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 .
Election/Restriction
Applicant's election with traverse of Invention I (claims 1-19) in the reply filed on 21 January 2026 is acknowledged. The traversal is on the ground(s) that the inventions would not require a different field of search. This is not found persuasive because the inventions would require different search queries, as further evidenced by the rejection below which would not apply to claim 20 as claim 20 requires the selection of a tip according to .
The requirement is still deemed proper and is therefore made FINAL.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected process, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 26 November 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 3, 6-7, 9, and 13-16 are objected to because of the following informalities:
Claim 3, line 1 “the track having” should be –the track has—.
Claim 6, line 1 “tip having” should be –tip has—.
Claim 7, line 1 “tip having” should be –tip has—.
Claim 9, line 1 “tube having” should be –tube has—.
Claim 13, line 1 “tip having” should be –tip has—.
Claim 14, line 1 “tip having” should be –tip has—.
Claim 15, line 1 “curved blade” should be –curved blade tip--.
Claim 15, line 1 “blade having” should be –blade has—.
Claim 15, line 2 “blade tip, a plurality” should be –blade tip, and a plurality--.
Claim 16, line 1 “curved blade” should be –curved blade tip--.
Appropriate correction is required.
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 6-19 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.
The term “generally” in claim 6 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It cannot be ascertained what "generally conical shape" means in the claim and how and how much this may differ from a simple conical shape.
Claim 10 recites the limitation "said sheath" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. It is not clear if some other component is intended to be the same as a sheath or if this is a newly introduced component. The limitation is interpreted as referring to a newly introduced sheath element.
The term “generally” in claim 13 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It cannot be ascertained what "generally curved blade shape" means in the claim and how and how much this may differ from a blade shape. It is additionally unclear if "generally" is meant to apply to "curved" or if it applies to the entirety of "curved blade shape".
The term “near” in claim 15 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It cannot be ascertained what "near an end of said bottom surface" means in the claim and how and how much this may differ from at an end of said bottom surface.
Claims 7-12 and 14-19 are additionally rejected as indefinite due to their dependence on claims 6, 10, 13, or 15 which have been rejected as indefinite.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnsen (US 20220233178 A1) in view of Baker (US 20220047283 A1).
Regarding claim 1, Johnsen teaches an endoscopic device for early HPV associated oropharyngeal cancer detection (Endoscope 101), said device comprising:
a water pump (Pump 175; paragraph 0154);
a saline solution (102) connected to said water pump with a first medical grade hose (see Fig. 2, connection between fluid container 102 and pump 175);
a handle (110) having a predetermined tip arranged therein (Insertion tube 111), said handle connected to said water pump with a second medical grade hose (See Fig. 2, connection between the handle 110 and the arrangement of the pump 175 and fluid container 102);
a vacuum component (Suction device 104) connected to a first collection container (First container 103) via a third medical grade hose (See Fig. 2, connection between first container 103 and vacuum component 104);
a fourth medical grade hose arranged between said handle and said first collection container (Inlet 131; see Fig. 2, connection between first container 103 and handle 110);
a second collection container (Second container 180) connected to said first collection container via a fifth medical grade hose (See Fig. 2, connection between first container 103 and second container 180).
However, Johnsen fails to disclose a filter system arranged between said first collection container and said second collection container.
Baker, in the same field of endeavor of an endoscope device for delivering fluid and capturing material from a site, discloses the device may be attached to a container (Container 258) which includes a filter system (Filter 256; paragraph 0055-0059--filter 256 can be positioned anywhere in container 258 to block free entry of material into outlet port 266).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen to include a filter system as described by Baker between a first and second collection container in order to retain a specimen in a first container while allowing waste to flow through to an additional container for disposal, which would predictably improve the ability of the system to remove body fluids from a patient for non-diagnostic purposes and for diagnostic purposes by allowing for control of the collection of a sample versus waste (see Johnsen, paragraph 0149-0151).
Regarding claim 2, the combination of Johnsen and Baker teaches the device of claim 1. Johnsen additionally teaches wherein said handle having a track arranged therein (Paragraph 0111-0114-- a handle at the proximal end and an insertion tube extending from the proximal end towards the distal end, the insertion tube comprising an internal working channel extending from the handle to the distal end of the insertion tube; Paragraph 0114, 0155-- a connection cable 105 for connecting the endoscope handle 110 with the fluid container 102 and the first specimen container 103, where the connection cable 105 has a proximal end 153 and one or more distal ends, the proximal 153 end being connectable to the endoscope handle). As the handle serves to connect the insertion tube and the connection cable to allow the collection of samples, it must have some track arranged therein for the lumens of the connection cable and insertion tube to follow and/or connect to.
Regarding claim 3, the combination of Johnsen and Baker teaches the device of claim 2. Johnsen additionally teaches wherein the track having a dual lumen tube (Cable 105) arranged therein (Lumens for suction 154 and fluid 155; Fig. 5).
Regarding claim 4, the combination of Johnsen and Baker teaches the device of claim 3. Johnsen additionally teaches wherein a predetermined portion of said dual lumen tube is arranged within said track (Paragraph 0114, 0155-- a connection cable 105 for connecting the endoscope handle 110 with the fluid container 102 and the first specimen container 103, where the connection cable 105 has a proximal end 153 and one or more distal ends, the proximal 153 end being connectable to the endoscope handle). As the handle serves to connect the insertion tube and the connection cable to allow the collection of samples, it must have some track arranged therein for the lumens of the connection cable and insertion tube to follow and/or connect to.
Claim(s) 5-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnsen in view of Baker, further in view of Linde (US 20130090665 A1).
Regarding claim 5, the combination of Johnsen and Baker teaches the device of claim 4. However, Johnsen does not explicitly disclose wherein said predetermined tip is a palatine tip for use on a palatine tonsil.
Linde, in analogous art of a device for providing suction to a site of a user’s body to remove material, discloses a tip of the device is a palatine tip for use on a palatine tonsil (Hollow tip 12/112 and arm 14/114; paragraph 0018-0019-- a user can direct the aperture 20 at the end of the tip 12 to a location adjacent to an individual's tonsil).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the particular tip style of Linde in order to predictably improve the device by allowing for the use of a tip which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a location such as the tonsils.
Regarding claim 6, the combination of Johnsen, Baker, and Linde teaches the device of claim 5. However, Johnsen does not disclose wherein said palatine tip having a generally conical shape.
Linde additionally teaches wherein said palatine tip having a generally conical shape (Hollow tip 12/112 and arm 14/114 is generally conical, Figs. 1-2).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the particular tip style of Linde in order to predictably improve the device by allowing for the use of a tip which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a location such as the tonsils.
Regarding claim 7, the combination of Johnsen, Baker, and Linde teaches the device of claim 6.
Johnsen additionally teaches a tip having an orifice at a mid-point thereof (Insertion tube 111, as a tube shape includes an orifice at a mid-point of the tip of the tube).
Linde additionally teaches wherein said palatine tip having an orifice at a mid-point thereof (Hollow tip 12/112 includes an aperture 20 to allow the passage of air and debris (for suction) and/or fluid (for irrigation); paragraph 0020-0021).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which has an orifice at a mid-point of the tip, to utilize the particular tip style of Linde including an orifice at a mid-point thereof in order to predictably improve the device by allowing for the use of a tip which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a location such as the tonsils.
Regarding claim 8, the combination of Johnsen, Baker, and Linde teaches the device of claim 7. However, Johnsen fails to disclose a first flange and a second flange extending from a bottom of said palatine tip.
Linde teaches further comprising a first flange and a second flange extending from a bottom of said palatine tip (Paragraph 0018-- Each connection can be made using any permanent or releasable solution for forming a fluid-tight connection between two components including, for example, glue, a screw/thread, a snap fit, a flange, and/or the like; the connection between arm 14 and central mechanism 16 shows flange pieces extending from the end of the tube and interacting with the sheath 16 similar to the flange pieces 37 which connect the tip to the arm).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the particular tip style of Linde in order to predictably improve the device by allowing for the use of a tip which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a location such as the tonsils, wherein the inclusion of flanges would predictably improve the ability to attach and exchange attachments of the tip.
Regarding claim 9, the combination of Johnsen, Baker, and Linde teaches the device of claim 8. Johnsen additionally teaches wherein said dual lumen tube having an irrigation port and an evacuation port arranged therethrough (Lumens for suction 154 and fluid 155 in cable 105; Fig. 5; paragraph 0155-0159-- the connection cable 105 has a proximal end 153 and one or more distal ends, the proximal 153 end being connectable to the endoscope handle 110 and the one or more distal ends being connectable to the fluid container 102 and the first specimen container 103… The connection cable 105 may further have a third distal end 159, and wherein the second part 152 extends from the first part 151 towards the first distal end 157, the second distal end 158, and the third distal end 159 where the suction channel 154, the fluid channel 155, and the one or more signal cables 156 splits into a first sub cable, a second sub cable, and a third sub cable in the second part 152 of the connection cable 105).
Regarding claim 10, the combination of Johnsen, Baker, and Linde teaches the device of claim 9.
Johnsen does not explicitly teach a sheath covers a portion of said dual lumen tube.
