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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/EP2022/0873130, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 11-19 and 22 do not have support for the following limitations:
Regarding claim 11, the claim recites the limitation: “the plasma is intended for direct or indirect treatment at the treatment site.” The priority specification does not disclose this limitation. There is no description of indirect treatment in the priority disclosure.
Claims 12-19 also do not receive priority due to their dependency on claim 11.
Regarding claim 13, the claim recites the limitation: “an optical coupling device for direct or indirect coupling...” The priority specification does not disclose this limitation. The specification discusses a coupling device and optical coupling (paragraphs [0023], [0024], and [0071] describing Figs. 6 and 7). However, the specification is silent with regard to direct and indirect coupling.
Regarding claim 22, the claim recites, “The method according to claim 20, wherein :an illumination duration of the illumination light is greater than the duration of a plurality of laser pulses in succession.” There is inadequate support for the recitation of an “illumination duration” in the instant specification. The priority specification fails to disclose any details regarding the illumination duration. The specification discloses the plasma duration (para. [0006-0008], [0010], [0041], [0043-0044], and [0058]). However, there is no disclosure directed to the illumination duration. Therefore, the priority specification lacks support for the claimed subject matter.
Further regarding claim 22, the claim recites “the illumination light is coupled in continuously.” The instant specification does not provide adequate support for continuously coupling the illumination light. The priority specification states the illumination light can light up continuously (para. [0066]). However, it is not supported how the light is coupled continuously, or to what is coupled to the light. Therefore, the priority specification lacks support for the claimed subject matter.
Due to the aforementioned reasons for inadequate support, the instant claims 11-19 and 22 have an effective filing date of 06/21/2024.
Specification
The disclosure is objected to because of the following informalities: In para. [0021 and 0022], a space is needed (i.e. “Fig 4 the”). In para. [0023 and 0024], there is only one Fig 6 and Fig 7 (not need for 6a and 7a). The text should match with the drawings, which are labeled as Fig 6 and Fig 7.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “LL” in Fig. 6 is referred to as LP. Para. [0068] correlates with Fig. 6 and discloses that 17 emits laser pulses LP, but LL is shown being emitted in Fig. 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Claim Objections
Claim 11 is objected to because of the following informalities: The claim recites “d)” and “e)” in a bulleted list twice (lines 14 and 18, respectively). It should be corrected to “g)” and “h).”
Claim 11 and 14 are objected to because of the following informalities: The recitation of “the illumination light” (cl. 11, line 15; cl. 14, line 4) should be amended to “the illuminating light,” which is how it is referenced in claim 11, line 4. Rewriting this would keep the language consistent.
Claim 17 is objected to because of the following informalities: The period in line 2 is unnecessary and should be removed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 11 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 11 requires “whereby the treatment site…is located in the area at the opening…”, which makes the treatment site part of the claimed invention. The treatment site encompasses a human organism. Therefore, independent claim 11 and dependent claims 12-19 are rejected for this reason.
Claim Rejections - 35 USC § 112(a)
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.
Claim 11-19 and 22 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.
Regarding claim 11, the claim recites the limitation: “the plasma is intended for direct or indirect treatment at the treatment site.” The instant specification does not disclose this limitation. There is no description of indirect treatment in the instant disclosure. Therefore, claim 11 lacks written description.
Claims 12-19 are rejected due to their dependency on claim 11.
Regarding claim 13, the claim recites the limitation: “an optical coupling device for direct or indirect coupling...” The instant specification does not disclose this limitation. The specification discusses a coupling device and optical coupling (paragraphs [0023], [0024], and [0071] describing Figs. 6 and 7). However, the specification is silent with regard to direct and indirect coupling. Therefore, claim 13 lacks written description.
Regarding claim 22, the claim recites, “The method according to claim 20, wherein :an illumination duration of the illumination light is greater than the duration of a plurality of laser pulses in succession.” There is inadequate support for the recitation of an “illumination duration” in the instant specification. The instant specification fails to disclose any details regarding the illumination duration. The specification discloses the plasma duration (para. [0006-0008], [0010], [0041], [0043-0044], and [0058]). However, there is no disclosure directed to the illumination duration. Therefore, the instant specification lacks support for the claimed subject matter.
