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 .
Status of Claims
Claims 1-13 and 21-27 are currently pending and under examination. Claims 14-20 are canceled. According to the 03/31/2026 reply, claims 1-2, 7-8 are amended and claims 21-27 are newly added.
Priority
The instant application (filed on 06/26/2022) is a continuation of PCT/JP2021/009430 (filed on 03/10/2021), filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for foreign priority based on an application (JP 2020-060401) filed in Japan on 03/30/2020. Amended claims 1-13 and 21-27 are adequately supported in the foreign application to receive an effective filing date of 03/30/2020.
Response to Arguments
Applicant's arguments, see Remarks pages 11-17, filed 03/31/2026, with respect to the rejections of Claims 1-13 under 35 USC § 102 and 35 USC § 103 been fully considered. Regarding independent claims 1 and 7, Applicant argues:
The claims pending in this application are thus Claims 1-13 and 21-27. These examined claims include two independent claims - Claims 1 and 7. This Amendment does not introduce new matter. The Official Action sets forth an anticipatory rejection of independent Claim 7 based on the disclosure in U.S. Patent Application Publication No. 20008/0065003 to Neuberger et al. (Neuberger). This publication describes several embodiments of a photonic device used to treat cervical dysplasia. The Figure 1 embodiment includes an illumination head 101 having a semi-spherically shaped reflector 105 at which are incorporated an LED array 109. A cylindrical tube 107 extends beyond the illumination head 101 to facilitate insertion of the photonic device into cervical regions during use. Another embodiment shown in Figure 2 is slightly different in that the LED array 209 is arranged in a hand piece 211 of the photonic device, and a light guide 203 connects the LED array 209 and the illumination head 201. This version also includes a tube 207 that extends beyond the illumination head 201 to facilitate insertion of the device into cervical regions. During operation of this second embodiment, radiation from the LED array 209 travels along the light guide 203, enters the tube 207 and is directed toward a reflector 205 on the illumination head 201. Neuberger comments that multiple scattering sources may be encased in the tube 207 so that the radiation is well able to leave the tube 207.
One significant difference between the Claim 7 treatment apparatus and the disclosure in Neuberger is that the treatment apparatus here is configured to include an irradiation unit that emits the excitation light from both the distal shaft and the distal structure portion to irradiate the antibody-photosensitive substance. That is, the treatment apparatus is configured so that the light emitting portion of the irradiation unit is positionable in a through hole in the distal structure portion, and the distal structure portion is made of a transparent/translucent material that allows the excitation light emitted by the light emitting portion to propagate through the distal structure portion so that the distal structure portion contributes to carrying out the irradiation. To better set forth these distinguishing aspects of the treatment apparatus, Claim 7 is amended to recite that the distal structure portion includes a through hole that is configured to movably accommodate the light-emitting portion of the irradiation unit, that the distal structure portion is formed of a transparent/translucent material allowing the excitation light emitted by the light-emitting portion while the light-emitting portion is accommodated in the through hole to propagate to outside of the distal structure portion, and that the length of the through hole is equal to or greater than the length of the light-emitting portion.
Examples of support for aspects of the treatment apparatus recited in Claim 7 include the original claims, the description in the specification such as in paragraphs [0047] and [0053], and the illustration in various drawing figures such as FIG. 3. (03/31/2026 Remarks, Pages 11-13)
This argument is persuasive. There is no evidence the light emitting portion (light guide lumen) in Neuberger is axially movable relative to the distal structure portion (reflector 15). Therefore, the rejections of claims 1 and 7 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly in view of Lim (WO 2018/093097 A2).
Applicant additionally argues:
The treatment apparatus recited in Claim 7 is quite different from the photonic device disclosed in Neuberger. As pointed out above, the Figure 1 version of Neuberger's photonic device is specifically configured so that the LED array 109 is arranged on the illumination head 101, with the light from the LED array 109 being used to irradiate tissue. And the Figure 2 embodiment involves an LED array 209 that guides radiation along a light guide 203 in a tube 207 so that the radiation is directed to a reflective coating 205 on the illumination head 201. There is no disclosure in Neuberger that the photonic device should be constructed to include the combination of a light emitting portion and a distal structure portion, wherein the distal structure portion has a through hole that movably accommodates such light-emitting portion and wherein the distal structure portion is made of a transparent/translucent material so that light emitted by the light emitting portion can propagate to outside. A careful reading of Neuberger reveals no disclosure that the tube 107, 207 (or the light guide 203) is movably accommodated in a through hole in the illumination head 101, 102. The reason of course is because such movable accommodation is not necessary for the intended use and operation of Neuberger's photonic device. (03/31/2026 Remarks, Pages 13-14)
This argument is similarly persuasive. Neuberger clearly discloses a reflector 105 (equivalent to the distal structure portion) with transparent tube 107 (equivalent to the light emitting portion) passing through (Fig. 1, [0042]). There is no evidence the light emitting portion (light guide lumen) in Neuberger is axially movable relative to the distal structure portion (reflector 15). The proposed combination with Lim yields an independently movable optical fiber and needle section ([0047]) relative to a flexible outer hose ([0055]). This would be implemented in Neuberger as a means to change the length of tubing containing the optical fiber relative to another encompassing element (i.e. the outer flexible hose is equivalent to the through hole in Neuberger as a location along the needle sheath).
