DETAILED ACTION
Summary
Claims 1-3, 5-11, 13-18, and 20 are pending in the application. Claims 6 and 14 are rejected under 35 USC 112(a). Claims 5-7, and 13-15 are rejected under 35 USC 112(b). Claims 1-3, 5-11, 13-18, and 20 are rejected under 35 USC 103.
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
Claims 5-6 and 13-14 objected to because of the following informalities:
Claim 5 recites “a longitudinal axis” in line 3. It should recite “the longitudinal axis”.
Claim 6 recites “forming each groove” in line 5. It should recite “forming each of the grooves”.
Claim 6 recites “a longitudinal axis” in line 5. It should recite “the longitudinal axis”.
Claim 13 recites “the groove” in line 7. It should recite “the at least one spiral groove”.
Claim 13 recites “a longitudinal axis” in line 3. It should recite “the longitudinal axis”.
Claim 14 recites “a longitudinal axis” in lines 5-6. It should recite “the longitudinal axis”.
Appropriate correction is required.
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 6 and 14 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.
Claim 6 recites “forming each groove at a neutral position relative to a longitudinal axis”. This is not supported by the originally filed specification. While the specification details non-tilted grooves [0040], it does not teach non-tilted crisscrossing grooves with a tilted spiral groove. The amendment is new matter.
Claim 14 recites “forming each of the groove at a neutral position relative to a longitudinal axis”. This is not supported by the originally filed specification. While the specification details non-tilted grooves [0040], it does not teach non-tilted crisscrossing grooves with a tilted spiral groove. The amendment is new matter.
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 5-7, and 13-15 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.
Claim 5 recite “at least one spiral groove” in line 2. It is not clear if this is referring to the spiral groove set forth in claim 1, or if this is setting forth another spiral groove. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 5 recites “an angle” in line 4. It is not clear if this is referring to the angle previously set forth, or if this is setting forth a new angle. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 5 recites “walls” in line 5. It is not clear if this is referring to walls previously set forth, or if this is setting forth new walls. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 6 recites “forming one spiral groove” and “forming an other spiral groove” in line 2-3. It is not clear if these grooves are in addition to the “at least one groove” of claim 1, or included in the at least one groove. Clarification is required. For the purposes of examination, the grooves will be interpreted in addition to the groove of claim 1.
Claim 6 recites “each groove” in line 5. It is not clear if this includes the groove set forth in claim 1, or if this only includes the grooves set forth in claim 6. Clarification is required. For the purposes of examination, the latter definition will be sued.
Claim 6 recites “a neutral position” in line 5. It is not clear if this is referring to the neutral position set forth in claim 1, or if this is setting forth another neutral position. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 7 recites “forming one spiral groove” and “forming an other spiral groove” in lines 2-3. It is not clear if these grooves are in addition to the “at least one groove” of claim 1, or included in the at least one groove. Clarification is required. For the purposes of examination, the grooves will be interpreted as including the groove of claim 1.
Claim 7 recites “an angle” in line 5. It is not clear if this is referring to the angle set forth in claim 1, or if this is setting forth a new angle. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 13 recite “at least one spiral groove” in line 2. It is not clear if this is referring to the spiral groove set forth in claim 10, or if this is setting forth another spiral groove. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 13 recites “an angle” in line 4. It is not clear if this is referring to the angle previously set forth, or if this is setting forth a new angle. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 14 recites “forming one spiral groove” and “forming an other spiral groove” in line 2-3. It is not clear if these grooves are in addition to the “at least one groove” of claim 10, or included in the at least one groove. Clarification is required. For the purposes of examination, the grooves will be interpreted in addition to the groove of claim 10.
Claim 14 recites “each of the grooves” in line 5. It is not clear if this includes the groove set forth in claim 10, or if this only includes the grooves set forth in claim 14. Clarification is required. For the purposes of examination, the latter definition will be sued.
Claim 14 recites “a neutral position” in line 5. It is not clear if this is referring to the neutral position set forth in claim 1, or if this is setting forth another neutral position. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 15 recites “forming one spiral groove” and “forming an other spiral groove” in lines 2-3. It is not clear if these grooves are in addition to the “at least one groove” of claim 10, or included in the at least one groove. Clarification is required. For the purposes of examination, the grooves will be interpreted as including the groove of claim 10.