Further regarding claim 22, the claim recites “the illumination light is coupled in continuously.” The instant specification does not provide adequate support for continuously coupling the illumination light. The instant specification states the illumination light can light up continuously (para. [0066]). However, it is not supported how the light is coupled continuously, or to what is coupled to the light. Therefore, the instant specification lacks support for the claimed subject matter.
Claim Rejections - 35 USC § 112(b)
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 11-20 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.
Regarding claim 11, the claim recites “wherein laser pulses are transmitted…and strike the target.” The term “laser pulses” lacks antecedent basis. It is unclear, as recited in the claim, where the laser pulses originate, and the structure necessary for generating the laser pulses. The applicator, light guide, and illumination light source do not produce laser pulses. For examination purposes, it will be assumed that the claim requires a light guide configured to transmit laser pulses”.
Further regarding claim 11, the recitation is indefinite because it is directed to both a product and a process. Claim 11 is directed to a device comprising a method step at lines 9-11. A single claim that claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See MPEP 2173.05(p).
Regarding claim 11, the phrase "in particular" (line 1 and line 2) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following “in particular” will be interpreted as optional subject matter.
Further regarding claim 11 recites the limitation "the light guide" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 11, the claim recites “whereby the treatment site to be illuminated is located in the area at the opening…”. The use of “in the area” is indefinite. One of ordinary skill in the art would not be able to define, based on the recited limitation” what is considered “in the area.” Therefore, the metes and bounds of the limitation are unclear. The recitation of “the area” also lacks antecedent basis.
Claims 12-19 are rejected due to their dependency from claim 11.
Claim 14 recites the limitations “the optical frequency spectrum” (ln. 2) and "the plasma frequency" (ln. 3). There is insufficient antecedent basis for the limitations in the claim.
Claim 15 recites the limitation “the distance” in line 1. There is insufficient antecedent basis for the limitations in the claim.
Claim 16 recites the limitation “the distance” in line 1. There is insufficient antecedent basis for the limitations in the claim.
Regarding claim 17, the claim recites “and has a cylindrical opening wall.” It is unclear how the cylindrical opening can both be a wall and an opening. It is also unclear which wall is referred to as the cylindrical opening wall. The ambiguity of this limitation renders the claim indefinite.
Regarding claim 18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following “preferably 45 °” will be interpreted as an angle of inclination of 45 degrees.
Regarding claim 18, the phrase “preferably” (line 2) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following “preferably” will be interpreted as optional subject matter.
Regarding claim 19, the phrase "for example" (line 6) and “preferably” (line 5) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following “in particular” and “preferably” will be interpreted as optional subject matter.
Regarding claim 20, the phrase "in particular" (line 1 and line 2) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following “in particular” will be interpreted as optional subject matter.
Further regarding claim 20, recites the limitation "the light guide" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 20, the claim recites “a2) further comprises an optical fiber guided in the hollow needle to the distal end with a free end oriented towards the target, is used.” It is unclear if the applicator further comprises the optical fiber or if the hollow needle further comprises the optical fiber. Therefore, the claim is rendered indefinite.
Claims 21 and 22 are rejected due to their dependency from claim 20.
Regarding claim 21 recites the limitation “the distance” in line 1. There is insufficient antecedent basis for the limitations in the claim. Further, it is unclear if “the distance” is referring to a time between two laser pulses or if it refers to a physical distance (i.e., the distance between two points). For examination purposes, it is interpreted as a time between pulses.
Regarding claim 22, the claim recites “the illumination light is coupled in continuously.” It is unclear what “coupled in continuously” means. The specification does not provide detail on continuous coupling. Further, it is unclear what the illumination light is coupled in with since no steps or structures are recited in the claims that refer to being “coupled in continuously” with the illumination light. For examination purposes, coupled in continuously will be interpreted as a light that is continuous and includes other lights being used with it at the same time.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-17, 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krespi (US 20100160903 A1).
