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 .
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.
Claims 1-14, and 17-18 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 claims 1, 5, and 17, the claims recite, “…to a target through a first medium…”. However, the claimed recitation of a “first medium” is so broad that it could be one of any number of medium (e.g., air, water, solids, or other gases).
Citing MPEP 2163(II)(3a)(ii): “The written description requirement for a claimed genus (i.e., a medium) may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus… [T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. [Ariad, 598 F.3d at 1353–54]. (MPEP 2163, II, 3(a), ii).”
The specification discloses that the medium may be biological tissue (para. [0025]). Although support is provided for delivering light through biological tissue, the claim, as cited, encompasses a range of medium much larger than biological tissue (e.g.,, a medium could be interpreted as anything that propagates waves, which a solid, liquid, and gas can all do). Further, Since the medium is not clearly defined, and the representative species (i.e., biological tissue) is not representative of the broad species of medium, the written description is therefore inadequate to provide ownership of light passing through a first medium while not interacting with a first medium. Further, it is not clear how light would be able to pass through a medium without interacting with the medium (when a photon passes through something, it interacts with it).
Similarly, claim 3 has the same issue as claim 1 since the claim recites a “second medium.” Therefore, claim 3 is also rejected under 35 USC 112(a).
Claims 2-14 are rejected due to their dependency from claim 1. Claim 18 is rejected due to its dependency from claim 17.
Claim 5 recites, “delivering the light through the first medium along a path not intersecting an iris of the eye…” There is no support for the claimed limitation in the instant specification. Claims 6-9 are rejected due to their dependency from claim 1.
Claim 6 recites, “delivering the light through the first medium along the path substantially not intersecting the cornea of the eye.” There is no support for the claimed limitation in the instant specification.
Claim 8 recites, “wherein said delivering excludes delivering along the path traversing aqueous humor.” There is no support for the claimed limitation in the instant specification.
Claim 13 recites, “wherein said first portion of the optical path is a substantially straight linear portion.” There is no support for the claimed limitation in the instant specification.
Claims 1-14 and 17-20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, as detailed above, the examiner contends that the applicant fails to provide how one of ordinary skill in the art would perform the methods of claim 1 as recited. Specifically, it is unclear, due to the breadth of the claim how one would deliver light to a target through a first medium without interacting with the first medium. The recitation of a “medium” is so broad as to encompass any physical matter. The applicant recites a single example of a medium, but a medium encompasses any physical matter. Additionally, what is considered to be “not interacting” is recited so broadly as to encompass all different kinds of interactions. Even the recitation of a “target” is claimed so broadly as to encompass anything the light hits. The Examiner also notes that almost no guidance is provided in the instant specification regarding how the full scope of the claimed method would be performed. The instant specification describes experimenting with simulations to demonstrate that emulsification of a target can be performed with a millisecond laser. However, very little guidance is provided in para. [0049] and [0050] regarding how to perform the claimed method. Given the nature and complexity of the claimed invention, as well as the state of the prior art, one of ordinary skill would not know how to emulsify a target without passing light through a medium, and without thermal diffusion through a target, as claimed. Therefore, the examiner contends that undue experimentation would be required to make/use the full scope of the claimed invention.
Claims 2-14 are rejected due to their dependency from claim 1.
Claim 17 is rejected for the same reason since the claim recites the same subject matter of claim 1 that the specification does not enable is recited in claim 17. Additionally, claim 17 recites the methods of claim 1 as a method of “performing phacolysis surgery.” In addition to the reasons detailed in the enablement rejection of claim 1 above, the recitation of “performing a laser phacolysis” does not remedy the failure to comply with the enablement requirement. Performing a laser phacolysis is still incredibly broad since laser phacolysis can be performed in many different ways. Further, laser phacolysis uses ultrasound waves to break down the lens tissue in the eye. The instant specification does not disclose adequate detail required for enabling the breaking down of lens tissue with ultrasound waves, and the claims merely recite steps generally related to delivering light.. Performing phacolysis is a complicated procedure in nature, and one of ordinary skill would not know how this is achieved. Therefore, the examiner contends that undue experimentation would be required to make/use the full scope of the claimed invention.
