DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 8/7/2026 wherein claims 16, 17, 19, 21, 24-28 and 34 have been amended and claims 18 and 20 have been cancelled.
Claims 16, 17, 19 and 21-35 are presented for examination on the merits.
The following rejections are made.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/23/2024 was considered by the examiner.
Response to Applicants’ Arguments
Applicant’s amendments filed 5/19/2026 renders moot the rejection of claims 24-26 made by the Examiner under 35 USC 112(b) over Hammang et al. (US 2002/0061327). This rejection has been withdrawn.
Applicant’s arguments filed 5/19/2026 regarding the rejection of claims 16, 17, 19, 21-23, 26 and 27 made by the Examiner under 35 USC 102(a)(1) over Hammang et al. (US 2002/0061327) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/19/2026.
Applicant’s arguments filed 5/19/2026 regarding the rejection of claims 16, 17, 19 and 21-30 made by the Examiner under 35 USC 102(a)(1) over de Juan et al. (US 2020/0038240) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/19/2026.
Applicant’s arguments filed 5/19/2026 regarding the rejection of claims 16, 17, 19 and 21-35 made by the Examiner under 35 USC 103 over de Juan et al. (US 2020/0038240) in view of Hammang et al. (US 2002/0061327) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 5/19/2026.
In regards to the 102(a)(1) and 103 rejections, Applicant asserts the following:
A) neither reference describes ‘an eyelet fixedly connected with both ends of the elongate body’ ‘wherein the eyelet comprises a gripping portion and a linking portion, said linking portion connecting the gripping portion to at least one end of the body, wherein the gripping portion comprises an opening.’
B) de Juan’s device is not intended for intraocular positioning but instead the superior eyelid. One would not be motivated to modify de Juan’s device so as to include Hammang’s eyelet because this would result in replacing the retention structure with an eyelet which would be undesirable and less effective at retaining the device position than the original retention structure.
In response to A, the features described in Applicant’s arguments are broadly encompassed by both Hammang and de Juan. Hammang provides the following structure:
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wherein the linking portion is attached to the body and the gripping portion is attached to the linking portion and comprises an opening.
De Juan provides the following structure:
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wherein 120 is an elongated polymeric support structure and retention structure 110 is viewed as a griping portion that comprises an opening and is connected to the polymeric support by way of a linking portion. Applicant argues that the retention structure 110 fails to comprise the opening but the Examiner respectfully disagrees as the opening is the area within the frame of the retention structure. The amendments fail to differentiate the claimed structure from the prior art structures.
In response to B, MPEP 2111.02(II) states that where a claim defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, then the preamble is not a claim limitation as it merely describes how the composition may be used rather than a limitation to the structure itself. In the present case, the intended use of being an ‘intraocular drug delivery device’ provides some structure in that device has to be shaped and sized sufficiently small to be placed into the eye.
With respect to de Juan’s device, it is intended for placement in the eyelid or in the conjunctival sac of the eye, which is adjacent to the eye or in the eye, respectively. De Juan’s device therefore is sufficiently small to expect that it be placed into an area of the eye so as to release drug to treat an ocular condition. De Juan states at [0038] that their insert is to be inserted into an eye with Fig. 1-2-1 demonstrating that the therapeutic device being placed within the eye as an ‘ocular insert’. As the structure, the sizing and the purpose of de Juan’s device are overlapping with that claimed there is little to no reason to expect that that the system of de Juan could not be used in the manner as presently claimed absent some evidence to the contrary, especially given de Juan’s qualification that their device be placed into an eye (thereby suggesting an intraocular device).
Regarding combining de Juan and Hammang, the eyelet ring of Hammang would be a desirable feature to add to de Juan as Hammang teaches that the eyelet is useful for attaching the structure to a target area to prevent the device from moving once placed. Attaching the eyelet ring of Hammang to the system of de Juan would yield a drug delivery system capable of being localized and secured to a target area for release of therapeutic thereby ensuring the device of de Juan would remain in position once inserted onto the eye/eyelid. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is supportive of a finding of obviousness. Applicant’s arguments are not found persuasive.
Maintained Rejections, of Record
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 16, 17, 19, 21-23, 26 and 27 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammang et al. (US 20020061327).
Hammang discloses a sustained release device for treating ophthalmic diseases, the device having the following structure
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(see [0026] and Fig 1) wherein the device comprises an elongated capsule having a polymeric core (see [0066, 0067]) surrounded by a polymeric capsule jacket (i.e. mantle) (see [0064, 0074, 0075]) (see instant claims 16 and 17). The device is to possess the polymeric jacket on the distal ends of the capsule (see [0102-0106]) (see instant claims 22 and 23). Attached to the end of the capsule jacket is an eyelet (see Figures and [0024, 0070]) (see instant claim 16). The eyelet is attached to the device by way of a gripping portion and a linking portion, wherein the linking portion attaches the extended section of the eyelet to the body of the capsule and is responsible for connecting the gripping portion to both ends of the body (see Figures) (see instant claims 16 and 19) according to the following interpretation:
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(Examiner’s understanding of Hammang’s Figure 1 in relation to the claimed invention). The linking portion and the gripping portion are directly connected (see instant claim 27). The eyelet has an opening for which sutures can go through (see instant claim 16), the opening being characterized as oblong whereby at the linking portion of the eyelet to the capsule, the linking portion possesses a narrowed section (‘junction’) relative to the gripping portion (see instant claims 21, 26 and 27) which could enable the folding of the device at this area (see instant claim 21).
Although Hammang’s eyelet is not described as being ‘adapted to assist in the withdrawal’ of their device, it would none the less retain this function as this feature is solely a functional limitation applied to a structural feature. So long as the structural feature is present in the prior art device, then it would necessarily possess the function despite not being used for such. Where the claimed and prior art products are identical or substantially identical in structure, said products must have the same properties, unless shown otherwise. See MPEP 2112.01.
Claims 16, 17, 19 and 21-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Juan et al. (US 2020/0038240).
De Juan discloses a sustained release ocular insert having the following structure:
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wherein insert 100 comprises a retention structure 110 shaped with an inward extension 117 to inhibit irritation of the lacrimal gland and an inward extension 116 to inhibit contact with the caruncle of the eye, in which the support structure 120 is located on the retention structure 110 so as to correspond with a superior placement under the superior eyelid (see [0361]). Support structure 120 may have a structure wherein an elongated solid polymeric core (e.g. polyurethane, polyethylene, etc (see [0218] and claim 5; see instant claim 24) contains at least one drug where the polymeric core possesses a polymeric coating disposed thereon (e.g. polymethylmethacrylate (PMMA), polyethylene, polyurethane, etc. (see claim 7; see instant claim 25) (see claim 1 and [0218]) (see instant claims 16 and 17). To the distal ends of the support core a retention structure 110 is secured, the retention structure being free of drug (see [0008, 0238]) and providing an eyelet structure which could be used to assist in the removal of the device from the eye (see instant claim 16). As the retention structure is attached to the support structure, it has a linking portion (that which connects directly to the support structure) as well as a gripping portion (that in excess of the linking portion) (see instant claims 16, 19 and 27). According to the figures, the retention portion is narrower than the support structure (see instant claims 21, 26 and 27). As the retention structure attaches to the polymeric coating of the support structure, the support structure is considered sealed at its distal ends (see instant claim 22). De Juan’s ocular insert has a 360 degree or about a 360 degree circumference (see claim 1) (see instant claim 28) which provides it with an opening via the retention structure looping around to connect to the distal ends of the insert (thereby protruding towards the center of the ring) (see instant claims 16, 28 and 29). De Juan describes their insert as flexible and thus would have the property of being foldable or being folded (see instant claim 30).
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.
Claims 16, 17, 19 and 21-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al. (US 2020/0038240) in view of Hammang et al. (US 20020061327).
In the event that the eyelet is a structure wherein an eyelet is secondary to the implant structure, the following rejection is applied.
De Juan is relied upon above for the rejection of claims 16, 17, 19 and 21-30 under 35 USC 102(a)(1) and are incorporated herein.
De Juan’s insert may have a diameter across the structure of less than 2 mm, e.g. 1 mm or less (see [0236]) (see instant claim 32). It is taught that such dimensions allow the structure of fit comfortably within the eye. Assuming a diameter of the eyelet ring structure of 1 mm would result in an approximate circumference of 3.1 mm (math not shown) of which some subsegment would be attributable to the linking portion. The length of the linking portion relative to the support structure would be optimizable in accordance to therapy needed and implant lifetime. Thus the length of the retention structure making up the linking and gripping portion of the eyelet structure connected to the support structure would be an adjustable parameter, and if such adjustment/optimization resulted in lengths as claimed, such would have been the product of ordinary skill and common sense (see instant claim 31 and 34). The cross-section of the device is to have a dimension of 0.1 to about 3 mm which overlaps and obviates the minimal width of 0.15 mm required by instant claim 33.
Methods of making the inserts are described wherein the retention structure is prepared from a polymer, the retention structure having a support structure attached thereto, the support structure comprising a therapeutic agent within a silicone matrix (see Experiment 6, [0462]). Although the structure of Experiment 6 does not possess a polymeric coating over the support structure, such would have been obvious as support structure coatings are contemplated by de Juan (see claim 1) (see instant claim 35).
De Juan fails to teach their ring structure as possessing an eyelet being attached thereto.
Hammang is directed to a sustained release device for treating ophthalmic diseases, the device having the following structure
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(see [0026] and Fig 1). Hammang’s device comprises an elongated capsule comprising a polymeric core (see [0066, 0067]) surrounded by a polymeric capsule jacket (i.e. mantle) (see [0064, 0074, 0075]) (see instant claims 16 and 17). The device is to possess the polymeric jacket on the distal ends of the capsule (see [0102-0106]) (see instant claims 22 and 23). Attached to the end of the capsule jacket is an eyelet (see Figures and [0024, 0070]) (see instant claim 16). The eyelet is attached to the device by way of a gripping portion and a linking portion, wherein the linking portion attaches the extended section of the eyelet to the body of the capsule and is responsible for connecting the gripping portion to both ends of the body (see Figures) (see instant claims 18 and 19) according to the following interpretation:
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(Examiner’s understanding of Hammang’s Figure 1 in relation to the claimed invention). The linking portion and the gripping portion are directly connected (see instant claim 27). The eyelet has an opening for which sutures can go through (see instant claim 16), the opening being characterized as oblong whereby at the linking portion of the eyelet to the capsule, the linking portion possesses a narrowed section (‘junction’) relative to the gripping portion (see instant claims 21, 26 and 27) which could enable the folding of the device at this area (see instant claim 21).
Hammang’s eyelet is intended for securing the insert to the eye to prevent movement of the device once implanted. Such a structural feature would be desired on the structure of de Juan to ensure that their ocular implant once placed on the eye did not move. See MPEP 2143(I)(A). Regarding the present limitation that the eyelet be ‘adapted to assist in the withdrawal’ of their device, the presence of Hammang’s eyelet structure on de Juans ring structure would possess this function as this feature (‘being adapted to assist in the withdrawal’) is solely a functional limitation applied to a structural feature. So long as the structural feature is present in the prior art device, then it would necessarily possess the function even if not taught to be used in that particular way. Lastly, although the eyelet of Hammang is intended for an entirely different function (securing the implant rather than removing the implant), motivation to modify the structure of de Juan may be different from what the invention intended. It is not necessary that the prior art suggest the combination to achieve the same advantage intended by Applicant. See MPEP 2144(IV).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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