DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Response to Arguments
4. Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive. The applicant argues that Woloszko U.S. 2005/0288665 fails to teach a filter operable to remove “gases, fluids, and particulates” from the flow of fluid, recited in Claim 1. They site that Woloszko only teaches that the screen (para 0262) serves to filter out large tissue fragments, and is silent to filtering of gases and fluids. However, the examiner disagrees. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Since Woloszko does teach a filter, then this would read on the claim language. Therefore, the previous rejection of this claim limitation stands.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 3, 4, 6, 9, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hufnagel U.S. 2015/0335376 (herein referred to as “Hufnagel”), and in view of Woloszko U.S. 2005/0288665 (herein referred to as “Woloszko”) and Flom U.S. 5,830,214 (herein referred to as “Flom”).
7. Regarding Claim 1, Hufnagel teaches a surgical apparatus (Fig. 1 and 2), comprising:
a. an elongated body comprising a longitudinal axis (Fig. 1, ref num 115, “A” indicates the longitudinal axis), a distal end, and a proximal end (see Fig. 1, ref num 115 has a proximal end, to the right, and a distal end, to the left), the elongated body comprising a fluid conduit extending through the longitudinal axis (Figs. 1 and 2, ref num 120, 156, para 0034);
b. a fluid inlet (Fig. 1, ref num 121) disposed adjacent to the distal end (see Fig. 1, ref num 121 is disposed adjacent to the distal end of ref num 115), wherein the fluid inlet is operable to allow a flow of fluid at a first flow rate (para 0037, “selectively activate the application of aspiration suction… to aspiration tube 120”; para 0040-0041);
c. a cutting element disposed adjacent to the distal end (Fig. 1, ref num 135; para 0034, “electrode 135…enables dissection instrument”); and,
d. a fluid outlet (Figs. 1 and 2, ref num 132) disposed adjacent to the proximal end (see Figs. 1 and 2, the most-proximal end of ref num 132 is adjacent to the proximal end of ref num 115), wherein the fluid inlet and the fluid outlet are in fluid communication via the fluid conduit (see Figs. 1 and 2, ref nums 121 and 132 are in fluid communication via ref num 120; para 0037, 0040-0041).
e. at least one perforation (Fig. 1, ref num 122) defined by the elongated body adjacent to the distal end (Fig. 1, ref num 122 is adjacent the distal end of ref num 115), wherein the at least one perforation is in fluid communication with the fluid conduit (Fig. 1, ref num 122 is in fluid communication with ref num 120; para 0040-0041).
Hufnagel fails to teach the plurality of perforation comprises a first perforation series and a second perforation series, wherein the first perforation series comprises more than one perforation arranged radially around the elongated body adjacent to the distal end and the second perforation series comprises more than one perforation arranged radially around the elongated body and spaced proximally from the first series of perforations, wherein each perforation of the first perforation series maintains an open passage to the fluid conduit and, wherein the at least one each perforation of the second perforation series maintains a filter, the filter operable to remove gases, fluids, and particulates from the flower of fluid through the filter.
Woloszko teaches a surgical apparatus of analogous art (Figs. 34B and 35A), wherein the apparatus comprises an elongated body (Fig. 34B, ref num 1402) comprising a fluid conduit (Fig. 35A, ref num 1442), and at least one perforation defined by the elongated body (Figs. 34B and 35A, ref num 1440), wherein the perforation is in fluid communication with the fluid conduit (para 02262). The perforation further maintains a filter (para 0262, “aspiration port 1440 may have a screen (not shown) to prevent relatively large fragments of resected tissue from entering the aspiration lumen 1442…screen may serve as a mechanical sieve or filter”), the filter operable to remove particulates from the flower of fluid through the filter (para 0262, “aspiration port 1440 may have a screen (not shown) to prevent relatively large fragments of resected tissue from entering the aspiration lumen 1442…screen may serve as a mechanical sieve or filter”). The filter serves to exclude entry of any unwanted fragments/fluids/etc. (para 0262). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Since the filter taught by Woloszko performs the intended use, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel and included a filter to exclude any unwanted substances from the fluid conduit.
Flom teaches a device of analogous art (Fig. 1), wherein the device comprises a plurality of perforation (Fig. 1, ref num 8), such that the plurality of perforation comprises a first perforation series and a second perforation series, wherein the first perforation series comprises more than one perforation arranged radially around the elongated body adjacent to the distal end (Fig. 1, the two most distal ref nums 8) and the second perforation series comprises more than one perforation arranged radially around the elongated body and spaced proximally from the first series of perforations (Fig. 1, the two more proximal ref nums 8), wherein each perforation of the first perforation series maintains an open passage to the fluid conduit (Col. 5, lines 38-50). This configuration allows for the evacuation of debris and fluid (Col. 8, lines 24-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel to have two perforation series, one more proximal to the other, as this produces the same expected result of providing an evacuation line to the device from the target site.