Claim 15 recites “an angle” in line 5. It is not clear if this is referring to the angle set forth in claim 10, or if this is setting forth a new angle. Clarification is required. For the purposes of examination, the former definition will be used.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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 1-2, 5, 10, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini et al. (U.S PGPub 2010/0160731 A1) in view of Field (U.S PGPub 2010/0256577 A1), Guzman (U.S PGPub 2011/0201930 A1), Sato (JP2010194013A) and Iwase et al. (U.S PGPub 2014/0336687 A1).
Regarding Claim 1, Giovannini teaches a method of placing an echogenic needle assembly in a body (Abstract), comprising:
an echogenic feature (Fig. 3, 306) at or proximate to a sharp distal tip (Fig. 3, 308) of a needle [0024]
mounting the needle [0024] into an echogenic cannula (Fig. 3, 302+303 is an echogenic feature of the cannula, making it an echogenic cannula) [0024] having a distal end such that at least a portion of the echogenic feature of the needle extends beyond the distal end of the echogenic cannula (Fig. 3, 308 extends beyond 302) [0021]+[0024].
While Giovannini teaches that the system is used for ultrasonic visualization during navigation ([0020]+[0024]), Giovannini fails to explicitly teach confirming positioning of the echogenic cannula in the body by observing under ultrasound the echogenic feature of the needle as the needle is inserted to a desired location inside the body.
Field teaches a needle assembly for use during ultrasonic navigation (Abstract). This system confirms the positioning of the echogenic cannula (needle 1) in the body by observing under ultrasound the echogenic feature of the needle (stylet 2) as the needle is inserted to a desired location inside the body [0007]+[0017].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Giovannini to confirm the position of the cannula by using the echogenic feature of the needle, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
The combination fails to explicitly teach observing under ultrasound the echogenic cannula in the body after the needle is removed from the echogenic cannula to confirm the echogenic cannula remains at the desired location inside the body. While Giovannini teaches the system acts as a needle assembly, Giovannini is silent regarding the stylet being a needle.
Guzman teaches an ultrasound guided procedure (Abstract). This system uses a needle (Fig. 3A, 24) [0033] and an echogenic introducer sheath (Fig. 3C, 14) [0-035]-[0036] to perform a percutaneous procedure [0008]. This system observes the echogenic cannula in the body after the needle is removed in order to confirm the cannula remains at the desired location [0013].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to observe the cannula after the needle is removed, as taught by Guzman, because it provides better localization of the tools, and better medicine delivery, thereby improving the procedure, as recognized by Guzman [0005]. It further would have been obvious to substitute the inner stylet of Giovannini with an echogenic needle, as taught by Guzman, as the substitution for one known pointed medical device with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle as the inner member are reasonably predictable.
The combination fails to explicitly teach forming the echogenic feature on the needle by forming at least one spiral groove having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis of the needle where the walls of the groove would have substantially the same length.
Sato teaches an echogenic needle [0001]. This needle has an echogenic feature formed as a groove (Fig. 5, 15) having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis [0031]-[0033]. The walls of the groove would have substantially the same length [0031] (V-shaped means the walls are the same length).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach the groove is a spiral groove.
Iwase teaches a method for making an echographic needle (Abstract). This system has an echographic feature of a spiral groove [0009].
It would have been obvious to substitute the echographic groove of the combination with a spiral groove, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a spiral groove are reasonably predictable.
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Giovannini further teaches wherein the mounting step comprises inserting the needle to the echogenic cannula along a coaxial bore of the echogenic cannula (Fig. 3, stylet 306 shares an axis with the bore 312 of cannula 302, and therefore is inserted along a coaxial bore) such that the sharp tip of the needle extends beyond the distal end of the echogenic cannula (Fig. 3, 308 extends beyond 302) [0021]+[0024]).
While Giovannini teaches the system acts as a needle assembly, Giovannini is silent regarding the stylet being a needle.
Guzman teaches an ultrasound guided procedure (Abstract). This system uses a needle (Fig. 3A, 24) [0033] and an echogenic introducer sheath (Fig. 3C, 14) [0-035]-[0036] to perform a percutaneous procedure [0008].
It further would have been obvious to substitute the inner stylet of Giovannini with an echogenic needle, as taught by Guzman, as the substitution for one known pointed medical device with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle as the inner member are reasonably predictable.
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach providing the echogenic feature by forming at least one spiral groove at or proximate to the tip of the needle, the needle having a longitudinal axis; and tilting the at least one spiral groove at an angle relative to the longitudinal axis of the needle toward a non-patient end of the needle while keeping the walls of the groove orthogonal to each other so that one of the walls of the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle..