Applicant additionally argues:
Neuberger also does not disclose that the illumination head 101, 102 should be made of a transparent/translucent material that allows the excitation light emitted by the light-emitting portion while the light-emitting portion is accommodated in the through hole to be transmitted through the transparent or translucent material of the distal structure portion to outside of the distal structure portion. Again, such structure is not necessary in the context of Neuberger's photonic device because Neuberger does not envision radiation from the LED array 109, 209 being transmitted through the material forming the illumination head 101, 201. As a still further distinction, Neuberger says nothing about the length of a through hole in the illumination head 101, 201 relative to the length of a light emitting portion that is movably accommodated in a through hole in the illumination head 101, 201. For at least the reasons discussed above, The treatment apparatus recited in independent Claim 7 patentably distinguishes over the disclosure in Neuberger. Withdrawal of the anticipatory rejection of Claim 7 is respectfully requested. (03/31/2026 Remarks, Page 14)
This argument is overall persuasive. There is no evidence that the reflector disk in Neuberger is transparent as the reflector layer is positioned on the inner surface of the reflector. Therefore, the rejections of claims 1 and 7 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly in view of Burwell (US 2008/0033519 A1). The combination with Lim teaches on the movement of a tube relative to a fixed location ([0055] – relative to the sheath). In this combination, transparent tube 107 in Neuberger would be able to move relative to a fixed location in the reflector and adjust length relative to the reflector’s through hole length.
Applicant additionally argues:
The Official Action also sets forth an obviousness rejection of independent Claim 1 based on the disclosure in Neuberger considered in light of the disclosure in International Patent Application Publication No. 2018/093097 to Lim. This secondary reference discloses a medical photodynamic therapy device having a light guide embedded in a transparent needle to effect forward irradiation of a tumor. Lim is not at all concerned with constructing a treatment device to include a distal structure portion made of transparent/translucent material so that excitation light emitted by a light emitting portion movably located in a through hole passing through the distal structure portion will propagate to the outside and carry out tissue irradiation. Thus, if a person of ordinary skill in the art was led to modify Neuberger's photonic device to include a light guide embedded in a transparent needle to effect forward irradiation of a tumor as suggested in the Official Action, the result would not be a treatment apparatus having the combination and arrangement of features recited in Claim 1. That is, the collective disclosures in Neuberger and Lim would not have suggested to one of ordinary skill in the art that Neuberger's photonic device should be constructed to include a distal structure portion provided with a through hole configured to movably accommodate a light-emitting portion, and wherein such distal structure portion is formed of transparent/translucent material to allow excitation light emitted by the light-emitting portion to propagate outside the distal structure portion.
Thus, considering the disclosures in Neuberger and Lim together, an ordinarily skilled artisan would not have been held to construct a treatment apparatus having the claimed combination and arrangement of features set forth in independent Claim 1. Withdrawal of the obviousness rejection of Claim 1 is respectfully requested. (03/31/2026 Remarks, Pages 14-15).
This argument is not persuasive. The disclosure of Neuberger does not specify whether tube 107 is fixed to the passage through reflector 105. The combination with Lim, as explained earlier in in this action, merely improves Neuberger by implementing the ability of the light carrying tube 107 to be adjusted in length to be able to irradiate at a variety of treatment depths.
Regarding newly added claims 21-27, Applicant argues:
New dependent Claims 21-27 define additional distinguishing aspects of the treatment apparatus. Examples of support include original Claim 1, the description in the specification such as in paragraphs [0059], [0060] and [0066], and the associated illustrations in the drawing figures.
Dependent Claims 22 and 25 state that the distal structure portion includes structure configured to scatter the excitation light emitted by the light-emitting portion so that the distal structure portion itself emits the excitation light. This is not the case with the photonic device in Neuberger. As noted, Neuberger merely discloses an LCD array arranged on the illumination head 101 or scattering sources encased in the tube 207. There is no disclosure that Neuberger's illumination head 101 /201 should be provided with structure configured to scatter excitation light. And there is no need for the illumination head 101, 201 to be provided with such structure in view of the particular manner of operation described by Neuberger. Lim does not suggest modifying Neuberger's photonic device to include the additional features recited in Claims 22 and 25. (03/31/2026 Remarks, Pages 15-16)
This argument is not persuasive. The inner section of reflector 105 in Neuberger is described as having a scattering surface 113 (Fig. 1, [0042]). See rejections of claims 22 and 25.
