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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/22/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 8 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.
Response to Arguments
Applicant’s arguments, filed 6/22/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the added limitation “a diameter of the orifice is 0.05mm to 0.15 mm, and a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm so that a plurality of streams of water jets that are ejected in parallel and provide a clustering effect are generated” 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 Therefore, the rejection has been withdrawn.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 Palasis and Starck, Stoller in view of Palasis and Ivey.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 12-18, and 21-24 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 1 recites the limitation “the orifice” in line 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “each one of the plurality of orifices”.
Claims 2-8, 12-18, and 21-24 are rejected due to their dependence on claim 1.
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, 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 Palasis et al. (US 20020095124 A1) and in view of Starck et al. (EP 0634187 A1) (in text citations correspond to attaches Espacenet translation).
Regarding claim 1, as best understood in view of the 112(b) issues above, 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), wherein the plurality of orifices are uniformly arranged on an end surface of the water jet nozzle (Figure 14-15; Paragraph 0054).
Sussman fails to explicitly disclose a diameter of each of the plurality of orifices is 0.05 mm to 0.15 mm, and a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm so that a plurality of streams of water jets that are ejected in parallel and provide a clustering effect are generated.
However, Palasis is directed to a fluid injection device and teaches a plurality of orifices (26) having a diameter ranging from approximately 1 to 500 microns, which encompasses the claimed range of .05-0.15 mm (Paragraph 0032).
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 diameter of each of the plurality of orifices is 0.05mm to 0.15 mm, as taught by Palasis, as both references and the claimed invention are directed to surgical fluidic 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 with the teachings of Palasis by incorporating a diameter of the orifice is 0.05 mm to 0.15 mm in order to control the desired injection parameter, i.e., create a thin steam of fluid (Palasis Paragraph 0013; 0026).
Further, 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). As a result of the modification, the device of Sussman would be fully capable so that a plurality of streams of water jets that are at least partially ejected in parallel, specifically before the streams converge or diverge, and provide a clustering effect are generated, as the present specification states the distance between the jet regions contributes to creating the clustering effect (present specification [0053]). Thus, a modification to adjust the distance between the centers of the orifices would generate a clustering effect.
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 Palasis 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 as modified by Palasis 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 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 Palasis and in view of Ivey (US 5605537 A) (previously of record).
Regarding claim 1, as best understood in view of the 112(b) issues above, 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), wherein the plurality of orifices are uniformly arranged on an end surface of the water jet nozzle (Figure 10A; 10C).
Stoller fails to explicitly disclose a diameter of each of the plurality of orifices is 0.05 mm to 0.15 mm, and a distance between centers of two adjacent orifices among the plurality of orifice is 0.4 mm to 4.0 mm so that a plurality of streams of water jets that are ejected in parallel and provide a clustering effect are generated.
However, Palasis is directed to a fluid injection device and teaches a plurality of orifices (26) having a diameter ranging from approximately 1 to 500 microns, which encompasses the claimed range of .05-0.15 mm (Paragraph 0032).
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 diameter of each of the plurality of orifices is 0.05mm to 0.15 mm, as taught by Palasis, as both references and the claimed invention are directed to surgical fluidic 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 Stoller with the teachings of Palasis by incorporating a diameter of the orifice is 0.05 mm to 0.15 mm in order to control the desired injection parameter, i.e., create a thin steam of fluid (Palasis Paragraph 0013; 0026).
Further, 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). As a result of the modification, the device of Stoller would be fully capable so that a plurality of streams of water jets that are at least partially ejected in parallel, as each stream would be parallel to an adjacent stream, and provide a clustering effect are generated, as the present specification states the distance between the jet regions contributes to creating the clustering effect (present specification [0053]). Thus, a modification to adjust the distance between the centers of the orifices would generate a clustering effect.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman in view of Palasis and 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 Palasis and 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.
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).
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 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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman in view of Palasis and Starck, as applied to claim 1 above, and further in view of Fletcher et al. (US 20020045911 A1)
Regarding claim 9, Sussman as modified by Palasis and Starck teaches the medical water jet scalpel according to claim 1, but fails to explicitly disclose wherein a flow rate of a jet of the medical liquid ejected from the plurality of orifices is 50 m/s to 100 m/s.
However, Fletcher is directed to a liquid jet surgical device and teaches a flow rate of a microjet ranges from about 1 m/s to 100 m/s, which encompasses the claimed range of 50 m/s to 100 m/s (Paragraph 0016; 0035). When modified with Sussman, a flow rate of a jet of the medical liquid ejected from the plurality of orifices would be 50 m/s to 100 m/s, as Fletcher only teaches one orifice rather than a plurality of orifices.
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 Palasis and Starck such that wherein a flow rate of a jet of the medical liquid is 50 m/s to 100 m/s, as taught by Fletcher, as both references and the claimed invention are directed to fluidic surgical 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 Palasis and Starck, with the teachings of Fletcher by incorporating wherein a flow rate of a jet of the medical liquid is 50 m/s to 100 m/s in order to effectively cut tissue (Fletcher Paragraph 0037) and Sussman is silent to the flow rate.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sussman in view of Palasis and 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 Palasis and 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 Palasis and 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 Palasis and 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 (Kojima Paragraph 0036).
Regarding claim 24, Sussman as modified by Palasis, Starck and Kojima teaches the medical system according to claim 23, but fails to further disclose 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 Palasis, 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 (Kojima Paragraph 0044), 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 Actions for detailed reasons for the indication of allowable subject matter.
Conclusion
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
/BRIGID K BYRD/Examiner, Art Unit 3771
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