8. Regarding Claim 3, Hufnagel teaches the at least one perforation defines a gap having an area less than the fluid inlet (Fig. 1, ref num 122 defines a gap that is smaller than inlet, ref num 132; also see Fig. 2).
9. Regarding Claim 4, Hufnagel fails to teach the at least one perforation is operable to allow the flow of fluid at a second flow rate, and wherein the first flow rate is greater than the second flow rate.
Woloszko teaches an apparatus of analogous art (Fig. 1, 70A, and 70B) comprising at least one perforation (Fig. 70B, ref num 2240, i.e., working zone, ref num 2208a) and a fluid inlet (Fig. 70B, ref num 2240’, i.e., working zone, ref num 2208b). The fluid inlet is operable to allow a flow of fluid at a first flow rate (para 0357, “aspiration rate from first working zone 2208b”), while the at least one perforation is operable to allow the flow of fluid at a second rate (para 0357, “aspiration rate from second working zone 2208a”). The first flow rate is greater than the second flow rate (para 0357, “aspiration rate from first working zone 2208a [i.e., the second flow rate] is less than the aspiration rate of the second working zone 2208n [i.e., the first flow rate]”). Woloszko goes on to explain that the maintaining of plasma at the target site is crucial to the breakdown of tissue when aspirating the target site (para 0017, “ionized plasma is formed…caus[ing] the molecular breakdown or disintegration of tissue components in contact with the plasma”). The application of suction flow rate has a correlation to the maintenance of the plasma (para 0352, 0357), indicating that the greater the rate, the less likely the plasma will be initiated and maintained. The varying of the flow rates allows a variation of the ablation, or treatment, or the target area (para 0352). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel and had the perforation have a second fluid rate less than the first flow rate, as this indicates different levels of treatment at the working end of the apparatus.
10. Regarding Claim 6, Hufnagel teaches the cutting element comprises an electrode extending from the distal end (Figs. 1 and 2, ref num 135 is an electrode; para 0034).
11. Regarding Claim 9, Hufnagel as modified teaches the apparatus further comprises:
i. a vacuum tube fluidly coupled with the fluid conduit (Fig. 1, ref num 155; see Figs. 1 and 2, ref num 155 is coupled with ref num 120 via ref num 156); and
ii. a vacuum source fluidly coupled with the vacuum tube (Fig. 1, ref num 150 coupled with 155; para 0034), the vacuum source operable to create a flow of fluid (para 0037, “vacuum source…activate the application of aspiration suction”).
12. Regarding Claim 10, Hufnagel teaches the apparatus further comprises: a first button and a second button (Fig. 1, ref num 130 and 131) coupled to the elongated body (ref nums 130 and 131 are coupled to 115), wherein the first button is operable to control the cutting element (para 0037, “electrosurgical actuator 130…activate the delivery of electrosurgical energy to electrode 135”).
Hufnagel fails to teach the second button is operable to control the cutting element.
Flom teaches an apparatus of analogous art (Figs. 1 and 6A), wherein the apparatus comprises a first and a second buttons (Fig. 6A, ref num 112 and 114), such that the first and the second buttons are operable to control a cutting element (Col. 9, lines 9-11, “handle 108 includes a cutting switch 112 and coagulation switch 114 (for changing the frequency of radiofrequency current delivered to electrode 106…)”). This allows the user to change the energy that has been applied to the cutting element with regard to the treatment being implemented (Col. 9, lines 9-11). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel to have both buttons control the cutting element, as this controls the energy delivered to the cutting element for treatment.
13. Regarding Claim 11, Hufnagel teaches the first button is operable to activate a first power level (para 0037-0038).
Hufnagel fails to teach the second button is operable to activate a second power level.
Flom teaches an apparatus of analogous art (Figs. 1 and 6A), wherein the apparatus comprises a first and a second buttons (Fig. 6A, ref num 112 and 114), such that the first and the second buttons are operable to control a cutting element, such that the first button operates at a first power level and the second button operates at a second power level (Col. 9, lines 9-11, “handle 108 includes a cutting switch 112 and coagulation switch 114 (for changing the frequency of radiofrequency current delivered to electrode 106…)”). This allows the user to change the energy that has been applied to the cutting element with regard to the treatment being implemented (Col. 9, lines 9-11). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel to have the buttons operate at different power levels, as this controls the energy delivered to the cutting element for treatment.