Applicant additionally argues:
New Claims 23 and 26 specify that the structure configured to scatter the
excitation light is a scatterer in the material forming the distal structure portion. There is no disclosure of such a scatterer in Neuberger or Lim. (03/31/2026 Remarks, Page 16)
This argument is not persuasive. The inner section of reflector 105 in Neuberger is described as having a scattering surface 113 (Fig. 1, [0042]). See rejections of claims 23 and 26.
Applicant additionally argues.
Claims 24 and 26 define first and second surfaces of the distal structure portion provided with a reflective coating while a third surface of the distal structure portion is not provided with such reflective coating. As discussed above regarding Claims 22 and 25, Neuberger does not disclose or suggest configuring the illumination head 101, 201 to include structure that scatters light. Similarly, Neuberger does not disclose or suggest that the material forming the illumination head 101, 201 should be configured in the manner recited in Claims 24 and 26 where several surfaces are provided with a reflective coating while a third surface is not. (03/31/2026 Remarks, Page 16)
This argument is persuasive in that Neuberger does not disclose the three surfaces having individual determinations of whether a reflective coating is applied. However, Prozee (EP 0358273 A1)
is relied upon for the rejections of claims 24 and 26.
Summary: The prior art rejections of claims 1-13 are withdrawn. However, new 35 U.S.C. § 103 rejections are added for claims 1-13 newly in view of Lim (WO 2018/093097 A2) and Burwell (US 2008/0033519 A1). Prior art rejections for newly added claims 21-27 are added.
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 24 and 27 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.
Claims 24 and 27: The limitation “ a second surface facing radially outward” is indefinite because the structural element from which the second surface faces radially outward is not specified.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-5, 7-9, 11, 21-23, and 25-26 are rejected under U.S.C 103 as being unpatentable over Neuberger (US 2008/0065003 A1) in view of Lim (WO 2018/093097 A2) and Burwell (US 2008/0033519 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim (WO 2018/093097 A2) - see attached for copy of the disclosure’s translation.
Regarding Claim 1, Neuberger discloses a treatment apparatus configured to irradiate a photosensitizer substance bound ([0037]) to a tumor cell with excitation light ([0003], [0006]), the treatment apparatus comprising:
• a main shaft having a central axis (Figure 2, [0043] – the device has radial symmetry and a central axis along the light pathway) and including a lumen extending throughout the main shaft, the main shaft including a distal portion (Figure 2, [0043] – a lumen containing the light guide through the handle and cylindrical tube, which would naturally have a distal portion);
• a distal structure portion (Figures 1-2, reflector 105, 205) disposed at the distal portion of the main shaft, the distal structure portion possessing a proximal end and a distal end (Figure 2, [0043] – the illumination head 201 containing 205 is positioned at the distal end of the tubing connection between the distal tubing 207 and hand piece 211, where the illumination head is inserted into cervical region; the components 207 and 205 have a proximal and distal end);
• an irradiation shaft positioned in the lumen in the main shaft (Figure 2, [0043] – light guide 203 placed in tube) and the irradiation shaft including an irradiation lumen (light guide 203);
• the irradiation shaft including a distal portion at which is located a distal shaft ([0043] - distal cylindrical tube 207 containing a light guide), the irradiation lumen extending into a distal portion of the distal shaft ([0043] – tube 207 contains a light guide: “In order for the radiation to leave tube 207, multiple scattering sources, for example, may be encased within tube 207”);
• the distal portion of the distal shaft being located distally beyond a distal-most part of the distal structure portion (Figures 1-2, [0043-0043] – tube 107, 207 extends distally beyond reflector 105, 205), the irradiation lumen extending through the distal structure portion ([0042-0043] – light radiation travels down tube 107, 207);
• the distal structure portion being configured so that an outermost surface of the distal structure portion is radially outwardly of an outer surface of the main shaft and radially outwardly of an outer surface of the distal portion of the distal shaft (Figures 1-2, [0042] – the reflector is in a cup shape where the tube containing the light guide passes through the center of the surrounding reflector cup: “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113”); and
• an irradiation unit positioned in the irradiation lumen ([0043] – a light guide can be used to carry irradiation from the LED arrays 209 in hand piece 211 to the illuminator head 201), and configured to emit, from both the distal structure portion ([0042] – light can be reflected from reflector or emitted by LED arrays) and the distal portion of the distal shaft that is located distally beyond the distal-most part of the distal structure portion ([0042] – “A portion of the radiation from LED array 109 enters into tube 107 and is transmitted from the distal end of tube 107 by means of internal reflection sources, not shown. Further, there may be LEDs solely for the purpose of transmitting radiation through tube 107 either directly into tube 107 or by means of optical fibers attached thereto”; [0043] – “In this embodiment, the radiation from LED array 209 travels down guide 203 and enters into tube 207. In order for the radiation to leave tube 207, multiple scattering sources, for example, may be encased within tube”) the excitation light to irradiate the photosensitizer substance ([0043] – “The illuminator head 201 consists of a reflector 205 with a cylindrical tube 207 designed for insertion into the cervical region for uniform irradiation of precancerous and cancerous cells”).
