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
In light of Applicant’s amendment, claim(s) 1 and 9 is/are amended and claim(s) 10-11 and 19-20 were previously canceled. Claims 1-8, 12-18, and 21-24 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments, filed 2/20/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 102 have been fully considered and are persuasive. Examiner agrees the added limitation “wherein a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sussman in view of Starck, Stoller in view of Ivey and Staid in view of Ivey.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-7, 9, 18, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman et al. (US 20020077585 A1) (noted on IDS) in view of Starck et al. (EP 0634187 A1) (in text citations correspond to attaches Espacenet translation).
Regarding claim 1, Sussman discloses a medical water jet scalpel (10) (Paragraph 0054 states Figs. 14-21 shows a variety of different distal tips which may be used with the handpiece of the present invention, which is disclosed as handpiece 10 in Figs. 1-7, thus the main device 10 further comprises elements such as 600, found in later figures)., comprising:
a water jet tube (600), comprising an inlet (proximal opening into lumen 611), an outlet (distal opening into lumen 611), and an inner lumen (611) configured to provide space for circulation of medical liquid, wherein the inlet is configured for an inflow of the medical liquid (Figure 14-17; Paragraph 0054); and
a water jet nozzle (602), comprising a plurality of orifices (604), wherein the plurality of orifices are communicated with the outlet of the water jet tube, and the plurality of orifices are configured to eject the medical liquid passing through the outlet (discharge orifices 604 are located at the outlet and project fluid onto target tissue, thus are configured to eject the medical liquid passing through the outlet) (Figure 14-15; Paragraph 0054).
Sussman fails to explicitly disclose wherein a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm.
However, Starck is directed to a fluidic surgical device and teaches a distance between centers of two adjacent orifices among the plurality of orifices (18) is between 3 and 6 mm, which includes values within the claimed range of 0.4 mm to 4.0 mm (Figure 2; Paragraph 0009; 0019).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sussman such that a distance between centers of two adjacent orifices among the plurality of orifice is between 3 and 6 mm, as taught by Starck, as both references and the claimed invention are directed to fluidic surgical devices and Sussman is silent to any dimensions pertaining to the distances between the center of orifices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sussman with the teachings of Starck by incorporating wherein a distance between centers of two adjacent orifices among the plurality of orifice is between 3 and 6 mm in order to achieve high coverage of the surgical area (Starck Paragraph 0008). Further, Sussman is silent to the distance between centers of two adjacent orifices among the plurality of orifices.
Regarding claim 2, Sussman further discloses wherein the water jet nozzle comprises a multi-orifice sub-nozzle (distal end of 600) provided with the plurality of orifices (Figure 14-15; Paragraph 0054).
Regarding claim 4, Sussman further discloses wherein the outlet of the water jet tube is a blind end (602’), and at least part of the blind end serves as the water jet nozzle (Figure 17; Paragraph 0055).
Regarding claim 5, Sussman further discloses wherein the outlet of the water jet tube is a blind end (602’), and the water jet nozzle is arranged at the blind end of the water jet tube (Figure 17; Paragraph 0055).
Regarding claim 6, Sussman further discloses wherein the water jet tube is a sleeved tube opened at both ends (Figure 14-15; Paragraph 0054), and
the water jet nozzle is fixed at the outlet of the water jet tube (Figure 14-15; Paragraph 0054), and the water jet nozzle is connected with the outlet of the water jet tube in a sealed manner, directly (distal end 602 of tip 600 is integral, thus is directly connected in a sealed manner) (Figure 14-15; Paragraph 0054).
Regarding claim 7, Sussman further discloses an outer aspiration tube (20) (Figure 5; Paragraph 0045), wherein the outer aspiration tube is sleeved outside the water jet tube (Figure 5; Paragraph 0045), and a gap space (48) between an outer sidewall of the water jet tube and an inner sidewall of the outer aspiration tube serves as an aspiration channel (Figure 5; Paragraph 0046). (Paragraph 0054 states Figs. 14-21 shows a variety of different distal tips which may be used with the handpiece of the present invention, which is disclosed as handpiece 10 in Figs. 1-7, thus the main device 10 further comprises elements such as 600, found in later figures).
