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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2025 was filed is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-7, 9, 14, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boston Scientific TheraSphere™ infusion training youtube video dated March 07 2021, https://www.youtube.com/watch?v=JrfYLfPcNY8&t=2s (hereinafter referred to as “TheraSphere video”) in view of Amato (US 5386958A, hereinafter referred to as “Amato”), and further in view of Instructions for Use manual for TheraSphere™ Yttrium-90 Glass Microspheres from Boston Scientific dated 03/2021, (hereinafter referred to as “Y-90 instructional manual”).
Regarding claim 1, TheraSphere video discloses a medical device support stand (video at 12:17 min, a plexiglass support stand) comprising: a vertical frame member (see annotated video capture A below); an adjustable support arm (see annotated video capture A below), wherein the adjustable support arm is configured to be removably attached to the vertical frame member (via adjusting rotating knob) thereon (see annotated video capture A below); ….. and wherein the adjustable support arm (see annotated video capture A below) is configured to engage with a portion of a cancer therapy delivery system (microcatheter) to retain at least a portion of the cancer therapy delivery system in a vertical orientation (video at 17:55 min to 18:04 min showing a microcatheter secured at “E” in the holder in vertical orientation).
However, TheraSphere video alone fails to disclose the adjustable support arm is
an adjustable height support arm, wherein the adjustable height support arm is configured to be removably attached to the vertical frame member at varying heights thereon; and a support leg, wherein the support leg is configured to be removably attached to a bottom portion of the vertical frame member;
However, TheraSphere video and Amato and Y-90 Instructional manual combined teach the adjustable support arm is an adjustable height support arm (Amato: Figs 1, 2, 7 and 7A, support arm (21) is height adjustable via support legs 34 and 35 and rotary gear 37 and gear rack 36), wherein the adjustable height support arm (21) is configured to be removably attached to the vertical frame member (15) at varying heights thereon (Amato: Figs 3 and 4, removably attachable via strap 23, lug 25 and hinge 17, Fig 7 for adjusting height); and a support leg (Amato: Fig 1-4, 11), wherein the support leg (11) is configured to be removably attached to a bottom portion of the vertical frame member (Amato: Fig 4, hinge 16 removably attached at recess 18; TheraSphere video, the height of the microcatheter at 18:02 min ~ 18: 06 min at “E” is continuously higher than the height of the tubing from the dose vial chamber at needle injector assembly; Y-90 instructional manual: page 14, “Do not use extension tubing between the Therasphere Administration Set and the microcatheter. The use of extension tubing will cause significant residual microspheres that will result in an under-dose”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine and modify TheraSphere video by Amato in view of Y-90 instructional manual based on the following rationale: Referring to TheraSphere video, the height of the microcatheter at 18:02 min ~ 18: 06 min at “E” is continuously higher than the height of the tubing from the dose vial chamber at needle injector assembly due to having fixed height from vertical frame. Therefore, based on the knowledge that any significant amount of residual microspheres will result in an under-dose due to use of extension tubing as taught by Y-90 instructional manual in page 14, which in essence is also very similar to having a tube section of gravity induced fallen out of suspension Y-90 glass microspheres being unable to transport properly, when height of the microcatheter held at “E” is always higher than height of the tubing from the dose vial chamber at needle injector assembly, and thus possible for providing poor quality infusion. In other words, such constant height elevation of microcatheter (tube outlet) with respect to the height of the tubing from the dose vial chamber at needle injector assembly (tube inlet) would lead to gravity induced falling out of suspension of Y-90 glass microspheres, which always results in more amount of residual microspheres remaining in the tubing section. On the other hand, Amoto teaches a medical tube support apparatus that is height adjustable and can be adapted for supporting the support arm of TheraSphere video for holding the microcatheter. As a result, near the end of the Y-90 dosing procedure, the height of adjustable height support arm can be lowered by means of the support apparatus of Amato, and thus reducing the amount of residual microspheres left behind in the tube section, since the height of the microcatheter (at tube outlet) can then be changed to be lower than the height of the tubing from the dose vial chamber at needle injector assembly (tube inlet), as the infusion procedure progresses.
According to MPEP 2143, one common example of rationale which may support a conclusion of obviousness that falls under (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; is consistent with or matching with the applying a known technique (adopting change in elevation of heights in view of gravity induced falling out of suspension of microspheres for reducing amount of residual microsphere dose left behind in the tubing section) to a known device (Boston Scientific Y90 targeted-radioembolization system) ready for improvement to yield predictable results of improved infusion quality. As a result, above discussed advantages of using height adjustable support arm and height adjustable vertical frame member of Amato to modify the existing non-height adjustable support arm of TheraSphere video thereby serving as teaching, suggestion, or motivation, in the knowledge generally available to one of ordinary skill in the art to combine and modify the Boston Scientific Y90 targeted-radioembolization system.
