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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/7/2025 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a barrier positioned in the lumen and below the channel” and “the barrier is configured such that a first portion of the pressurized fluid in the lumen travels around the barrier and through the gap while the space is configured to simultaneously receive a second portion of the pressurized fluid through the pair of openings and the passage to mix with the agent stored therein, thereby combining the pressurized fluid and the agent within the lumen” of Claims 1, 16 and 24 must be shown or the feature(s) canceled from the claim(s). The examiner notes, that the applicant has elected Figures 3A-3J. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 3-7, 10-19 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 “a barrier positioned in the lumen and below the channel” in line 5. In the restriction election on 6/28/2023, the applicant elected Figures 3A-3J. It appears that Figures 3A-3B are one embodiment, Figures 3C-3D are another embodiment, Figures 3E-3F are another embodiment, Figures 3G-3H are another embodiment and Figures 3I-3J are a different embodiment. None of these figures appear to have a barrier (36) positioned in the lumen and below the channel. Claim 1 additionally recites “the barrier is configured such that a first portion of the pressurized fluid in the lumen travels around the barrier and through the gap while the space is configured to simultaneously receive a second portion of the pressurized fluid through the pair of openings and the passage to mix with the agent stored therein, thereby combining the pressurized fluid and the agent within the lumen”. None of the figures 3A-3J appear to show these configurations of the position in which a “first portion” of fluid “travels around the barrier” while a “second portion” simultaneously travels through the space in the pair of openings. All embodiments of Figures 3A-3J appear to show the fluid (1000) traveling through the openings/space (39) of the barrier. It is unclear what the design of this embodiment is or if this is a combination between the embodiments of Figure 3A-3J and other disclosed Figures.
The examiner notes a similar rejection is made for the other independent claims (claims 16 and 24) which recite similar limitations.
Claims 3-7, 10-15, 17-19, and 21-23 are rejected due to their dependency on claims 1 and 16.
Claim 3 recites “in the second position, the barrier seals the cavity from the lumen, inhibiting the pressurized fluid of the lumen from entering into the cavity.” However, in claim 1 it was recited that “in the second position of the barrier, the barrier is configured such that a first portion of the pressurized fluid in the lumen travels around the barrier and through the gap while the space is configured to simultaneously receive a second portion of the pressurized fluid through the pair of openings and the passage to mix with the agent stored therein”. It is unclear how the second position could seal the cavity from the lumen, have fluid flow around the barrier but also mix the fluid within the passage of the barrier”. None of the Figures 3A-3J appear to show this second position, with a portion of the pressurized fluid traveling around the gap, a portion of the pressurized fluid mixing with the agent in the passage and sealing the cavity from the lumen. For purposes of examination it is interpreted that the second position seals the pair of openings from the cavity and lumen.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 10-13, 15-17, 19, 21, and 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oscarsson (US Patent 4645496).
Regarding Claim 1, Oscarsson teaches (Fig 1, 3 and 5) A medical device, comprising:
an enclosure (Fig 1, B) defining a cavity for containing an agent (see Col 6 lines 20-21 teaching B is a container comprising medical fluid);
a lumen (74) for receiving a pressurized fluid (col 8 lines 67-68 teach that the fluid in container B may be pressurized; as this fluid will travel into lumens 74, it is interpreted that 74 could receive a ‘pressurized fluid’);
a channel (12, 18, 72) between the cavity (Cavity within B) and the lumen (74); and
a barrier (80) positioned in the lumen (74) and below the channel (18, 12, 72), the barrier (80) including a pair of openings (102, 104, in Fig. 3) and a passage (100) extending between the pair of openings (col 8 lines 31-33, “The open ends 102, 104 of the transverse bore passageway 100 are located at points along the length of the drum element 80”), the passage (100) and the pair of openings (102, 104) defining a space (106) extending through the barrier (80), wherein in a first position (Fig 3) of the barrier (80), the space (106) is in fluid communication with the cavity (Cavity within B, note in Fig 1, B is fluidically connected to 18, therefore the examiner interprets that the cavity is located on top of where 18 is labeled in Figs 3 and 5) and the lumen (74) to receive and deliver the agent from the cavity to the lumen, and wherein the barrier is configured to rotate from the first position (Fig 3) to a second position (Fig 5) in which the space (106) is not in fluid communication with the cavity (cavity within B) and the lumen (72, 74); and wherein the barrier (80) includes a diameter less than an interior diameter of the lumen (portion 112 has a diameter less than the lumen as 112 is a groove within the barrier 80), and a gap (112) is formed between an interior of the lumen (72, 74) and an exterior of the barrier (80) such that, in the second position (Fig 5) of the barrier (80), the barrier is configured such that a first portion of the pressurized fluid in the lumen travels around the barrier and through the gap (see Fig 5, there is fluid communication from the pressurized fluid in lumen 72 to go through gap 112 and to lumen portion 74) while the space (106) is configured to simultaneously receive a second portion of the pressurized fluid through the pair of openings (102, 104) and the passage to mix with the agent stored therein, thereby combining the pressurized fluid and the agent within the lumen (while some fluid goes through passage 112, it is interpreted some fluid could also go through 112 into opening 102, which would lead to the mixing with the agent in space 106).
