DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Remarks, filed 8 July 2026, in the matter of Application N° 18/199,117. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the previously submitted claims. No new matter has been added.
Thus, claims 1-30 continue to represent all claims currently under consideration.
Information Disclosure Statement
One new Information Disclosure Statements (IDS) filed 19 February 2026 is acknowledged and has been considered.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 13 February 2026 since the art that was previously cited continues to read on the previously recited limitations.
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.
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. Applicants are 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.
Claims 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Melnick et al. (US Pre-Grant Publication Nº 2019/0083513 A1; of record) in view of Cade et al. (US Pre-Grant Publication Nº 2010/0168410 A1).
The limitations of claim 1 are directed to a hard-shell capsule that contains a solid or semi-solid composition comprising a 25-hydroxyvitamin D compound (i.e., calcifediol), wherein the hard-shell capsule comprises a cellulose ether and a gelatinizing (gelation) agent and is in a size range of a size 3 capsule to a size 5 capsule. Claims 29 and 30 reflect similar limitations. Claims 22-26 each recite various pharmacokinetic release profile parameters that occur at various time points (i.e., 2 hours, 4 hours, etc.). Looking to Applicants’ instant specification, these limitations appear to be properties that are tethered to and definitive of the instantly encompassed hard shell capsule comprising a 25-hydroxyvitamin D compound discussed therein (see Spec., ¶[0093]). As such, consistent with MPEP §2111.01(IV), and §2112.01(I) and (II), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited limitation of claims 22-26, will also be considered met.
Melnick discloses the composition that is contained within the recited capsule.
Paragraph [0084] discloses a particular formulation of 25-hydroxyvitamin D3 (aka calcifediol) in an extended-release, oral formulation. The dosage contains the following:
about 30-900 µg calcifediol;
about 2 wt% anhydrous/dehydrated ethanol;
about 19 wt% lauroyl polyoxyglycerides;
about 20 wt% hard paraffin;
about 23 wt% mono- and di-glycerides;
about 35 wt% liquid paraffin (i.e., mineral oil);
about 10 wt% hypromellose; and
about 0.02 wt% butylated hydroxytoluene (BHT).
The foregoing is considered to meet the limitations of the encapsulated 25-hydroxyvitamin D composition of claims 1, 14, 18, and 19.
The limitations of claim 15 recite that the encapsulated 25-hydroxyvitamin D composition further comprises about 2-18 wt% of a release stabilizing agent. Claim 16 recites that the encapsulated 25-hydroxyvitamin D composition will further comprise about 10-26 wt% of an emulsifier. Claim 17 recites that the encapsulated 25-hydroxyvitamin D composition will further comprise about 3-17 wt% of an absorption enhancer.
The reference discloses that the practiced compositions will comprise all three of the above additives (see e.g., claims 11-18). Paragraph [0074] teaches that that stabilizing agent will be a cellulose compound (e.g., hypromellose) and will be present in an amount that meets the claim (e.g., about 9-15 wt%). Paragraphs [0069]-[0070] disclose that the emulsifier will be represented by such compounds as glycerides (e.g., mono- and diglycerides) and present in amounts that meet the claim (e.g., about 20-25 wt%). Paragraph [0071] discloses definitions of the absorption enhancing agents (e.g., GELLUCIRE or lauroyl polyoxyglycerides) and that the amounts used meet the claim (e.g., about 10 wt%).
The above formulations are further taught as being optionally encased in a soft capsule shell, for example, a capsule shell comprising carrageenan gelatin, and starch. The reference also teaches that the practiced formulations may be placed inside a hard capsule. See ¶[0067]. However, where Melnick is deficient is with respect to the definition of the hard capsule shell.
Despite disclosing the instantly claimed gelatinizing agent (e.g., carrageenan), the practiced shells of Melnick do not expressly teach that the hard-shell capsules comprise HPMC.
Cade discloses the instantly recited hard capsule component that may be filled with liquid to solid pharmaceutical compositions for administration to a subject (see e.g., Abstract ¶[0087]-¶[0088]). Preferred embodiments of the practiced hard capsules comprise HPMC between 70 and 99%, preferably between 80 and 99% by weight based on the shell weight. If no other film-forming polymers are used, the HPMC range will more preferably range from 92-99%, more preferably between 93-98%, and even more preferably between 94-97% by weight of the shell. See ¶[0062].
Gelling agents are also disclosed as being preferably included in an amount between 0% and 1% of the aqueous composition of a gelling system (i.e., one or more cations and/or one or more gelling agents). Cations are defined as K+, Na+, Li+, NH4+, Ca++, Mg++, and mixtures thereof. Typical gelling agents are further defined as alginates, agar gum, guar gum, locust bean gum (carob), carrageenans, tara gum, gum arabic, ghatti gum, khaya grandifolia gum, tragacanth gum, karaya gum, pectin, arabian (araban), xanthan, gellan gum, konjac mannan, galactomannan, funoran, and mixtures thereof. See ¶[0023].
The reference additionally discloses that the HPMC has a viscosity of 3.5-6.0 cps, more specifically, 4.0-5.0 cps, as a 2% w/w solution in water at 20ºC (see e.g., Abstract; ¶[0019]; ¶[0033]).
