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 Restriction Requirement Response filed on 02/27/2025; and IDS filed on 02/27/2025 and 09/14/2021.
Claims 6, 7, 10-12, 14-16 are drawn to non-elected species
Claims 1-22 are pending in the instant application.
Claims 6, 7, 10-12, 14-16, 20-22 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) and specie elections of “collector channel” and “claim 13) in the reply filed on 02/27/2025 is acknowledged.
Note, claims 6, 7, 10-12, 14-16 are drawn to non-elected species.
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, 13 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,679,167 in view of WARDLE et al (US 2014/0249463).
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 ophthalmic devices.
WARDLE teaches a method of treating glaucoma in a human eye (see abstract) with ophthalmic surgery (see [0081]), which reads on ocular surgery, comprised of: delivering a dye (see abstract and [0011]), which reads on instilling an ophthalmic composition into the patient’s eye, to identify the location of obstruction (see [0011]); during ophthalmic surgery (see [0081]), which reads on performing the ocular surgery of the patient’s instilled eye; incisions made in the eye (see [0075]), which form a first opening and a second opening (see [0076]); and may include steps of advancing first aqueous humor drainage device through first opening and advancing a second aqueous humor drainage device through second opening (see [0076]), which reads on introducing a plurality of ophthalmic devices into the instilled eye; ocular implant within Schlemm’s canal (see [0011]; [0076] and Fig. 9), which reads on positioned around the circumference of the drainage angle to maintain physiological aqueous humor circulation and proximate approximately opposite a main collector channel. Additional disclosures include: identify the location of obstructions within Schlemm's canal (see [0011]), including collector channel (see [0066] and CC in Fig. 9); known glaucoma treatment devices in the prior art, such as US patent application 2006/0195187 (see [0005]); dye to provide enhanced viewing of the canal (see [0062]).
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 drainage devices. 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.
Claims 1-5, 9, 13 and 17-19 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).
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.
Claims 4, 9 and 18 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.
Regarding claim 4, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, “collector channel” is repeated twice in the instant claim.
Regarding claim 9, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “at least 2”, and the claim also recites “at least 3” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 13, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WARDLE et al (US 2014/0249463) in view of BRUNO (US 7,014,991) and STEGMANN et al (US 2006/0195187).
WARDLE teaches a method of treating glaucoma in a human eye (see abstract) with ophthalmic surgery (see [0081]), which reads on ocular surgery, comprised of: delivering a dye (see abstract and [0011]), which reads on instilling an ophthalmic composition into the patient’s eye, to identify the location of obstruction (see [0011]); during ophthalmic surgery (see [0081]), which reads on performing the ocular surgery of the patient’s instilled eye; incisions made in the eye (see [0075]), which form a first opening and a second opening (see [0076]); and may include steps of advancing first aqueous humor drainage device through first opening and advancing a second aqueous humor drainage device through second opening (see [0076]), which reads on introducing a plurality of ophthalmic devices into the instilled eye; ocular implant within Schlemm’s canal (see [0011]; [0076] and Fig. 9), which reads on positioned around the circumference of the drainage angle to maintain physiological aqueous humor circulation and proximate approximately opposite a main collector channel. Additional disclosures include: identify the location of obstructions within Schlemm's canal (see [0011]), including collector channel (see [0066] and CC in Fig. 9); known glaucoma treatment devices in the prior art, such as US patent application 2006/0195187 (see [0005]); dye to provide enhanced viewing of the canal (see [0062]).
WARDLE does not teach using a specific dye, such as indigo carmine; or that the ophthalmic/drainage device is a stent.
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).
STEGMANN, which is the US patent application 2006/0195187 disclosed in WARDLE (see WARDLE at [0005]), teaches the prior art had known of stent device to expand and maintain the patency (opening) of Schlemm’s canal (see [0005]), which reads on drainage device. Additional disclosures include: “Glaucoma is a disease condition of the eye in which increased intraocular pressure (IOP) is created by blockage of the drainage mechanism for the aqueous fluid produced in the anterior portion of the eye. Such aqueous outflow conditions are usually treated by topical drugs in the form of eye drops, but may result in surgical treatment if drug treatment becomes ineffective due to loss of response to the drug or poor patient compliance” (see [0002]).
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. 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 eye and reasonably would have expected success because WARDLE teaches using dyes to provide enhanced viewing.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a stent as the ophthalmic/drainage device. The person of ordinary skill in the art would have been motivated to make those modifications, because the stent would open the canal and drain the fluid pressure, and reasonably would have expected success because WARDLE teaches using a drainage device.
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.
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.
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/JAKE M VU/Primary Examiner, Art Unit 1618