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 .
Response to Arguments
Regarding the 112(f) claim interpretation, applicant has provided no arguments or amendments that would change the examiner’s position, therefore the “diverting feature” continues to be interpreted under 112f.
Regarding the claim objections, applicant’s amendments have overcome this objection and it is hereby withdrawn.
Regarding the 102 rejection to Hastings, applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner has found a new prior art reference to teach the amended limitations; see new 103 below.
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: diverting feature in claims 1-19.
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.
For clarity, it is emphasized that an inflation media is not positively recited/required by the current claims language. Instead, the claims require an inflation lumen that is configured to permit an inflation media to fill the inflation chamber of the balloon. Therefore claims 2, 3, 15 and 16 that require the diverting features to be configured to form a plasma in the inflation media is a purely functional limitation/effect that is not required to be taught by the prior art. MPEP 2114 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “diverting features comprise a dome-shaped surface extending past an outer surface of the elongate shaft” of claims 8 and 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended limitations “diverting features comprise a dome-shaped surface extending past an outer surface of the elongate shaft” are not supported by applicant’s specification. While the specification and drawings, e.g. 802, 804 and 806 of Fig. 8, disclose dome-shaped diverting features, it is clear that these diverting features do not extend PAST an outer surface of the elongate shaft, as they are concave domes within the shaft. It seems that applicant has mixed features from mutually exclusive embodiments/features, as the claimed dome-shaped surface that extends past an outer surface of the elongate shaft is disclosed in reference to the protection structure, not the diverting features as claimed. Therefore, applicant has possession of a dome-shaped protection structure extending past an outer surface of the elongate shaft NOT a diverting feature, as claimed.
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 8 and 19 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.
Due to the conflict between the specification and the claims, as discussed above in relation to the 112a written description rejection, these claims are indefinite; see MPEP 2173.03. For examination purposes, the examiner is interpreting the dome-shaped diverting features to be concave, i.e. within the elongate shaft, as shown in Fig. 8.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
HASTINGS REJECTION
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0257641 to Hastings in view of US 2017/0265942 to Grace, as evidenced by US 5,432,876 to Appeldorn.
[Claim 1] Hastings discloses a balloon catheter system (Figs. 6, 8 and 17), comprising:
an elongate shaft (catheter 51 and/or shaft 67; Figs. 6 and 8) having a proximal end region, a distal end region, a wall and an inflation lumen extending from the proximal end region to the distal end region (inlet and outlet manifolds 61 and 63; Fig. 8; Pars 0113 and “One approach to keeping the phototherapy unit 50 at a constant distance from the wall of the renal artery is to incorporate the into a balloon which can be expanded until it fills the arterial lumen, embodiments of which are discussed below with reference to FIGS. 8, 13, and 14” Par 0106);
an expandable balloon (stabilizing arrangement 55 or balloon; Figs. 6 and 8) coupled to the distal end region of the elongate shaft, the balloon having an inflation chamber in fluid communication with the inflation lumen of the elongate shaft, and wherein the inflation lumen is configured to permit an inflation media to fill the inflation chamber of the balloon (at least Pars 0106 and 0113, as discussed above. See also Pars 0117-118); and
a light guide (92, Fig. 17 and/or coupling 56, Fig. 6; Pars 0094, 0139 and 0162) extending within the wall of the elongate shaft (tip assembly 95) and including a first light diverting feature and a second light diverting feature (notches 82, only one of which is shown in Fig. 17; Pars 0162-163 “The remaining light continues to propagate within the optical fiber 92, where it may impinge upon successive notches 82 (not shown), and at each notch, a further proportion of the light is diverted out through wall 92a”), wherein each of the first and second light diverting features are configured to divert light away from a longitudinal axis of the light guide (see the path of light 83; Fig. 17);
wherein a portion of the first light diverting feature is longitudinally aligned with at least a portion of the second light diverting feature (Based on this explicit teaching “The remaining light continues to propagate within the optical fiber 92, where it may impinge upon successive notches 82 (not shown), and at each notch, a further proportion of the light is diverted out through wall 92a” referring to Fig. 17 and the successive notches, which are not shown, the examiner contends that necessarily/inherently the successive notches are longitudinally aligned. This is further supported by Figs. 18 which shows a different, i.e. mutually exclusive, embodiment where the notches are not longitudinally aligned).
