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 .
Response to Amendment
In the reply filed 10/24/2025, Applicant amended claims 25, 28, 29, 33, 35, 37, and 39, and canceled claims 26 and 34. Claims 25, 27-33, and 35-41 are currently pending.
Response to Arguments
Applicant’s arguments with respect to the statutory double patenting rejection of Claims 25-32 have been found persuasive in view of the amendments to the claims. The rejection has been withdrawn. However, a nonstatutory double patenting rejection has been made in view of the amended claims.
Applicant’s arguments with respect to claim(s) 33 and 35-41 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection has been updated in view of the amendments to the claims.
Specifically, applicant has amended claim 33 to include the language of claim 34, but has also further narrowed the subject matter of claim 34 to require that the gap portion at the base portion of each of the plurality of strips is U-shaped. The rejection has been updated in view of these amendments.
The examiner maintains that Wilcox does in fact teach U-shaped portions in the gaps between each of the plurality of strips. As illustrated in the figure below, it can be seen that Wilcox’s shunt comprises a gap portion between the base portions of each of the plurality of strips, the gap[ portion comprising a curved, U-shaped cross-section.
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However, in the event that applicant does not clearly envisage this interpretation, an alternative rejection has been presented in view of Baerveldt.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
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.
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.
Claims 33, 35-41 is rejected under 35 U.S.C. 102(b) as anticipated by Wilcox (US 2015/0313758) or, in the alternative, under 35 U.S.C. 103 as obvious over Wilcox in view of Baerveldt (US 8,353,856).
With respect to Claim 33, Wilcox teaches an implantable glaucoma shunt (Figures 19-21), comprising:
a base portion 409; and
a plurality of strips 416 extending from the base portion; wherein each one of the plurality of strips is separated from at least one other strip of the plurality of strips via a gap portion (see the gaps between strips 416 in Figure 19 and in the annotated figure below);
wherein the gap portion at the base portion 409 is U-shaped (see the annotated figure below), such that a surface between at least one of the plurality of strips 416 and another one of the plurality of strips 416 is curved (Figure 20 shows that channel 410, which is a surface between each of the plurality of strips 416, defines a U-shaped surface; as clarified in the annotated figure below).
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In the event that Applicant does not clearly envisage Wilcox’s shunt as having a U-shaped gap at the base port between each of the plurality of strips, Baerveldt teaches a similar implantable glaucoma shunt comprising a plate 40 for placement over the sclera for receiving fluid drained from the anterior chamber (Abstract). Specifically, Baerveldt teaches that the edges of the plate are desirably radiused, tapered, blended, or rounded to facilitate insertion and discourage scar tissue formation, and that the use of smooth, rounded edges present a smooth surface to decrease tissue irritation (Column 5, Lines 46-50). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Wilcox’s glaucoma shunt to have rounded surfaces on all areas of the plate, as suggested by Baerveldt, in order to provide a well-known means for facilitating insertion and discouraging scar tissue formation and tissue irritation.
With respect to Claim 35, Wilcox teaches that the plurality of strips 416 comprise a first outer strip and a second outer strip, each having a curved side portion. See annotated Figure 19 below.
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Annotated Figure 19 of Wilcox
With respect to Claim 36, Wilcox teaches the device substantially as claimed, but does not specifically teach an antifibrotic drug. However, the examiner takes official notice that the use of anti-fibrotic drugs is well-known in the art of glaucoma shunts, as doing so prevents scarring and/or prolongs the efficacy of the implant within the eye. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Wilcox’s glaucoma shunt such that it is provided in conjunction with an anti-fibrotic drug, as is well-known in the art, in order to prevent scarring and/or prolong the efficacy of the implant within the eye.
With respect to Claim 37, Wilcox teaches that the device may be made of silicone or other elastomers [0058]. Wilcox, however, does not specifically teach that the plurality of strips are formed of a material that is softer than 40 Shore A. However, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (MPEP 2144.07. In this case, it would have been fully within the scope of one of ordinary skill in the art to provide Wilcox’s strips with a hardness that is biocompatible with the soft tissue of the patient's eye. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to provide Wilcox’s strips with a hardness of 40 Shore A or less, or with any other hardness that was considered desirable or expedient, in order to make the glaucoma shunt biocompatible with the patient's eye.
With respect to Claim 38, Wilcox teaches that the shunt further comprises an elastomeric drainage tube 402 (specifically silicone or another flexible, elastomeric material [0036], the outflow end (shown adjacent numeral 406 in Figures 20-21) being coupled with the plurality of strips. See Figures 19-21.
With respect to Claim 39, Wilcox teaches the device of claim 33, wherein the tube has a diameter (i.e. thickness) of 500 microns or less (for example, 400 microns; paragraphs [0010-0011] and [0040]; Figure 13). As can be seen in Figures 19-21, the tube feeds into the strip portion, such that strips have substantially the same or smaller diameter/thickness as the tube. Therefore, the strips must have a thickness that is no greater than 0.7mm / 700 microns.
In the event that this interpretation is not clearly envisaged by applicant, it has been held that mere changes in size or proportion do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP § 2144.04.IV.A.). In this case, Wilcox suggests that the strips may be of a variety of sizes [0050], and it is obvious that sizing the strips such that they have a thickness of less than 0.7mm would make them sized to fit appropriately on the sclera. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Wilcox’s glaucoma shunt such that the strips have a thickness of 0.7mm or less, because a change in size is generally recognized as being within the level of ordinary skill in the art
With respect to Claim 40, With respect to Claim 10, Wilcox’s embodiment of Figures 19-21 shows a plurality of parallel strips that are spaced apart, wherein gaps are defined between each strip. This configuration satisfies the condition required by the claimed formula. In the example shown in Figure 19, there are 8 strips and 7 gaps, thereby meeting the condition Gaps = Strips – 1.
With respect to Claim 41, applicant is merely claiming a physical relationship between force and surface area. Wilcox’s Figures 19-21 show a plurality of parallel strips that are spaced apart and define gaps therebetween. Wilcox’s ocular implant is bound by the same relationship between force and area as defined by the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25 and 27-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,672,701. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an implantable glaucoma shunt comprising a first outer strip and a second outer strip, each comprising a curved side portion positioned away from the other strips, an intermediate strip positioned between the first and second outer strips, and a drainage tube, wherein at least two of the first and second outer strip and the intermediate strip are interconnected on the side proximal to the drainage tube, and wherein there is no interconnection between the strips at the side distal to the drainage tube. The instant claims are broader than the ‘701 claims at least because they do not require that the intermediate strip has a first side portion that runs in parallel with straight inner side portion of the second strip.
Allowable Subject Matter
Claims 25 and 27-32 would be allowable upon filing a terminal disclaimer to overcome the double patenting rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Wilcox, which teaches an implantable glaucoma shunt comprising a first outer strip and a second outer strip, each comprising a curved side portion positioned away from the other strips, an intermediate strip positioned between the first and second outer strips, and a drainage tube, wherein at least two of the first and second outer strip and the intermediate strip are interconnected on the side proximal to the drainage tube. Wilcox, however, does not teach or suggest that there is no interconnection between the strips at the side distal to the drainage tube. It is unclear why one of ordinary skill in the art would have modified Wilcox’s implant to have the claimed configuration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781