Regarding claim 11, Krespi teaches a device for illuminating a treatment site (para. [0054]; “For example, a treatment cycle can comprise illumination and inspection, followed by shockwave treatment followed by irrigation and/or aspiration to remove debris and the cycle can then be repeated, if desired.”), comprising: a) an applicator (Fig. 7; tip assembly 10 for delivering shockwave therapy) and b) an illumination light source for generating illuminating light, (para. [0040]; “An optical fiber 16 is supported within stabilizer tube 14 and outer tube 12 and extends proximally to a light source (not shown).) c) wherein the applicator comprises a hollow needle (Fig. 1; shows the applicator with nose 24; para. [0044]; “Nose 24 is hollow with an internally curved, part conical target surface 28 on which a laser beam emerging from optical fiber 16 can impinge.”) with a distal end (the left side of the applicator 10; Fig. 7) and with a target at the distal end (Fig. 7; Nose 24; para. [0044]; “Nose 24 is hollow with an internally curved, part conical target surface 28 on which a laser beam emerging from optical fiber 16 can impinge.”) and with an opening at the distal end (Fig. 7; output port 26), d) wherein the applicator has an optical fiber (Fig. 7; optical fiber 16) guided in the hollow needle to the distal end with a free end oriented towards the target (Fig. 7; The distal end of 16 is shown as an output and facing towards the target 24), e) wherein laser pulses are transmittable or transmitted via the light guide (optical fiber 16; Fig. 7), which emerge from the light guide at the free end and strike the target and generate a plasma in front of a target surface of the target (para. [0057]; “Laser energy pulses emerge from the distal end face of optical fiber 16, through end plate 18 and strike target surface 28 which ionizes, creating a plasma and generating shockwaves. The shockwaves emanate from target surface 28 in the vicinity of the point of impact on target surface 28 of the light pulses leaving optical fiber 16, as shown by the arrow. The shockwaves radiate from this point of impact and are guided by the configuration of target surface 28 and output port 26 to leave tip assembly 10 in a divergent shockwave beam 38 and strike the treatment object 40. In the example shown, treatment object 40 is a portion of vascular occlusion 36.”) , f) whereby the treatment site to be illuminated is located in the area at the opening and the plasma is intended for direct or indirect treatment at the treatment site, (para. [0057]; “Laser energy pulses emerge from the distal end face of optical fiber 16, through end plate 18 and strike target surface 28 which ionizes, creating a plasma and generating shockwaves. The shockwaves emanate from target surface 28 in the vicinity of the point of impact on target surface 28 of the light pulses leaving optical fiber 16, as shown by the arrow. The shockwaves radiate from this point of impact and are guided by the configuration of target surface 28 and output port 26 to leave tip assembly 10 in a divergent shockwave beam 38 and strike the treatment object 40. In the example shown, treatment object 40 is a portion of vascular occlusion 36.”) d) the illumination light source being optically coupled or couplable to the light guide of the applicator in such a way that the illumination light of the illumination light source is transmitted via the light guide and emerges from the light guide at the free end (para. [0079]; “A further embodiment of treatment instrument according to the invention comprises illumination means or an illumination device to illuminate the target area to facilitate monitoring of the treatment. If desired, the illumination means can comprise an illumination fiber having proximal light input end communicating with a light source and having a distal light output end locatable in the vicinity of the treatment site to illuminate the treatment site. The illumination fiber can be movable with the treatment instrument. For example, it may be a component of the treatment instrument or it can be a separate device. Illumination means not only can be usefully employed to illuminate concealed treatment sites but may also be useful for treatment of endoluminal structures resident at exposed treatment sites.”).
