DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Acknowledgement is made of the response filed on June 17, 2026. In that response, claims 59, 106, 119-125, and 129 were amended, claim 111 was cancelled, and claim 13 was added. Claims 59, 106-110, and 112-130 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Here the Abstract filed on 03/22/2023 includes “Table 1A. Therapeutic Agent List” spanning 18 pages, following the opening paragraph. The amendment filed 06/17/2026 amends the paragraph only and there is no deletion of the Table 1A.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because: Figure 1 fails to show pars plana 25 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
The amended drawing filed June 17, 2026 is Figure 1A-2, not Figure 1.
Claim Objections
Claim 130 is objected to because of the following informalities.
“[D]evired” appears to be a typo.
The closing parenthesis in “RNAI (RNA interference of angiogenic factors)” should be moved to follow “interference”.
“Exenatide” is capitalized.
In “nilotinib, NS398”, nilotinib and NS398 appear to be the same compounds. If so, the comma raises confusion; parentheses are acceptable.
SDZ-RAD is everolimus which is recited earlier in claim 130.
Appropriate corrections are 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 59, 106-110, and 112-130 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 59 recites an “elongate barrier defining a reservoir, the barrier having a proximal end and a distal end”. The term “elongate” in claim 59 is a relative term which renders the claim indefinite. The term “elongate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure does not define “elongate”.
Furthermore a “claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty.” MPEP § 2173.03 (citations omitted). The plain meaning of “elongate” as an adjective is having notably more length than width or long and narrow, i.e., oblong. However the disclosure states, “[i]n many embodiments, the portion comprises an elongate cross-sectional profile having the first width extending along a first axis and the second width extending along a second axis”. (Para.0193, pre-grant publication US 20230338282.) In other words “elongate” includes a shape having substantially equal length and width. Thus as used in the disclosure, the term “elongate” is broader than the plain meaning as oblong, or having notably more length than width or long and narrow. Therefore it is unclear that “elongate” has the plain meaning, and one would not be apprised of the metes and bounds of the “elongate barrier”. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
For the purposes of examination now “elongate barrier” is construed as a barrier having the first width extending along a first axis and the second width extending along a second axis.
Claim 59 recites “extended time”. The term “extended” in claim 59 is a relative term which renders the claim indefinite. The term “extended” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure does not define “elongate”, but uses the term “extended time” or “extended period” without sufficient context to enlighten the extent of “extended”.
Claims 107-110 recite “about…”. The disclosure does not define “about”. “In determining the range encompassed by the term “about,” one must consider the context of the term as it is used in the specification and claims of the application.” MPEP § 2173.05(b)(III)(A)(citations omitted). The Federal Circuit has held a claim invalid for indefiniteness “where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term “about.” Id. (citations omitted). Here, the disclosure does not define or otherwise indicate the meaning of “about”. The disclosure uses “about” throughout the specification in various contexts, e.g., “about twelve months” or “about 20 days”. However there is no instance where “about…” is used in sufficient context, e.g., a series of “about…” numerical values that would aid in ascertaining the extent of “about”.
Claim 130 recites “A0003”, which cannot be ascertained. “Table 1A. Therapeutic Agent List” in the Abstract lists “A0003 (Aqumen BioPharmaceuticals)”. However no such combination of active agent and company name has been found.
In “compstatin derivative peptide, POT-4” the underlined comma renders the phrase unclear whether it is referring to compstatin derivative peptide generally or just to POT-4. The same issue appears in “FK605-binding proteins, FKBPs”. Note that 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).
“RNAI (RNA interference of angiogenic factors)” appears to be a therapeutic approach or concept rather than a therapeutic agent.
“siRNAi molecule synthetic, FTP-801i-14”, from Quark Pharmaceuticals according to “Table 1A. Therapeutic Agent List”, cannot be ascertained. The underlined comma renders the phrase unclear whether it is referring to synthetic siRNAi molecules generally or just to “FTP-801i-14”.
Applicant’s independent review of the agents in claim 130 is requested to avoid further objections and/or rejections under 35 U.S.C. 112(b).
