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 .
Response to Amendment
As of the reply filed 10/02/2025 claims 16-17 and 19-33 are pending. Claims 16-17, 19-20, 22, 25-27, 29, and 32 are amended while claims 1-15 and 18 remain cancelled. Claim 33 is new.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim 32 under 35 U.S.C. 112(a) have been considered but are not persuasive.
Applicant argues that “a person skilled in the art would be able to recognize in Applicant’s disclosure a description of the features defined in claim 32” (see Remarks pages 9-10), asserting that Fig. 2 shows the over pressure chamber 115 being formed in the inner fitting portion, but the Examiner respectfully disagrees. The inner fitting portion is not mentioned by name or structure in the present specification (the only fitting mentioned is an unrelated male/female luer lock arrangement in PP [0039]), and the present figures do not clearly show the structure of the inner fitting portion. The Applicant provided an annotated Fig. 2 to show the alleged inner fitting portion (see below), but this annotation does not clearly show the intended structure. A vertical line bisects the portion which the Applicant states is the “distal end of [the] main body fitted in the inner fitting portion”, separating this portion from the remainder of the main body and making it unclear whether or not this portion is truly attached to the main body or not. With no written disclosure of the inner fitting arrangement in the present specification to support the Applicant’s annotated figure, the Examiner argues that one of ordinary skill in the art would not be able to recognize Fig. 2 as providing adequate support for “an inner fitting portion arranged upstream the injection channel and configured to receive the distal end of the main body, the distal end of the main body being fitted in the inner fitting portion of the distal part at a distance from the injection channel, the over-pressure chamber being formed in the inner fitting portion between the distal end of the main body and the injection channel” as recited by dependent claim 32.
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Applicant’s arguments, see Remarks, filed 10/02/2025, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Paraschiv et al. (as previously cited), Scheller et al. (US PGPub 2019/0336161 A1), and Miller et al. (as previously cited).
Since Paraschiv et al. and Miller et al. are still relied upon in the rejections below, the arguments against those references which still apply in view of the addition of the Scheller et al. reference are addressed below.
Applicant argues that Paraschiv et al. fails to disclose an injection channel offset from the longitudinal axis X12 (see pages 11-12 of Remarks), but the Examiner respectfully disagrees. Independent claim 16 defines the longitudinal axis X12 via the downstream portion of the main body, reciting “the main body comprising a downstream portion extending along a longitudinal axis X12”. The Examiner argues that any axis parallel to an extension direction of the downstream portion would read on this claim language, including an axis slightly offset to a center line of the downstream portion (see annotation below of Scheller et al.) since a longitudinal axis does not inherently need to be geometrically centered. If the longitudinal axis X12 itself is interpreted to be offset, the distal part as disclosed by Paraschiv et al., when attached to the adaptor and handpiece of Scheller et al., would include an injection channel being offset from the longitudinal axis X12. Since the downstream portion of Scheller et al. (portion of 1300 past 1330) extends “along” the proposed longitudinal axis X12, the combination as proposed and further elaborated on below would read on the amended claim language.
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Applicant further argues that the prior art fails to disclose or teach the delivery of “a pressurized fluid stream in a direction above the hook” (see pages 11-12 of Remarks). The Examiner respectfully argues that this language is a functional limitation, and the MPEP states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01). Regardless of the disclosures, the structures recited by claim 16, including the main body lumen, the over-pressure chamber, and the injection channel, can be considered to be configured to deliver a pressurized fluid stream in a direction above the hook because they are configured for attachment to a fluid source capable of providing a pressurized fluid stream. Additionally, the fluid ejected from the injection channel (138 in Fig. 1 of Paraschiv et al.) is configured to be delivered in a direction above the hook (126) since it is capable of spraying out of the injection channel (138) and dispersing in the air above the hook (126). Since the injection lumen of Paraschiv et al. meets each of the structural requirements of the claim, it can be considered to be configured to deliver the fluid as claimed.
Applicant further argues that Paraschiv et al. fails to disclose an injection channel “located in the vicinity of the distal end of the main body” because “the channel 138 in Paraschiv is located in the blade body 112, and not in the vicinity of the distal end of the main body” (see page 14 of Remarks), but the Examiner respectfully disagrees and argues that “in the vicinity” is a broad limitation. Merriam-Webster Dictionary defines the term “in the vicinity of” to mean “in the area that is close to (a place)”, and the Examiner argues that since the combination as proposed would attach the distal part in Fig. 1 of Paraschiv et al. to 1301 in Figs. 13A-B of Scheller et al., the injection channel 138 of Paraschiv et al. would be in the vicinity of the main body of Scheller et al. (see Figs. 23A-B) since the injection channel would be relatively close to the distal end of the main body (see body including 1200, 100, and 1300 in Figs. 23A-B).
