DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
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. 63/173225, 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.
Application No. 63/173225, fails to provide adequate support for claims 2-8, 10-12, 18-20, 22, 24-25, 29-30 & 33-37, 41-47 & 52-53.
Accordingly, claims 1, 9, 13-17, 21, 23, 26-28, 31-32 , 38-40 & 48-51 are given the priority benefit date of 4/9/2021.
Claims 2-8, 10-12, 18-20, 22, 24-25, 29-30 & 33-37, 41-47 & 52-53 are given the priority benefit date of 4/8/2022.
Drawings
The drawings are objected to because Figs. 1B & 3-7B are shaded.
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 Objections
Claims 4 & 5 are objected to because of the following informalities: amend “a thickness” to -of a thickness--. Appropriate correction is required.
Claims 4 is objected to because of the following informalities: amend “the thickness” to -of the thickness--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “at least on cavity” to -at least one of the cavities-. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “tissue” to -the surface of the eye-. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “the limbus” to -a limbus-. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “depth of insertion” to -insertion depth-. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “each rod” to -a respective rod-. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “the plate” to -the depth-setting plate- (twice). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “the position” to -a position-. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “the plate” to -the depth-setting plate-. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “reduces” to -is configured to reduce-. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “each rod” to -each rod of the plurality of rods-. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “proximally increases an exposed length of each rod” to -proximally is configured to increase the exposed length of each rod of the plurality of rods-. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: amend “the plate” to -the depth-setting plate-. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “each rod” to -each of the plurality of rods-. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “the sclera” to -a sclera-. Appropriate correction is required.
Claims 34 & 35 is objected to because of the following informalities: amend “operates” to -is configured to operate-. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: amend “uses” to -is configured to generate-. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: amend “uses” to -is configured to generate. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: amend “the array” to -the array of rods-. Appropriate correction is required.
Claim 42 is objected to because of the following informalities: amend “the array” to -the array of rods-. Appropriate correction is required.
Claim 42 is objected to because of the following informalities: amend “tissue” to -the surface of the eye-. Appropriate correction is required.
Claim 43 is objected to because of the following informalities: amend “the cavity” to -each of the cavities formed by a respective rod of the array of rods-. Appropriate correction is required.
Claim 44 is objected to because of the following informalities: amend “is automatically advanced” to -is automatically advanceable-. Appropriate correction is required.
Claim 47 is objected to because of the following informalities: amend “an extendable needle” to -a respective extendable needle of the plurality of extendable needles-. Appropriate correction is required.
Applicant is advised that should claims 1 & 26-29 be found allowable, claims 48-52 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 1 positively claims the “energy delivery generator” with the limitation of “an array of rods…electrically-connected to an energy delivery generator-.
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 2-6, 12 & 36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “wherein the surface of the eye includes the sclera”; however, claim 1, upon which claim 2 depends, recites “a surface of the eye” as part of a functional limitation and it is unclear how claim 2 further limits claim 1 since it fails to limit the claim either implicitly or explicitly.
Claims 3-6 depend from claim 2 and are thus also rejected.
Claim 6 recites “resistance to diffusion by the sclera is lowered”; however, since claim 1, upon which claim 2 depends, recites forming cavities to “enhance drainage of aqueous humor from the eye” which results in lowering the “resistance to diffusion by the sclera”, it is unclear how claim 6 further limits claim 1 since it fails to limit the claim either implicitly or explicitly.
Claim 36 recites the limitation “1000V or more” which is an open-ended range and indefinite. For purposes of examination, the claim will be interpreted as -1000 V-.
