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 .
Priority
This application is a continuation of U.S. Patent Application No. 18/419,659 filed January 23, 2024, which is a continuation of U.S. Patent Application No. 17/354,199 filed June 22, 2021, which is a continuation of U.S. Patent Application No. 16/242,064 filed January 8, 2019, which is a continuation of International Application No. PCT/US2017/057569 filed October 20, 2017, which claims the benefit of U.S. Provisional Patent Application No. 62/411,023 filed October 21, 2016.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 5, 11-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrett (US 4,706,661, hereinafter “Barrett”) in view of Riskin et al. (US 2006/0200198, hereinafter “Riskin”) and further in view of Cartmell et al. (U 5,947,998, hereinafter “Cartmell”).
Referring to claim 1, Barrett disclose a package (“In the operation of the embodiments of FIGS. 1-4, assuming the device 10 is packaged or maintained in a sterile condition, being removed from such container at the point of use.” (col. 2, lns. 49-52. FIGS. 1-4, FIGS. 2-4 are reproduced below), comprising:
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(Barrett fails to disclose a support comprising a central section that is positioned between first and second outer sections of the support)
a medical article (Barrett fails to disclose the medical article releasably mounted to the support), wherein:
the medical article 14 comprises a body and first and second areas of adhesive 16, 18 (FIG. 1, “The device 10 comprises a handle or control portion 12 and a base or pad portion 14. The base portion 14 includes rectangular planar pads or strips 16 and 18 of substantially equal width and a desired thickness, relatively thin, when compared with the pad perimeter dimensions” (col. 2, lns. 12-20)),
the body comprises a central section 26 connected to, and positioned between, first and second outer sections of the body, so that outer sections of the body extend outwardly from the central section of the body (FIGS. 1-4, The elastic material 26 normally draws the confronting edge surfaces 22 and 24 toward each other.” (col. 2, lns. 22-28)),
the first and second areas of adhesive 16, 18 are respectively connected to the first and second outer sections of the body (“The longitudinal confronting edge surfaces 22 and 24 of the respective pads are secured to opposing longitudinal legs of a U-shape in transverse section coextensive strip of transparent resilient or elastic material 26. The elastic material 26 normally draws the confronting edge surfaces 22 and 24 toward each other.” (col. 2, lns. 22-28)), and
the first and second areas of adhesive 16, 18 are configured to be adhered to tissue of a patient for at least partially securing the medial device to the patient after the medical article is in the extended configuration;
wherein a gap is defined between at least a portion of the central section 26 and the bottom surface of bases 16, 18 (Barrett fails to disclose the gap is between the central section 26 and the support).
Barrett discloses the package includes a plurality of wound closure devices 10 (“In another embodiment a plurality of adhesive pads or strips are similarly resiliently secured in spaced relation in a common plane and are individually attached to a patient's skin by spreading handle members converging toward an overlying control and release point.” (col. 1, lns. 42-46)).
Barrett discloses the invention substantially except for disclosing a support comprising a central section that is positioned between first and second outer sections of the support, the medical article releasably mounted to the support, and a gap is between the central section 26 and the support.
In the same field of endeavor, which is a package for wound closure, Riskin discloses a plurality of wound closure devices 106 and tool 104 for applying the wound closure devices to patient’s skin are provided in a sterile container 101 and the wound closure devices are presented on a tray 105 (FIGS. 17G-17H, para. [0141]). Cartmell discloses (FIG. 1) a plurality of wound closure devices 20, 21, 22 etc. are releasably attached to tray 10 by a release liner on the upper surface 11 of tray 10 (col. 4, lns. 38-45).
In view of the teachings of Riskin and Cartmell, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to arrange the plurality of wound closure devices of Barrett on a tray with a release liner and store them inside a container similar to container 101 as suggested by Riskin to ensure that the plurality of wound closure devices are easily remove from the tray while remaining releasably attached to the tray in an orderly fashion during shipment of the package.
Examiner notes that Barrett in view of Riskin and Cartmell would have the condition of a gap is between the central section 26 and the tray (support) and the medical article 14 is configured to be elastically deformed by handle 12 to an extended configuration after being separated from the support (FIGS. 2-4 of Barrett reference).
Referring to claim 5, Barrett in view of Riskin and Cartmell discloses the package according to claim 1, wherein: the medical article comprises first and second foot pads 16, 18 (Barrett: FIGS. 1-4); the first foot pad is connected to the first outer section of the body and includes the first area of adhesive; and the second foot pad is connected to the second outer section of the body and includes the second area of adhesive (Barrett: FIGS. 1-4).
Referring to claim 11, Barrett in view of Riskin and Cartmell discloses the package according to claim 1 in combination with a base (container 101 as shown in FIG. 17G of Riskin reference), wherein the support (tray 105 as shown in FIG. 17G of Riskin reference) is configured to be releasably connected to the base.
Referring to claim 12, Barrett in view of Riskin and Cartmell discloses a package (see rejection of claim 1 above), comprising:
a support comprising a central section that is positioned between first and second outer sections of the support (see rejection of claim 1 above); and
a medical article releasably mounted to the support (see rejection of claim 1 above), wherein:
the medical article comprises a central section and first and second foot pads connected to the central section (see rejection of claim 1 above),
the first foot pad comprises adhesive connected to the first outer section of the support (see rejection of claim 1 above),
the second foot pad comprises adhesive connected to the second outer section of the support (see rejection of claim 1 above),
the medical article is configured to be elastically deformed to an extended configuration after being separated from the support (see rejection of claim 1 above), and
the adhesive of the first foot pad and the adhesive of the second foot pad are configured to be adhered to tissue of a patient for at least partially securing the medial device to the patient after the medical article is in the extended configuration (see rejection of claim 1 above);
wherein a gap is defined between at least a portion of the central section of the support and the central section of the medical article (see rejection of claim 1 above).
Referring to claim 20, Barrett in view of Riskin and Cartmell discloses the package according to claim 12 in combination with a base (see rejection of claim 11 above), wherein the support is configured to be releasably connected to the base (see rejection of claim 11 above).
Allowable Subject Matter
Claims 2-4, 6-10, and 13-19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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