Regarding claim 9, Sussman further discloses wherein the plurality of orifices are uniformly arranged (Figure 14-15; Paragraph 0054).
Regarding claim 18, Sussman further discloses an ejection connecting tube (18), wherein the ejection connecting tube is communicated with an end of the water jet tube away from the water jet nozzle (Figure 5; Paragraph 0045).
Regarding claim 21, Sussman further discloses wherein the plurality of orifices comprise at least two orifices configured to eject the medical liquid to selectively separate a target tissue (Figure 14-15; Paragraph 0054).
Regarding claim 22, Sussman discloses a medical system, comprising:
the medical water jet scalpel according to claim 1 (see rejection to claim 1 above);
a liquid supply unit (34) configured to provide the medical liquid (Paragraph 0047); and
a pressure pump (42) configured to apply a pressure to the medical liquid to input the medical liquid into the inner lumen of the water jet tube (Paragraph 0046) (Paragraph 0054 states Figs. 14-21 shows a variety of different distal tips which may be used with the handpiece of the present invention, which is disclosed as handpiece 10 in Figs. 1-7, thus the main device 10 further comprises elements such as 600, found in later figures).
Claim(s) 1-3, 6-7, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stoller (US 5788667 A) (previously of record) in view of Ivey (US 5605537 A).
Regarding claim 1, Stoller discloses a medical water jet scalpel, comprising:
a water jet tube (10), comprising an inlet (1), an outlet (14), and an inner lumen (lumen of 10) configured to provide space for circulation of medical liquid, wherein the inlet is configured for an inflow of the medical liquid (Figure 1-2; Col 6, lines 26-37); and
a water jet nozzle (11), comprising a plurality of orifices (15) (Figure 10A, 10C), wherein the plurality of orifices are communicated with the outlet of the water jet tube (Figure 3), and the plurality of orifices are configured to eject the medical liquid passing through the outlet (fluid jet orifices 15 are located at the outlet and supply fluid, thus are configured to eject the medical liquid passing through the outlet) (Col 7 line 63- Col 8 line 4).
Stoller fails to explicitly disclose wherein a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm.
However, Ivey is directed to a fluidic surgical device and teaches a distance between centers of two adjacent orifices among the plurality of orifices (18) is 2.5 mm, which is within the claimed range of 0.4 mm to 4.0 mm (Figure 1; Col 6, line 25-35).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Stoller such that a distance between centers of two adjacent orifices among the plurality of orifice is 2.5 mm, as taught by Ivey, as both references and the claimed invention are directed to fluidic surgical devices and Stoller is silent to any dimensions pertaining to the distances between the center of orifices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stoller with the teachings of Ivey by incorporating wherein a distance between centers of two adjacent orifices among the plurality of orifice is 2.5 mm, to ensure uniform flow and distribution of fluid, as well as being able to determine length and depth of the surgical arena (Ivey Col 6, line 33-39). Further, Stoller is silent to the distance between consecutive orifices.
Regarding claim 2, Stoller further discloses wherein the water jet nozzle comprises a multi-orifice sub-nozzle (distal end of 10s) provided with the plurality of orifices (Figure 11-12; Col 7 line 63- Col 8 line 4).
Regarding claim 3, Stoller further discloses wherein the water jet nozzle comprises a plurality of single-orifice sub-nozzles (each of 10 forms a single orifice sub-nozzle and Figure 11-12 show a plurality of sub-nozzles), and at least part of the plurality of orifices are respectively formed in the plurality of single- orifice sub-nozzles (each of 10 is provided with at least one opening, thus at least one orifice is provided in each sub-nozzle) (Figure 11-12; Col 8, line 5-11).
Regarding claim 6, Stoller further discloses wherein the water jet tube is a sleeved tube opened at both ends (Figure 1-2) (the tube is opened at the distal end via orifices 15 and at the proximal end in order to be able to receive fluid), and
the water jet nozzle is fixed at the outlet of the water jet tube (Figure 11-12), and the water jet nozzle is connected with the outlet of the water jet tube in a sealed manner, directly (distal end 10 and nozzle 11 are integral, thus is directly connected in a sealed manner) (Figure 11-12; Col 10, line 27-28).