Claim 12 recites “gauge tool or gauge feature” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 & 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “wherein the surface of the eye includes the sclera”; however, claim 1, upon which claim 2 depends, recites “a surface of the eye” as part of a functional limitation and it is unclear how claim 2 further limits claim 1 since it fails to limit the claim either implicitly or explicitly. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 recites “resistance to diffusion by the sclera is lowered”; however, since claim 1, upon which claim 2 depends, recites forming cavities to “enhance drainage of aqueous humor from the eye” which results in lowering the “resistance to diffusion by the sclera”, it is unclear how claim 6 further limits claim 1 since it fails to limit the claim either implicitly or explicitly. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Claims 3-5 recite limitations relating to the depth of the cavity based on “a thickness of the sclera”. The thickness range of is known to a POSITA and interpreted as being 0.45-1.5 mm as taught by LoRusso (2002/0133184, [0050]).
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: “depth-setting mechanism in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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) 1-9, 26, 32-35, 37, 41-42, 48-49 & 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders et al. (2007/0161981).
Concerning claims 1-2, 6 & 48, as illustrated in at least Figs. 3-5, Sanders et al. disclose an ablation system/device for the treatment of an eye to lower intraocular pressure (system 30 for treating glaucoma comprises probe 32; [0021]), the system/device comprising:
an energy delivery generator (power supply 48; [0021]);
a handle (handle 42; [0021]); and
an array of rods projecting from a distal end region of the handle and electrically-connected to the energy delivery generator (a single electrode or an electrode array may extend form a distal end of the shaft, the rods comprising active electrode 62 and return electrode 64 form a rod that extends from handle 42 and are connected to generator via cable 44; [0021], [0035], [0037-0038]), wherein each rod of the array of rods is configured to create a cavity in a surface of the eye via ab externo tissue ablation to enhance to enhance drainage of aqueous humor from the eye (tissue may be volumetrically removed or destroyed (i.e., ablated to effect molecular dissociation of the tissue structure) to form holes, channels, divots, or other spaces on the trabecular meshwork, such that the electrode array is capable of forming cavities in the surface, including the sclera of the eye, such that resistance to diffusion by the sclera is lowered; [0029]).
Concerning claim 3, Sanders et al. disclose the system (30)/device (32) is capable of forming cavities that have a depth that is less than a full thickness of the sclera ([0029]; Fig. 2A-C).
Concerning claims 4-5, Sanders et al. disclose the system (30)/device (32) is capable of forming cavities that are at least about 70% a thickness of the sclera up to about 90% the thickness of the sclera, or 100% the thickness of the sclera ([0029]; Fig. 2A-C).
Concerning claim 7¸Sanders et al. disclose each rod of the array of rods is square-tipped or rounded in profile ([0037], Fig. 4F-H).
Concerning claim 8¸Sanders et al. disclose a cross-section of each rod of the array of rods is rectangular, circular, triangular, or hexagonal ([0036-0038], Fig. 4F-H).
Concerning claim 9¸Sanders et al. disclose the array of rods is designed to penetrate tissue without applying energy from the energy delivery generator (48) ([0036]; Fig. 4D-E).
Concerning claims 26 & 49, Sanders et al. disclose the energy delivery generator (48) is an external generator coupled to the handle (42) by a cable (44) ([0021]; Fig. 3).
Concerning claim 32, Sanders et al. disclose the energy delivery generator (48) is a bipolar RF generator ([0039]; Fig. 3).
Concerning claim 33, Sanders et al. disclose the array of rods contains two poles (62, 64) ([0037]; Fig. 4A-B).
Concerning claim 34, Sanders et al. disclose the energy deliver generator (48) configured to operate at a frequency in the range of about 350 kHz to 500 kHz ([0039]).
Concerning claim 35, Sanders et al. disclose the energy deliver generator (48) configured to operate at a frequency of 490 kHz ([0039]).
Concerning claim 37, Sanders et al. disclose the bipolar voltage is under 1000 V ([0039-0040]).
Concerning claim 41, Sanders et al. disclose each rod of the array is stationary ([0037]; Fig. 4A-B).
Concerning claim 42, Sanders et al. disclose each rod of the array is hollow for deposition of a substance into the cavity ([0036]).