14. Regarding Claim 12, Hufnagel teaches that the apparatus further comprises a second at least one perforation defined by the elongated body adjacent to the proximal end (see Fig. 1, ref num 122, there is a plurality of perforations), wherein the second at least one perforation is in fluid communication with the fluid conduit (para 0040-0041).
15. Regarding Claim 13, Hufnagel teaches the elongated body defines a third at least one perforation (see Fig. 1, ref num 122, there is a plurality of perforations) disposed between the at least one perforation and the second at least one perforation, (see Fig. 1, there are 3 perforations, ref nums 122, present, one residing in the middle; also see alternative embodiment, Fig. 6, ref nums 322) wherein the third at least one perforation is in fluid communication with the fluid conduit (para 0040-0041).
16. Regarding Claim 14, Hufnagel teaches the fluid inlet is operable to capture a fluid adjacent the cutting element, and wherein the at least one perforation is operable to capture a fluid spaced from the cutting element (para 0040-0041).
17. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hufnagel, Woloszko, and Flom, and further in view of Kidder U.S. 2002/0019631 (herein referred to as “Kidder”).
18. Regarding Claim 2, Hufnagel teaches the apparatus (Figs. 1 and 2), but fails to teach the apparatus further comprises: (i) a swivel portion rotatably coupled with the elongated body adjacent to the fluid outlet, wherein the swivel portion includes a socket in fluid communication with the fluid conduit; (ii) a ball portion at least partially disposed within the socket, wherein the ball portion is in fluid communication with the socket; and (iii) a second fluid conduit coupled with the ball portion, wherein the second fluid conduit is in fluid communication with the ball portion.
Kidder teaches an apparatus of analogous art (Figs. 1, 12, and 15), the apparatus comprising an elongated body (Figs. 1 and 15, ref num 12), a fluid conduit (Fig. 1, interior lumen of ref num 12, para 0050), a fluid inlet (Fig. 1, ref num 18, para 0050), and a fluid outlet (Fig. 1, ref num 20, para 0050). The apparatus further comprises a swivel portion (Fig. 13, ref num 100) rotatably coupled with the elongated body adjacent to the fluid outlet (see Figs. 13 and 15; para 0062), wherein the swivel portion includes a socket (Fig. 13, ref num 102) in fluid communication with the fluid conduit (para 0062, Fig. 15); a ball portion (Fig. 13, ref num 104) at least partially disposed within the socket (see Fig. 13, ref num 104 partially disposed in ref num 102), wherein the ball portion is in fluid communication with the socket (para 0062); and a second fluid conduit (Fig. 13, ref num 105) coupled with the ball portion (see Fig. 13), wherein the second fluid conduit is in fluid communication with the ball portion (para 0062). The swivel portion allows for flexibility/rotation when manipulating the apparatus (para 0062), as well as provide grip to the tubing that evacuates fluid during the treatment (para 0050-0051, 0062). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel to include a swivel portion, ball and joint, in order to provide flexibility in manipulation of the apparatus, as well as a coupling mechanism for the evacuation of the fluid during the procedure.
19. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hufnagel, Woloszko, and Flom and further in view of Carrillo U.S. 2017/0172602 (herein referred to as “Carrillo”).
20. Regarding Claim 5, Hufnagel teaches the at least one perforation comprises an exterior opening and an interior opening (Fig. 1, ref num 122, it is known that the perforation must have an interior and exterior opening to allow fluid communication; see an alternative embodiment, also comprising of perforations, Fig. 6, ref nums 322, and that they have interior and exterior openings).
However, Hufnagel fails to teach a path between the interior opening and exterior opening angled toward the distal end, the exterior opening is disposed closer to the distal end [of the elongated body] than the interior opening.
Carrillo teaches an apparatus of analogous art (Figs. 1A and 1B), comprising at least one perforation (Figs. 1A, 1B, ref nums 122), wherein the perforation is disposed at an angle, there is a path between the interior opening and exterior opening angled toward the distal end, so that its exterior opening is closer to the distal end of the body than the interior opening (distal end = ref num 142; para 0038, “ports 122 may be angled toward the distal end 134”). This is to point the suction toward the distal end of the device, assisting in securing the target and suctioning (para 0038). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hufnagel and had angled the perforation in order to aid with the suctioning.
Conclusion
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights