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 .
Claim Objections
Claim 13 is objected to because of the following informalities:
“the means” recited in line 1 of the claim should be “the means for irrigating fluid or aspirating fluid”. Appropriate correction is required.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: means for irrigating fluid or aspirating fluid in claim 12 and 13.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 12 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 12 recites the limitation "the port" in line 2. There is no mention of a port in claim 1, from which claim 12 depends. It is unclear what port the applicant is referring to. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the limitation will be interpreted as “a port”.
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.
Claims 1, 8-9, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haffner et al. (US 20100087774 A1), hereinafter referred to as “Haffner”.
Regarding Claim 1, Haffner teaches a goniotomy device (applicator 2 for treatment of glaucoma by implanting a glaucoma stent in an eye to reduce the intraocular pressure, see Paragraph [0002]) comprising:
a handle (handle section 34);
a fluidics control (a plurality of fluid ports 41, 42, 43 for administering various fluids to various target tissue sites. For example, the first fluid port 41 is connected through a fluid channel 47 to a fluid supplier source 44, see Paragraph [0063]; Figure 8);
a shaft (see Figure 8) having a distal portion (distal section 29) that is insertable into an opening of an operating site of an eye (a small incision 6 is created at an appropriate location of the cornea 12 allowing inserting an applicator 2 into the anterior chamber, see Paragraph [0065]), wherein the shaft comprises an outer tube (68) and an inner tube (79 disposed therein, wherein the inner tube extends through a lumen of the outer tube (the grasping tip 79 in a stent delivery system with irrigation/aspiration is accomplished with a concentric tubing 68 having swaged end details, see Paragraph [0055]; Figure 4) and a distal portion of the inner tube extends out of and beyond a distal end of the outer tube (A trabecular or glaucoma stent 61, particularly an axisymmetric stent, is placed and grasped by a grasping tip 79 at the distal section of a delivery system 62, see Paragraph [0055]; Figure 4); and
a sleeve encasing at least a portion of the fluidics control and a portion of the shaft (the aspiration step 67 is carried out by returning fluid entering the aspiration ports 66, see Paragraph [0055]; Figure 4) and spaced therefrom for fitting into the opening of the operating site (the aspiration step 67 is carried out by returning fluid entering the aspiration ports 66, see Paragraph [0055]; Figure 4), wherein the sleeve is configured to restrict fluid ingress or egress at the opening of the operating site (a small incision 6 is created at an appropriate location of the cornea 12 allowing inserting an applicator 2 into the anterior chamber, see Paragraph [0065], Figure 10).
Regarding Claim 8, Haffner further teaches wherein the sleeve is affixed to the device (see Figure 4).
Regarding Claim 9, Haffner further teaches wherein the sleeve is affixed to the fluidics control by threads, a friction fit, glue, or mechanically fastened in a fluid tight manner (the tight fit 69 between an inner tubing 71 and the outer tubing 68 creates barrier between the channel 65A for irrigation and the channel 66A for aspiration, see Paragraph [0056]; Figure 4 and 5).
Regarding Claim 12, Haffner further teaches means for irrigating fluid or aspirating fluid, tissue or other debris through a space between the shaft and the sleeve, and through a port into or out of the eye (the grasping tip 79 in a stent delivery system with irrigation/aspiration is accomplished with a concentric tubing 68 through ports 66, see Paragraph [0055]; Figure 4).
Regarding Claim 13, Haffner further teaches wherein the means for irrigating fluid or aspirating fluid are attached to the device (see Figure 4).
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.
Claims 2-6, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Haffner (US 20100087774 A1) in view of Koplin (WO 2014138330 A1).
Regarding Claim 2, Haffner teaches all of the limitations as discussed above in claim 1. However, Haffner does not explicitly disclose wherein the sleeve comprises a conical receiving area, a tubular passage and a tapering section.
Koplin teaches an apparatus for performing phacoemulsification and fluid infusion and maintenance within the eye (see Abstract; Figure 1) wherein the apparatus includes a sleeve (42) with lateral outlets or ports for ejecting fluid into the eye in a predetermined pattern (see Figure 1), and wherein the sleeve comprises a conical receiving area, a tubular passage and a tapering section (the silicone sleeve is drawn down along the shaft of the hand-piece stopping with a tight seal above the needle prongs, see Col. 11 ln 20-22; Col. 12 ln 1-2).
Haffner and Koplin are analogous art because both teach a surgical ocular device comprising a sleeve.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sleeve of Haffner and further include wherein the sleeve comprises a conical receiving area, a tubular passage and a tapering section, as taught by Koplin. Koplin teaches stabilizing the needle within the sleeve further insures that orifices in the sleeve near the tip do not blocked by the needle and therefore the fluid from the sleeve is free to flow outwardly, preferably in a predetermined plume or other shape (see Col. 5 ln 22-23).
Regarding Claim 3, Haffner and Koplin teaches all of the limitations as discussed above in claim 2 and Koplin further teaches wherein the sleeve comprises one or more ports at the tapering section (further the flaps may be partially leashed proximally to the proximal edges of the port at the sleeve, see Col. 12 ln 12-22).
Regarding Claim 4, Haffner and Koplin teaches all of the limitations as discussed above in claim 3 and Haffner further teaches wherein the sleeve receives an irrigation fluid (the aspiration step 67 is carried out by returning fluid entering the aspiration ports 66, see Paragraph [0055]; Figure 4). Koplin further teaches wherein the sleeve has a space between the shaft and the sleeve for supplying the irrigation fluid through the port (when infusion fluid is directed down the sleeve 42 surrounding the tube 40, see Col. 12 ln 12-22).