Claim Interpretation
Amended claim 59 recites “the container comprising an elongate barrier defining a reservoir, the barrier having a proximal end and a distal end, the container further comprising a porous structure at the distal end of the barrier, the porous structure being configured to release…”. For clarify of record it is noted that neither this phrase nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. In other words an elongate barrier that is (i) entirely made of a porous material, or (ii) partly made of a porous material at one end, comprises the porous structure. This interpretation is supported in the drawings. For example Figure 6C (page 17 of 62) shows post 604 comprising the reservoir 605 defined by the rigid porous structure 606.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 59, 106-110, 113-117, 119-123, 126-128, and 130 are rejected under pre-AIA 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Weiner (US 5466233).
Weiner teaches a method of treating an eye using a “tack for intraocular drug delivery and a method for insertion and removal of an intraocular device for sustained release of a drug” (abstract; see entire document including title; col.3 lines 26-47, col.10 line 33-col.11 line 8; Figs. 2, 9, 14 and accompanying text). The tack is a therapeutic device. “The tack comprises a post, an anchoring region and a head” with the post “positioned within the vitreous region” (abstract) and thus “away from the retina”, comprising a first and second ends, and including a drug to be administered (col.2 lines 54-67; col.13 lines 65-67). The “post” is thus a container having walls or “an elongate barrier” with proximal and distal ends.
In one embodiment the tack comprises “a post having a membrane, a hollow central portion and a head”, wherein the membrane is at least semi-permeable and forms a hollow void”, i.e., a container (col. 3 lines 11-14). Examples of permeable materials which may be used for the membrane 70 include microporous, biocompatible materials” (col.8 lines 52-67) and thus the membrane is a porous structure. “In one preferred embodiment as shown in FIGS. 1, 5, 8 and 12, the post 12 comprises a outer membrane 70 which may be permeable or semi-permeable. The membrane 70 forms a cavity 72. The cavity is filled with a drug in liquid or gel form to be administered.” (Col. 8 lines 28-32 (emphasis added)). In each of Figures 1, 5, 8, and 12, the permeable membrane 70, i.e., including “microporous, biocompatible materials” comprise the distal end of the membrane or the barrier. For example, Figure 1 is shown below.
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“The first portion of the device is maintained in the vitreous region until the first portion of the device has delivered a predetermined dosage of the drug into the vitreous region” (col.3 lines 39-42).
The present claims recite identifying a target location of the retina for treatment; however Weiner teaches treating diseases involving the retina (col.10 lines 23-27) and standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. Also “convective flow of the vitreous humor” is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. As seen in Weiner’s Figure 14 (Fig.14 and accompanying text col.14 lines 24-39; see, e.g., claim 1) the tack is inserted into the vitreous humor, and the drug is released into that environment which the retina abuts. A substantially similar diagram of the eye appears as Figure 1 in this application. Thus the skilled person would understand that the drug once released into the vitreous would reach a region of the retina.
Regarding claim 106 the tack is inserted by making an incision through the scleral tissue into the vitreous region “such that an opening for insertion of the device is created” (col.3 lines 26-37; col.14 line 52-col.15 line 8). Regarding claims 113 and 114, “[a]s shown in FIG. 14, the tack 10 of the present invention is preferably inserted into those portions of the sclera 24 on either side of the eye 18 posterior to the ciliary bodies 44 known as the ciliary pars plana35.” (col.14 lines 24-27). Figure 14 shows that the length of the incision is greater than the diameter of the tack or the “distance across the pars plana”. Regarding claims 115 and 116, the “portion of the conjunctival membrane [that had been separated to cut the scleral tissue for inserting the tack] is reattached to the portion of the scleral tissue underlying the portion of the conjunctival membrane” (col.3 lines 37-40).
Regarding claims 106, 117 and 119-123, the anchoring region comprises the second or the proximal end of the post and has a width that anchors or retains the tack in at least one of the sclera, retina, and the choroid (col.2 lines 57-67; see Fig. 14). Figures 1-5 show a neck portion having indented profile, i.e., concave and thus of a smaller diameter.
