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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2-4, 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mick (US 2008/0064916), as cited in the IDS.
Regarding claim 1, Mick discloses a brachytherapy applicator comprising:
an interstitial tube including a body having a body proximal end and a body distal end; (Fig. 21. paragraph [0081] “a central tandem 282”, The examiner notes the central tandem is a hollow tube.)
a first connector coupled to the body between the body proximal end and the body distal end; (paragraph [0081] “the pivot bracket 208”)
a first ovoid tube having a first ovoid positioned at a distal end of the first ovoid tube, wherein the first ovoid tube is coupled to the first connector and is positioned toward a first lateral side of the interstitial tube; (paragraph [0081] “a pair of adjustable split ring tubes, of which only one adjustable split ring tube 272 is illustrated in FIG. 21 for clarity.” The examiner notes tube 272 is coupled to connector 208, can be seen in figs 21.)
and a second ovoid tube having a second ovoid located at a distal end of the second ovoid tube, wherein the second ovoid tube is coupled to the first connector and is positioned toward a second lateral side of the interstitial tube opposite the first lateral side; (The examiner notes in figure 21, there is a pair of split ring tubes but only one pictured, so in figure 21 there would be a mirror of tube 272 on the opposite side connected to connector 208.)
wherein at least one of the first ovoid tube and the second ovoid tube is moveable relative to the first connector when coupled to the first connector to alter a lateral distance between the first ovoid and the second ovoid. (paragraph [0069] “Adjustable split ring tubes 72, 74 are adjustable laterally to a cervical axis through adjustable brackets 88” paragraph [0081] “It should be appreciated that the adjustable split ring tubes of the split ring applicator 201 are substantially the same as the adjustable split ring tubes described above.”.)
Regarding claim 2, Mick teaches the brachytherapy applicator of claim 1, wherein both of the first ovoid tube and the second ovoid tube are independently moveable relative to the first connector. (paragraph [0071] “The split ring tubes 72, 74 of split ring applicator 70 are capable of being locked in varying open positions.”)
Regarding claim 3, Mick discloses the brachytherapy applicator of claim 1, and in another embodiment (figure 21) discloses wherein the
the first connector includes an aperture; (Figure 21, element 208 is the first connector. Paragraph [0084] “The pivot bracket 208A includes a bore 226A, which receives the adjustable split ring tube 272,” )
the at least one of the first ovoid tube and the second ovoid tube includes an anchor extending therefrom (paragraph [0084] “a tab 227A into which the pivot 206 is received.”)
and the at least one of the first ovoid tube and the second ovoid tube is coupled to the first connector via rotational engagement of the anchor within the aperture. (paragraph [0084] “Threaded bores 225A, 225A are provided and receive set screws to secure the pivot bracket 208A to the adjustable split ring tube 272.”)
Regarding claim 4, Mick discloses the brachytherapy applicator of claim 1, and in another embodiment (figure 21) discloses wherein the
the first connector includes a first aperture and second aperture; (paragraph [0085] “The pivot bracket 208B includes a bore 226B” The examiner notes 226A and 226B are the first and second apertures.)
the first ovoid tube includes a first anchor extending therefrom; the second ovoid tube includes a second anchor extending therefrom; (paragraph [0085] “a tab 227B into which the pivot 206 is received”)
the first ovoid tube is coupled to the first connector via rotational engagement of the first anchor within the first aperture; and the second ovoid tube is coupled to the first connector via rotational engagement of the second anchor within the second aperture. (paragraph [0085] “Threaded bores 225B, 225B are provided and receive set screws to secure the pivot bracket 208B to the adjustable split ring tube 272.”)
Regarding claim 9, Mick teaches the brachytherapy applicator of claim 1, wherein application of inward forces against the first ovoid tube and the second ovoid tube proximally of the first connector causes the lateral distance between the first ovoid and the second ovoid to increase. (paragraph [0069] “Adjustable split ring tubes 72, 74 are adjustable laterally to a cervical axis 80 through adjustable brackets 88 and may be locked in place by lock nuts 86. Adjustable split ring tubes 72, 74 may be selectively locked in one of multiple positions.” The examiner notes that the lock nuts apply inward forces against the ovoid tubes proximally of the first connector.)
