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 2 (Figure 7) in the reply filed on 12/11/2025 is acknowledged. In the reply, Applicant indicates that claims 16-25, 27 and 29-32 correspond to the elected species. Therefore, claims 26 and 28 are withdrawn from consideration.
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 16-25, 27 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Borrero et al. (US 11,897,682) in view of Pozzo (US 5,620,096) and Loeffler (US 6,006,917).
Regarding claim 16, Borrero discloses a packaging (packaging 10 shown in Fig. 7 – shown in its unexpanded state in Fig. 2) capable of holding a sterile medical product therein, the packaging comprising: a second barrier (See Fig. 7 labeled below) configured to form a receiving space (cavity within layer 16) capable of receiving a medical product in a sealed manner, the second sterile barrier comprising a double membrane (formed from layers 16 and 14 in Figs. 2 and 4 – Examiner would like to point out that the lead line coming from reference numeral 16 in Fig. 7 should be pointing to the layer of material below 14, not to the space below the layer) forming at least two air pockets (See air pockets labeled in Fig. 7 shown below), the at least two air pockets being separated from each other by a predefined folding edge (folded edge at 8 in Fig. 6 - described in column 7, lines 50-55) in the double membrane, the double membrane being foldable into a folded-down state along the predefined folding edge, and the at least two air pockets being aligned with each other in the folded-down state such that the receiving space is created between the at least two air pockets.
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Borrero discloses the claimed invention except for the outer protective packaging and the first sterile barrier.
Regarding the outer protective packaging, Pozzo teaches a packaging (See Fig. 2) comprising a protective barrier (at 11/12 in Fig. 2) for holding an article (at A), wherein the protective barrier is held within an outer protective packaging (carton/box) for the purpose of shipping the article (column 4, lines 6-9). 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 packaging of Borrero within an outer protective packaging as taught by Pozzo in order to better protect the contents during shipping.
Regarding the first sterile barrier, Loeffler teaches a medical packaging (See Fig. 3) comprising an outer protective packaging (at 26), a second sterile barrier (at 7/8) and a first sterile barrier (at 2 – formed from portions 3/4) for holding a medical product (1) within the second barrier, for the purpose of holding a medical product in a gastight manner within the packaging (column 1, lines 27-40). 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 packaging of Borrero-Pozzo with medical product within a first sterile barrier which is positioned within the second sterile barrier as taught by Loeffler in order to facilitate protection of a medical product during storage/shipping.
Regarding claim 17, Borrero discloses the double membrane comprises an inner membrane (at 16) and an outer membrane (at 14), the outer membrane bulges out concavely (See Fig. 7 labeled above), and the inner membrane is planar (See Fig. 7 labeled above).
Regarding claim 18, Borrero discloses the predefined folding edge connects the inner membrane and the outer membrane (See Figs. 6-7).
Regarding claim 19, the determination of patentability in a product-by-process claim is based on the product itself, even though the claim may be limited and defined by the process. That is, the product in such a claim is unpatentable if it is the same as or obvious from the product of the prior art, even if the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. (Same cite as above).
Regarding claim 20, Borrero discloses the inner and outer membranes can be made from a polypropylene material which is known in the art for being elastic and having at least some degree of rigidity.
Regarding claim 21, Borrero discloses the inner membrane comprises at least two inner membrane sections (at 29 and 32 at the right side of Fig. 7), the at least two inner membrane sections are aligned adjacent to each other in proximity to the at least two air pockets in the folded-down state, and the receiving space is positioned between the at least two inner membrane sections.
Regarding claim 22, Borrero discloses the receiving space is formable by plastic or elastic deformation of the at least two inner membrane sections (depending on the size of the contents placed therein).
Regarding claim 23, Borrero discloses the at least two inner membrane sections lie flat in sections against each other in the folded-down state (as shown in the Fig. 5 orientation).
Regarding claim 24, Borrero discloses the at least two air pockets consists of exactly two air pockets (as labeled in Fig. 7 above).
Regarding claim 25, Loeffler teaches the first sterile barrier (2) comprises two films (film 3 and film 4), and the first sterile barrier is configured to seal the medical product between the two films to limit movement of the medical product relative to the two films (as shown in Fig. 3).
Regarding claim 27, Borrero discloses the at least two air pockets consists of two air pockets (as labeled in Fig. 7 above), the two air pockets are separated from each other by predefined folding edges, and the two air pockets are foldable in such a way that an additional pocket (at 33 in Fig. 7) for receiving the first sterile barrier is positioned between the two air pockets.
Regarding claim 29, Borrero-Pozzo-Loeffler discloses the two air pockets (as labeled in Fig. 7 of Borrero above) are arranged on a same side (left side) of the additional pocket, and the first sterile barrier is located in the additional pocket.
Regarding claim 30, Borrero discloses the two air pockets are folded down on the predefined folding edges in such a way that the additional pocket is surrounded by the two air pockets on at least two sides.
Regarding claim 31, Borrero-Pozzo-Loeffler discloses a medical product that is packaged in a sterile manner in the sterile medical packaging, the at least two air pockets being folded down around the medical product such that a planar membrane of the double membrane faces toward the medical product and the receiving space is configured in the planar membrane.
Regarding claim 32, Borrero-Pozzo-Loeffler discloses the planar membrane extends beyond the medical product, and the receiving space completely encloses the medical product.
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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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735