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 2 and 13 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.
The specification and claims as originally filed (parent US Application No. 15/419,416) does not reasonably convey possession of a relationship between shaft outer diameter and the ability to be rotated up to 220 rpm. The disclosure instead ties rotation performance to tip diameter, and provides no correlation or examples linking shaft outer diameter to maximum usable RPM (see TABLES 2 and 3, and paragraph [0122]). Therefore, at the time the application was filed, the applicant to did not have possession of an elongate shaft formed at a first outer diameter such that the elongate shaft is configured to be rotated about a longitudinal axis up to 220 rpm.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 4, 13, 14 and 15 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 2 and 13, the limitation “the elongated shaft … formed at a outer diameter … configured to be rotated … up to 220 rpm” renders the claims indefinite. The phrase lacks objective boundaries because no test conditions, failure criteria, or claim to what about the diameter provides such rpm limit has been provided. Furthermore, as claimed, it is unclear if 220 rpm is a claimed upper limit, or if the rotation rpm is intended to be in a range (meaning can be rotated between 0-220 rpm). For purposes of examination the indefinite limitation has been deemed to claim that the shaft has a diameter, and the shaft has a diameter that allows rotation at a speed not exceeding 220 rpm.
Regarding Claims 3, 4, 14 and 15, the limitation “withstand a torque” renders the claims indefinite because the term “withstand” is a relative term. The term “withstand” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Withstand” is a relative, results-oriented term that provides no objective boundary because the claims do not constitute what constitutes the shaft a torque not being withstood (e.g., breaking, fracture, lumen collapse, motor stall, loss of toque transmission, destruction of bone marrow sample), under what conditions (e.g., RMG, duration, temperature, vacuum levels), or by what test method, so a person of ordinary skill cannot determine whether a given shaft meets withstanding a torque of 35 inches-ounce to 85/100 inches-ounce with reasonable certainty. For purposes of examination the indefinite limitation has been deemed to claim that the shaft is capable of achieving a torque of 35 inches-ounce to 85/100 inches-ounce.
Regarding Claim 20 recites the limitation "the first portion". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim a proximal portion of the elongate shaft.
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) 1-4, 6, 10-15 and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090131827 A1 to Crocker et al. (hereinafter, Crocker).
Regarding Claims 1, 6 and 12, Crocker discloses a cannula, comprising inter alia:
an elongate shaft (cannula 108) having a length (length between proximal portion 222 and distal portion 226) (paragraph [0070] “The shaft of cannula 108 extends distally and may generally comprise a proximal portion 222 and a distal portion 226…”); and
a tip (tissue disruptor assembly 138, which in the selected embodiment is unitary tissue disrupter 270 that extends distally from tubular member 272, see FIGS. 12A-12D) attached to a distal end of the elongate shaft (paragraph [0071] “…the distal portion of cannula 108 may comprise tissue disruptor assembly 138 which may be configured in a number of different variations.”) (paragraph [0080] “In yet another variation of the tissue disruptor, FIG. 12A shows a side view of a unitary disruptor tip which may be swaged or otherwise attached to the distal end of a cannula shaft.”), the tip defining one or more openings (aspiration openings 278) which is in fluid communications with a lumen defined through the elongate shaft and tip (paragraph [0080] “…the aspiration openings 278 are in communication with lumen 280 defined through tubular member 272…”),
where the one or more openings through the tip defines an enlarged entry pathway in a direction transverse to the elongate shaft such that the entry pathway faces distally at the distal end of the elongate shaft (enlarged entry pathway is indicated below in annotated Fig. 12B and also box in Fig. 12C to demonstrate how the entry pathway is in a direction transverse to the elongated shaft and faces distally at the distal end of the elongate shaft) and is in fluid communications with the lumen (paragraph [0080] “…the aspiration openings 278 are in communication with lumen 280 defined through tubular member 272…”), and
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wherein the tip further includes radiused portions defining an arc angle up to 180 degrees (outer rim of semicircular disruptor member 274) (top and bottom “portions” of 274 are seen in annotated Fig. 12B, thus, radiused “portions” are disclosed) and side edges (edges that define opening 276) (top and bottom “edges” of the opening are seen in annotated Fig. 12B, thus, “edges” are disclosed) which are bounded by the radiused portions (side edges are bounded by radiused portions, as seen in annotated Fig. 12A).
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Regarding Claims 2 and 13, Crocker discloses where the elongated shaft is formed at a first outer diameter such that the elongated shaft is configured to be rotated about a longitudinal axis up to 220 rpm (Crocker sets forth at paragraph [0075] that shaft having an outer diameter of about 0.128 that can transmit torque, a shaft having such a diameter is capable of being attached to a motor to rotate the shaft up to 220 rpm, as the claim does not set forth how the diameter allows such rotation, or what mechanism provides such rotation; any shaft is capable of being rotated at a desired speed, including 220 rpm).
Regarding Claims 3, 4, 14 and 15, Crocker discloses where the elongated shaft is configured to withstand a toque of 35 inches-ounce to 85 inches-ounce (paragraph [0070] “…cannula 108 is desirably stiff enough to transmit between 20 to 40 inoz, and preferably 40 inoz, of torque to rotate cannula 108 through the bone marrow”).
