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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 03/10/2026, and 03/16/2026 have been entered.
Status of the Claims
Claims 9-11 and 40-66 are pending in a Supplemental Response of 03/16/2026.
Terminal Disclaimer
The terminal disclaimer filed on 03/10/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of copending application no. 19/201650 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 03/10/2026 and 03/16/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
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 of this title, 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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 9-11 and 40-66 are rejected under 35 USC 103 as being obvious over Xiang et al. (WO2017/050259A1, IDS of 05/05/2022, citation is obtained by its corresponding US2019/0194120A1) in view of Murphy et al. (EP2566462A1, IDS of 05/05/2022) as evidenced by Cabot Brochure 2013 (obtained from website: http://www.sanmargroup.com/images/Cabot_Brochure.pdf, 2013, pp. 1-5) and further in view of Allphin et al. (US10,398,662B1, IDS of 05/05/2022) and Takahashi et al. (WO2009133774A1, citation is obtained from Google English translation).
Applicant claims including the below claims 9-11 filed on 03/16/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
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 examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a relevant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmacy, cosmetics, physiology and chemistry— without being told to do so.
Indeed, 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). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(1)) and an artisan must be presumed to know something about the art apart from what the references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07). In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(11)).
Determination of the scope and content of the prior art
(MPEP 2141.01); 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)
Xiang teaches prodrugs of gamma-hydroxybutyric acid compound (GHB) compositions and uses thereof (title); the gamma-hydroxybutyric acid includes the below prodrug compound (s)-4-(2-amino-3-methylbutanoyloxy)butanoic acid
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([0052], [0378], the Examples, Tables 2-4, and claims 1 and 23 of prior art) which reads on the claimed compound of 4-(L-valyl)oxy)butanoic acid; the pharmaceutical composition containing the said prodrug is in the form of oral solid formulation such as powders, granules, pills, tablets, caplets, capsules, gelcaps, suspension, e.g., for the immediate (=quick), sustained or controlled-release form ([0074], and [0128]-[0131]); the oral dosage forms of the composition may have carriers including solvents, polymeric excipients, in particular, binder, polymeric materials such as HPMC, HPC which reads on the claimed binder material, lubricant such as magnesium stearate, and the composition further comprises controlled release polymeric material ([0098]), protective (=sealing), enteric, or sustained release polymeric materials including which can be hydroxypropyl cellulose (HPC) or hydroxypropylmethyl cellulose (HPMC) which reads on the claimed HPC or HPMC ([0129] and [0131]-[0133]); the compounds may be adhered to or coated on the polymer-based components ([0127]) and the tablets or pills of the pharmaceutical composition are coated or otherwise formulated to provide a dosage form affording the advantage of prolonged action ([0132]), which suggests the formulation can contain uncoated and/or coated granules (instant claims 9-11 (in part), claims 42-48, 51-57, and 60-66: GHB prodrug of formula (2a), seal coating, controlled release, HPC binder and coated or uncoated); and the compounds can convert to parent drug GHB after oral administration ([0096] and claim 26 of prior art); and an effective amount of one or more compounds is administered for the treatment of disease, and the frequency of administration of the
compounds will vary depending upon what is being administered, the amount of the therapeutic agent, the purpose of the administration, the state of the patient, the manner of administration, and the like, and effective amount can vary with the subject’s history, age, condition, sex as well as the severity and type of the medical condition in the subject, and administration of the other agents that inhibit diseases or disorders, but in some embodiment, the therapeutic agent is from about 0.5 to 30g ([0110]-[0116]); and the granules contains pharmaceutical carriers including all solvents, excipients, tec. ([0123]).
However, Xiang does not expressly teach the amount of the claimed compound of formula (2a) and the amount of fumed silica of instant claims 9-11; particle size distribution of instant claims 9-11; and the properties of sphericity, friability and bulk density of instant claims 9-11, 40, 41, 49, 50, 58 and 59. The deficiencies are cured by Murphy, Allphin and Takahashi.
