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 .
Claims 1-9 and claims 10-20 are before the Examiner.
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.
Claims 1-9 and claim 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Owen US20060257486; Koenen WO2003099278 and Scott US 9192623 .
Owen teachers suspension Formulations Of Nepafenac And Other Ophthalmic Drugs For Topical Treatment Of Ophthalmic Disorders. The drugs includes the instant PDE4) inhibitor roflumilast. See Owen page 1, column B [0014] and page 3 column B Example 2.
Also see Koenen page 1, 3rd line from the bottom.
Unlike Owen which teaches roflumilast along with many active ingredients for ophthalmic formulations, Koenen focuses on roflumilast, makes many examples of compositions of roflumilast and mentions roflumilast one hundred twenty one times (as per word search). Koenen in the opening paragraph includes disorders of the eye:
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Reference to ‘eye’ appears 62 times, for example at page 6
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Likewise, the inherent property of PDE4 inhibition of roflumilast is explicitly taught in the Koenen teaching. A word search for PDE returns 45 hits.
As such the position taken is that the roflumilast as active ingredient for treating eye disorder is taught in the prior art.
Owen discloses a method for treating a patient having an inflammatory disorder of an ocular surface or anterior tissue of the eye (the topically administrable composition may be used to treat ophthalmic disorders of the ocular surface as well as the posterior section of the eye, including surgically induced inflammation and scleritis; Para. [0013]), comprising administering an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of roflumilast, or a pharmaceutically acceptable salt thereof (the ! topically administrable composition may contain !he active agent roflumilast; Para. [0014]), to the cornea of said patient (the composition is administered topically to the ocular surface, i.e. the cornea; Para. [0013]), wherein the composition delivers roflumilast to a cornea of said patient and subsequently travels laterally through the ocular surface and anterior tissues of the eye (the composition has enhanced corneal drug flux and travels from the ocular surface through the anterior to the posterior tissues of the eye; F0ara_[0013], Example 3).
Owen discloses the method of claim 1o, wherein the ophthalmic pharmaceutical composition is a suspension (the compositions of the invention are aqueous suspensions of ophthalmic drugs; Para. [0008l}.
Also, with regards to “wherein the administration produces elevated levels of roflumilast in the cornea, the sclera, the iris-ciliary body, the conjunctiva, and the aqueous humor of the eye of the patient relative to a posterior tissue of the eye of the patient", and wherein the administration produces a depot effect in the cornea of the patient characterized by an increase in the concentration of roflumilast in the cornea relative to the concentration of roflumilast in the cornea at an earlier time period following administration", “wherein the administration produces a depot effect in an iris-ciliary body of the patient characterized by an increase in the concentration of roflumilast in the iris-ciliary body relative to the concentration of roflumilast in the iris-diary body at an earlier time period following administration", Further regarding "wherein the administration produces a depot effect in a sclera of the patient characterized by an increase in the concentration of roflumilast in the sclera relative to the concentration of roflumilast in the sclera at an earlier time period following administration", the discovery of a previously unappreciated property of a prior art method, or of a scientific explanation for the prior art's j functioning, does not render the old method new to the discoverer. Thus the claiming of a new use, new function, or previously unknown property which is inherently present in the prior method does not make the limitations novel.
Owen discloses a method as in claim 10 for treating a patient having an inflammatory disorder of an ocular surface or anterior tissue l of the eye (the topically administrable composition may be used to treat ophthalmic disorders of the ocular surface as well as the posterior I section of the eye, including surgically induced inflammation and scleritis; Para. [0013]), comprising administering an ophthalmic pharmaceutical composition comprising a therapeutically effective amount of roflumilast, or a pharmaceutically acceptable salt thereof (the topically administrable composition may contain the active agent roflumilast; Para. [0014]), to the cornea of said patient (the composition is administered topically to the ocular surface, i.e. the cornea; Para. [0013]}. For the limitations of dependent claims 11-20 see above, dependent claims 2-9 discussed above.
The teachings of Scott is also invoked here for the limitations of ophthalmic formulations containing roflumilast for administration into cornea relating to the limitations of cellulose, polysorbate, buffer, tyloxapol, polyvinylpyrrolidone, posterior, iris-ciliary, sclera, conjunctiva, concentration of dependent claims 2-9 and 11-20. These routinely used ingredients in ophthalmic formulations are taught in Scott throughout.
Applicant is encouraged to use word search technique to locate the limitations in cited references: Applicant is encouraged to use word search *technique to locate disclosures in the cited references with respect to the presence (or absence/silence) for various active components in the claims.
*word search:
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Disclosure in the specification refers at [0007]. [0008] and [0042] surprising results
delivery of roflumilast to the cornea deliver drug laterally to the ocular surface and anterior tissues and that the roflumilast has been found preferentially to migrate laterally through the ocular surface and anterior tissues, rather than transversely through the cornea and that the administration of pharmaceutical compositions comprising roflumilast to the cornea results in drug delivery that preferentially travels laterally through the eye
are considered in the context of the references cited. The position taken is that cited references teach ophthalmic formulations with roflumilast as active ingredient for treating eye disorder and the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for controlling parasites. This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 136 F.2d 715, 718, 58 USPQ 262, 264 (CCPA 1943). Further, . “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Suggestion:
See prosecution history of US Application No. 17668858.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11129818, Owen US20060257486; Koenen WO2003099278 and Scott US 9192623 . Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
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The discussion under Claim Rejections - 35 USC § 103 is invoked here in its entirety with regards to Owen, Koenen and Scott for the obviousness analysis.
The anti-inflammatory property and ophthalmological use of roflumilast for the treatment of diseases of the eye for topical application of the pharmaceutical preparation is taught by Koenen at page 18, line last paragraph. Further according to Loch, “the scientific interest in new therapeutic possibilities to treat ophthalmic diseases is also increasing. Currently drugs for topical application account for the majority of prescriptions. These preparations are washed away by tear fluid within a few seconds after application and may enter systemic circulation possibly causing side effects”. Loch teaches how to obtain more efficient concentrations at the target organ. Page 131 column A onto column B.
At page 23, 11129818 teaches topical application of roflumilast ocular surface and at page 2, 11129818 admits to the anti-inflammatory property roflumilast. The limitations of the method claims of 11129818 do not match the limitations of the instant claims, but the active ingredient and method of administration are the same. Recitation such as travels laterally etc. in the claims relate to the inherent property of the active ingredient when administered, for example in the form of eye drops. Further with the combined teachings of Koenen and Loch, one of skill in the art would arrive at the instant limitation with a reasonable expectation of success.
Likewise (Likewise means for the same rationale discussed above),
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 12263160 in view of Owen US20060257486; Koenen WO2003099278 and Scott US 9192623. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 12144802 in view of Owen US20060257486; Koenen WO2003099278 and Scott US 9192623. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 12102622 in view of Owen US20060257486; Koenen WO2003099278 and Scott US 9192623. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