Regarding Claims 10 and 11, Crocker discloses a hub (aspiration assembly 132) attached to a proximal end of the elongate shaft (paragraph [0050] “The aspiration cannula 108 can be removably coupled to the aspiration assembly 132…”) and a handle (handle 104) removably attached to the hub (paragraph [0068] “Aspiration assembly 132 is removably coupled to handle 104…”).
Regarding Claim 20, Crocker discloses a handle (handle 104) removably attachable to the first portion (paragraph [0070] “The shaft of cannula 108 extends distally and may generally comprise a proximal portion 222 and a distal portion 226…”) (paragraph [0050] “The aspiration cannula 108 can be removably coupled to the aspiration assembly 132…”) (paragraph [0068] “Aspiration assembly 132 is removably coupled to handle 104…”).
Regarding Claims 21 and 22, Crocker discloses where the elongate shaft includes a first portion having a first length (proximal portion 222 of cannula 108) and a first stiffness and a second portion having a second length (distal portion 226) attached to the first portion, the second length having a second stiffness which is less than the first stiffness (paragraph [0073] “…the proximal portion 222 of cannula 108 may generally be stiffer relative to distal portion 226…”).
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) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crocker in view of US 8,034,003 B2 to Pesce et al. (hereainfter, Pesce).
Crocker in view of Pesce teach where the elongate shaft is configured to deflect about a longitudinal axis of the cannula at less than 50 grams of force, as explained in detail below.
Paragraph 0122 of the instant application sets forth in order to provide deflection of the elongate shaft at less than 50 grams, the characteristics of the disruption tip would have (a) radius ([0089] The device radius 140 can be between, e.g., 0.050 and 0.065 in), (b) width ([0075] … the longitudinal base sides 108 can have a width of between, e.g., 0.122 in. and 0.132 in. … ) and a (c) diameter ([0120] … having a tip diameter of e.g., 0.127 inch.) when being rotated at the described rates (up to 220 rpm). These dimensions are disclosed and/or taught as being obvious by Crocket, with the exception of the described rotational rate of up to 220 rpm, which is taught by Pesce.
(a) Regarding the radius, Crocker discloses where the disruption tip has a width between 0.050 and 0.065 (as set forth at paragraph 0081, the outer diameter of the aspirator tip is 0.130 inches, therefore, the radius of the aspirator tip is 0.065 inches).
(b) Regarding the width, Crocker discloses wherein the disruption tip has a width of 0.130 inches (as set forth at paragraph 0081, the outer diameter of the aspirator tip is 0.130 inches, and the outer diameter is the same as the aspirator thickness).
(c) Regarding the diameter, Crocker discloses wherein the disruption tip has a width of 0.130 inches (as set forth at paragraph 0081). While Crocker does not expressly disclose a radius of 0.127 inches, one of ordinary skill in the art at the time the invention was made would have found it obvious to modify the diameter of 0.130 inches to be the diameter of 0.127 inches as claimed, as this would have been any number of diameters a skilled artisan would chose for the purposes of providing a disruption tip with a diameter deflection as less than 50 grams of force. Such a modification would have involved a mere change in the size of a component and a change in size is generally recognized within the level of ordinary skill in the art.
Crocker does not expressly disclose where the speed of rotation is up to 220 rpm. However, Pesce teaches a cannula for tissue harvesting and further teaches a rotational speed of that a rotational speed of 100-500 rpm (col. 16, ll. 60-64). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the rpm speed of Crocker with the speeds of Pesce as Pesce sets forth that this would have provided an extraction device that maximizes cell viability and provides an efficient and easy-to-use device (col. 1, ll. 54-61).
Therefore, Crocker in view of Pesce teach the required dimensions and rotational speeds to provide deflection about a longitudinal axis of the cannula at less than 50 grams of force
Claim(s) 7-9 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crocker in view of Fort Wayne Metals (cited in IDS dated 5/24/2023 #144).
Crocker does not expressly disclose where the elongate shaft is formed of a single-layered coiled body formed at a first outer diameter, where the single-layered coiled body is comprised of 14 strands of wires positioned circumferentially adjacent to one another, each wire having a 0.016 wire diameter, wherein the first outer diameter is between 0.112 inches and 0.117 inches.
However, Fort Wayne Metals teaches Fort Wayne Metals teaches a 1 layer (Page 2, “Layers: 1-3”), 14 strand (Page 2, “Filars: 6-18”) wire coiled body (Page 1, “Helical Hollow Strand”). Fort Wayne Metals teaches an inside diameter of the coil body ranging from 0.001-0.130 inches and an outer diameter of the coil body ranging from 0.0025-0.160 inches, meaning, an outer diameter of 0.117 inches falls within taught range. Furthermore, an outer diameter of 0.117 inches and an inner diameter of 0.101 inches (which also falls within taught range) yields each wire having a 0.016 inch wire diameter (i.e., 0.117 inch outer diameter – 0.101 inch inner diameter = 0.016 inch wire diameter). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the first and second portion of Crocker to be the coiled body of Fort Wayne Metals, as Fort Wayne Metals teaches that these dimensions are often used to transmit torque and pushing forces due to its exceptional whip free characteristics and high resistance to kinks (see Page 1).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791