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 .
Receipt is acknowledged of Applicant’s Amendment filed on 10/30/2025.
Claims 1, 4, 10-12, 14-16, 18-19 have been amended.
Claims 23-27 have been added.
Claims 13, 17, 20-22 are canceled.
Claims 1-12, 14-16, 18-19, 23-27 are pending in the instant application.
Claims 6-8, 10-12, 14-16 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-5, 9, 18-19, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,679,167 in view of TU et al (US 2013/0253405).
The patent recites a method of cataract extraction and treatment of glaucoma in an eye of a patient in need thereof, comprising: i) instilling the ophthalmic composition of claim 1 into the patient's eye; ii) surgically extracting the cataract of the instilled eye; and iii) surgically treating the glaucoma of the cataract extracted eye (see claim 14), wherein claim 1 recites an ophthalmic composition, comprising: i) 0.001-0.04 wt. % Indigo Carmine (see claim 1), wherein the identified, marked, or stained intraocular structure(s) or membrane(s) within the patient's eye is selected from a group consisting of: a fine vessel, an aqueous vein, an episcleral vein, a collector channel (see claim 18), wherein the method further comprises introducing an ophthalmic device into the instilled eye (see claim 20), wherein the ophthalmic device is introduced proximate to canal of Schlemm of the patient's eye or is inserted into the canal of Schlemm of the patient's eye (see claim 21), wherein the ophthalmic device is a stent (see claim 22).
The patent does not recite a plurality of 4-6 ophthalmic stent devices.
TU teaches trabecular bypass surgery (see [0032]-[0043]), which appears to be the same surgery that Applicant is describing/reciting in the claims (see Applicant’s specification at [0010]-[0014]) for treating glaucoma (see abstract; and [0030]-[0035]) or cataract (see [0184]) comprised of: using an applicator (see abstract) for implanting multiple intraocular stents (see abstract), which are fluid drainage devices (see claim 1), positioned in the suprachoroidal space (see claim 1), Schlemm’s canal (see claim 58) and trabecular meshwork (see claim 226), which reads on positioned around the circumference of the drainage angle to maintain physiological aqueous circulation and proximate humor circulation.
Additional disclosures included: “glaucoma causes pathological changes in the optic nerve, visible on the optic disk, and it causes corresponding visual field loss, resulting in blindness if untreated. Lowering intraocular pressure is the major treatment goal in all glaucomas” (see [0006]), wherein the stents provide for reducing intraocular pressure by providing outflow of aqueous from an anterior chamber of the eye (see [0037]), wherein “the source of resistance to outflow of aqueous humor is mainly in the trabecular meshwork. The tissue of the trabecular meshwork allows the aqueous humor ("aqueous") to enter Schlemm's canal, which then empties into aqueous collector channels in the posterior wall of Schlemm's canal and then into aqueous veins, which form the episcleral venous system. Aqueous humor is a transparent liquid that fills the region between the cornea, at the front of the eye, and the lens. The aqueous humor is continuously secreted by the ciliary body around the lens, so there is an essentially constant flow of aqueous humor from the ciliary body to the eye's anterior chamber. The anterior chamber pressure is determined by a balance between the production of aqueous and its exit through the trabecular meshwork (major route) or uveal scleral outflow (minor route). The trabecular meshwork is located between the outer rim of the iris and the back of the cornea, in the anterior chamber angle” (see [0007]), which reads on the drainage angle.
TU further teaches “if it is determined, in light of the first bypass flow model, that multiple stents should be used, the location of the multiple stents is first optimized. Then, the multiple stents are implanted. Afterwards, it is again determined if additional intraocular pressure reduction is needed” (see [0271]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a plurality of ophthalmic devices, such as stents. The person of ordinary skill in the art would have been motivated to make those modifications, because the multiple drainage devices would increase drainage, and reasonably would have expected success because both references dealt in the same field of endeavor, such as treatment of glaucoma.
The references do not specifically teach implanting 4-6 stents as claimed by Applicant. The number of implanted stents is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, especially when TU teaches using multiple stents if needed to decrease eye pressure. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal number of stents to implant in order to best achieve the desired results, such as decreasing/balancing the eye pressure in the glaucoma patient. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of number of stents implanted would have been obvious at the time of Applicant's invention.
Claims 1-5, 9, 18-19, 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/419,184 and 18/827,166 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-applicants recite a method of cataract extraction and treatment of glaucoma in an eye of a patient in need thereof, comprising: i) instilling a first ophthalmic composition comprising Trypan Blue into the patient's eye; ii) surgically extracting the cataract of the Trypan Blue instilled eye; iii) instilling a second ophthalmic composition into the cataract extracted eye, wherein the second ophthalmic composition is the ophthalmic composition of any one of claims 1-25; and iv) surgically treating the glaucoma of said cataract extracted eye (see claim 30), wherein the Indigo Carmine of the ophthalmic composition identifies, marks, or stains a trabecular meshwork and a canal of Schlemm in the patient's eye (see claim 94), wherein the method facilitates accurate and/or precise inserting, placement, positioning, repositioning, lifting, and/or removal, of a plurality of ophthalmic devices within the Indigo Carmine instilled patient's eye (see claim 108).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
The co-applications do not specifically teach implanting 4-6 stents as claimed by Applicant. The number of implanted stents is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, especially when TU teaches using multiple stents if needed to decrease eye pressure. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal number of stents to implant in order to best achieve the desired results, such as decreasing/balancing the eye pressure in the glaucoma patient. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of number of stents implanted would have been obvious at the time of Applicant's invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 4 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 4 recites the limitation "the ocular drainage structure identified" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Note, it appears claim 4 should be dependent on claim 3.
