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 .
Claims 1, 3-14, 16 and 21-27 are pending.
Claims 2, 15, 17-20 are cancelled.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/2026 has been entered.
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, 3-14, 16, 21-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12419844B2 in view of COUCH (Use of triamcinolone during vitrectomy surgery to visualize membranes and vitreous. Clinical Ophthalmology. 2008).
The patent teaches a method for the treatment of myodesopsia, wherein said treatment is a laser ablation treatment, and wherein said treatment comprises a composition arranged to be injected into the vitreous of an eye of a human or animal subject, the composition comprising particles for the treatment of myodesopsia as a light sensitizing agent, by attachment of the particles to collagen aggregates and treatment by irradiation inducing formation and collapse of nanobubbles, for removal of said aggregates (claim 1).
The patent does not teach administering a dye to a vitreous body of an affected eye of the subject.
COUCH teaches that dyes, such as triamcinolone acetonide, indocyanine green and trypan blue (Page 892, paragraph 2), are used to aid in visualization for ophthalmic procedures involving the posterior cortical vitreous, which is located in the vitreous body (abstract). When the vitreous boundaries are highlighted, the procedure is more efficient and effective (Page 892, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering a dye to the vitreous body. The person of ordinary skill in the art would have been motivated to make those modifications, because visualization of the vitreous boundaries makes procedures more efficient and effective, and reasonably would have expected success because both references are in the same field of endeavor, such as ophthalmic procedures regarding the vitreous body.
Claims 1, 3-14, 16, 21-27 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/014,222 in view of SAUVAGE (Photoablation of Human Vitreous Opacities by Light-Induced Vapor Nanobubbles. ACS Nano. 07/09/2019.).
The copending application recites a method that comprises: administering a dye to a vitreous chamber of the eye of the subject; and irradiating at least part of the ILM of the eye of the subject, thereby photoporating at least part of the ILM in the subject.
Note, the virtuous body, that is recited in the instant claims, is the gel like substance that fills the virtuous chamber recited in the copending application.
The copending application does not teach using this method on virtuous opacities.
SAUVAGE teaches a ophthalmic procedure using pulsed-laser illumination/photoablation, which reads on irradiation and photodestruction, on virtuous opacities, located in the vitreous body, to induce destruction of the virtuous opacities (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using the method on virtuous opacities. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow the method to be used for another condition, and reasonably would have expected success because the references are in the same field of endeavor, such as ophthalmic procedures that comprises irradiation to destroy part of the eye.
This is a provisional nonstatutory double patenting rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6-14, 16, 21-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over SAUVAGE (Photoablation of Human Vitreous Opacities by Light-Induced Vapor Nanobubbles. ACS Nano. 07/09/2019.) in view of COUCH (Use of triamcinolone during vitrectomy surgery to visualize membranes and vitreous. Clinical Ophthalmology. 2008).
Regarding claim 1 and 14, SAUVAGE teaches a ophthalmic procedure using pulsed-laser illumination/photoablation, which reads on irradiation and photodestruction, on virtuous opacities, located in the vitreous body, to induce destruction of the virtuous opacities (abstract).
Regarding claims 11-12, SAUVAGE teaches the method uses a pulsed-laser (abstract), which reads on electromagnetic radiation. The laser preforms nanosecond laser pulses (abstract), which read on the number of pulses of the laser may be at least 1 laser pulse.
Regarding claim 13, SAUVAGE teaches the method treats myodesopsia (abstract).
Regarding claim 24, SAUVAGE teaches using gold nanoparticles for the procedure (abstract).
Regarding claims 26, SAUVAGE teaches the method uses a pulsed-laser (abstract), which reads on electromagnetic radiation. The laser preforms nanosecond laser pulses (abstract), which read on the number of pulses of the laser may be at least 1 laser pulse.
SAUVAGE does not teach administering a dye to a vitreous body of an affected eye of the subject.
