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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/25 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129 as discussed below. Applicant’s arguments with respect to claim(s) 37 and 38 have been considered but are moot because the new ground of rejection over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129 and further in view of Okamura US 2018/0280008.
Castelli teaches a similar system comprising an inflation device comprising an expandable member or balloon (paragraph 0047) connected to one or more inflation devices such as a pump or a syringe to controllably inflate or deflate the balloon (paragraph 0070-0072) and provide a tissue compression device configured to be inflated by a syringe and engage the and apply pressure to selected tissue (paragraph 0052). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kalb et al. to be connected to an expandable member or balloon, as taught by Castelli, for applying a variable amount of pressure to the selected tissue. Examiner further notes that the balloon relaxes based on an external pressure applied to the balloon is functional language and the device in combination with the syringe of Kalb et al. being connected with the balloon of Castelli, form the same structure as claimed. Although not explicitly disclosed, when the syringe plunger seal is positioned between the first and second position and applying pressure to the balloon from an external force, the balloon would be configured to relax with an external force, as the air would flow through the bypass channel in the same manner.
Okamura US 2018/0280008 teaches a similar system comprising an inflation device further comprising opening or closing a check valve between the syringe with connector 173 to close off the air being injected by syringe (paragraphs 0066, 0068 and 0069) for inflating a balloon-like member 160 (paragraph 0062).
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 2-4 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 2 discloses “a continuous bypass channel” on lines 1-2. The language is unclear as to whether this is the same bypass channel as disclosed in claim 1, line 4. For purposes of examination, the Examiner is interpreting the continuous bypass channel to be the same as the bypass channel, as multiple bypass channels are introduced in claims 5-8.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129.
Regarding claim 1, Kalb et al. discloses an inflation device comprising a syringe barrel 8, a syringe plunger shaft (see annotated figure 4 below), a syringe nozzle 14 in fluid communication with the syringe barrel (figure 4, paragraph 0032, material inserted into device barrel and discharged through nozzle), and a syringe plunger seal 12, wherein the syringe barrel comprises a fluid bypass channel 2 extending laterally from the syringe barrel (figure 4), the fluid bypass channel beginning at a first position on the syringe barrel and ending at a second position on the syringe barrel (see annotated figure 4 below), wherein the distance between the first position and the second position is greater than the width of the syringe plunger seal such that when syringe plunger shaft is pushed toward the syringe nozzle (figure 4, forming a bypass channel, fluid configured to bypass because channel distance 4 is greater than plunger), the syringe plunger seal may be positioned between the first position and the second position so that fluid may flow through the syringe nozzle into the syringe barrel and around the syringe plunger seal to an area behind the syringe plunger seal (figure 4, forming a bypass channel, bypass channel by definition provides a secondary channel for fluid to flow around the plunger seal, shown in figure 4, the plunger 12 fits within the first and second position).
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Kalb et al. fails to disclose a balloon in fluid communication with the syringe nozzle, wherein when the syringe plunger seal is positioned between the first and second position, the balloon relaxes based on an external pressure applied to the balloon.
Castelli discloses a similar system comprising an inflation device comprising an expandable member or balloon (paragraph 0047) connected to one or more inflation devices such as a pump or a syringe to controllably inflate or deflate the balloon (paragraph 0070-72) and provide a tissue compression device configured to be inflated by a syringe and engage the and apply pressure to selected tissue (paragraph 0052).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kalb et al. to be connected to an expandable member or balloon, as taught by Castelli, for applying a variable amount of pressure to the selected tissue. Examiner further notes that the balloon relaxes based on an external pressure applied to the balloon is functional language and the device in combination with the syringe of Kalb et al. being connected with the balloon of Castelli, form the same structure as claimed. Although not explicitly disclosed, when the syringe plunger seal is positioned between the first and second position and applying pressure to the balloon from an external force, the balloon would be configured to relax with an external force, as the air would flow through the bypass channel in the same manner.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129 and further in view of Chong et al. US 2008/0269687.
