DETAILED ACTION
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 .
Response to Election/Restriction
Applicant’s election without traverse of Group I, claims 1-9, and the species colloidal silica, 8-(2-hydroxybenzamide) sodium octanoate, semaglutide, microcrystalline cellulose, “croscamellose” sodium, and polyvinylpyrrolidone K90 in the reply filed on 21 May 2026, is acknowledged.
Status of Claims
The preliminary amendment, filed on 21 May 2026, is acknowledged.
Claims 1-10 are pending in the instant Office Action.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 21 May 2026.
Claims 1-9 are under consideration in the instant Office Action, to the extent of the following elected species:
the specific first and fifth excipients are colloidal silica;
the specific first and second penetration accelerators are 8-(2-hydroxybenzamide) sodium octanoate;
the specific peptide is semaglutide;
the specific second and fourth excipients are microcrystalline cellulose;
the specific third and sixth excipients are “croscamellose” sodium which, as stated in the Requirement for Restriction/Election mailed on 27 March 2026, is interpreted as being equivalent to the commonly accepted croscarmellose sodium; and
the specific first and second adhesives are polyvinylpyrrolidone K90.
Claim Objections
Claims 1, 3, and 7 are objected to because of the following informalities:
Claim 1 recites “a second penetration accelerator mixing with a peptide” in line 4 (bold added for emphasis). The bolded word “mixing” should be “mixed”, so the resulting phrase reads “a second penetration accelerator mixed with a peptide”.
Claims 3 and 7 recite “croscamellose sodium” in the fifth line of each claim. “Croscamellose” is a common misspelling of “croscarmellose” and each recitation should be amended to recite the proper name.
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 3-9 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.
Claims 3 and 7 recite “(colloidal silica, SiO2)”, (microcrystalline cellulose, MCC)”, and “(croscamellose sodium)” in lines 3-5 of each claim. The use of parentheses renders the limitations of the claims indefinite because it is unclear if the species in the parentheses are meant to limit the claim or are merely exemplary. In addition, in the first two parenthetical statements there are two items and it is unclear if the two items are in a Markush group or if the second item is an abbreviation of the first, which also makes the claims indefinite. Claims 4-6 depend from claim 3 and claims 8-9 depend from claim 7, incorporating all of the limitations of the preceding claims. Neither claims 4-6 nor claims 8-9 resolve the indefiniteness of the claims from which they depend and are therefore also rejected as being indefinite.
Applicant may overcome these rejections by amending claims 3 and 7 to remove the parenthetical statements. If the parenthetical statements are intended to limit the claims, Applicant may include the further limitations in newly submitted dependent claims. Applicant is also reminded that the first use of an abbreviation must be preceded by the abbreviated word/phrase written in full, e.g., if “MCC” is an abbreviation for microcrystalline cellulose, the phrase should read “microcrystalline cellulose (MCC)”.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sauerberg et al. (U.S. Patent No. 9,278,123 B2, priority to 16 December 2011, hereafter referred to as Sauerberg) in view of Rowe et al. (U.S. Patent No. 12,458,635 B2, priority to 30 December 2022, hereafter referred to as Rowe), Gan and Lee Pharmaceuticals Co. Ltd. (Chinese Patent Application Publication No. CN 117561072 A, published on 13 February 2024, hereafter referred to as Gan and Lee), and Hwang et al. (J. Pharm. Invest. 2024, 54, 161., published on 6 March 2024, hereafter referred to as Hwang).
Sauerberg teaches solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (Abstract). In some embodiments, the GLP-1 agonist is taught to be semaglutide (col. 3, lines 53-58, Example 1, and Tables 1-10) and the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid is a sodium salt, or sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC) (col. 9, lines 33-67 and claims 6, 11, and 18), which is equivalent to the elected 8-(2-hydroxybenzamide) sodium octanoate as evidenced by instant spec. para. [0036-0037] and [0059-0060]). Sauerberg teaches their solid composition to also comprise one or more pharmaceutically acceptable excipients, which include the filler microcrystalline cellulose, the flow control agent colloidal silica, and polyvinyl pyrrolidone, also known as povidone, which is taught to capable of use as a binder, crystallization retarder, or solubilizer (col. 10, lines 7-42). An additional excipient is taught to be croscarmellose, interpreted as equivalent to the elected croscamellose sodium, which is taught to be useful as a disintegrant (col. 11, lines 34-37).
SNAC is taught to be a delivery agent in the composition of Sauerberg and, in some embodiments, is present in an amount of “at least 60% (w/w), such as at least 70% (w/w) or at least 75% (w/w)” (col. 9, lines 1-21 and col. 10, lines 51-57). The composition is further taught to comprise <10% w/w binder, which may be povidone, and 5-40% w/w filler, which may be microcrystalline cellulose (col. 10, lines 51-57). In Table 1, Sauerberg teaches tablets that comprise 1.4%, 2.5%, 3.75%, or 5% w/w semaglutide, which fall within the range recited in instant claim 7. Finally, Sauerberg teaches that their tablet may be in the form of a coated tablet (col. 12, lines 56-57).
