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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/22/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numerals “31” and “33” in Fig. 3; reference numeral “58” in Fig. 5; reference numeral “63” in Fig. 6; and reference numeral “92” in Fig. 9. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract is objected to for being greater than 150 words in length. 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 1-30 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 1 (and thereby dependent claims 2-14 and 26-30) recites the limitation "blade" in line 10 of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 2 recites the limitation "a first end of the blade" in line 2 of the claim. Claim 1 already introduces “a first end of the blade” in line 3 of claim 1. Amending claim 2, such as “[[a]] the first end of the blade” will moot this rejection. Appropriate correction is required.
Claim 5 (and thereby dependent claims 6-8) recites the limitation "the tip portion" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 10 recites the limitation "blade" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 11, the phrase "may be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required.
Regarding claim 12, the phrase "other materials" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "other materials"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Appropriate correction is required.
Regarding claim 15 (and thereby dependent claims 16-18), the phrase "a material selected for a predetermined characteristic" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "a material selected for a predetermined characteristic"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Appropriate correction is required.
Claim 16 recites the limitation "the drug" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 20 (and thereby dependent claims 21-24 and 27-30), the phrase "a polymer selected for a predetermined property" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "a polymer selected for a predetermined property"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Appropriate correction is required.
Regarding claim 20 (and thereby dependent claims 21-24 and 27-30), the phrase "a thickness of the sleeve selected based on a type of tissue to be cut and/or dissected" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "a thickness of the sleeve selected based on a type of tissue to be cut and/or dissected"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Appropriate correction is required.
Claim 20 (and thereby dependent claims 21-24 and 27-30) recites the limitation "blade" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 21, the phrase "selected from … and …" renders the claim(s) indefinite because either (1) the claim is not written in the alternative using “or” as required or (2) fails to use “consisting of” as required (e.g. “a polymer selected from the group consisting of”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(h). Appropriate correction is required.
Regarding claim 25 (and thereby dependent claim 26), the phrase "applying a predetermined amount of pressure of the first tissue location" (emphasis added) in line 6 renders the claim(s) indefinite because it is unclear how one applies pressure “of the first tissue location”, thereby rendering the scope of the claim(s) unascertainable. Appropriate correction is required.
Regarding claim 30, the phrase "of any of claim 27" in line 1 renders the claim(s) indefinite because the phrasing infers multiple option of claims but only claim 27 is listed (i.e., very unclear/ambiguous language to be corrected), thereby rendering the scope of the claim(s) unascertainable. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 5, 9-13, 20-21 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eaton et al. (US 5,312,413).
Eaton discloses (see Figs. 3A-3D) an ophthalmic cutting device comprising the following claim limitations:
