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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 requires penetrating a fibrous encapsulation of a bleb, a flow path penetrating a bleb, and a flow path draining an aqueous humor.
Claim 2 requires a lower surface facing a sclera.
Claim 4 requires a glaucoma drainage device located inside the bleb.
Claim 6 requires the front of main body is supported on an outer surface of the fibrous encapsulation and the rear of main body is supported on an inner surface of the fibrous encapsulation.
Claim 8 requires the fibrous encapsulation, but the claim is further unclear and is further rejected under 35 U.S.C 112b.
Claim 9 requires the main body is located adjacent to a connection part between the bleb and sclera.
Claim 13 requires the support members including a curved surface which gets closer to the sclera.
Claim 14 requires the main body including a curved surface which gets closer to the sclera.
Claim 17 requires a first and second shunt mounted as different locations of the fibrous encapsulation.
Claim 18 requires a glaucoma drainage device inside the bleb
Claim 19 requires the first and second shunt arranged along a perimeter of the cornea
Claim 20 requires a first shunt mounted in the fibrous encapsulation of the bleb, a second shunt formed by the aqueous humor drained to the outside of the bleb, and the second shunt being mounted in a fibrous encapsulation of a second bleb.
The examiner notes that the above claims require specific steps of using the device within the humor body. The examiner suggests amending the claims to recite configured to language. For example, “configured to penetrate a fibrous encapsulation”.
Claim 3,5,7,10,11,12,15,16 are rejected based on dependency.
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.
Claim 8,14,17-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 8, it is unclear how the fibrous encapsulation itself can be implanted. From the examiner’s understanding, the encapsulation is a structure of the eye and thus exists absent of the implant. As such the claim is unclear how said structure can be implanted. The examiner notes that as long as the shunting device is within (at least partially) the fibrous encapsulation, the device reads to the claim.
Regarding claim 14, it is unclear where the main body surface is curved in view of the term “the curved surface of the main body”. The term lacks antecedent basis as there is no support for a curved main body surface. The examiner notes that even if changed to “a curved main body surface”, the examiner fails to see this structure within the figures, when interpreted broadly. Therefore, for purposes of examination, if the main body is one piece with the supports and the supports curve, the main body is therefore also curved and the supports are part of an “extended” main body.
Regarding claim 17, it is unclear what “a first shunt” is referring to. Based on the claim language it seems as if there exists the shunt of claim 1, a first shunt, and a second shunt. However, it is interpreted that the first shunt is the shunt of claim 1. As such the first shunt is the shunt previously described and the second shunt is an additional shunt. Claim 18 and 19 depend from claim 17 and are thus rejected. However, it is further unclear how a claim directed to “a shunt” can comprise multiple shunts. The examiner notes that claims 17-20 would read better as system claims, where the two shunts are part of a system.
Regarding claim 20, it is unclear what “a first shunt” is referring to. Based on the claim language it seems as if there exists the shunt of claim 1, a first shunt, and a second shunt. However, it is interpreted that the first shunt is the shunt of claim 1. Further it is unclear how the second shunt is “formed by the aqueous humor”, when the shunt is a structural component and the aqueous humor is within the eye configured to be drained by the shunt. As such it is interpreted that the second shunt is formed to drain the aqueous humor.
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.
(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) 1,9,16-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sponsell et al. US 9381112, hereafter Sponsell, provided in the IDS.
Regarding claim 1, Sponsell discloses a shunt comprising (bleb drainage device (10)): a main body (10) penetrating a fibrous encapsulation of a bleb formed between a sclera and a conjunctiva (see figure 4 within bleb “B”); and a flow path penetrating the main body (passageway “p” see figure 2), the flow path draining an aqueous humor within the bleb to an outside of the bleb (abstract, column 5, lines 9-33).
Regarding claim 3, Sponsell discloses the shunt of claim 1, wherein a width of the main body is greater than a height of the main body. The examiner notes that based on the figures, it appears that the stop (Ramp) element (RE) extends in the width direction further than a height direction (see figure 1). As such it is interpreted that at the ramp element a width of the main body is greater than a height of the main body. Should applicant disagree, the examiner further notes that when apertures are located at the height and not at the width (see annotated figure below), the width at this location would be greater than the height at this location, as the aperture is cut into the wall, thus decreasing the location of the furthest structural point from the center as compared to the width that maintains a solid wall.
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Regarding claim 4, Sponsell discloses the shunt of claim 1, wherein a glaucoma drainage device (valve 40) is located inside the bleb. While it is not specifically disclosed that a height of the main body is less than a height of the glaucoma drainage device, the examiner notes that as seen in figure 4, the further lengthwise point at end 14 narrows to a tip (see beveled end in figure 1D). As this tip portion narrows from the overall height and width of the main body, and in figure 4, can be seen to be shorter than the overall height of the drainage device, the device of Sponsell reads to the claim.
