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 .
Priority
The instant application is a Continuation of earlier application 18/227, 463 filed 28 July 2023, now U.S. Patent 12,109,302, which is a Continuation of earlier application 17/681,238 filed 25 February 2022, now U.S. Patent 11,779,536, which is a Continuation of earlier application 17/483,220 filed 23 September 2021, now U.S. Patent 11,331,267, which claims the benefit of provisional U.S. applications 63/124,204 filed 11 December 2020, and 63/082,505 filed 24 September 2020.
Status of the Claims
Claims 15, 16, and 18-30 are pending, presented for examination, and disposed as set forth in greater detail below.
Claim Interpretation
The instant claims encompass biodegradable hydrogels containing defined quantities of cyclosporine dispersed through the hydrogel. Applicants are reminded that during patent prosecution, claims are given their broadest reasonable interpretation consistent with the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005). It has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). An inventor of a structure (machine or article of manufacture) is entitled to benefit from all of its uses, even those not described, Roberts v. Ryer, 91 U.S. 150, 157 (1875), and conversely, patentability of the structure cannot turn on the use or function of the structure, In re Michlin, 256 F.2d 317, 320 (CCPA 1958). A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). As such, the language of the claims specifying that the cyclosporine laden biodegradable hydrogel is an “intracanalicular insert” is not afforded patentable weight so far as the scope of the claim is concerned. Dependent claims narrow the concentration of cyclosporin in the composition, incorporates defined amounts of a non-ionic surfactant, specify the dimensions and shape of the composition, or defines periods of time over which the composition is to release the cyclosporine contained therein.
Claim Rejections - 35 USC § 103
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 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 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 15, 16, and 18-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sawhney (U.S. 8,409,606) in view of Utkhede (U.S. 10,603,274).
Sawhney describes biodegradable hydrogels for placement in the canaliculus of the eye for controlled release of a drug contained therein. (Col.3, L.54-60; Col.5, L.14-18; Col.6, L.45-46). Sawhney describes the hydrogels as containing particles of therapeutic agent dispersed throughout the hydrogel, (Col.6, L.47-61), which in some instances is represented simply by solid drug particles contained therein. (Col.38, L.45-47). Solid cyclosporine A is a particularly recited active agent incorporable into the hydrogel formulations useful for placement in the lacrimal canaliculi. (Col.16, L.40-51; Col.25-26 “Table 2”). Sawhney indicates that the compositions can take the form of a rod, which the examiner considers equivalent to the “fiber” recited by Claims 23-25, having lengths in the range of 0.5-15mm, and a diameter of between 0.1-1mm, which is to swell by about a factor of two when placed within the canaliculus. (Col.23, L.37-55). Sawhney indicates that these compositions may be formulated to biodegrade over periods of time anywhere within the range of about 5 to 365 days, with degradation being used as a means of releasing drug from within the composition. (Col.24, L.13-40).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a biodegradable hydrogel containing solid cyclosporine suitable for placement in the lacrimal canaliculi, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen 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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of a biodegradable hydrogel containing cyclosporine having a rod shape having lengths in the range of 0.5-15mm and a diameter of between 0.1-1mm suitable for placement in the lacrimal canaliculi to degrade and release drug within the range of about 5 to 365 days from within the Sawhney disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Despite this, Sawhney does not describe a composition having the cyclosporine content required by the claims, or is the inclusion of any of the additional elements recited by dependent claims identified.
Utkhede also describes medical devices for drug delivery by placement in the lacrimal canal. (Col.1, L.21-25). Utkhede indicates that the drug contained within the devices may be cyclosporine, and may be incorporated in concentrations of between 36-60%. (Col.4, L.62-67). Incorporating hydrophilic and hydrophobic polymers and nonionic surfactants permit drugs to be delivered from the devices of Utkhede for periods of up to 12 weeks. (Col.4, L.48-55). Utkhede describes embodiments of such implants having a substantially cylindrical shape. (Col.6, L.10). Utkhede indicates that nonionic surfactants such as polysorbate 80 or tyloxapol may be incorporated into such implants in concentrations falling within the range of about 4% to about 29.5%. (Col.9, L.23-24; 53). Utkhede indicates that these implants may be configured to deliver between 2-17 micrograms of cyclosporin per day for periods of 4 weeks. (Col.4, L.45-49).
The art at the time of the instant applications filing therefore describes rod-shaped hydrogel implants having dimensions overlapping those of the instant claims in both the dehydrated and hydrated states, containing cyclosporin in concentrations and delivering daily amounts overlapping the ranges set forth by the claims, designed to deliver cyclosporin and degrade within ranges of time overlapping the ranges of the instant claims, also containing nonionic surfactants in concentrations overlapping those of the instant claims. It must be remembered that a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). By the recitation of certain dimensions as well as the desire to provide such implants in a manner where the diameter of the implant is to double when hydrated, the Examiner considers the limitations of Claim 25 at least the result of the routine optimization of a result-effective variable, and obvious thereby. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). While certain properties recited by Claims 21-24 are not specifically identified in the art of record, Applicants are reminded that the U.S. Patent office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. Where the claimed invention and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 15, 16, and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,291,627. Although the claims at issue are not identical, they are not patentably distinct from each other because the implants recited as being used by the methods of the ‘627 application anticipate the biodegradable hydrogel cyclosporine implants of the instant claims.
Claims 15, 16, and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,331,267. Although the claims at issue are not identical, they are not patentably distinct from each other because the biodegradable hydrogel intracanalicular implants containing solid cyclosporine particles anticipate the biodegradable hydrogel cyclosporine implants of the instant claims.
Claims 15, 16, and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,779,536. Although the claims at issue are not identical, they are not patentably distinct from each other because the biodegradable hydrogel intracanalicular implants containing solid cyclosporine particles anticipate the biodegradable hydrogel cyclosporine implants of the instant claims.
Claims 15, 16, and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,109,302. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treating disease recited by the ‘302 patent inherently disclose biodegradable hydrogel intracanalicular implants containing cyclosporine which anticipate the biodegradable hydrogel cyclosporine particulate implants of the instant claims.
Claims 15, 16, and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,161,753. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treating disease recited by the ‘753 patent inherently disclose biodegradable hydrogel intracanalicular implants containing cyclosporine which anticipate the biodegradable hydrogel cyclosporine particulate implants of the instant claims.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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