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 .
Election/Restrictions
Applicant’s election of the species:
Ibuprofen for the therapeutic compound;
mixtures of saturated C10-C18 triglycerides having a melting point around 43°C (manufactured under the trademark GELUCIRE® 43/01) as the species of the genus one or more pharmaceutically-acceptable hard fats comprising one or more glycerolipids; and
a mixture of one or more monoglycerides including glycerol monolinoleate, one or more diglycerides, and one or more triglycerides (manufactured under the trademark MAISINE 35-1) as the species of the genus one or more pharmaceutically acceptable liquid lipids comprising one or more partially hydrolyzed fats;
in the reply filed on 2/26/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims Status
Claims 1-18 are pending and presented for examination as they read upon the elected subject matter.
Priority
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The claimed subject matter is afforded the effective filing date of 1/14/2014.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 1/28/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by 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 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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US20090074859) and Hamilton et al. (AU2005309808).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical formulation and possess specialized knowledge in drug delivery, material science, and physical chemistry to convert active pharmaceutical ingredients (APIs) into stable, effective medicines. They understand how to select excipients, optimize stability, and ensure compliance with regulatory standards (FDA, GMP). Their expertise covers formulation development, dosage form design, and manufacturing processes. One can assume comfortably that such an educated artisan will draw conventional ideas from these areas— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 17-18, Patel teach solid pharmaceutical compositions comprising combinations of pharmaceutical active ingredients, surfactants and triglycerides (Abstract; claim 1) where the active ingredient ibuprofen (elected species) is most preferred [0038-0039]. Patel teach glycerol monolinoleate as a lipophilic component (Claims 1, 12 and 16) and name Maisine 35-1 (elected species) in an amount of 4.5% w/w and 8.8% w/w active omeprazole [0112, 0264]. Patel teach that the hydrophobic active ingredient can be present Patel also identify Gelucire commercial surfactant compositions including Gelucire 43/01 (glycerol fatty acid esters) (elected species) as a preferred triglyceride ([0112]; Table 9, page 11; see also claim 15 “glyercol fatty acid esters”). Patel teach: “Preferred triglycerides are those which solidify at ambient room temperature, with or without addition of appropriate additives, or those which in combination with particular surfactants and/or active ingredients solidify at room temperature.” [0110] The same species taught by Patel also have the same functional properties claimed.
Regarding claims 12-13, disclosure of Gelucire 43/01 by Patel implicitly meets these limitations.
Regarding claims 14-15, 4.5% w/w Maisine 35.1 (Example 5, [0264]) is less than 45% by weight and falls within about 4-40% by weight.
Regarding claims 1 and 6-11, Hamilton et al. teach pharmaceutical formulations comprising Maisine and Gelucire components (Claims 1-4) where low HLB surfactants can be present from 40-80% (Claim 19).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Patel is that Patel do not expressly teach ibuprofen in an amount of less than about 50% by weight or about 5-45% by weight or about 5-25% by weight or about 20-45% by weight of the solid solution composition. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ ibuprofen in the solid composition of Patel in the amounts claimed and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because it is merely routine optimization of the dosage amount by the ordinary artisan with a reasonable expectation of success. Pharmaceutical dose has been recognized as a result-effective parameter susceptible to routine optimization. See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989). Especially when Patel teach examples with 8.8% active, as discussed above and 50% active saquinavir in Example 28 [0296], thus establishing a range of at least 8.8% to 50% which embraces the claimed ranges.
The difference between the instant application and Patel is that Patel do not expressly teach the liquid lipid Maisine 35-1 in an amount of from about 8 to about 38% by weight of the solid solution composition. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the liquid lipid Maisine 35-1 in an amount of from about 8 to about 38% by weight of the solid solution composition in the solid composition of Patel and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Patel also teach functional equivalence of glycerol monolinoleate with other glyceryl esters (Claim 16) and examples with glycerol monolaurate in an amount of, for example, 13% w/w (Example 2; [0261]). Consequently, it would be obvious to employ glyceryl monolinoleate (Maisine 35-1) representing liquid lipids comprising one or more partially hydrolyzed fats in an amount of about 8-38% with a reasonable expectation of success.
The difference between the instant application and Patel is that Patel do not expressly teach the hard fat Gelucire 43/01 in an amount of at least 25, 30, 35, 40, 45, about 30-60, about 34-50% by weight of the solid solution composition and wherein the solid solution pharmaceutical composition is formulated to be a solid at a temperature of about 15°C or lower and has a melting point of 30°C or higher. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the hard fat Gelucire 43/01 in an amount of from at least 30, 35, 40, 45, about 30-60, about 34-50% by weight of the solid solution composition, as suggested by Hamilton et al., and have a solid solution pharmaceutical composition formulated to be a solid at a temperature of about 15°C or lower and has a melting point of 30°C or higher in the solid composition of Patel and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because not only is it merely routine optimization of the triglyceride component Gelucire 43/01 taught by Patel to make the solid composition, but also the artisan is aware that it has a low HLB value of 1 (Page 11, of Patel) and the art of Hamilton suggests amount of low HLB components in pharmaceutical dosage forms in an overlapping range 40-80% of the instantly claimed amounts/ranges. The same hard fats comprising one or glycolipids and liquid lipids comprising one or more partially hydrolyzed fats in the same amounts implicitly produce a solid solution composition formulated to be a solid at a temperature of about 15°C or lower and has a melting point of 30°C or higher. The ordinary artisan would then add Gelucire 43/01 in that range and do so with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over: claims 1-20 of U.S. Patent No. 11918654; claims 1-20 of U.S. Patent No. 11224659; claims 1-20 of U.S. Patent No. 11202831; claims 1-20 of U.S. Patent No. 11826428; claims 1-25 of U.S. Patent No. 11000493; claims 1-20 of U.S. Patent No. 11844773; claims 1-20 of U.S. Patent No. 11154500; claims 1-20 of U.S. Patent No. 10835490; claims 1-20 of U.S. Patent No. 10695432; claims 1-15 of U.S. Patent No. 10695421; and claims 1-20 of U.S. Patent No. 11992555. Although the claims at issue are not identical, they are not patentably distinct from each other because patents are also directed to solid solutions with the same hard fats and liquid lipids, including glyceryl monolinoleate, and a therapeutic compound(s). For example, the following patents are representative where claim 1 of 11224659 reads:
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Claim 1 of 11918654 reads:
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Claim 1 of 10695432 reads:
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Claim 1 of US 10695431 reads:
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Claim 1 of US 11992555:
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The other patents listed also read in a similar manner to render the instantly claimed subject matter obvious. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
Prosecution Insights