• the irradiation unit including a light-emitting portion ([0042-0043]);
• the distal structure portion including a through hole that extends through the distal structure portion from the proximal end of the distal structure portion to the distal end of the distal structure portion ([0042-0043] – light is carried via the light guide through the hole in the distal structure); and
However, Neuberger does not disclose (1) an antibody-photosensitive substance, (2) an irradiation shaft axially movable relative to the main shaft, (3) the through hole being configured to movably accommodate the light-emitting portion of the irradiation unit, and (4) the distal structure portion being formed of a transparent or translucent material that allows the excitation light emitted by the light-emitting portion while the light emitting portion is accommodated in the through hole to propagate to outside of the distal structure portion.
Note the antibody-photosensitive substance is not interpreted as a structural component of the “treatment apparatus configured to irradiate.”
MPEP 2114 (II) states:
[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
MPEP 2115 (II) states:
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
The irradiation apparatus works on the antibody-photosensitive substance, which is therefore interpreted as an intended use of the apparatus and not a structural limitation of the claim.
Lim, in the same field of endeavor of placing photodynamic therapy in tissue using a light guide to destroy tumor tissue ([0001]), teaches a needle containing an optical fiber as a light guide where the needle is surrounded by a flexible hose ([0046]). The optical fiber is able to move with respect to the needle section ([0047]) and the needle is able to move with respect to the flexible outer hose ([0055]). This would be implemented in Neuberger as a means to change the length of tubing containing the optical fiber relative to another encompassing element (i.e. outer flexible hose is equivalent to the through hole in Neuberger as a location along the needle sheath).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating a moveable optical fiber or needle in Lim. This would have been obvious because both Neuberger and Lim discuss placement of photodynamic therapy devices and Lim provides a solution/improvement to allow for independently adjustable placement of an optical fiber from which to irradiate relative to a surrounding container or a container/fiber combination relative to a surrounding tube. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the moveable optical fiber and needle in Lim.
Burwell, in the same field of endeavor of an internally applied phototherapy device ([0007]) teaches a transparent polymer 23 placed around internal optical fibers to allow light to be transmitted through the polymer for treatment ([0061-0063]). A reflective coating can be applied to the outer surface of the overall structure 4 to focus light toward the distal end of the device ([0063] – “Additionally, a reflective coating 43 (such as aluminum or another reflective material), is applied to the outer surface of body 4 adjacent to light source array 40. Any light from LEDs 40a directed to the sides (i.e., towards body 4) is redirected by reflective coating 43 towards distal end 6. Reflective disk 40b and reflective coating 43 thus cooperatively maximize the intensity of light delivered through distal end 6”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the transparent polymer layer in Burwell. This would have been obvious because both Neuberger and Burwell discuss the use of internal phototherapy devices and Burwell provides a solution/improvement to allow enhanced levels of light transmission by using a transparent substrate as a medium to propagate light and a reflective coating applied to the outer surface to focus light toward the distal treatment area. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the transparent polymer layer surrounding an optical fiber in Burwell and reflector on the outer surface into the reflector shell in Neuberger (where Neuberger’s reflector can be treated as a layer surrounding the internal optical fiber tube) .
Regarding Claim 2, the treatment apparatus according to Claim 1 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses wherein the irradiation shaft passes through the through hole ([0042-0043] – light is carried via the light guide through the hole). Neuberger does not explicitly disclose the irradiation shaft is axially movable in the through hole.
As stated in claim 1, the proposed combination with Lim yields an independently movable optical fiber and needle section ([0047]) relative to a flexible outer hose ([0055]). This would be implemented in Neuberger as a means to change the length of tubing containing the optical fiber relative to another encompassing element (i.e. the outer flexible hose is equivalent to the through hole in Neuberger as a location along the needle sheath).
Regarding Claim 3, the treatment apparatus according to Claim 1 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger discloses a cylindrical distal tube 107/207 for irradiating tissue (Figures 1-2, [0042-0043]). However, Neuberger does not disclose wherein a distal-most end of the distal shaft is closed so that a distal-most end of the irradiation lumen is closed.
