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 Objections
Claim 6-9 and 11- 20 are objected to because of the following informalities:
Claim 6, Line 2 states “each of the at least one secondary dam positioned”, it is suggested to change this to “each of the at least one secondary dam is positioned”.
Claims 7-9 are objected to for being dependent on objected claim 6.
Claim 11, Line 6 states “each of the at least one secondary dam positioned”, it is suggested to change this to “each of the at least two secondary dams is positioned”.
Claims 12- 14 are objected to for being dependent on or from objected claim 11.
Claim 13, Line 1 states “the least one secondary dam”, it is suggested to change this to “the at least two secondary dams”.
Claim 14, Line 1 states “at least one secondary dam”, it is suggested to change this to “at least two secondary dams”.
Claim 15, Line 9 states “dam, each of the at least one secondary dam positioned”, it is suggested to change this to “dam, wherein each of the at least one secondary dam is positioned”.
Claims 16- 20 are objected to for being dependent on or from objected claim 15.
Claim 19, Line 1 states “claim 15 wherein”, it is suggested to change this to “claim 15, wherein”.
Appropriate correction is required.
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.
Claim(s) 1- 8, 10- 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webb et al. (WO 2015/012877).
Regarding claim 1, Webb teaches a half- pipe cannula (abstract)(Figs. 22- 26e) having: a flexible portion (2220, 2230) of a first material (Paragraphs 0013, 0016, and 0127); and a rigid portion (one half of 2210)(Paragraph 0124) of a second material (Paragraphs 0012 and 0127);
Wherein the flexible portion comprises: a proximal end, a distal end (see annotated Fig. 26d below), and a cannulated cylindrical elongated body extending between the proximal end and the distal end (see annotated Fig. 26d below), the cannulated cylindrical elongated body having a surface feature (threads 2234) structured to prevent the half pipe cannula from moving in a portal during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body (Paragraphs 0131 and 0132)(Alternatively, as this language is functional, the structure of the device only needs to have the ability to complete the function, as Webb teaches that the cannulated cylindrical elongated body has a surface feature (2234) on its exterior surface, then the surface feature is capable of preventing the half pipe cannula from moving in a portal during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body.);
Wherein the rigid portion comprises: an elongated tab with an inner surface and an exterior surface (see annotated Fig. 26d below), the cannulated cylindrical elongated body of the flexible portion being overmolded to the elongated tab via the inner surface such that the surface feature of the cannulated cylindrical elongated body is formed on the exterior surface of the elongated tab of the non-cylindrical body (see annotated Fig. 26d below)(Paragraph 0131).
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Regarding wherein the rigid portion comprises a non-cylindrical body, as set forth in applicant’s disclosure, a non-cylindrical rigid portion can be at least half- cylindrical (see Applicant’s disclosure, Fig. 5a and Paragraph 0078), therefore since the rigid portion is interpreted as one half of 2210, which forms a cylindrical body, then the rigid portion is a half cylinder and is a non-cylindrical body.
Regarding claim 2, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the surface feature comprises threads, bumpers, stubs, knobs, or ridges (Paragraphs 0131 and 0132).
Regarding claim 3, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the surface feature has a length that extends longitudinally and horizontally along the elongated tab (Paragraph 0131).
Regarding claim 4, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the surface feature is located near the proximal end (see annotated Fig. 26d below)(Paragraph 0131).
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Regarding claims 5 and 6, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the flexible portion further comprises a primary dam and one or more secondary dams in the cannulated cylindrical elongated body, wherein each of the at least one secondary dam is positioned a distance from a side of the primary dam (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 7, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the primary dam and the at least one secondary dam are positioned in the cannulated cylindrical elongated body approximately halfway between the proximal end and the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 8, Webb teaches the half-pipe cannula as discussed above.
In an alternate interpretation from claims 6 and 7, Webb further teaches wherein the primary dam and the at least one secondary dam are positioned in the cannulated cylindrical elongated body near the proximal end or the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 10, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches the cannula further comprising: a membrane (proximal most dam 2222) disposed in the cannulated cylindrical elongated body at or near the proximal end (see annotated Fig. 26d below) to prevent fluid from exiting the proximal end during instrument insertion or removal (Paragraphs 0127 and 0128)(As this language is functional, the structure of the device only needs to have the ability to complete the function, therefore as the membrane is positioned near the proximal end of the cannula and acts as a dam, then it is capable of preventing fluid from exiting the proximal end during instrument insertion or removal.).
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Regarding claims 11 and 12, Webb teaches a cannula (abstract)(Figs. 22- 26e) having: a proximal end, a distal end (see annotated Fig. 26d below), and a cannulated cylindrical elongated body (2220, 2230) extending between the proximal end and the distal end (see annotated Fig. 26d below), the cannulated cylindrical elongated body having a primary dam and at least two secondary dams (2222), each of the at least two secondary dams is positioned a distance from a side of the primary dam (see annotated Fig. 26d below)(Paragraphs 0127 and 0128);
Wherein the cannulated cylindrical elongated body is made of a flexible material (Paragraphs 0013, 0016, and 0127) and has a surface feature (threads 2234) structured to prevent the cannula from moving in a portion during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body (Paragraphs 0131 and 0132)(Alternatively, as this language is functional, the structure of the device only needs to have the ability to complete the function, as Webb teaches that the cannulated cylindrical elongated body has a surface feature (2234) on its exterior surface, then the surface feature is capable of preventing the half pipe cannula from moving in a portal during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body.) and wherein the cannula further comprises a non-cylindrical body (one half of 2210)(Paragraph 0124) made of a rigid material (Paragraphs 0012 and 0127), the non-cylindrical body having an elongated tab with an inner surface and an exterior surface (see annotated Fig. 26d below), the cannulated cylindrical elongated body of the flexible portion being overmolded to the elongated tab via the inner surface such that the surface feature of the cannulated cylindrical elongated body is formed on the exterior surface of the elongated tab of the non-cylindrical body (see annotated Fig. 26d below)(Paragraph 0131).