The foregoing is considered to teach each of the instantly recited compositional limitations for the hard capsule as recited by instant claims 2-12 and 29.
The recited hard shell capsule sizes of 3-5, and size 4, as presented in claims 1, 13, 29, and 30, are also taught and suggested by Cade.
Paragraph [0033] discloses a process for manufacturing the practiced HPMC hard capsules in steps (a) through (e). Step (a) produces the aqueous composition. Step (b) pre-heats the dipping pins to 55-95ºC, when dipped into the aqueous composition. Step (c) dips the pre-heated pins into the aqueous composition maintained at a temperature of 10ºC to 1.0ºC below its gelling temperature. Step (d) withdraws the now coated dipping pins and step (e) dries the film on the pins at a temperature above the gelling temperature to obtain the molded capsules.
Paragraph [0036] elaborates on step (b) directly correlating the pin-heating temperature range to the size of hard capsule being produced. Therein, the reference discloses an inverse relationship between temperature and size such that within the range of 55-95ºC, the cooler the temperature, the larger the capsule, and vice versa. Thus, in order to achieve a size 4 capsule, the skilled artisan would simply heat the dipping pins to a range of 85-95ºC.
What this establishes is that the size for a hard-shell capsule is easily modified and that the result of modifying the temperature of the pins leads to a result that is clearly a result-effective variable. See MPEP §2144.05(II).
The limitations of claim 28 are considered to be met by the foregoing teachings as the recited method simply requires administering the dosage form to a subject.
Lastly, the limitations of claim 30 are directed to a method of providing increased recovery and/or reduced degradation of 25-hydroxyvitamin D or calcifediol in a dosage form after exposure of said dosage form to acidic conditions in the hard-shell capsule form.
The Examiner again considers the compositional merits of the practiced invention to meet this claimed method. Of particular note is that the encapsulated calcifediol formulation is shown to comprise a preservative (i.e., 0.02 wt% BHT) as claimed, thereby providing a measure of action against degradation. Furthermore, Melnick teaches and suggests the encapsulation of the its practiced compositions within a hard-capsule shell such as one disclosed by Cade. As the latter reference meets the compositional and structural limitations of the recited hard-shell capsule, the Examiner respectfully submits that the said capsule would provide the ordinarily skilled artisan with a reasonable expectation of reducing the degradation of the contents contained therein.
Based on 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 composition.
Melnick is acknowledged as disclosing the use of a hard capsule shell in producing its practiced invention, but does not specifically disclose the compositional or structural aspects of such a capsule. Cade, on the other hand, discloses the instantly claimed hard capsule component, but is not specific with respect to the pharmaceutical compositions with which it will be filled. Overlap in the disclosures of the two references guides the skilled artisan to a reasonable expectation of producing a hard capsule-filled formulation with a composition that ranges from liquid to solid, for the administration to a subject in need thereof.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1-30 under 35 USC 103(a) as being unpatentable over the combined teachings of Melnick et al. and Cade et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the grounds that “the official action has not established that capsule size is properly characterized as a result-effective variable under MPEP §2144.05(II).”
More pointedly, Applicants assert that Cade does not teach that the capsule size affects dissolution, bioavailability, release profile or any other functional result relevant to the claimed dosage form. Therein, the reference is argued as only showing how to make different sizes, not why one would select size 3 to 5 for any particular result. Applicants also argue that Cade says nothing about why a skilled artisan would select size 3, 4, or 5 for any particular pharmaceutical formulation, or what therapeutic or pharmacokinetic benefit would be achieved by doing so.
The Examiner, in response, respectfully disagrees. Cade, as discussed above, is relied upon for bridging the gap found in Melnick’s disclosure of hard capsules. Therein, Cade not only teaches preparing capsules that are of the claimed size, but more critically, the composition. As discussed above, Cade discloses preparing hard capsules that meet the compositional limitations recited by instant claims 2-12 and 29. Furthermore, ¶[0031] discloses that optimal dissolution properties and dissolution profile are key points to be focused on in therapy to obtain a complete and reproducible release of the substance contained in the capsule. Paragraph [0059] discloses that the practiced capsule compositions will not only have dissolution rates comparable to conventional gelatine capsules, but also possess better mechanical properties compared to conventional gelatine capsules.
Paragraph [0036] is relied upon to demonstrate that while the composition of the HPMC dip might not change, the size of the desired capsule (e.g., size 4) can and is at the discretion of the ordinarily skilled artisan. The manner in which this is accomplished is by altering the temperature of the dip used to form the capsules. Applicants are also directed to MPEP §2144.04(IV)(A.), wherein it states that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.”
Applicants attest that the instant invention stands apart from the teachings of Cade because the instant specification discloses that “the size of the hard capsule can be adjusted depending upon the particular fill ratios of the paraffin and the other excipients, e.g., from size 3 to size 4, to further control the release of the drug.”
However, the Examiner observes that the instantly claimed invention does not recite any such combinations of variables. Claim 18 recites the sole range of paraffin, and capsule sizes are recited with respect to generic capsule formulations and fill formulations.
As such, Applicants’ position alleging criticality of the capsule size does not appear to be commensurate in scope with the claimed invention.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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