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
This application, filed on August 8, 2024, is a Continuation of application No. 17/554,808, filed on December 17, 2021, now abandoned, which is a continuation of application No. 17/350,888, filed on June 17, 2021, now Pat. No. 11,279,729, which is a continuation of application No. PCT/IB2021/000332, filed on Apr. 29, 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) filed on August 3, 2024 and November 22, 2024 have been acknowledged and considered.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 167-168 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 167-168 recite, “… wherein the pharmaceutical implant is suitable for administration…” The recitation of intended use, namely “suitable for administration,” does not provide further structural limitations to the product claims 165-166, of which claims 167-168 respectively depend. Therefore, instant claims 167-168 fail to further limit the subject matter of the claims from which they depend. Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). See MPEP §2111.02.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Art Made of Record but not Applied
Close prior art is WO2007056457 (“Chappell”) which discloses methods, compositions, and kits for treating an immunoinflammatory disorder, an ophthalmic disorder, etc. (Abstract).
Chappell discloses administration of two drugs simultaneously or in the form of drug conjugates (pp. 30 and 95) to treat ophthalmic disorders (p. 1). One of the combinations disclosed in Table 1A is a corticosteroid, e.g., prednisolone, and prostaglandin (p. 32). Another corticosteroid disclosed is anecortave acetate and one of the prostaglandins disclosed is bimatoprost (p. 36, lines 16-17; p. 54, lines 6-17). Anecortave acetate is the ester form of the steroidal aspect and bimatoprost is the amide form of the prostaglandin aspect of the compound in instant claim 165. Chappell further states: “that functional groups in drug (A) and/or drug (B) may, if desired, be converted to other functional groups prior to reaction, for example, to confer additional reactivity or selectivity.” (p. 99). While the combination of drugs taught can be in the form of covalently attached conjugates, there is nothing in Chappell that would suggest to a skilled artisan to specifically choose and combine the corticosteroid anecortave acetate and the prostaglandin bimatoprost. Furthermore, there is no teaching nor suggestion to make such a drug conjugate in the art, nor would such modifications be expected to produce predictable results with respect to the compound of the pharmaceutical implant in the instant claims. Accordingly, claims 165-174 are both novel and nonobvious over the prior art.
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 165-174 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,279,729 (“ ‘729 “) in view of Chappell. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 165-174 are obvious over claims 1-11 of ‘729 in view of Chappell.
Claim 11 of ‘729 recites: “A pharmaceutical implant comprising at least 50 wt. % of the compound of claim 1.” Claim 6 recites: “The compound of claim 1, of the structure:
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.” The compound in the instant claims is the same as claim 6 (“Drug Conjugate”) and is a species of the genus of claim 1-3 of ‘729. The pharmaceutical implant of claim 11 of ‘729 is the same as the one recited in the instant claims and therefore the claims of ‘729 encompass instant claims 165-166.
‘729 fails to teach a method of administering an implant to the eye of an individual.
Chappell teaches administration of two drugs simultaneously or in the form of drug conjugates (pp. 30 and 95) to treat ophthalmic disorders (p. 1). One of the combinations disclosed in Table 1A is a corticosteroid, e.g., prednisolone, and prostaglandin (p. 32). Another corticosteroid disclosed is anecortave acetate and one of the prostaglandins disclosed is bimatoprost (p. 36, lines 16-17; p. 54, lines 6-17). Chappell further states: “that functional groups in drug (A) and/or drug (B) may, if desired, be converted to other functional groups prior to reaction, for example, to confer additional reactivity or selectivity.” (p. 99). Chappell teaches ophthalmic formulations of the compositions including “…intraocular biodegradable and non-biodegradable implants; implants that are inserted through incisions made in the eye wall or sutured around the globe of the eye; tack for intraocular drug delivery; and bioadhesive ophthalmic inserts.” (p. 92, lines 15-17). Chappell further states: “The pharmaceutical preparation may also be in the form of a solid insert such as one which after dispensing the drug remains essentially intact… or a bioerodible insert that either is soluble in lacrimal fluids, or otherwise disintegrates…”
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to administer the pharmaceutical implant comprising the Drug Conjugate of ‘729 to the eye of an individual by implant into the eye through incisions made in the eye wall or sutured around the globe of the eye, through a tack for intraocular delivery, or a bioadheseive ophthalmic inserts as taught by Chappell to arrive at the method instantly claimed. The optional removal of the implant would have been prima facie obvious to a PHOSITA because Chappell teaches that the formulation can be in the form of a solid insert that could be solubilized in lacrimal fluid or otherwise disintegrates into the eye of an individual, which would necessarily not require removal of an implant. Accordingly, claims 167-174 are prima facie obvious over ‘729 in view of Chappell.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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