Regarding claim 7, Stoller further discloses an outer aspiration tube (9) (Figure 2; Col 6 line 43-47), wherein the outer aspiration tube is sleeved outside the water jet tube (Figure 2; Col 6 line 43-47), and a gap space between an outer sidewall of the water jet tube and an inner sidewall of the outer aspiration tube serves as an aspiration channel (Figure 2; Col 6 line 43-47).
Regarding claim 12, Stoller further discloses wherein the water jet nozzle comprises metal (Col 10, line 19-28); and the water jet tube comprises metal (Col 10, line 19-28).
Regarding claim 14, Stoller further discloses wherein the water jet nozzle is fixed at an inner side of the outlet of the water jet tube in a sealed manner (Col 10, line 19-28).
Claim(s) 1-2, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Staid et al. (WO 2020181278 A1) in view of Ivey (US 5605537 A).
Regarding claim 1, Staid discloses a medical water jet scalpel (100) (Paragraph 0004), comprising:
a water jet tube (105) (Figure 7; Paragraph 0020; 0028), comprising an inlet (116), an outlet (112), and an inner lumen (110) configured to provide space for circulation of a medical liquid (154) (Figure 1A; Paragraph 0020; 0023; 0038), wherein the inlet is configured for an inflow of the medical liquid (Figure 1A; Paragraph 0038; 0040); and
a water jet nozzle (120+152) (Figure 1A, 7; Paragraph 0022; 0037), comprising a plurality of orifices (122) (Figure 1; Paragraph 0031), wherein the plurality of orifices are communicated with the outlet of the water jet tube (Figure 1A; Paragraph 0031), and the plurality of orifices are configured to eject the medical liquid passing through the outlet (openings 122 are located out the outlet and are designed to release liquid, thus the plurality of orifices are configured to eject the medical liquid passing through the outlet) (Figure 1A; Paragraph 0031).
Staid fails to explicitly disclose wherein a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm.
However, Ivey is directed to a fluidic surgical device and teaches a distance between centers of two adjacent orifices among the plurality of orifices (18) is 2.5 mm, which is within the claimed range of 0.4 mm to 4.0 mm (Figure 1; Col 6, line 25-35).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Staid such that a distance between centers of two adjacent orifices among the plurality of orifice is 2.5 mm, as taught by Ivey, as both references and the claimed invention are directed to fluidic surgical devices and Staid is silent to any dimensions pertaining to the distances between the center of orifices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Staid with the teachings of Ivey by incorporating wherein a distance between centers of two adjacent orifices among the plurality of orifice is 2.5 to ensure uniform flow and distribution of fluid, as well as being able to determine length and depth of the surgical arena (Ivey Col 6, line 33-39). Further, Staid is silent to the distance between consecutive orifices.
Regarding claim 2, Staid further discloses wherein the water jet nozzle comprises a multi-orifice sub-nozzle provided with the plurality of orifices (a plurality of openings 122 are provided on the nozzle and carrier 120+152, thus the water jet nozzle comprises a multi-orifice sub-nozzle provided with the plurality of orifices) (Figure 1A-B; Paragraph 0031; 0051).
Regarding claim 21, Staid further discloses wherein the plurality of orifices comprise at least two orifices configured to eject the medical liquid to selectively separate a target tissue (Figure 1A-B; Paragraph 0031; 0051).
Regarding claim 22, Staid discloses a medical system (500+100), comprising:
the medical water jet scalpel according to claim 1 (see rejection to claim 1 above);
a liquid supply unit (513) configured to provide the medical liquid (Paragraph 0047); and
a pressure pump (pump) configured to apply a pressure to the medical liquid to input the medical liquid into the inner lumen of the water jet tube (Paragraph 0047).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman in view of Starck and further in view of Kikawada et al. (JP H0984801 A) (citations correspond to attached Espacenet translation) (previously of record).