Sauerberg does not teach the amount of colloidal silica or croscarmellose sodium recited in instant claims 3 and 7, the specific povidone species povidone K90, nor the formulation of a tablet with distinct body and coating layers. These deficiencies are offset by the teachings of Rowe, Gan and Lee, and Hwang.
Rowe teaches solid pharmaceutical compositions comprising Compound 1 and excipients for the treatment of cystic fibrosis (Abstract, col. 3, lines 34-40, and claim 9). The composition is taught to be in the form of a tablet with a coating (claims 6-8) and intended to be administered orally (col. 6, lines 4-11). The excipients are taught to include a glidant and a disintegrant (col. 3, lines 34-40 and col. 13, line 19 - col. 19, line 58). Glidants taught to be suitable for the solid tablet composition are taught to include colloidal silica and are present in an amount of less than 2% w/w, such as 0.05-2.0% w/w (col. 24, line 60 - col. 24, line 15). Disintegrants taught to be suitable for the invention include sodium croscarmellose and are present in an amount of 10% w/w or less, such as 1-10% w/w (col. 24, line 44-66).
Gan and Lee teach a pharmaceutical composition comprising a GLP-1 compound, a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC), and excipients (Abstract and claims 7-8). In some embodiments, the salt of NAC is a sodium salt (SNAC) and the excipients are glidants, binders, fillers, disintegrants, and lubricants (pg. 10, line 18). A preferred glidant is taught to be colloidal silica (pg. 10, line 19), a preferred binder is taught to be povidone, in particular the species povidone K90 (pg. 10, line 20), and a preferred filler is taught to be microcrystalline cellulose (pg. 10, lines 21-23).
Hwang teaches a review of new pharmaceutical tablet compression technologies, including multi-layer tablets (MLTs), the advantages of the technologies, manufacturing challenges, and underlying mechanisms of their action (Abstract). Multiple MLT designs are taught in Fig. 1, including multiple layers for a combination of fixed doses (Fig. 1a), compression-coated tablets (Fig. 1c), and active or sustained release coated tablets (Fig. 1d) which enable modification of release profiles, additional stability, combinations of multiple APIs which can produce additional or synergistic effects, and modification of gastrointestinal delivery (pg. 162-163, Applications of MLTs and potential risks of product failure and Fig. 1). Hwang finishes their review with an overview of manufacturing challenges encountered when producing MLTs, methods to overcome these challenges, and methods to assess the properties of MLTs (pg. 164, Theories and technologies for assessing the compression profiles of the formulation - pg. 170, Assessing interfacial adhesion of MLTs).
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 quantities of semaglutide, SNAC, povidone as a binder, and microcrystalline cellulose as a filler taught by Sauerberg and the quantity of colloidal silica as a glidant and croscarmellose sodium as a disintegrant taught by Rowe. In the absence of limitations regarding the proportion of the whole oral peptide drug structure represented by the tablet body versus the coating layer, the ranges taught in the prior art as w/w with respect to the whole are interpreted as applying to the ranges recited in the instant claims. Therefore, each of the ranges taught by Sauerberg and Rowe either encompass or significantly overlap with 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 invention of Sauerberg with the teachings of Rowe, Gan and Lee, and Hwang to arrive at the claimed invention because combining prior art elements in related inventions according to known methods yields predictable results. Sauerberg teaches solid compositions which in some embodiments comprise semaglutide, SNAC, microcrystalline cellulose, colloidal silica, polyvinyl pyrrolidone, and croscarmellose and may be in the form of a coated tablet. In addition, Sauerberg teaches quantities of semaglutide, SNAC, microcrystalline cellulose, and polyvinyl pyrrolidone which either encompass or significantly overlap with the ranges recited in the instant claims.
In view of the teachings of Rowe, one of ordinary skill would be motivated to use colloidal silica and croscarmellose in the quantities 0.05-2.0% w/w and 1-10% w/w, respectively, because Sauerberg teaches the use of the species for the same purpose as Rowe but does not teach a range of quantities for the glidant or disintegrant. The teachings of Rowe provide missing information that an ordinary artisan would need to complete their invention, which would motivate their use in a similar invention. In addition, while Sauerberg teaches their composition to include povidone, they do not teach a specific species. Gan and Lee teach that a pharmaceutical composition comprising a GLP-1 related compound, SNAC, microcrystalline cellulose, and colloidal silica is compatible with the specific povidone species povidone K90. An ordinary artisan would be motivated to select this specific species for use in the invention of Sauerberg because they would desire their selected components to be compatible and because Gan and Lee provide missing information that the ordinary artisan would need to complete their invention.
Finally, while Sauerberg teaches that their composition may be formulated as a coated tablet, they do not teach further detail regarding the form. In view of the teachings of Hwang, a person of ordinary skill would be motivated to formulate their composition with multiple layers such as an MLT or compression-coated tablet because Hwang teaches these forms to provide multiple benefits over traditional tablets including enabling modification of release profiles, adding additional stability, and enabling modification of gastrointestinal delivery. An ordinary artisan would recognize the utility of these benefits in formulating a pharmaceutical product and would be motivated to use the teachings to optimize their invention. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-9 in view of the teachings of Sauerberg, Rowe, Gan and Lee, and Hwang.
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