Annotated video capture A from TheraSphere video
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Regarding claim 2, TheraSphere video discloses wherein the portion the cancer therapy delivery system comprises at least one of a hub, a manifold, or a connector (see annotated video capture B below).
Annotated video capture B from TheraSphere video
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Regarding claim 4, TheraSphere video and Amato combined teach the adjustable height support arm (Amato: Figs 1 and 7) comprising a retention member (see annotated video capture C below), wherein the retention member is configured to engage with a portion of the cancer therapy delivery system to retain at least a portion of the cancer therapy delivery system in a vertical orientation (ThereSphere video at 17:57min, see annotated video capture C below).
Annotated video capture C from TheraSphere video
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Regarding claim 5, TheraSphere video and Amato combined teach the adjustable height support arm (Amato: Figs 1 and 7) comprising attachment jaws (see annotated video capture D below), wherein the attachment jaws are configured to engage with a portion of the cancer therapy delivery system to retain at least a portion of the cancer therapy delivery system in a vertical orientation (see annotated video capture D below).
Annotated video capture D from TheraSphere video
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Regarding claim 6, TheraSphere video fails to disclose further comprising an angled connector.
However, Amato teaches further comprising an angled connector (Figs 3-4, hinge 16 and pedestal 14 combined together serve as angled connector).
Regarding claim 7, TheraSphere video fails to disclose wherein the angled connector is configured to engage both the vertical frame member and the support leg thereby connecting the two together.
However, Amato teaches wherein the angled connector is configured to engage both the vertical frame member and the support leg thereby connecting the two together (Figs 3-4, hinge 16 and pedestal 14 together serve as angled connector for connecting vertical frame member (15) and support leg (11)).
Regarding claim 9, TheraSphere video fails to disclose the adjustable height support arm comprising a channel, wherein the vertical frame member is configured to fit at least partially within the channel.
However, Amato teaches the adjustable height support arm comprising a channel, wherein the vertical frame member is configured to fit at least partially within the channel (Figs 3-4, recess 18, vertical frame member (15) fits within channel/recess 18).
Regarding claim 14, TheraSphere video discloses a cancer-therapy delivery system (video at 8:25 min and 14:30 min, administration set, TheraSphere accessory kit and dose vial) comprising: a fluid reservoir (video at 18:17 min showing a saline bag); a catheter (video at 17:55 min to 18:04 min showing a microcatheter secured at “E” in the holder in vertical orientation); and a support stand (video at 12:17 min, a plexiglass support stand), the support stand comprising a vertical frame member (see annotated video capture A above); an adjustable support arm (see annotated video capture A above), ….. and wherein the adjustable height support arm is configured to engage with the catheter and retain at least a portion of the same in a vertical orientation (video at 17:55 min to 18:04 min showing a microcatheter secured at “E” in the holder in vertical orientation).
However, TheraSphere video, Amato and Y-90 Instructional manual combined teach the adjustable support arm is an adjustable height support arm (Amato: Figs 1, 2, 7 and 7A, support arm (21) is height adjustable via support legs 34 and 35 and rotary gear 37 and gear rack 36), wherein the adjustable height support arm (21) is configured to be removably attached to the vertical frame member (15) at varying heights thereon (Amato: Figs 3 and 4, removably attachable via strap 23, lug 25 and hinge 17, Fig 7 for adjusting height); and a support leg (Amato: Fig 1-4, 11), wherein the support leg (11) is configured to be removably attached to a bottom portion of the vertical frame member (Amato: Fig 4, hinge 16 removably attached at recess 18; TheraSphere video, the height of the microcatheter at 18:02 min ~ 18: 06 min at “E” is continuously higher than the height of the tubing from the dose vial chamber at needle injector assembly, which will lead to gravity induced y90 microsphere fallen out of suspension; Y-90 instructional manual: page 14, “Do not use extension tubing between the Therasphere Administration Set and the microcatheter. The use of extension tubing will cause significant residual microspheres that will result in an under-dose”).
Regarding claim 16, TheraSphere video and Amato combined teach the adjustable height support arm (Amato: Figs 1 and 7) comprising a retention member (see annotated video capture B above), wherein the retention member is configured to engage with a body member of a medical device and retain the same in a vertical orientation (ThereSphere video at 17:57min, see annotated video capture B above, microcatheter is the medical device).
