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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
-[0041] references element 117 of Fig. 1
-[0044-0045] references elements 150-151, 153A/B, 155, 157 of Fig. 3
-[0049] references elements 158, 162, 164, 165, 166 of Fig. 5A
-[0050] references element 171 of Fig. 5B
-[0051] references elements 161, 170, 172 of Fig. 6
-[0052] references elements 180, 182, 184 of Fig. 8
-[0054-0055] references elements 187-188 of Fig. 9B/C
-[0070] references elements 200, 1802, 56A/B, 1806A/B, 1808A/B of Fig. 18A
-[0072] references elements 1822 and 156C of Fig. 18B
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
-Fig. 2 contains blurry text labels
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term MATLAB, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 1 recites “stabilizing subsystem” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to stabilize the housing along the cavity. According to the specification the stabilizing subsystem includes balloon catheters [0048] and equivalents thereof.
-Claim 5 recites “fluoroscopy subsystem” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to verify a predetermined position of one or more radiation elements. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 6 recites “applicator subsystem” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to apply first and second portions of the radiation treatment. According to the specification the applicator subsystem includes housing, plurality of channels and a guidewire [0041] and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “a predetermined different position” in line 9. It is unclear what different position this limitation is referring to. Further clarification should be provided to identify whether this is referring to positioning of different radiation elements, different positioning of channels, different positions of the bodies in relation to the cavity or a separate embodiment.
-Claim 3 recites “different from general concentric shapes” in lines 2-3. It is unclear what shapes are included under the characterization of general concentric shapes. Further clarification should be provided.
-Claim 5 recites “one or more radiation elements” in line 2. It is unclear whether this is the same or different from the one or more radiation elements originally introduced in claim 1, line 10. Further clarification should be provided.
-Claim 10 recites “one or more radiation elements” in line 4. It is unclear whether this is the same or different from the one or more radiation elements originally introduced in claim 1, line 10. Further clarification should be provided.
-Claim 12 recites “a balloon” in line 3. It is unclear whether this is the same or different from a respective balloon originally referenced in claim 11, lines 5-6. Further clarification should be provided.
Claim limitation “Fluoroscopy subsystem” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While fluoroscopy subsystem is mentioned in the disclosure, no particular aspect related to a specific fluoroscopy system or subsystem is described. While CT and X-Ray are mentioned in [0043] these do not appear to be the referenced fluoroscopy subsystem as claimed but rather mentioned as traditional imaging techniques. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 2, 4, 8, 9, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herskovic (U.S. 20150190654).
Regarding Claim 1, Herskovic teaches a system for precision radiation treatment, comprising: a device associated with an endoscopy guided procedure [0070, “An endoscope 26 can be used to load or replace the radioactive particles in situ by delivering the radioactive particles through a delivery catheter or loading tool 28.”] comprising: a housing defining a housing channel extending along a longitudinal axis of the housing [Fig. 1, element 10 (stent)] and [0062; “longitudinal axis a of the stent”], at least a portion of the housing configured for deployment within a cavity [0096; “The stent is then filled with bone cement or other material, permanently affixing the stent and radioactive sources within the cavity.”]; a plurality of bodies defining a plurality of channels extending through the housing and defined around the longitudinal axis [Fig. 1, element 12 (tubular members)] and [0062; “The tubular members are arranged parallel to each other and also parallel with a longitudinal axis a of the stent 10.”], wherein each of the plurality of channels accommodates selective activation of radiation emittance from a predetermined different position along the housing via one or more radiation elements [0022], [0062], and [0046]—describing the radioactive brachytherapy particles, such that the plurality of channels collectively provides a predetermined spatial distribution of a radiation treatment to a target area along the cavity [0022; “tubular members which receive the medicament wherein the medicament comprises discrete entities and each of said entities are removably positioned at predetermined regions within the members.”] and [0017; “provide a device to enable focalized delivery of radiation in patients.”]; and a stabilizing subsystem that stabilizes the housing along the cavity [0045; “A method of stent insertion is to wrap the stent around a deflated balloon and then inflate the balloon within the target lumen, thereby expanding the stent in situ.”]