Regarding Claim 3, Oscarsson teaches the medical device of claim 1, wherein, in the second position (Fig 5), the barrier (80) seals the cavity (cavity within B) from the lumen (74), inhibiting the pressurized fluid of the lumen from entering into the cavity (see 112 rejection above. The interpretation is that the openings of the barrier are sealed from the cavity and lumen, which is what can be seen in Fig 5).
Regarding Claim 4, Oscarsson teaches the medical device of claim 1, further comprising at least one seal (walls of lumen 72) defining at least a portion of the channel (72), wherein the at least one seal contacts the barrier (80) to inhibit the agent from entering the lumen (74) without entering the space (106), and to inhibit the agent from exiting the space when the barrier is in the second position (barrier 80 would be contacting the walls of lumen 72, similar to instant Fig 3A barrier 36 contacting walls 18).
Regarding Claim 10, Oscarsson teaches the medical device of claim 1, wherein the barrier is a ball valve (barrier 80), wherein the ball valve includes at least one pair of prongs (walls at one of the port openings 102, 104) and a gap between the prongs defines at least one of the pair of openings (walls of port openings 102, 104 to passage 100 would necessarily be defining the opening to the passage 100 within barrier 80).
Regarding Claim 12, Oscarsson teaches the medical device of claim 1, wherein a rotation of the barrier (80) is actuated by a mechanical system (122, 132) or a hydraulic system associated with the medical device (See Figs 3, 5; actuator lever 122, 132 is considered a mechanical system).
Regarding Claim 13, Oscarsson teaches the medical device of claim 1, wherein the lumen (74) is a flexible catheter (lumen 74 is connected to catheter 32 shown in in Fig 1 through port 28) capable of traversing a tortuous body lumen, and further comprising a source of the pressurized fluid (col 8 lines 67-68 teach that the fluid in container B may be pressurized).
Regarding Claim 15, Oscarsson teaches the medical device of claim 1, wherein the barrier (80) is configured to rotate at least one of 90° or 180°, to transition from the first position to the second position (See Oscarsson Figs 3 and 5, there is a 90° rotation).
Regarding Claim 16, Oscarsson teaches (Figs 1, 3 and 5) a medical device, comprising:
an enclosure (Fig 1, B) defining a cavity for containing an agent (see Col 6 lines 20-21 teaching B is a container comprising medical fluid);
a lumen (74) for receiving a pressurized fluid (col 8 lines 67-68 teach that the fluid in container B may be pressurized; as this fluid will travel into lumens 74, it is interpreted that 74 could receive a ‘pressurized fluid’); and
a barrier (80) including a pair of openings (102, 104) and a passage (100) between the pair of openings (102, 104) for collectively defining a space (106) through the barrier (80), and the barrier (80) is configured to be positioned relative to the enclosure (B) and the lumen (74) to selectively allow and inhibit fluid communication between the cavity (cavity within B) and the lumen (74), the barrier (80) includes a diameter less than an interior diameter of the lumen (portion 112 has a diameter less than the lumen as 112 is a groove within the barrier 80), thereby forming a gap (112) between an interior of the lumen (74) and an exterior of the barrier (80), and wherein in a first position (Fig 3) of the barrier (80), the space (106) is in fluid communication with the cavity (Cavity within B, note in Fig 1, B is fluidically connected to 18, therefore the examiner interprets that the cavity is located on top of where 18 is labeled in Figs 3 and 5) and the lumen (74) to receive and deliver the agent from the cavity to the lumen, and wherein the barrier (80) is configured to rotate from the first position (Fig 3) to a second position (Fig 5) in which the space (106) is not in fluid communication with the cavity (Cavity within B, note in Fig 1, B is fluidically connected to 18, therefore the examiner interprets that the cavity is located on top of where 18 is labeled in Figs 3 and 5) and the lumen (74); and wherein in the second position (Fig 5) of the barrier (80), the barrier is configured to form the gap (112) between the interior of the lumen and the exterior of the barrier is in fluid communication with the lumen to receive a first portion of the pressurized fluid as the barrier inhibits delivery of the agent from the cavity to the lumen (see Fig 5, there is fluid communication from the pressurized fluid in lumen 72 to go through gap 112 and to lumen portion 74), and the space (106) is configured to simultaneously receive a second portion of the pressurized fluid through the pair of openings (102, 104) to mix with the agent stored in the passage, thereby combining the pressurized fluid and the agent within the lumen (while some fluid goes through passage 112, it is interpreted some fluid could also go through 112 into opening 102, which would lead to the mixing with the agent in space 106).
Regarding Claim 17, Oscarsson teaches the medical device of claim 1, wherein the barrier is a ball valve (barrier 80), wherein the ball valve includes at least one pair of prongs (walls at one of the port openings 102, 104) and a gap between the prongs defines the space (walls of port openings 102, 104 to passage 100 and space 106 would necessarily be defining the space 106 within barrier 80).
Regarding Claim 19, Oscarsson teaches the medical device of claim 1, wherein the barrier (80) is configured to rotate 90° to transition from the first position to the second position (See Oscarsson Figs 3 and 5, there is a 90° rotation).
Regarding Claim 21, Oscarsson teaches the medical device of claim 1, wherein the pair of openings (102, 104) are positioned on opposing sides of the barrier (80), and the passage (100) extends parallel to a longitudinal axis of each of the pair of openings (102, 104).
Regarding Claim 23, Oscarsson teaches the medical device of claim 1, wherein the enclosure (B) includes a bottom portion that is tapered radially-inwards (See Fig 1, bottom portion of B towards 12 is tapered) such that the cavity funnels the agent radially-inwards towards at least one of the pair of openings of the barrier (See Fig 3, 18 and 72 funnels the agent radially inward to the opening 102).
Regarding Claim 24, Oscarsson teaches (Fig 1, 3 and 5) a medical device, comprising:
an enclosure (Fig 1, B) containing an agent (see Col 6 lines 20-21 teaching B is a container comprising medical fluid);
a lumen (74) for receiving a pressurized fluid (col 8 lines 67-68 teach that the fluid in container B may be pressurized; as this fluid will travel into lumens 74, it is interpreted that 74 could receive a ‘pressurized fluid’); and
a barrier (80) positioned in the lumen (74) and below the enclosure (B; note in Fig 1, B is fluidically connected to 18, therefore the examiner interprets that the enclosure is located on top of where 18 is labeled in Figs 3 and 5), the barrier (80) including a pair of openings (102, 104) and a passage (100) extending between the pair of openings (102, 104), the barrier (80) is configured to move relative to the enclosure and the lumen to selectively mix the agent from the enclosure with the pressurized fluid from the lumen (See Figs 3 and 5, the barrier rotates relative to the enclosure and lumen), wherein the barrier includes a diameter less than an interior diameter of the lumen (portion 112 has a diameter less than the lumen as 112 is a groove within the barrier 80), thereby forming a gap (112) between an interior of the lumen (74) and an exterior of the barrier (80); wherein, in a first position (Fig 3), the pair of openings (102, 104) are aligned with the enclosure (B) and the lumen (74) such that the passage is in fluid communication with the agent and the pressurized fluid, thereby receiving the agent through the barrier for mixing with the pressurized fluid; and wherein, in a second position (Fig 5), the pair of openings (102, 104) are misaligned with the enclosure (B) and the lumen (74) such that the passage is not in fluid communication with the enclosure agent and the pressurized fluid, and the gap (112) formed between the interior of the lumen and the exterior of the barrier remains in fluid communication with the pressurized fluid such that a first portion of the pressurized fluid is directed around the barrier and through the gap (see Fig 5, there is fluid communication from the pressurized fluid in lumen 72 to go through gap 112 and to lumen portion 74) while the barrier is configured to simultaneously receive a second portion of the pressurized fluid through the pair of to mix with the agent stored in the passage, thereby combining the pressurized fluid and the agent within the lumen for delivery from the medical device (while some fluid goes through passage 112, it is interpreted some fluid could also go through 112 into opening 102, which would lead to the mixing with the agent in space 106).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson (US Patent 4645496) as applied to claim 1 above, and further in view of Mendels et al. (US Patent Pub. 20150051536 hereinafter “Mendels”).
Regarding Claim 5, Oscarsson teaches all elements of claim 1 as described above. The combination does not specify the medical device (Original) further comprising a second channel between the cavity and the lumen.
Mendels teaches (Fig 11b) two channels (106, 108) between a cavity (262) and a lumen (portion of tube where channels 106 and 108 lead to).
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 the device of Oscarsson such that it includes a second channel between the cavity and the lumen as taught by Mendels. One of ordinary skill in the art would have been motivated to do so in order to increase the flow rate of the agent in the cavity to the lumen.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson (US Patent 4645496) and Mendels (US Patent Pub. 20150051536) as applied to claim 5 above, and further in view of Pic et al. (US Patent Pub. 20190232030 hereinafter “Pic”).