Concerning claim 51, Sanders et al. disclose the energy delivery generator (48) is a RF generator ([0039]).
Claim Rejections - 35 USC § 102/103
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sanders et al. (2007/0161981), as applied to claim 1.
Concerning claim 10¸Sanders et al. disclose each rod of the array of rods is fixed relative to the distal end region of the handle so that the array of rods forms a footprint having a distal concave contour that complements an external convex contour of a portion of the eye being treated ([0038]). In the alternative, Sanders et al. each a variety of geometries such as concave, convex, hemispherical for use in reshaping procedures ([0038]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sanders et al. such that the array of rods forms a footprint having a distal concave contour that complements an external convex contour of a portion of the eye being treated is of whatever desired or expedient form or shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 1-6, 9, 12, 26, 38-39 & 48-49 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Herekar et al. (2018/0207029), or, in the alternative, under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels et al. (WO92/19167).
Concerning claims 1 & 48, as illustrated in at least Figs. 4A-9C, Herekar et al. disclose an ablation system/device for the treatment of an eye to lower intraocular pressure (systems to treat glaucoma by lowering intraocular; [0006], [0051]), the system/device comprising:
an energy delivery generator (energy may comprise energy from one or more of a pulsed laser, a continuous laser, a pulsed ultrasound transducer, a HIFU array, or a phased HIFU array, where the light outputs may be replaced by radiofrequency electrodes or the like; [0026], [0036], [0077], [0185], [0211], [0315]);
a handle (handpiece of probe in Fig. 9B); and
an array of rods projecting from a distal end region of the handle and electrically-connected to the energy delivery generator (outputs may be radiofrequency electrodes and/or electroporation needles in a shaped array; [0165], [0311], [0315], [0319]), wherein each rod of the array of rods is configured to create a cavity in a surface of the eye via ab externo tissue ablation to enhance to enhance drainage of aqueous humor from the eye (vacuoles in the sclera are generated with the energy; [0037], [0077], [0185], [0210]).
In the alternative, while Herekar et al. teach electroporation rods comprising needles or shaped contact electrodes without needles in a shaped array ([0165]), Herekar et al. fail to specifically relate the rod array to have the capability of creating the vacuoles/cavities. However, Reimels discloses an ablation system/device for glaucoma treatment comprising a rod (18) projecting from a distal end of handle (42) that is used to create a cavity (52) in a surface of the eye to enhance drainage of aqueous humor from the eye (Pg. 11-12, ll. 34-9). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. such that the array of rods of Herekar et al. is specifically configured to create cavities in the surface of the eye via ab externo tissue ablation to enhance drainage of aqueous humor from the eye in order to provide the benefit of also cauterizing bleeding from blood vessels in the puncture area as taught by Reimels. (Pg. 11-12, ll. 34-8; Fig. 1-4)
Concerning claim 2, Herekar et al. disclose the surface of the eye includes the sclera (102) ([0243]; Fig. 1).
Concerning claim 3, Herekar et al. disclose each cavity can have a depth that is less than a full thickness of the sclera ([0069], [0201]).
Concerning claim 4, Herekar et al. disclose each cavity can be at least about 70%-90% the thickness of the sclera ([0069], [0201]).
Concerning claim 5, Herekar et al. disclose at last one cavity can be 100% a thickness of the sclera ([0069], [0201]).
Concerning claim 6, Herekar et al. disclose resistance to diffusion by the sclera is lowered ([0051]).
Concerning claim 9, Herekar et al. further disclose the array of rods is designed to penetrate tissue without applying energy from the energy delivery generator ([0165]).
Concerning claim 12, Herekar et al. disclose a gauge tool or feature near a distal end of the device to align the array a selected distance form the lumbus of the eye ([0321-0324]).
Concerning claims 26 & 49, Herekar et al. disclose the energy generator is an external generator coupled to the handle by a cable (Fig. 9A-C).