Murphy teaches immediate release formulations and dosage forms of gamma-hydroxybutyrate (GHB) and the formulation comprises GHB in an amount of at least 95%, 96%, 97% or 98% (claim 8 of prior art), and please note that the ordinary artisan in the pharmaceutical arts understands that the prodrug is metabolized in the body into the active drug, GHB (see also [0096], claim 26 of Xiang and [0053] of the instant specification) and thus one prodrug would be one active drug, and the amount of GHB would be that of prodrug, and accordingly, the amount of Murphy overlaps the instant ranges of greater than 95% or 96-99.5% or 98-99% (instant claims 9-11: amount of GHB prodrug), and the formulation contains at least one pharmaceutically acceptable excipients including fillers, binder (e.g., HPC, HPMC, EC, polyvinyl alcohol, HEC, povidone, covidone, etc.) in an amount of about 1% or 2% ([0038] and [0058]) which overlaps or touches the instant range of 0.1 to 3% or 0.1 to 1.0% (instant claims 9-11: HPC or HPMC amount), and lubricant such as magnesium aluminum silicate or magnesium stearate in an amount of 0.5 to 2% or 2% ([0035] and [0058]); and other ingredient such as colloidal silica (Cab-O-Sil MP5)(see [0046]-[0047] of the Examples). It is noted that the fumed silica (antistatic agent) of instant claims 9-11 would be equivalent to colloidal silica as supported by the instant specification at [0112] and [0121] (“antistatic agent can comprise, for example, hydrophilic fumed silica such as Aerosil®fumed silica from Evonik Industries, and Cab-O-Sil®fumed silica from Cabot Corporation” ([0112] of the instant publication) and “fumed silica (colloidal silicon dioxide)” ([0121] of the instant publication), and also as evidenced by Cabot Brochure of 2013 wherein Cab-O-Sil®M5P is hydrophilic fumed silica (page 3, left column); the formulation can be provided in the form of granules (e.g., [0057]-[0058], [0062], [0069] & [0073]) wherein the particle size ranges from 45 to 850 microns (Tables 4C and 12C) which overlaps the instant range of D50 from 150 to 500microns; the formulation further comprises coating materials such as PVP, HPC, HPMC, PEG, HEC, etc. ([0034] and [0046]); the formulation is provided in the form of oral suspension ([0045]); the loss on drying was between 1.0 to 2.5% ([0052]); and the friability of tablet obtained by compressing granules is about 0.02% or low ([0055] and [0058]) which may overlap the instant range of less than 2% (instant claims 10, 40 and 59 - friability).
Allphin teaches GHB formulation containing GHB and excipients such as binders, e.g.., HPC, etc. (col. 12, lines 55-67), glidant to facilitate powder flow by reducing interparticle friction and cohesion such as fumed silica, magnesium carbonate, in an amount of about 0.5 to 2% (col. 19, line 7) which overlaps the instant range of 0.1 to 2%, 0.5 to 1.5%; the formulation is provided in the form of extended release such as controlled release (col. 4, lines 30-35) or oral suspensions (e.g., col. 6, line 2 and line 47 and col. 7, line 9); and the formulation contains coating such as controlled release coating (col. 2, lines 17-24) (instant claims 9-11: fumed silica and its amount).
Takahashi discloses spherical granules, which have been improved in abrasiveness and granular hardness each to a sufficiently high level and have a high sphericity and, in the case of being surface-coated with a physiologically active substance or the like and employed in a medicinal preparation, which show an excellent ability to control the release of the physiologically active substance; and a method whereby the above-described spherical granules can be efficiently and conveniently produced (abstract); the sphericity of the spherical granules thus obtained is preferably 0.85 or more, more preferably 0.90 or more that overlaps the instant range of greater than 0.9. When the sphericity is less than 0.85, when the spherical granule is used as a core particle for a preparation, the solubility of the physiologically active substance in the preparation in the body is not uniform, and the drug delivery Quality as a system-applied formulation may be insufficient (page ); and the spherical granules have a friability of 1.08% and particle size of 355-500micrometer (Example 1) and sphericity of 0.98, friability of 0.05 and particle size of 150-250 micrometer (Example 6), in which the sphericity, friability and particle size overlap the claimed ranges.
It would have been obvious to modify the teachings of Xiang with hydrophilic fumed silica of Murphy as evidenced by Cabot and Allphin because Murphy and Cabot disclose Cabot-O-Sil M5-P, and Allphin discloses fumed silica and its overlapping amount, and accordingly, addition of conventional glidant fumed silica at a known and overlapping amount to prodrug GHB formulation of Xiang facilitate or control flow of API e.g. by reducing interparticle friction and cohesion, unless evidence to the contrary is given.
Although the applied art does not expressly teach the exact ranges of formula 2a compound (API), HPC, and fumed silica, the applied art teaches overlapping ranges thereof. Therefore, it would have been prima facie obvious to one of the skilled in the art before the effective filing date of the claimed invention to optimize the ranges of API, binder, antistatic agent, and particle size D50 of API with the claimed sizes without undue experimentation in the absence of criticality evidence. In this context, please see MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further it would have been obvious to provide higher sphericity greater than 0.9 because higher sphericity allows the active substances to be uniformly coated and its release rate to be controlled more accurately as taught by Takahashi.