Regarding Claim 6, the combination of Oscarsson and Mendels teaches all elements of claim 5 as described above. The combination does not specify the medical device further comprising a second barrier positioned in the second channel and defining a second barrier space, wherein in a first position of the second barrier, the second barrier space is in fluid communication with the cavity to receive the agent from the cavity, and wherein the second barrier is configured to rotate from the first position to a second position in which the second barrier space is in fluid communication with the lumen to deliver the agent from the second barrier space to the lumen.
Pic teaches (Fig 9) a channel (102) comprising a barrier (92) position in the channel and defining a barrier space (110) wherein in a first position of the barrier (92) the barrier space (110) is in fluid communication with the cavity (Fig 9) to receive the agent (54) from the cavity (92) and wherein the barrier (92) is configured to rotate from the first position to a second position in which the barrier space (100) is in fluid communication with the lumen (106) to deliver the agent (54) from the barrier space (110) to the lumen (106; [0049]).
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 the second channel in the modified Oscarsson to include a barrier as taught by Pic as doing so would improve the functionality and/or the accuracy of the medical device by providing a means to agitate and/or dispense predetermined quantities of the agent as taught by Pic in [0047].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson (US Patent 4645496) as applied to claims 1 above, and further in view of Pic (US Patent Pub. 20190232030).
Regarding Claim 7, Oscarsson teaches all elements of claim 1 as described above. The combination does not specify the medical device further comprising a turbine positioned within the lumen so that the pressurized fluid rotates the turbine, and rotation of the turbine rotates the barrier from the first position to the second position.
Pic teaches [0036] the medical delivery device may comprise a turbine so that pressurized fluid rotates the turbine, and rotation of the turbine rotates the barrier from the first position to the second position ([0053] teaches that the barrier may be rotated by any suitable actuator and [0036] teaches that suitable actuators include turbines).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have located the turbine within lumen of Oscarsson as taught by Pic. One of ordinary skill in the art would recognize this as a known actuator for a device (Pic [0036]).
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson (US Patent 4645496) as applied to claims 1 and 17 above, and further in view of Manska (US Patent 5046528).
Regarding Claim 14, Oscarsson teaches all elements of claim 1 as described above. Oscarsson does not specify the medical device wherein the barrier is configured to rotate from the first position to the second position via both clockwise rotation and counterclockwise rotation.
Manska (Col 14 lines 62-64) teaches a valve is rotatable in both directions.
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 the barrier of Oscarsson such that is configured to rotate from the first position to the second position via both clockwise rotation and counterclockwise rotation as taught by Manska. One of ordinary skill in the art would recognize that the direction of rotations does not affect the resulting functionality of moving the openings from one position to another position.
Regarding Claim 18, Oscarsson teaches all elements of claim 17 as described above. Oscarsson further teaches wherein the ball valve is positioned in the lumen below the cavity (Figs 3 and 5, 80 is located below 18). Oscarsson does not specify wherein the ball valve is configured to rotate counterclockwise to rotate from the first position to the second position.
Manska (Col 14 lines 62-64) teaches a valve is rotatable in both directions.
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 the barrier of Oscarsson such that is configured to rotate from the first position to the second position via both clockwise rotation and counterclockwise rotation as taught by Manska. One of ordinary skill in the art would recognize that the direction of rotations does not affect the resulting functionality of moving the openings from one position to another position.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oscarsson (US Patent 4645496) as applied to claim 1 above, and further in view of Finlay et al. (US Patent Pub. 20040107963 hereinafter “Finlay”).
Regarding Claim 22, Oscarsson teaches all elements of claim 1 as described above. The combination does not teach a porous filter disposed within the barrier, the porous filter being configured to inhibit the agent from flowing in a direction opposite to the pressurized fluid and allow the pressurized fluid to flow through the barrier, such that the agent remains contained within the barrier for mixing with second portion of the pressurized fluid.
Finlay teaches (Fig 5) a barrier (12) comprising a passage (22) and a porous filter (28; [0041]) disposed within the barrier (12), the porous filter being configured to allow pressurized fluid to flow through the passage ([0041]).
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 the barrier of Oscarsson such that it includes a porous filter as taught by Finlay. One of ordinary skill in the art would have been motivated to do so in order to prevent agglomerates beyond a predetermined size from exiting the barrier (Finlay [0041]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 16 and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al (US Patent Pub. 20180193574) teaches a device with a cavity comprising an agent, barrier, and lumen.
Evans (US Patent 5466228) teaches a barrier with multiple openings that rotate from a first position to a second position to connect an enclosure to a lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
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