Linde teaches a sheath (Central mechanism 16) which covers a portion of a lumen tube (See Fig. 1, the central mechanism 16 covers portions of a lumen tubes extending from the tip in one direction and from the bulb in the other direction).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the sheath of Linde in order to predictably improve the device by ensuring that the dual lumen tube is securely connected to the passage through the tip of the device.
Regarding claim 11, the combination of Johnsen, Baker, and Linde teaches the device of claim 10.
Johnsen does not explicitly teach further comprising a circumferential lip extending from an outer surface of said sheath.
Linde teaches further comprising a circumferential lip extending from an outer surface of said sheath (See Fig. 1, the central mechanism 16 includes a wider circumferential lip where it connects with the arm 14, extending from the outer surface of the lower portion (near the bulb 18) of the mechanism).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the sheath having a lip as described by Linde in order to predictably improve the device by ensuring that the dual lumen tube is securely connected to the passage through the tip of the device.
Regarding claim 12, the combination of Johnsen, Baker, and Linde teaches the device of claim 11.
Johnsen does not explicitly teach wherein said palatine tip engages with and contacts surfaces of said sheath and engages with and contacts a surface of said dual lumen tube.
Linde teaches wherein said palatine tip engages with and contacts surfaces of said sheath (Fig. 1, contact between the end of arm 14 with the central mechanism 16) and engages with and contacts a surface of said dual lumen tube (Inside the central mechanism 16, the end surface of the arm 14 engages with and contacts a surface of a lumen tube formed by the end of the bulb 18).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the sheath as described by Linde in order to predictably improve the device by ensuring that the dual lumen tube is securely connected to the passage through the tip of the device.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnsen in view of Baker, further in view of Galloway (US 20200170498 A1).
Regarding claim 13, the combination of Johnsen and Baker teaches the device of claim 4. However, Johnson does not disclose wherein said predetermined tip having a generally curved blade shape.
Galloway, in the same field of endeavor of a device for providing suction to a site of a user’s body to collect a sample (Paragraph 0158, 0169), discloses a tip may have a generally curved blade shape (Blade 2100).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the particular tip style of Galloway in order to predictably improve the device by allowing for the use of a tip which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a given location.
Regarding claim 14, the combination of Johnsen, Baker, and Galloway teaches the device of claim 13. However, Johnson does not disclose wherein said curved blade tip having a mounting rod extending from a bottom surface thereof.
Galloway teaches wherein said curved blade tip having a mounting rod extending from a bottom surface thereof (Paragraph 0158, 0165-- the handle 2200 and the blade 2100 may be separate units that are conjoined by, e.g., screw, nail, fastener, glue, adhesive, and the like). As the handle attaches to a bottom surface of the curved blade tip, a connection via screw may be considered a mounting rod extending from a bottom surface of the curved blade tip.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube which may have attachments, to utilize the mounting rod of Galloway in order to predictably improve the device by allowing for the easy exchange of different tip styles which enables easier and more precise placement and direction of the irrigation and suction to collect samples at a given location.
Regarding claim 15, the combination of Johnsen, Baker, and Galloway teaches the device of claim 14. However, Johnson does not disclose wherein said curved blade having a plurality of evacuation ports and tracks at or near an end of said bottom surface of said curved blade tip, a plurality of irrigation ports and tracks arranged adjacent to said evacuation ports and tracks.
Galloway teaches wherein said curved blade having a plurality of evacuation ports and tracks at or near an end of said bottom surface of said curved blade tip, a plurality of irrigation ports and tracks arranged adjacent to said evacuation ports and tracks (Paragraph 0158--the distal tip 1490 includes at least one distal fluid inlet 1320… at least one proximal fluid inlet 1330; Paragraph 0165--a distal fluid inlet 2320, and a proximal fluid inlet 2330…a distal fluid channel 2360 that is configured to extend internally to the distal fluid inlet 2320 for fluid communication…a proximal fluid channel 2350 that is configured to extend internally to the proximal fluid inlet 2330 for fluid communication; See Fig. 2C; Paragraph 0169--the proximal fluid inlet 2330 may, in addition to collecting bodily fluid or sample through the inlet, exert air or fluid to clean (or clear the obstructions in front of) the at least one sensor 2430 so that the at least one sensor 2430 can more clearly view or monitor in vivo). In particular, Galloway discloses at least one proximal fluid inlet, where this inlet may additionally be used to exert fluid, such that Galloway includes a plurality of evacuation ports and irrigation ports and their corresponding tracks which may be seen as adjacent as any ports near the same position shown Fig. 2C would necessarily be adjacent to one another.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube having a port for evacuation and irrigation and which may have attachments, to utilize the plurality of ports of Galloway in order to predictably improve the device by permitting more thorough or forceful irrigation and suction via a plurality of ports to collect samples at a given location.