The Applicant states that “Miller does not teach or suggest a hook” (see page 17 of Remarks), however the Examiner notes that Figs. 1 and 6 of Miller et al. do contain an instrument comprising a hook (see 14 in Fig. 1 and 70 in Fig. 6, col. 5, lines 33-35: “FIG. 6 illustrates a reverse cut knife end 70 that is substituted for the working end 14 in the angled surgical tool 10 (shown in FIG. 1) to create a reverse cut knife 74”) and a concave elbow (20) facing the same side as the hook (see Fig. 1, 14 extends towards the same side as the concave elbow).
The Applicant argues that Paraschiv et al. fails to disclose an “upstream blade portion being inclined towards the inside of the hook at an angle…” because “Paraschiv teaches an ‘outwardly facing cutting edge 130’” (see Remarks page 18), but the Examiner respectfully disagrees and points out the difference in language between the claimed “being inclined towards the inside of the hook” and the argued “outwardly facing cutting edge”. The cutting edge 130 of Paraschiv et al. is still curved in a direction that is angled towards the inside of the hook (126), therefore Paraschiv et al. reads on this limitation.
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.
Claim 32 is 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 32 recites “wherein the distal part comprises an inner fitting portion arranged upstream the injection channel and configured to receive the distal end of the main body, the distal end of the main body being fitted in the inner fitting portion of the distal part at a distance from the injection channel, the over-pressure chamber being formed in the inner fitting portion between the distal end of the main body and the injection channel”, and the Applicant states that “Support for new claim 32 can be found in the specification, for example in the structural features that can be derived from Figure 2” (see Remarks page 7), however Fig. 2 does not provide sufficient support for these added limitations as it does not clearly show the inner fitting portion nor the distal end of the main body which it receives. Furthermore, the present specification does not describe this inner fitting portion in a way that could clarify the structures shown in Fig. 2, only describing a fitting in PP [0039] with reference to the male or female luer lock fittings of the syringe (3 in Fig. 1). Additionally, when compared to the present application’s Fig. 7 which shows a thicker wall portion surrounding lumen 111 (see annotation below) while the distal part is detached from the main body, it is further unclear whether Fig. 2 actually illustrates an inner fitting portion which receives a distal end of the main body, as Fig. 2 does not show that the main body includes a portion which is received by the inner fitting portion. It is recommended that this claim be cancelled for containing new matter.
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-17, 19-26, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Paraschiv et al. (US Patent No. 8,814,870 B2) in view of Scheller et al. (US PGPub 2019/0336161 A1) and Miller et al. (US Patent No. 5,269,796).
With respect to claim 16, Paraschiv et al. discloses a surgical treatment instrument for tenolysis, tenotomy or neurolysis (see Fig. 1, col. 5, lines 13-18: “A blade in accordance with the present invention provides the user with the option of cutting sideways through a patient's tissues, that is, in a direction generally perpendicular to the axis of the blade and the shank. In addition, the user may cut tissue by pulling backward toward the proximal end of the device after hooking material on the inner hook section”, see MPEP 2112.01, the device of Paraschiv et al. is configured to treat tenolysis, tenotomy, or neurolysis), comprising:
a distal part (110 in Fig. 1), wherein the distal part (110) has a curved portion forming a hook (126) and is provided with a cutting blade (144) on the inner side of the hook (126, col. 11, lines 33-39: “the surgeon pulls the blade 110, 210, 310, 410 in a proximal direction out of the patient so that cutting edge 144, 244, 344, 444 engages bony tissue of the patient. Blade 110, 210, 310, 410 is ultrasonically vibrated during the pulling of the blade against the bony tissue to thereby enable the cutting of the bony tissue by cutting edge 144, 244, 344, 444”), and
and wherein the distal part (110) has:
an over-pressure chamber (136), and
an injection channel (138) in fluidic connection with the over-pressure chamber (136, col. 6, lines 56-61: “A bore or channel 136 provided in shank 114 communicates at a distal end with a narrower bore or channel 138 in proximal blade portion 122. Channel 138 in turn communicates with recess 134. Channels 136 and 138 deliver irrigating and cooling liquid to recess 134 for distribution over blade body 112”), the injection channel (138) being disposed opposite the hook opening (134) extending radially from a middle portion of the hook (126) to a free end of the hook (134 extends from the middle of 126 to the free end of the hook 126 near 144) to direct a fluid stream above the hook, the injection channel (138) having an outlet (upper end of 138 which communicates with 134) located in the vicinity of the distal end of the main body (110, “in the vicinity” is broad, the upper end of 138 is near the distal end of 110), the injection channel (138) being in fluidic connection with a fluid source via the over-pressure chamber (13, col. 6, lines 56-61: “A bore or channel 136 provided in shank 114 communicates at a distal end with a narrower bore or channel 138 in proximal blade portion 122. Channel 138 in turn communicates with recess 134. Channels 136 and 138 deliver irrigating and cooling liquid to recess 134 for distribution over blade body 112”),
