of the at least two positioning elements is at least partly disposed on a second edge of the four edges, the first edge and second edge being adjacent to each other, wherein, when the plate is disposed in the packaging, each positioning element extends a lateral distance beyond the sidewall of the plate and axially beyond the upper surface of the plate such that each positioning element forms an acute angle relative to the longitudinal axis of the plate and such that each of the positioning elements contacts the interior surface of the sidewall of the packaging when the plate is disposed therein (see figures above).
Claim 5
Wells further discloses the first of the at least two positioning elements is disposed exclusively on a first edge of the four edges, the second of the at least two positioning elements is disposed on a second edge of the four edges, the first edge and second edge being adjacent to each other, and the first positioning element being separate from the second position element (see figures above).
Claim 8
Wells further discloses the positioning elements are formed integrally with the plate (see figures 4b and 4c).
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.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wells (WO 2021/126676) as applied to claim 5 above.
Claim 6
Wells further discloses the positioning elements (408) are formed from compressible/flexible U-shaped portions configured to friction fit within the packaging/tub and when the plate is exterior to the packaging/tub (see page 5). Wells discloses the packaging/tub in which the device is attached is tapered, reducing its width, from top to bottom of the packaging/tub. Wells does not explicitly disclose the acute angle could be variable by 65 to 80 degrees. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wells having the positioning elements with the required variable angles depending how depth the device is inserted into the packaging and/or depending the desired amount of friction between the positioning elements and the packaging/tub.
Claim 7
Wells further discloses a positioning element in two of the four edges of the device. Wells discloses, other embodiments, the positioning elements could be disposed on different edges of the device (see page 5). Wells does not explicitly disclose at least one positioning element coupled to each edge of the sidewall of the device. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have at least one positioning element on each edge of the sidewall of the device, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art to have better engagement between the device and the packaging/tub and/or to have a friction fit on each of the sidewalls between the device and the packaging/tub. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderbush (US 8,100,263) in view of Wells (WO 2021/126676).
Claim 9
Vanderbush discloses a packaging system (10’) for receiving a plurality of medical containers, the packaging system comprising a packaging (14’) comprising a sidewall extending from a bottom wall, an interior surface of the sidewall being stepped so as to define a ledge (50); a device (45) comprising a plate (45a) having an upper surface, a lower surface, and a sidewall (defined by peripheral edges 46) defining a perimeter of the plate and extending between the upper surface and the lower surface, the sidewall comprising four edges intersecting at corners, a longitudinal axis (defined by axis extending across top to bottom of the device) of the plate extending perpendicular to the upper surface, the plate defining a plurality of openings (60a) extending through the plate from the upper surface to the lower surface (see figure 6), each opening configured to retain a medical container therein, the plate being dimensioned to be disposed in a packaging (14’) for transporting a plurality of medical containers such that a distance measured between opposing edges of the sidewall is less than a distance measured between opposing sidewalls of an interior surface of the packaging (see figures 7 and 10a), wherein when the plate (45a) disposed in the packaging, the lower surface of the plate is disposed on the ledge (see column 16 lines 53-55). Vanderbush does not disclose the device comprising at least wo positioning elements, as required. However, Wells discloses a device (400) comprising at least two positioning elements (408) disposed on edges of the device (see figure 4a). Wells discloses the uses of the positioning elements are for frictionally engage with sidewalls of a packaging when inserted and preventing the device to move upwards helping the device to stay in place and immovable with respect to the packaging (see page 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wells the device having the positioning elements as taught by Wells for frictionally engage with sidewalls of the packaging when inserted and preventing the device to move upwards helping the device to stay in place and immovable with respect to the packaging.
Claim 11
After Vanderbush is modified by Wells, a minority of a surface area of the surface of the positioning element will be disposed against the interior surface of the sidewall of the packaging.
Claim 12
After Vanderbush is modified by Wells, an axial dimension of each positioning element will be less than or equal to an axial dimension measured between the ledge and an uppermost surface of the packaging. After Vanderbush is modified by Wells each of the positioning elements will be completely inserted within the interior of the packaging.
Claim 13
Wells further discloses the positioning elements friction fit within the interior of the packaging/tub (see figure 6). After Vanderbush is modified by Wells, the plate including the positioning elements will engage the interior surface of the sidewalls of the packaging by interference fit.
Claim 14
Vanderbush further discloses the device further comprises a plurality of chimneys (60), each chimney extends circumferentially about an opening (60a) of the plurality of openings and extends axially over the upper surface of the plate, each chimney configured to retain a medical container therein (see figure 7).
Allowable Subject Matter
Claims 2-4 and 10 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 05/05/2026 have been fully considered but they are not persuasive. Regarding applicant’s argument that the “holes” 412 are not configured to retain a medical device, the examiner disagrees. The examiner points out that the language recited in claim 1 “opening configured to retain a medical container” only requires the capability of the opening to perform the function of retaining a medical container. In the Office Action, the examiner interpreted the teachings of Wells as holes 412 capable to retain a medical container. Recited language “configured” is an intended use language in which the structure of the prior art only needs to be capable to perform the required function. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding applicant’s argument of the positioning elements, the examiner disagrees. Wells, figure 4A, discloses positioning elements/clips 408 on opposite edges of the plate. The recited language in claim 1 requires a positioning element disposed in a first edge and a second positioning element disposed on a second edge, wherein the first and second edges are adjacent to each other. The examiner points out that page 5 of Wells discloses that the clips 408 could be disposed on opposing edges of the body, but additionally, in other embodiments the clips are disposed on different edges of the body which in that case, the clips will be located on an edge next to the first edge. Furthermore, the examiner points out that the term “adjacent” is a broad term which meant an edge close to the first edge, in which if that is the case, the opposing edge to the first edge is adjacent to the first edge. After considering applicant’s arguments with respect to the rejection of the claims in view of the teachings Wells, the examiner considered the limitations required in claim 1 are fully disclosed by Wells.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
THIS ACTION IS MADE FINAL. 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 RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
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.
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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736
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