Regarding Claim 2, Herskovic teaches further comprising an endoscope [Fig. 2, element 26 (endoscope)] and [0070], wherein the endoscope assists with endoscopy-guided placement of the device along a gastrointestinal tract [0003], [0017-0018] and [0070].
Regarding Claim 4, Herskovic teaches wherein the plurality of channels comprises a first channel configured to receive a first radiation element and emit radiation along a first position relative to the longitudinal axis of the housing [Fig. 1, element 12]—tubular member shown at the top portion of the stent, [0066]—tubular members may receive radioactive particles, and [0071]—describing position adjustment and [0022]—describing positioning at predetermined regions within members, and a second channel of the plurality of channels configured to receive a second radiation element and emit radiation along a second position relative to the longitudinal axis [Fig. 1, element 12]—tubular member shown at the bottom portion of the stent, [0066], [0071] and [0022].
Regarding Claim 8, Herskovic teaches wherein the housing is configured to receive at least one radiation seed [0066] at a variable position along a predetermined channel of the plurality of channels [0022; “the vehicle comprised of tubular members which receive the medicament wherein the medicament comprises discrete entities and each of said entities are removably positioned at predetermined regions within the members.”]
Regarding Claim 9, Herskovic teaches wherein the housing comprises a flexible material [0045; “comprises flexible or stretchable tubular members of suitable diameter (for example, surgical tubing) attached to…expanded within the lumen by a surgical or other technique.”] such that the housing accommodates a predetermined amount of deflection between a proximal portion of the housing and a distal portion of the housing [Fig. 5] and [0085; “containing radioactive material follow the curvature of the esophageal wall 54. As a result, the distribution of radiation dosage at 100 percent 55 and at 200 percent 56 follows the curvature of the esophageal wall as well.”]
Regarding Claim 13, Herskovic teaches further comprising a metal coating applied along outer surfaces of the plurality of channels of the housing that attenuates radiation and protects healthy tissue proximate to the target area [Fig. 2, element 23 (shielding material)] and [0072; “Shielding material 23 (such as tungsten) may be included as part of the tubular member 12 to prevent radiation exposure of undesired tissue.” And “This shielding material may be used to prevent exposure of healthy or other tissue in which it is not desirable to expose the tissue to radiation.”]
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 3, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herskovic (U.S. 20150190654) in view of Song (WO 2015023307).
Regarding Claim 3, Herskovic is silent on wherein the predetermined spatial distribution of the radiation treatment defines a plurality of shape configurations different from general concentric shapes for customizable dose delivery. Song teaches wherein the predetermined spatial distribution of the radiation treatment defines a plurality of shape configurations different from general concentric shapes for customizable dose delivery [0024; “The shielding element 310 and the radioactive element 312 may be configured to be selectively positioned within the elongated intracavitary applicator 304 30 (e.g., about the distal end 308) in a desired pattern for the particular patient and condition to generate an anisotropic directional radiation profile for the treatment of cancer or other disease.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention include various shape configurations as taught by Song to deliver radiation treatment to different regions as suggested by Herskovic as Herskovic discusses delivery of radiation to different patient regions of different size [0045] with Song because Song teaches the specific arrangement depending on the particular patient and/or disease being treated [0026].
Regarding Claim 6, Herskovic is silent on wherein the housing and the plurality of channels collectively define an applicator subsystem, the applicator subsystem configured to: apply a first portion of the radiation treatment according to a first spatial distribution configuration along the target area during a first time period, and apply a second portion of the radiation treatment according to a second spatial distribution configuration along the target area during a second time period. Song teaches wherein the housing and the plurality of channels collectively define an applicator subsystem [0023; “the brachytherapy applicator 300 may include a plurality of channels 302 disposed within the elongated intracavitary applicator 304.”], the applicator subsystem configured to: apply a first portion of the radiation treatment according to a first spatial distribution configuration along the target area during a first time period [0024; “The shielding element 310 and the radioactive element 312 may be configured to be selectively positioned within the elongated intracavitary applicator 304 (e.g., about the distal end 308) in a desired pattern for the particular patient and condition to generate an anisotropic directional radiation profile for the treatment of cancer or other disease.”], and apply a second portion of the radiation treatment according to a second spatial distribution configuration along the target area during a second time period [0026; “Similarly, the radioactive elements 312 and/or the shielding elements 310 may be repositioned within the channels 302 during treatment or additional radioactive elements 312 and/or shielding elements 310 may be positioned in the channels 302 during or after treatment.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for repositioning of the applicator subsystem and radioactive elements as taught by Song to allow for removal, replacement and accessibility as suggested by Herskovic as Herskovic discusses placement of the medicament in the tubular members which can be removed and replaced according to clinical need [0090] with Song because Song teaches real-time flexibility of dosage during treatments and for additional treatments [0026].
