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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-18 in the reply filed on 10/30/2025 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
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 2 and 12 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 2 and 12 recites the limitation "the ocular surface contacting surface" in line 1. There is no previous mention of an ocular surface contacting surface and it is unclear which surface applicant is referring to. There is insufficient antecedent basis for this limitation in the claim.
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 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 1-5, 9, 11, 13, 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shih et al. (US 20190269850 A1), hereinafter referred to as “Shih”.
Regarding Claim 1, Shih teaches an ophthalmic liquid delivery apparatus (device 500, see Figures 4A-5B; for treatment of the eye, see Paragraph [0050]) comprising:
a bulbar conjunctiva contacting surface (the shell of the pump is curved to fit the outer radial curvature of the eye and can be implanted under the conjunctiva similar to the placement of a glaucoma drainage device, see Paragraph [0050]; Figure 5A);
a palpebral conjunctiva contacting surface which is opposite the bulbar conjunctiva contacting surface (see below);
a therapeutic storage reservoir (drug reservoir 200); and
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at least one fluid delivery port (cannula 415).
Regarding Claim 2, Shih further teaches wherein the ocular surface contacting surface has the same curvature as the sclera of the human eye (device 500 has a contacting surface with the curvature as the eye, see Figure 5A).
Regarding Claim 3, Shih teaches wherein the at least one fluid delivery port (415) comprises a modular flow resistor to control the flow rate (valves may be may be strategically placed through the cannula 415, see Paragraph [0071]).
Regarding Claim 4, Shih further teaches a fill port (refill port 460, see Figure 4C).
Regarding Claim 5, Shih further teaches a therapeutic liquid (a therapeutic agent e.g., medicament, drugs, etc.,. see Paragraph [0003]) within the therapeutic storage reservoir (drug reservoir 200).
Regarding Claim 9, Shih teaches all of the limitations as discussed above in claim 3 and Shih further teaches wherein the modular flow resistor's fluid pathway consists of a flexible material (the cannula is over molded with silicone, thereby making a shroud, which is more flexible and durable, see Paragraph [0063]).
Regarding Claim 11, Shih further teaches wherein the therapeutic liquid storage reservoir (200 in housing 410 has a base 405) has a curvature to secure the device within the superior or inferior conjunctival fornix of the human eye (base 405 of the reservoir 200 is curved to secure to the eye, see Figure 5A; , the shell of the pump is curved to fit the outer radial curvature of the eye and can be implanted under the conjunctiva similar to the placement of a glaucoma drainage device, see Paragraph [0050]).
Regarding Claim 13, Shih further teaches an over-molded layer of silicone hydrogel (the cannula 415 is over molded with silicone, thereby making a shroud, which is more flexible and durable, see Paragraph [0063]).
Regarding Claim 16, Shih further teaches wherein the apparatus is asymmetrical when comparing the medial nasal portion vs. the lateral portion of the apparatus (see Figure 5B).
Regarding Claim 17, Shih further teaches a one-way check valve between the therapeutic storage reservoir and the fluid delivery port (check valves may be placed through the cannula 415, see Paragraph [0071]).
Regarding Claim 18, Shih further teaches a variable resistance check valve (check valves with a zero or near zero cracking pressure, and which close sufficiently to stop any flow when there is no forward flow pressure or in response to a net reverse pressure, see Paragraph [0071]) between the therapeutic storage reservoir and the fluid delivery port (placed through the cannula 415, see Paragraph [0071]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shih (US 20190269850 A1) in view of Santini et al. (US 20080076975 A1), hereinafter referred to as “Santini”.
Regarding Claim 6, Shih teaches all of the limitations as discussed above in claim 1. However, Shih does not explicitly disclose a lyophilized therapeutic within the therapeutic storage reservoir.
Santini teaches a drug delivery device comprising a drug formulation stored in a first reservoir (see Figure 2) comprising a lyophilized therapeutic within the therapeutic storage reservoir (the reservoir contents can include essentially any natural or synthetic, organic or inorganic molecule or mixture thereof, for release (i.e., delivery including lyophilized powders, see Paragraph [0036]).
Shih and Santini are analogous art because both teach an implantable drug delivery device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the therapeutic storage reservoir and further include wherein a lyophilized therapeutic is within the reservoir, as taught by Santini. Santini teaches the drugs are desirably provided in a solid form, particularly for purposes of maintaining or extending the stability of the drug over a commercially and medically useful time, e.g., during storage in a drug delivery device until the drug needs to be administered (see Paragraph [0038]).
Claim 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shih and Santini as applied to claim 6 above, and further in view of Haffner et al. (WO 2010135369 A1), hereinafter referred to as “Haffner”.
Regarding Claim 7, Shih and Santini teaches all of the limitations as discussed above in claim 6. However, Shih and Santini do not explicitly disclose wherein the bulbar conjunctiva contacting surface allows for water vapor to pass into the therapeutic storage reservoir.
Haffner teaches an ophthalmic liquid delivery apparatus (see Abstract) wherein the bulbar conjunctiva contacting surface allows for water vapor to pass into the therapeutic storage reservoir (the drug delivery implant may be made from any biological inert and biocompatible materials having desired characteristics. Desirable characteristics, in some embodiments, include permeability to liquid water or water vapor, see Paragraph [0252]).
Shih, Santini, and Haffner are all analogous art because all teach an implantable drug delivery device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the bulbar conjunctiva contacting surface of Modified Shih and further include wherein the contacting surface allows for water vapor to pass into the therapeutic storage reservoir, as taught by Haffner. Haffner teaches the vapor permeable surface is beneficial to allow for an implant to be manufactured, loaded with drug, and sterilized in a dry state, with subsequent rehydration of the drug upon implantation (see Paragraph [0252]).
Regarding Claim 8, Shih and Santini teaches all of the limitations as discussed above in claim 6. However, Shih and Santini do not explicitly disclose wherein the palpebral conjunctiva contacting surface allow for water vapor to pass into the therapeutic storage reservoir.
Haffner teaches an ophthalmic liquid delivery apparatus (see Abstract) wherein the palpebral conjunctiva contacting surface allows for water vapor to pass into the therapeutic storage reservoir (the drug delivery implant may be made from any biological inert and biocompatible materials having desired characteristics. Desirable characteristics, in some embodiments, include permeability to liquid water or water vapor, see Paragraph [0252]).
Shih, Santini, and Haffner are all analogous art because all teach an implantable drug delivery device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the palpebral conjunctiva contacting surface of Modified Shih and further include wherein the contacting surface allows for water vapor to pass into the therapeutic storage reservoir, as taught by Haffner. Haffner teaches the vapor permeable surface is beneficial to allow for an implant to be manufactured, loaded with drug, and sterilized in a dry state, with subsequent rehydration of the drug upon implantation (see Paragraph [0252]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shih (US 20190269850 A1).
Regarding Claim 10, Shih teaches all of the limitations as discussed above in claim 1. However, Shih does not explicitly disclose wherein the thickest portion is the therapeutic liquid storage reservoir with a thickness less than 1.5mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shih to have the therapeutic liquid storage reservoir with a thickness less than 1.5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Shih would not operate differently with the claimed storage reservoir thickness and since the storage reservoir is intended to reside within the liquid delivery apparatus with an approximate largest thickness of 1.5 mm the device would function appropriately having the claimed thickness. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “can be adjusted” be within the claimed ranges (specification pg. 12 ln 19).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shih (US 20190269850 A1) in view of LaBombard (US 20210121324 A1).
Regarding Claim 12, Shih teaches all of the limitations as discussed above in claim 1. However, Shih does not explicitly disclose wherein the surface opposite the ocular surface contacting surface comprises one or more protrusions to help secure the device against the palpebral conjunctiva.
LaBombard teaches an ocular device (3592, see Figures 24A-C) wherein the surface opposite the ocular surface contacting surface (plate 3511) comprises one or more protrusions (have protrusions 3331 on both the back surface and the front surface, see Paragraph [0420]) to help secure the device against the palpebral conjunctiva (to facilitate orientation of ocular device 3592 in an eye, see Paragraph [0420]; to be placed under the eyelid, see Abstract).
Shih and LaBombard are analogous art because both teach an ocular device for placement under an eyelid.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the surface opposite the ocular surface contacting surface and further include one or more protrusions to help secure the device against the palpebral conjunctiva, as taught by LaBombard. LaBombard teaches it is advantageous to place an ocular device under an eyelid that can adapt to patient-to-patient variability of ocular anatomical structures and kinetic motions of the eye, including variability that can result from factors such as age, health, and genetics or ancestral factors (see Paragraph [0006]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shih (US 20190269850 A1) in view of Heitzmann et la. (WO 2017040855 A1), hereinafter referred to as “Heitzmann”.
Regarding Claim 14, Shih teaches all of the limitations as discussed above in claim 13 and Shih further teaches the over-molded layer of silicone hydrogel (see Paragraph [0063]). However, Shih does not explicitly disclose wherein the over-molded layer of silicone hydrogel has one or more channels to allow for water vapor diffusion.
Heitzmann teaches a drug delivery implant (50) configured to be implanted into the eye (see Abstract; Figures 10A-G) comprising a shell (54) that has one or more channels (orifices 56a) to allow for water vapor diffusion (the orifices 56a are covered, wholly or partially, with one or more elution membranes 100 that is permeable to the therapeutic agent, to bodily fluids or to both, see Paragraph [0154]; wherein the elution membrane may be silicone, see Paragraph [0154]).
Shih and Heitzmann are analogous art because both teaches an ocular device for delivery of drugs.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the over-molder layer of silicone hydrogel of Shih and further include one or more channels to allow for water vapor diffusion, as taught by Heitzmann. Heitzmann teaches the expandable material 100 is positioned on selected areas of the implant shell 54, such that the expanded material exerts pressure on the surrounding ocular tissue, but also maintains the patency of a natural ocular fluid passageway by the creation of zones of fluid flow 102 around the implant shell and expandable material (see Paragraph [0230]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shih (US 20190269850 A1) in view of Lobl et al. (WO 2008011125 A2), hereinafter referred to as “Lobl”.
Regarding Claim 15, Shih teaches all of the limitations as discussed above in claim 1. However, Shih does not explicitly disclose wherein the fluid delivery port further comprises an anti- bacterial membrane filter.
Lobl teaches a drug delivery system (see Figure 1; Abstract) comprising an implantable pump (105) and a fluid delivery port (a filter housing 106 and catheter 108, see Figure 2) wherein the fluid delivery port further comprises an anti- bacterial membrane filter (distal end of housing 106 contains a three-dimensional antibacterial filter 112, see Figure 2).
Shih and Lobl and are analogous art because both teach an ophthalmic drug delivery device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the fluid delivery port of Shih and further include an anti- bacterial membrane filter, as taught by Lobl. Lobl teaches its beneficial for a filter having a pore size that is small enough to allow a drug-carrying fluid to pass, but which obstructs passage of bacteria or other undesirable elements (see Paragraph [0085]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (2/8/2026)Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781