the over-pressure chamber (136) being configured to deliver pressurized fluid to the injection channel (138, col. 6, lines 56-61: “A bore or channel 136 provided in shank 114 communicates at a distal end with a narrower bore or channel 138 in proximal blade portion 122. Channel 138 in turn communicates with recess 134. Channels 136 and 138 deliver irrigating and cooling liquid to recess 134 for distribution over blade body 112”), the over-pressure chamber (136) having a cross-sectional area greater than the cross-sectional area of the injection channel (see Fig. 1, 136 has a greater cross-sectional area than 138),
the injection channel (138) being configured to emit the pressurized fluid as a pressurized fluid stream in a direction above the hook (126, see MPEP 2112.01, 138 can emit fluid configured to spray above and beyond 126).
However, Paraschiv et al. fails to disclose:
a main body extending between a proximal end and a distal end, the main body comprising a downstream portion extending along a longitudinal axis X12 and including the distal end, an upstream portion including the proximal end, a longitudinal lumen for passage of fluid from the proximal end to the distal end of the main body, and an elbow presenting an angle formed by the upstream portion and the downstream portion of the main body,
the distal part extending from the main body,
wherein the angle of the elbow defines a concavity facing the inner side of the hook,
the over-pressure chamber in fluidic connection with the lumen,
the injection channel being in fluidic connection with the lumen via the over-pressure chamber parallel to the longitudinal axis X12, the injection channel being offset from the longitudinal axis X12, or
the over-pressure chamber having a cross-sectional area greater than the cross-sectional area of the lumen of the main body.
In the same field of cutting surgical instruments (see abstract), Scheller et al. discloses a surgical instrument (see Figs. 23A-B) comprising a distal connector for attachment to a cutting end (1300, see also Fig. 13A showing distal thread 1320), and further comprising:
a main body (see body including 1200, 100, and 1300 in Figs. 23A-B) extending between a proximal end and a distal end (see Figs. 23A-B), the main body (1200, 100, and 1300) comprising a downstream portion (distal end of 1300 beyond 1330 as seen in Fig. 13A) extending along a longitudinal axis X12 and including the distal end (the bent portion of 1300 beyond 1330 includes the distal end, note that the claim language does not require the axis to be centered on the upstream portion, but that the downstream portion need only extend “along” it, this language supports an axis parallel but offset from the downstream end of the main body), an upstream portion (remainder of 1200, 100, and 1300 before 1330 as seen in Fig. 13A) including the proximal end (this portion includes the proximal end of the device as a whole), a longitudinal lumen (1350 and 1360 in Fig. 13B) for passage of fluid from the proximal end to the distal end of the main body (see PP [0188]: “a pump of an ultrasonic surgical system may be configured to pump an irrigation fluid into medial inner bore 1350”), and an elbow (see elbow formed by angled piece 1300 in Fig. 13A) presenting an angle formed by the upstream portion (remainder of 1200, 100, and 1300 before 1330 as seen in Fig. 13A) and the downstream portion (distal end of 1300 beyond 1330 as seen in Fig. 13A) of the main body (1200, 100, and 1300 in Figs. 23A-B),
a distal end (1301 in Fig. 13A) configured to couple to a distal part including a blade portion extending from the main body, the distal part including an over-pressure chamber and an injection channel (the device of Scheller et al. is configured to mate with a distal end piece and would be configured to couple with a piece like this),
wherein the angle of the elbow (see elbow formed by angled piece 1300 in Fig. 13A) defines a concavity (see concavity on bottom of piece 1300),
the lumen (1350 and 1360 in Fig. 13B) configured to be in fluid communication with the over-pressure chamber of the distal part (the device of Scheller et al. is configured to mate with a distal end piece and would be configured to be in fluid communication with an additional chamber/bore), and
the lumen (1350 and 1360 in Fig. 13B) configured to be in fluid connection with the injection channel via the over-pressure chamber (the device of Scheller et al. is configured to mate with a distal end piece and would be configured to be in fluid communication with an additional chamber/bore).