Krespi teaches that the distal end is titanium (para. [0046]; “Metal tip 20 can be formed in one piece of an ionizable metal suitable for generating shockwaves, for example titanium, stainless steel or zirconium. Alternatively, metal tip 20 can be formed of another material, possibly a nonmetallic material and can be provided with an ionizable metal insert to serve as target surface 28.”). In the instant specification, the inner surface is disclosed as also being a titanium (para. [0045]). Therefore, Krespi’s titanium distal end meets the instant mirror surface limitation. The material in Krespi is capable of generating plasma (Krespi, para. [0057]; “Laser energy pulses emerge from the distal end face of optical fiber 16, through end plate 18 and strike target surface 28 which ionizes, creating a plasma and generating shockwaves.”), and that the illumination light would be able to reflect from the surface and the plasma. Further, Krespi discloses that illumination can be performed simultaneously with the delivery of shockwaves (para. [0061]; “If desired, as described herein, irrigation, aspiration, inspection, illumination or other adjunctive services can be performed concomitantly with the shockwave treatment or intermittently, in between steps of shockwave treatment.”). Therefore, given the disclosure of the structural limitations of Krespi, and further evidence that the structure can produce shockwaves and illuminate, the device of Krespi is capable of reflecting light. Thus, Krespi anticipates the following limitation: wherein an inner surface of the hollow needle at the distal end is designed as a mirror surface for the illuminating light, such that the illuminating light is reflected from this mirror surface after emerging from the light guide and at least partially with or after one or more intermediate reflections from the plasma to the opening.
Regarding claim 12, Krespi discloses the device according to claim 11 (see above), wherein the mirror surface is arranged at least around the target and around the opening (Fig. 1; para. [0057]; “The shockwaves emanate from target surface 28 in the vicinity of the point of impact on target surface 28 of the light pulses leaving optical fiber 16, as shown by the arrow. The shockwaves radiate from this point of impact and are guided by the configuration of target surface 28 and output port 26 to leave tip assembly 10 in a divergent shockwave beam 38 and strike the treatment object 40. In the example shown, treatment object 40 is a portion of vascular occlusion 36.”; In Fig. 1, it is clear, by the arrow, that the laser reflects off 24 to generate shockwaves near the opening near 40).
Regarding claim 13, Krespi discloses the device according to claim 11 (see rejection above), further comprising: a laser light source for generating the laser pulses (para. [0053]; “In a further aspect, the present invention provides a treatment system comprising tip assembly 10 and a pulsed laser light source (not shown)…”), and an optical coupling device for direct or indirect optical coupling of the light guide to the laser light source and the illumination light source (para. [0054]; In a further aspect, the present invention provides a treatment system comprising tip assembly 10 and a pulsed laser light source (not shown), with associated controls, disposed externally of the mammalian treatment subject, wherein the tip assembly 10 is functionally coupled to the laser light source to receive light therefrom by optical fiber 16.”; Additionally, see para. [0079]; “The illumination fiber can be movable with the treatment instrument. For example, it may be a component of the treatment instrument or it can be a separate device.”).
Regarding claim 14, Krespi discloses illuminating light (para. [0079]; “The illumination fiber can be movable with the treatment instrument. For example it may be a component of the treatment instrument or it can be a separate device.”) and plasma (para. [0012]; “if desired, for example, by impinging a pulsed laser beam on an ionizable material, for example, a metal target, to generate a plasma. The process can form a- plasma adjacent to the ionizable target and can generate mechanical shockwaves emanating from the plasma and moving away from the ionizable target.”). Illumination light is encompassed by the optical frequency spectrum. The purpose of the illumination is for the operator to see the light, so it must be a visible frequency. Further, plasma frequency is higher than the visible, illumination frequency. Lastly, since the illumination light is a lower frequency than the plasma, the plasma would reflect the illumination light (para. [0008] of the instant specification lends supports that the light reflected from the plasma cannot penetrate the plasma.)
Regarding claim 15 and 16, Krespi discloses wherein the distance of the free end of the light guide from the target surface corresponds to a value between 0.7 mm and 1.2 mm (para. [0073]; “Employing an optical fiber to deliver the laser energy, any suitable fiber-to-ionizable-target distance can be employed, for example, from about 0.7 mm to about 1.5 mm.”), in particular approximately 0.9 mm (The claim language “in particular” is interpreted as optionally claimed subject matter (see 112b rejection)).