Sato teaches an echogenic needle [0001]. This needle has the echogenic feature by forming at least one groove (Fig. 5, 15) at or proximate to the tip of the needle, the needle having a longitudinal axis (Fig. 5+6, the needle has a longitudinal axis) [0032]. The system tilts the groove at an angle relative to the longitudinal axis of the needle toward a non-patient end of the needle while keeping the walls of the groove orthogonal to each other so that one of the walls of the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle [0031]-[0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach the groove is a spiral groove.
Iwase teaches a method for making an echographic needle (Abstract). This system has an echographic feature of a spiral groove [0009].
It would have been obvious to substitute the echographic groove of the combination with a spiral groove, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a spiral groove are reasonably predictable.
Regarding Claim 10, Giovannini teaches a method of placing an echogenic needle assembly in a body (Abstract), comprising:
providing a needle having a sharp distal tip (Fig. 3, 308) and an echogenic feature at or proximate to the sharp distal tip (Fig. 3, 306) [0024]
providing a cannula (Fig. 3, 302) having an echogenic shaft (Fig. 3, 303) including a distal end and an axial bore (Fig. 3, 312) longitudinally along the cannula [0024]
mounting the needle through the axial bore of the cannula such that the sharp distal tip and at least a portion of the echogenic feature extend beyond the distal end of the cannula (Fig. 3, 308 extends beyond 302) [0021]+[0024].
While Giovannini teaches that the system is used for ultrasonic visualization during navigation ([0020]+[0024]), Giovannini fails to explicitly teach observing by ultrasound the echogenic feature of the needle as the needle and the cannula mounted about the needle are inserted into and moved to a desired location inside the body;.
Field teaches a needle assembly for use during ultrasonic navigation (Abstract). This system observes under ultrasound the echogenic feature of the needle (stylet 2) as the needle and the cannula mounted about the needle are inserted into and moved to a desired location inside the body [0007]+[0017].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Giovannini to confirm the position of the cannula by using the echogenic feature of the needle, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
The combination fails to explicitly teach removing the needle from the cannula when the cannula is positioned to the desired location inside the body; confirming by ultrasound that the echogenic shaft remains at the desired location inside the body. While Giovannini teaches the system acts as a needle assembly, Giovannini is silent regarding the stylet being a needle.
Guzman teaches an ultrasound guided procedure (Abstract). This system uses a needle (Fig. 3A, 24) [0033] and an echogenic introducer sheath (Fig. 3C, 14) [0035]-[0036] to perform a percutaneous procedure [0008]. This system removes the needle when the cannula is positioned to the desired location, and confirms the echogenic shaft remains at the desired location inside the body [0013].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to observe the cannula after the needle is removed, as taught by Guzman, because it provides better localization of the tools, and better medicine delivery, thereby improving the procedure, as recognized by Guzman [0005]. It further would have been obvious to substitute the inner stylet of Giovannini with an echogenic needle, as taught by Guzman, as the substitution for one known pointed medical device with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle as the inner member are reasonably predictable.
The combination fails to explicitly teach the echogenic feature on the needle by formed by at least one spiral groove having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis of the needle where the walls of the groove would have substantially the same length.
Sato teaches an echogenic needle [0001]. This needle has an echogenic feature formed as a groove (Fig. 5, 15) having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis [0031]-[0033]. The walls of the groove would have substantially the same length [0031] (V-shaped means the walls are the same length).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach the groove is a spiral groove.
Iwase teaches a method for making an echographic needle (Abstract). This system has an echographic feature of a spiral groove [0009].
It would have been obvious to substitute the echographic groove of the combination with a spiral groove, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a spiral groove are reasonably predictable.
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach providing the echogenic feature by forming at least one spiral groove at or proximate to the tip of the needle, the needle having a longitudinal axis; and tilting the at least one spiral groove at an angle relative to the longitudinal axis of the needle toward a non-patient end of the needle while keeping the walls of the at least one spiral groove orthogonal to each other so that one of the walls of the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle..
Sato teaches an echogenic needle [0001]. This needle has the echogenic feature by forming at least one groove (Fig. 5, 15) at or proximate to the tip of the needle, the needle having a longitudinal axis (Fig. 5+6, the needle has a longitudinal axis) [0032]. The system tilts the groove at an angle relative to the longitudinal axis of the needle toward a non-patient end of the needle while keeping the walls of the groove orthogonal to each other so that one of the walls of the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle [0031]-[0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach the groove is a spiral groove.
