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 .
DETAILED ACTION
The Applicant’s reply filed on 12/15/25 is acknowledged. Claims 1-10 and 12-20 are pending. Claims 16-20 have been withdrawn. Claim 1 has been amended. Claims 1-10 and 12-15 are under consideration.
Rejections Withdrawn
The rejection of Claims 1-10 and 12-15 under 35 U.S.C. 103 as being unpatentable over Shiah et al. (US 2013/0295157; cited previously) is withdrawn in view of the amended claim(s).
Rejections Maintained and New Grounds of Rejections
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shiah et al. (US 2013/0295157) in view of Gerold et al. (US 8,871,829; 2014).
Shiah et al. teach biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye (e.g. abstract).
Shiah et al. teach an implant drug delivery system comprising an implant, which comprises a core which comprises: (a) a biocompatible bioerodible polymer (e.g. claim 1) and (b) mometasone furoate (e.g. paragraph 0179; Claim 5) which is present in the core between 10% to 60% by weight, which overlaps the claimed range of 5-70% (e.g. paragraph 0181; claim 6). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding the limitation “wherein said implant is implanted into the vitreous of the eye and mometasone furoate is continually released into the vitreous at a rate resulting in a plasma concentration of mometasone furoate in ocular tissue between 0.1 and 0.5 mcg/d for a period of three months to thirty-six months” this is an intended use. The claim is directed to a product and not to a method of use. 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. In the instant case, the implant of Shiah et al. comprises the claimed ingredients in the claimed amounts for implantation into an eye, and is therefore capable of performing the intended use. Shiah et al. further disclose that the active agent may be release over a time period including, but is not limited to, approximately six months, approximately three months, approximately one month, or less than one month (e.g. paragraph 0174) and further teach the release kinetics may be adjusted and optimized (e.g. paragraphs 0192-0221).
Shiah et al. do not teach the inclusion of 1-20 wt% of a radiopaque material. This is made up for by the teachings of Gerold et al.
Gerold et al. teach a radio-opaque marker for medical implants comprising between 10 and 90 weight percent of a biodegradable base component, between 10 and 90 weight percent of one or more radio-opaque elements (e.g. abstract). Gerold et al. teach that biodegradable polymers for medical implants known from the related art have the disadvantage that they are not detectable. However, x-ray diagnosis is an important instrument for postoperative monitoring of the healing progress or for checking minimally invasive interventions (e.g. column 1, lines 43-50).
Regarding Claims 1-3 and 15, it would have been obvious to one of ordinary skill in the art at the time of filing to include 10-90% by weight of radio-opaque materials of Gerold, which overlaps with the claimed range of 1-20 wt%, for use in the implant of Shiah. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both Shiah and Gerold are directed to implants comprising biodegradable materials, and one would have been motivated in order to provide the benefits of postoperative monitoring of the healing progress or for checking minimally invasive interventions, as disclosed by Gerold et al.
Regarding Claims 4-8, Shiah et al. teach an implant drug delivery system comprising mometasone furoate (e.g. paragraph 0179; Claim 5) which is present in the core between 10% to 60% by weight, which overlaps the claimed ranges (e.g. paragraph 0181; claim 6). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claims 9 and 10, Shiah et al. teach that the biodegradable polymer may be homo- or copolymers of D-lactic acid, L-lactic acid, racemic lactic acid, glycolic acid, caprolactone, and combinations thereof (e.g. paragraph 0186).
Regarding Claims 12-14, Shiah et al. teach that the implant may be sterilized by gamma irradiation in a dose within the range of 25-40 kGy (e.g. paragraph 0326).
Response to Arguments
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive.
Applicant argues that it would not have been obvious to one of ordinary skill in the art to combine the Shiah and Gerold references. Shiah is directed to drug infused ocular implants made of biodegradable polymers. Conversely, Gerold is directed to radiopaque markers for surgical implants with a particular focus to stents and orthopedic implants. (See Gerold at c. 5, 11.13-20) Applicant respectfully submits that one of ordinary skill in the art faced with the deficiencies of the Shiah reference would not have been motivated to consult the Gerold reference without impermissible hindsight.
This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case it would have been obvious to one of ordinary skill in the art at the time of filing to include 10-90% by weight of radio-opaque materials of Gerold. One of ordinary skill in the art would have predicted success as both Shiah and Gerold are directed to implants comprising biodegradable materials, and one would have been motivated in order to provide the benefits of postoperative monitoring of the healing progress or for checking minimally invasive interventions, as disclosed by Gerold et al. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Conclusion
No claim is 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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619