Furthermore, Hastings teaches “in order to maintain a substantially uniform output light intensity along the notched region of the optical fiber 92, the spacing between successive notches 82 is decreased in the direction of intended light travel. Although the light emitted from each successive notch 82 decreases as a result of the leakage of light from preceding notches, this is compensated by increasing the notch density in the direction of light travel. Alternatively, the angle of inclination of the notch surface(s) may be changed or the cross-sectional area of each surface of successive notches 82 may be increased in the direction of intended light travel, so as to compensate for the aforesaid light loss. Additional details of a notched optical fiber 92 that can be adapted for use in a tip assembly 95 of the present invention are disclosed in U.S. Pat. No. 5,432,876, which is incorporated herein by reference” (Par 0167). As explicitly shown in Figs. 6-7 of US 5,432,876 of Appeldorn, the successive notches are longitudinally aligned. Since this configuration is incorporated by reference into Hastings, such a configuration is explicitly taught by Hastings.
Hastings fails to explicitly teach the wall having an inner surface defining a lumen and an outer surface with the light guide extending within the wall between the inner surface and the outer surface of the wall. However, in the same field of endeavor, Grace teaches such a configuration; see Figs. 1-4. Specifically, any of the emitters (120 or 140, Figs. 1-2; 310, 320 or 330, Figs. 3; 400, Fig. 4) are interpreted as a wall having an inner surface defining a lumen and an outer surface with a light guide (dashed circles 115 or 135, Figs. 1; although not labelled with an element number the light guides are clearly shown in Fig. 3C as dashed circles located between the inner and outer surfaces of the wall) extending within the wall between the inner surface and outer surface of the wall (at least Pars 0273-278 and 0304-308). Therefore, it would have been obvious to modify the configuration of the wall and light guides taught by Hastings such that the walls have an inner surface that defines a lumen and an outer surface and the light guides are positioned within the wall between the inner and outer surface, as taught by Grace, as a known configuration for light guides and shaft walls in similar laser balloon catheters, i.e. combining prior art elements according to known methods to yield predictable results.
[Claims 2-3] The examiner contends that Hastings discloses all of the necessary structural elements and configurations to achieve the claimed function/effect. Specifically, after being redirected/reflected by the diverting feature (82), the light travels through the balloon fluid, as best seen in Figs. 6 and 8. The reaction the light has with the balloon fluid (as it passes through this balloon fluid) is dependent on many factors, e.g. the wavelength, pulse duration, fluence, specific type of fluid, etc. Therefore, the examiner contends that depending on the light parameters (which are unclaimed) and the inflation media (also unclaimed), the device of Hastings is inherently capable of providing this function/effect; MPEP 2114.
The examiner contends that Hastings discloses all of the necessary structural elements and configurations to be capable of performing the claimed function/effect, but if applicant disagrees, then such a configuration is obvious. Hastings, specifically the embodiment shown in Fig. 17, is discussed above, but this embodiment fails to explicitly teach/show wherein the first light diverting feature, the second light diverting feature, or both the first and the second light diverting features are configured to divert light to form a plasma in the inflation media and wherein the formation of the plasma forms a bubble configured to impart a pressure wave on a treatment site adjacent to the balloon. However, in a different embodiment (Figs. 32 and 33), Hastings discloses directing the light into a balloon fluid to cause plasma/shockwave formation within the balloon fluid (Pars 0211-213). Furthermore, Hastings discloses “the fluid vessel 64 defines a channel that is fluidly coupled to a circulating coolant path via a lumen arrangement provided within a shaft 67 of the balloon 64” (Par 0211). Therefore, the fluid that inflates the balloon is the same fluid that fills the fluid vessel (261) where the plasma is created, therefore Hastings teaches an embodiment that is capable of performing the claimed function. It’s not clear from the disclosure of Hastings if the multiple diverting features (notches 82; Fig. 17) are encompassed in the embodiment where the plasma is generated within the balloon (Figs. 32-33). However, the examiner contends that it would be obvious to combine these two embodiments, i.e. multiple diverting features on a light guide (Fig. 17) and focusing light within a balloon fluid, as this is combining prior art elements according to known methods to yield predictable results.
[Claims 4-7 and 13-14] Hastings discloses “Alternatively, the angle of inclination of the notch surface(s) may be changed or the cross-sectional area of each surface of successive notches 82 may be increased in the direction of intended light travel, so as to compensate for the aforesaid light loss” (Par 0167); See also Fig. 7 of Appeldorn which explicitly shows 4 longitudinally-aligned diverting features that get progressively larger/bigger as their position/location along the fiber gets more distal.
