Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, and the species lactose, water, and sodium starch glycolate in the reply filed on 9 June 2026, is acknowledged.
Status of Claims
Claims 1-15 are pending in the instant Office Action.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 June 2026.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 June 2026.
Claims 1-3 and 5-14 are under consideration in the instant Office Action to the extent of the following elected species:
the specific binder lactose;
the specific solvent water; and
the specific superdisintegrant sodium starch glycolate.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 2 February 2024, and 9 June 2026, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, specifically on pg. 7, line 33 of the spec. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms Erweka© (pg. 6, line 5), Pharmatose® (pg. 10, line 24), Lactochem® (pg. 10, line 25), DFE Pharma© (pg. 10, line 25), Roquette© (pg. 10, line 30), SPI Pharma© (pg. 10, line 30), Pearlitol® (pg. 10, line 30), Pharmacel® (pg. 11, line 1), Primojel® (pg. 11, line 13), Primellose® (pg. 11, line 14), Polyplasdone™ (pg. 11, line 15), Ashland© (pg. 11, line 15), MilliQ® (pg. 15, line 4), Thermo Fisher Scientific© (pg. 15, lines 25-26), Turbula® (pg. 17, line 5), Memmert© (pg. 17, line 27), Luxner© (pg. 17, line 29), Sotax© (pg. 18, line 2), which are trade names, trade marks, or copyrights used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 2 and 12-13 are objected to because of the following informalities:
Claim 2 recites “Th method” in line 1. The missing letter “e” should be inserted so the phrase reads “The method” (bold added for emphasis.
Claims 12-13 recite “the extruder” in the first line of each claim. While it is apparent that the claims are referring to the co-rotating twin-screw extruder recited in instant claim 1, clarity would be improved if claims 12-13 were amended to recite “the co-rotating twin-screw extruder”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “at least one binder” in line 4. However, claim 1 also recites “the binder” in lines 5, 7, and 13, “the wetted binder” in lines 8 and 10, and “binder” in lines 12-13 and 15. The phrase “the binder” is also recited in line 1 of claim 2 and “binder” is recited in line 1 of claim 6. It is unclear if the limitations are limiting one binder, multiple binders, or all of the binders and the phrases are therefore indefinite. Claims 2-3 and 5-14 depend from claim 1, incorporate all of its limitations, and are therefore also rejected as being indefinite. Applicant may overcome this rejection by amending each phrase to recite the “at least one binder” as done in line 4 of claim 1 or amending the phrase in line 4 of claim 1 to recite “a binder” if only one binder is intended.
Claim 1 also recites “one or more superdisintegrants” in line 11. The recitations of “superdisintegrant” in lines 13 and 15 of claim 1 and line 2 of claim 6, and “the superdisintegrant” in line 28 of claim 1, lack antecedent basis and are indefinite because it is unclear if the limitations are limiting one superdisintegrant, multiple superdisintegrants, or all of the superdisintegrants, rendering the claims indefinite. Claims 2-3 and 5-14 depend from claim 1, incorporate all of its limitations, and are therefore also rejected as being indefinite. Applicant may overcome this rejection by amending each phrase to recite the “one or more superdisintegrants” as done in line 11 of claim 1 or amending the phrase in line 11 of claim 1 to recite “a superdisintegrant” if only one superdisintegrant is intended.
Claims 12-13 recite “the screw speed of the extruder” in line 1 of each claim. There is insufficient basis for this limitation because claim 1, from which both claims depend, does not recite “a screw”. If Applicant intended for claim 12 to limit the at least one screw mixer element recited in claim 11, Applicant could overcome this rejection by amending claim 12 to depend from claim 11 and amend claims 12-13 to recite “the speed of the at least one screw mixer element”.
Claim 14 recites “the screw” in line 1. There is insufficient basis for this limitation because claim 1, from which claim 14 depends, does not recite “a screw”. If Applicant intended for claim 14 to limit the at least one screw mixer element recited in claim 11, Applicant could overcome this rejection by amending claim 14 to depend from claim 11 and to recite “the angular velocity of the at least one screw mixer element”.
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 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.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dhaval et al. (J. Pharm. Innov. 2022, 17, 294., published online 23 November 2020, hereafter referred to as Dhaval) as evidenced by R+W America (Refresher on the Basics of Angular Acceleration and Moment of Inertia, published online 13 November 2023, accessed 30 July 2026, www.rw-america.com/refresher-on-the-basics-of-angular-acceleration-and-moment-of-inertia/, hereafter referred to as R+W America) in view of Sundaramoorthy et al. (U.S. Patent Application Publication No. US 2013/0217774 A1, published on 22 August 2013, hereafter referred to as Sundaramoorthy) and Keleb et al. (Int. J. Pharm. 2002, 239, 69., hereafter referred to as Keleb).