Regarding claim 10, Mick teaches the brachytherapy applicator of claim 1, further comprising:
a spreading clip positioned proximally of the first connector (figure 21, element 208; paragraph [0081] “A pivot bracket 208 is affixed to each adjustable split ring tube 272”) , wherein the spreading clip is configured to apply inward forces against the first ovoid tube and the second ovoid tube to cause the lateral distance between the first ovoid and the second ovoid to increase. (paragraph [0081] “A locking knob 212 is provided on the locking sleeve, e.g., threadedly, so that the adjustable split-ring tube 272 is pivotable about the pivot 206 and lockable in position relative to the central tandem 282.” The examiner notes that the spreading clip and locking knob apply inward forces against the first and second ovoid tube (only one pictured in fig 21, element 272))
Regarding claim 11, Mick teaches the brachytherapy applicator of claim 1, wherein the spreading clip includes a plurality of indentations configured to engage the first ovoid tube and the second ovoid tube. (paragraph [0086] “The tandem holder 214 includes detents or bores 205a . . . 205e, 207a . . . 207e for locking the adjustable split ring tubes in predetermined positions”)
Regarding claim 12, Mick discloses the brachytherapy applicator of claim 11, wherein:
the spreading clip is configured to apply inward forces of a first magnitude when the first ovoid tube and the second ovoid tube are engaged with a first set of indentations of the plurality of indentations (paragraph [0081] “A locking knob 212 is provided on the locking sleeve, e.g., threadedly, so that the adjustable split-ring tube 272 is pivotable about the pivot 206 and lockable in position relative to the central tandem 282.” The examiner notes the indentations are fig 26, elements 205, 207 and that the locking knob provides inward forces when engaged with the bores 205 and 207.);
the spreading clip is configured to apply inward forces of a second magnitude when the first ovoid tube and the second ovoid tube are engaged with a second set of indentations of the plurality of indentations (The examiner notes that there are multiple indentations that the ovoid tubes can be locked in, thus the force applied would be different depending on the position the tube is locked in.);
and the first magnitude and the second magnitude differ (The examiner notes that there are multiple indentations that the ovoid tubes can be locked in, thus the force applied would be different depending on the position the tube is locked in.).
Regarding claim 13, A brachytherapy applicator comprising:
an interstitial tube including a body having a body proximal end and a body distal end; (paragraph [0069] “a central tandem 82”, The examiner notes the central tandem as the interstitial tube, the proximal end as figure 8, the device side with labeled elements 92-93, and the distal end as the device side with elements 94 and 96.)
a first connector coupled to the body between the body proximal end and the body distal end; (paragraph [0069] “a universal connector 84 (a coupling device)…..Central tandem locator 90 is formed as a part of central tandem 82 and connects to universal connector 84.”)
a first ovoid tube having a first ovoid positioned at a distal end of the first ovoid tube, wherein the first ovoid tube is coupled to the first connector and is positioned toward a first lateral side of the interstitial tube; (paragraph [0069] “Adjustable split ring tubes 72, 74” & “Semi-circular rings 76, 78” The examiner notes figure 8, element 74 as the first ovoid tube, element 78 as the first ovoid positioned at the at a distal end of an ovoid tube, that is located laterally of the central tandem (interstitial tube).)
a second ovoid tube having a second ovoid located at a distal end of the second ovoid tube, wherein the second ovoid tube is coupled to the first connector and is positioned toward a second lateral side of the interstitial tube opposite the first lateral side; (paragraph [0069] “Adjustable split ring tubes 72, 74” & “Semi-circular rings 76, 78” The examiner notes figure 8, element 72 as the second ovoid tube, element 76 as the first ovoid positioned at the distal end of an ovoid tube, that is located laterally of the central tandem (interstitial tube).)
and a rectal retractor coupled to the first connector and positioned below the interstitial tube, wherein the rectal retractor extends from the first connector toward the first ovoid and second ovoid. (paragraph [0074] “Rectal retractor 110 is attached to the split ring applicator 70 through universal connector 84.” The examiner notes in figure 12 the rectal retractor extends from connector 84 to ovoids, elements 76, 78.)