[Claim 8] Figs. 3b and 3c of Appeldorn show dome-shaped diverting features (6). Since the entirety of the Appeldorn reference is incorporated into the Hastings reference, this feature is anticipated by Hastings.
If applicant disagrees with the incorporation of the entirety of the Appeldorn reference, then Hastings is technically silent to a dome-shaped diverting feature. However, it would have been obvious to one of ordinary skill in the art to change the shape of the diverting features in order to achieve the desired light path and/or beam shape, as is known in the art. Furthermore, applicant has no criticality or unexpected result for the specific shape. In fact, applicant’s specification states “In various examples, the light windows, diverting features, or both can be dome-shaped, square, triangular, circular, rectangular, and the like”. Therefore, it has been held that changes in shapes are obvious; MPEP 2144.04.
[Claims 9-11] It’s clear from Hastings that the light exits the fiber at surface 92a (“Each notch 82 extends through the fiber cladding into the core material and defines a first surface 82a, inclined at an angle (e.g., 45.degree.) to a plane normal to the longitudinal axis of the optical fiber 92, which acts as a reflection mirror such that a portion of the light propagated through the optical fiber 92 and impinging upon the surface 82a is reflected through the opposing wall 92a of the optical fiber 92” Par 0162). Therefore, this surface (92a) is a light window. It stands to reason that when successive diverting features (notches 82) are present; see Fig. 7 of Appeldorn, then inherently/implicitly multiple light windows are present and associated with a specific diverting feature. These windows are directly associated with the diverting features, so they would inherently be longitudinally spaced, in the same manner as the diverting features and would also inherently be proportionally sized to match the size of the diverting feature. Furthermore, the multiple diverting features (Figs. 6a-7 of Appeldorn) define multiple windows that are spaced apart from each other by non-light emitting portions of the light guide, i.e. the portion of the light guide located between the notches/windows does not emit light.
It’s not explicitly clear from Hastings or Appeldorn, if the light window is a single/large window or separate windows that allow light to escape/exit out of the fiber. In the case that it’s not inherently separate windows, such a modification would be obvious as a separation of parts; MPEP 2144.04. Since the windows are designed to allow light from the diverting features to escape the optical fiber, then it would be obvious to space and size these windows to match the diverting features, as a matter of routine engineering/design choices.
[Claim 12] Hastings discloses an embodiment (Fig. 17) with longitudinally aligned diverting features and a separate embodiment (Figs. 18) with circumferentially offset diverting features, but the references seemingly fails to teach a single embodiment with both. Throughout Pars 0162-169, Hastings discloses changing the properties of diverting features, including the location, size, shape, etc. to produce the desired beam shape and direction. Therefore, the combination of both longitudinally aligned and circumferentially offset diverting features is obvious, based on the teachings of Hastings, as this is combining prior art elements according to known methods to yield predictable results.
[Claim 15] Hastings discloses a balloon catheter system, comprising:
an elongate shaft (catheter 51 and/or shaft 67; Figs. 6 and 8) having a proximal end region coupled to a light source (external source 54b; Fig. 4), a distal end region coupled to an expandable balloon (stabilizing arrangement 55 or balloon; Figs. 6 and 8), and an inflation lumen (inlet and outlet manifolds 61 and 63; Fig. 8; Pars 0113 and “One approach to keeping the phototherapy unit 50 at a constant distance from the wall of the renal artery is to incorporate the into a balloon which can be expanded until it fills the arterial lumen, embodiments of which are discussed below with reference to FIGS. 8, 13, and 14” Par 0106) extending from the proximal end region to the distal end region, wherein the expandable balloon includes an inflation chamber in fluid communication with the inflation lumen of the elongate shaft, and wherein the inflation lumen is configured to permit a balloon inflation media to fill the inflation chamber of the balloon (at least Pars 0106 and 0113, as discussed above. See also Pars 0117-118);
a first light guide (one of light guides 92; shown in Figs. 21A-C) extending within a wall of the elongate shaft and including a first light diverting feature (82, Figs.17-18) configured to divert light away from a longitudinal axis of the light guide (Pars 0162-169; It’s clear that each of optical fibers 92 can include the diverting feature 82, as shown on optical fiber 92 in Figs. 17-18. This is the same configuration taught by applicant with each of the light guides shown in Figs. 2-5 having a diverting feature, as shown in Figs. 6-9. In the same way that applicant uses separate figures, i.e. one figure to show the arrangement of the plurality of fibers and the other figure to show the details/specifics of each fiber including a diverting feature, so does Hastings); and
a second light guide (another one of light guides 92; shown in Figs. 21A-C) extending within the wall of the elongate shaft and including a second light diverting feature (82, Fig. 17-18), configured to divert light away from the longitudinal axis of the light guide (Pars 0162-169; It’s clear that each of optical fibers 92 can include the diverting feature 82, as shown on optical fiber 92 in Figs. 17-18. This is the same configuration taught by applicant with each of the light guides shown in Figs. 2-5 having a diverting feature, as shown in Figs. 6-9. In the same way that applicant uses separate figures, i.e. one figure to show the arrangement of the plurality of fibers and the other figure to show the details/specifics of each fiber including a diverting feature, so does Hastings);
wherein light diverted by a portion of the first light diverting feature, a portion of the second light diverting feature, or a portion of both the first and the second light diverting features is configured to form a plasma in the balloon inflation media (see explanation for claim 2 above).