Regarding Claim 5, Haffner and Koplin teaches all of the limitations as discussed above in claim 3 and Haffner further teaches wherein the sleeve aspirates fluid, tissue or other debris through the port (the aspiration step 67 is carried out by returning fluid entering the aspiration ports 66, see Paragraph [0055]; Figure 4). Koplin further teaches wherein the sleeve has a space between the shaft and the sleeve (infusion fluid is directed down the sleeve 42 surrounding the tube 40, see Col. 12 ln 12-22).
Regarding Claim 6, Haffner and Koplin teaches all of the limitations as discussed above in claim 2 and Koplin further teaches wherein the sleeve comprises one or more flats in the conical receiving area for finger grips (the sleeve 42 presents a substantially continuous outer surface, see Figure 1; allowing an area for finger grips).
Regarding Claim 11, Haffner teaches all of the limitations as discussed above in claim 1. However, Haffner does not explicitly disclose wherein the sleeve is elastically deformable in the opening of the operating site of the eye to match a shape or contour of the opening.
Koplin teaches an apparatus for performing phacoemulsification and fluid infusion and maintenance within the eye (see Abstract; Figure 1) wherein the apparatus includes a sleeve (42) with lateral outlets or ports for ejecting fluid into the eye in a predetermined pattern (see Figure 1), and wherein the sleeve is elastically deformable in the opening of the operating site of the eye to match a shape or contour of the opening (the sleeve is often manufactured of silicone and is attached tightly around the central tube 40 past the irrigation apertures 32, see Col. 8 ln 3-6; silicone being an elastically deformable).
Haffner and Koplin are analogous art because both teach a surgical ocular device comprising a sleeve.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sleeve of Haffner and further include wherein the sleeve is elastically deformable in the opening of the operating site of the eye to match a shape or contour of the opening, as taught by Koplin. Koplin teaches the silicone sleeve is drawn down along the shaft of the hand-piece stopping with a tight seal above the needle prongs and positioned in such a way as to provide the most efficient maintenance of the anterior chamber without setting up undue turbulence in relation to nuclear lens material at the lumen of the needle prong arrangement (see Col. 11 ln 20-22; Col. 12 ln 1-2).
Regarding Claim 14, Haffner teaches all of the limitations as discussed above in claim 1. However, Haffner does not explicitly disclose wherein the sleeve is translucent to allow further visualization of an anterior chamber and confirmation of fluid transfer within the sleeve.
Koplin teaches an apparatus for performing phacoemulsification and fluid infusion and maintenance within the eye (see Abstract; Figure 1) wherein the apparatus includes a sleeve (42) with lateral outlets or ports for ejecting fluid into the eye in a predetermined pattern (see Figure 1), and wherein the sleeve is translucent to allow further visualization of an anterior chamber and confirmation of fluid transfer within the sleeve (the sleeve is often manufactured of silicone and is attached tightly around the central tube 40 past the irrigation apertures 32, see Col. 8 ln 3-6; silicone being a translucent material).
Haffner and Koplin are analogous art because both teach a surgical ocular device comprising a sleeve.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sleeve of Haffner and further include wherein the sleeve is translucent, as taught by Koplin. Koplin teaches the silicone sleeve is drawn down along the shaft of the hand-piece stopping with a tight seal above the needle prongs and positioned in such a way as to provide the most efficient maintenance of the anterior chamber without setting up undue turbulence in relation to nuclear lens material at the lumen of the needle prong arrangement (see Col. 11 ln 20-22; Col. 12 ln 1-2).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Haffner (US 20100087774 A1) in view of Ben (WO 9741784 A1).
Regarding Claim 7, Haffner teaches all of the limitations as discussed above in claim 1. However, Haffner does not explicitly disclose wherein the sleeve is disposable.
Ben teaches an ocular device (a cryomanipulator 50 having a body 52 and a head 66 with a cryogenic tip 72 for freeze-gripping and manipulating material in an eye, see Abstract); the cryomanipulator may include an irrigation/suction sleeve (54), wherein the sleeve is disposable (sleeve 54 is preferably mounted to body portion 52 using a bayonet structure including an outer connector 80 on sleeve 54 and an inner connector 78 on body portion 52, this enables simple removal of sleeve 54, see Col. 18 ln 15-17).
Haffner and Ben are analogous art because both teach a surgical ocular device comprising a sleeve.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sleeve of Haffner and further include wherein the sleeve is disposable, as taught by Ben. Ben teaches it would be beneficial for cleaning and/or for replacement by a different sleeve, or a different mounting configuration (see Col. 18 ln 17-19).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Haffner (US 20100087774 A1) in view of De Juan et al. (AU 2018200325 A1), hereinafter referred to as “De Juan”.
Regarding Claim 10, Haffner teaches all of the limitations as discussed above in claim 1. However, Haffner does not explicitly disclose wherein the sleeve is made of a layer of a compliant biocompatible material.
De Juan teaches methods and devices are adapted for implanting into the eye (see Abstract) comprising a shunt (105) and sleeve (one or more sleeves 3405 are positioned over the outer surface of the shunt, see Figure 30) wherein the sleeve is made of a layer of a compliant biocompatible material (sleeves can be manufactured of various materials. In one embodiment, at least one of the sleeves is made of an antimicrobial silver material, see Col. 41 ln 21-23).
Haffner and De Juan are analogous art because both teach a surgical ocular device comprising a sleeve.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the sleeve of Haffner and further include wherein the sleeve is made of a layer of a compliant biocompatible material, as taught by De Juan. De Juan teaches its beneficial to have a device that can be coated on its inner or outer surface with one or more drugs or other materials, wherein the drug or material maintains the patency of the lumen or encourages in-growth of tissue to assist with retention of the shunt within the eye or to prevent leakage around the shunt. The drug can also be used for disease treatment (see Col. 16 ln 4-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/E.R./ (6/11/2025)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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