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.
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) 5-8, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mick in view of Steller (US 2017/0291041), as cited in the applicant’s IDS.
Regarding claim 5, Mick teaches the brachytherapy applicator of claim 1, but fails to teach a collar coupled to the body distal end of the body; a first recess extending along a first surface of the first ovoid; and a second recess extending along a second surface of the second ovoid; wherein the collar is configured to engage with the first recess and the second recess at least when the lateral distance between the first ovoid and the second ovoid is a minimum distance.
Steller teaches a brachytherapy device with:
collar coupled to the body distal end of the body (figure 25A, element 2570)
a first recess extending along a first surface of the first ovoid; (figure 25A, element 2510 shows an oval slot receiving the edge of the collar near the left side of element 2520.)
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and a second recess extending along a second surface of the second ovoid (the examiner notes 2510 is mirrored on each side, therefore on there will be a second recess on the second ovoid.);
wherein the collar is configured to engage with the first recess and the second recess at least when the lateral distance between the first ovoid and the second ovoid is a minimum distance. (The examiner notes in image 25A ovoids 2510 are pushed together and the collar 2570 is engaging with the recesses on each ovoid.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the applicator taught by Mick to have the collar and recesses taught by Steller. One of ordinary skill in the art would have been able to recognize that the collar would push back the surrounding tissue in the cervix and allow for accurate delivery of radiation to a targeted area.
Regarding claim 6, Mick and Steller teach the brachytherapy applicator of claim 5, and Steller further teaches wherein engagement of the collar with the first recess and the second recess is configured to permit lateral movement of the first ovoid and the second ovoid while inhibiting anterior and posterior movement of the first ovoid and the second ovoid. (paragraph [0018] “By engaging with notch 2562, cervical stopper may not travel along the axis of intra uterine tube tip 2560.” The examiner notes that since the cervical stopper will not move posterior or anterior that the ovoids will be unable to move that direction as well but are not restrained in the lateral direction, and would be able to have lateral movement.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Mick and Steller to not be able to move posterior or anterior. One of ordinary skill in the art would be able to recognize that lateral movement is needed in brachytherapy applicators to be able to account for user anatomy and designated treatment sites.
Regarding claims 7 and 8, Mick and Steller teach the brachytherapy applicator of claims 6, and Steller further teaches wherein each of the first recess and the second recess include at least one of a chamfer, a protrusion, and a bevel for engaging the collar (of claim 7) and wherein each of the first recess and the second recess is configured to engage with the collar by at least one of a snap-fit, a friction-fit, a slide-fit, and a bayonet-fit (of claim 8). (fig. 3A. Paragraph [0054] “Locking mechanism 304 may be attached towards the end of central applicator tube 103 to provide a securing mechanism at the applicator head end. Locking mechanism 304 may include slots or channels to receive and secure ring-shaped ovoid applicator head pieces 101. The channels or slots may provide a tool-free snap-fit or friction-fit connection.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Mick and Steller in view of Steller. One of ordinary skill in the art would have been able to recognize that as the device is inserted in the patient the collar must be secure to ensure the safety of the patient.