Concerning claim 38, Herekar et al. disclose the energy delivery generator uses high voltage pulses ([0077], [0185], [0319]).
Concerning claim 39, Herekar et al. disclose the energy delivery generator is an ultrasonic energy generator ([0026], [0077], [0166], [0185], [0319]).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 8-9, 21, 23, 26, 31, 42 & 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hood et al. (2004/0049186) in view of Reimels (WO 92/19167).
Concerning claims 1 & 48, as illustrated in at least Figs. 1 & 7, Hood et al. disclose an ablation system/device for the treatment of an eye to lower intraocular pressure (probe 60 for use on eye; [0063]), the device comprising:
an energy delivery generator (power supply 14; [0044]);
a handle (handle, not shown; [0063]); and
an array of rods projecting from a distal end region of the handle and electrically-connected to an energy delivery generator (electrodes 62 project from handle and are used as a uni-polar device, wherein the current flows through the tissue from power supply unit 14; [0049]), wherein each rod of the array of rods is configured to create a cavity in a surface of the eye via ab externo tissue treatment to enhance drainage of aqueous humor from the eye (electrodes 62 are capable of creating cavities in surface of the eye via ab externo tissue treatment to enhance drainage due to the sharpened tip; [0016]).
Hood et al. fails to disclose the array of rods configured to create the cavity in the eye surface via ab externo tissue ablation. However, Reimels discloses a system/device comprising an energy delivery generator (RF source) and a rod (18) configured to create a cavity (52) in a surface of the eye via ab externo tissue treatment 200 to enhance drainage of aqueous humor from the eye. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Hood et al. such that the array of rods configured to create the cavity in the eye surface via ab externo tissue ablation in order to provide the benefit of relieving symptoms of glaucoma as taught by Reimels. (Pg. 1, ll. 6-8
Concerning claim 8, Hood et al. disclose the cross-section of each rod of the array of rods (62) to be circular in cross-section (Fig. 7).
Concerning claim 9, Hood et al. disclose the array of rods (62) designed to penetrate tissue without applying energy from the energy delivery generator ([0016]; Fig. 7).
Concerning claim 21, Hood et al. disclose each rod (62) has an exposed length available to extend within the surface of the eye (Fig. 7).
Concerning claim 23, Hood et al. disclose the exposed length is adjustable ([0064]; Fig. 7).
Concerning claims 26 & 49, Hood et al. disclose the energy delivery generator (14) is an external generator coupled to the handle by a cable (18) (Fig. 1).
Concerning claim 31, Hood et al. disclose the generator is a monopolar or bipolar RF generator ([0049], [0055]).
Concerning claim 42, Hood et al. disclose each rod (62) of the array of rods is movable relative to the handle (proximal) so as to extend distally to penetrate tissue upon actuation ([0064]; Fig. 7).
Claim(s) 31 & 36 is/are rejected under 35 U.S.C. 103 as obvious over Sanders et al. (2007/0161981), as applied to claim 1, in further view of Baerveldt et al. (2002/0111608).
Concerning claim 31, Sanders et al. disclose the energy delivery generator is a RF generator ([0039]). Sanders et al. fail to disclose the energy deliver generator is a monopolar generator. However, Baerveldt et al. disclose an ablation device for eye treatment with an energy delivery generator that is either monopolar or bipolar ([0182]).
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Sanders et al. such that the generator is a monopolar RF generator, since Applicant has not disclosed that the monopolar generator solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either a monopolar or bipolar generator as Baerveldt et al. teaches monopolar and bipolar generators to be equivalents in the art for the purposes of ablating ocular tissue.
