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 .
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.
Claim Objections
Claim 1 objected to because of the following informalities:
“for positioning” in line 2 should be written “configured for positioning”
“the outer surface” in line 5 should be written “an outer surface”
Appropriate correction is required.
Claim 20 objected to because of the following informalities:
“the outer surface” in line 10 should be written “an outer surface”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 20 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.
Claim 20 recites the limitation "the needle" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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) 1-15 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reid, (US 20110264084).
Regarding claim 1, Reid (Figure 5) discloses a cryoprobe (300) comprising: a shell (346) extending in an axial direction and forming a needle (340) for positioning at a target tissue; and a tube (126) extending in the axial direction positioned radially inward of the shell (346); wherein an inner surface (124) of the shell (346) and the outer surface (126) of the tube (346) define an insulating cavity (122) therebetween ([0038], [0043]).
Regarding claim 2, Reid (Figure 5) further discloses wherein the insulating cavity (122) forms a vacuum sleeve to insulate the outer surface of the shell ([0010]-[0012], [0038]).
Regarding claim 3, Reid (Figure 5) further discloses wherein the shell (340) and the tube (126) comprise cylindrical shapes ([0038], [0043]).
Regarding claim 4, Reid (Figure 5) further discloses wherein the insulating cavity (122) comprises a sealed cavity configured to maintain a vacuum ([0030], [0038], [0043]).
Regarding claim 5, Reid (Figure 5) further discloses wherein a proximate end of the tube (126) comprises a mating surface configured to seal to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 6, Reid (Figure 5) further discloses wherein a diameter of the mating surface at the proximate end of the tube (126) is greater than a diameter of a central portion of the tube (126), ([0030], [0038], [0043]: since the proximal and distal ends of the tube 126 have a greater diameter than the central portion of the tube 126).
Regarding claim 7, Reid (Figure 5) further discloses wherein the mating surface of the tube (126) is connected to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 8, Reid (Figure 5) further discloses wherein the mating surface of the tube (126) is brazed to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 9, Reid (Figure 5) further discloses wherein a distal end of the tube (126) is axially separated from a distal end of the shell (346) by a predetermined distance, as shown in Figure 5, ([0038], [0043]).
Regarding claim 10, Reid (Figure 5) further discloses wherein the predetermined distance is configured to cause an iceball of a predetermined shape to be formed by the cryoprobe (300) during use ([0038], [0043], [0051]).
Regarding claim 11, Reid (Figure 5) further discloses wherein a distal end of the tube (126) comprises a joining surface configured to seal to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 12, Reid (Figure 5) further discloses wherein a diameter of the joining surface at the distal end of the tube (126) is greater than a diameter of a central portion of the tube (126), ([0030], [0038], [0043]: since the proximal and distal ends of the tube 126 have a greater diameter than the central portion of the tube 126).
Regarding claim 13, Reid (Figure 5) further discloses wherein the joining surface of the tube (126) is connected to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 14, Reid (Figure 5) further discloses wherein the joining surface of the tube (126) is brazed to the inner surface (124) of the shell (346), ([0030], [0038], [0043]).
Regarding claim 15, Reid (Figure 5) further discloses wherein the tube (126) is positioned radially outward of a lumen (152) that is configured to supply cryogen (coolant fluid) to the cryoprobe (300), ([0039]).
Regarding claim 18, Reid (Figure 5) further discloses wherein a proximal end and a distal end of the tube (126) have an outer diameter that is different from an outer diameter of a central portion of the tube (126), ([0030], [0038], [0043]: since the proximal and distal ends of the tube 126 have a greater diameter than the central portion of the tube 126).
Regarding claim 19, Reid (Figure 5) further discloses wherein the insulating cavity (122) extends in the axial direction from a handle (790) to a predetermined location relative to a tip of the cryoprobe (300), [0052]).
Regarding claim 20, Reid (Figures 5 and 9) discloses a cryoprobe (300) comprising: an outer shell (124) extending in an axial direction configured to be positioned at a target tissue of a subject; a tip (346) connected to a distal end of the outer shell (124); a handle (790) connected to a proximal end of the outer shell (124) opposite to the tip (340); a lumen (152) positioned inside the outer shell (124) and configured to supply cryogen (coolant fluid) to an ice formation zone of the needle at or near the tip (340); and an insulating tube (126) inside the outer shell (124) and radially outward of the lumen (152), the insulating tube (126) joined (sealed) to an inner surface of the outer shell (124) at opposite ends to form a vacuum cavity (122) between the inner surface of the outer shell (124) and the outer surface of the insulating tube (126), ([0030, [0038], [0043]).
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.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reid, as applied to claim 1 above, and further in view of Trumer et al., (US 20200138499; hereinafter Trumer).
Regarding claim 16, Reid discloses the cryoprobe of claim 1, but fails to disclose wherein a thickness of the insulating cavity is in a range of about 0.02 mm to about 0.08 mm. However, Trumer (Figure 1) teaches a cryoprobe (1), wherein the thickness of an insulating cavity is in a range of about 0.02 mm to about 0.087 mm ([0009], [0011], [0024]: the diameter of the second passageway/tube 4 may be 0.6 to 1.2 mm in diameter and the diameter of the shell 27 may be between 0.9 to 2.0 mm; therefore the insulating cavity formed by the space between these two elements may be 0.02 for example when the diameter of the tube 4 is 1.2 mm and the diameter of the shell is 1.22). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Reid to include a thickness of the insulating cavity in a range of about 0.02 mm to about 0.08 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 17, Reid discloses the cryoprobe of claim 1, but fails to disclose wherein an outer diameter of the shell is in a range of about 1.5 mm to about 2.5 mm. However, Trumer (Figure 1) teaches a cryoprobe (1), wherein the outer diameter of the shell is in a range of about 1.5 mm to about 2.5 mm ([0009], [0011]: between 0.9 to 2.0 mm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Reid to include an outer diameter of the shell in a range of about 1.5 mm to about 2.5 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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