--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 .
Applicant's response dated January 16, 2026 is acknowledged.
Priority
This application is a continuation of 17/495,369 filed 10/06/2021, which is a continuation
of 16/935,027 filed on 07/21/2020, which is a continuation of PCT/US20/39990 filed on
06/26/2020, which claims benefit in provisional application 63/012,994 filed on 04/21/2020 and
claims benefit in provisional application 62/867,233 filed on 06/27/2019.
Claim Status
Claims 72, 74, 77, 80, 82-88, and 90 are pending and examined. Claims 1-71, 73, 75, 76, 78, 79, 81, 89, and 91 were canceled. Claims 72, 74, 77, 80, and 90 were amended.
Information Disclosure Statement
Foreign patent document EP-3562489 A1 was not considered because applicant did not provide a copy of the document.
It is noted that Applicant submitted Supplementary European Search Report and Annex to Supplementary European Search Report for EP 3 562 489 A4 Dated June 30, 2020, however these documents were not cited in the IDS.
Terminal Disclaimer
The terminal disclaimer filed on January 20, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,185,441 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Claim Rejections - 35 USC§ 103
Rejections of claims 72-81 and 83-90 over Venkatraman (US 2015/0209274 Al Published July 30, 2015 – of record in IDS dated 04/28/2023) and rejection of claim 82 over Venkatraman and Thomes (US 2010/0016439 Al Published January 21, 2010) are withdrawn because claim 72 was amended to require the article to be positioned at a region of a haptic, which is not obvious over Venkatraman. Arguments directed to these rejections are moot because rejections are withdrawn.
Withdrawn Double Patenting Rejections
Rejections of claim 72-82, 84-87, 89, and 90 over claims 1-30 of U.S. Patent No. 11,185,441 B2 (of record in IDS dated 10/12/2023), rejections of claims 83 and 88 over claims 1-30 of U.S. Patent No. 11,185,441 B2 and Venkatraman are withdrawn because applicant filed a terminal disclaimer which was approved. Arguments directed to these rejections are moot because rejections are withdrawn.
New Claim Rejections - 35 USC§ 112
Necessitated by Amendment
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 72, 74, 77, 80, 82-88, and 90 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 72 was amended to require the ophthalmic article to be positioned at a region of a haptic of an IOL without use of an external force or external agent. This limitation introduces new matter because the application as filed does not provide support for positioning the ophthalmic article without use of an external force or external agent. Applicant cited paragraph 0336 of the specification for support of amendments to claim 72.
Paragraph 0336 recites:
“In some embodiments, the ophthalmic article may be configured to associate with the surface (e.g., an outward surface) of the portion of the ocular device (e.g., haptic of an IOL) through an indent, groove, narrowing, or protrusion along the surface of the portion of the ocular device. For
example, the ophthalmic article may comprise an internal structure for securing around a notched region of the haptic of an IOL. In this case, the elastic annulus ophthalmic article can be applied to a notched haptic, such that it is first stretched to an inner circumference at least as large as the outer perimeter of the haptic distal to the notch. Next, the elastic annulus ophthalmic article may be advanced over the notch and allowed to constrict around the narrow portion of the haptic. In this case, friction is less relevant and the sides of the notch secure the ophthalmic article and may prevent dislocation of the ophthalmic article. The ophthalmic article can be hooked in the notch and can freely move or rotate within the notch. Alternatively, the ophthalmic article may be hooked in the notch with restricted movement or rotation within the notch. In another example, the ophthalmic article may be hooked in the notch so that it can compressively associate (e.g., attach) to a surface of the haptic within the notch.”
There is nothing in the cited paragraph nor the application as filed that supports positioning of the article at a region of a haptic without use of an external force or external agent.
Claims 74, 77, 80, 82-88, and 90 are rejected for new matter because the claims depend from claim 72 and contain new matter limitations of claim 72.
