DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to an ab externo method of placing an intraocular shunt into an eye to create a fluid-flow pathway from the anterior chamber to the subconjunctival region of lower pressure, directed to claims 2-9, in the reply filed on January 22, 2026 is acknowledged.
Claims 10-11 have been canceled.
Claim Objections
Claim 2 is objected to because of the following informalities: There appears to be a typographical error in lines 5-6. The following correction is suggested:
“…subconjunctival region of lower pressure in the eye…”
Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The claim appears to be combining two claims and contains two sentences. The Examiner suggests separating claim 3 into two separate claims or combining the limitations into a single sentence. 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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 5 and 7-9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Yu et al. (US 6,544,249, hereinafter “Yu”).
Regarding claim 5, Yu discloses the invention substantially as claimed including a method of treating glaucoma, the method comprising the steps of: inserting, into an eye through the sclera (57) (Figs 3-8; col 6, ln 62 – col 7, ln 18) a hollow needle (32) carrying an intraocular shunt (10) (Fig 2; col 6, ln 31-44, 56-57) and releasing the shunt (10) from the needle such that the shunt conducts fluid away from the anterior chamber (50) of the eye to a subconjunctival region (52) (Fig 8; col 6, ln 64-67).
It is noted the recitation “an ab externo method” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 7, further comprising positioning an inlet end portion of the shunt in the anterior chamber (50) (Figs 3-8; col 6, ln 62 – col 7, ln 18).
Regarding claims 8-9, wherein the shunt (10) comprises a pharmaceutical or biological agent, wherein the pharmaceutical or biological agent comprises a coating on the surface of the shunt (biological cells lining the inner surface of the tube – col 6, ln 1-9).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 2, 4-5, 7-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yu et al. (US 6,544,249, hereinafter “Yu”) in view of Tu et al. (US 2004/0127843, hereinafter “Tu”).
Regarding claims 2, 5, and 7, Yu discloses the invention substantially as claimed including a method of placing an intraocular shunt (10) (Fig 1) into an eye to treat glaucoma, the method comprising the steps of: advancing a needle (32), in which the shunt (10) is disposed (Fig 2; col 6, ln 31-44, 56-57), into the eye through sclera (57) of the eye (Figs 3-8; col 6, ln 62 – col 7, ln 18); positioning an inlet end portion of the shunt in the anterior chamber (50); positioning an outlet end portion of the shunt in a subconjunctival region of lower pressure in the eye (52); and releasing the intraocular shunt to create a fluid-flow pathway from the anterior chamber to the subconjunctival region of lower pressure (Fig 8; col 6, ln 64-67).
However, Yu teaches the method is an ab interno method (Figs 3-8 – insertion through the cornea and across anterior chamber to sclera and subconjunctival region) and fails to teach an ab externo method comprising the steps of advancing the needle into the eye through the conjunctiva and sclera of the eye. Tu discloses a similar method of placing an intraocular shunt into an eye to treat glaucoma (abstract) and teaches the methods “include both ab interno and ab externo procedures that involve non-flap operations” (para [0032]). In one embodiment, the stent (30) or intraocular shunt is delivered through a delivery apparatus from the anterior chamber toward the scleral wall (Fig 31; para [0054]), similar to the method of Yu in an ab interno approach. However, Tu teaches an alternate embodiment comprising an ab externo approach wherein a small puncture is created from the outside of the eye and the stent (30t) or shunt is inserted through a delivery apparatus (100c) from the scleral side rather than the anterior chamber side (Fig 45; para [0296-0299]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Yu such that the shunt was implanted in an ab externo method, as taught by Tu, instead of an ab interno method and the method comprised the steps of advancing the needle into the eye through the conjunctiva and sclera of the eye since substitution of one known method for another to reach the same desired target location would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
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Regarding claim 4 and 8-9, Yu teaches the shunt (10) comprises a pharmaceutical or biological agent, wherein the pharmaceutical or biological agent comprises a coating on the surface of the shunt (biological cells lining the inner surface of the tube – col 6, ln 1-9).
Claims 3 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yu (US 6,544,249) and Tu (US 2004/0127843), as applied to claims 2 and 5 above, further in view of Pinchuk et al. (US 2007/0123812, hereinafter “Pinchuk”). Yu and Tu disclose the invention substantially as claimed, as shown above, including further comprising positioning an inlet end portion of the shunt in the anterior chamber (50) (Fig 8; col 6, ln 64-67). However, they fail to disclose the step of piercing the Tenon’s capsule of the eye. Pinchuk teaches the conjunctiva (30) covers the sclera (26) and “a portion of the sclera 26 is covered by a thin tissue called Tenon’s membrane 36 which envelopes the bulb of the eye from the optic nerve (not shown) to the ciliary region, and separates the eye from the orbital fat and forms a socket in which the eye moves. Near its front, Tenon's membrane 36 blends into the conjunctiva 30 where it is attached to the ciliary region of the eye as shown” (Fig 1; para [0008]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the combination of Yu and Tu (see proposed modification in annotated Fig 7 of Yu above) such that the advancing step of the method additionally comprised piercing the Tenon’s capsule of the eye since it is obvious an ab externo method advancing through the conjunctiva and sclera of the eye to reach the anterior chamber would additionally have to advance through the Tenon’s membrane due to the anatomy of the eye.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ritch et al. (US 5,092,837) additionally teaches implanting a shunt (21) to create a fluid-flow pathway from the anterior chamber to the subconjunctival region of the eye (col 4, ln 55-67; col 5, ln 27-39; col 6, ln 41-45; Figs 3-4D).
Zhou et al. (US 7,192,412) additionally teaches a shunt device may be inserted into the eye in an ab interno OR in an ab externo procedure (col 1, ln 16-21; col 3, ln 64 – col 4, ln 11; col 22, ll 53-55).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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