Concerning claim 36, Sanders et al. in view of Baerveldt et al. fail to specifically disclose the monopolar voltage to be 1000 V or more. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sanders et al. in view of Baerveldt et al. such that the monopolar voltage is 1000 V, since Applicant has placed no criticality on the value (“Monopolar voltage can be 1000 V or greater” and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 8, 10-11, 32-33 & 41 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claims 1 & 48,
Concerning claim 8, Herekar et al. fail disclose the cross-section of each rod of the array of rods is rectangular, circular, triangular or hexagonal. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Herekar et al. such that the cross-section of each rod of the array of rods is rectangular, circular, triangular or hexagonal and is thus of whatever desired or expedient form or shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Concerning claims 10-11, Reimels et al. further disclose the rod (18) is fixed relative to the distal end region of the handle (14) (Fig. 1). Herekar et al. further disclose multiple treatment annuli forming a footprint on the distal surface that has a concave shape to engage the external convex contour of the eye, the footprint of the array conforming generally to the external convex contour when a longitudinal axis of the handle is aligned perpendicular to a point of contact with the eye ([0165], [0316]; Fig. 4C-5B & Fig. 9A). Thus, the modified invention of Herekar et al. in view of Reimels et al. disclose each rod of the array of rods is fixed relative to the distal end region of the handle so that the array of rods forms a footprint having a distal concave contour that complements an external convex contour of a portion of the eye being treated, the footprint of the array conforms generally to the external convex contour when a longitudinal axis of the handle is aligned perpendicular to a point of contact with the eye. In, the alternative, based on the teachings of Herekar et al. it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that each rod of the array of rods is fixed relative to the distal end region of the handle so that the array of rods forms a footprint having a distal concave contour that complements an external convex contour of a portion of the eye being treated, the footprint of the array conforms generally to the external convex contour when a longitudinal axis of the handle is aligned perpendicular to a point of contact with the eye in order to provide the benefit of a shape that engages the eye as taught by Herekar et al.
Concerning claim 21, Reimels et al. further disclose the rod (18) has an exposed length available to extend within the surface of the eye (Fig. 2).
Concerning claim 22, Herekar et al. disclose the treatment depth can be greater than a known thickness of the sclera ([0201]) and thus the modified invention teaches the exposed length is greater than a thickness of the sclera.
Concerning claim 32, Reimels et al. further disclose the energy generator is a bipolar RF generator (Pg. 5-6, ll. 29-14, Pg. 9, ll. 8-17).
Concerning claim 33, Reimels et al. further disclose the rod (18) contains two poles (20 & 24 or 12) (Pg. 5-6, ll. 29-14; Fig. 2).
Concerning claim 41, Reimels et al. further disclose the rod (18) is stationary (Fig. 1).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029), as applied to claim 1.
Concerning claim 40, Herekar et al. disclose the energy delivery generator is an electroporation generator ([0077], [0185]). Herekar et al. fail to specifically disclose the electroporation generator to be an irreversible electroporation generator. However, since Herekar et al. teach forming the vacuoles as a means to lower intraocular pressure ([0051]) and there are only two types of electroporation energy, reversible and irreversible, it would have been an obvious matter of choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Herekar et al. in view of Reimels such that the electroporation generator is an irreversible electroporation generator in order to provide the benefit of forming vacuoles that are permanent and lead to permanent lowering of intraocular pressure.
Claim(s) 13-20, 23 & 44 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claims 1 & 48, in further view of Lerner (2013/0296825).
Concerning claims 13-16, while Herekar et al. disclose forming cavities of various depths ([0069], [0201]), Herekar et al. in view of Reimels et al. fail to disclose an adjustable depth-setting mechanism configured to control depth of insertion of the array that comprises an actuator coupled to a depth setting plate having a plurality of openings extending through its thickness, each opening of the plurality of openings is sized and shaped to receive each rod of the array of rods so that the array of rods projects a distance distal to the plate. However, Lerner discloses a device for treatment of the eye comprising an adjustable depth-setting mechanism (9, 13) configured to control depth of insertion of a needle (11) having an exposed length available to extend within the surface of the eye that comprises an actuator (9) coupled to a depth setting plate (13) having an opening extending through its thickness sized and shaped to receive a needle that projects a distance distal to the plate (13) when deployed. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. to further comprise an adjustable depth-setting mechanism configured to control depth of insertion of the array that comprises an actuator coupled to a depth setting plate having a plurality of openings extending through its thickness, each opening of the plurality of openings is sized and shaped to receive each rod of the array of rods so that the array of rods projects a distance distal to the plate in order to provide the benefit of controlling the maximum length of needle exposure during deployment as taught by Lerner. ([0206]; Fig. 19-20).
