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 .
Status of Application
Receipt of the Preliminary Amendment dated October 3, 2024 is acknowledged.
Claims 5-31 are pending in this application.
Claims 1-4 have been cancelled. Claims 5-31 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on September 17, 2024; May 30, 2025; October 6, 2025; and July 23, 2026 is acknowledged. Signed copies are attached to this office action.
Claim Objections
Claims 13-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As noted in parent application 15/555,325, After Final remarks dated December 16, 2019, at paragraphs [0073]-[0074], Hori teaches that suppositories having melting temperatures exceeding 50 °C are free from risks of melting during handling and deforming prior to administration, and that suppositories having melting temperatures lower than 40 °C have a risk of melting when held between the fingers, and deforming if temperatures rise during storage. Thus, Hori teaches away from a suppository that has a melting temperature in the range of about 37 °C to about 39 °C, in favor of suppositories with higher melting temperatures that do not melt or deform when held between fingers or when exposed to rising temperatures during storage. Neither Rowe, Baviskar nor Hiromi (discussed below) contains a teaching that contradicts Hori's statement regarding the susceptibility of suppositories having a melting temperature below 40 degrees Celsius to melting or deformation when handled. Accordingly, none of Rowe, Baviskar and Hiromi teaches, suggests or provides a motivation to modify the suppositories of Hori to make a suppository, or other formulation, having a melting temperature in the range of about 37 °C to about 39 °C.
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 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 5, 7-12, and 16-31 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US 2003/0185861), as evidenced by Rowe R.C. et al. (Colloidal Silicon Dioxide; Handbook of Pharmaceutical Excipients, pg. 180-190; 2006) in view of Baviskar et al. (Drug Delivery on Rectal Absorption: Suppositories, Int. J. Pharm. Sci.Rev.Res., 21(1), Jul-Aug 2013), and further in view of Hiromi (JP 02178228).
Hori discloses a suppository for the lower region of a rectum which comprises a base containing:
a fatty acid triglyceride;
one or more C14-18 fatty acid glycerides; and
a base ingredient for retaining the suppository in the lower region of the rectum, has quite high safety, does not melt by the body temperature when it is held by the fingers before insertion into the rectum so that it is easy to handle, does not deform by elevation of temperature during storage, and prevents stimulation to the rectum mucosa such as congestive hemorrhage and expansion of the rectum mucosa after the insertion (abstract).
The fatty acid triglycerides include cacao butter, lanolin butter, medium chain fatty acid triglycerides, and hard fats (paragraph 0013).
The C14-18 fatty acid glycerides include myristic acid monoglyceride, palmitic acid monoglyceride, and stearic acid monoglyceride (paragraph 0014).
It is noted that this base is oleaginous.
The powders insoluble in the fatty acid triglyceride include anhydrous silicic acid, starches, crystalline celluloses, zinc oxide, and alginic acid (paragraph 0016). It is noted that silicic acid is a synonym for colloidal silicon dioxide, as evidenced by Rowe.
It is noted that colloidal silicon dioxide is a suspending/dispersing agent.
Various drugs can be formulated with the suppository of retaining in the lower region of the rectum. Examples include hydrocortisone acetate (paragraph 0023).
Hori does not disclose the amount of hydrocortisone acetate in weight or the dissolution of the suppository.
Baviskar discloses adult rectal suppositories weight about 2g (suppositories, page 73).
Hiromi discloses a suppository composition having extremely improved stability by blending a base of a fatty acid triglyceride.
Regarding claims 7 and 16, Hydrocortisone acetate is present as an active agent from 0.1-10% by weight. It is noted that 90 mg of hydrocortisone in a 2 g suppository is approximately 4.5%.
Regarding claims 8-9 and 17-18, as noted above, silicic acid (colloidal silicon dioxide) is added.
Claims 10 and 19, as noted above, the base comprises triglycerides.
Regarding claims 11-12 and 20-21, the blend can also optionally comprise lecithin.
Regarding the dissolution of the suppository, the dissolution profiles are a property of the composition itself. Since the prior art disclose the same composition, it would have the same properties, absent a showing of factual evidence to the contrary.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to have included the hydrocortisone acetate at the percentage disclosed by Hiromi into the composition of Hori since both references discloses suppository compositions comprising hydrocortisone acetate therefore it would have been obvious to have included medicaments in their routinely accepted amounts.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US 2003/0185861), as evidenced by Rowe R.C. et al. (Colloidal Silicon Dioxide; Handbook of Pharmaceutical Excipients, pg. 180-190; 2006) in view of Baviskar et al. (Drug Delivery on Rectal Absorption: Suppositories, Int. J. Pharm. Sci.Rev.Res., 21(1), Jul-Aug 2013), and further in view of Hiromi (JP 02178228) as applied to claims 5, 7-12 and 16-31 above, and further in view of Han (CN 101618014).
The teachings of Hori et al. (US 2003/0185861), Baviskar et al. (Drug Delivery on Rectal Absorption: Suppositories, Int. J. Pharm. Sci.Rev.Res., 21(1), Jul-Aug 2013), and Hiromi (JP 02178228) are discussed above.
The combination does not disclose a shell comprising polyethylene/polyvinyl chloride.
Han discloses suppository preparations comprising suppository made of PVC (polyvinyl chloride) and PVC/PE (polyvinyl chloride/polyethylene) plastic capsule shell made of plastic.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have prepared the suppositories of Horr, Baviskar and Hiromi since such shells are routinely used in the art to prepare the suppository.
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 5-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,653,623. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims and the instant claims are drawn to a suppository comprising hydrocortisone acetate, a suspending agent, and an oleaginous base. The patented claims recite specific species of the suspending agent and oleaginous base. The instant claims and the patented claims recite identical dissolution parameters. The instant and patented claims additionally recite identical dependent claims. The patented claims anticipate the instant claims.
Claims 5-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 122,115,253. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method of making the suppository of the instant claims. Following the method of the patented claims would necessarily result in the composition of the instant claims.
Conclusion
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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