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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-18 in the reply filed on August 13, 2025 is acknowledged. Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 5, “said tubular sheath” lacks proper antecedent basis because that term was not recited previously. It appears that this should instead recite “said outer sheath”
In line 7, “a laser fiber probe” should instead recite “the laser fiber probe” or “said laser fiber probe” since the laser fiber probe was already recited earlier in the claim in line 4.
In the limitation “followed by the fourth step …” this should instead recite “followed by a fourth step” to be in agreement with how the other steps are recited, and because the fourth step was never previously introduced.
In the fourth step limitation, “the laser emitting portion” lacks proper antecedent basis as that limitation was never previously recited.
In the fifth step limitation, “activating said laser energy” should most likely read as “activating said laser energy source” since it is the source itself which is technically activated.
Claim 5 is objected to because of the following informalities:
In line 1 “on outer sheath” should recite “on the outer sheath” or “on said outer sheath.”
In the last line, “laser memory” is not a standard terminology to refer to memory which is part of a laser system. The claim should be amended to more clearly recite that this is referring to some kind of physical storage media within the laser system.
Claim 8 is objected to because of the following informalities: “laser energy source” in line 1 should either recite “the laser energy source” or “said laser energy source.”
Claim 12 is objected to because of the following informalities: “laser” in line 2 should either recite “the laser” or “said laser.” However, also consider the § 112(b) rejection below concerning this term.
Claim 13 is objected to because of the following informalities: “next patient” in line 3 should recite “a next patient.”
Claims 14-17 are objected to because of the following informalities: “laser” in line 1 of all of these claims should either recite “the laser” or “said laser.” However, also consider the § 112(b) rejection below concerning this term.
Appropriate correction is required.
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, 6-7 and 11-18 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 1, the phrase "such as" (see line 6: “such as a vagina or rectum”) 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).
Regarding Claims 6-7, both of these claims recite “said fourth step of translating …” but depend from claim 1 which recites the translating as the sixth step, not the fourth. As such, it is unclear whether claims 6-7 are in fact referring to the fourth step (of inserting the laser fiber probe into the outer sheath …) or the sixth step (of translating …).
Regarding Claims 11-18, all of these claims refer to either “laser” or “said laser.” This term lacks proper antecedent basis but also raises uncertainty because the preceding claims (e.g. claim 1) recite several “laser” limitations including a “laser fiber probe,” “laser fiber,” “laser energy” and “laser energy source.” When claims 11-18 refer simply to a “laser” or “said laser,” it is not immediately clear to which of those previous limitations is being referred. To render the scope of the claims definite, claims 11-18 should clarify which exact previous laser limitation is recited.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0008837 A1 to Zhang (hereinafter “Zhang”) in view of US Patent No. 4,998,930 to Lundahl (hereinafter “Lundahl”) in view of US 2017/0172658 A1 to Zipper (hereinafter “Zipper”).
Regarding Claim 1, Zhang teaches a method for reshaping transmucosal energy delivery to pelvic tissue (see e.g. the title, abstract and the background section in Paras. 3-9), said method comprising:
a first step of providing an outer sheath (“insert” 110 and/or 200 and/or 300 in FIGS. 1-3 respectively) with an inner diameter sufficient to allow insertion of a laser fiber probe (135 and/or 205 and/or 305 in FIGS. 1-3 respectively);
followed by a second step of inserting said tubular sheath into a patient body cavity potential space such as a vagina or rectum (see e.g. FIG. 1):
followed by a third step of providing a laser fiber probe (135 and/or 205 and/or 305 in FIGS. 1-3 respectively) composed of a laser fiber (135 and/or 205 and/or 305 in FIGS. 1-3 respectively) (130 in FIGS. 1 and 3; “dosed light source” in FIGS. 2A-C);
followed by the fourth step of inserting said laser fiber probe into the outer sheath until the laser emitting portion of said laser fiber is within said body cavity (see e.g. FIGS. 1-3):
followed by a fifth step of activating said laser energy and transmitting said laser energy through said protective sheath and outer sheath (see e.g. FIGS. 1-3 and Paras. 72 and 77);
followed by a sixth step of translating said laser fiber probe distal end (see e.g. FIGS. 1-3):
followed by a seventh step of deactivating said laser energy and removing said outer sheath and laser fiber probe from body cavity (this necessarily occurs at some point after the conclusion of a treatment session as Zhang’s device is not a permanent implant).