Regarding claims 2 and 4, Kalb et al. discloses an inflation device essentially as claimed as discussed above, but fails to explicitly disclose wherein the syringe barrel comprises a continuous bypass channel connected to the syringe barrel at two channel openings, wherein one channel opening is located at a position on the syringe barrel beginning at a point corresponding to 10 to 65% of the total volume of the syringe barrel and one channel opening is located at a position on the syringe barrel at a point corresponding to 25 to 80% of the total volume of the syringe barrel, wherein the continuous bypass channel is formed integrally with the syringe barrel.
Chong et al. discloses an inflation device comprising a syringe barrel 4410 (see annotated figure 88 below), a syringe plunger shaft 4430 (see annotated figure 88 below), a syringe nozzle (see annotated figure 88 below), and a syringe plunger seal 4420 (see annotated figure 88 below) wherein the syringe barrel comprises a fluid bypass channel 4454 beginning at a first position on the syringe barrel and ending at a second position on the syringe barrel wherein the distance between the first position and the second position is greater than the width of the syringe plunger seal such that when syringe plunger shaft is pushed toward the syringe nozzle (see annotated figure 88 below), the syringe plunger seal may be positioned between the first position and the second position so that fluid may flow around the syringe plunger seal to an area behind the syringe plunger seal (see annotated figure 88 below).
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Chong et al. discloses wherein the syringe barrel comprises a continuous bypass channel connected to the syringe barrel at two channel openings (channel 4454, figure 88; two openings at the first and second position), wherein the continuous bypass channel is formed integrally with the syringe (channel 4454 is integral with the syringe).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Chong et al. with a continuous bypass channel connected to the syringe barrel at two channel openings, as taught by Chong et al., and known in the art for providing a simple substation of one known element for another to obtain predictable results, such as providing a bypass channel on a syringe. Further, in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e -the continuous bypass channel being formed integrally with the syringe, does not depend on its method of production, i.e. ----. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 3, Kalb et al. discloses an inflation device essentially as claimed as discussed above, but fails to explicitly disclose wherein the syringe barrel comprises a continuous bypass channel connected to the syringe barrel at two channel openings, wherein one channel opening is located at a position on the syringe barrel beginning at a point corresponding to 10 to 65% of the total volume of the syringe barrel and one channel opening is located at a position on the syringe barrel at a point corresponding to 25 to 80% of the total volume of the syringe barrel.
Chong et al. discloses wherein one channel opening is located at a position on the syringe barrel beginning at a point corresponding to 10 to 65% of the total volume of the syringe barrel and one channel opening is located at a position on the syringe barrel at a point corresponding to 25 to 80% of the total volume of the syringe barrel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Chong et al. to have one channel opening corresponding to 10 to 65% and one channel opening corresponding to 25 to 80% of the syringe since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Chong et al. would not operate differently with the claimed opening dimension configuration, as the openings are intended to function successfully with the claimed range, as shown in figure 88. Furthermore, applicant places no criticality on the range claimed, indicating that the openings could be located on that syringe location, only assuming the average syringe has a plunger of a particular length (paragraph 0043).
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129 and further in view of Sudo US 5637100.
Regarding claims 5-8, Kalb et al.in combination discloses a syringe having a bypass channel, but fails to disclose multiple bypass channels or multiple continuous bypass channels, wherein none of the multiple bypass channels is in fluid contact with another of the multiple bypass channels, or wherein at least one of the multiple bypass channels is in fluid contact with another of the multiple bypass channels
However, Sudo teaches an inflation device comprising multiple bypass channels or multiple continuous bypass channels (syringe body may comprise one or more bypasses, bypass 11, bypass 14; figure 10, 12, column 3, lines 39-43), wherein none of the multiple bypass channels is in fluid contact with another of the multiple bypass channels (figure 12, first bypass 11 is blocked from fluid contact from bypass 14 by sealing stoppers 8 and 10), wherein at least one of the multiple bypass channels is in fluid contact with another of the multiple bypass channels (figure 8, bypass channels 11 and 14 are in fluid communication as the fluid may flow around the first sealing member when placed within bypass 14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kalb et al. with multiple bypass channels, as taught by Sudo, as is known in the art to provide one or more bypass channels as required for a particular bypass syringe design for a particular use, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalb et al. US 20190315028 in view of Castelli US 2020/0289129 and further in view of Okamura US 2018/0280008.