Iwase teaches a method for making an echographic needle (Abstract). This system has an echographic feature of a spiral groove [0009].
It would have been obvious to substitute the echographic groove of the combination with a spiral groove, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a spiral groove are reasonably predictable.
Regarding Claim 18, Giovannini teaches a method of placing a needle assembly in a body (Abstract), comprising:
forming an echogenic feature (Fig. 3, 306) at or proximate to a sharp distal tip (Fig. 3, 308) the needle [0024]
mounting a cannula having a longitudinal echogenic shaft including a distal end (Fig. 3, 302+303 is an echogenic feature of the cannula, making it an echogenic cannula) [0024] and the needle having a distal portion that includes the sharp distal tip (Fig. 3, 308) and the echogenic feature (Fig. 3, 306) [0024] to each other to form the needle assembly that has the sharp distal tip and the distal portion having the echogenic feature extending beyond the distal end of the cannula (Fig. 3, 308 extends beyond 302) [0021]+[0024].
While Giovannini teaches that the system is used for ultrasonic visualization during navigation ([0020]+[0024]), Giovannini fails to explicitly teach continue to move the needle assembly to position the cannula to a desired location inside the body by observing under ultrasound the movement of the echogenic feature at the distal portion of the needle.
Field teaches a needle assembly for use during ultrasonic navigation (Abstract). This system moves the needle assembly to position the echogenic cannula to a desired location inside the body by observing under ultrasound the movement of the echogenic feature at the distal portion of the needle [0007]+[0017].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Giovannini to confirm the position of the cannula by using the echogenic feature of the needle, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
The combination fails to explicitly teach observing by ultrasound the echogenic feature of the needle as the sharp distal tip of the needle makes an initial incision into the body to insert the needle assembly into the body or removing the needle from the cannula after the cannula is positioned at the desired location inside the body; confirming by ultrasound that the cannula remains in the desired location inside the body. While Giovannini teaches the system acts as a needle assembly, Giovannini is silent regarding the stylet being a needle.
Guzman teaches an ultrasound guided procedure (Abstract). This system uses a needle (Fig. 3A, 24) [0033] and an echogenic introducer sheath (Fig. 3C, 14) [0035]-[0036] to perform a percutaneous procedure [0008]. The system observes by ultrasound the echogenic feature of the needle as the sharp distal tip of the needle makes initial incision into the body to insert the needle assembly into the body (Fig. 5A-5B) [0044] (the system inserts the needle assembly under ultrasonic guidance, one of ordinary skill would recognize this includes the initial incision). This system removes the needle from the cannula after the cannula is positioned at the desired location inside the body and confirms by ultrasound that the cannula remains in the desired location inside the body [0013].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to image the needle during the initial incision and observe the cannula after the needle is removed, as taught by Guzman, because it provides better localization of the tools, and better medicine delivery, thereby improving the procedure, as recognized by Guzman [0005]. It further would have been obvious to substitute the inner stylet of Giovannini with an echogenic needle, as taught by Guzman, as the substitution for one known pointed medical device with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle as the inner member are reasonably predictable.
The combination fails to explicitly teach providing the echogenic feature on the needle by forming at least one spiral groove having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis of the needle where the walls of the groove would have substantially the same length.
Sato teaches an echogenic needle [0001]. This needle has an echogenic feature formed as a groove (Fig. 5, 15) having walls orthogonal to each other at an angle tilted from a neutral position relative to the longitudinal axis [0031]-[0033]. The walls of the groove would have substantially the same length [0031] (V-shaped means the walls are the same length).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach the groove is a spiral groove.
Iwase teaches a method for making an echographic needle (Abstract). This system has an echographic feature of a spiral groove [0009].
It would have been obvious to substitute the echographic groove of the combination with a spiral groove, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a spiral groove are reasonably predictable.
Claims 3, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini in view of Field, Guzman, Sato, and Iwase as applied to claims 1 and 10, respectively, above, and further in view of Hawkins Jr. (U.S Patent 4,874,376) and Field et al. (U.S Patent 8,170,648 B2) (Field’648).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach inserting a guidewire through the echogenic cannula into the body after the needle is removed from the echogenic cannula; removing the echogenic cannula; and inserting a tube guided by the guidewire into the body.