Concerning the order of the steps, Zhang doesn’t appear to specify whether the laser fiber probe is inserted into the outer sheath after the outer sheath has already been inserted into the patient’s body cavity. However, there would only be two possible options here: either the probe is inserted into the sheath prior to the sheath being inserted into the patient’s body cavity, or the probe is inserted into the sheath after the sheath is inserted into the patient’s body cavity. Given only these options, both of which would yield only predictable results, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to consider and experiment with both options to see which one was preferable in a given situation, particularly since it does not appear that either option would significantly impact the resulting therapy on the patient since the desired end result requires that both objects be inserted into the body cavity, and either option would yield that result. As such, both options would be equally obvious to one skilled in the art.
Zhang fails to explicitly teach (1) that the fiber is enclosed in a protective sheath, (2) wherein said laser fiber is capable of emitting laser energy from an area in its distal 4 cm, (3) the translating of the fiber is a “back and forth” motion.
Concerning (1), it is remarkably common and well known for optical fibers to be enclosed in a protective sheath (which may be referred to by various names, such as a “jacket” or “outer jacket” among others). As such, as an initial matter, it is the Examiner’s position that this explicit disclosure is simply omitted from Zhang because it is so common. However, as one example providing an explicit disclosure of this limitation, attention is directed to Lundahl which teaches a similar phototherapy device including an optical fiber; Lundahl teaches that it was known to provide such a protective sheath around the fiber (see “However, it will typically have known cladding and an outer ensheathing jacket or coating (not illustrated).”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang (provided that Zhang doesn’t already include this) to enclose the fiber in a protective sheath because it was extraordinarily well known and common to do this for optical fibers, and doing so would predictably help protect the fiber.
Concerning (2) and (3), another reference, Zipper, teaches an extremely similar device for treatment of body cavities including a tip that can emit light from its distal 4 cm (see “4.0 cm” throughout Zipper’s claims, e.g. in claim 3; the sphere emits energy in a spherical pattern and has a diameter of up to 4 cm, and thus emits energy in an area in the distal 4 cm) and which can include back-and-forth translation (see the phrase “back and forth” in Paras. 11, 46-47, 51 and 53 and claims 1, 21 and 42). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang to provide a distal tip that emits energy in its distal 4cm, and to provide a back-and-forth translation, because it would increase the amount and/or uniformity of the emitted light to the tissue of the surrounding body cavity. It would have been additionally obvious to select the back-and-forth motion in combination with the tip shape seen in Zipper because it would predictably enhance Zhang by allowing the addition of Zipper’s disclosed massaging function in combination with the laser energy emission, thereby yielding an enhanced therapeutic result.
Regarding Claim 2, see e.g. Para. 44 and 73 of Zhang discussing multiple wavelengths failing within Applicant’s claimed range.
Regarding Claim 3, see e.g. FIGS. 1-3 and the abstract of Zhang (Zhang is directed toward treatment of the vaginal cavity).
Regarding Claim 4, Zhang is silent as to treating the rectum. However, Zipper discloses a similar invention for treating a variety of body cavity conditions, including both the vagina and the rectum (see e.g. the title, Para. 5, FIG. 9). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zhang to treat the rectum because it would predictably and advantageously allow condition(s) of that body cavity to be treated, as taught by Zipper.
Regarding Claim 6, see the rejection of claim 1 above; the “back and forth” motion incorporated from Zipper is specifically a distal and proximal motion (see e.g. Para. 46 of Zhang: “in a back and forth fashion, over a treatment length L between proximal position D and distal position E”).