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It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the device of Paraschiv et al. to incorporate the teachings of Scheller et al. such that the distal piece of Paraschiv et al. is attached to the distal end of the handpiece shown in Figs. 23A-B of the Scheller et al. reference and specifically such that the injection channel of Paraschiv et al. is parallel to and offset from the longitudinal axis X12 that the downstream portion “[extends] along” (note that the claim language does not require the axis to be centered on the upstream portion, but that the downstream portion need only extend “along” it, this language supports an axis parallel but offset from the downstream end of main body 24 which would yield the offset injection channel as claimed). One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been a simple substitution of distal tip elements that would have yielded predictable results (see PP [0189] of Scheller et al.), since the distal element of Parashiv is intended to be coupled with a body of an ultrasonic handpiece (col. 6, lines 13-15: “an externally threaded neck 115 for connecting blade 110 to a source of ultrasonic vibrations (not shown)”). Modifying the respective external threads of the tip element of Paraschiv et al. and the adaptor of Scheller et al. so that they are compatible furthermore would have been obvious to try, since there are a finite number of solutions (internal or external threads) that one of ordinary skill in the art could have explored with a reasonable chance of success in mating these components together.
However, Paraschiv et al. as modified by Scheller et al. does not explicitly disclose wherein the angle of the elbow defines a concavity facing the inner side of the hook or wherein the over-pressure chamber comprises a cross-sectional area greater than the cross-sectional area of the lumen of the main body.
In the same field of surgical cutting instruments (abstract), Miller et al. discloses a cutting instrument (see Figs. 1 and 6, col. 5, lines 33-35: “FIG. 6 illustrates a reverse cut knife end 70 that is substituted for the working end 14 in the angled surgical tool 10 (shown in FIG. 1) to create a reverse cut knife 74”) comprising a hook (70 in Fig. 6, see comparable working end 14 in Fig. 1) and a main body (26 and 28) comprising an elbow (20), wherein the angle of the elbow (20) defines a concavity facing the inner side of the hook (see Figs. 1 and 6, 20 is concave facing the extrusion of 14 and therefore faces the inner side of the hook shown in Fig. 6).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Paraschiv et al. and Scheller et al. further according to the teachings of Miller et al. to include wherein the angle of the elbow defines a concavity facing the inner side of the hook. One of ordinary skill in the art would have been motivated to perform this modification because it involves the use of a known feature (the hook/elbow alignment as taught by Miller et al.) to improve a similar device (the combination of Paraschiv et al. and Scheller et al.) in the same way to yield predictable results (the distal tip of Paraschiv et al. mounted on the handpiece of Scheller et al. such that the inner side of the hook of Paraschiv et al. faces the concavity of the elbow of Scheller et al.).
Paraschiv et al. as modified by Scheller et al. and Miller et al. further fail to disclose wherein the over-pressure chamber comprises a cross-sectional area greater than the cross-sectional area of the lumen of the main body.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date to have further modified the combination as proposed to include wherein the over-pressure chamber comprises a cross-sectional area greater than the cross-sectional area of the lumen of the main body. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been obvious to try, as there are a finite number of predictable solutions (the over-pressure chamber is larger than, the over-pressure chamber is smaller than, or the over-pressure chamber is the same size as the lumen of the main body) that one of ordinary skill in the art could have explored with a reasonable expectation of success, particularly since modifying the devices of Paraschiv et al. and Scheller et al. to have respective female and male threaded connection sections would yield the cross-sectional areas as claimed.
Regarding claim 17, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the injection channel (138 in Fig. 1 of Paraschiv et al.) is configured to direct a stream of fluid radially outwardly (138 is configured to direct fluid past the distal end of the hook 126, and the spray would radiate outwardly, see MPEP 2112.01).