Concerning claim 17, Lerner et al. further disclose a position of the plate (13) relative to the distal end region of a handle sets a length of the needle (11) that is exposed distal to the plate (13) ([0206]; Fig. 19-20).
Concerning claim 18¸Lerner et al. further disclose the actuator (9) configured to incrementally change a position of the plate (13) ([0206]; Fig. 19-20).
Concerning claim 19¸Lerner et al. further disclose actuating the actuator (9) to advance the depth setting plate (13) distally reduces an exposed length of the needle (11) wherein actuating the actuator (9) to retract the depth setting plate (13) proximally increases an exposed length of the needle (11) ([0206]; Fig. 19-20).
Concerning claim 20, Lerner et al. further disclose the depth setting mechanism (9, 13) further comprises a locking mechanism (Back-stop) configured to fix a position of the plate (13) ([0206]; Fig. 19-20).
Claim 23 is rejected upon the same rationale as applied to claim 13.
Concerning claim 44, Herekar et al. in view of Reimels et al. fail to disclose each rod of the array of rods is automatically advanced to a fixed target depth. However, Lerner discloses a device for treatment of the eye comprising a manually, partially automatically or automatically advanceable rod (11) that is advanced to a fixed target depth ([0009], [0205]; Fig. 19-20). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Herekar et al. in view of Reimels et al. such that each rod of the array of rods is automatically advanced to a fixed target depth since Lerner teaches manual, partially automated, and automated actuation of an ocular rod to be equivalents in the art, and since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claim 1, in further view of Yamamoto et al. (2002/0072673).
Concerning claim 24, Herekar et al. in view of Reimels et al. fail to disclose the one or more rods of the array to be hollow and usable as a flashback indicator for detecting liquid. However, Yamamoto et al. disclose a hollow needle tip that can be used as a flashback indicator of aqueous humour. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that the one or more rods of the array to be hollow and usable as a flashback indicator for detecting liquid in order to provide the benefit of determining proper access of the tip as taught by Yamamoto et al. ([0101])
Claim(s) 25, 27 & 50 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claims 1 & 48, in further view of Andino et al. (2019/0307606).
Concerning claim 25, Herekar et al. in view of Reimels et al. fail to disclose one or more rods of the array of rods is a depth sensor. However, Andino et al. disclose a device for eye treatment where a rod (13966) is a depth sensor (13520, 13525). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that one or more rods of the array of rods is a depth sensor in order to provide the benefit of depth control as taught by Andino et al. ([0201]; Fig. 29-20)
Concerning claims 27 & 50¸Herekar et al. in view of Reimels et al. fail to disclose the energy delivery generator is integrated into the handle. However, Andino et al. disclose a device for eye treatment where an energy delivery generator (2650) can be included in a stand-alone housing or any portion of the device (2000) ([1115]). It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Herekar et al. in view of Reimels et al. such that the energy delivery generator is integrated into the handle, since Applicant has not disclosed that the monopolar generator solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the energy source external to or integral with the handle as Andino et al. energy sources external to or integral with the handle to be equivalents in the art for the purposes of treating eye tissue.
Claim 28 is rejected upon the same rationale as applied to claim 32.
Claim(s) 29-30 & 52-53 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167) and Andino et al. (2019/0307606), as applied to claim 27, in further view of O’Brien, III et al. (9,629,991).