Regarding claim 17, Krespi discloses the device according to claim 11 (see above), wherein the opening has a central axis which is inclined relative to an applicator axis of the hollow needle wall by an angle of inclination. and has a cylindrical opening wall. (Fig. 1 shows the central axis, applicator axis at an angle, and cylindrical opening; see below for each part labeled).
PNG
media_image1.png
366
702
media_image1.png
Greyscale
PNG
media_image2.png
227
695
media_image2.png
Greyscale
Regarding claim 20, Krespi discloses a method for illuminating a treatment site (para. [0054]; “For example, a treatment cycle can comprise illumination and inspection, followed by shockwave treatment followed by irrigation and/or aspiration to remove debris and the cycle can then be repeated, if desired.”), wherein: a) an applicator (Fig. 7; tip assembly 10 for delivering shockwave therapy) which comprises a1) a hollow needle (Fig. 7; tip assembly 10) with a distal end (left end of tip assembly 10) and with a target (Fig. 7; nose 24) at the distal end and with an opening at the distal end (see Fig. 1 above where the opening is circled) and a2) further comprises an optical fiber (Fig. 7; optical fiber 16) guided in the hollow needle to the distal end with a free end oriented towards the target (Fig. 7; end of 16 shown open towards the target at 24), is used and b) the opening is located at the distal end of the hollow needle of the applicator at the treatment site to be illuminated (see para. [0054] where illumination is mentioned), c) laser pulses from a laser light source are coupled into the light guide and emerge from the light guide at the free end and strike the target and generate a plasma in front of a target surface of the target (Fig. 1; “Laser energy pulses emerge from the distal end face of optical fiber 16, through end plate 18 and strike target surface 28 which ionizes, creating a plasma and generating shockwaves. The shockwaves emanate from target surface 28 in the vicinity of the point of impact on target surface 28 of the light pulses leaving optical fiber 16, as shown by the arrow.), d) illuminating light from an illumination light source is coupled into the light guide and emerges from the light guide at the free end (para. [0079]; “A further embodiment of treatment instrument according to the invention comprises illumination means or an illumination device to illuminate the target area to facilitate monitoring of the treatment. If desired, the illumination means can comprise an illumination fiber having proximal light input end communicating with a light source and having a distal light output end locatable in the vicinity of the treatment site to illuminate the treatment site.”),
Krespi teaches that the distal end is titanium (para. [0046]; “Metal tip 20 can be formed in one piece of an ionizable metal suitable for generating shockwaves, for example titanium, stainless steel or zirconium. Alternatively, metal tip 20 can be formed of another material, possibly a nonmetallic material and can be provided with an ionizable metal insert to serve as target surface 28.”). In the instant specification, the inner surface is disclosed as also being a titanium (para. [0045]). Therefore, Krespi’s titanium distal end meets the instant mirror surface limitation. The material in Krespi is capable of generating plasma (Krespi, para. [0057]; “Laser energy pulses emerge from the distal end face of optical fiber 16, through end plate 18 and strike target surface 28 which ionizes, creating a plasma and generating shockwaves.”), and that the illumination light would be able to reflect from the surface and the plasma. Further, Krespi discloses that illumination can be performed simultaneously with the delivery of shockwaves (para. [0061]; “If desired, as described herein, irrigation, aspiration, inspection, illumination or other adjunctive services can be performed concomitantly with the shockwave treatment or intermittently, in between steps of shockwave treatment.”). Therefore, given the disclosure of the structural limitations of Krespi, and further evidence that the structure can produce shockwaves and illuminate, the device of Krespi is would reflect light. Thus, Krespi anticipates the following limitation: wherein an inner surface of the hollow needle at the distal end is designed as a mirror surface for the illuminating light, such that the illuminating light is reflected from this mirror surface after emerging from the light guide and at least partially with or after one or more intermediate reflections from the plasma to the opening.
