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 is in response to the reply filed on 4/11/2026, wherein claims 1, 3-15 and 19 were amended; and claim 20 was added. Claims 3-8 and 17-18 remain withdrawn from consideration.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 14, 16 and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McAdam et al. (US 2021/0361403).
Regarding claim 1, McAdam discloses a packaging (See Figs. 5-7) for a medical product (at 202), the packaging comprising: a secondary packaging (at 300 in Fig. 7) forming a sterile barrier, the sterile barrier forming a sealed or sealable receiving space (space within 302) for the medical product; and a product storage space and/or holder (at 204) for contact-free storage of the medical product within the secondary packaging (as shown in Fig. 7), the product storage space and/or holder being a protective cover for receiving the medical product and for interspacing the secondary packaging of the medical product, wherein the protective cover is made of a single, flexible flat blank (shown in Fig. 5) by folding along at least one hinged-fold line (fold line between 246 and 238 in Fig. 5) that is located between a first plate (246) of the flat blank and a second plate (238/244) of the flat blank, wherein: the first plate comprises a tab-shaped portion (at 250) extending away from the at least one hinged-fold line along a first plate edge (left-most edge of 246 in Fig. 5, from which 250 extends) located opposite the at least one hinged-fold line, and the second plate has a receptacle opening (at 254) in proximity to a second plate edge (right-most edge of 244 in Fig. 5) located opposite the at least one hinged-fold line that receives the tab-shaped portion of the first plate in a closed state of the product storage space (as shown in Fig. 6).
Regarding claim 2, McAdam discloses the protective cover is closed on all sides toward the secondary packaging in a closed state produced by folding (as shown in Figs. 6-7).
Regarding claim 14, McAdam discloses the first plate edge is parallel to the at least one hinged-fold line and the second plate edge (as shown in Fig. 5).
Regarding claim 16, McAdam discloses the protective cover is shaped like a pocket.
Regarding claim 19, McAdam discloses the receptacle opening if formed like a slit (as shown in Figs. 5-6).
Regarding claim 20, McAdam discloses a packaging (as shown in Figs. 5-7) for a medical product, the packaging comprising: a secondary packaging (at 300) forming a sterile barrier, which forms a sealed or sealable receiving space (space within 302) for the medical product, and a product storage space and/or holder (at 204) for contact-free storage of the product within the secondary packaging, wherein: the product storage space and/or holder is pocket-shaped protective cover for receiving the medical product (as shown in Figs. 5-6) and for interspacing the secondary packaging of the medical product (as shown in Fig. 7), wherein the protective cover is made of a single, flexible flat blank (at 204 in Fig. 5) by folding along at least one predefined hinged-fold line (fold line between 246 and 238 in Fig. 5), the flat blank comprises a first plate (at 246), a second plate (at 238/244) coupled to the first plate via the at least one predefined hinged-fold line, and a latching device (at 250/254) comprising a first part (250) on the first plate and a second part (254) on the second plate, wherein the first part and the second part can be brought into operative engagement when second plate is folded onto the first plate to hold the first plate and the second plate in a closed state (as shown in Fig. 6), and wherein the first part and the second part seal the first plate to the second plate along sides located opposite the at least one predefined hinged-fold line when the first plate and the second plate are in a flat unfolded position, and the protective cover is closed on all sides toward the secondary packaging in the closed state (as shown in Figs. 5-7).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McAdam et al. (US 2021/0361403) as applied to claim 1 above, and further in view of Sinn (US 5,390,782). As described above, McAdam discloses the claimed invention except for the specific material of the protective cover. However, Sinn teaches a protective cover (100) for a medical product, wherein the protective cover is formed from a Tyvek material for the purpose of its puncture-resistant properties (column 3, lines 28-34). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cover of McAdam to be formed from a Tyvek material in order to better protect from damage. Moreover, it is known in the art that Tyvek is a flexible, abrasion-resistant and sterilizable material. 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. In re Leshin, 125 USPQ 416.
Allowable Subject Matter
Claims 9-13 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
In view of Applicant's amendment, the search has been updated, and new prior art has been identified and applied. Applicant's arguments have been considered but are moot in view of the new ground(s) 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 STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735
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