Regarding claim 19, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the injection channel (138 in Fig. 1 of Paraschiv et al.) is defined as an extension of an upper portion of the lumen of the main body (1350 and 1360 in Figs. 13A-B of Scheller et al., the combination as proposed would add the tip of Paraschiv et al. onto 1301 such that the injection channel is an extension), and an upper portion of the over-pressure chamber (136 in Fig. 1 of Paraschiv et al., see 1350 and 1360 in Figs. 13A-B of Scheller et al., the combination as proposed would add the tip of Paraschiv et al. onto 1301 such that the over-pressure chamber is an extension), wherein the injection channel (138 in Fig. 1 of Paraschiv et al.) is offset from the longitudinal axis X12 (see above, the combination as proposed would yield this as the claim language does not specifically recite the location or orientation of the longitudinal axis X12) and disposed opposite the hook opening (134) extending radially from a middle portion of the hook (126) to a free end of the hook (134 extends from the middle of 126 to the free end of the hook 126 near 144)
Regarding claim 20, Paraschiv et al. as modified by Scheller et al. and Miller et al. in the rejection of claim 18 above fails to disclose wherein the ratio of the cross-sectional area of the lumen of the main body to the cross-sectional area of the over-pressure chamber is less than or equal to 0.7 and wherein the ratio of the cross-sectional area of the injection channel to the cross-sectional area of the over-pressure chamber is less than or equal to 0.5.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Paraschiv et al., Scheller et al., and Miller et al. combination to incorporate the claimed cross-sectional area ratios because applicant appears to have placed no criticality on the claimed range, citing to a different preferred range of between 0.6 and 0.7 or 0.45 and 0.5 for the two ratios within the present specification (see PP [0014-0015]) in contrast to the “less than or equal to 0.7” and “less than or equal to 0.5” ranges claimed. Applicant states that these ratios allow for ensuring the delivery of pressurized fluid without latency (see PP [0015] of present specification), but cites to two different workable ranges with only a small overlap, suggesting that other ratios would be appropriate for achieving the desired effect. Since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)) and the devices of Paraschiv et al. and Scheller et al. would not operate differently with the claimed ratios between the over-pressure chamber, lumen, and injection channel. Since Paraschiv et al. and Scheller et al. also both aim to deliver irrigating fluid to a distal blade body, such a modification would be obvious to one of ordinary skill in the art.
Regarding claim 21, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the elbow (see Fig. 13A of Scheller et al. with bend between 1330 and 1301) defines on the concave side an angle of between 90 degrees and 160 degrees (PP [0185]: “angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is in a range of 5.0 to 25.0 degrees, e.g., angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is 20.0 degrees. Illustratively, angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is less than 5.0 degrees or greater than 25.0 degrees”, the angle would be 180 degrees minus the disclosed range, yielding an angle between 155 and 175 degrees which is encompassed by the claimed range) the upstream portion (remainder of 1200, 100, and 1300 before 1330 as seen in Fig. 13A) of the main body (1200, 100, and 1300 in Figs. 23A-B) and the downstream portion (distal end of 1300 beyond 1330 as seen in Fig. 13A) of the main body (1200, 100, and 1300 in Figs. 23A-B).
Regarding claim 22, Paraschiv et al. as modified by Miller et al. further discloses wherein the cutting blade of the hook (126 in Fig. 1 of Paraschiv et al.) comprises an inner blade portion (144) inside the hook (126) and an upstream blade portion (130) proximal to the inner blade portion (144, 130 begins proximal to 144 and is therefore proximal to the inner blade portion 144), the upstream blade portion (130) being inclined towards the inside of the hook (126) at an angle ranging between 5 degrees and 30 degrees, relative to the longitudinal axis X12 (col. 7, lines 28-30: “Elongate portion 124 of blade body 112 is tapered, the outwardly facing cutting edge 130 extending at an angle of 5-15 degrees relative to axis 128”, the combination as proposed would yield a device along a longitudinal axis parallel to axis 128, the angle would be the same as disclosed).
Regarding claim 23, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses a tip (irrigation barb 1600 in Figs. 23A-B of Scheller et al., see also Figs. 16A-B) configured to cooperate with a syringe (PP [0149]: “an irrigation fluid may be configured to ingress irrigation barb 1600 via irrigation barb distal end 1601, e.g., an irrigation fluid may be configured to ingress irrigation barb inner bore 1650”) so as to bring the syringe body into fluidic connection with the lumen of the main body (1200, 100, and 1300 in Figs. 23A-B) at the proximal end (the opening of 1600 is configured to transport fluid, see PP [0149]).