Lim, in the same field of endeavor of placing photodynamic therapy in tissue using a light guide to destroy tumor tissue ([0001]), teaches a needle containing an optical fiber as a light guide where the needle is surrounded by a flexible hose ([0046]). The optical fiber is able to move with respect to the needle section ([0047]) and the needle is able to move with respect to the flexible outer hose ([0055]). The needle is depicted as either open at the distal end to allow the optical fiber to protrude (Figure 7 – [0057]) or closed at the distal end to contain the optical fiber and emit light through the extreme distal end (Figures 11-12).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device irradiating a photosensitizer in Neuberger with the use of an extreme distal tube with a closed end and which contains a light guide in Lim. The use of a closed distal end would be included in a finite number of configurations (closed or open) and obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the closed extreme distal tube in Lim.
Regarding Claim 4, the treatment apparatus according to Claim 1 is obvious over Neuberger in view of Lim and Burwell. Neuberger further discloses wherein the distal structure portion includes a connection portion that is connected to the main shaft (Figures 1-2, [0042-0043] - the tubing containing the light guide is connected to illumination head 101/201), a diameter expanded portion that extends radially outward from the connection portion (Figures 1-2, [0042-0043] – reflector 105/205 is in a cup shape that increases in diameter in the distal direction), and a wall portion that extends in a distal direction and axially overlaps an axially extending part of the distal shaft (Figures 1-2, [0042-0043] – reflector 105/205 surrounds at least some of the length of cylindrical tube 107/207).
Regarding Claim 5, the treatment apparatus according to Claim 1 is obvious over Neuberger in view of Lim and Burwell. Neuberger further discloses wherein the distal structure portion is cup-shaped so that a radially outwardly located part of the distal structure is located more distal of a radially inwardly located part of the distal structure portion (Figures 1-2, the reflector is in a cup shape, with an expanding radius the more distal the reflector, where the tube containing the light guide passes through the center of the surrounding reflector cup; [0042] – “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113”).
Regarding Claim 7, Neuberger discloses a treatment apparatus configured to irradiate a photosensitizer substance bound ([0037]) to a tumor cell with excitation light ([0003], [0006]), the treatment apparatus comprising:
• a main shaft having a central axis (Figure 2, [0043] – the device has radial symmetry and would have a central axis along the light pathway) and including a distal portion and a proximal portion (Figures 1-2, [0043] – a lumen containing the light guide through the handle and cylindrical tube, which would have more proximal and distal sections);
• a distal structure portion (Figure 2, reflector 105, 205) disposed at the distal portion of the main shaft and possessing a proximal end and a distal end (Figure 2, [0043] – the illumination head 201 containing 205 is positioned at the distal end of the tubing connection between the illumination head 201 and hand piece 211, where the illumination head is inserted into the cervical region; the components 201 and 205 have a proximal and distal end); the distal structure portion possessing an outer configuration that is larger in a radial direction of the main shaft than the main shaft in the radial direction of the main shaft (Figures 1-2, [0042] – the reflector is in a cup shape where the tube containing the light guide passes through the center of the surrounding reflector cup: “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113”);
• a distal shaft protruding in a distal direction from the distal structure portion so that a distal end of the distal shaft protrudes distally beyond the distal structure portion (Figures 1-2, [0043-0043] – tube 107, 207 extends distally beyond reflector 105, 205);
• at least one irradiation unit configured to emit ([0043] – a light guide can be used to carry irradiation from the LED arrays 209 in hand piece 211 to the illuminator head 201), from the distal shaft ([0042] – “A portion of the radiation from LED array 109 enters into tube 107 and is transmitted from the distal end of tube 107 by means of internal reflection sources, not shown. Further, there may be LEDs solely for the purpose of transmitting radiation through tube 107 either directly into tube 107 or by means of optical fibers attached thereto”; [0043] – “In this embodiment, the radiation from LED array 209 travels down guide 203 and enters into tube 207. In order for the radiation to leave tube 207, multiple scattering sources, for example, may be encased within tube”) and the distal structure portion ([0042] – light can be reflected from the reflector or emitted by LED arrays), the excitation light to irradiate the photosensitizer substance ([0043] – “The illuminator head 201 consists of a reflector 205 with a cylindrical tube 207 designed for insertion into the cervical region for uniform irradiation of precancerous and cancerous cells”).
• the irradiation unit including a light-emitting portion ([0042-0043]);
• the distal structure portion including a through hole that extends through the
distal structure portion from the proximal end of the distal structure portion to the distal end of the distal structure portion ([0042-0043] – light is carried via the light guide through the hole in the distal structure).