Dhaval teaches a review of twin-screw extruder instruments and methods used in the pharmaceutical industry (Abstract). Twin-screw extruders (TSE) are taught to have advantages over single-screw extruders including integration of “several unit operations” to improve efficiency, improved zone temperature and pressure control, and flexibility in screw arrangement to make it “a multipurpose instrument” (pg. 294-295, Introduction, para. 1-2). Twin-screw extruders are taught to typically have feeding, conveying, and mixing zones with screws that either rotate “in the same direction (co-rotation) or the opposite direction (counter-rotation)”, with counter-rotating screws taught to generate intense pressure allowing lower rotation speed than co-rotating screws (pg. 295, left col., para. 1-3). This pressure is taught to degrade materials commonly used in the pharmaceutical industry, therefore co-rotating TSEs are taught to be more commonly used in the pharmaceutical industry and have the advantages of higher material output, lower wear and tear, and versatility in screw elements to “generate unique screw design every time” (pg. 295, left col., para. 4).
A typical TSE is shown in Fig. 2, with a feeder supplying components into the screws, a conveying section that moves components downstream to the kneading section, and a motor that rotates the screw shaft. The screw elements of TSEs are taught to broadly fall into conveying, mixing/kneading, and zoning elements that help separate the other zones (pg. 295, Screw Elements, para. 1-3). Fig. 5 shows a typical arrangement of screw elements, with a conveying zone that moves components downstream to the kneading/mixing zone and another conveying zone further downstream to remove components from the extruder. Dhaval teaches that the characteristics of the mixing/kneading elements can be modified to exert different pressure or torque on components, including the offset angle, to change the intensity of mixing and/or kneading (pg. 295-296, Screw Elements, para. 3-4). It is also taught that a different number of mixing/kneading zones can be used and “can be strategically arranged on the shaft” (pg. 295, Screw Elements, para. 3 and Fig. 5).
Dhaval teaches that wet granulation is the most widely used granulation process in the pharmaceutical industry (pg. 300, Wet Granulation, para. 1). Wet granulation is taught to comprise disintegrating agents as suitable excipients and a granulating liquid which may be water (pg. 300, Wet Granulation, para. 1). In some embodiments, Dhaval teaches that dry components, including a binder, were added to a EuroLab-16 TSE, a granulating fluid, which is considered equivalent to a solvent, was added after the dry components were added, and then the extruded granules were dried and milled, which is considered to be equivalent to being “further subjected to milling” as recited in instant claim 10 (pg. 300, Wet Granulation, para. 3). Fig. 7 demonstrates that the granulating fluid was added to the TSE between the beginning and end of the conveying zone as recited in instant claim 1. In another embodiment, Dhaval teaches that an appropriate screw speed is 200 rpm and an appropriate temperature for wet granulation is 40-90 °C (pg. 300, Wet Granulation, para. 4). Following TSE granulation, Dhaval teaches that extruded granules may be milled and sieved (pg. 302, Taste Making, para. 2).
While Dhaval is silent on the angular velocity of screws in TSEs, the angular velocity (w) is related to the rotational rate (n) in rpm by the relationship w = (p/30) * n, as evidenced by R+W America. Therefore the teaching of a screw speed of 200 rpm is equivalent to an angular velocity of ~0.10472 * 200 rpm = 20.94 rad/s.
Dhaval does not teach the specific binder lactose, the specific superdisintegrant sodium starch glycolate, a superdisintegrant to be added to the mixing zone after the binder is wetted, nor the screw speed to be kept constant. These deficiencies are offset by the teachings of Sundaramoorthy and Keleb.
Sundaramoorthy teaches a process of preparing base granules and blending the granules with a compression aid to produce pharmaceutical tablets (Abstract and para. [0014]). The granulation process taught by Sundaramoorthy is, in one embodiment, a wet granulation process (para. [0022] and claims 5 and 13). The base granules are taught to comprise super disintegrants (para. [0031] and claims 6, 9-10, 12-14, and 16) and binders (para. [0032] and [0037] and claim 13). A preferred super disintegrant is taught to be sodium starch glycolate (para. [0038] and claim 16) and in one embodiment the binder is lactose (para. [0037] and Table 2). Finally, Sundaramoorthy teaches the solvent in their wet granulation process to be water (Table 2 and Examples 1-2) and that the ratio between binder and super disintegrant may be 20/0.1 to 1/15, which is equivalent to 100/0.5 to 6.67/100 (Table 1).