Regarding claim 24, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the distal part (112 in Fig. 1 of Paraschiv et al.) has a sharp distal end (132 is a cutting edge therefore the distal end is sharp).
Regarding claim 25, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the distal part (112 in Fig. 1 of Paraschiv et al.) has a rounded distal end (132 is rounded, see Fig. 1).
Regarding claim 26, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the main body (1200, 100, and 1300 in Figs. 23A-B of Scheller et al., see also 115 and 116 in Fig. 1 of Paraschiv et al. where the main body would connect) and the distal part (112 in Fig. 1 of Paraschiv et al.) are configured to cooperate with an insertion cannula having a sharp distal end, the insertion cannula comprising a tubular body delimiting a housing for receiving the distal portion and a support plate for the elbow of the main body (the insertion cannula is not positively recited by the claim, the main body and the distal portion are configured to cooperate with an insertion cannula as described therefore this combination reads on this claim, see MPEP 2112.01).
Regarding claim 31, Paraschiv et al. as modified by Scheller et al. and Miller et al. fails to disclose wherein the elbow (see elbow formed by angled piece 1300 in Fig. 13A of Scheller et al.) defines on the concave side an angle of about 120 degrees, between a portion of the upstream portion of the main body (remainder of 1200, 100, and 1300 before 1330 as seen in Fig. 13A) and the downstream portion of the main body (distal end of 1300 beyond 1330 as seen in Fig. 13A), because the elbow (see elbow formed by angled piece 1300 in Fig. 13A) defines on the concave side an angle of between 155 degrees and 175 degrees (PP [0185]: “angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is in a range of 5.0 to 25.0 degrees, e.g., angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is 20.0 degrees. Illustratively, angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is less than 5.0 degrees or greater than 25.0 degrees”, the angle would be 180 degrees minus the disclosed range, yielding an angle between 155 and 175 degrees which is encompassed by the claimed range).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Paraschiv et al., Scheller et al., and Miller et al. combination such that the elbow defines on the concave side an angle of about 120 degrees since applicant appears to have placed no criticality on the claimed range (PP [0016]: “the elbow defines on the concave side an angle of between 90 and 160 [degrees] preferably of the order of 120 [degrees], between a portion of the main body upstream of the elbow and a portion of the main body downstream of the elbow”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). In the present case, Scheller et al. contemplates that “Illustratively, angled adaptor 1300 may be configured to offset ultrasonic tip 3600 at an angle relative to amplifier 100 wherein the angle is less than 5.0 degrees or greater than 25.0 degrees” (PP [0185]), which overlaps with the claimed value of 120 degrees since Scheller et al. contemplates angles of greater than 25 degrees (the angle would be 180 degrees minus the disclosed range, yielding an angle less than 155 degrees when using the “greater than 25 degrees” teaching).
Regarding claim 33, Paraschiv et al. as modified by Scheller et al. and Miller et al. further discloses wherein the pressurized fluid stream is emitted with sufficient force to allow hydro-dissection of tissue (Scheller et al. PP [0187]: “a pump of an ultrasonic surgical system may be configured to pump an irrigation fluid into irrigation barb 1600”, Paraschiv et al. col. 4, lines 57-58: “The shank is preferably provided with an axially extending bore for the conveyance of cooling fluid to the blade body”), see MPEP 2112.01, this is functional language, any pump could be configured to do this).
Claims 27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Paraschiv et al. (US Patent No. 8,814,870 B2), Scheller et al. (US PGPub 2019/0336161 A1), and Miller et al. (US Patent No. 5,269,796) as applied to claim 16 above, and further in view of Rhee et al. (PGPub US 2019/0314561 A1).
Regarding claim 27, Paraschiv et al. as modified by Scheller et al. and Miller et al. fails to disclose an insertion cannula having a sharp distal end, the insertion cannula comprising a tubular body delimiting a housing for receiving the distal part, and a support plate for supporting the elbow of the main body.
