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 .
Examiner Comment
Examiner contacted applicant on 12/12/2025 to discuss a proposed Examiner’s amendment that would place the claims into condition for allowance. Specifically, the examiner proposed moving claims 14 and 17 into claim 1. Applicant declined the amendment and requested that a rejection be mailed.
However, upon further consideration of the Haffner reference, Claim 17 is no longer allowable. See the rejection below.
Response to Amendment
In the reply filed 10/20/2025, applicant amended claims 1, 2, 5, 7, 8, 10, and 12-14, canceled claims 4, 9, and 11, and added new claims 17-19. Claims 1-3, 5-8, 10, and 12-19 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-8, 10, and 12-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection below has been amended in view of Applicant’s amendments to the claims. An annotated version of Haffner’s Figure 7 has also been provided for clarity.
Applicant also argues that Haffner does not teach “one or more orifices at or near the distal end of the elongate shell and one or more orifices at or near the proximal end of the elongate outer shell” and “wherein the ocular implant is configured to elute the drug from the one or more orifices at or near the distal end and the one or more orifices at or near the proximal end.”
This argument has not been found persuasive. These limitations were previously presented separately in claims 4 and 11, which have been canceled in the reply filed 10/20/2025, and applicant has not provided any actual arguments that address why the rejection of these claims was improper. The rejection of claim 1 has been updated below in view of the amended claim language.
With respect to the 101 rejection of claims 1-16, the rejection has been withdrawn in view of the amendments to the claims.
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.
Claim 2 is 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.
With respect to Claim 2, the claim recites that a portion of the drug is positioned adjacent to at least a portion of the internal plug. This contradicts Claim 1, which requires that the drug is dispersed or mixed with the internal plug creating an internal plug and drug mixture. For examination purposes, the phrase “adjacent to a portion of the internal plug” has been interpreted to include a drug that is mixed with the plug.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
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.
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.
Claims 1-3, 5-8, 10, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Haffner et al. (US 2013/0289467).
With respect to Claim 1, Haffner teaches an ocular implant (Figures 7-9, 11A, 12, especially Figure 7) comprising an elongate outer shell 54 comprising a bioerodable material [0010] and shaped to define an interior lumen (58; defined between the outer shell 54 and a partition 64a, as illustrated in the annotated figure below), the elongate shell comprising a proximal end (adjacent partition 64a) and a distal end (adjacent opening 56b);
an internal plug positioned within the interior lumen (drug core 62 is mixed with a polymer for form a plug that has a drug 62 dispersed or mixed therein; see paragraph [0127], [0188] with respect to the configuration of Figure 11A), and [0312] with respect to the configuration of Figures 7-9 and 12);
a drug 62 positioned within the interior lumen 58 and dispersed or mixed within the internal plug creating an internal plug and drug mixture (paragraphs [0153] and [0159]; see paragraph [0127], [0188] with respect to the configuration of Figure 11A), and [0312] with respect to the configuration of Figures 7-9 and 12);
one or more orifices 56a/56b at or near the distal end of the elongate outer shell and one or more orifices 56a near the proximal end of the elongate outer shell (the implant is covered in orifices, as shown in Figures 7- 9, 11A, and 12; Haffner teaches that the orifices 56a are disposed over the entirety of the elongate outer shell from the distal end 50 to the proximal end 64a, and the examiner notes that at least some of these orifices 56a are disposed near the proximal end 64a of the lumen and at least some of the orifices 56a are disposed near the distal end of the lumen; see the annotated figure below);
wherein the drug is configured to pass through the internal plug to control elution of the drug (see entire disclosure, especially [0150]); and
wherein the ocular implant is configured to be positioned within the vitreous cavity (see at least paragraphs [0026] and [0192]);
wherein the ocular implant is configured to elute the drug from the one or more orifices 56a/56b near the distal end and the one or more orifices 56a near the proximal end (Figures 7-9, 11A, and 12; paragraphs [0147-0153]).
In the event that Applicant does not clearly envisage the citations in paragraphs [0127], [0188], and [0312] as being applicable to the embodiments of Figures 7-9, 11A, and 12, the examiner notes that Haffner teaches that the use of a drug mixed with a polymeric core/plug allows for the controlled elution of the drug over a predetermined period of time (see [0127], [0150], [0188], and [0312]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Haffner’s embodiment of Figures 7-9, 11A, and 12 to have an internal plug that has the drug 62 dispersed or mixed therein, as further suggested by Haffner, in order to provide a well-known means for controlling the elution rate and duration of the drug from the implant.
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Annotated Figure 7 of Haffner
With respect to Claim 2, Haffner teaches that the drug is admixed with the polymer core of the internal plug (Figures 7-9, 11A, and 12; paragraphs [0127], [0188], and [0312]), and is therefore a portion of the drug is positioned adjacent to at least a portion of the internal plug.
In the event that this interpretation is not clearly envisaged by applicant, Haffner teaches an alternate embodiment (Figures 10C-10E) wherein the drug 62 is admixed with a polymer (an internal plug; paragraphs [0150], [0153-0154], [0188]) and is also disposed adjacent an internal plug 210. In this configuration, the internal plug 210 is provided with size, density, porosity, and permeability that controls the release rate of the drug 62 through the internal plug and into the body [0154]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Haffner’s ocular implant of the embodiment of Figures 7-9 and 12 to have an internal plug disposed adjacent to the drug core 62, as suggested by Haffner in the embodiment of Species 10C-10E, in order to provide an alternate means for controlling the elution rate of the drug from the implant into the patient’s eye.
With respect to Claim 3, Haffner teaches that the internal plug/drug mixture 62 is positioned adjacent the distal-most end of the interior lumen 58. See Figure 7.
With respect to Claim 5, Haffner teaches a coating 60 surrounding at least a portion of the elongate outer shell 54. See Figures 7-9; paragraph [0149].
With respect to Claim 6, Haffner teaches that the closed proximal end 64a comprises an end cap (Figure 7; paragraph [0153]).
With respect to Claims 7 and 8, Haffner teaches that the elongate outer shell may be configured such that it begins to biodegrade after all or substantially all of the drug is eluted from the interior lumen of the implant. Haffner also teaches that the outer shell may be configured to begin to bioerode while at least a portion of the drug remains in the interior lumen. See entire disclosure, especially [0049-0050], [0111], [0116], [0149-0163], [0173-0178], and [0188].
However, in the event that this interpretation is not clearly envisaged by applicant, Haffner clearly suggests that the erosion rates of the drug and outer shell may be varied according to the desired release rate of the drug that is being used. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to provide release/degradation rates of the outer shell and drug at any rate that was considered desirable for a specific drug and treatment regimen.
With respect to Claim 10, Haffner teaches that the ocular implant is positioned inside a lumen of a 23-25 Gauge needle or cannula of a delivery device. See paragraphs [0026], [0161], [0192], [0248], and [0309].
With respect to Claims 12 and 13, Haffner’s embodiment of Figure 7 does not disclose a capsule-shaped implant, such that the proximal and distal ends are each rounded.
However, in a different embodiment, Haffner teaches that drug release orifices may be provided at both the proximal and distal ends of the implant, such that the same or different drugs may be administered in different intraocular regions [0136]. Specifically, in this configuration, the proximal and distal ends are both rounded, such that the implant is substantially capsule-shaped (see Figure 5). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Haffner’s embodiment of Figures 7-9 and 12 to be capsule shaped and have orifices at both the proximal and distal ends, as suggested in Figure 5 of Haffner, in order to provide a known means for administering the same or different drugs to different regions of the intraocular space.
In the event that Applicant does not clearly envisage Figure 5 of Haffner as being capsule-shaped, Haffner teaches a variety of additional (Figures 15, 18A-18Q, and 29-10; paragraphs [0177], [0181-0184], [0288-0289]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Haffner’s ocular implant to be substantially capsule-shaped, or any other shape that was considered desirable or expedient, as suggested by Haffner’s Figures 15, 18A-18Q, and 29-30, in order to provide a well-known, alternate configuration for the drug-eluting implant.
With respect to Claim 14, Haffner teaches that the drug is completely dispersed or mixed within the internal plug, as discussed above with respect to Claim 1, thereby creating the internal plug and drug mixture. See Figure 7 and paragraph [0312].
With respect to Claim 15, Haffner further teaches in the embodiment of Figure 11A that drug comprises at least fifty percent of the internal plug and drug mixture [0190]. Specifically, in Figure 11A, the internal plug and drug mixture comprises one or more micro-tablets that comprise a drug and a polymeric plug/core, these drug and plug micro-tablets being configured to fill the interior lumen of the elongate outer shell between the proximal end and the distal end (see Figure 11A and paragraph [0188]).
With respect to Claim 16, Haffner teaches that the internal plug and drug mixture is provided as either a polymeric material that is pre-mixed with the drug (Figures 7-9 and 12; paragraph [0312]) or as one or more micro tablets comprising the drug and a polymeric plug/core (Figure 11A; paragraph [0188]).
With respect to Claim 17, Haffner teaches that the internal plug and drug mixture fills the entire interior lumen as defined above with respect to Claim 1 (see the annotated Figure 7 above).
With respect to Claim 18, Haffner teaches that the interior lumen is a single continuous interior lumen extending from the proximal end to the distal end. See the annotated Figure 7 above.
With respect to Claim 19, Haffner teaches that the sidewalls of the elongate outer shell comprises a plurality of orifices 56a spaced evenly along the shell (Figures 7-9). An additional orifice 56b is disposed at the distal end, while the proximal end is closed off partition 64a. Therefore, Haffner’s distal portion will have one more orifice than the proximal end.
In the event that this interpretation is not clearly envisaged by applicant, Haffner further teaches that the number, size, location, and shape of the orifices can be changed depending on the desired drug release rate and location [0150]. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Haffner’s implant to have more orifices at the distal end than at the proximal end, or in any other configuration that was considered desirable or expedient, in order to achieve a desired release profile of the drug from the implant [0150].
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, 5-8, 10, and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,318,043 in view of Haffner. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an ocular implant configured for implantation into the eye, the implant comprising an elongate outer shell, an internal plug, a drug, and or more orifices, wherein the drug is configured to pass through one or more orifices to control elution, and wherein the implant is configured to be positioned within the vitreous cavity. The instant claims are broader than the ‘043 claims because they do not necessarily require that the proximal and distal ends are rounded.
The ’043 claims do not specifically require that the drug is at least partially dispersed or mixed within the internal plug creating an internal plug and drug mixture.
Haffner teaches a similar ocular implant, wherein in one embodiment, a drug is mixed with a polymer material (i.e. an internal plug) to form an internal plug and drug mixture (Figures 7-9, 11A, and 12; see paragraphs [0127], [0188], and [0312]. Specifically, Haffner discloses this configuration as an alternative to having the drug 62 disposed adjacent the internal plug (as shown in Figures 10C-E). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the device of the ‘043 claims to have the drug at least partially dispersed or mixed within the internal plug creating an internal plug and drug mixture, as suggested in Haffner’s embodiment of Figures 7-9, 11A, and 12, in order to provide a well-known alternate means for releasing the drug from the ocular implant at a controlled rate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heitzmann (US 10,245,178), Cohan (US 6,196,993), Li (US 2009/0306608) and Butuner (US 2009/0280158) teach ophthalmic inserts for sustained release of medication into the eye.
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 Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781