(claim 1) A surgical instrument assembly comprising a blade (25, Fig. 3A) having a diameter greater than about 34 gauge (col. 3, lines 26-39; inventive sheath expressly used with a conventional phacoknife having a 3.2mm wide diameter (i.e. greater/larger than 34 gauge)) comprising a cutting surface (i.e. distally-tapering triangular cutting edges) positioned at a first end (i.e. distal end) of the blade (25) and configured to (i.e. capable of) cut an eye tissue (see abstract; Figs. 1-2; col. 4, lines 36-47); a sleeve (28, Fig. 3A) positioned proximate at least a portion of the blade (25) (as expressly shown in Figs. 3A-3B) and configured to (i.e. capable of) displace at least some tissue proximate a predetermined cut location during use and further to control a depth to which the cutting surface of the blade enters tissue at the predetermined cut location during use and wherein the sleeve (28) is positioned such that the sleeve (28) substantially remains outside the surface of the eye during use (as expressly shown in Figs. 3C-3D; blunt distal end 29 of sheath 28 fully capable of providing an abutment shoulder to press against and displace tissue within the procedure tunnel and further limit the depth of penetration of blade 25); a shaft (26, Fig. 3A) coupled to blade (25); and wherein the sleeve (28) surrounds at least a portion of the blade (25) (as expressly shown in Figs. 3A-3B);
(claim 2) wherein the diameter of the blade (25) at a first end (i.e. widest proximal end of the diverging cutting edges) of the blade (25) comprises greater than about 27 gauge, greater than about 25 gauge, or greater than about 23 gauge (col. 3, lines 26-39; inventive sheath expressly used with a conventional phacoknife having a 3.2mm wide diameter (i.e. greater/larger than 34 gauge));
(claim 5) wherein the blade (25) comprises a tip section (i.e. angled portion of blade 25, as shown in annotated Fig. 3D below) and a proximate section (i.e. proximal end of blade 25 along longitudinal axis of device/shaft 26) positioned such that an angle between the tip portion and the proximate section is in a range from about 45 degrees to about 135 degrees (col. 3, lines 26-39; inventive sheath expressly used with a conventional phacoknife expressly having a 45 degree angle divergence from the device longitudinal axis);
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(claim 9) wherein the blade (25) comprises a proximate section (as shown in annotated Fig. 3D above); and wherein the proximate section and the shaft (26) are angled in a range from about 0 degrees to about 15 degrees to enable an improved angle of approach to the retina (as shown in annotated Fig. 3D above, proximate section and shaft expressly depicted angled at 0 degrees);
(claim 10) wherein blade (25) comprises a tip section (as shown in annotated Fig. 3D above) having an exposed section that has a length in a range from about 0.5 mm to about 2 mm (as shown between Figs. 3B and 3D, selective manual retraction of sleeve 28 allows for any and all customized ranges of tip exposure between no exposure (Fig. 3B) to full exposure (Fig. 3D)); and wherein the sleeve (28) comprises a semi-rigid polymer selected based on a type of membrane to be cut, peeled, or dissected (col. 4, lines 30-36; col. 8, lines 54-56; col. 9, lines 3-5 and 22-24; expressly disclosed sleeve material range from compliant plastics to more rigid and less compliant materials such as sheet metal or non-pliant plastic);
(claim 11) wherein the sleeve (28) comprises a polymer guard comprising heat-shrinking polymer (col. 4, lines 30-31; pliable polymer/plastic material expressly disclosed; the claimed “heat-shrinking polymer” is interpreted as product-by-process wherein the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two (i.e. the polymer sleeves of the present invention and Eaton); see In re Marosi, 218 USPQ 289 (Fed. Cir. 1983)), wherein the blade (25) is surrounded at least in part by the polymer guard (28) (as expressly shown in Figs. 3A-3B), and wherein the blade (25) may be further secured to the polymer guard (28) with medical grade epoxy (the claim language “may be” is interpreted as being optional and therefore not required to read on the claim; sleeve 28 and blade 25 are fully capable of being secured together with epoxy if one so desires);
(claim 12) wherein the sleeve (28) comprises a polymer material comprising at least one of a medical grade fluoroelastomer, polyolefin, polyvinylidene fluoride, silicone, silicone rubber, polyethylene, polyester, polyester block amide (PEBA) and other materials suitable for heat shrink tubing (col. 4, lines 30-31; silicone rubber material expressly disclosed);
(claim 13) wherein the sleeve comprises a guard (28) having a tip (i.e. distal end portion) fitted to the blade (as expressly shown in Figs. 3A-3B) and polymer material (col. 4, lines 30-31; pliable polymer/plastic material expressly disclosed); wherein the tip is fitted by applying heat to shrink the polymer material to form a tight fit (col. 4, lines 30-31; pliable polymer/plastic material expressly disclosed; the claimed “heat-shrinking polymer” is interpreted as product-by-process wherein the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two (i.e. the polymer sleeves of the present invention and Eaton); see In re Marosi, 218 USPQ 289 (Fed. Cir. 1983));
(claim 20) A surgical instrument assembly comprising a blade (25, Fig. 3A) having a diameter greater than about 34 gauge (col. 3, lines 26-39; inventive sheath expressly used with a conventional phacoknife having a 3.2mm wide diameter (i.e. greater/larger than 34 gauge)) comprising a material selected for a predetermined characteristic (col. 3, lines 26-39; inventive sheath expressly used with conventional phacoknives composed of material selected for ophthalmic surgical purposes, such as the Beaver Item 5522 instrument and/or the Alcon Ophthalmic Slit Knife); a cutting surface (i.e. distally-tapering triangular cutting edges) positioned at a first end (i.e. distal end) of the blade (25) and configured to (i.e. capable of) cut tissue (col. 4, lines 36-47; blade 25 expressly cuts tissue); a sleeve (28, Fig. 3A) positioned proximate at least a portion of the blade (25) (as expressly shown in Figs. 3A-3B) comprising a polymer selected for a predetermined property (col. 4, lines 30-36; pliable plastic or silicone rubber materials expressly disclosed for their preferred properties); a thickness of the sleeve (28) selected based on a type of tissue to be cut and/or dissected (as shown in Figs. 3A-3D; col. 4, lines 27-68; sleeve 28 materials and dimensions selected for the ophthalmic procedure); and wherein the sleeve (28) is configured to (i.e. capable of) displace at least some tissue proximate a predetermined cut location during, wherein the sleeve ()28 controls a depth to which the cutting surface of the blade enters the tissue at the predetermined cut location during use (as expressly shown in Figs. 3C-3D; blunt distal end 29 of sheath 28 fully capable of providing an abutment shoulder to press against tissue and displace tissue within the procedure tunnel and further limit the depth of penetration of blade 25), and wherein the polymer selected for the sleeve (28) allows the sleeve (28) to substantially remain at or above a surface of the eye during use (as expressly shown in Figs. 3C-3D; blunt distal end 29 of sheath 28 fully capable of providing an abutment shoulder to press against tissue and limit the depth of penetration of blade 25); and a shaft (26) coupled to blade (25) (as shown in Fig. 3A); and wherein the sleeve (28) surrounds at least a portion of the blade (25) (as shown in Figs. 3A-3B);
(claim 21) wherein the polymer selected for a predetermined property is selected from medical grade fluoropolymer, fluoroelastomer, polyolefin, polyvinylidene fluoride, silicone, silicone rubber, polyethylene, polyester, and polyester block amide (PEBA) (col. 4, lines 30-31; sleeve expressly disclosed to be composed of pliable plastic/polymer material including silicone rubber);
(claim 25) A method of dissecting tissue from an eye (see abstract; col. 1, lines 15-17 and 33-56; col. 3, line 37-col. 4, line 16; col. 4, lines 36-47; methods of cataract surgery and cataract removal expressly disclosed) comprising positioning a vitreoretinal surgical instrument proximate a first tissue location (col. 4, lines 36-47; device of Figs. 3A-3D expressly positioned at the end of the tunnel cut), wherein the vitreoretinal surgical instrument comprises a blade (25, Fig. 3A) having a cutting surface (i.e. distally-tapering triangular cutting edges); a sleeve (28, Fig. 3A) on the blade (25) (as expressly shown in Fig. 3A); and applying a predetermined amount of pressure of the first tissue location to deflect an area of tissue to be cut and/or dissected during use (col. 4, lines 36-47; distal end 29 of sleeve 28 applies pressure to deflect tissue of the tunnel cut during positioning and, upon sleeve 28 retraction, blade 25 then also applies pressure to deflect and then cut tissue); and
(claim 26) wherein the surgical instrument is a surgical instrument of any of claims 1 or 20 (as set forth in the rejections of claims 1 and 20 above).
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Betts (US 2010/0249785).