However, Neuberger does not disclose an (1) antibody-photosensitive substance, (2) the through hole being configured to movably accommodate the light-emitting portion of the irradiation unit, (3)
a length of the through hole, along the central axis of the main shaft, being equal to or greater than a length of the light-emitting portion.
While Neuberger does not disclose an antibody-photosensitive substance, the substance is not interpreted as a structural component of the “treatment apparatus configured to irradiate.” The irradiation apparatus works on the antibody-photosensitive substance, which is therefore interpreted as an intended use of the apparatus and not a structural limitation of the claim according to MPEP 2114 (II) and MPEP 2115 (II).
Lim, in the same field of endeavor of placing photodynamic therapy in tissue using a light guide to destroy tumor tissue ([0001]), teaches a needle containing an optical fiber as a light guide where the needle is surrounded by a flexible hose ([0046]). The optical fiber is able to move with respect to the needle section ([0047]) and the needle is able to move with respect to the flexible outer hose ([0055]). This would be implemented in Neuberger as a means to change the length of tubing containing the optical fiber relative to another encompassing element (i.e. outer flexible hose is equivalent to the through hole in Neuberger as a location along the needle sheath).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating a moveable optical fiber or needle in Lim. This would have been obvious because both Neuberger and Lim discuss placement of photodynamic therapy devices and Lim provides a solution/improvement to allow for independently adjustable placement of an optical fiber from which to irradiate relative to a surrounding container or a container/fiber combination relative to a surrounding tube. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the moveable optical fiber and needle in Lim.
Burwell, in the same field of endeavor of an internally applied phototherapy device ([0007]) teaches a transparent polymer 23 placed around internal optical fibers to allow light to be transmitted through the polymer for treatment ([0061-0063]). A reflective coating can be applied to the outer surface of the overall structure 4 to focus light toward the distal end of the device ([0063] – “Additionally, a reflective coating 43 (such as aluminum or another reflective material), is applied to the outer surface of body 4 adjacent to light source array 40. Any light from LEDs 40a directed to the sides (i.e., towards body 4) is redirected by reflective coating 43 towards distal end 6. Reflective disk 40b and reflective coating 43 thus cooperatively maximize the intensity of light delivered through distal end 6”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the transparent polymer layer in Burwell. This would have been obvious because both Neuberger and Burwell discuss the use of internal phototherapy devices and Burwell provides a solution/improvement to allow enhanced levels of light transmission by using a transparent substrate as a medium to propagate light rather and a reflective coating applied to the outer surface to focus light toward the distal treatment area. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the transparent polymer layer surrounding an optical fiber in Burwell and reflector on the outer surface into the reflector shell in Neuberger (where Neuberger’s reflector can be treated as a layer surrounding the internal optical fiber tube) .
Regarding Claim 8, the treatment apparatus according to Claim 7 is obvious over Neuberger in view of Lim and Burwell. Neuberger further discloses wherein the treatment apparatus includes an irradiation lumen communicating with the through hole and the inside of the distal shaft ([0042-0043] – light is carried via the light guide through the hole). Neuberger does not explicitly disclose the irradiation shaft configured to movably accommodate the irradiation unit.
As stated in claim 7, the proposed combination with Lim yields an independently movable optical fiber and needle section ([0047]) relative to a flexible outer hose ([0055]). This would be implemented in Neuberger as a means to change the length of tubing containing the optical fiber relative to another encompassing element (i.e. the outer flexible hose is equivalent to the through hole in Neuberger as a location along the needle sheath).
Regarding Claim 9, the treatment apparatus according to Claim 7 is obvious over Neuberger in view of Lim and Burwell. Neuberger further discloses wherein the distal structure portion is cup-shaped with a recessed portion formed on a distal side of the distal structure portion (Figures 1-2, [0042] – the reflector is in a cup shape with a recessed interior similar to a bowl: “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113”).
Regarding Claim 11, the treatment apparatus according to Claim 7 is obvious over Neuberger in view of Lim and Burwell. Neuberger further discloses wherein:
• the distal shaft is configured to emit the excitation light in a direction substantially perpendicular to central axis of the distal shaft (Figure 4, [0045] – the distal tube 407 emits light perpendicular to the axial direction of the distal tube 407), and
• the distal structure portion is configured to emit the excitation light in substantially the distal direction (Figure 4, [0045] – the reflector emits light in the distal axial direction).
Regarding Claim 21, the treatment apparatus according to Claim 1 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses wherein the distal structure portion is fixed to the main shaft so that the distal structure portion and the main shaft move together (Claim 10 – the tube is attached to the reflector: “a tube, said tube attached to said shaped reflector head and extending beyond said reflector head for a sufficient distance so as to be able to expose the cervix channel to radiation from said tube”).