Regarding claim 17, TheraSphere video and Amato combined teach the adjustable height support arm (Amato: Figs 1 and 7) comprising attachment jaws (see annotated video capture C above), wherein the attachment jaws are configured to engage with a body member of a medical device and retain the same in a vertical orientation (see annotated video capture C above, microcatheter is the medical device).
Regarding claim 18, TheraSphere video fails to disclose the support stand further comprising an angled connector, wherein the angled connector is configured to engage both the vertical frame member and the support leg thereby connecting the two together.
However, Amato teaches the support stand further comprising an angled connector (Figs 3-4, hinge16 and pedestal 14 combined together serve as angled connector), wherein the angled connector is configured to engage both the vertical frame member and the support leg thereby connecting the two together (Figs 3-4, hinge 16 and pedestal 14 together serve as angled connector for connecting vertical frame member (15) and support leg (11)).
Regarding claim 19, TheraSphere video fails to disclose the adjustable height support arm comprising a channel, wherein the vertical frame member is configured to fit at least partially within the channel.
However, Amato teaches the adjustable height support arm comprising a channel, wherein the vertical frame member is configured to fit at least partially within the channel (Figs 3-4, recess 18, vertical frame member (15) fits within channel/recess 18).
Regarding claims 6-7, 9, 14, 16-19, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine and modify TheraSphere video by Amato in view of Y-90 instructional manual based on the same rationale previously discussed for claim 1 above, thereby omitted herein for brevity.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boston Scientific TheraSphere™ infusion training youtube video dated March 07 2021, https://www.youtube.com/watch?v=JrfYLfPcNY8&t=2s (hereinafter referred to as “TheraSphere video”) in view of Amato (US 5386958A, hereinafter referred to as “Amato”), and further in view of Instructions for Use manual for TheraSphere™ Yttrium-90 Glass Microspheres from Boston Scientific dated 03/2021, (hereinafter referred to as “Y-90 instructional manual”), and further in view of Jackson (USD622377S, hereinafter referred to as “Jackson”).
Regarding claim 10, TheraSphere video and Amato and Y-90 instructional manual, singularly or in combination fails to disclose or teach the vertical frame member comprising a plurality of apertures, wherein the plurality of apertures are distributed vertically along a lengthwise axis of the vertical frame member.
However, Jackson teaches the vertical frame member comprising a plurality of apertures, wherein the plurality of apertures are distributed vertically along a lengthwise axis of the vertical frame member (Figs 1-2, vertical frame member have at least 5 apertures vertically distributed along lengthwise axis).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the support apparatus of Amato by Jackson based on the following rationale: Referring to Figs 7A, 7 and 8 of Amato, the height adjustable mechanisms are achieved via gear rack 36, rotary gear handle 38, rotary gear 37, and held together by guide tube 39. On the other hand, referring to Figs 1 and 4 of Jackson, the height adjustable mechanisms are achieved via multiple preset apertures and a detent mechanism (for details see also discussion for claim 11 below).
Thus, the changes and adjustments in height for Jackson is reproducible for subsequent repeated procedure. On the other hand, the changes and adjustments in height for Amato is not reproducible for subsequent repeated procedure due to the nature of the structures of the gear rack 36 and instant position of the gear 37. As a result, above discussed advantages of height adjustable mechanisms of Jackson over Amato thereby serving as teaching, suggestion, or motivation, in the knowledge generally available to one of ordinary skill in the art to combine and modify Amato by Jackson.
Regarding claim 11, TheraSphere video and Amato and Y-90 instructional manual, singularly or in combination fails to disclose or teach the adjustable height support arm comprising a detent mechanism, wherein the detent mechanism is configured to engage with at least one of the plurality of apertures to hold the adjustable height support arm at a specific point along the lengthwise axis of the vertical frame member.
However, Jackson teaches the adjustable height support arm comprising a detent mechanism (see annotated image D below), wherein the detent mechanism (see annotated image D below) is configured to engage with at least one of the plurality of apertures (see annotated image D below) to hold the adjustable height support arm at a specific point along the lengthwise axis of the vertical frame member (see annotated image D below).
Annotated image D taken from Jackson
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Regarding claim 12, TheraSphere video and Amato and Y-90 instructional manual, singularly or in combination fails to disclose or teach the detent mechanism comprising a spring-force detent mechanism.
However, Jackson teaches the detent mechanism comprising a spring-force detent mechanism (although not explicitly shown, but referring to Figs 4 and 5 of Jackson, it is implied that a spring kit may be used to maintain the angled locked position of the detent mechanism, in order to keep the detent mechanism protruding end firmly stay inside the locked recess hole, as shown).