Regarding claim 8, Sussman as modified by Starck discloses the medical water jet scalpel according to claim 7, but fails to explicitly disclose wherein an inner diameter of the outer aspiration tube is 3 mm to 7.6 mm, and an outer diameter of the outer aspiration tube is 4 mm to 8 mm; an inner diameter of the water jet tube is 1.5 mm to 5 mm, and an outer diameter of the water jet tube is 2 mm to 6 mm; and a diameter of the orifice is 0.05 mm to 0.15 mm.
However, Kikawada is directed to a water jet system and teaches an inner diameter of the outer aspiration tube (52) is 4 mm, which encompasses the claimed range of is 3 mm to 7.6 mm (Paragraph 0009), and an outer diameter of the outer aspiration tube is 6mm which is encompassed in the claimed range of 4 mm to 8 mm (Paragraph 0009); an inner diameter of the water jet tube (51) is 0.5 to 1.5 mm, which encompasses the claimed range of 1.5 mm to 5 mm (Paragraph 0007), and an outer diameter of the water jet tube is 2 mm, which encompasses the claimed range of 2 mm to 6 mm (Paragraph 0007) and a diameter of the orifice is 0.1 mm to 2 mm, which encompasses the claimed range of 0.05 mm to 0.15 mm (abstract; Paragraph 0005).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to wherein an inner diameter of the outer aspiration tube is 3 mm to 7.6 mm, and an outer diameter of the outer aspiration tube is 4 mm to 8 mm; an inner diameter of the water jet tube is 1.5 mm to 5 mm, and an outer diameter of the water jet tube is 2 mm to 6 mm; and a diameter of the orifice is 0.05 mm to 0.15 mm as taught by Kikawada, since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman in view of Starck, as applied to claim 22 above, in view of Kojima et al. (US 20120089164 A1) (noted on IDS).
Regarding claim 23, Sussman as modified by Starck further discloses a wastewater reservoir (43) (Paragraph 0047), wherein the medical water jet scalpel also comprises an outer aspiration tube (18) (Paragraph 0045), wherein the outer aspiration tube is sleeved outside the water jet tube (irrigation channel 18 is on the exterior of the device as depicted in Figure 5, thus us sleeved outside the water jet tube, which is in the lumen of the device) (Figure 5), and a gap space (space between wall of 18 and water jet tube) between an outer sidewall of the water jet tube and an inner sidewall of the outer aspiration tube is used as an aspiration channel (Figure 5) (Paragraph 0054 states Figs. 14-21 shows a variety of different distal tips which may be used with the handpiece of the present invention, which is disclosed as handpiece 10 in Figs. 1-7, thus the main device 10 further comprises elements such as 600, found in later figures.).
Sussman fails to explicitly disclose the wastewater reservoir is communicated with the outer aspiration tube.
However, Kojima is directed to a fluid instrument and teaches a wastewater reservoir (3) is communicated with an outer aspiration tube (80+5) (Figure 1; Paragraph 0036).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sussman as modified by Starck such that the wastewater reservoir is communicated with the outer aspiration tube, as taught by Kojima, as both references and the claimed invention are directed to water tube devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sussman as modified by Starck with the teachings of Kojima by incorporating the wastewater reservoir is communicated with the outer aspiration tube in order to collect and store waste from the procedure.
Regarding claim 24, Sussman as modified by Starck and Kojima teaches the medical system according to claim 23, further comprising a negative pressure aspirator, wherein the negative pressure aspirator is connected to the wastewater reservoir.
However, Kojima further teaches a negative pressure aspirator (11), wherein the negative pressure aspirator is connected to the wastewater reservoir (3) (Figure 1; Paragraph 0036; 0044).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sussman as modified by Starck with the teachings of Kojima by incorporating a negative pressure aspirator, wherein the negative pressure aspirator is connected to the wastewater reservoir in order to collect waste with improved suction, as Sussman is silent to any means of controlling the aspiration line.
Allowable Subject Matter
Claims 13 and 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. See previous Action for detailed reasons for the indication of allowable subject matter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771