Regarding claim 9, Sponsell discloses the shunt of claim 1, wherein the main body is located adjacent to a connection part between the bleb and the sclera (figure 4, see also column 6 lines 3-5). The examiner notes that per said citation, the defined main body is configured to be attached to the sclera nearby the bleb, and is thus considered to be adjacent to a connection part between the bleb and sclera.
Regarding claim 16, Sponsell discloses the shunt of claim 1, wherein the flow path includes a rounded edge (See figure 1, where the flow path is seen to be circular and thus has a rounded edge.
Regarding claim 17, Sponsell discloses the shunt of claim 1, further comprising a first shunt (as detailed under the rejection of claim 1) and a second shunt (tube 42, seen extending from within the bleb to outside) respectively mounted at different locations of the fibrous encapsulation (see figure 4). See also column 7 lines 63-67 and column 8 lines 1-12, where the tube drains fluid within the eye through the wall of bleb and is thus interpreted as a shunt.
Regarding claim 18, Sponsell discloses the shunt of claim 17, wherein the first shunt and the second shunt are arranged such that a glaucoma drainage device inside the bleb is located between the first shunt and the second shunt (see figure 4).
Regarding claim 19, Sponsell discloses the shunt of claim 18, wherein the first shunt and the second shunt are arranged along a perimeter of a cornea (see figure 4).
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) 2,6-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sponsell in view of Bene et al. US 2008/0161741, hereafter Bene.
Regarding claim 2, Sponsell discloses the shunt of claim 1, further comprising: a first support member connected to a front of the main body and positioned outside the fibrous encapsulation (open end 15, seen outside the bleb in figure 4); and a second support member connected to a rear of the main body and positioned inside the fibrous encapsulation (second open end 14),wherein the main body includes a lower surface facing the sclera (figure 4), and wherein the flow path penetrates the main body from the front to the rear (figure 2, where the flow path detailed under the rejection of claim 1 extends the length of the tube. The examiner notes that as detailed under the same rejection Sponsell reads to the limitation. However, in an effort to achieve compact prosecution, the examiner provides Bene as a secondary reference under 35 U.S.C 103, to provide a more analogous structure for the “support members”.
The examiner notes that the purpose of main body of Sponsell is to drain fluid outside of the bleb, where column 8 lines 63-67 detail a shunt being inserted.
Bene teaches an eye shunt and is thus considered analogous to the claimed invention. Bene teaches that the implant is configured to drain aqueous humor within the eye (abstract), where said device rests on the inner and outer portions of the sclera (para. 0014). Bene teaches various structures of said implant (see figures 1-45), but the examiner focuses on figure 43. The examiner notes that Bene teaches that the implant size and shape may be modified based on cornea thickness variations in patients (para. 0092). Referring to figure 43, the examiner notes that the flanges are interpreted as the support members, where the bottom (as seen in the figure) is the second support member and the top flange is the first support member. Further, the flow path can be seen extending through the implant. Therefore, as Sponsell teaches as shunting device suitable for bleb drainage, and Bene teaches a shunt device suitable for drainage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the shunting device in the drainage system of Bene. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being bleb drainage, and thus a prima facie case of obviousness exists. The examiner notes that per the combination a main body having two support members within one located in the bleb and the other located outside the bleb, where the main body comprises, a lower surface facing the sclera and the flow path extending through the main body is disclosed.
Regarding claim 6, Sponsell and Bene teach the shunt of claim 2, wherein the front of the main body is supported on an outer surface of the fibrous encapsulation by the first support member, and wherein the rear of the main body is supported on an inner surface of the fibrous encapsulation by the second support member (para. 0087 of Bene).
Regarding claim 7, Sponsell and Bene teach the shunt of claim 2, wherein the first support member extends in a width direction of the main body, and wherein the second support member extends in the width direction of the main body (see figure 43 of Bene, where both support members extend in a width direction).
Regarding claim 8, Sponsell and Bene teach the shunt of claim 7, wherein the fibrous encapsulation is implanted between the first support member and the second support member. The examiner notes that as the device is implanted in the fibrous encapsulation, the device reads to the claim.
Regarding claim 10, Sponsell and Bene teach the shunt of claim 2, wherein, in a longitudinal direction of the main body, the first support member is thinner than the second support member. The examiner notes that as seen in figure 43 of Bene the first support member is smaller than the second support member. However, no disclosure of thickness is made. Bene does disclose that “Cornea thickness variations between patients is taken into account by providing different size shunts” (para. 0092). An alternate embodiment of the shunt of Bene is seen in figure 1. In said figure, the “top” interpreted as the first support member is seen to be thinner than the “bottom” interpreted as the second support member. Therefore, as Bene teaches that the shunt dimensions may be adjusted as needed, and a suitable embodiment for drainage exists where a defined first support member is thinner than a second support member, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Sponsell and Bene to have the first support member be thinner than the second.
Regarding claim 11, Sponsell and Bene teach shunt of claim 2, wherein, in a longitudinal direction of the main body, a thickness of the first support member is similar to a thickness of the second support member. The examiner notes that as seen in figure 43 of Bene, the thickness of the first and second member appear to be the same and thus are interpreted as similar.