Regarding Claim 7, Zhang teaches that treatment can be done for a time span of at least one minute (see e.g. Paras. 79-80). Additionally, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal treatment parameters for each particular patient (including duration of treatment) based upon various factors known and understood to those skilled in the art, such as the patient’s particular condition and severity of the condition, other patient health factors, risk factors associated with the treatment etc. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claims 8-11, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal treatment parameters for each particular patient (including irradiance and energy output) based upon various factors known and understood to those skilled in the art, such as the patient’s particular condition and severity of the condition, other patient health factors, risk factors associated with the treatment etc. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claim 1 above, and further in view of US 2007/0050000 A1 to Esch et al. (hereinafter “Esch”).
Regarding Claim 5, Zhang as modified above teaches the method of claim 1, but fails to teach “wherein the user observes markings on outer sheath, protective sheath, fiber cladding, or other fiber covering such marking conveying information on a length of area and or surface area to be treated, user inputs said observations into a user interface of said laser energy source, said input observations resulting in alteration or maintenance of dosing based on dosing information maintained in laser memory.” Zipper teaches that the laser fiber probe may include markings (e.g. marking 202; see the term “markings” throughout Zipper) to indicate the depth of insertion to help facilitate the proper delivery of energy to the tissue. Furthermore, the Esch reference teaches an analogous device for treatment of a hollow anatomical structure which includes spaced apart index markings which the surgeon can input into a controller so that the controller can alter or maintain the dosing of the therapy based on information maintained in memory (see e.g. Paras. 454, 456, 460, 463). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to provide markings (as taught by Zipper and Esch) on the laser fiber probe and to allow a user to input observations of those markings into the laser controller for dosage control (as taught by Esch) because doing so would predictably and advantageously help ensure that the proper dosage is being delivered at each region of tissue.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claims 2 and 11 above, and further in view of US 2016/0136442 A1 to Zhu (hereinafter “Zhu”).
Regarding Claims 12-15, Zhang as modified above fails to teach that the user inputs diagnostic or symptom information into a user interface prior to or after activating the laser, and generating graphical data to display symptom improvement or worsening on the user interface. Another reference, Zhu, teaches a therapeutic system which includes a user interface for receiving user input related to symptom or diagnostic information both before and after treatment (see e.g. Paras. 14, 44) and in which the interface can display symptom improvement or worsening (see e.g. Paras. 47 and 89). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to provide that the user inputs diagnostic or symptom information into a user interface prior to and after activating the laser, because doing so would predictably and advantageously help ensure that the proper therapy is delivered, and to generate graphical data to display symptom improvement or worsening on the user interface, because doing so would predictably and advantageously help provide the user and/or operator with intuitive and easy-to-understand feedback concerning the effectiveness of the therapy, thereby helping to allow them to make any needed adjustments to the therapy.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper as applied to claims 1 and 11 above, and further in view of US 2017/0000946 A1 to Boyle et al. (hereinafter “Boyle”).
Regarding Claims 16 and 18, Zhang as modified above fails to specifically teach transmitting data to a database not located within the laser, specifically usage information used to maintain procedure related inventory. Another reference, Boyle, teaches a medical device which gathers usage data and transmits it to a remotely located database in order to maintain inventory (see e.g. Para. 82). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to transmit usage data to a remote database for maintaining inventory, as seen in Boyle, because doing so would predictably and advantageously help ensure that suitable inventory levels of various system components are maintained, which would help ensure that no lapses in treatment capability occur.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lundahl and Zipper and Zhu as applied to claim 12 above, and further in view of Boyle.
Regarding Claim 17, Zhang as modified above fails to specifically teach transmitting data to a database not located within the laser. Another reference, Boyle, teaches a medical device which gathers usage data and transmits it to a remotely located database in order to maintain inventory (see e.g. Para. 82). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Zhang to transmit usage data to a remote database for maintaining inventory, as seen in Boyle, because doing so would predictably and advantageously help ensure that suitable inventory levels of various system components are maintained, which would help ensure that no lapses in treatment capability occur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792