Hastings fails to explicitly teach the wall having an inner surface defining a lumen and an outer surface with the light guide extending within the wall between the inner surface and the outer surface of the wall. However, in the same field of endeavor, Grace teaches such a configuration; see Figs. 1-4. Specifically, any of the emitters (120 or 140, Figs. 1-2; 310, 320 or 330, Figs. 3; 400, Fig. 4) are interpreted as a wall having an inner surface defining a lumen and an outer surface with a light guide (dashed circles 115 or 135, Figs. 1; although not labelled with an element number the light guides are clearly shown in Fig. 3C as dashed circles located between the inner and outer surfaces of the wall) extending within the wall between the inner surface and outer surface of the wall (at least Pars 0273-278 and 0304-308). Therefore, it would have been obvious to modify the configuration of the wall and light guides taught by Hastings such that the walls have an inner surface that defines a lumen and an outer surface and the light guides are positioned within the wall between the inner and outer surface, as taught by Grace, as a known configuration for light guides and shaft walls in similar laser balloon catheters, i.e. combining prior art elements according to known methods to yield predictable results.
[Claim 16] See explanation for claim 3, above. Similar to claims 2-3 above, if applicant disagrees that Hastings is implicitly/inherently capable of producing the claimed function/effect in the balloon inflation media, then such a modification is obvious, based on the embodiment of Hastings shown in Figs. 32-33. See explanation for claims 2-3, above.
[Claim 17] See Fig. 21C which show multiple light guides (92) that are circumferentially spaced from one another on opposite sides of the elongate catheter
[Claim 18] See explanation for claim 9, above.
[Claim 19] See explanation for claim 8, above.
CIOANTA REJECTION
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0034832 to Cioanta et al. in view of US 2017/0265942 to Hastings
[Claim 1] A balloon catheter system (Fig. 44), comprising:
an elongate shaft (shockwave catheter 340 including tubes 441 and 443) having a proximal end region, a distal end region, a wall and an inflation lumen (tubes 441 and/or 443) extending from the proximal end region to the distal end region;
an expandable balloon (balloon 440) coupled to the distal end region of the elongate shaft, the balloon having an inflation chamber in fluid communication with the inflation lumen of the elongate shaft, and wherein the inflation lumen is configured to permit an inflation media to fill the inflation chamber of the balloon (saline brought into the balloon; see Pars 0448 and 0452); and
a light guide extending within the wall of the elongate shaft and including a first light diverting feature and a second light diverting feature (reflectors 402 and 404), wherein each of the first and second light diverting features are configured to divert light away from a longitudinal axis of the light guide;
wherein a portion of the first light diverting feature is longitudinally aligned with at least a portion of the second light diverting feature (reflectors 402 are longitudinally aligned with each other and reflectors 404 are longitudinally aligned with each other).
The embodiment shown in Fig. 44 of Cioanta shows the claimed diverting features, but this embodiment seemingly relates to electrical energy (“electrohydraulic discharge” Par 0448), and not necessarily light or a light guide. However, throughout the entirety of the reference, Cioanta teaches “methods to produce pressure shock waves include electrohydraulic, electromagnetic, piezoelectric, laser discharge, explosive, mechanical, etc.”. For example, Cioanta explicitly discloses a laser discharge embodiment (Fig. 55) including a light guide (laser fiber 555) that runs within catheter 340 (Par 0542). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the electrical energy source implicitly taught by Cioanta in Fig. 44 for the laser energy source and light guide taught in Fig. 55, as a simple substitution of one known type of energy for another to obtain predictable results, i.e. produce shockwaves within a balloon catheter, as Cioanta makes it clear throughout the disclosure that these are known alternative equivalents for each other in order to produce pressure shock waves.