Regarding claim 21, Krespi discloses the method according to claim 20 (see above), wherein: the laser pulses have a pulse duration in the range from 1 ns to 10 ns and/or have a pulse energy in the range from 2 mJ to 15 mJ (claim 25; “a pulse energy in a range of from about 2 mJ to about 15 mJ of energy per pulse,”) and/or the distance between two laser pulses is selected to be greater than the plasma duration of the plasma, the plasma duration being in particular in the range from 50µs to 200µs.
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.
Claim(s) 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over by Krespi (US 20100160903 A1) in view of Dodick (US 5324282 A).
Regarding claim 18, Krespi discloses the device according to claim 17 (see 102 rejection above). However, Krespi does not disclose wherein the angle of inclination is selected from a range of 30° to 60°, preferably 45°.
Dodick, in the same field of endeavor of applying shockwaves to tissue, discloses a surgical instrument that uses laser pulses to do so. Dodick discloses wherein the surgical instrument has an angle of inclination is selected from a range of 30° to 60°, preferably 45°. (para. (15); “This FIG. 5 embodiment primarily differs from the FIG. 1 embodiment in that the distal end of the probe 10 is a plane at an angle of forty-five degrees (45.degree.) to the horizontal and provides a port 22a which more optimally positions the tissue to receive the shockwaves generated off the inner surface of the titanium insert 24a.”). Although Dodick does not discuss a range of 30-60 degrees, the preferred angle of 45 degrees is disclosed.
It would have been obvious to one of ordinary skill in the art before the effective filing date to try a range of angles for the angle of inclination. As disclosed by Dodick, 45 degrees is known to be an angle of inclination that produces shock waves. Attempting a range from 30 to 60 degrees would have been obvious to try, and one of ordinary skill in the art could reasonably conclude an optimal angle for producing shock waves. It would have been obvious to repeat this process until the conclusion is made that 30 to 60 degrees is a workable range, and 45 is optimal.
Regarding claim 19, Krespi discloses the device according to claim 11 (see 102 rejection above). Dodick also discloses a needle interior (Fig. 1; the inside of metal tip 20), an opening (see circled opening in Fig. 1 of claim 17 in the 102 rejection), and smooth mirror surfaces (Fig. 1; nose 24; para. [0044]; “Desirably, the point of nose 24 is smoothly contoured, for example rounded and free of sharp contours, to facilitate delivery through the subjects vascular system or other lumen or into a bodily cavity.).
Citing MPEP 2113(I): "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Since the structure of claim 19 is disclosed by Krespi, it would have been obvious to produce the same structures by different methods.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over by Krespi (US 20100160903 A1) in view of McDonnell et al. (US 20160175149 A1, “McDonnell”).
Krespi discloses the method according to claim 20 (102 rejection above). However, Krespi does not disclose wherein: an illumination duration of the illumination light is greater than the duration of a plurality of laser pulses in succession; and/or the illumination light is coupled in continuously.
McDonell, in the same field of endeavor of illuminating a target site, discloses a method of visualizing moving tissue. McDonell discloses wherein: an illumination duration of the illumination light is greater than the duration of a plurality of laser pulses in succession; and/or the illumination light is coupled in continuously. (para. [0026]; “The light source 202 provides continuous, bright, background, broadband, and/or white light to illuminate the entire surgical field. The light source 202 can include an incandescent light bulb, a halogen light bulb, a metal halide light bulb, a xenon light bulb, a mercury vapor light bulb, a light emitting diode (LED), other suitable components, and/or combinations thereof that provide continuous light.” ; Additionally, para. [0026] mentions two light sources (202 and 204). These light sources can be considered to be coupled.)
It would have been obvious to one of ordinary skill in the art before the effective filling date to combine McDonell’s method of continuous lighting with the method of claim 20, as disclosed by Krespi. Continuous lighting coupled with other sources of light would improve the method by constantly lighting the target site, which would allow the operator, or person of ordinary skill performing the method, to visualize the surgical area throughout the duration of the laser surgery.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) and 8am – noon (F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796