Betts discloses (see Figs. 1-3) a similar surgical cutting device (10) comprising the following claim limitations:
(claim 1) A surgical instrument assembly comprising a blade (26, Figs. 1-3) having a diameter greater than about 34 gauge ([0038]; each blade 26 expressly has a width/diameter of 0.5 mm to 10 mm (i.e. greater than 34 gauge)) comprising a cutting surface ([0009]; sharpened blade edges expressly disclosed) positioned at a first end (i.e. adjacent distal end 16 in Figs. 1-2) of the blade (26) and configured to (i.e. capable of) cut an eye tissue ([0009]; blade capable of cutting tissue expressly disclosed); a sleeve (12, Figs. 1-3) positioned proximate at least a portion of the blade (26) (as expressly shown in Figs. 1-2) and configured to (i.e. capable of) displace at least some tissue proximate a predetermined cut location during use (as shown between Figs. 1-2, expansion of blades 26 shown fully capable of outwardly displacing tissue) and further to control a depth to which the cutting surface of the blade (26) enters tissue at the predetermined cut location during use (as shown between Figs. 1-2, the amount of blade 26 exposed from within sleeve 12 selectively adjusts the depth/diameter of the tissue to be cut) and wherein the sleeve (12) is positioned such that the sleeve (12) substantially remains outside the surface of the eye during use (as shown in Fig. 2-3, cutting via rotation of device 10 only cuts tissue laterally outward from sleeve 12 at the radially deflected curved blades 26); a shaft (20, Figs. 1-3) coupled to blade (26) (as shown in Figs. 1-2); and wherein the sleeve (12) surrounds at least a portion of the blade (26) (as expressly shown in Figs. 1-2; blade 26 portions expressly shown within sleeve 12);
(claim 2) wherein the diameter of the blade (26) at a first end of the blade comprises greater than about 27 gauge, greater than about 25 gauge, or greater than about 23 gauge ([0038]; each blade 26 expressly has a width/diameter of 0.5 mm to 10 mm (i.e. greater than 23, 25 or 27 gauges));
(claim 3) wherein the shaft (20) comprises a stainless steel or titanium rod ([0054]; shaft attached to blade expressly composed of stainless steel);
(claim 4) wherein an end (at 22) of the shaft (20) tapers to the blade (26) (as shown in Figs. 1-2, proximal end 22 tapers distally to/toward the blade 26);
(claim 5) wherein the blade (26) comprises a tip section (as shown in annotated Fig. 2 below, tip portion parallel to the device longitudinal axis and embedded in distal end 16) and a proximate section (i.e. as shown in annotated Fig. 2 below, exposed blade portion) positioned such that an angle between the tip portion and the proximate section is in a range from about 45 degrees to about 135 degrees (i.e. as shown in annotated Fig. 2 below, bend creating the semicircular exposed blade portion forms approximately 90 degree bend as blade 26 exits slot 27 in sleeve 12);
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(claim 6) wherein the angle is about 90 degrees (i.e. as shown in annotated Fig. 2 above, bend creating the semicircular exposed blade portion forms approximately 90 degree bend as blade 26 exits slot 27 in sleeve 12);
(claim 7) wherein the blade (26) comprises a shape-memory metal ([0009]; Nitinol expressly disclosed);
(claim 8) wherein the blade (26) can be configured to (i.e. capable of) have a first angle and a second angle, wherein the first angle is present when the blade (26) is deformed (as shown in Fig. 2-3) and the second angle is present when the blade (26) is not deformed (as shown in Fig. 1); and
(claim 9) wherein the blade (26) comprises a proximate section (as shown in annotated Fig. 1 below); and wherein the proximate section and the shaft (20) are angled in a range from about 0 degrees to about 15 degrees to enable an improved angle of approach to the retina (as shown in annotated Fig. 1 below, both the shaft and proximate section are parallel with the device longitudinal axis and therefore angled at 0 degrees relative to each other).
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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.
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) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton as applied to claim 1 above, and further in view of Wishinsky (US 5,217,476).
Eaton, as applied above, discloses an ophthalmic cutting device comprising all the limitations of the claim except for the shaft comprising a stainless steel or titanium rod and the shaft tapers to the blade. However, Wishinsky teaches (see Fig. 1) a similar cataract cutting device including a shaft (22, Fig. 1) comprising a stainless steel or titanium rod (col. 5, lines 26-43; stainless steel expressly disclosed) and the shaft (22) tapers (at 24) to the blade (10, Fig. 1) in order to beneficially provide a shaft made from material suitable to be inserted in the body with the shaft further providing desirable configuration to be easily and comfortably grasped by a surgeon to manipulate the blade (col. 4, lines 33-44; col. 5, lines 26-28). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Eaton to have the shaft comprising a stainless steel or titanium rod and the shaft tapers to the blade in order to beneficially provide a shaft made from material suitable to be inserted in the body with the shaft further providing desirable configuration to be easily and comfortably grasped by a surgeon to manipulate the blade, as taught by Wishinsky.
