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 .
Election/Restrictions
Applicant’s election without traverse of Species 6 (Figures 12-15L) in the reply filed on 12/3/2025 is acknowledged. In the reply, Applicant indicates that claims 1, 2, 9-16 and 19 correspond to the elected species. Claims 3-8 and 17-18 are withdrawn from consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 1, it appears “A packaging for or of a medical product” should be “A packaging for a medical product”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 9-16 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rendered indefinite by the limitation “which is made of a single, flexible flat cut by folding along at least one hinged-fold line” since it is unclear what structural element is made of a single, flexible flat cut by folding along at least one hinged-fold line. For examination purposes, Examiner interprets the phrase “which is made of” as “wherein the protective cover is made of”. Furthermore, it is unclear what structure is being defined by “flat cut” since it is not a known term in the art. For examination purposes, Examiner interprets “flat cut” as “flat blank” since the protective cover appears to be formed by a flat blank of material that is folded. Applicant is advised to amend other instances of the phrase in subsequent claims as well.
Claim 2 is rendered indefinite by the limitation “closed on all sides toward the secondary packaging in a closed state produced by folding” since it is unclear how the protective cover can be closed toward the secondary packaging. For examination purposes, Examiner interprets the limitation as “closed on all sides by folding”.
Claim 10 is rendered indefinite by the limitation “a first end of the at least one perforation line and a second end of said at least one perforation line or, where the at least one perforation line comprises two perforation lines on the same folding or cover plate, a first perforation line and a second perforation line open into a side edge of the folding or cover plate opposite the hinged-fold line” since it is unclear what structure is being encompassed in the claim. For examination purposes, Examiner interprets the claim limitation as “a first end of the at least one perforation line and a second end of said at least one perforation line that open into a side edge of the folding or cover plate opposite the hinged-fold line, or, the at least one perforation line comprises two perforation lines on the same folding or cover plate, wherein the two perforation lines include a first perforation line and a second perforation line which are both open into a side edge of the folding or cover plate opposite the hinged-fold line”.
Regarding claim 11, the phrase "tab-like portion" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "-like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For examination purposes, Examiner interprets the phrase "tab-like portion" as “tab-shaped portion” since element 6 in the drawings is a tab structure.
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, 2, 14-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malinowski et al. (US 7,600,634).
Regarding claim 1, Malinowski discloses a packaging (shown in Fig. 1) for a medical product, the packaging comprising: a secondary packaging (envelope 50 in Fig. 1) forming a sterile barrier (described in column 3, lines 24-43), the sterile barrier forming a sealed receiving space (cavity within 50 in Fig. 1 which accommodates element 100) for the medical product; and a product storage holder (at 200 in Fig. 2 – shown in detail in Fig. 7) capable of contact-free storage of a medical product within the secondary packaging, the product storage holder being a protective cover for receiving the medical product and for interspacing the secondary packaging of the medical product (as shown in Fig. 1), which is made of a single, flexible flat blank (shown at 200 in Fig. 7) by folding along at least one hinged-fold line (fold lines 218/220/218/220 which surround panel 210 in Fig. 7).
Regarding claim 2, Malinowski discloses the protective cover is closed on all sides by folding (as shown in Figs. 7-12).
Regarding claim 14, Malinowski discloses a base latching device (at 264 in Fig. 7) of a base plate (portions 210/240/244 in Fig. 7 make up the base plate) is configured as a receptacle, which is arranged in the proximity to a side edge of the base plate, and a folding plate (at 242 in Fig. 7) has a tab-shaped portion (at 262) which extends outwardly from the side edge of the folding or cover plate, which in the closed state is opposite the side edge with receptacle of the base plate, and which is insertable into the receptacle of the base plate (as shown in Fig. 11).
Regarding claim 15, Malinowski discloses the protective cover (200) can be made of a Tyvek material (which is known in the art to be a flexible, abrasion-resistant and sterilizable material).
Regarding claim 16, Malinowski discloses the protective cover is shaped like a pocket (as shown in Fig. 12).