Regarding claims 107-110, the device may release for up to 6 months or “an indefinite period of time” (col.8 lines 12-27). Furthermore Weiner teaches injecting subsequent doses of a drug through an opening in the head which is fluid communication with the void such that explanting the device is not necessary.
The void [cavity] is filled with a first portion of a liquid drug to be administered. The first end of the post is for positioning in the vitreous region of the eye. The hollow central portion is affixed to the second end of the post and is filled with a second portion of the liquid drug to be administered. The void and hollow central portion are in fluid communication with one another. The central portion is for being positioned within at least one of the retina, the choroid and the sclera. The head extends from the central portion in the manner described above, and has an opening for injection of subsequent doses of the liquid drug. The opening is in fluid communication with the hollow central portion. (Col.3 lines 14-25; see col. 7 lines 56-66; claim 21.)
Regarding claims 126-128, the refillable chamber 58 is accessible through the head 15 by an injection port 68 …[comprising] any puncturable membrane” or septum and a “drug in liquid or gel form may be injected through the injection port 68 without unnecessary exposure to the external environment thereby aiding in the prevention of infection from subsequent injections of the drug” (col.7 lines 57-66; see, e.g., Fig.5 col.7 lines 39-43, interior space 60 prevents needle penetrating the sclera or choroid). The conjunctiva would be penetrated since Weiner teaches reattaching the portion of conjunctival membrane after implanting the device in the vitreous region (col.3 lines 28-40).
Response to Arguments
Although the rejections over Weiner are modified to address the claim amendments, Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive. Applicant argues that Weiner fails to disclose “an elongate barrier defining a reservoir…at the distal end of the barrier”. (Remarks, 12, June 17, 2026.)
In response it is noted that the above rejections discusses that neither this phrase nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. For example Applicant’s Figure 6C (page 17 of 62) shows post 604 comprising the reservoir 605 defined by the rigid porous structure 606. As further discussed above Weiner teaches, “FIGS. 1, 5, 8 and 12, the post 12 comprises a outer membrane 70 which may be permeable or semi-permeable. The membrane 70 forms a cavity 72. The cavity is filled with a drug in liquid or gel form to be administered.” (Col. 8 lines 28-32 (emphasis added).
Applicant further argues that the Office has not met the standard of establishing inherency regarding the convective flow of the vitreous humor to deliver the therapeutic agent to the target location. (Remarks, 12.)
In response it is noted that the target location is the retina according to claim 59. As discussed above Figure 1 of Applicant’s disclosure (as does Weiner’s Figure 14) shows that implantation of the device into the vitreous humor as Weiner teaches would reach the retina. Should Applicant pursue this argument, further evidentiary support is requested. “Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection.” MPEP §2145 (I).
Each of the dependent claims has been addressed in the rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 59, 106-110, and 112-130 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weiner (US 5466233).
Weiner does not specifically teach all of the limitations in claims 112, 118, 124, 125, and 129. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to modify the teachings of Weiner as recited in the instant claim(s).
Regarding claim 112, Weiner teaches the septum. The refillable chamber 58 is accessible through the head 15 by an injection port 68 …[comprising] any puncturable membrane” or a septum and a “drug in liquid or gel form may be injected through the injection port 68 without unnecessary exposure to the external environment thereby aiding in the prevention of infection from subsequent injections of the drug” (col.7 lines 57-66). Weiner does not teach a needle coupled to a fill syringe wherein the needle comprises a stop configured to prevent the tip of the needle from advancing beyond the maximum stop distance. However Weiner teaches refilling the reservoir by injection and notes the head 16 as a feature “which prevents the device from being inserted too far into the eye 18” (col.6 lines 43-44). Therefore the skilled person could devise safety needle that “prevents the device from being inserted too far into the eye 18”.
Regarding claims 118, 124, and 125, Weiner teaches a “circular shape is preferred as there are no pointed edges which may irritate the eye, however, other shapes such as generally elliptical, square or triangular may be used for the head 16 and are within the scope of the present invention as long as the head 16 is configured to minimize irritation or risk of damage to the scleral surface 28” (col.7 lines 8-14). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).Therefore the skilled person would have been motivated to combine circular and elliptical, square, or other shapes within the scope of Weiner to avoid irritation to the eye.