Keleb teaches methods of continuous twin screw extrusion for the wet granulation of lactose and the impact of varied extrusion parameters (Abstract). Lactose, the binder in the method of Keleb, is taught to be capable of use as a dry or wet binder (pg. 71, left col., para. 2). The granulation liquid is taught to be water in one embodiment (pg. 71, left col., para. 2). When lactose undergoes wet granulation with water, Keleb teaches addition of the disintegrant polyvinylpyrrolidone (PVP) in an aqueous solution separately from the lactose (pg. 71, left col., para. 2).
Keleb also teaches the screw speed in their TSE to be 250 rpm (pg. 71, right col., para. 3) or varied between the discrete speeds of 200, 250, 300, 350, 400, and 450 rpm (Fig. 3). Keleb concluded that optimizing the screw speed is required for processes but the parameter has “no important influence on the granule and tablet properties” (pg. 80, left col., para. 1). Finally, Keleb teaches that when lactose is wetted by water for wet granulation, the water concentration is 7.5, 10.0, or 12.5% w/w, which is equivalent to ratios of 7.5/100, 10/100, and 12.5/100 (pg. 71, right col., final para.).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the processing temperature, screw speed, angular velocity, and ratios of binder to superdisintegrant and solvent to binder taught by the Dhaval, Sundaramoorthy, and Keleb references. In each instance, the values or ranges taught by the references either falls within or encompasses the ranges recited in the instant claims, rendering them obvious.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the methods taught by Dhaval in view of the teachings of Sundaramoorthy and Keleb because modifying a method known in the art to use known pharmaceutically acceptable excipients and known experimental parameters produces predictable results. Dhaval teaches methods of producing granules with a co-rotating twin-screw extruder that comprise a conveying zone, kneading/mixing zone that comprises a screw mixer element, and zoning elements to separate other zones. The methods of Dhaval teach feeding a binder into the conveying zone, conveying the binder toward a kneading/mixing zone, wet granulation of the binder with water, the addition of disintegrants, and processing conditions of a 200 rpm screw speed, which is equivalent to an angular velocity of ~21 rad/s, and a temperature of 40-90 °C. In addition, Dhaval teaches that TSEs may comprise multiple kneading/mixing zones separate by zoning elements and further milling and/or sieving of granules.
In view of the teachings of Sundaramoorthy, a person of ordinary skill in the art would be motivated to use lactose as a binder and sodium starch glycolate as a super disintegrant because "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense." KSR, 550 U.S. at 421, 82 USPQ2d at 1397, see also MPEP § 2143. Dhaval teaches a number of binders and disintegrants may be used with TSEs and Sundaramoorthy teaches that lactose and sodium starch glycolate are compatible and may be processed together into granules. A person of ordinary skill would desire the components of their granule to be compatible and would know the species were options for excipients that successfully produce a granule, demonstrating a reasonable expectation of success. In addition, the ordinary artisan would be motivated to use a ratio of binder to disintegrant of 20/0.1 to 1/15, which is equivalent to 100/0.5 to 6.67/100, because Dhaval does not teach an appropriate ratio to use and Sundaramoorthy teaches this range of ratios to be appropriate in co-processed granules, providing missing information one of ordinary skill would need to complete their method.
Further, in view of the teachings of Keleb a person of ordinary skill in the art would be motivated to add the superdisintegrant separately from the wet granulated lactose binder because Keleb teaches this order to be appropriate when using wetted lactose. The ordinary artisan would also be motivated to use a constant screw speed because Keleb teaches that changing the screw speed to different discrete speeds, i.e. different constant speeds, has “no important influence on the granule and tablet properties” and would desire a constant speed once optimized. Finally, one of ordinary skill would be motivated to use a solvent to binder ratio of 7.5, 10.0, or 12.5% w/w, which is equivalent to ratios of 7.5/100, 10/100, and 12.5/100, because Dhaval does not teach a ratio between solvent and binder for use in TSE and Keleb teaches the above ratios to be appropriate for processing granules comprising water, lactose, and a disintegrant. As a result, there is a reasonable expectation of success in arriving at the method of claims 1-3 and 5-14 in view of the teachings of Dhaval, Sundaramoorthy, and Keleb.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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, David Blanchard, can be reached at (571) 272-0827. 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.
/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
Prosecution Insights