Regarding claim 16, the combination of Johnsen, Baker, and Galloway teaches the device of claim 15. However, Johnsen is silent as to wherein said curved blade having a plurality of channels in a surface of a bottom component of said curved blade tip, a plurality of channels in a surface of a top component of said curved blade tip.
Galloway teaches wherein said curved blade having a plurality of channels in a surface of a bottom component of said curved blade tip, a plurality of channels in a surface of a top component of said curved blade tip (Paragraph 0158--the distal tip 1490 includes at least one distal fluid inlet 1320… at least one proximal fluid inlet 1330; Paragraph 0165--a distal fluid inlet 2320, and a proximal fluid inlet 2330…a distal fluid channel 2360 that is configured to extend internally to the distal fluid inlet 2320 for fluid communication…a proximal fluid channel 2350 that is configured to extend internally to the proximal fluid inlet 2330 for fluid communication; See Fig. 2C; Paragraph 0169--the proximal fluid inlet 2330 may, in addition to collecting bodily fluid or sample through the inlet, exert air or fluid to clean (or clear the obstructions in front of) the at least one sensor 2430 so that the at least one sensor 2430 can more clearly view or monitor in vivo). In particular, Galloway discloses at least one proximal fluid inlet and at least one distal fluid inlet where one inlet is positioned on the top surface and one is positioned on the bottom surface of the tip, where this inlet may additionally be used to exert fluid, such that Galloway includes a plurality of evacuation ports and irrigation ports which include at least one channel or opening around each port where the port is exposed through the surface of the tip as shown in Fig. 2C.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube having a port for evacuation and irrigation and which may have attachments, to utilize the plurality of ports and channels of Galloway in order to predictably improve the device by permitting more thorough or forceful irrigation and suction via a plurality of ports to collect samples at a given location.
Regarding claim 17, the combination of Johnsen, Baker, and Galloway teaches the device of claim 16. However, Johnsen is silent as to wherein said plurality of channels of said bottom component align with said evacuation ports, said plurality of channels of said top component align with said irrigation ports.
Galloway teaches wherein said plurality of channels of said bottom component align with said evacuation ports, said plurality of channels of said top component align with said irrigation ports. (Paragraph 0158--the distal tip 1490 includes at least one distal fluid inlet 1320… at least one proximal fluid inlet 1330; Paragraph 0165--a distal fluid inlet 2320, and a proximal fluid inlet 2330…a distal fluid channel 2360 that is configured to extend internally to the distal fluid inlet 2320 for fluid communication…a proximal fluid channel 2350 that is configured to extend internally to the proximal fluid inlet 2330 for fluid communication; See Fig. 2C; Paragraph 0169--the proximal fluid inlet 2330 may, in addition to collecting bodily fluid or sample through the inlet, exert air or fluid to clean (or clear the obstructions in front of) the at least one sensor 2430 so that the at least one sensor 2430 can more clearly view or monitor in vivo). In particular, Galloway discloses at least one proximal fluid inlet and at least one distal fluid inlet where one inlet is positioned on the top surface and one is positioned on the bottom surface of the tip, where this inlet may additionally be used to exert fluid, such that Galloway includes a plurality of evacuation ports and irrigation ports which include at least one channel or opening around each port where the port is exposed through the surface of the tip as shown in Fig. 2C.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Johnsen which teaches a generic insertion tube having a port for evacuation and irrigation and which may have attachments, to utilize the plurality of ports and channels of Galloway in order to predictably improve the device by permitting more thorough or forceful irrigation and suction via a plurality of ports to collect samples at a given location.
Conclusion
Claims 18 and 19 are not currently rejected under 35 U.S.C. 102/103.
Regarding claim 18, while Galloway discloses a curved blade tip having a bottom component and top component, each of Johnson, Baker, and Galloway is silent as to a membrane arranged between the two components and provides no motivation to make such a modification. As Galloway teaches the suction and irrigation lumens connect via tubing placed into tracks to the ports, a membrane arranged between the top and bottom component such as to separate the two lumens would provide no improvement, and could instead break the invention by preventing one of the tubes from reaching its corresponding port, as the tubes follow tracks along the same inner surface to reach the different ports.
Regarding claim 19, while Galloway discloses a curved blade tip having a bottom component and top component, each of Johnson, Baker, and Galloway is silent as to a connector member arranged in a slot of a bottom component of said curved blade tip and a slot of the top component of said curved blade tip and instead teach tip components where a top and bottom surface are integrally formed and do not include or motivate the use of a slot in each component.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791