Concerning claims 29-30, Herekar et al. in view of Reimels and Andino et al. disclose the energy delivery generator is integrated within a proximal portion of the handle. Herekar et al. in view of Reimels and Andino et al. fail to disclose the proximal handle portion to be a reusable portion of the handle designed to operatively couple with a distal, disposable portion of the handle. However, O’Brien, III et al. disclose a treatment device a proximal, reusable portion of a handle (120), the reusable portion of the handle is (120) designed to operatively couple with a distal, disposable needle portion (160) of the handle (120) via attachment feature (170) that is a snap-fit type or threaded. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that the proximal handle portion is a reusable portion of the handle designed to operatively couple with a distal, disposable portion of the handle in order to provide the benefit of preventing contamination from one patient to another as taught by O’Brien, III et al. (Col. 1, ll. 25-40, Col. 4-5, ll. 64-11; Fig. 1)
Claim 52 is rejected upon the same rationale as applied to claims 48 & 29.
Concerning claim 53, O’Brien, III et al. further disclose the distal disposable portion (160) comprising the array of rods (Col. 4-5, ll. 64-11; Fig. 1).
Claim(s) 43 & 47 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claim 1, in further view of LoRusso (2002/0133184).
Concerning claim 43¸ Herekar et al. in view of Reimels et al. fail to disclose each rod of the array of rods is hollow for deposition of a substance to the cavities formed by the rods. However, LoRusso discloses a device (200) for eye treatment comprising a rod (210) that is hollow for deposition of a substance to the cavities formed by the rods. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that each rod of the array of rods is hollow for deposition of a substance to the cavities formed by the rods in order to provide the benefit of transferring material from the treatment space as taught by LoRusso. ([0026], [0029], [0034])
Concerning claim 47, Herekar et al. in view of Reimels et al. fail to disclose a plurality of extendable needles, each rod of the array comprising an extendable needle. However, LoRusso discloses a device (200) for eye treatment comprising a rod (210) comprising an extendable needle (214). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. such that each rod of the array comprises an extendable needle in order to provide the benefit of draining fluid below the treated section as taught by LoRusso ([0056-0059; Fig. 4A-B).
Claim(s) 45-46 is/are rejected under 35 U.S.C. 103 as obvious over Herekar et al. (2018/0207029) in view of Reimels (WO92/19167), as applied to claim 1, in further view of Lerner (2013/0296825) and Andino et al. (2019/0307606).
Concerning claims 45-46, Herekar et al. in view of Reimels et al. fail to disclose Herekar et al. in view of Reimels et al. fail to disclose each rod of the array of rods is automatically advanced to a target depth. However, Lerner discloses a device for treatment of the eye comprising a manually, partially automatically or automatically advanceable rod (11) that is advanced to a fixed target depth ([0009], [0205]; Fig. 19-20). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Herekar et al. in view of Reimels et al. such that each rod of the array of rods is automatically advanced to a fixed target depth since Lerner teaches manual, partially automated, and automated actuation of an ocular rod to be equivalents in the art, and since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192. Herekar et al. in view of Reimels et al. and Lerner fail to specifically disclose the rods automatically advanced to a depth determined by a sensor of the device. However, Andino et al. disclose a device for eye treatment where a rod (13966) is a physical depth sensor (13520, 13525) is used for depth control. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Herekar et al. in view of Reimels et al. and Lerner such the depth is determined by a sensor of the device in order to provide the benefit of depth control as taught by Andino et al. ([0201]; Fig. 29-20)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Andino et al. (WO2017/192565) forms a cavity in the sclera via fluid jet for drug delivery to the suprachoroidal space (Fig. 16) or via a microneedle assembly that extends through to the suprachoroidal space (Fig. 33-34). Manstein (2005/0222565) teach a needle array with a depth-setting mechanism (315) (Fig. 3).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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