However, Xiang in view of Murphy/Allphin/Takahashi do not expressly teach bulk density of instant claims 11, 41, and 50, and but the claimed properties would be obvious in the absence of evidence to show that the compound of formula (2a) of the prior art Xiang does not show the claimed bulk density as claimed. That is, such properties would be implicit because the claimed features are a natural result of the combination of elements of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). Further, please see caselaw stating that In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). Thus, in the absence of evidence to the contrary, such properties would be implicit (instant claims 11, 41, 49, 50 and 58: properties of sphericity and bulk density).
Further, although the applied art alone or in combination does not expressly teach embodiments of instant claims 11, 41 and 50, they would be obvious because a reference(s) is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference(s) but the reference(s) (Xiang in view of Murphy) does not disclose the specific combination of variables (for example, the granulation comprising specific amounts of API, binder and antistatic agent), in a specific embodiment or in a working example, “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).
However, "when 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 v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the disclosed elements and embodiments of from Xiang/Murphy as evidenced by Cabot/Allphin e.g., the applied references teach granule type pharmaceutical composition comprising the same, overlapping amounts of GHB (at least 95% Murphy and Xiang), antistatic agent such as equivalent fumed silica and Cab-O-Sil® M5P (0.5-2% Murphy as evidenced Cabot and Allphin), and binder such as HPMC (1% Murphy and Xiang) to prepare the claimed product with properties of sphericity, friability and bulk density. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the claimed invention is within the purview of the ordinary skilled artisan upon reading the applied art and would yield predictable results.
In view of the foregoing, instant claims 9-11 and 40-66 are obvious over Xiang in view of Murphy as evidenced by Cabot/Allphin/Takahashi.
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, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
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 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 before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that Murphy discloses immediate formulation which essentially requires lubricant ([0030] of Murphy), and thus one skilled in the art would not select the disclosed constituents of a granule and omit the lubricant.
The Examiner responds that the claimed formulation uses “comprising” which does not exclude introduction of lubricant; additionally the claimed formulation does not require any release type; and the instant specification discloses conventional excipients including lubricant, glidants, etc. ([0133] of instant publication).
Applicant argues that the Office cannot pick and choose an aspect of a prior art reference because it is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art.” In re Wesslan; the Office cannot hindsight to reconstruct the claimed invention; Allphin does not disclose or suggest that a glidant is incorporated into the GHB resinate beads, and here the glidant is an additive to the pharmaceutical composition that is external to the GHB resinate beads; the comparison confirms at instant Fig. 1B and Figs. 8B-8C that the sphericity and the bulk density of the granules can be different depending on the processing conditions; Xiang, Murphy, and Allphin do not disclose or suggest how the constituents of the composition influence the sphericity of the granule and therefore they do not provide motivation to select the constituents or the amounts thereof; and the claimed GHB prodrug and GHB of Murphy and Allphin are not interchangeable, and a comparison of the claimed granules with the closest art, Xiang for establishing prima facie obviousness should have been made by the Office.
The Examiner responds that glidants, lubricants, and the like are conventional excipients. In this respect, Xiang teaches the composition can contain excipients, Murphy also teaches conventional excipients for related GHB compound. Thus adding a conventional glidant of Murphy at a known amount to prodrug GHB-containing formulation of Xiang is not inventive. Please note that the Office relies on the conventional excipients from Murphy; as to the pick and choose arguments, please see, for example, pages 14-15 of current body of Action, and the combined references teach overlapping sphericity, friability, particle sizes, and bulk density; hindsight recognition must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art before the claimed invention was filed and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). MPEP 2145; Allphin discloses conventional excipients. Although Allphin does not expressly teach an embodiment containing a glidant, it is noted that a glidant is conventional excipient in pharmaceutical field. In this context, please see MPEP 2123 stating that “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)); As to the properties of sphericity, friability and bulk density, the claimed invention is directed to a product not a method of making. Thus, different processing conditions do not matter in the claimed composition; As taught by Takahashi, granule’s higher sphericity provides uniformity of the composition with excellent controlled release of the active substance; please note that the Examiner relied on Murphy/Allphin for disclosing conventional excipients such as glidant and the amount thereof, not for GHB itself. However, GHB and its prodrug are in relevant art for use in treating cataplexy associated with e.g., narcolepsy (Xiang -[0004], Murphy -see background of the invention, Allphin -claim 17), making combination of the references valid, and when the additive, for example silica is used in the composition, it would also act as glidant; and the instant specification does not provide unexpected results from using the composition comprising glidants.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S 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.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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