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Regarding wherein the rigid portion comprises a non-cylindrical body, as set forth in applicant’s disclosure, a non-cylindrical rigid portion can be at least half- cylindrical (see Applicant’s disclosure, Fig. 5a and Paragraph 0078), therefore since the rigid portion is interpreted as one half of 2210, which forms a cylindrical body, then the rigid portion is a half cylinder and is a non-cylindrical body.
Regarding claim 13, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the primary dam and the at least two secondary dams are positioned in the cannulated cylindrical elongated body approximately halfway between the proximal end and the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 14, Webb teaches the half-pipe cannula as discussed above.
In an alternate interpretation from claims 11 and 13, Webb further teaches wherein the primary dam and the at least two secondary dams are positioned in the cannulated cylindrical elongated body near the proximal end or the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 15, Webb teaches a half pipe cannula (abstract)(Figs. 22- 26e) having: a flexible portion (2220, 2230) of a first material (Paragraphs 0013, 0016, and 0127); and a rigid portion (one half of 2210)(Paragraph 0124) of a second material (Paragraphs 0012 and 0127);
Wherein the flexible portion comprises: a proximal end, a distal end (see annotated Fig. 26d below), and a cannulated cylindrical elongated body extending between the proximal end and the distal end (see annotated Fig. 26d below), the cannulated cylindrical elongated body having a primary dam and at least one secondary dam (dams 2222), wherein each of the at least one secondary dam is positioned a distance from the primary dam (see annotated Fig. 26d below)(Paragraphs 0127 and 0128) and the cannulated cylindrical elongated body having a surface feature (threads 2234) structured to prevent the half pipe cannula from moving in a portal during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body (Paragraphs 0131 and 0132)(Alternatively, as this language is functional, the structure of the device only needs to have the ability to complete the function, as Webb teaches that the cannulated cylindrical elongated body has a surface feature (2234) on its exterior surface, then the surface feature is capable of preventing the half pipe cannula from moving in a portal during instrument insertion into, or instrument removal from, the cannulated cylindrical elongated body.);
Wherein the rigid portion comprises: an elongated tab with an inner surface and an exterior surface (see annotated Fig. 26d below), the cannulated cylindrical elongated body of the flexible portion being overmolded to the elongated tab via the inner surface such that the surface feature of the cannulated cylindrical elongated body is formed on the exterior surface of the elongated tab of the non-cylindrical body (see annotated Fig. 26d below)(Paragraph 0131).
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Regarding wherein the rigid portion comprises a non-cylindrical body, as set forth in applicant’s disclosure, a non-cylindrical rigid portion can be at least half- cylindrical (see Applicant’s disclosure, Fig. 5a and Paragraph 0078), therefore since the rigid portion is interpreted as one half of 2210, which forms a cylindrical body, then the rigid portion is a half cylinder and is a non-cylindrical body.
Regarding claim 16, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the surface feature comprises threads, bumpers, stubs, knobs, or ridges (Paragraphs 0131 and 0132).
Regarding claim 17, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches wherein the primary dam and the at least one secondary dam are positioned in the cannulated cylindrical elongated body approximately halfway between the proximal end and the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 18, Webb teaches the half-pipe cannula as discussed above.
In an alternate interpretation from claim 17, Webb further teaches wherein the primary dam and the at least one secondary dam are positioned in the cannulated cylindrical elongated body near the proximal end and the distal end (see annotated Fig. 26d below)(Paragraphs 0127 and 0128).
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Regarding claim 20, Webb teaches the half-pipe cannula as discussed above.
Webb further teaches the cannula further comprising: a membrane (proximal most dam 2222) disposed in the cannulated cylindrical elongated body at or near the proximal end (see annotated Fig. 26d below) to prevent fluid from exiting the proximal end during instrument insertion or removal (Paragraphs 0127 and 0128)(As this language is functional, the structure of the device only needs to have the ability to complete the function, therefore as the membrane is positioned near the proximal end of the cannula and acts as a dam, then it is capable of preventing fluid from exiting the proximal end during instrument insertion or removal.).
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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.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (WO 2015/012877).
Regarding claims 9 and 19, Webb teaches the half-pipe cannula as discussed above.
Webb does not teach in the current embodiment wherein each of the at least one secondary dam is thinner than the primary dam and is cylindrically shaped.
Webb teaches an alternate embodiment of the dams within a cannula (2700)(Fig. 27), with a primary dam (2720) and at least one secondary dam (dams 2710, 2740), wherein the secondary dam is thinner than the primary dam and is cylindrically shaped (Paragraph 0133)(see annotated Fig. 27 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the primary dam and the at least one secondary dam as taught by the first embodiment of Webb to have the primary dam be thicker than the at least one secondary dam as taught by the second embodiment of Webb, since Webb teaches that the cannula can have “multiple dams of the same or difference configurations” and that having one dam be thicker than other is a possibility that would be known in the art (Paragraph 0133).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771