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
Claims 14 and 29 are objected to because of the following informalities: “a longitudinal axis of the shaft” in line 2 of each claim should read “the longitudinal axis of the shaft” since this axis has been previously recited in claims 1 and 16. 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 19-21 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 19 includes “the front opening” which lacks antecedent basis. Claim 20 includes “the closed back of the groove” which lacks antecedent basis.
For purposes of claim interpretation, claim 19 is being treated as though it reads “wherein a front opening of the groove is aligned….”, and claim 20 is being treated as though it reads “wherein a closed back of the groove…”. Claim 21 depends from claim 20 and is therefore also indefinite.
Claim Rejections - 35 USC § 102
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) 1-5, 11, 13-20, 26, and 28-30 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Baerveldt et al. (US 2002/0111608). Regarding claims 1 and 16, Baerveldt discloses a bladeless device for tearing a trabecular meshwork of an eye of a subject, the device comprising a shaft (2940; fig. 29a) comprising a distal end, and a bladeless tip (i.e., no sharp surface on tip meant for cutting) coupled to the distal end of the shaft, the tip comprising an elongate lower foot (2920) configured to be inserted into Schlemm’s canal (similar to fig. 6D), the lower foot comprising a central longitudinal axis that is transverse to a longitudinal axis of the shaft, an elongate upper foot (2950) positioned proximally of the lower foot and configured to be positioned over the trabecular meshwork, and a groove (space between feet) formed between the lower foot and the upper foot and configured to grasp a portion of the trabecular meshwork, and tear without cutting, the trabecular meshwork (par. 22, 152). Note that the device of fig. 29A may be used without sending current through the electrode (2930) such that tissue is merely torn as the blunt lower foot is advanced through the trabecular meshwork. See also the bladeless trabeculotome 600 in fig. 6D (par. 87), which also comprises a shaft and a tip having a lower foot capable of tearing without cutting the trabecular meshwork, an upper foot, and a groove therebetween.
Regarding claims 2 and 17, the groove has a variable height (see examiner-annotated figure below; height variation due to the curved tips of the upper and lower feet).
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Regarding claims 3 and 18, the height of the groove decreases along a central longitudinal axis of the upper foot from a tip of the upper foot toward the shaft (see figure above).
Regarding claims 4 and 19, the groove comprises a front opening and a closed back and the front opening is aligned with a tip of the foot (see figure above).
Regarding claims 5 and 20, the closed back of the groove is rounded (due to round shape of probe body shaft, which is cylindrical along the longitudinal axis of the shaft).
Regarding claims 11 and 26, a length of the lower foot is greater than a length of the upper foot (see fig. 29A).
Regarding claims 13 and 28, the upper foot comprises a central longitudinal axis transverse to the longitudinal axis of the shaft (fig. 29A).
Regarding claims 14 and 29, an angle formed between the central longitudinal axis of the lower foot and a longitudinal axis of the shaft is between about 80 degrees and about 140 degrees (in particular, the angle is about 90 degrees; fig. 28,29A).
Regarding claims 15 and 30, the lower and upper feet are integral to the tip (fig. 29A).
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.
Claim(s) 12 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt. Baerveldt discloses the invention substantially as stated above including an upper foot and a lower foot, but does not disclose that a maximum width of the upper foot is greater than a maximum width of the lower foot. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Baerveldt to size the upper foot to have a maximum width greater than the maximum width of the lower foot since it has been held that “wherein the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S> 830, 225 SPQ 232 (1984). In the instant case, the device of Baerveldt would not perform differently with an upper foot having a maximum width greater than the maximum width of the lower foot since the lower foot of Baerveldt is sized to be inserted into Schlemm’s canal and a groove between the upper and lower foot is configured to grasp a portion of the trabecular meshwork. Further, it appears that applicant places no criticality on this feature, indicating simply that “in some variations” the maximum width of the upper foot “may” be greater than the maximum width of the lower foot (par. 15, 75).
Claim(s) 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt in view of Huculak (US 2009/0287233). Baerveldt discloses the invention substantially as stated above except for a closed back having a radius of curvature as claimed.