Cioanta fails to explicitly teach the wall having an inner surface defining a lumen and an outer surface with the light guide extending within the wall between the inner surface and the outer surface of the wall. However, in the same field of endeavor, Grace teaches such a configuration; see Figs. 1-4. Specifically, any of the emitters (120 or 140, Figs. 1-2; 310, 320 or 330, Figs. 3; 400, Fig. 4) are interpreted as a wall having an inner surface defining a lumen and an outer surface with a light guide (dashed circles 115 or 135, Figs. 1; although not labelled with an element number the light guides are clearly shown in Fig. 3C as dashed circles located between the inner and outer surfaces of the wall) extending within the wall between the inner surface and outer surface of the wall (at least Pars 0273-278 and 0304-308). Therefore, it would have been obvious to modify the configuration of the wall and light guides taught by Cioanta such that the walls have an inner surface that defines a lumen and an outer surface and the light guides are positioned within the wall between the inner and outer surface, as taught by Grace, as a known configuration for light guides and shaft walls in similar laser balloon catheters, i.e. combining prior art elements according to known methods to yield predictable results.
[Claim 2] wherein the first light diverting feature, the second light diverting feature, or both the first and the second light diverting features are configured to divert light to form a plasma in the inflation media (“The only role for the non-occlusion balloon 440 is to provide an enclosed chamber in which the pressure shock waves can be generated in more efficient way” Par 0449. “FIG. 44 shows an embodiment where multiple reflectors (three reflectors 402 and three reflectors 404) are disposed inside a dedicated non-occlusion balloon 440 that allows the electrohydraulic discharge in saline solution 445 instead of blood, which can increase the efficiency of the pressure shock waves treatment.” Par 0448)
[Claim 3] Cioanta discloses all the necessary structure elements and configurations to be capable of such an effect; see MPEP 2114. See also Fig. 44 and Par 00249 which discloses “treatment can occur to various blood vessels 15 (arteries or veins) or human/animal conduits/lumens, as long as the focal volume 108 intersects the vessel 15 or human/animal conduit/lumen”.
[Claims 4-7] It has long been held that changes in size are obvious; “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” MPEP 2144.04. Therefore, it would have been obvious to change the size of any of the diverting features/reflectors (402 or 404) in order to obtain the desired focused pressure shock wave. It is emphasized that applicant has no criticality or unexpected results to the specific size of the diverting features.
[Claim 8] As shown in Figs. 43 and 44, the diverting features (reflectors 402 and 404) are dome shaped. If applicant disagrees, the examiner contends that such a change in shape is obvious in order to obtain the desired focused pressure shock wave; MPEP 2144.04. It is further emphasized that applicant has no criticality or unexpected results to such a shape.
[Claims 9-10] As shown in Figs. 43 and 44, clearly/inherently there exists a window for the energy to escape, otherwise it would never exit the catheter (340), e.g. see dotted lines that connect the reflectors (402 or 404) with the focal volumes (108). Therefore, in the same way a window exists for electrical energy, when the energy source is light and a light guide is used to transmit the light, a window is also inherent/necessary in order for the light to be transmitted into the balloon. Furthermore, in the same sense that the diverting features are spaced apart, so inherently are the associated windows (where the light exits from). See applicant’s Fig. 8 with diverting features (802, 804 and 806) and windows (808, 810 and 812). Cioanta discloses the same configuration of a diverting feature and inherent window.
[Claim 11] As discussed above, in relation to claims 4-7, it would be obvious to change the size of the diverting features/reflectors and therefore, for the same reasons, it would be obvious to change the size of the associated/respective windows, as changing the size of the reflector would necessarily result in a corresponding change in size for the window to create the desired effect.
[Claim 12] Cioanta discloses two reflectors are longitudinally aligned, e.g. any two reflectors 402, and a third (404) that is circumferentially offset from the first; see Fig. 44.
[Claim 13] Cioanta discloses three longitudinally aligned diverting features (3 reflectors 402 or 3 reflectors 404; Fig. 44).
[Claim 14] As discussed above, in relation to claims 4-8, it would be obvious to change the size of any of the reflectors, including the distal-most reflector.