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 72, 74, 77, 82-88, and 90 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 72 was amended to require the ophthalmic article to be positioned at a region of a haptic of an IOL without use of an external force or external agent. This limitation renders the claim indefinite because it is not clear what structure is implied by the product by process language “without use of an external force or external agent” in reference to positioning the ophthalmic article at a region of a haptic. The specification was reviewed and it does not provide any clarification of this limitation.
Claim 80 recites the limitation "the region of the ocular device" in line 2. There is insufficient antecedent basis for this limitation in the claim. Did applicant mean “the region of the haptic”?
Claims 74, 77, 82-88, and 90 are indefinite because the claims depend from an indefinite base claim.
New Claim Rejections - 35 USC§ 103
Necessitated by Amendment
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.
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.
Claims 72, 74, 77, 80, 83-88, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Bossy-Nobs (US 2009/0130176 Al Published May 21, 2009 – of record in IDS dated 04/28/2023) and Venkatraman (US 2015/0209274 Al Published July 30, 2015 – of record in IDS dated 04/28/2023).
The claims encompass an ophthalmic article.
The teachings of Bossy-Nobs are related to a device comprising an intraocular lens and a drug delivery system attached thereto, wherein said drug delivery system is or can be loaded with one or more therapeutic agents. Preferably, said drug delivery system comprises a biodegradable matrix material wherein said biodegradable matrix material is preferably selected from the group consisting of: poly(lactic acid), poly(glycolic acid), poly(lactide-co-glycolide), polycaprolactones, polyorthoesters, polyanhydrides, polyesteramides and mixtures thereof. Preferred therapeutic agent(s) is/are selected from anti-inflammatory agents, anti-vasoproliferative agents, immunosuppressive agents, antibiotics, antiviral agents, antimitotic agents and combinations thereof (Abstract). Figures 1A and B show an IOL and a haptic in different configurations with drug delivery systems (paragraphs 0009 and 0011). Preferably the shape of said drug delivery system is selected from: disc, cylinder, nail-like-plug, rod, tablet,
sphere, truncated cone with a bended axis, polymer wire rolled around a haptic, and polymer sheet wrapped around a haptic. In case of a disc-shaped drug delivery system, the attaclunent of the drug delivery system to a haptic of the intraocular lens may be achieved by a small hole in the disc, for example in the center of the disc, wherein the size of the hole is such that the haptic may be inserted into the hole (see FIG. 4). Such a drug delivery device is particularly suitable for filiform haptics, but not limited thereto. As indicated in FIG. 1 (upper part, right and bottom part), the attachment of more than one drug delivery system may easily be achieved by these means. Polymer wires and polymer sheets may be sealed by heating to ensure that the drug delivery device remains attached to the haptic. Polymer sheets are particularly suitable for lenses with wider or thicker haptics such as one-piece lenses, but may also be used for attachment to
filiform haptics (paragraph 0035).
Bossy-Nobs does not teach copolymers of caprolactone and at least one other monomer in the matrix.
The teachings of Venkatraman are related to drug eluting member adapted to be attachable onto a perimeter edge of a lens portion of an intraocular lens, the drug eluting member including an interfacing portion adapted to receive a portion of the perimeter edge (Abstract). A typical composition for a fully-degradable drug eluting member with drugs surrounds the edge of the IOL would be as follows: polylactide-co-caprolactone, with LA/CL ratio of (70:30), (60:40) and (50:50); and polylactide-co-TMC-caprolactone-co-polylactide tri-block polyurethane, with LA/TMC/CL ratio of (0.38:1:1), (0.75:1:1), (1.5:1:1), (1.5:0.33:1) and (1:0.33:1) (paragraphs 0110-0112).
The teachings of Bossy-Nobs and Venkatraman are related to drug eluting matrix compositions intended for ophthalmic delivery of a drug, and it would have been obvious to have combined them because they are in the same field of endeavor.