Regarding claim 19, Malinowski discloses the receptacle forming the base latching device is formed like a slit (slit-shaped opening at 264).
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, 9-14, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grabowski et al. (US 9,707,039) in view of Van Ness (US 5,788,063).
Regarding claim 1, Grabowski discloses a packaging (See Figs. 1-5) for a medical product, the packaging comprising: a product storage holder (holder shown at 600 in Fig. 14 – shown in the folded configuration at 400 in Fig. 12) capable of contact-free storage of a medical product, the product storage holder being a protective cover for receiving the medical product, wherein the protective cover is made of a single, flexible flat blank (at 602 in Fig. 14) by folding along at least one hinged-fold line (at 607a/608a). Grabowski discloses the claimed invention except for the secondary packaging.
However, Van Ness teaches sealing a product storage holder (at 5 in Fig. 1-2, which holds a medical product/device 205) within a secondary packaging (at 10 in Fig. 1), wherein the secondary packaging forms a sterile barrier by forming a sealed space (cavity within 10 that accommodates 5 in Fig. 1), for the purpose of providing a secure, sterile, moisture-proof space for medical devices (column 2, lines 44-51). 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 provided the product storage holder of Grabowski within a secondary packaging as taught by Van Ness in order to better protect the medical product during storage and transport.
Regarding claim 2, Grabowski discloses the protective cover is closed on all sides by folding.
Regarding claim 9, Grabowski discloses the flat blank comprises: a base plate (at 608) serving as a storage space for the medical product and having a base latching device (at 620/618); and a folding or cover plate (at 606), which is coupled to the base plate via the hinged-fold line at (608a), the folding or cover plate operatively engageable with the base latching device in a position where the folding or cover plate is folded onto the base plate in order to hold the folded position (as shown in Fig. 12 - similar to that shown in Figs. 3-4), the folding or cover plate is being divided into a connecting portion (at 650a/b) and a tear-open portion (at 614) separated from the connecting portion by at least one perforation line (at 622/628) that forms a predetermined breaking point between the connecting portion and the tear-open portion.
Regarding claim 10, Grabowski discloses a first end (right-most end of 622) of the at least one perforation line and a second end (right-most end of 628) of said at least one perforation line that open into a side edge of the folding or cover plate opposite the hinged-fold line.
Regarding claim 11, Grabowski discloses starting from the side edge of the folding or cover plate opposite the hinged-fold line, a tab-shape portion (portion between 622 and 628) of the folding or cover plate extends away from the folding or cover plate, which is operatively engageable with the base latching device on the base plate and integrally configured with the tear- open portion.
Regarding claim 12, Grabowski discloses the first end of the at least one perforation line and the second end of said at least one perforation line are spaced apart by a width of the tab-like portion at the at a point at which they each open into the side edge of the folding or cover plate opposite the hinged-fold line (as shown in Fig. 14).
Regarding claim 13, Grabowski discloses two perforation lines (at 622/628 in Fig. 14) are provided which are configured non-linearly and are arranged axially symmetrically to one another with respect to a line bisecting the hinged-fold line and extend continuously in each case starting from the hinged-fold line to a side edge of the folding or cover plate opposite the hinged-fold line (as shown in Fig. 14).
Regarding claim 14, Grabowski discloses a base latching device (at 620/618) of a base plate (at 608) is configured as a receptacle, which is arranged in the proximity to a side edge of the base plate, and a folding plate (at 606) has a tab-shaped portion (portion between 622 and 628) which extends outwardly from the side edge of the folding or cover plate, which in the closed state is opposite the side edge with receptacle of the base plate, and which is insertable into the receptacle of the base plate.
Regarding claim 16, Grabowski discloses the protective cover is shaped like a pocket when closed.
Regarding claim 19, Grabowski discloses the receptacle forming the base latching device is formed like a slit.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Grabowski et al. (US 9,707,039) in view of Van Ness (US 5,788,063) as applied to claim 1 above, and further in view of Sinn (US 5,390,782). As described above, Grabowski-Sinn 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 Grabowski-Sinn 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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735