Regarding claim 129, “wherein liquid disposed within reservoir is [ ] removed ….when the additional quantity is injected” would occur when “the additional quantity” is sufficient to force out the liquid disposed in the reservoir. The skilled person would have been motivated to inject sufficient volume of the additional liquid depending on the treatment desired. For instance to deliver a new drug using the tack, s/he may inject a sufficient amount of a “flushing” liquid to eliminate the prior drug in the reservoir and/or condition the vitreous so as to prepare it for sustained delivery of the new drug.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive. Applicant argues the Office has not articulated a rationale as to why a skilled person would have modified Weiner as in the claims at issue. (Remarks, 13.)
In response it is noted that the rejection above addresses each of claims 112, 118, 124, 125, and 129. Furthermore the reply by the applicant or patent owner “must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action” and “must present arguments pointing out the specific distinctions believed to render the claims, …, patentable over any applied references”. 37 CFR 1.111(b)(emphasis added).
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 59, 106-110, and 112-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 14-18, and 24-26 of U.S. Patent No. 8298578.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor (claim 17), i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The present claims also recite “elongate barrier defining a reservoir…” and the porous structure at the distal end of the barrier”; however neither the claims nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. Both sets of claims recite a barrier defining a space for a therapeutic agent, with a porous portion. The ‘578 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59, 106-110, and 112-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 and 22-26 of U.S. Patent No. 11642310.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior segment, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container or reservoir comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor (claim 7), i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The present claims also recite “elongate barrier defining a reservoir…” and the porous structure at the distal end of the barrier”; however neither the claims nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. Both sets of claims recite a barrier defining a space for a therapeutic agent, with a porous portion. The ‘310 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59, 106-110, and 112-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 9, and 10 of U.S. Patent No. 9474756.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The present claims also recite “elongate barrier defining a reservoir…” and the porous structure at the distal end of the barrier”; however neither the claims nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. Both sets of claims recite a barrier defining a space for a therapeutic agent, with a porous portion. The ‘756 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59, 106-110, and 112-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9895369.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye having a vitreous humor and a retina of a posterior chamber, the method comprising: positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The present claims also recite “elongate barrier defining a reservoir…” and the porous structure at the distal end of the barrier”; however neither the claims nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. Both sets of claims recite a barrier defining a space for a therapeutic agent, with a porous portion. The ‘369 patent’s claims recite further limitations and therefore anticipate the present claims.
Claims 59, 106-110, and 112-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 20, 21, and 23 of U.S. Patent No. 12251336.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of treating an eye comprising positioning or implanting a container having a therapeutic amount of a therapeutic agent, the container comprising a porous structure to release therapeutic amounts of the at least one therapeutic agent for the extended time, wherein the porous structure is positioned in the vitreous humor or vitreal cavity of the eye, i.e., at a location away from the retina to deliver the therapeutic agent to the target location with convective flow of the vitreous humor. The present claims recite identifying a target location of the retina for treatment; however standard medical practice would require identifying an optimal location of the retina for treatment rather than a random location. The present claims recite also “convective flow of the vitreous humor” which is a natural fluid movement caused by temperature/pressure differences in the posterior chamber and therefore inherent to an eye. The present claims also recite “elongate barrier defining a reservoir…” and the porous structure at the distal end of the barrier”; however neither the claims nor any relevant disclosure requires the container, the elongate barrier, and the porous structure to be physically separate structural elements. Both sets of claims recite a barrier defining a space for a therapeutic agent, with a porous portion. The ‘336 patent’s claims recite further limitations and therefore anticipate the present claims.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive. Applicant argues that claim 59 now recites “an elongate barrier…” and the Office has not articulated a rationale why a skilled person would have modified the claims of the patents to arrive at amended claim 59. (Remarks, 13-14, June 17, 2026.)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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, Ali Soroush can be reached at (571)272-9925. 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.
/H. SARAH PARK/Primary Examiner, Art Unit 1614
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