Regarding claim 12, Sponsell and Bene teach the shunt of claim 2, wherein a front surface of the first support member includes a curved surface which gets closer to a rear surface of the first support member as it goes away from the main body. As seen in figure 43 of Bene, the first support forms a curve which curves downward toward the rear of the device (toward the second support)
Regarding claim 13, Sponsell and Bene teach the shunt of claim 2, wherein an upper surface of the first support member and an upper surface of the second support member each include a curved surface which gets closer to the sclera as it goes away from the main body (first support upper curved surface seen in figure 43). As seen in figure 43, the second surface is curved (rounded). However, should applicant argue that the curve does not get closer to the sclera, the examiner points to figure 14 of Bene. Said figure depicts an alternate shunt in which the bottom (second support) curves upwards toward what would be the sclera, when in use. Therefore, as Bene teaches that the shunt dimensions may be adjusted as needed (para. 0092), and a suitable embodiment for drainage exists where a defined second support member curves toward the sclera, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Sponsell and Bene to have the second support member be curved.
Regarding claim 14, Sponsell and Bene teach the shunt of claim 13, wherein an upper surface of the main body includes a curved surface which gets closer to the sclera as it goes away from a center of the main body in a width direction (see rejection of claim 13), and wherein the curved surface of the main body is formed continuously with the curved surface of the first support member and the curved surface of the second support member (the examiner notes that as the first and second supports are part of the main body and flow into the main body portion, it is interpreted that the main body exhibits the curved structure by way of the supports).
Regarding claim 15, Sponsell and Bene teach the shunt of claim 2, wherein the main body, the first support member, and the second support member each include a rounded edge. As seen in figure 43 of Bene, both the support members are seen to have a rounded edge.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sponsell in view of Camras et al. US 2016/0058616, hereafter Camras .
Regarding claim 5, Sponsell discloses the shunt of claim 1, but fails to specifically teach wherein a width of the flow path is greater than a height of the flow path. The examiner notes that as seen in the figures the lumen is generally oval shaped and thus may be interpreted as having a width greater than a height. However, as said dimensions or relationship is not specifically detailed, the examiner incorporates Bene to form the rejection.
Camras teaches an apparatus for reducing intraocular pressure and is thus considered analogous to the claimed invention. Camras teaches that the tubular body for drainage may suitably be circular, oval, square, rectangular, or any combination, where the lumen defined by the body may vary to selectively alter fluid flow characteristics (para. 0038). As such, a suitable example of the device is seen in figure 8, where the lumen is seen to be rectangular in shape where the width is greater than the height. Further, the examiner notes that per MPEP Section 2144.04 IV B In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. As Camras teaches that various shapes are suitable for the same purpose, it would have been obvious to one having ordinary skill to modify the rounded lumen of Sponsell for a rectangular one as an obvious matter of change in shape, since Camras teaches that both shapes are suitable for the same purpose.
Further, per Camras (as detailed above per para. 0038) the lumen construction is disclosed to be a result effective variable in that changing the construction (size/shape) changes the fluid flow characteristics of the device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Sponsell device to have shape/size within the claimed range (width being greater than the height), as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Sponsell by making the width greater than the height as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sponsell in view of Stergiopulos et al. US 2017/0348149, hereafter Stergiopulos .
Regarding claim 20, Sponsell discloses the shunt of claim 1, further comprising: a first shunt mounted in the fibrous encapsulation of the bleb (detailed under the rejection of claim 1, where the first shunt (10) is seen); and a second shunt formed by the aqueous humor drained to the outside of the bleb (second shunt 42). See also column 7 lines 63-67 and column 8 lines 1-12, where the tube drains fluid within the eye through the wall of bleb and is thus interpreted as a shunt. The examiner notes that as tube (42) can be seen in figure 5 extending into another section of the eye it is interpreted that the second shunt is mounted outside the first bleb. However, it is unclear if this constitutes a second bleb.
Stergiopulos teaches an eye fluid treatment device and thus is considered analogous to the claimed invention. Stergiopulos teaches that flow exiting through an outlet conduit (figure 3 per para. 0054)) is deposited in the sclera, where it drains to the connecting vein network (para. 0054). Per the same citation, alternatively, a surgeon may make a second scleral flap with a cavity beneath it (a bleb) and then form a channel to connect the scleral cavity (first bleb) holding the implantable device to the second cavity. Based on said disclosure, the system of Stergiopulos details an implantable device within a first bleb, where the outlet of the device may be directed into a second bleb. Therefore, as Sponsell discloses that the implantable device is within a first bleb, and comprises an outlet that extends outside the bleb (outlet 42), and Stergiopulos teaches that outlet may drain to the sclera or be provided with a second bleb for drainage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a second bleb for the drainage outlet of Sponsell, as Stergiopulos teaches that creation of a second bleb for drainage is a know technique in the art and thus a prima facie case of obviousness exists. The examiner notes that as a channel is formed to connect the two blebs (per para. 0054 if Stergiopulos) it is interpreted that the blebs are connected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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