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
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 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, 7-9, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stellon et al (US 2010/0286484).
Regarding claim 1, Stellon discloses:
A subcutaneous port (10; Fig. 1), comprising: a rigid inner member (14) (¶0030 – semi-rigid plastic) comprising a cavity (20; Fig. 5) opened to a first cavity opening closed with a septum member (17), configured for repeated needle penetrations therethrough into the cavity (¶0030), and to a second cavity opening (16) configured for facilitating fluid communication between the cavity and a lumen of a catheter (5; Fig. 10); and an outer member (12) comprising of flexible material (¶0032 – flexible material) connected to the inner member (14) along at least one lateral periphery portion (46; Fig. 4) of the inner member (14) thereby forming a predetermined spatial shape of the subcutaneous port (Fig. 6) when in an elastically relaxed state (¶0032 – the default shape is that of Fig. 6 and must be compressed to fit within a surgical opening); wherein the subcutaneous port (10) is configured to squeeze into a subcutaneous void (distal opening within a patient as seen in Fig. 10) when pushed through a surgical opening (I; Fig. 8) greater than a maximal cross-sectional circumference of the inner member (14) and smaller than a maximal cross-sectional circumference of the predetermined spatial shape (Fig. 6) (Fig. 10; ¶0032 – outer member 12 is compressed to fit within a surgical opening I; the subcutaneous port 10 is fully capable of reducing in maximal width by at least 10% when the outer member is compressed under a force greater than 5 N and by at least 25% when the outer member is compressed under a force greater than 20 N, as the outer member 12 is folded almost in half as seen in Fig. 8).
Regarding claim 2, Stellon discloses:
The subcutaneous port according to claim 1, wherein the subcutaneous port (10) in the elastically relaxed state (Fig. 6) is greater than the inner member (14) by at least 50% in width, in area and/or in volume (the port 10 in total is greater than 50% in volume than inner member 14), in a maximal axial cross section (cross section of the view in Fig. 6) of the predetermined spatial shape.
Regarding claim 7, Stellon discloses:
The subcutaneous port according to claim 1, wherein the flexible material includes soft elastomer and/or silicone rubber (¶0026 - silicone).
Regarding claim 8, Stellon discloses:
The subcutaneous port according to claim 7, wherein the flexible material (12) fills most or all space formed in the predetermined spatial shape around the inner member (14) (Fig. 3).
Regarding claim 9, Stellon discloses:
The subcutaneous port according to claim 1, comprising at least one elastic extension (15) stiffer than the flexible material (material of outer member 12), projecting from the inner member (14) and surrounding the at least one lateral periphery portion (46) of the inner member (14), wherein the at least one extension (15) is embedded in the flexible material (12) (Fig. 3; the extension 15 is semi-rigid and is therefore fully capable of distributing compressing loads originating from a locally compressed portion to other portions of the outer member).
Regarding claim 11, Stellon discloses:
The subcutaneous port according to claim 10, wherein the at least one extension (15) is configured to approximate the at least one lateral periphery portion (46) of the inner member (14) when the outer member (12) is compressed laterally (see Fig. 8) and/or extended axially proximally relative to the inner member.
Regarding claim 14, Stellon discloses:
The subcutaneous port according to claim 9, wherein the at least one extension (15) encircles or surrounds most or all lateral periphery (46) of the inner portion (14).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-26 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Stellon.
Regarding claim 25, Stellon discloses:
A method comprising: forming a surgical opening (I; Fig. 7) across skin layers (T) of a subject, the surgical opening (I) comprising an opening neck portion enclosing and restricting a maximal opening circumference (Fig. 10); creating a subcutaneous void beneath the skin layers (T) via the surgical opening (I); providing a subcutaneous port (10; Fig. 1) comprising a rigid inner member (14) (¶0030 – semi-rigid plastic) and a flexible outer member (12; ¶0032 – flexible material), and configured to reduce in maximal width (Fig. 8); pushing the subcutaneous port (10) into the subcutaneous void via the surgical opening (I), the subcutaneous port (10) has a predetermined spatial shape (Fig. 6) having a maximal cross-sectional circumference greater than the maximal opening circumference (circumference of incision I) when in an elastically relaxed state (Fig. 6), the subcutaneous port (10) is locally elastically compressible along a length (length of diameter) thereof; wherein the pushing forces the subcutaneous port (10) to elastically compress in diameter and/or extend proximally in length when pressed against the opening neck portion, thereby allowing squeezing of the subcutaneous port through the surgical opening (¶0032).
Stellon discloses all of the elements of the claim but is silent regarding reducing in maximal width “by at least 10% when the outer member is compressed under a force greater than 5 N, and/or by at least 25% when the outer member is compressed under a force greater than 20 N.” However, Fig. 8 of Stellon discloses the outer member being compressed in width by about 50%, which would be possible by a force greater than 5 N or 20 N. As such, Stellon makes obvious reducing the width by at least 10% when the outer member is compressed under a force greater than 5 N, and/or by at least 25% when the outer member is compressed under a force greater than 20 N as required by the claim.
Regarding claim 26, Stellon discloses:
The method according to claim 25, following the pushing, comprising allowing the subcutaneous port (10) to voluntarily expand elastically up to the elastically relaxed state (¶0033).
Regarding claim 29, Stellon discloses:
The method according to claim 25, wherein the subcutaneous port (10) includes a flexible outer member (12) connected to a rigid inner member (14) along at least one lateral periphery portion (46; Fig. 2) of the inner member (14) thereby forming the predetermined spatial shape of the subcutaneous port (Fig. 3) when in an elastically relaxed state (Fig. 6).
Regarding claim 30, Stellon discloses:
The method according to claim 29, wherein the rigid inner member (14) comprising a cavity (20; Fig. 5) opened to a first cavity opening closed with a septum member (17), configured for repeated needle penetrations therethrough into the cavity (¶0030), and to a second cavity opening (16) configured for facilitating fluid communication between the cavity and a lumen of a catheter (5; Fig. 10).
Regarding claim 31, Stellon discloses:
The method according to claim 29, wherein the outer member (12) is configured with elastic resistance to compression sufficient to maintain the predetermined spatial shape within a surgically formable subcutaneous void when under naturally occurring subcutaneous stresses (Fig. 10; ¶0033).
Regarding claim 32, Stellon discloses:
The method according to claim 29, wherein the pushing forces the outer member (12) to compress locally against the inner member (14) while substantially maintaining an overall volume thereof by enlarging remotely to a compressed region thereof (Fig. 10).
Allowable Subject Matter
Claims 10, 12-13, 27-28, and 33-34 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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783