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 .
Status of Claims
Claims 1-17 are pending and examined on the merits.
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 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 said 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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8-10, 12-17 of U.S. Patent No. 10,881,548. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite all of the current limitations as mapped in the table below.
Current claim #
1
2
3
4
5
6
7
8
9
Corresponding claim # in 10,881,548
1
1
2
1
4
5
6
8
9
Current claim #
10
11
12
13
14
15
16
17
Corresponding claim # in 10,881,548
10
12
13
14
15
16
1
17
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,963,905. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite all of the current limitations as mapped in the table below.
Current claim #
1
2
3
4
5
6
7
8
9
Corresponding claim # in 11,963,905
1
1
-
1
2
3
3
4
5
Current claim #
10
11
12
13
14
15
16
17
Corresponding claim # in 11,963,905
6
7
8
9
10
11
12
12
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.
Claims 1-2, 13-14, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman (US 2015/0182756).
Re Claim 1, Peyman discloses a method of delivering an agent to the retina, the method comprising:
removing at least a portion of a fluid from the eye ([0207] “the vitreous gel is removed”);
removing at least a portion of the inner limiting membrane (ILM) to expose a section of the retina ([0207] “the internal limiting membrane (ILM is removed”);
introducing a non-diluting, fluid into the eye ([0207] “the vitreous gel is … replaced with saline”);
applying a composition comprising an agent to the exposed section of the retina ([0207] e.g., “permit particle dissemination within the retina and throughout retinal intracellular spaces,” see e.g., [0010], [0013]-[0016] for disclosure of therapeutic agents associated with the particles); and
maintaining the composition on the exposed section of the retina for a time sufficient to allow the agent to enter cells in the retina (at least [0207] “[p]articles may adhere to the outer cellular membrane and/or may enter retinal cells”);
thereby delivering the agent to the retina (implied because the particles are disclosed to be able to enter retinal cells).
Re Claim 2, Peyman discloses claim 1 and further disclosing wherein the fluid from the eye is vitreous fluid ([0207]).
Re Claims 13-14, Peyman discloses claim 1 and also discloses wherein the agent comprises (see [0084]) one or more of a viral delivery vector, a non-viral delivery vector, an antibody, a cell, a small molecule, or a nanoparticle; and
wherein the agent comprises a viral delivery vector selected from the group consisting of adeno-associated virus (AAV), ancestral AAV, adenovirus, lentivirus, retrovirus, herpes simplex virus (HSV), and baculovirus (at least [0084]).
Re Claim 16, Peyman discloses claim 1 and further disclosing wherein the maintaining step comprises maintaining the agent on the exposed section of the retina for at least about 1 minute ([0048] since it takes 100 seconds to activate the particles, it is implied that the particles are maintained on the exposed retina for at least that long).
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.
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.
Claims 3, 8, 11, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman.
Re Claim 3, Peyman teaches the method of claim 1 but does not explicitly teach wherein at least about 50% of the fluid from the eye is removed. However, in order to remove the ILM, it is likely that the surgeon would need to remove all of the vitreous fluid to gain access of the ILM and then the retina. As such, one skilled in the art would find it obvious to remove all of the vitreous fluid (thus more than 50%) from the eye for easier operation on the ILM and retina.
Re Claim 8, Peyman teaches the method of claim 1 but does not teach wherein the portion of the ILM that is removed has an area from about 0.62 mm² to about 62 mm². However, Peyman discloses that the area of the retina being covered by the particles can vary by manipulating the delivery cannula ([0203]), suggesting that it is up to the surgeon who performs the procedure to determine how much of the retinal surface should be exposed to the particles/therapeutic agent. As such, one skilled in the art would have the knowledge and skills to remove an area of ILM that is appropriate for the treatment prescribed by the doctor.
Re Claim 11, Peyman teaches the method of claim 1 but does not disclose that wherein the composition comprises from about 50 % to about 95 % by weight of the agent. However, since Peyman discloses that one skilled in the art can change multiple operating parameters (e.g. pulsing pressure, distribution area, diameter of outlet port, angle of outlet ports) with the ultimate goal of achieve the right amount of particle penetration into the retinal tissues ([0203]), one skilled in the art would likely look to vary the weight percentage of agents/particles in the fluid composition, because that can also determine the amount of particles that enter the retinal tissues. As such, one may be able to arrive at the claimed percentages through routine experimentation by observing the retinal penetration rate by the particles.
Re Claim 15, Peyman teaches the method of claim 1 but does not teach in the same embodiment that wherein the non-diluting, fluid replacement material is selected from the group consisting of C3F8, SF6, air, nitrogen, oxygen, perfluoro-n-octane, and silicone oil. Peyman discloses in a different embodiment that the fluid replacement material may be saline, air or a biocompatible fluid ([0205]). It would have been obvious to one skilled in the art at the time of filing to modify with the use of air as a replacement fluid for the vitreous fluid since the selection of a material (i.e. air) suitable for its intended use (i.e. replacing vitreous gel) supports a prima facie case of obviousness (MPEP 2144.07).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Matsuhisa et al. (US 2007/0225727).
Re Claims 4-5, Peyman teaches the method of claim 1 but does not teach introducing a fluid detection agent into the eye prior to or during the step of removing at least a portion of the vitreous fluid from the eye, wherein the fluid detection agent is triamcinolone. Matsuhisa discloses that it is common in vitrectomy (removal of vitreous gel) to stain the vitreous gel with triamcinolone in order for the surgeon to clearly visualize the vitreous body ([0003]), and thus be able to remove the vitreous body. It would have been obvious to one skilled in the art at the time of filing to modify Peyman with Matsuhisa so the surgeon can safely remove the vitreous body.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Horsager et al. (US 2012/0093772).
Re Claims 6-7, Peyman teaches the method of claim 1 but does not explicitly teach that the portion of the ILM is surgically removed or enzymatically removed. Horsager discloses delivering therapeutic agent to the retina of an eye by first removing the inner limiting membrane (ILM), wherein the removal of the ILM can be achieved surgically or enzymatically ([0127]). It would have been obvious to one skilled in the art at the time of filing to modify Peyman with Horsager for efficient removal of the ILM so that therapeutic agents can be more easily delivered to the retina.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Askari et al. (US 2014/0248231).
Re Claims 9-10, Peyman teaches the method of claim 1 but does not teach wherein the ILM is visualized with an ILM-visualization material and wherein the ILM-visualization material is indocyanine green (ICG). Askari teaches a standard vitrectomy procedure wherein the ILM is made visible with indocyanine green ([0245]) such that the surgeon can safely remove the ILM. It would have been obvious to one skilled in the art at the time of filing to modify Peyman with Askari so the surgeon can safely remove the ILM.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Lyons et al. (US 2009/0226531).
Re Claim 12, Peyman teaches the method of claim 1 but does not teach that the composition further comprises a viscoelastic composition. Lyons teaches a composition having nanoparticles to deliver therapeutic agent to the retina ([0024]), wherein the composition comprises a viscoelastic component (at least [0010]). It would have been obvious to one skilled in the art at the time of filing to modify Peyman with the viscoelastic physical form of the Lyon's composition since simple substitution of one known element (e.g. particles in liquid suspension or gas suspension) with another (e.g. viscoelastic suspension) to yield predictable results establishes a prima facie case of obviousness (MPEP 2143).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Shapiro et al. (US 2015/0374543).
Re Claim 17, Peyman teaches the method of claim 1 but is silent to maintaining the position of the agent on the exposed retina for at least about 30 minutes. However, Peyman discloses throughout the Specification that the particles may diffuse into the retinal tissues and Peyman also discloses an embodiment where the particles may be activated by magnetic forces. Shapiro teaches a method of magnetically pushing nanoparticles to the retina to treat the eye, wherein the magnetic push system is aligned to push the magnetic nanoparticles for one hour ([0069]). It would have been obvious to one skilled in the art at the time of filing to modify Peyman with Shapiro for improving uptake of the particles (and the associated therapeutic agents) by the retinal tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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, Rebecca Eisenberg can be reached at 571-270-5879. 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.
/SUSAN S SU/ Primary Examiner, Art Unit 3781
14 February 2026