Claim(s) 5, 7, 10, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herskovic (U.S. 20150190654) in view of Sutton (U.S. 20110257459).
Regarding Claim 5, Herskovic is silent on further comprising a fluoroscopy subsystem that verifies a predetermined position of one or more radiation elements along one or more of the plurality of channels. Sutton teaches further comprising a fluoroscopy subsystem that verifies a predetermined position of one or more radiation elements along one or more of the plurality of channels [0018]—describing radiopaque elements being visible by an imaging device and [0096]—describing imaging of the cavity by CT, MRI, X-Ray to allow for precision.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement imaging and fluoroscopy techniques as taught by Sutton to calculate and plan positioning of radioactive particles as suggested by Herskovic as Herskovic discusses using imaging for precise positioning to allow for customized delivery of radiation [0099] with Sutton because Sutton teaches automation of three-dimensional dose planning using imaging to improve dosing accuracy and safety [0096].
Regarding Claim 7, Herskovic is silent on wherein the housing is configured to receive a radiation element and urge the radiation element through a selected channel of the plurality of channels. Sutton teaches wherein the housing is configured to receive a radiation element and urge the radiation element through a selected channel of the plurality of channels [0100; “or by a machine (automatic remote afterloading) after the brachytherapy applicators are positioned. In other variations, hot loading may be employed. With hot loading, the brachytherapy applicator contains the radiation sources at the time of placement into the subject in need of radiation therapy. The radiation therapy that is subsequently delivered by the radiation sources may provide radiation therapy in a pre-determined dose cloud shape, as previously stated.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver the radioactive element through the channels as taught by Sutton to allow for customized delivery of radiation as suggested by Herskovic as Herskovic discusses determining position of the particles against the cavity through use of imaging techniques [0099] with Sutton because Sutton teaches the requirements of confirming applicator position, dose planning and source loading [0022].
Regarding Claim 10, Herskovic is silent on further comprising an applicator cap that engages to a proximal portion of the housing, the applicator cap including a plurality of applicator channels configured for alignment with the plurality of channels of the housing to feed one or more radiation elements through the plurality of applicator channels to the plurality of channels for the radiation treatment. Sutton teaches further comprising an applicator cap that engages to a proximal portion of the housing [Fig. 2A, element 208 (hub), 202 (first stacking component)] and [0058], the applicator cap including a plurality of applicator channels [0057; “source catheter (210) and include a central lumen (212), as shown in FIG. 2A. The hub (208) may comprise one or more openings for the insertion of the central lumen (212) and/or the source catheter (210).”] configured for alignment with the plurality of channels of the housing to feed one or more radiation elements through the plurality of applicator channels to the plurality of channels for the radiation treatment [0058; “The array of openings may define the configuration of the source lumens within the brachytherapy…may be advanced from the hub (208), through each of the stacking components, into the tip.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include opening and alignment configurations of the plurality of channels and openings as taught by Sutton to allow for sealing of these openings as suggested by Herskovic as Herskovic discusses the use of a permanent or removable cap to seal the tubes at the distal end [0062] with Sutton because Sutton teaches the use of openings and sealing caps the maintain position of discrete units upon placement within the body or to seal against fluid leaks [0018].