[Claim 15] Cioanta discloses a balloon catheter system (Figs. 43 and 44), comprising:
an elongate shaft (shockwave catheter 340 including tubes 441 and 443) having a proximal end region, a distal end region coupled to an expandable balloon (balloon 440), and an inflation lumen (tubes 441 and 443) extending from the proximal end region to the distal end region, wherein the expandable balloon includes an inflation chamber in fluid communication with the inflation lumen of the elongate shaft, and wherein the inflation lumen is configured to permit a balloon inflation media to fill the inflation chamber of the balloon (saline brought into the balloon; see Pars 0448 and 0452);
a first light guide extending within a wall of the elongate shaft and including a first light diverting feature (402, Figs. 43 and 44) configured to divert light away from a longitudinal axis of the light guide; and
a second light guide extending within the wall of the elongate shaft and including a second light diverting feature (404, Figs. 43 and 44), configured to divert light away from the longitudinal axis of the light guide;
wherein light diverted by a portion of the first light diverting feature, a portion of the second light diverting feature, or a portion of both the first and the second light diverting features is configured to form a plasma in the balloon inflation media (see explanation for claim 2 above).
The embodiment shown in Figs. 43 and 44 of Cioanta show the claimed diverting features (402 and 404), but this embodiment seemingly relates to electrical energy (“electrohydraulic discharge” Par 0448), and not necessarily light or a light guide. However, throughout the entirety of the reference, Cioanta teaches “methods to produce pressure shock waves include electrohydraulic, electromagnetic, piezoelectric, laser discharge, explosive, mechanical, etc.”. For example, Cioanta explicitly discloses a laser discharge embodiment (Fig. 55) including a light guide (laser fiber 555) that runs within catheter 340 (Par 0542). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the electrical energy source implicitly taught by Cioanta in Figs. 43 and 44 for the laser energy source and light guide taught in Fig. 55, as a simple substitution of one known type of energy for another to obtain predictable results, i.e. produce shockwaves within a balloon catheter, as Cioanta makes it clear throughout the disclosure that these are known alternative equivalents for each other in order to produce pressure shock waves.
Regarding the first and second light guides, it’s clear from Fig. 43 that each reflector (402 and 404) are coupled to their own energy source (see the “+” and “-” symbols in Fig. 43, clearly one set of “+” and “-” symbols represents a single electrical source). Therefore, when these sources emit light (instead of electrical energy), as proposed in the substitution above, it would have been obvious to include two light guides that each include a diverter/reflector (402 or 404, as seen in Fig. Fig. 43), as this is a known configuration for electrical energy and therefore would be just as obvious for light energy, as well. Specifically, with regards to the embodiment shown in Fig. 44, it would be obvious to substitute the electrical energy source for light energy and additionally to include a separate light guide for each set of reflectors (402 and 404), similar to what is shown in Fig. 43, as this is a known configuration to produce pressure shock waves, and Cioanta explicitly teaches that electrical energy and light energy are alternative equivalents.
Cioanta fails to explicitly teach the wall having an inner surface defining a lumen and an outer surface with the light guide extending within the wall between the inner surface and the outer surface of the wall. However, in the same field of endeavor, Grace teaches such a configuration; see Figs. 1-4. Specifically, any of the emitters (120 or 140, Figs. 1-2; 310, 320 or 330, Figs. 3; 400, Fig. 4) are interpreted as a wall having an inner surface defining a lumen and an outer surface with a light guide (dashed circles 115 or 135, Figs. 1; although not labelled with an element number the light guides are clearly shown in Fig. 3C as dashed circles located between the inner and outer surfaces of the wall) extending within the wall between the inner surface and outer surface of the wall (at least Pars 0273-278 and 0304-308). Therefore, it would have been obvious to modify the configuration of the wall and light guides taught by Cioanta such that the walls have an inner surface that defines a lumen and an outer surface and the light guides are positioned within the wall between the inner and outer surface, as taught by Grace, as a known configuration for light guides and shaft walls in similar laser balloon catheters, i.e. combining prior art elements according to known methods to yield predictable results.
[Claim 16] See explanation for claim 3, above.
[Claim 17] As seen in Figs. 43 and 44, the diverting features (402 and 404), and therefore their respective/associated light guides, are circumferentially spaced from one another on opposite side of the elongate shaft. Par 0448 “Referring to FIGS. 43 and 44, independent reflectors (402 and/or 404) are disposed 180.degree. apart (opposite)”. If applicant disagrees, such a configuration would be obvious based on the positioning of the reflectors. Specifically, if the reflectors associated with each of the light guides are positioned on opposite sides of the elongate shaft, it would be obvious to position the light guides in the same manner, as this is the most logical position.
[Claim 18] See explanation for claim 9, above
[Claim 19] See explanation for claim 8, above.
Conclusion
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.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796