Claim 18 is rejected due to its dependency from claim 17, and claim 20 is rejected due to its dependency from claim 18.
Regarding claim 19, the examiner contends that the applicant fails to provide how one of ordinary skill in the art would perform the methods of claim 1 as recited. The recitation of “a method of carrying a phacolysis procedure” is so broad as to encompass any phacolysis procedure, and the claim does not recite specific steps for performing the procedure. The examiner contends that the instant specification does not provide enough detail as to how the procedure is performed without use of a femtosecond laser, without traversing light through the iris, or without forming an incision. The examiner also contends that the specification does not provide enough detail as to how one would be able to deliver pulsed light during this procedure without interacting the light with the clear and without heating the cornea above 65 degrees centigrade. The instant specification merely recites the general language of the claim. Due to the nature and complexity of a phacolysis procedure, and that a phacolysis procedure is typically done with a femtosecond laser (as recited in the instant specification para. [0019] which talks about phacoemulsification with a femtosecond laser), it would require undue experimentation for one of ordinary skill to be able to perform the method of carrying a phacolysis procedure with a millisecond pulse laser, as claimed, in the method of claim 19. Therefore, the examiner contends that undue experimentation would be required to make/use the full scope of the claimed invention.
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 1-20 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 1, the claim recites, “delivering light…to a target” (line 2). However, in line 6, the claim recites, “irradiating a target.” It is unclear if the target in line 6 is the same target from line 2. For this reason, the claim is rendered indefinite. For examination purposes, the target is considered to be the same.
In claim 1, the claim recites, “delivering light…while not interacting the light with the first medium…”. The recitation of the limitation “not interacting the light with the first medium” is so broad that one of ordinary skill would not be able to determine the metes and bounds of the claimed limitation. Delivering light is such a broad methods step that one of ordinary skill would consider there to be many different types of light, and that it is unclear how to deliver said light without interacting with a target. For Examination purposes, it is interpreted that the light is delivered without causing thermal damage to the target.
Further regarding claim 1, the claim recites, “said light is configured such as to ensure that heating of the target is substantially confined to irradiate an area of the target and not lost by thermal diffusion through a target.” The recitation of “substantially confined” is indefinite since it is unclear to one of ordinary skill how confined is considered to be “substantially confined.” Further, in light of the specification, it is unclear how the light is substantially confined. Given the broad, generality of the claim, it is unclear what is “substantially confined” would be given that there are many different steps that could be performed for irradiation and emulsification. Lastly, it is not entirely clear what how light can be “configured.” Thus, the claim is rendered indefinite. For examination purposes, the claim will be interpreted as irradiating a target with light that is able to emulsify or liquify the irradiated area.
Claim 17 is rejected for the same reasons as claim 1 since the method steps of claim 1 are also recited in claim 17.
Claim 18 is rejected due to its dependency from claim 17.
Claims 2-14 are rejected due to their dependency from claim 1.
Regarding claim 4, the claim is generally recited as a method of “delivering light” to a target. The recitation of “not changing a degree of divergence” does not clearly define the scope of the method steps, and does not distinctly point out the invention since one of ordinary skill would not be able to determine the metes and bounds of the claimed limitation. Therefore, the claim is indefinite.
Regarding claim 5, the claim recites, “…delivering the light through the first medium along a path not intersecting an iris of the eye...” The claim is so broad as to encompass a method of delivering light. The limitation of “not intersecting the eye” does distinctly point out the step of delivering the light, and is so broad as to encompass any type of light delivery. Therefore, the metes and bounds of the claim are unclear, and the claim is rendered indefinite. Additionally, claim 5 recites “along a path not substantially coinciding with the optical path of the lens.” The claim is directed to the general step of delivering light. One of ordinary skill in the art would not be able to determine what is “not substantially coinciding with the optical path of the lens.” The claim is therefore rendered indefinite.
Claims 6 and 8 are rejected for the same reason as claim 5.
Claim 9 and 11 recite the limitation "each of said…thermally ablating" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “not heating the cornea above 65 degrees Centigrade.” However, the step of heating the cornea is not recited in the claim or in the claim 1. Therefore, the claim is rendered indefinite.
Claim 12 recites, “wherein said generating light includes generating light at a wavelength substantially overlapping with a spectral range corresponding to an absorption band of water.” The step of “generating” lacks antecedent basis. Further, one of ordinary skill would not be able to determine the metes and bounds of “substantially overlapping” since the claim is generally directed towards light generation and delivery. Therefore, the claim is rendered indefinite.
Claim 13 recites, “wherein said first portion of the optical path is a substantially straight linear portion…”. One of ordinary skill would not be able to determine the metes and bounds of “substantially straight linear portion” since the claim is generally directed towards light generation and delivery. Therefore, the claim is rendered indefinite.
Claim 14 recites, “[a] method according to claim 1, configured to carry out a laser phacoemusification procedure…”. It is unclear how a method can be “configured.” Further, the claim is indefinite since the steps for a laser phacoemuslfication procedure are not recited in the claim. Therefore, the claim is rendered indefinite.
Claim 15 recites, “wherein said apparatus is configured as a laser phacolysis apparatus.” It is unclear what particular elements are included in a laser phacolysis apparatus, and a number of different elements may be interpreted as being included in a laser phacolysis apparatus. Therefore, one of ordinary skill would be able to determine the metes and bounds of the claimed limitation “configured as a laser phacolysis apparatus.” For examination purposes, the claim is interpreted as reciting the intended use of the apparatus, and the limitation therefore does not further limit the structure of the apparatus.
Claims 16-18 are rejected due to their dependency from claim 1.
Regarding claim 16, Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “termination” in claim 16 is used by the claim to mean “the end of the optical fiber,” while the accepted meaning is “the action of bringing something to an end.” The term is indefinite because the specification does not clearly redefine the term. Further, it is unclear what structure is considered to be a “termination” and how it is configured to “spatially converge light.”
Claim 19 recites, “[A] method comprising: carrying a laser phacolysis procedure without the use of a femtosecond laser source and/or without traversing laser light through the iris and/or without forming an incision at the cornea by: delivering pulsed laser light with a millisecond pulse duration from a laser diode source to the lens of an eye through the sclera while not interacting said pulsed laser light with the sclera and with at least a portion of a humor body of the eye along a path of said delivering; and ablating at least a portion of the lens of the eye while not heating the cornea above 65 degrees Centigrade.” The claim is rendered indefinite since the claim generally recites, “carrying a laser phacolysis procedure,” followed by further defining the steps in a method based on what the method doesn’t do (i.e., “without the use of a femtosecond laser source and/or without traversing laser light through the iris and/or without forming an incision at the cornea”; “while not interacting said pulsed laser light with the sclera and with at least a portion of a humor body of the eye along a path of said delivering; and ablating at least a portion of the lens of the eye while not heating the cornea above 65 degrees Centigrade.”). The steps in a laser phacolysis procedure are not definite, and one of ordinary skill would not be able to determine what steps are definitely included in the method of carrying out the procedure. For examination purposes, the claim will only be interpreted based on the positively recited method steps (delivering pulsed laser light…ablating at least a portion…”).
Further regarding claim 19, the claim recites, “the use of a femtosecond laser source,” “the iris,” “the cornea,” “the lens,” “the sclera,” and “the eye.” There is a lack of antecedent basis for the recited terms in the claim.
Regarding claim 20, the claim recites, “configuring said pulsed light.” It is unclear how pulsed light can be configured. For examination purposes, it is interpreted that light configuration is actually referring to changing parameters of the light delivery.
Further regarding claim 20, recitation of “substantially confined” is indefinite since it is unclear to one of ordinary skill how confined is considered to be “substantially confined.” Further, in light of the specification, it is unclear how the light is substantially confined. Given the broad, generality of the claim, it is unclear what is “substantially confined” would be given that there are many different possible steps for irradiation and emulsification.
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.
Claims 1, 3, and 13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Billie et al. (US 5246435 A, “Billie”).
The Examiner notes that independent claim 1 is rejected under 112(a) for failing to comply with the written description requirement, failing to comply with the enablement requirement, and for containing including indefinite subject matter. It is interpreted that claim 1 is method of delivering light for emulsification by heating a target, and that the heat does not cause damage to the tissue. Given the broadest reasonable interpretation, and since the claim recites such a high level of generality, the Examiner contends that Billie teaches the limitations of claim 1.
Regarding claim 1, Billie teaches a method comprising: delivering light, generated by a laser diode source of light (Abstract: “A method for using an ophthalmic laser system to remove cataractous tissue from the lens capsule of an eye requires phacofragmentation of the lens tissue and subsequent aspiration of the treated tissue.”), to a target through a first medium surrounding the target while not interacting the light with the first medium along at least a first portion of an optical path of the light from the laser diode (para. (4): “ How this is done is crucial because, it is extremely important that all photoablation occur within the lens 10 itself.”), said first portion traversing the first medium (the tissue the light irradiates before reaching the lens); irradiating a target with the light (para. (2): “The present invention pertains generally to ophthalmic procedures. More particularly, the present invention pertains to a method for using a cutting beam of laser light to photoablate selected tissue of the eye.”), wherein said light configured such as to ensure that heating of the target, caused by the light, is substantially confined to an irradiated area of the target and not lost by thermal diffusion through the target (para. (9): “Another object of the present invention is to provide a method for using a laser beam to remove cataractous tissue from the lens capsule of an eye which is accomplished by focusing the cutting laser beam through unfragmented tissue to reduce light scattering and improve laser efficiencies.”); and thermally emulsifying or liquifying the irradiated area of the target with the light (abstract: “…which result from the incisions are allowed to infiltrate between the layers of the lens tissue to fragment and liquify the tissue. The liquified lens tissue is then aspirated.”; para. (11): “The present invention pertains to a method for removing cataractous tissue from the lens capsule of an eye. Essentially, this is a two phase procedure wherein the cataractous tissue in the lens capsule is first liquified, and then the liquified tissue is aspirated.”).
Regarding claim 3, Billie teaches a method according to claim 1 (see above), wherein said delivering includes delivering said light through a second medium that is different from the first medium. (para. (2): “More specifically, each of the layers 16 completely surround both the cortex 12 and any of the other layers 16 that are located between that particular layer 16 and the cortex 12.” The layers before the lens could be a first medium, and the anterior capsule 20 would be the second medium”).
Regarding claim 13, Billie teaches the method of claim 1 (see above), wherein said first portion of the optical path is a substantially straight linear portion (Fig. 1; Laser beam 30, beams 32a and 32b, are shown with substantially linear paths.).
Claims 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harrah (“Low-Cost Device for Laser Phacoemulsification: A Preliminary Study”; Published June, 2021).
Regarding claim 15, Harrah discloses an apparatus comprising: a laser diode configured to generate light in a millisecond pulsed regime (pg. 7: “Lastly, the millisecond laser is inspired by the femtosecond laser. This means that the idea of pulsing the laser is not novel, but the alterations in operation parameters and implementing a diode rather than a crystal provide substantial differences.”); and an optical fiber element structured to be cooperated with the laser diode at a proximal end of the optical fiber element to receive the light from the laser diode (pg. 12: “To begin, a small optical fiber will be inserted in the lateral side of the sclera via a small incision. The fiber will then provide a short laser pulse to create a small gap to enter the lens capsule. The laser fiber will then be placed close above the cataract nucleus. The laser will then pulsate to induce the thermal and mechanical changes to the material. This will proceed for a total of ten seconds.” The “optical fiber” as recited by Harrah would be cooperating with the laser; the end of the optical fiber would be considered to be the proximal end.), wherein said apparatus is configured as a laser phacolysis apparatus (pg. 13: “the millisecond phacolysis laser utilizes various laser settings.”).
Regarding claim 16, Harrah teaches an apparatus according to claim 15 (see above), wherein: (16A) said light has a wavelength within an absorption band of water (para. [0047]: “The laser also has a typical laser wavelength of 1480 nanometers, which keeps the laser output within the infrared wavelength range.”); and/or (16B) said light has an average power within a milliwatt range (abstract: “From this, the most favorable power settings were between 1000 milliwatts and 2000 milliwatts.”); and/or (16C) an output surface of a distal end of the optical fiber element is curved; and/or (16D) the distal end of the optical fiber element is equipped with a termination configured to spatially converge light exiting from the distal end upon propagating of such light through the termination.
Conclusion
49. 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), 8am- noon (F).
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/O.L.M./
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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