Hawkins Jr. teaches a method of performing a percutaneous procedure (Abstract). This system guidewire through the echogenic cannula into the body after the needle is removed from the echogenic cannula (Fig. 4) (Col 4-5, lines 58-5); and inserts a tube guided by the guidewire into the body (Col 5, lines 43-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date to insert a guidewire for guiding a tube, as taught by Hawkins Jr, because this allows for a safe and accurate placement of a drainage tube, thereby improving patient care, as recognized by Hawkins Jr (Col 1, lines 11-17).
The combined system is silent regarding removing the cannula.
Field’648 teaches a system for implanting a wire (Abstract). This system inserts a cannula, inserts the wire, and then removes the cannula (Col 1, lines 46-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of placing the wire with a method that involves removing the cannula, as taught by Field’648, as the substitution for one known method of implantation with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of removing the cannula are reasonably predictable. Furthermore, one of ordinary skill would recognize that having fewer medical devices implanted results is fewer points of failure for the surgery, thereby increasing the safety and efficacy of the surgical procedure.
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach replacing the cannula with a tube in the body for fluid transfer by inserting a guidewire through the cannula into the body; removing the cannula from the guidewire; and using the guidewire to guide the tube into the body.
Hawkins Jr. teaches a method of performing a percutaneous procedure (Abstract). This system replacing the cannula with a tube in the body for fluid transfer (Col 3, lines 61-67) by inserting a guidewire through the cannula into the body (Fig. 4) (Col 4-5, lines 58-5); and using the guidewire to guide a tube into the body (Col 5, lines 43-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date to insert a guidewire for guiding a tube, as taught by Hawkins Jr, because this allows for a safe and accurate placement of a drainage tube, thereby improving patient care, as recognized by Hawkins Jr (Col 1, lines 11-17).
The combined system is silent regarding removing the cannula from the guidewire.
Field’648 teaches a system for implanting a wire (Abstract). This system inserts a cannula, inserts the wire, and then removes the cannula (Col 1, lines 46-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of placing the wire with a method that involves removing the cannula, as taught by Field’648, as the substitution for one known method of implantation with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of removing the cannula are reasonably predictable. Furthermore, one of ordinary skill would recognize that having fewer medical devices implanted results is fewer points of failure for the surgery, thereby increasing the safety and efficacy of the surgical procedure.
Claims 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini in view of Field, Guzman, Sato, and Iwase as applied to claims 1 and 10 respectively above, and further in view of Syed et al. (U.S PGPub 2016/0120509 A1) and Matsuzawa (U.S PGPub 2012/0253297 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle so that the one and other spiral grooves crisscross each other; forming each groove at a neutral position relative to a longitudinal axis of the needle so that respective walls of each of the grooves are orthogonal to each other and have substantially the same length; and forming each of the grooves to have a pitch in the range of approximately 0.001 in - 0.003 in.
Sato teaches an echogenic needle [0001]. This needle has an echogenic feature formed as a groove (Fig. 5, 15) and forming each groove at a neutral position relative to the longitudinal axis of the needle so that the respective walls of each of the grooves are orthogonal to each other [0031]-[0033]. The walls of the groove would have substantially the same length [0031] (V-shaped means the walls are the same length).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle so that the one and other spiral grooves crisscross each other.
Syed teaches a method for making an echogenic needle (Abstract). This system forms one spiral groove in one direction at or proximate to the tip of the needle (Fig. 1, 140) and forms an other spiral groove in an other direction at or proximate to the tip of the needle (Fig. 1, 140) so that the one and other spiral grooves crisscross each other [0011].
It would have been obvious to modify the echographic groove of the combination to further include crisscrossing spiral grooves, as taught by Iwase, as including crisscrossing grooves would make the needle more visible, thereby allowing the needle to be more accurately identified in the ultrasound image, as recognized by Syed [0028].
The combination fails to explicitly teach forming each of the grooves to have a pitch in the range of approximately 0.001 in - 0.003 in (0.025 mm - 0.075 mm).
Matsuzawa teaches an ultrasound guided needle (Abstract). This system has grooves with a pitch in the range of 0.001 in - 0.003 in [0043].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a pitch between 0.001 in – 0.003 in, as taught by Matsuzawa, as the substitution for one known groove pitch with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a pitch in the claimed range are reasonably predictable.
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle so that the one and other spiral grooves crisscross each other; forming each of the grooves at a neutral position relative to a longitudinal axis of the needle so that respective walls of each of the grooves are orthogonal to each other and have substantially the same length; and forming each of the grooves to have a pitch in the range of approximately 0.001 in - 0.003 in (0.025 mm - 0.075 mm).