Regarding claims 37 and 38, Kalb et al. in combination with Castelli discloses an inflation device wherein the syringe plunger seal is selectively moveable within the syringe barrel (plunger seal moves with plunger shaft to deliver fluid within the syringe through the nozzle, figure 4, paragraph 0032, material inserted into device barrel and discharged through nozzle) and configured to provide a plurality a plurality of pre-inflation positions with both the first position on the syringe barrel and the second position on the syringe barrel between the syringe plunger seal and the nozzle effective to form a closed system and create pressure when the plunger seal is depressed towards the nozzle to inflate the balloon (when plunger of Kalb et al. is positioned proximally, as shown in figure 4); a plurality of balloon relaxation position with the syringe plunger seal between the first position on the syringe barrel and the second position on the syringe barrel effective to allow fluid to flow through the fluid bypass channel around the syringe plunger seal and out of the syringe barrel effective to allow the balloon to partially deflate (Kalb et al. when plunger seal is positioned within the bypass channel 2, configured to allow a balloon to partially deflate); and a plurality of balloon inflation positions with the syringe plunger seal between (1) the nozzle and (2) the first position and the second position on the syringe barrel such that the syringe plunger seal prevents fluid communication between the balloon and the fluid bypass channel and fluid is injected into the balloon as the syringe plunger seal is depressed towards the nozzle (when plunger is fully depressed to the distal end adjacent the nozzle, material has been delivered through the nozzle, the bypass channel being fully proximal to the nozzle resulting in no communication). Examiner notes in combination as discussed above, Castelli discloses a similar system comprising an inflation device comprising an expandable member or balloon (paragraph 0047) connected to one or more inflation devices such as a syringe to controllably inflate or deflate the balloon (paragraph 0070-0072) and provide a tissue compression device configured to be inflated by a syringe and engage the and apply pressure to selected tissue (paragraph 0052).
Kalb et al. in combination with Castelli fails to further disclose a check valve secured to the syringe nozzle, a tube secured to the check valve with the check valve between the tube and the syringe, wherein the check valve is configured to maintain balloon inflation when the syringe barrel is not in fluid communication with the balloon.
Okamura teaches a similar system comprising an inflation device comprising a balloon-like member 160 and a syringe (not shown, paragraph 0068, figure 1), further comprising a check valve secured to the syringe nozzle (with connector 173, paragraphs 0066, 0068 and 0069) for inflating a balloon-like member 160 (paragraph 0062), a tube 171 (figure 1) secured to the check valve (check valve within portion 173, with the check valve between the tube and the syringe, paragraph 0066, figure 1), wherein the check valve is configured to maintain balloon inflation when the syringe barrel is not in fluid communication with the balloon (closed and syringe is removed from connector, paragraph 0069).
Examiner notes that in combination with a system comprising a syringe, balloon, tube and check valve as taught by the prior art, it would result in the structure and be configured for the functional language including plurality of positions as claimed.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kalb et al. with a check valve secured to the syringe nozzle, a tube secured to the check valve with the check valve between the tube and the syringe, and a balloon secured to and in fluid communication with the tube, as taught by Castelli and Okamura, as is known in the art to provide inflation devices as claimed in combination with a check valve for positioning an occlusion balloon for stopping blood flow or providing controlled pressure at a particular tissue site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771