Regarding Claim 14, Herskovic is silent on further comprising a plurality of radiopaque markers defined along the housing that guide a physician to position the housing under a CT scan. Sutton teaches further comprising a plurality of radiopaque markers defined along the housing that guide a physician to position the housing under a CT scan [0018]—describes radiopaque markers used for positioning that are visible by CT and [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include radiopaque markings as taught by Sutton to aid in positioning of radiation delivery with imaging technologies as suggested by Herskovic as Herskovic discusses the tubular members comprising radiopaque substrates that allow for diagnostic imaging [0081] with Sutton because Sutton teaches the use of the radiopaque materials to allow for slight attenuation of the radiation source [0039].
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herskovic (U.S. 20150190654) in view of D’Andrea (U.S. 20150375010).
Regarding Claim 11, Herskovic is silent on wherein the stabilizing subsystem includes: one or more balloon catheters formed within the housing along the longitudinal axis and one or more balloons positioned along the housing, each balloon catheter of the one or more balloon catheters being configured for fluid flow communication with a respective balloon, the one or more balloons being positioned exterior to a distal portion of the housing to stabilize the housing along the cavity. D’Andrea teaches wherein the stabilizing subsystem includes: one or more balloon catheters formed within the housing along the longitudinal axis [Fig. 10A, element 710 (catheter)] and [0102], and one or more balloons positioned along the housing [Fig. 10A, element 740 (therapeutic balloon)] and [0103], each balloon catheter of the one or more balloon catheters being configured for fluid flow communication with a respective balloon [Fig. 10A, element 760 (passageway)], the one or more balloons being positioned exterior to a distal portion of the housing to stabilize the housing along the cavity [0102; “the therapeutic balloon 740 is sized, shaped and positioned for treatment of the subglottic region 88 or esophagus 93…the therapeutic balloon 740 often will adequately anchor the device.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include balloons and balloon catheter technologies as taught by D’Andrea to engage with and create a cavity within the body as suggested by Herskovic as Herskovic discusses inflation of the balloon to create the cavity and allow for natural anatomical positioning [0094-0095] with D’Andrea because D’Andrea teaches the use of balloons to allow for uniform treatment dosage for the treatment regimen [0102].
Regarding Claim 12, Herskovic is silent on wherein each balloon catheter of the one or more balloon catheters includes a respective valve for intake and expulsion of air from a balloon. D’Andrea teaches wherein each balloon catheter of the one or more balloon catheters includes a respective valve for intake and expulsion of air from a balloon [0060]—describes the passageways including one- or two-way valves and [0061]—further describes the use of gas and air to inflate the balloons.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a valve or inlet type structure for fluid and/or air as taught by D’Andrea to provide a means for inflating and deflating the balloon as suggested by Herskovic as Herskovic discusses inflation of the balloon to create the cavity and allow for natural anatomical positioning [0094-0095] with D’Andrea because D’Andrea teaches the use of balloons to allow for uniform treatment dosage for the treatment regimen [0102].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herskovic (U.S. 20150190654) in view of White (U.S. 20150306421).
Regarding Claim 15, Herskovic is silent on further comprising a guidewire extending along the longitudinal axis of the housing that provides assistance with guiding the housing to a predetermined position relative to the cavity. White teaches further comprising a guidewire extending along the longitudinal axis of the housing that provides assistance with guiding the housing to a predetermined position relative to the cavity [Fig. 2, element 18 (distal portion)], [0057], and [0017; “To improve the uniformity of the radiation dose, the device may employ a secondary radiation source in the form of a guide wire inserted into the central lumen of the balloon catheter.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a guidewire as taught by White to provide a means for positioning the device as suggested by Herskovic as Herskovic discusses the use of a guide sleeve or trocar [0096] with White because White teaches deployment of a secondary radiation source via the guidewire to improve radiation dose uniformity [0017].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Liu (U.S. 20100030127)-includes a duct stent that releases radiation particles according to cancer distributions
-Allan (WO 2008077073)—references a brachytherapy device used to form an asymmetric radiation dosing profile
-Lamoureux (U.S. 11446515)—discloses a treatment device with a balloon that is used to deliver radiation to adjacent tissue
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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