Sato teaches an echogenic needle [0001]. This needle has an echogenic feature formed as a groove (Fig. 5, 15) and forming each groove at a neutral position relative to the longitudinal axis of the needle so that the respective walls of each of the grooves are orthogonal to each other [0031]-[0033]. The walls of the groove would have substantially the same length [0031] (V-shaped means the walls are the same length).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle so that the one and other spiral grooves crisscross each other.
Syed teaches a method for making an echogenic needle (Abstract). This system forms one spiral groove in one direction at or proximate to the tip of the needle (Fig. 1, 140) and forms an other spiral groove in an other direction at or proximate to the tip of the needle (Fig. 1, 140) so that the one and other spiral grooves crisscross each other [0011].
It would have been obvious to modify the echographic groove of the combination to further include crisscrossing spiral grooves, as taught by Iwase, as including crisscrossing grooves would make the needle more visible, thereby allowing the needle to be more accurately identified in the ultrasound image, as recognized by Syed [0028].
The combination fails to explicitly teach forming each of the grooves to have a pitch in the range of 0.001 in - 0.003 in.
Matsuzawa teaches an ultrasound guided needle (Abstract). This system has grooves with a pitch in the range of approximately 0.001 in - 0.003 in (0.025 mm - 0.075 mm) [0043].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a pitch between 0.001 in – 0.003 in, as taught by Matsuzawa, as the substitution for one known groove pitch with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a pitch in the claimed range are reasonably predictable
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini in view of Field, Guzman, Sato, and Iwase as applied to claims 1 and 10 respectively above, and further in view of Syed et al. (U.S PGPub 2016/0120509 A1).
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle; tilting each of the grooves at an angle toward a non-patient end of the needle so that the one and other grooves are adapted to reflect an ultrasound wave that impinges onto the grooves in a substantially reverse direction when the needle is inserted into the body at an insertion angle.
Sato teaches an echogenic needle [0001]. This needle has the echogenic feature by forming at least one groove (Fig. 5, 15) at or proximate to the tip of the needle [0032]. The system tilts the groove at an angle toward a non-patient end of the needle so that the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle [0031]-[0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle.
Syed teaches a method for making an echogenic needle (Abstract). This system forms one spiral groove in one direction at or proximate to the tip of the needle (Fig. 1, 140) and forms an other spiral groove in an other direction at or proximate to the tip of the needle (Fig. 1, 140) [0011].
It would have been obvious to substitute the echographic groove of the combination with a crisscrossing spiral grooves, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using crisscrossing spiral grooves are reasonably predictable.
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle; tilting each of the grooves at an angle toward a non-patient end of the needle so that the one and other grooves are adapted to reflect an ultrasound wave that impinges onto the grooves in a substantially reverse direction when the needle is inserted into the body at an insertion angle.
Sato teaches an echogenic needle [0001]. This needle has the echogenic feature by forming at least one groove (Fig. 5, 15) at or proximate to the tip of the needle [0032]. The system tilts the groove at an angle toward a non-patient end of the needle so that the groove is adapted to reflect an ultrasound wave that impinges onto the groove in a substantially reverse direction when the needle is inserted into the body at an insertion angle [0031]-[0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a groove with tilted walls, as taught by Sato, because this increases the intensity of the reflected ultrasound signal, thereby making the needle easier to see, as recognized by Sato [0003].
The combination fails to explicitly teach forming one spiral groove in one direction at or proximate to the tip of the needle; forming an other spiral groove in an other direction at or proximate to the tip of the needle.
Syed teaches a method for making an echogenic needle (Abstract). This system forms one spiral groove in one direction at or proximate to the tip of the needle (Fig. 1, 140) and forms an other spiral groove in an other direction at or proximate to the tip of the needle (Fig. 1, 140) [0011].
It would have been obvious to substitute the echographic groove of the combination with a crisscrossing spiral grooves, as taught by Iwase, as the substitution for one known echographic feature with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using crisscrossing spiral grooves are reasonably predictable.
Claims 8, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini in view of Field, Guzman, Sato and Iwase as applied to claims 1, 10, and 18 respectively above, and further in view of Boslet (U.S Patent 5,289,831).
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Giovannini fails to explicitly teach making the echogenic cannula from a plastic material having bubbles along its length; and providing a smooth outer surface layer on the echogenic cannula.
Field further teaches making the echogenic cannula from a plastic material having bubbles along its length [0020]-[0021] (the marker is a bubble filled plastic, and the sheath can be the marker, which suggests the sheath is a bubble filled plastic).
It would have been obvious to one of ordinary skill in the art to modify the combined system to have bubbles along its length, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
While the outer surfaces of the cannula of Giovanni, Field, and Guzman all appear smooth, the combination is silent regarding providing a smooth outer surface layer on the cannula.
Bosley teaches a system for echogenic medical devices (Abstract). This system produces echogenic medical devices with smooth outer layers in order to increase the safety of using the device (Col 6, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a smooth outer surface, as taught by Bosley, because that decreases the risk of thrombuses forming, thereby increasing the safety of using the device, as recognized by Bosley (Col 6, lines 1-6).
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Giovannini fails to explicitly teach making the cannula from a plastic material having bubbles along its length; and providing a smooth outer surface layer on the cannula.
Field further teaches making the echogenic cannula from a plastic material having bubbles along its length [0020]-[0021] (the marker is a bubble filled plastic, and the sheath can be the marker, which suggests the sheath is a bubble filled plastic).
It would have been obvious to one of ordinary skill in the art to modify the combined system to have bubbles along its length, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
While the outer surfaces of the cannula of Giovanni, Field, and Guzman all appear smooth, the combination is silent regarding providing a smooth outer surface layer on the cannula.
Bosley teaches a system for echogenic medical devices (Abstract). This system produces echogenic medical devices with smooth outer layers in order to increase the safety of using the device (Col 6, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a smooth outer surface, as taught by Bosley, because that decreases the risk of thrombuses forming, thereby increasing the safety of using the device, as recognized by Bosley (Col 6, lines 1-6).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. Giovannini fails to explicitly teach making the cannula from a plastic material having bubbles along its length; and providing a smooth outer surface layer on the cannula.
Field further teaches making the echogenic cannula from a plastic material having bubbles along its length [0020]-[0021] (the marker is a bubble filled plastic, and the sheath can be the marker, which suggests the sheath is a bubble filled plastic).
It would have been obvious to one of ordinary skill in the art to modify the combined system to have bubbles along its length, as taught by Field, because this increases the visibility of the assembly, thereby allowing for easier and more accurate placement confirmation, as recognized by Field [0007].
While the outer surfaces of the cannula of Giovanni, Field, and Guzman all appear smooth, the combination is silent regarding providing a smooth outer surface layer on the cannula.
Bosley teaches a system for echogenic medical devices (Abstract). This system produces echogenic medical devices with smooth outer layers in order to increase the safety of using the device (Col 6, lines 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a smooth outer surface, as taught by Bosley, because that decreases the risk of thrombuses forming, thereby increasing the safety of using the device, as recognized by Bosley (Col 6, lines 1-6).
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Giovannini in view of Field, Guzman, Sato and Iwase as applied to claims 1 and 10 respectively above, and further in view of Hawkins Jr.
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Giovannini fails to explicitly teach attaching a non-patient end of the echogenic cannula to a cannula hub; attaching a proximal end of the needle to a needle cannula; configuring the cannula hub and the needle hub to frictionally couple to each other when the needle and the echogenic cannula are fully mounted to each other.
Field further teaches attaching a proximal end of the needle to a needle hub [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the needle of the combination with a needle with a needle hub, as taught by Field, as the substitution for one known needle with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle with a hub are reasonably predictable.
Field fails to explicitly teach attaching a non-patient end of the echogenic cannula to a cannula hub and configuring the cannula hub and the needle hub to frictionally couple to each other when the needle and the echogenic cannula are fully mounted to each other.
Hawkins Jr further teaches attaching a non-patient end of the echogenic cannula to a cannula hub (Fig. 3, 20) and configuring the cannula hub (Fig. 3, 20) and the needle hub (Fig. 3, 20A) to frictionally couple to each other when the needle and the echogenic cannula are fully mounted to each other (Fig. 4, lines 13-35) (as the hubs are secured to each other, they are considered “frictionally coupled”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of securing the cannula and needle of the combination to use hubs to frictionally secure them, as taught by Hawkins Jr, as the substitution for one known method for securing the cannula and needle with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of frictionally coupling the needle and cannula hubs are reasonably predictable.
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Giovannini fails to explicitly teach attaching a non-patient end of the cannula to a cannula hub; attaching a proximal end of the needle to a needle hub; wherein when the cannula and the needle are fully mounted to each other, the cannula hub and the needle hub are fictionally coupled to each other.
Field further teaches attaching a proximal end of the needle to a needle cannula [0015] (as detailed above, the needle cannula is being interpreted as a needle hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the needle of the combination with a needle with a needle hub, as taught by Field, as the substitution for one known needle with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a needle with a hub are reasonably predictable.
Field fails to explicitly teach attaching a non-patient end of the echogenic cannula to a cannula hub and wherein when the cannula and the needle are fully mounted to each other, the cannula hub and the needle hub are frictionally coupled to each other.
Hawkins Jr further teaches attaching a non-patient end of the echogenic cannula to a cannula hub (Fig. 3, 20) and wherein when the cannula and the needle are fully mounted to each other, the cannula hub (Fig. 3, 20) and the needle hub (Fig. 3, 20A) are frictionally coupled to each other (Fig. 4, lines 13-35) (as the hubs are secured to each other, they are considered “frictionally coupled”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of securing the cannula and needle of the combination to use hubs to frictionally secure them, as taught by Hawkins Jr, as the substitution for one known method for securing the cannula and needle with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of frictionally coupling the needle and cannula hubs are reasonably predictable.
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant argues that the phrase “to position the echogenic cannula to a desired location” is correct as the needle assembly is being moved to the desired location. The Examiner disagrees. Claim 18 recites “continue to move the needle assembly to position the cannula to a desired location inside the body”. The “move” of claim 18 is modifying “position” (continue to move the needle assembly to position the cannula). The “position” of the claim is being describe by “a desired location” (to position the cannula to a desired location). The desired location does not appear to be modifying the “move” step. Therefore, the claim would be more grammatically correct if it recite “continue to move the needle assemble to position the cannula at a desired location inside the body”.
Applicant argues that the Sato reference does not teaches tilting of the groove, nor walls of the groove being orthogonal to each other. The Examiner disagrees. The angle θ of Sato described in [0030] is describing the tilting of the groove from the neutral position. Furthermore, [0031] explicitly teaches that the walls of the groove are orthogonal to each other.
Applicant argues that Fig. 5 does not show the apex angle of 90°. However, Fig. 5 was cited to illustrate how the groove would look, and how they are tilted from the neutral position. As stated above, [0031] explicitly teaches that the grooves have an apex angle of 90° and are tilted from the neutral position.
Applicant continues to argue that walls do not have the same length. The Examiner disagrees. The Specification details how the “length” of the walls is the height of the wall [0034]. As illustrated in Fig. 6c, if the length of the wall is interpreted not as the height, but the actual length, the tilted walls clearly do not have the same length [0034]-[0036]. As such, the broadest reasonably interpretation of “length” of the wall is the height. In Sato, as the walls all have the same height (as they share a top and bottom), they all have the same length.
Applicant argues that if the spiral groove of Iwase was combined with the grooves of Sato, the walls would be different lengths and not orthogonal. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). When viewed together, one of ordinary skill would recognize the combination would have the spiral configuration of Iwase with the orthogonal grooves with same length walls as taught by Sato,.
Applicant argues that Field’577 teaches the echogenic cannula, and it would not be obvious to substitute the cannula of Field’577 with the cannula of Giovannini. The Examiner disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The cannula of Giovannini is the “echogenic cannula”. Field’577 is relied on to teach confirming the location cannula using ultrasound.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As all the features were taught by the cited art, with a reason to combine, the combination is proper under 35 USC 103 and not improper hindsight reasoning.
Applicant’s argues that the crisscrossing spiral grooves of Iwase would have the cross-section of Iwase. The Examiner disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). One of ordinary skill in the art would recognize that the spiral grooves of the combination would have the cross-section of Sato, which has the orthogonal walls of the same length, as detailed above.
Applicant argues that Matsuzawa does not teach the pitch of the grooves being .001-.003 in. The Examiner disagrees. The Examiner notes that this argument appears similar to an argument presented to the Patent Trial and Appeal Board in Application 15/297,767 on 6/8/2021. The Board affirmed the rejection which used Matsuzawa to teach the claimed pitch. The Examiner therefore defers to the board decision regarding this argument. Furthermore, [0043] details how the ridged and grooved portion have a length L3 [0043], and one of ordinary skill would recognize that the pitch of the grooved portion of L3 would be between 0.001 in – 0.003 in (See at least [0043] and [0047], which elaborates on the width (pitch) of only the grooved portion of L3).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798