Regarding claim 20, Mick teaches a brachytherapy applicator comprising:
an interstitial tube including a body having a body proximal end and a body distal end; (paragraph [0069] “a central tandem 82”, The examiner notes the central tandem as the interstitial tube, the proximal end as figure 8, the device side with labeled elements 92-93, and the distal end as the device side with elements 94 and 96.)
a first connector coupled to the body between the body proximal end and the body distal end; (paragraph [0069] “a universal connector 84 (a coupling device)…..Central tandem locator 90 is formed as a part of central tandem 82 and connects to universal connector 84.”)
a first ovoid tube having a first ovoid positioned at a distal end of the first ovoid tube, wherein the first ovoid tube is coupled to the first connector and is positioned toward a first lateral side of the interstitial tube; (paragraph [0069] “Adjustable split ring tubes 72, 74” & “Semi-circular rings 76, 78” The examiner notes figure 8, element 74 as the first ovoid tube, element 78 as the first ovoid positioned at the at a distal end of an ovoid tube, that is located laterally of the central tandem (interstitial tube).)
a second ovoid tube having a second ovoid located at a distal end of the second ovoid tube, wherein the second ovoid tube is coupled to the first connector and is positioned toward a second lateral side of the interstitial tube opposite the first lateral side; (paragraph [0069] “Adjustable split ring tubes 72, 74” & “Semi-circular rings 76, 78” The examiner notes figure 8, element 72 as the second ovoid tube, element 76 as the first ovoid positioned at the distal end of an ovoid tube, that is located laterally of the central tandem (interstitial tube).)
a rectal retractor coupled to a protrusion extending downwardly from the first connector, wherein the rectal retractor is positioned below the interstitial tube and extends from the first connector toward the first ovoid and second ovoid; (paragraph [0074] “Rectal retractor 110 is attached to the split ring applicator 70 through universal connector 84.” The examiner notes in figure 12 the rectal retractor extends from connector 84 to ovoids, elements 76, 78.)
But fails to teach wherein the first ovoid tube and the second ovoid tube are configured to rotate relative to the first connector when coupled to the first connector to alter a lateral distance between the first ovoid and the second ovoid.
Steller teaches a brachytherapy applicator configured to rotate relative to the first connector when coupled to the first connector to alter a lateral distance between the first and second ovoid. (paragraph [0065] “vaginal cap 112 may connect to ring-shaped ovoid applicator head piece 602 (e.g., ring-shaped ovoid applicator head pieces 101). As shown in FIG. 6A, vaginal cap 112 may include alignment pin 603,” paragraph [0066] “vaginal cap 112 may rotate about the alignment pin connection. As shown in FIG. 6B, vaginal cap 112 may include an opening to receive an ovoid tube (e.g., ring-shaped ovoid tube 303).” The examiner notes that as rotation occurs the lateral distance between head pieces 101 would change.)
It would be prima facie obvious to one of ordinary skill In the art before the effective filing date to modify the system taught by Mick to have rotatable ovoids to alter the distance. One of ordinary skill in the art would be able to recognize that this is a simple substitution for the ovoids taught in Mick, to obtain the predictable results of laterally adjustable ovoids.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mick in view of Van Erp (US 2014/0121444), as cited in the applicant’s IDS.
Regarding claim 14, Mick teaches the brachytherapy applicator of claim 13 but fails to teach the first connector includes a protrusion extending downwardly therefrom; the rectal retractor includes one or more retractor apertures configured to engage with the protrusion.
Van Erp teaches a modular brachytherapy applicator with a connector with a downward protrusion on a connector (Paragraph [0042] “The fixation mechanism 32 may be glued to the central element, or may be provided on it using different means. A suitable peripheral element 33, may be clicked on a projection 32a provided on the fixation mechanism 32.” The examiner notes that element 32a is a downward protrusion on connector 32, therefore the examiner would modify connector 206 to have this downward protrusion. The examiner notes element 33 is the aperture to receive element 32A for connection, and would modify the connecting rectal retractor taught by Mick to have the aperture.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the connector taught by Mick (fig 21, element 206) to have a downward protrusion and receiving aperture as taught by Van Erp. One of ordinary skill in the art would have been able to recognize that this is would be simple substitution of a connection means for a rectal retractor to obtain the predictable results of easily connecting different parts of a modular brachytherapy applicator.
Regarding claim 15, Mick in view of VanErp teach the brachytherapy applicator of claim 14, Van erp further teaches a modular brachytherapy applicator with a slot for an attachment mechanism. (Fig. 1B, element 4A. paragraph [0052] “It is seen that the fixation mechanism comprises surfaces 4a, 4b which are suitably shaped to allow connection to a peripheral element. An embodiment of a peripheral element which may be connected to such fixation mechanism is a rectal spacer, or a bladder spacer, for example.” The examiner is modifying the rectal retractor to have the slot of connector 4A, thus this modification would provide a slot extending in a longitudinal direction, and an aperture to engage with a protrusion as taught in claim 14.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by Mick and Van Erp to have a slot fixation mechanism further taught by Van Erp. One of ordinary skill in the art would have been able to recognize that this is a known technique to yield the predictable results of easily connecting different parts of a modular brachytherapy applicator.
However, both Mick and Van Erp fail to teach a plurality of apertures.
It would be prima facie obvious to one of ordinary skill in the art to modify the system taught by Mick and Van Erp to have a plurality of apertures. One of ordinary skill in the art would have recognized that this is a duplication of parts, which would be necessary to provide a variety of adjustable positions for the rectal retractor depending on the user anatomy and treatment needs, and would thus have no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04, VI, B and In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mick in view of Van Erp further in view of Mick (US 2013/0006097), herein referred to as Mick 2.
Regarding claim 16, Mick and Van Erp teach the brachytherapy applicator of claim 15, but fail to teach wherein the plurality of retractor apertures are spaced apart from one another by between 1 mm and 7 mm.
Mick 2 teaches an extender for a shield with grooves spaced between 1mm and 7mm apart. (paragraph [0068] “the markings 128 may be placed every 5 mm and/or 1 cm, or any other length”)
It would be prima facie obvious to one of ordinary skill to modify the system taught by Mick and Van erp in view of Mick 2. One of ordinary skill in the art would have recognized that it would be necessary to provide a variety of adjustable positions for the rectal retractor depending on the user anatomy and treatment needs.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mick in view of Van erp further in view of Mick 2 further in view of Rahimian (US 2013/0109908), as cited in the applicant’s iDS.
Regarding claim 17, Mick, Van erp, and Mick 2 teach the applicator of claim 15, and Mick 2 further teaches the protrusion is configured to snap-fit within each of the retractor apertures (paragraph [0042] “ The peripheral element may be detached in the directions schematically shown by arrow R.” and paragraph [0053] “It is further found that it is advantageous if the peripheral elements are connectable to the fixation mechanism using snap-fit, seal ring, or bayonet joint connectors.”) but fail to teach wherein the retractor apertures are defined by a pair of flexible portions.
It would be prima facie obvious to modify the applicator taught by Mick, Van erp, and Mick 2 to have a snap fit as taught by Mick 2. One of ordinary skill in the art would have been able to recognize that the retractor must be secure to prior to using it for treatment for safety.
Rahimian teaches a brachytherapy applicator with a flexible portions (fig. 16. paragraph [0083] “The ovoid assembly preferably has tabs 285, 287”)
It would be prima facie obvious to one of ordinary skill in the art to modify the system taught by Mick, Van erp, and Mick 2 to have the flexible portions as taught by Rahimian. One of ordinary skill in the art would have been able to recognize that these attachment configurations can adjust for the length of the vaginal canal by pressing the spring-actuated locking mechanism similar to a key-lock attachment. See paragraph [0083] of Rahimian.
Allowable Subject Matter
Claims 18-19 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. The prior art of record fails to teach a first and second flex tab that spread apart upon application of a squeezing force that allow adjustment of the device as specifically claimed, in combination with all other recited limitations.
Rahimian (US 2013/0109908) teaches a pair of flex tabs that have a spring actuated lock mechanism to adjust the applicator for anatomical needs (paragraph [0083]) but does not teach that the flexible tabs spread apart to allow for adjustment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fairbanks teaches a brachytherapy applicator with a retractor (US 2017/0106207).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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