Regarding claim 1, COUCH teaches that dyes are used to aid in visualization for ophthalmic procedures involving the posterior cortical vitreous, which is located in the vitreous body (abstract). Localization of vitreous is difficult because of the invisible nature of vitreous (Page 892, paragraph 3). Removal of minute amounts of vitreous requires patience and careful observation, but when the vitreous boundaries are highlighted, the process is more efficient and effective (Page 892, paragraph 4).
Regarding claim 3-4, 16, COUCH teaches dyes commonly used for ophthalmic procedures include triamcinolone acetonide, indocyanine green and trypan blue (Page 892, paragraph 2). Indocyanine green and trypan blue are vital dyes according to instant claim 4.
Regarding claim 6, COUCH teaches the dyes commonly used are not bound to any other chemicals or particles (Page 892, paragraph 1), which reads on a free dye.
Regarding claim 7, COUCH teaches the dye is administered intravitreally (Page 892, paragraph 1).
Regarding claims 21-23, 27, COUCH teaches dyes commonly used for ophthalmic procedures include triamcinolone acetonide, indocyanine green and trypan blue (Page 892, paragraph 2). Indocyanine green and trypan blue are vital dyes according to instant claim 4.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering a dye to the vitreous body. The person of ordinary skill in the art would have been motivated to make those modifications, because visualization of the vitreous boundaries makes procedures, like the one in SAUVAGE more efficient and effective, and reasonably would have expected success because both references are in the same field of endeavor, such as ophthalmic procedures regarding the vitreous body.
Regarding claims 8-10, the prior art’s dye would have the same chemical/physical properties of “wherein the dye is capable of diffusing in the vitreous body after administration”, “wherein the dye is capable of binding to the vitreous opacity after administration” and “wherein the dye is capable of forming vapor nanobubbles at the vitreous opacity when irradiated” as claimed by Applicant, because the prior art has the same dye as claimed by Applicant, unless proven otherwise.
Claims 1, 3-14, 16, 21-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over SAUVAGE (Photoablation of Human Vitreous Opacities by Light-Induced Vapor Nanobubbles. ACS Nano. 07/09/2019.) and COUCH (Use of triamcinolone during vitrectomy surgery to visualize membranes and vitreous. Clinical Ophthalmology. 2008) in view of MAIA (Vital Dyes for Staining Intraocular Membranes and Tissues During Vitrectomy. Retina Surgery. 2010).
SAUVAGE and COUCH teach Applicant invention as discussed above.
SAUVAGE and COUCH do not teach using a specific concentration of indocyanine green dye.
Regarding claim 5, MAIA teaches that vital dyes are commonly used during ophthalmic procedures (abstract). Indocyanine green, a vital dye, when used at a concentration between 0.025 mg/mL and 0.5 mg/mL is considered safe and leads to less damage to the eye (Page 29, paragraph 3-4). MPEP 2114.05 states, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using indocyanine green at a concentration between 0.025 mg/mL and 0.5 mg/mL. The person of ordinary skill in the art would have been motivated to make those modifications, because this concentration is considered safe and leads to less damage to the eye, and reasonably would have expected success because both references are in the same field of endeavor, such as ophthalmic procedures.
Claims 1, 3-14, 16 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over SAUVAGE (Photoablation of Human Vitreous Opacities by Light-Induced Vapor Nanobubbles. ACS Nano. 07/09/2019.), COUCH (Use of triamcinolone during vitrectomy surgery to visualize membranes and vitreous. Clinical Ophthalmology. 2008) and MAIA (Vital Dyes for Staining Intraocular Membranes and Tissues During Vitrectomy. Retina Surgery. 2010) in view of KOMPELLA (Nanomedicines for Back of the Eye Drug Delivery, Gene Delivery, and Imaging. Prog Retin Eye Res. 2013.).
SAUVAGE, COUCH and MAIA teach Applicant’s invention discussed above.
SAUVAGE, COUCH and MAIA do not teach using a protein nanoparticle.