Regarding claims 11-12, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Amato by Jackson based on the same rationale previously discussed for claim 10 above, thereby omitted herein for brevity.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boston Scientific TheraSphere™ infusion training youtube video dated March 07 2021, https://www.youtube.com/watch?v=JrfYLfPcNY8&t=2s (hereinafter referred to as “TheraSphere video”) in view of Amato (US 5386958A, hereinafter referred to as “Amato”), and further in view of Instructions for Use manual for TheraSphere™ Yttrium-90 Glass Microspheres from Boston Scientific dated 03/2021, (hereinafter referred to as “Y-90 instructional manual”), and further in view of Lamb (US 10898639B1, hereinafter referred to as “Lamb”).
Regarding claim 13, TheraSphere video and Amato and Y-90 instructional manual, singularly or in combination fails to disclose or teach the adjustable height support arm comprising: a first base piece; and a second telescoping piece, wherein the second telescoping piece can be moved in or out relative to the first base piece.
However, Lamb teaches the adjustable height support arm comprising: a first base piece; and a second telescoping piece, wherein the second telescoping piece can be moved in or out relative to the first base piece (Fig 2, second telescoping piece (66) can be moved in or out relative to the first base piece (58), adjustable height support arm (24) in Fig 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the support apparatus of Amato by Lamb based on the following rationale: Referring to Figs 7A, 7 and 8 of Amato, the height adjustable mechanisms are achieved via gear rack 36, rotary gear handle 38, rotary gear 37, and held together by guide tube 39. On the other hand, referring to Figs 1, 2 and 4 of Lamb, the height adjustable mechanisms are achieved via a telescoping two-piece upright column that is height adjustable via a collar coupling assembly 60.
Thus, the changes and adjustments in height for Lamb is very quick and easy to do by simply pushing the upper column tube 66 up or down while the extension locking collar 60 is loosened. On the other hand, the changes and adjustments in height for Amato is not quick or easy to perform due to the nature of the structures of the gear rack 36 and instant position of the gear 37, and the slow moving up and down action as gear teeth mesh and travel. As a result, above discussed advantages of height adjustable mechanism of Lamb over Amato thereby serving as teaching, suggestion, or motivation, in the knowledge generally available to one of ordinary skill in the art to combine and modify Amato by Lamb.
Allowable Subject Matter
Claim 20 is allowable.
Claim(s) 3, 8 and 15 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
None of cited prior art including TheraSphere video, Amato, Y-90 Instructional manual, Jackson and Lamb, singularly or in combination, disclose or teach “wherein the stability wing is configured to engage with the support leg and rotate between a first position wherein a lengthwise axis of the stability wing is parallel to a lengthwise axis of the support leg and a second position wherein the lengthwise axis of the stability wing is perpendicular to the lengthwise axis of the support leg” of claims 3 and 15, respectively, “the angled connector comprising: a first snap-fit mechanism, wherein the first snap-fit mechanism is configured to engage with the vertical frame member; and a second snap-fit mechanism, wherein the second snap-fit mechanism is configured to engage with the support leg” of claim 8, “and moving a stability wing into a deployed position” of claim 20.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pappas (US 20100057017A1) discloses a feeding syringe assembly for endoscopic tube. Osborne, Dustin et al. “Insights into handling and delivery of Y-90 radioembolization therapies” discloses about infusion quality and residue dose and data for TheraSpheres infusions and a rapid fall to baseline values. Jackson (US 20040262463A1) disclose an adjustable support device for feeding tube. Andrews (US 6135983) disclose a gastric-tube feeding system. Yazbeck (US 9642778B1) discloses a feeding tube holder. Domingues (US 10455923B1) disclose an enteral feeding system. Donovan (US 6464188B1) discloses a nutrient feeding support apparatus. Donaldson (US 10244852B1) disclose a support with a cross base. Horst (DE202009007761U1) discloses a holding device for a catheter bag. Ohanian (US 6179260B1) discloses a device coupling an IV stand to patient transport. Yunker (US 7533428B2) discloses a medical bag support assembly. Schuler (US 4666111) discloses a IV tube holder.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DING Y TAN whose telephone number is (303)297-4271. The examiner can normally be reached on Monday-Friday, 8:00am MT--5:00pm MT. 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, Terrell McKinnon can be reached on 571-272-4797. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DING Y TAN/Examiner, Art Unit 3632
/TERRELL L MCKINNON/Supervisory Patent Examiner, Art Unit 3632
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