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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 5, 2026 has been entered.
Claim Objections
Claims 3 and 6 is objected to because of the following informalities: Claim 3 recites the acronym “VEGF”. While the definition of this abbreviation is provided in the specification, the full name should appear in the claims with the first use of the acronym. Claim 6 recites a listing of options for anti-VEGF compounds. The listing that recites category names followed by a colon and one or two options would be clearer without the category names (e.g., deletion of “monoclonal antibodies:”, “aptamers:” and “fusion proteins:”). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 recites a method of providing and inserting a device comprising “at least two hollow solids inscribed one into the other, where the walls of the at least two hollow solids comprise biodegradable material comprising magnesium, and where the at least two hollow solids inscribed one into the other delimit a core volume inside an innermost of the hollow solids and one or more crown volumes comprised between the innermost hollow solid and the hollow solid at the exterior thereof, where the core volume and at least one of the one or more crown volumes comprise at least one active ingredient, at least one of the one or more active ingredients being in liquid form…wherein the walls are impermeable continuous walls which become permeable as a function of the post-implantation time of the device” [emphasis added]. This claim requires that in addition to at least one of the one or more active compounds being in liquid form, the walls are impermeable continuous walls which become permeable as a function of the post-implantation time of the device. This functional limitation constrains the liquid that can be employed in the device to those that do not make the magnesium comprising walls permeable. Permeability could be induced by dissolution and degradation, as well as corrosion. The impact of implantation time on device permeability occurs on the exterior surface of the device due to physical contact and potentially on the interior surfaces due to in vivo temperature and pressure. Kumar et al. detail that magnesium rapidly corrodes and dissolves in physiological aqueous environments (previously cited – see page 156 first column). The specification discusses permeability being induced due to exposure of the outermost wall surface in vivo. The in vivo environment contains water, therefore the use of water as the active ingredient liquid would encourage corrosion from the inside of the device such that induction of permeability of the core’s wall is not dependent on implantation time. The instant disclosure does not name any particular fluid in which the active ingredient is dissolved or dispersed inside the core and crown volumes. Thus the disclosure does not provide adequate structure-function correlation for the claimed method. As a result, the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as currently claimed at the time of filing.
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 16 and 17 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.
Given the absence of adequate written description of the liquid employed for the active ingredient component, the scope of the liquid component required as part of the active ingredient and yields a device that meets the functional limitations of the claims is unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13 and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding claim 13, the rate of degradation of the walls are necessarily determined, at least in part, by their thickness because the walls are made of degradable material. In addition, claim 14 recites a conditional limitation that does not narrow the scope of the parent claim because the walls are required to contain magnesium. This material is susceptible to corrosion when in contact with vitreous fluid and movement of such fluid induces shear stress that impacts erosion, according to the instant specification (see paragraphs 61-65). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3-4, 6-8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US PGPub No. 2014/0276595) in view of Aghion et al. (previously cited) and Pryce er al. (previously cited) as evidence by Wong et al. (previously cited).
Imran teaches a muti-stage degradable drug delivery platform for sequential release of contained drugs (see abstract). The walls of the device sequentially dissolve/degrade in vivo (see paragraph 18; instant claim 1). They teach the device as needle shaped which implies a cylindrical shape (see paragraph 16). An embodiment providing two delivery stages is arranged as an outer hollow degradable shell within which is inscribed an inner hollow degradable shell as shown in figure 1A below (see paragraph 17 and figure 1A):
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Here components 102 and 108 are the outer and inner hollow shells/solids, respectively, while components 103 and 109 are the instant crown and core regions (see paragraph 17; instant claim 1). They detail that the degradable material is envisioned as magnesium or a magnesium alloy with aluminum, lithium, calcium, manganese and/or zinc such that the outer shell and inner shell materials are different (see paragraph 17; instant claims 1 and 4). A cavity outside the inner shell (component 103) that is defined by the outer shell (crown) contains drug as does a cavity inside the inner shell (component 109) (core volume) (see paragraph 17). Components 106 and 110 represent drug located in the hollow region of the outer (crown) and inner shell (core) which may be in the form of a liquid, gel, colloid, or solid (see paragraphs 9 and 17; instant claim 1). Imran goes on to teach that the thickness of the inner wall component 108 is greater than that of outer wall 102 so that the time for release of the inner drug component 110 is greater than that of the outer drug component 106 (see paragraph 18; instant claims 1 and 12-14). They additionally teach that such thicknesses can be selected to yield the desired duration of time between releases from each shell (see paragraphs 18-19; instant claims 1 and 15). Component 104 is a penetrating end (end cap) that may be the same material as component 102 (see paragraph 16). An additional hollow region with a third quantity of drug inside the device is also envisioned to yield a third delivery period after degradation of its wall (see paragraph 21; instant claim 7). Imran further teaches the device for subcutaneous implantation, where its size can vary based on the size of the patient and they envision the wall thickness of the inner shell to range from 0.001 to 0.02 in (about 25-500 mm) (see paragraphs 18-19 and 28). They also envision loaded drugs in the device to include antibiotics (see paragraph 25). Imran does not explicitly teach the degradable shells in their device to have a common opening (e.g., concentric bases/ends).
Aghion et al. teach a magnesium alloy implant configured as a layered construct with two or more layers (inscribed hollow solids), where at least one is the magnesium alloy and they differ in magnesium composition (see abstract and paragraph 197 and 208; instant claims 1 and 15). They go on to teach a core where a sequence of layers are applied (see paragraph 199). Aghion et al. detail the inclusion of an active substance for sustained release that is envisioned as a variety of drugs which include anti-inflammatory agents, proteins (biological material), antibiotics, and DNA (biological material) (see paragraphs 212, 218 and 221; instant claim 3). Anti-inflammatory agents are also known to treat intraocular pathologies (see Wong et al. column 1 lines 14-23). A rod shape with a circular cross-section (cylinder) is exemplified and rods as well as more generic surgical implants are named as well (see paragraphs 216 and 269 and figures 1 and 8). The metal can be shaped in a variety of ways including melting and casting as well as extrusion, thereby generating impermeable, but degradable materials (see paragraphs 255-256 and 272). They further envision subcutaneous implantation (see paragraph 377).
Pryce et al. teach layered drug delivery device forms with various configurations where one is composed of a core covered by a series of layers that are all cylindrical in shape and another that is a series of nested cylinders (see figures 3A and 5). The arrangement of layers and end caps below from figure 5 provide radial release, where components 610 and 612 are the degradation resistant end caps that close the common openings of the cylindrical core that is component 635 and the components 631-634 that are concentric hollow cylinders that have concentric ends:
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The cylindrical shape is further taught to degrade radially, through the curved wall, and release drug as a result of this degradation due to both its initially open ends being covered by caps which resist degradation and drug release (guarantee maintenance until degradation of the innermost solid) (see paragraphs 24, 72, and 153 and figure 2B and 5; instant claim 1). The innermost region followed by one layer or a succession of layers have a zero or non-zero concentration of drug (see paragraph 78). Figure 3A, shown below,
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provides a series of cylinders inscribed inside one another, where component 335 is the core and components 331-334 are concentric hollow cylinders that encapsulate each smaller sized cylinder (see paragraph 79). They additionally teach alternative shapes such as rectangular prisms (parallelepiped) and spheres (see paragraph 72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the drug containing implant of Imran with magnesium alloys of differing composition as the inner and outer shell because they suggest magnesium as the degradable material to compose the walls of the device and differing rates of degradation for the walls that that contain each drug portion. Aghion et al. further support this choice for a magnesium based implant that provides concentric cylindrical layers that are composed of magnesium of different composition and therefore differing degradation properties. Similarly, it also would have been obvious to select a liquid for the drug portions in the inner and outer cylinders of Imran because they suggest to do so. This liquid in the outer shell, but outside of the inner shell would fill the void volume between the two shells and take on the shape of this void. In light of Pryce et al. and the alternative arrangements of implants composed of concentric cylinders that provide sequential release of drugs, it also would have been obvious to configure the device of Imran such that the bases of the cylindrical shells are concentric and closed by a magnesium alloy pointed endcap on one end and a magnesium alloy blunt endcap on the other like Pryce et al. figure 5 (see instant claims 1 and 15). This modification in configuration would have been obvious as the simple substitution of one known element/configuration for another in order to yield a predictable outcome and the magnesium endcaps follow from the suggestion of Imran to make the pointed tip the same material as the outer shell. The result would be the instant claimed hollow solids inscribed one into the other with a core volume and crown volume filled with liquid drug that constrains drug release to the radial surface of the implant. The implementation of a third concentric interior shell for a third stage of drug release would follow as suggested by Imran (see instant claims 7-8). Similarly, a parallelepiped shape as opposed to a cylinder shape also would have been obvious from the teachings of Pryce et al. who teach them as alternative geometries (see instant claim 10). The preparation of the device implicitly requires making the core and layers and loading the spaces between the walls with drug. Additionally it would have been obvious to select an anti-inflammatory agent for the drug of Imran in light of Aghion et al. as the simple substitution of one known element for another in order to yield a predictable outcome. The compounds of instant claim 6 are met by this selection because the claim lists further limitations of the options for the anti-VEGF compounds of claim 3, but do not require that one of them be selected. The recitation “intraocular” is an intended use that does not distinguish the claimed device from the structure of the modified device of Imran et al. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The device rendered obvious by Imran in view of Aghion et al. and Pryce et al. could be employed for intraocular drug delivery and pathology treatment, thus the intended use requirements are met. Therefore claims 1, 3-4, 6-8, and 10-15 are obvious over Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al.
Claim 1, 3-8, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al. as applied to claims 1, 3-4, 6-8, and 10-15 above, and further in view of Mao et al. (previously cited).
Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al. render obvious the limitation of instant claims 1, 3-4, 6-8, and 10-15. Various alloys of magnesium are envisioned by Imran; however, a magnesium alloy with the instantly claimed composition is not detailed.
Mao et al. teach a magnesium alloy termed JDBM with a formula Mg-2.5Nd-.2Zn-0.4Zr for implant applications (see abstract; instant claim 5). The material offers superior control of degradation rates over other varieties of magnesium alloy as well as more uniform degradation (see figures 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the magnesium alloy of Mao et al. as the magnesium material in the device of Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al. This choice would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome and as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3-8, and 10-15 are obvious over Imran in view of Aghion et al., Pryce et al., and Mao et al. as evidenced by Wong et al.
Claims 1, 3-4, 6-8, 10-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al. as applied to claims 1, 3-4, 6-8, and 10-15 above, and further in view of Reiff et al. (previously cited) and Varner et al. (US PGPub No. 2006/0257451).
Imran in view of Aghion et al. and Pryce et al. as evidenced by Wong et al. render obvious the limitation of instant claims 1, 3-4, 6-8, and 10-15. Ocular applications are not explicitly detailed.
Much like the implant rendered obvious by the modified teachings of Imran, Reiff et al. teach an elongate degradable drug releasing device for implantation to provide controlled release (see abstract, paragraph 50-53, and figures 1A, 3B, and 4A). They teach the tube device to have a cross section with various shapes such as a polygon, rectangle, and circle which releases its contents via degradation and diffusion (see paragraphs 215-216 figures 1A, 3B, and 4A). The device is envisioned with layers that release in series (see paragraphs 51-52). Reiff et al. go on to teach the utility of such devices as intraocular implants, where they are placed in the posterior chamber of the eye to release a desired drug or drug combination (see paragraph 31). The drugs of interest include anti-inflammatory agents and anti-agents that act against chemokines such as vascular endothelial growth factor (VEGF) (see paragraph 44; instant claims 3 and 18).
Varner et al. teach the utility of magnesium as a material that provides structural support and acts as a physical carrier onto which drug is loaded in an ocular implant (see abstract and paragraphs 22 and 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the modified device of Imran as an intraocular implant that releases a drug relevant to the eye. This choice would have been obvious in light of Varner et al. who teach that magnesium as a compositional material for ocular implants that is suitable and Reiff et al. who teach the utility of similarly structured and functioning devices in the eye. More specifically, selecting an anti-inflammatory agent (instant claim 3 and 6) or an anti-VEGF compound (instant claim 18) for the core and volumes between magnesium containing layers and implanting the device in the posterior chamber would have been obvious from the teachings of Reiff et al. Therefore claims 1, 3-4, 6-8, 10-15, and 18 are obvious over Imran in view of Aghion et al., Pryce et al., Reiff, and Varner et al. as evidenced by Wong et al.
Claims 1, 3-4, 6-8, 10-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Aghion et al., Pryce et al., Reiff, and Varner et al. as evidenced by Wong et al. as applied to claims 1, 3-4, 6-8, 10-15, and 18 above, and further in view of Coppeta et al. (previously cited).
Imran in view of Aghion et al., Pryce et al., Reiff, and Varner et al. as evidenced by Wong et al. render obvious the limitation of instant claims 1, 3-4, 6-8, 10-15, and 18. The device can include an anti-VEGF compound, but a specific variety is not named.
Coppeta et al. teach ranibizumab and bevacizumab as anti-VEGF antibodies known to be delivered by rod shaped, implantable drug delivery systems (see paragraphs 43 and 45-53 and figure 1-3; instant claims 6). They further envision the implants for use in the eye (see paragraph 99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ ranibizumab or bevacizumab as the anti-VEGF compound/antibody in the device rendered obvious by Imran in view of Aghion et al., Pryce et al., Reiff, and Varner et al. as evidenced by Wong et al. This modification would have been obvious in light of Coppeta et al. as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3-4, 6-8,10-15, and 18 are obvious over Imran in view of Aghion et al., Pryce et al., Reiff, and Varner et al., and Coppeta et al. as evidenced by Wong et al.
Response to Arguments
Applicant's arguments filed February 5, 2026 have been fully considered. In light of the amendment to the claims, the objections as well as the rejections under 35 USC 112(b), 35 USC 103, and 35 USC 112(a) for claims 1, 3-8, 10-15, and 18 are hereby withdrawn. New grounds of rejection are detailed that address the new limitations.
Regarding rejections under 35 USC 112(a):
The applicant argues that the disclosure specifically reciting that wall thickness variation is “advantageously applied when said active ingredient is in liquid form” is sufficient written description for the claimed embodiments. Claim 16 does not have a recitation concerning wall thickness. This claim requires that in addition to at least one of the one or more active compounds being in liquid form, the walls also are impermeable continuous walls which become permeable as a function of the post-implantation time of the device. This limitation constrains the liquid that can be employed in the device to those that do not impact the wall permeability, but the disclosure does not discuss any liquid that is able to perform this function. The discussion of wall thickness does not address this issue. Thus it is not clear that the applicant had possession of the claimed devices with at least one active ingredient in liquid form that performs as recited due to an inadequate structure-function correlation.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615