KOMPELLA teaches that albumin, a protein, can be added to nanoparticles for ophthalmic use (figure 4). In the eye, serum albumin filtrates through the blood-aqueous barrier and is the major component (50% of total proteins) of aqueous humor and provides important metabolites for the growth of rapidly dividing lens epithelial cells (page 7, paragraph 4). Nanoparticles prepared with human serum album (HSA) may be less prone to degradation in the vitreous humor/body (page 11, paragraph 3), which is where virtuous opacities are located.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using a protein nanoparticle, such as a HSA nanoparticle. The person of ordinary skill in the art would have been motivated to make those modifications, because nanoparticles made from HSA are less prone to degradation in the vitreous humor/body, which is where virtuous opacities are located, and reasonably would have expected success because all references are in the same field of endeavor, such as ophthalmic procedures regarding the vitreous body.
Response to Arguments
Applicant argues, the combination of patent -844 and COUCH would be inoperable since the nanoparticles of SAUVAGE are the active component and the dye of COUCH is a passive component, that is not an active component of destruction. Thus a substitution would be inoperable. Furthermore, there would be no motivation to combine.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, as discussed in the rejection, the patent teaches a ophthalmic procedure using pulsed-laser illumination/photoablation, which reads on irradiation and photodestruction, on virtuous opacities, located in the vitreous body, to induce destruction of the virtuous opacities (abstract).
The patent does not teach administering a dye to a vitreous body of an affected eye of the subject.
However, COUCH teaches that dyes are used to aid in visualization for ophthalmic procedures involving the posterior cortical vitreous, which is located in the vitreous body (abstract). Localization of vitreous is difficult because of the invisible nature of vitreous (Page 892, paragraph 3). Removal of minute amounts of vitreous requires patience and careful observation, but when the vitreous boundaries are highlighted, the process is more efficient and effective (Page 892, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering a dye to the vitreous body. The person of ordinary skill in the art would have been motivated to make those modifications, because visualization of the vitreous boundaries makes procedures, like the one in recited in the patent more efficient and effective, and reasonably would have expected success because both references are in the same field of endeavor, such as ophthalmic procedures regarding the vitreous body.
Furthermore, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed composition, especially since SAUVAGE and COUCH teach all claim components and active steps.
The above rejection is not a substitution, but rather an addition. Furthermore, instant claim 24, teaches having a particle and a dye, which is what is taught by the prior art as discussed above.
Applicant argues, the combination of SAUVAGE and COUCH would be inoperable since the nanoparticles of SAUVAGE are the active component and the dye of COUCH is a passive component, that is not an active component of destruction. Thus a substitution would be inoperable. Furthermore, there would be no motivation to combine.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, as discussed in the rejection, SAUVAGE teaches a ophthalmic procedure using pulsed-laser illumination/photoablation, which reads on irradiation and photodestruction, on virtuous opacities, located in the vitreous body, to induce destruction of the virtuous opacities (abstract).
SAUVAGE does not teach administering a dye to a vitreous body of an affected eye of the subject.
However, COUCH teaches that dyes are used to aid in visualization for ophthalmic procedures involving the posterior cortical vitreous, which is located in the vitreous body (abstract). Localization of vitreous is difficult because of the invisible nature of vitreous (Page 892, paragraph 3). Removal of minute amounts of vitreous requires patience and careful observation, but when the vitreous boundaries are highlighted, the process is more efficient and effective (Page 892, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate administering a dye to the vitreous body. The person of ordinary skill in the art would have been motivated to make those modifications, because visualization of the vitreous boundaries makes procedures, like the one in SAUVAGE more efficient and effective, and reasonably would have expected success because both references are in the same field of endeavor, such as ophthalmic procedures regarding the vitreous body.
Furthermore, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed composition, especially since SAUVAGE and COUCH teach all claim components and active steps.
The above rejection is not a substitution, but rather an addition. Furthermore, instant claim 24, teaches having a particle and a dye, which is what is taught by the prior art as discussed above.
Applicant argues the dye in COUCH is not taught to have any special energy-absorbing properties for generating and thus locally exerting a mechanical force.
The Examiner does not find the argument percussive because, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the dye possessing special energy-absorbing properties for generating and thus locally exerting a mechanical force) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, COUCH teaches the same dye used by Applicant, so it would inherently have this same property, unless proven otherwise.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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