Regarding Claims 22 and 25, the treatment apparatus according to Claims 1 and 7 are obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses the distal structure portion comprises structure configured to scatter the excitation light emitted by the light-emitting portion such that the distal structure portion itself emits the excitation light ([0042] – the reflector 105 has a scattering surface: “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113; onto which an LED array 109 is incorporated”; Figure 4, [0045] – reflector 405 emits light).
Regarding Claims 23 and 26, the treatment apparatus according to Claim 22 and 25 are obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses wherein the structure configured to scatter the light emitted by the light-emitting portion comprises a scatterer within the material forming the distal structure portion ([0042] – the reflector 105 has a scattering surface: “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113; onto which an LED array 109 is incorporated”; Figure 4, [0045] – reflector 405 emits light).
Claim 10 is rejected under U.S.C 103 as being unpatentable over Neuberger (US 2008/0065003 A1) in view of Lim (WO 2018/093097 A2), Burwell (US 2008/0033519 A1), and Shihata (US 4,858,624). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim (WO 2018/093097 A2) - see attached for copy of the disclosure’s translation.
Regarding Claim 10, the treatment apparatus according to Claim 9 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses wherein:
• the distal structure portion includes a wall portion surrounding the recessed portion and protruding in the distal direction (Figures 1-2, [0042] – the reflector is in a cup shape with a recessed interior similar to a bowl).
However, Neuberger does not disclose the wall portion includes, at a part in a peripheral direction surrounding the recessed portion, a protruding portion that protrudes further in the distal direction than all other parts of the distal structure portion.
Shihata, in the same field of endeavor of placing a device in contact with the cervix (Col 2, Lines 5-13), teaches a contraceptive dome modified to fit the dimensions of the female reproductive track (Col 2, Lines 14-35). The posterior portion of the dome’s brim extends further than the anterior portion of the dome’s brim to better fit the dimensions of the reproductive track (Col 3, Lines 66-68 and Col 4, Lines 1-11).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the non-circular rim dimensions in the contraceptive device in Shihata. This would have been obvious because both Neuberger and Shihata discuss placement of devices to be in contact with the cervix and Shihata provides a solution/improvement with dimensions for a better fit within the reproductive tract to maintain secure and properly positioned irradiation from the emitters in Neuberger. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the non-circular rim dimensions in the contraceptive device in Shihata.
Claims 6 and 12 are rejected under U.S.C 103 as being unpatentable over Neuberger (US 2008/0065003 A1) in view of Lim (WO 2018/093097 A2), Burwell (US 2008/0033519 A1), and Kang (US 2010/0145416 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim (WO 2018/093097 A2) - see attached for copy of the disclosure’s translation.
Regarding Claims 6 and 12, the treatment apparatus according to Claims 1 and 7 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger discloses a photodynamic therapy system for treating cancer with an excitation light ([0003]). Neuberger does not disclose a detection unit configured to detect fluorescence emitted by the antibody-photosensitive substance when the antibody-photosensitive substance is irradiated by the excitation light.
While Neuberger does not disclose an antibody-photosensitive substance, the substance is not interpreted as a structural component of the “treatment apparatus configured to irradiate.” The irradiation apparatus works on the antibody-photosensitive substance, which is therefore interpreted as an intended use of the apparatus and not a structural limitation of the claim according to MPEP 2114 (II) and MPEP 2115 (II).
Kang, in the same field of endeavor of providing photodynamic therapy to an interior portion of the body ([0003]), teaches a detector using an optical imaging system 20 connected to a multispectral imaging system 40 ([0069]) where the multispectral imaging system can used in an endoscope design ([0070]). This detector is used during photodynamic therapy to measure fluorescence and reflected light to produce an image ([0073]) as a feedback mechanism for photodynamic therapy ([0160]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the fluorescence photodetector in Kang. This would have been obvious because both Neuberger and Kang discuss photodynamic therapy of internal tissue and Kang provides a solution/improvement by including a photodetector to monitor feedback during the photodynamic therapy treatment where the photodetector can be positioned as a tube placed into the body (endoscope). Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the fluorescence photodetector in Kang.
Claim 13 is rejected under U.S.C 103 as being unpatentable over Neuberger (US 2008/0065003 A1) in view of in view of Lim (WO 2018/093097 A2), Burwell (US 2008/0033519 A1), and Kim (KR 20120016750 A1”). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim (WO 2018/093097 A2) - see attached for copy of the disclosure’s translation. Note an English translation of Kim was accessed via the EPO global dossier (see attached).
