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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 36 and 46, the limitation of the prevention of shearing when the distal portion is “bent” around the sharp end of the needle was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The original specification and claims as filed, never describe the distal portion being bent around the sharp end of the needle nor any relation to how a material of the distal portion, when bent, prevents shearing.
Claims 36-50 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.
Regarding Claims 36 and 46, the limitation of the prevention of shearing when the distal portion is “bent” around the sharp end of the needle renders the claim indefinite, because it is not understood what is meant by bending the distal portion around the sharp end of the needle when the specification or claims do no explain what is intended by such limitation. For purposes of examination the indefinite limitation has been deemed to claim that the selected material itself prevents shearing when the distal portion of the protective sheath extends distally beyond a distal end of the needle.
Regarding Claims 38 and 48, the limitation “wherein the material of which the reinforced portion formed as a metal ring located so that” is awkwardly phrased, and the claim is indefinite because the relation between the reinforced portion the metal ring are unclear. It is unclear if the material itself is a metal ring, or if the metal ring is in addition to the material of the reinforced portion. Furthermore, the limitation “is positioned in contact with the distal end of the needle” as is awkwardly phrased, and the claim is indefinite, because it is unclear what element of the claimed invention is intended to be positioned in contact with the distal end of the needle. For purposes of examination the indefinite limitation has been deemed to claim that the protective sheath is formed of a material, and separately, there is a metal ring on a distal portion of the protective sheath, where when the protective sheath is inserted in the lumen of the needle, is capable of being positioned within the distal end of the needle.
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.
Claim(s) 36, 37, 39-42, 46 and 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20020087152 A1 to Mikus et al. (hereinafter, Mikus).
Regarding Claims 36 and 46, Mikus discloses a system for diagnostic and therapeutic procedures, comprising inter alia:
a hollow needle (introducer sheath 1030) extending longitudinally from a proximal end (proximal end 1032) to a sharpened distal end (distal end 1034) configured for cutting a tissue sample to be collected in the needle ([0036] “…the distal end 1034 preferably being tapered…) (see cutting/penetration of tissue by distal end 1034 in FIG. 3);
a guide wire (stylet 1010); and
a protective sheath (dilator 1020) sized and shaped to be inserted through the needle, a length of the protective sheath being selected so that a distal end of the protective sheath may be extended distally past the distal end of the needle a desired distance ([0036] “…dilator 1020 is disposed within a lumen 1036 in the introducer sheath 1030 such that the distal end 1024 of the dilator extends beyond the distal end 1034 of the introducer sheath 1030…”), the protective sheath including a lumen extending therethrough sized and shaped to slidably receive the guide wire therethrough ([0034] “…the dilator 1020 is slidably disposed over the stylet 1010, i.e., such that the stylet 1010 extends through a lumen 1026 in the dilator 1020…”), a distal portion of the protective sheath being formed of a material selected to prevent shearing thereof when the distal portion is bent around the sharpened distal end of the needle ([0035] “The dilator 1020 may be formed from stainless steel, plastic, or other biocompatible material, and may be coated with teflon or other similar material to facilitate substantially atraumatic advancement through tissue.”).
Regarding Claims 37 and 47, Mikus discloses the system of claim 36, wherein the distal portion of the protective sheath includes a reinforced portion formed of a material having an increased stiffness relative to a stiffness of a portion of the protective sheath extending proximally from the distal portion ([0035] “The dilator 1020 may be formed from stainless steel, plastic, or other biocompatible material, and may be coated with teflon or other similar material to facilitate substantially atraumatic advancement through tissue.” – a coating of Teflon or other similar material would inherently increase stiffness due to the additional material).
Regarding Claim 39, Mikus discloses the system of claim 36, wherein the needle (introducer sheath 1030) includes an engaging element at the proximal end thereof (flared portion at proximal end 1032 of introducer sheath 1030, see FIG. 1B in combination with female portion 1044a of Luer lock 1044 when device is fully assembled, as best seen in FIG. 1A).
Regarding Claim 40, Mikus discloses the system of claim 39, wherein the protective sheath (dilator 1020) includes an engaging structure at the proximal end thereof (flared portion at proximal end proximal end 1022 of dilator 1020 in combination with male portion 1044b of Luer lock 1044 when the device is fully assembled, as best seen in FIG. 1A) engageable with the engaging element of the needle (when flared portions are nested within one another and also when male and female portions lock as seen in FIG. 1A) so that, when the protective sheath (dilator 1020) is inserted in the lumen of the needle (introducer sheath 1030), the engaging element and the engaging structure engage one another to lock the protective sheath relative to the needle (the flared portions at both the distal ends of dilator 1020 and introducer sheath 1030 lock the dilator 1020 to the introducer sheath 1030, because, in cooperation, the dilator 1020 is “locked” from moving further distally with respect to the introducer sheath 1030 when they meet). .
Regarding Claim 41, Mikus discloses the system of claim 39, wherein the engaging element is a Luer fitting (Luer lock 1044).
Regarding Claim 42, Mikus discloses the system of claim 36, further comprising: a stylet extending from a proximal end to a distal end and sized and shaped to be inserted through the lumen of the needle ([0046] “Alternatively, other instruments may be inserted into subcutaneous tissue regions of a patient using the apparatus 1005, such as other thermal probes, which may cool or heat the tissue, RF energy probes, radiation treatment devices, and the like.”).
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.
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) 38 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikus in view of US 20090076482 A1 to Jonkman et al. (hereinafter, Jonkman).
Regarding Claims 38 and 48, Mikus discloses the system of claims 37 or 47. Mikus does not expressly disclose wherein the material of which the reinforced portion is formed as a metal ring located so that, when the protective sheath is inserted in the lumen of the needle with the distal end of the protective sheath extending beyond the distal end of the needle to a desired distance, is positioned in contact with the distal end of the needle. However, Jonkman teaches a cannula system that includes a distal reinforcing band ([0029]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the protective sheath of Mikus to have the distal reinforcing band of Jonkman, as Jonkman teaches that such band would have minimized the likelihood of kinking or bucking ([0034]). Examiner notes that such combination would yield a metal ring on the protective sheath capable of being in contact with any portion of the needle, as both elements are separately manipulatable with respect to one another.
Claim(s) 43-45, 49 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mikus in view of US 20050288695 A1 to Jenson et al. (hereinafter, Jenson).
Regarding claims 43-45, Mikus discloses the system of claims 36 or 46. Mikus does not expressly discloses wherein the protective sheath is formed of one of Nitinol and Cobalt Chromium, wherein an outer diameter of the protective sheath ranges from between 0.030 inches and 0.035 inches, and wherein an inner diameter of the protective sheath ranges from between 0.0265 inches and 0.030 inches. However, Jenson teaches a protective sheath 82 of a nest catheter system, where the sheath is made of Nitinol and has an outer diameter between ranging between 0.010 inches and 0.035 inches and an inner diameter ranging between 0.006 inches and 0.030 inches. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the protective sheath of Mikus to be the materials and dimensions as set forth in Jenson, because Jenson teaches that nitinol is a suitable alternative for Nitinol and would have provided suitable flexibility (Jenson [0047]) and further a skilled artisan would have recognized that picking such diameters would have been an obvious design choice for the purpose of providing a device meant for in vivo operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791