Huculak discloses another device for treating glaucoma including a foot that is configured to be inserted into Schlemm’s canal and a groove (310) above the foot. The groove has a rounded closed back, wherein the radius of curvature of the closed back is at least 20 microns (in particular, greater than 0.1 mm; [0029], [0030]) in order to be able to be able to accommodate the trabecular meshwork, which is about 0.1mm. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Baerveldt to provide the groove with a rounded back similar to that disclosed by Huculak and having a radius of curvature of greater than 0.1 mm (100 micron), which falls within the claimed range of “at least 20 microns”, as taught by Huculak in order to allow the trabecular meshwork to be located in the groove, thus facilitating mechanical disruption of the trabecular meshwork as desired by Baerveldt.
Claim(s) 7, 9, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt in view of Kahook et al. (2020/0107961). Baerveldt discloses the invention substantially as stated above including a bladeless tip, but fails to expressly disclose that the bladeless tip comprises a tissue collection opening, wherein the opening is a window through the lower foot, upper foot, or closed back of the groove.
Kahook discloses another device for treating glaucoma, the device comprising a tip having a foot and a groove located above the foot (fig. 11), the tip includes a tissue collection opening (23), wherein the opening is a window (23) through the back of the groove (see fig. 11). The window provides a pass-through window for cut tissue ([0059], [0159]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Baerveldt to include a tissue collection opening comprising a window through the back of the groove in order to allow sheared tissue to pass through the groove as the foot is advanced into the trabecular meshwork ([0159]).
Claim(s) 7-8, 10, 22, 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt in view of Pournaras et al. (US 2023/0098330). Baerveldt discloses the invention substantially except for a tissue collection opening as claimed and a roughened surface on the dorsal surface of the lower foot.
Pournaras discloses another ophthalmic device that can be used to separate or tear tissue of an eye of a subject ([0010], [0011]). Pournaras discloses that the surface of the ophthalmic device that is meant to engage tissue can include a roughened (“augmented”) surface, and that the roughened surface may be included on all portions of the tip of the device (see at least figs. 2a-c, 6, 9B, 14, 16, 18a,b; ). The roughened surface imparts frictional shearing forces onto the tissue, thus avoiding pulling forces prone to pull on and damage nearby tissue ([0043]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Baerveldt to include a roughened surface on the entire tip of the device, and thus on the dorsal surface of the lower foot in view of Pournaras’ teaching for the predictable result of enhancing frictional shearing forces on the tissue, thereby enhancing tearing of the trabecular meshwork of the subject.
Regarding claims 7, 8, 22, and 23, the augmented surface is added to the entire tip of Baerveldt as taught by Pournaras (see at least [0053], [0058] of Pournaras). With such a modification, the bladeless tip of Baerveldt in view of Pournaras comprises a tissue collection opening in the form of an indentation (i.e., any of the spaces between adjacent teeth 200, which are capable of receiving tissue therein) formed on a surface of the groove (see esp. fig. 9A of Pournaras, which shows augmented surface on surface of groove formed between an upper and lower foot).
Claim(s) 10 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baerveldt in view of Nallakrishnan (US 2021/0000648). Baerveldt discloses the invention substantially as stated above except for a dorsal surface of the lower foot comprising a roughened surface. Nallakrishnan discloses another ophthalmic device comprising a distal portion that is inserted into Schlemm’s canal (abstract, par. [0001]). Nallakrishnan discloses that the distal portion may comprise a roughened surface extending all the way around its circumference (see [0007]; figs. 2,3) in order to massage the outer wall of the Schlemm’s canal and the trabecular meshwork in order to facilitate drainage of the eye via the trabecular meshwork ([0028]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Baerveldt to include a roughened surface on all surfaces of the lower foot (including the dorsa surface) since the lower foot is inserted into Schlemm’s canal and, as taught by Nallakrishnan, the roughened surface facilitates massage of the trabecular meshwork and Schlemm’s canal to dislodge deposits within the meshwork and canal thus improving drainage of the eye.
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 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30, respectively, of U.S. Patent No. 11,877,954. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1-30 are merely broader than claims 1-30 of ‘954, respectively, and are thus “anticipated” by claims 1-30 of ‘954.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nallakrishnan (US 2009/0137992) describes a Harms Trabeculotomy Probe (38; illustrated in fig. 3-5), wherein an upper prong (44) acts as a guide while lower prong (46) is used to tear a hole in the trabecular meshwork (30) (see par. [0041]).
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KSH 7/9/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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