Regarding Claim 13, the treatment apparatus according to Claim 7 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger discloses reflector 105/205 has a proximal tube containing the optical fiber which passes through the reflector’s center and emerges in the distal direction as tube 107/207 (Figures 1-2, [0042-0043]). However, Neuberger does not explicitly disclose wherein the distal structure portion is configured to move relative to the main shaft in an axial direction of the main shaft.
Kim, in the same field of endeavor of photodynamic therapy applied to cervical cancer ([0002-0003], [0007]), teaches a light diffuser for photodynamic therapy which is able to be moved relative to a expander placed near the cervix ([0015] – “And a holder having an insertion part protruding from an outer surface of the body to be inserted into an end part of the vaginal expander to be fixed by a fastening bolt, and having a diffuser for irradiating light for photodynamic treatment inserted and mounted inside the body to be spaced apart from the surface of the affected area at a predetermined interval, wherein the diffuser is fixed to the vaginal expander by using the holder so that the light irradiated through the diffuser can be accurately, stably, and continuously irradiated to the surface of the affected area”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the movability between a structure placed near the cervix and a light diffuser in Kim. This would have been obvious because both Neuberger and Kim discuss placement of devices to be in contact with the cervix and Kim provides a solution/improvement with adaptably changing the emitter position relative to an expanded structure placed near the cervix. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the movability between a structure placed near the cervix and a light diffuser in Kim.
Claims 24 and 27 are rejected under U.S.C 103 as being unpatentable over Neuberger (US 2008/0065003 A1) in view of Lim (WO 2018/093097 A2), Burwell (US 2008/0033519 A1), and Prozee (EP 0358273 A1). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim (WO 2018/093097 A2) - see attached for copy of the disclosure’s translation.
Regarding Claims 24 and 27, the treatment apparatus according to Claims 1 and 7 is obvious over Neuberger in view of Lim and Burwell, as indicated hereinabove. Neuberger further discloses wherein the distal structure portion includes:
• a first surface facing the proximal end of the distal structure portion (Fig. 4, reflector 105 has an inner surface at the proximal end which faces the opposing wall in the neck of the reflector 105),
• a second surface facing radially outward (see 112(b) rejection - Fig. 4, reflector 105 has an outer curved surface which faces radially outward from the wall), and
• a third surface facing the distal end of the distal structure portion (Fig. 4, reflector 105 has an inner surface at the distal end which faces the opposing wall),
• the first surface and the second surface being covered with a reflective coating that reflects the excitation light emitted by the light emitting portion (Fig. 1, [0042] – “An illumination head 101 has a semi spherical reflector 105 that can be flexible or rigid with a reflective/scattering surface 113; onto which an LED array 109 is incorporated”), and
Note the Examiner has not found a special definition of the term end when delineating what constitutes the boundaries at the end of the distal structure portion. In the above rejection, the plain meaning of end is being interpreted as pertaining to walls near the proximal and distal extremes. However, Neuberger does not disclose the third surface not being covered with the reflective coating.
If “a second surface facing radially outward” is meant to be interpreted as the outside surface of the reflector, the proposed combination in claims 1 and 7 with Burwell teaches a reflective coating can be applied to the outer surface of structure 4 to focus light toward the distal end of the device ([0063]).
The reflector lamp in Prozee would be considered “reasonably pertinent” (see MPEP
2141.01(a)1) to the claimed invention because Prozee teaches the use of reflective coatings to direct and condition light emitted from the lamp. The need to direct light from a particular surface would be a consideration in the both the instant application and Prozee. Prozee teaches a first surface near the neck of the lamp does not have a reflective coating, a second surface in an intermediate section does have a reflective coating, and a third surface has a scattering surface at the distal end of the lamp (Fig 1, Col 1, Lines 1-33).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Neuberger’s cervical photodynamic therapy device by incorporating the selective use of reflective coatings on surfaces in Prozee. This would have been obvious because both Neuberger and Prozee discuss light emitting devices using reflective coatings and Prozee provides a solution/improvement to allow selective placement of reflective coatings to better direct and enhance the properties of light emitted from the device. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Neuberger by incorporating the selective use of reflective coatings on surfaces in Prozee.
Discussion of Prior Art Cited but Not Applied
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Klem (US 2017/0072217), relevant to claim 10, teaches a photodynamic device to irradiate the cervix, where Klem teaches the dimensions of a housing are optimally based on the fit able to be achieved in contraceptive devices ([0026] – “The shape of the housing can vary, but is generally designed so that it comfortably fits within the orifice and remains in place independent of the patient's physical activity. Where the orifice of interest is the female reproductive tract, suitable shapes for the outer portion of the housing can for example be similar to the shapes of some contraceptive devices used to prevent pregnancy, such as FemCap® and other similar devices intended for blocking sperm from entering the uterus”).
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights