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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9 and 11-18, drawn to a biodegradable capsule implant and a method of supplying a therapeutic agent to a recipient, classified in A61K 9/0024.
II. Claims 19-20, drawn to a method of making a biodegradable capsule implant, classified in A61J 3/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, instant biodegradable capsule implant of Group I can be made by: electro-spinning biodegradable polymer(s) (mixed with porogens) on a conductive rod and later taking away the rod to form a hollow polymer tube having an inner surface and an outer surface; dissolving the porogens in a solvent to form a hollow polymer tube with pores; depositing therapeutic agents in the cylindrical space via the first open end or the second open end; and then sealing the open ends to form a capsule implant.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
- the inventions have acquired a separate status in the art in view of their different classification.
- the inventions have acquired a separate status in the art due to their recognized divergent subject matter.
- the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Mr. David Jefferies on December 19, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9 and 11-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 2 is objected to because of the following informalities: on line 2, applicant need to change “a group” to --- the group ---; on line 3, applicant need to delete “and”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: on line 2, applicant need to change “the antibody” to --- an antibody ---. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on line 2, applicant need to change “the anti-inflammatory” to --- an anti-inflammatory ---. Appropriate correction is required.
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.
Claim(s) 1 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al (US 2019/0336603 A1).
Park teaches (title, [0004], [0005], claims 1, 6 and 8, Fig.2A and 2E) a biodegradable, light-activatable drug delivery implant device comprising: (i) a biodegradable polymer tube including an enclosed inner space; and (ii) a mixture of a plurality of light activatable particles (“LAP”) (including drug) and a hydrogel for dispersing the LAP within the enclosed inner space of the polymer tube, wherein each of the LAP includes a shell, drug within the shell, and one or more photothermal agents (such as gold nanoparticles) on the surface of the shell. Park teaches (claim 9) a method for manufacturing such implant device, wherein after the LAPs are injected into the biodegradable polymer tube, both ends of the polymer tube are sealed (thus, forming instant capsule body comprising a polymer having an inner and an outer surface, the inner surface defining a hollow interior space; and instant therapeutic agent housed in the hollow interior space). Park further teaches (claims 2-4 and [0034]) that the wall of the polymer tube includes a plurality of nano-sized pores (instant plurality of pores on the capsule body) where the pores are big enough to let the drug be released but not big enough to let the LAPs be released (i.e., the pores are bigger than the drug but smaller than the LAP in size). After Park’s light-activatable drug delivery implant device is injected into a vitreous of the eye by a syringe needle, a light (a laser) is projected at the eye. As the plurality of LAPs in the implant device are light-activatable, when the surface of the LAP is irradiated by light, the gold nanoparticles (photothermal agents on the surface of the shell of the LAP) generate heat, which reversibly melts the shell, and as a result, drug elutes out of the LAP and is released through the pores of the polymer tube in order to be delivered to the target to treat eye diseases (see [0005] and [0024]). Thus, Park teaches instant capsule body configured to absorb the therapeutic agent at the inner surface and desorb the therapeutic agent out of the outer surface.
Thus, Park teaches instant claim 1.
With respect to instant claims 11-13, for the plurality of the nano-sized pores on the wall of the polymer tube, Park teaches ([0035]) that polyethylene glycol (PEG) is used as a pore generation agent (a porogen) and that depending on the ratios of the PEG to PLGA (Park’s biodegradable polymer tube material – see [0032]), the pore size can be controlled. Park then gives an example ([0038], Fig.5A, Fig.5B) where its biodegradable implant device was made using 0.1 as the PEG to PLGA polymer ratio giving a pore size of less than 10 nm. Thus, Park teaches instant claims 11-13.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (US 2019/0336603 A1).
With respect to instant claim 16, Park teaches ([0032]) that when PLGA (its biodegradable polymer tube material) having high molecular weight with high L/G ratio is used, the degradation of the polymer tube is prolonged up to 12 months, which implies that the drug can be released through the pores of the polymer tube up to 12 months by using PLGA having high molecular weight with high L/G ratio. It would have been obvious to one skilled in the art to use PLGA having high molecular weight as Park’s polymer tube material and optimize the L/G ratio in order to achieve a biodegradable drug delivery implant device that is configured to release the drug for a predetermined amount of time close to 12 months. Thus, Park teaches instant limitation “wherein the biodegradable capsule is configured to release the therapeutic agent for a predetermined amount of time when the biodegradable capsule implant is administered to the recipient”. Thus, Park renders obvious instant claim 16.
With respect to instant claims 17 and 18, the predetermined amount of time close to 12 months (as discussed above) overlaps with instant range “at least 50 days” of claim 17 and instant range “at least 200 days” of claim 18, thus rendering instant ranges prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior at,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Park renders obvious instant claims 17 and 18.
Claim(s) 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (US 2019/0336603 A1) in view of Christen et al (“Polycaprolactone: How a Well-Known and Futuristic Polymer Has Become an Innovative Collagen-Stimulator in Esthetics”, Clinical, Cosmetic and Investigational Dermatology, vol.13 (2020), pg.31-48, obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC7065466/ ).
With respect to instant claims 2 and 3, Park teaches ([0032]) that its biodegradable polymer tube material can be chosen from PLGA, polylactic acid, polyglycolic acid, chitosan, cellulose or polycaprolactone. As evidenced by Christen et al (see the last paragraph on the left-hand column on pg.33), polycaprolactone (PCL) is known in the art as being suitable for long-term drug delivery (up to 2 years) due to its high permeability to many drugs, excellent biocompatibility, slow biodegradability and bioresorbability. It would be obvious to one skilled in the art to use PCL as Park’s biodegradable polymer tube material with a reasonable expectation of obtaining high permeability to many drugs, excellent biocompatibility and slow biodegradability, thus achieving a long-term (up to 2 years) drug delivery. Thus, Park in view of Christen renders obvious instant claims 2 and 3.
Claim(s) 4-6, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (US 2019/0336603 A1) in view of Gower (“Anti-VEGF therapies for the treatment of age-related macular degeneration”, Journal of Comparative Effectiveness Research, vol.1(6), (2012), pg.485-488, obtained from the website: https://becarispublishing.com/doi/10.2217/cer.12.57 ) and JIANG et al (US 2022/0117888 A1).
Park teaches ([0024]) that the drug released through its biodegradable implant device is delivered to the target of interest to treat eye diseases, such as age-related macular degeneration (AMD), but the reference does not name any specific drugs. Gower teaches (see the two paragraphs under “Age-related macular degeneration & available treatments” on pg.485) that age-related macular degeneration (AMD) is a leading cause of blindness and visual impairment worldwide, and anti-VEGF therapies are the first line of therapy that actually improves vision, whereas previous treatments, at best, only prevented further vision loss. Gower then teaches bevacizumab and ranibizumab as the two most commonly used anti-VEGF drugs. Besides, as evidenced by Jiang et al (see [0002], [0003], claims 1, 27, 29 and 43 ) drug delivery capsules for delivery of anti-VEGF therapeutic agent, such as bevacizumab or ranibizumab to the eye of the AMD patients are already known in the art. Thus, it would be obvious to one skilled in the art to use bevacizumab or ranibizumab as Park’s drug to treat AMD with a reasonable expectation of improving vision of AMD patients. Thus, Park in view of Gower and Jiang renders obvious instant claims 4-6.
With respect to instant claim 14 and 15, since both bevacizumab and ranibizumab are being individually taught in Gower to be useful for the same purpose (i.e., useful as drugs that treats AMD), it would be obvious to one skilled in the art to use combination of bevacizumab (instant first therapeutic agent) and ranibizumab (instant second therapeutic agent) as Park’s drug with a reasonable expectation of success. MPEP 2144.06 states that “[i]t 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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Besides, Jiang already teaches (claims 29 and 43) that combination of anti-VEGF therapeutic agents (such as bevacizumab and ranibizumab) can be used in a drug delivery capsule to treat AMD. Thus, Park in view of Gower and Jiang renders obvious instant claims 14 and 15.
Claim(s) 7-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (US 2019/0336603 A1) in view of Gower (“Anti-VEGF therapies for the treatment of age-related macular degeneration”, Journal of Comparative Effectiveness Research, vol.1(6), (2012), pg.485-488, obtained from the website: https://becarispublishing.com/doi/10.2217/cer.12.57 ) and JIANG et al (US 2022/0117888 A1) as applied to claim 4 above, and further in view of Vakalis et al (“Intravitreal Combination of Dexamethasone Sodium Phosphate and Bevacizumab in The Treatment of Exudative AMD”, Scientific Reports, 5, Article number 8627 (2015), obtained from the website: https://www.nature.com/articles/srep08627 ).
As discussed above, Park in view of Gower and Jiang teaches using bevacizumab or ranibizumab as Park’s drug to treat age-related macular degeneration (AMD) with a reasonable expectation of improving vision of AMD patients. Park in view of Gower and Jiang does not teach instant anti-inflammatory agent. Vakalis teaches (see abstract) that the combination of dexamethasone sodium phosphate and bevacizumab offers encouraging results in the treatment of AMD, providing immediate response to macular edema, reduced number of intravitreal injections and stabilization or improvement of visual acuity. It would be obvious to one skilled in the art to use the combination of dexamethasone sodium phosphate (instant anti-inflammatory agent of claims 7-9 – see [0103] of present specification) and bevacizumab as Park’s drugs to treat AMD with a reasonable expectation of providing immediate response to macular edema and stabilization or improvement of visual acuity, as taught by Vakalis. Thus, Park in view of Gower and Jiang, and further in view of Vakalis render obvious instant claims 7-9 and 14.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
February 16, 2026