In the analogous field of surgical device insertion (abstract), analogous in that the present application also concerns itself with the delivery of a surgical device towards a target site, Rhee et al. teaches an instrument (14 in Fig. 1) comprising a main body connected to an insertion cannula (12) having a sharp distal end (16), the insertion cannula (12) comprising a tubular body (see Fig. 1) delimiting a housing (22), and a support plate (30) configured to support an elbow of a main body (“support” is a broad term, the combination as proposed would result in the main body and plate being connected to one another via other components therefore element 30 can be considered configured to support the elbow).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed above to further incorporate the teachings of Rhee et al. and include the insertion cannula as described above such that the combination of Paraschiv et al., Scheller et al., and Miller et al. is supported within the insertion cannula of the Rhee et al. reference for delivery to the target site. One of ordinary skill in the art would have performed this modification because the main body of Scheller et al. and the distal blade of Paraschiv et al. is ready for improvement and introduction to a patient via an insertion, and because attaching the main body of Scheller et al. coaxially to the insertion cannula of Rhee et al. would have yielded predictable results, since it is known in the art that a sharp outer cannula helps to facilitate insertion of surgical instruments into patients (Rhee et al. PP [0005]).
Regarding claim 29, Paraschiv et al. as modified by Scheller et al., Miller et al. and Rhee et al. further discloses an insertion cannula (12 in Fig. 1 of Rhee et al.) having a sharp distal end (16), the insertion cannula (12) comprising a tubular body (see Fig. 1 of Rhee et al.) delimiting a housing (22) for receiving the distal part (112 in Fig. 1 of Paraschiv et al., 11 is configured to receive 112 when placed on the main body of Scheller et al., see 14 entering the housing 22 in Fig. 5 of Rhee et al.) and a support plate (30 in Fig. 1 of Rhee et al.) for supporting the elbow (see elbow formed by angled piece 1300 in Fig. 13A of Scheller et al.) of the main body (1200, 100, and 1300 in Figs. 23A-B) wherein the support plate (30 in Fig. 1 of Rhee et al.) has a length, in the longitudinal direction of the tubular body (body of 12) equal to or greater than the length of a fibrous tissue to be severed (the support plate 30 has a length which can be greater to a fibrous tissue depending on the fibrous tissue chosen).
Regarding claim 30, Paraschiv et al. as modified by Scheller et al., Miller et al., and Rhee et al. further discloses wherein the support plate (30 in Fig. 1 of Rhee et al.) comprises a median part (medial radial part of 30) for supporting the elbow (“support” is a broad term, the combination as proposed would result in the main body and plate being connected to one another via other components therefore element 30 can be considered configured to support the elbow) in the extension of the tubular body (body of 14 in Fig. 1) and two lateral wings (162 and 164 in Figs. 33-34) on either side of the median part (162 and 164 are placed on either side of a medial part of 146, see also 30 in Fig. 1), which are capable of being folded towards each other on the side of the tubular body (body of 12, see also 102 in Figs. 33-34, PP [0074]: “two arms 162, 164 extending from the collar portion 158 and movable between a first position (FIG. 33) and a second position”).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Paraschiv et al. (US Patent No. 8,814,870 B2) over Scheller et al. (US PGPub 2019/0336161 A1) and Miller et al. (US Patent No. 5,269,796), as applied to claim 16 above, and further in view of Stokes et al. (PGPub US 2016/0143658 A1).
Regarding claim 28, Paraschiv et al. as modified by Scheller et al. and Miller et al. fails to explicitly disclose a syringe in fluidic connection with the lumen (1350 and 1360 in Figs. 13A-B of Scheller et al.) of the main body (1200, 100, and 1300 in Figs. 23A-B) at the proximal end (end near 1600).
In the same field of ultrasonic cutting instruments, Stokes et al. teaches an ultrasonic cutting instrument (see Fig. 1) comprising a syringe (570 in Fig. 40A) in fluidic communication with a lumen (580) extending through the main body of the device “to provide fluid communication between syringe 570 and the end effector” (PP [0161]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Paraschiv et al., Scheller et al., and Miller et al. combination with the teachings of Stokes et al. and include a syringe for providing irrigation fluid. One of ordinary skill in the art would have been motivated to perform this modification because using a syringe as a fluid source is a known technique in the field of ultrasonic cutting instruments and combining it with the known devices of Paraschiv et al. and Scheller et al. to supply fluid would have yielded predictable results since Paraschiv et al. and Scheller et al. are each silent on any preferred fluid sources.
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771