Regarding claim 72, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed an ophthalmic article comprising an active agent comprising an antibiotic and a polymer matrix comprising polycaprolactones, wherein the ophthalmic article is positioned at a region of a haptic of an IOL wherein the region comprises a valley, with a reasonable expectation of success because Bossy-Nobs teaches an ophthalmic article comprising an active agent comprising an antibiotic and a polymer matrix comprising polycaprolactones, wherein the ophthalmic article is positioned at a region of a haptic of an IOL where it is apparent from Figure 1 that the article is positioned at a valley region of the hepatic. The claim describes the positioning of the article at a region of the haptic as a product by process, “without use of an external force or external agent”. The limitation is indefinite for reasons described above. However, the claims are treated for the purpose of compact prosecution, and Bossy-Nobs’ article could have been positioned at a region of the haptic without use of an external force or external agent, absent evidence to the contrary.
It would have been obvious to have modified Bossy-Nobs’ article by using polylactide-co-caprolactone to form the drug eluting matrix, with a reasonable expectation of success because Venkatraman teaches polylactide-co-caprolactone as a suitable matrix forming polymer for delivering drugs ophthalmically, and the selection of a known material based on its suitability for its intended use supports obviousness. Additionally, Bossy-Nobs teaches that polycaprolactones are suitable for forming the drug eluting matrix and it would have been reasonable to interpret “polycaprolactones” to encompass homopolymers of caprolactone as well as copolymers of caprolactone and another monomer.
Regarding claim 74, the claim describes the article as configured to associate compressively to an outer surface of the hepatic within the region. The prior art article is made from the same material as claimed and it associated with the haptic by attaching the article to the haptic (paragraph 0014). In view of these teachings, it would have been reasonable to expect the article to be configured to compressively associate with the haptic region.
Regarding claim 77, based on the drawings in Figures 1 A and B, the article does not extend beyond the haptic, which meets the limitation that requires the article to extend no more than 0.32 mm beyond the haptic. The claimed range includes embodiments where the article does not extend beyond the haptic or 0 mm.
Regarding claim 80, the article is described as attached to the haptic, therefore the article has an internal structure configured to associate with the region of the haptic.
Regarding claim 83, it would have been obvious to have formulated the drug releasing matrix to provide a sustained release of the drug over a 1-12 week period, with a reasonable expectation of success because Bossy-Nobs teaches that the DDS provided an in vivo drug release over a 1-12 week period (Paragraphs 0093 and 0099, Table 3).
Regarding claim 84, Bossy-Nobs’ article made in view of Venkatraman is made from the same material as claimed and it would have been reasonable to expect it to have the same properties as claimed when tested under the same conditions, including having an elongation at break of at least about 100% when measured at from about 18°C to 24°C because a composition and its properties as inseparable.
Regarding claim 85, Venkatraman teaches a copolymer of lactide and caprolactone.
Regarding claim 86, it would have been obvious to have formed the article with antibiotics because Bossy-Nobs teaches antibiotics as suitable drugs for delivery via the drug delivery article.
Regarding claim 87, polylactide-co-caprolactone is a random copolymer. Furthermore, it would have been obvious to have formed the matrix with polylactide-co-TMC-caprolactone-co-polylactide tri-block polyurethane, which is a block copolymer, because Venkatraman teaches that polylactide-co-TMC-caprolactone-co-polylactide tri-block polyurethane is suitable for making a drug eluting matrix.
Regarding claim 88, it would have been obvious to have formed the article to contain the active agent in a concentration of 35 wt. % because Bossy-Nobs teaches an embodiment of an article comprising 35 wt. % triamcinolone acetonide (paragraph 0078 and 0090). It would have been further obvious to have varied the concentration of the drug in the range of to 50 wt. % because Venkatraman teaches that the drug eluting device comprises up to 50 wt. % of active agent (paragraph 0104). The claimed range is obvious because it encompasses 35 wt. % and overlaps with the range of up to 50 wt. %.
Regarding claim 90, example 2 describes DDS in the shape of disc where the average thickness of the disc is 0.3 mm and average diameter of the disk is 2.1 mm. Example referred to Figure 1 for a schematic representation of the IOL combined with DDS (paragraphs 0090 and 0091). The following drawing is from Figure 1 A
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The attachment of the drug delivery system to a haptic of the intraocular lens may be achieved by a small hole in the disc, for example in the center of the disc, wherein the size of the
hole is such that the haptic may be inserted into the hole (see FIG. 4) (paragraph 0035).
It would have been reasonable to expect the perimeter of the internal structure of the ophthalmic article to be less than about 6 mm with a reasonable expectation of success because a perimeter of a disc having a diameter of 2.1 mm is about 6 mm. The hole punctured in the center of the disk necessarily has a smaller perimeter than the disk itself, and it will fall in the range of less than 6 mm. The claimed range of about 2.2 mm and less is obvious because it overlaps with the prior art range of less than 6 mm.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Bossy-Nobs and Venkatraman as applied to claims 72, 74, 77, 80, 83-88, and 90 above, and further in view of Thomes (US 2010/0016439 Al Published January 21, 2010 – of record in PTO-892 dated 10/20/2025).
The claim further defines the article of claim 72.
The teachings of Bossy-Nobs and Venkatraman are relied upon as summarized above. While Venkatraman teaches that the drug eluting device comprises up to 50 wt. % of active agent such as levofloxacin, moxifloxacin, and gatifloxacin (paragraph 0104). Venkatraman does not teach mass of the active agent. Bossy-Nobs teaches that articles contain about 1000 micrograms of the active agent TA (paragraph 0090).
The teachings of Thomes are related to ophthalmic devices that are loaded with
therapeutic agent. The devices provide prolonged release of the therapeutic agent to the eye. The
ophthalmic devices are typically formed of an ophthalmic material that is particularly desirable
for the loading of therapeutic agent and/or the therapeutic agent is typically particularly desirable
for loading to the ophthalmic material (Abstract). The ophthalmic device may be suitable for
location within an eye or location upon an outer surface of the eye. In a preferred embodiment,
the ophthalmic device, which will be partially or entirely formed of the ophthalmic material, is
an IOL or a device suitable for location within the eye along with an IOL (paragraph 0009).
Drugs include anti-infective agents such as moxifloxacin and gatifloxacin (paragraph 0039). The
amount of therapeutic agent disposed upon the ophthalmic material can vary widely depending
upon the therapeutic agent itself and the desired dosing of the agent. Generally, the total weight
of therapeutic agent disposed upon the ophthalmic material is at least about 0.01 microgram and
is typically less than about 1 milligram (paragraph 0044).
The teachings of Bossy-Nobs modified byVenkatraman and Thomes are related to intraocular lenses intended for delivering a drug such as an antibiotic selected from moxifloxacin and gatifloxacin, and it would have been obvious to have combined them because they are in the same field of endeavor.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed Bossy-Nobs’s article as modified by Venkatraman to comprise an active agent selected from an antibiotic moxifloxacin and gatifloxacin, with a reasonable expectation of success because Venkatraman teaches that the drug eluting member is suitable for delivering moxifloxacin and gatifloxacin. It would have been obvious to have added the antibiotic in an amount from 0.01 micrograms to 1 milligram because it was known from Thomes that 0.01 micrograms to 1 milligram is suitable amount of moxifloxacin and gatifloxacin loaded into a drug eluting ophthalmic device. Combining prior art elements according to known methods to obtain predictable results supports obviousness and the selection of a known amount based on its suitability for its intended purpose supports obviousness. The claimed amount range is obvious because it overlaps with the prior art range. The specification was reviewed and there is no evidence that the claimed range is critical.
Conclusion
No claims are allowed.
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.
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/ALMA PIPIC/ Primary Examiner, Art Unit 1617