Claim(s) 14 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton as applied to claims 1 and 20 above.
Eaton discloses the claimed invention except for the sleeve having a thickness ranging from 0.1 mm to about 1 mm. However, it would have been obvious to construct the device of Eaton with the sleeve having a thickness ranging from 0.1 mm to about 1 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 15-19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Eaton as applied to claims 1 and 20 above, and further in view of Lamson et al. (US 2006/0276871).
Eaton, as applied above, discloses an ophthalmic cutting device comprising all the limitations of the claim except for the sleeve comprising an impregnated wound-healing/anti-VEGF drug, such as bevacizumab (Avastin).
However, Lamson teaches a similar surgical instrument and system comprising every component of the surgical system being impregnated/embedded with a drug such as bevacizumab (Avastin) in order to beneficially inhibit angiogenesis by blocking vascular endothelial growth factors ([0196]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/system of Eaton to have every component of the surgical system impregnated/embedded with a drug such as bevacizumab (Avastin) in order to beneficially inhibit angiogenesis by blocking vascular endothelial growth factors, as taught by Lamson.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Eaton as applied to claim 20 above, and further in view of Betts (US 2010/0249785).
Eaton, as applied above, discloses an ophthalmic cutting device comprising all the limitations of the claim except for the selected blade material comprising titanium, stainless steel, or nitinol. However, Betts teaches (see Fig. 1) a similar surgical cutting device wherein the selected blade material comprises titanium, stainless steel, or nitinol (see claim 7; [0009]) in order to beneficially provide a tissue cutting blade that is composed of a well-known physiologically acceptable material that will not irritate tissue (see claim 7; [0009]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Eaton to have the selected blade material comprising titanium, stainless steel, or nitinol in order to beneficially provide a tissue cutting blade that is composed of a well-known physiologically acceptable material that will not irritate tissue, as taught by Betts.
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (US 5,312,413) in view of Mansour (US 2018/0042772).
Eaton discloses (see Figs. 3A-3D) an ophthalmic cutting device and method comprising the following claim limitations:
(claim 31) inserting a vitreoretinal surgical instrument comprising a blade (25, Fig. 3A) wherein the blade (25) is surrounded by a longitudinally movable shield (28, Fig. 3A) (as shown n Figs. 3A-3B); and retracting the longitudinally movable shield (28) to expose the blade (25) (as shown in Figs. 3C-3D).
Eaton, as applied above, discloses an ophthalmic cutting device and method comprising all the limitations of the claim except for the steps of inserting a trocar into the eye of a subject and inserting the surgical instrument through the trocar.
However, Mansour teaches (see Fig. 1) a similar ophthalmic surgical method comprising the steps of inserting a trocar (4) into the eye (2) of a subject and inserting the surgical instrument (5) through the trocar (4) in order to beneficially provide a guiding path to a desired surgical instrument and thereby allowing the instrument to be consistently and effectively maneuvered to a desired intraocular treatment site ([0002]-[0006]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Eaton to include the steps of inserting a trocar into the eye of a subject and inserting the surgical instrument through the trocar in order to beneficially provide a guiding path to a desired surgical instrument and thereby allowing the instrument to be consistently and effectively maneuvered to a desired intraocular treatment site, as taught by Mansour.
Allowable Subject Matter
Claims 27-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of allowable subject matter: the art of record does not teach or render obvious a device as claimed that includes, in combination with the claim(s) as a whole, a vitreoretinal surgical instrument comprising a shaft coupled to a blade and a sleeve surrounds a portion of the blade and further is configured to displace tissue and control the depth of cutting, and further including a surgical handpiece comprising a longitudinally movable shield, a rod-shaped body and a control slider for moving the shield from a first position covering the blade and a second position exposing the blade.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Rotenstreich (US 10,285,852).
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771