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.
Claim(s) 1-5, 9, 18-19, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over TU et al (US 2013/0253405)) as evidenced by CIGNA (downloaded on 12-20-2025) in view of BRUNO (US 7,014,991) and LINGENFELDER et al (US 2011/0190728).
Regarding claim 1, TU teaches trabecular bypass surgery (see [0032]-[0043]), which appears to be the same surgery that Applicant is describing/reciting in the claims (see Applicant’s specification at [0010]-[0014]) for treating glaucoma (see abstract; and [0030]-[0035]) or cataract (see [0184]) comprised of: using an applicator (see abstract) for implanting multiple intraocular stents (see abstract), which are fluid drainage devices (see claim 1), positioned in the suprachoroidal space (see claim 1), Schlemm’s canal (see claim 58) and trabecular meshwork (see claim 226), which reads on positioned around the circumference of the drainage angle to maintain physiological aqueous circulation and proximate humor circulation.
Additional disclosures included: “glaucoma causes pathological changes in the optic nerve, visible on the optic disk, and it causes corresponding visual field loss, resulting in blindness if untreated. Lowering intraocular pressure is the major treatment goal in all glaucomas” (see [0006]), wherein the stents provide for reducing intraocular pressure by providing outflow of aqueous from an anterior chamber of the eye (see [0037]), wherein “the source of resistance to outflow of aqueous humor is mainly in the trabecular meshwork. The tissue of the trabecular meshwork allows the aqueous humor ("aqueous") to enter Schlemm's canal, which then empties into aqueous collector channels in the posterior wall of Schlemm's canal and then into aqueous veins, which form the episcleral venous system. Aqueous humor is a transparent liquid that fills the region between the cornea, at the front of the eye, and the lens. The aqueous humor is continuously secreted by the ciliary body around the lens, so there is an essentially constant flow of aqueous humor from the ciliary body to the eye's anterior chamber. The anterior chamber pressure is determined by a balance between the production of aqueous and its exit through the trabecular meshwork (major route) or uveal scleral outflow (minor route). The trabecular meshwork is located between the outer rim of the iris and the back of the cornea, in the anterior chamber angle” (see [0007]), which reads on the drainage angle.
TU further teaches “if it is determined, in light of the first bypass flow model, that multiple stents should be used, the location of the multiple stents is first optimized. Then, the multiple stents are implanted. Afterwards, it is again determined if additional intraocular pressure reduction is needed” (see [0271]).
CIGNA teaches the trabecular meshwork is part of the drainage angle of the eye.
TU does not teach using a dye, such as indigo carmine.
BRUNO teaches the prior art had known of staining an ocular structure with dyes, such as indigo carmine (see col. 1, line 43-56), thereby aiding in its visualization (see col. 1, line 35-40).
LINGENFELDER teaches the prior art had known of using dyes for staining in cataract and glaucoma treatment (see [0002]), such as indigo carmine (see [0021]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a dye, such as indigo carmine, into the anterior chamber of the patient’s eye. The person of ordinary skill in the art would have been motivated to make those modifications, because the dye would aid in visualization of the anterior chamber of the eye for surgery and reasonably would have expected success because the references are in the same field of endeavor, such as eye surgeries.
The references do not specifically teach implanting 4-6 stents as claimed by Applicant. The number of implanted stents is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, especially when TU teaches using multiple stents if needed to decrease eye pressure. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal number of stents to implant in order to best achieve the desired results, such as decreasing the eye pressure in the glaucoma patient. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of number of stents implanted would have been obvious at the time of Applicant's invention.
Regarding claim 2, TU teaches glaucoma surgery (see abstract; and [0030]-[0035]).
Regarding claims 3-5, and 9, TU teaches Schlemm’s canal (see [0055]) and “wherein the locations are determined from morphological data on collector channel locations” (see [0055]), which reads on identifying an ocular drainage structures, such as a collector channel and the canal of Schlemm.
Regarding claim 18, as discussed above, the stents are positioned in the suprachoroidal space (see claim 1), Schlemm’s canal (see claim 58) and trabecular meshwork (see claim 226), which reads on positioned around the circumference of the drainage angle to maintain physiological aqueous circulation and proximate humor circulation.
Regarding claim 19, although the reference is silent about the “density of corneal cells”, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same glaucoma surgery patient is being administered the same dye and stents by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, the prior art teaches, either expressly or inherently, each and every limitation of the instant claims.
Regarding claims 23-27, as discussed above, the references teach these limitations.
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights