DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/10/26 was filed after the mailing date of the Non-Final Rejection on 12/10/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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 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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Sassene et al (WO 2023/012263 A1 hereafter Sassene) in view of Shenoy et al (US 2024/0122847 hereafter Shenoy).
Sassene discloses an oral composition comprising a polypeptide targeting GLP-1 receptor, one or more amino acids, N-(8[2-hydroxybenzoyl]-amino) caprylic acid (NAC) and a medium chain fatty acid (page 3, line. 5-10, 20-25). The mass ratio of the NAC to the medium chain fatty acid is from 1:0.5-2 (page 36, lin. 5-25). The medium chain fatty acid is not attached to the polypeptide by a covalent bond (page 5, lin. 10-25). The polypeptide can be semaglutide (page 21, lin. 5-10). the amino acid can be lysine (page 5, lin. 14-18). The salt form of NAC can be SNAC (page 35, lin. 18-30). The formulation is present in the form of tablets, capsule and other oral dosage forms (page 32, lin. 18-22). The dosage form can be applied to method of treating diseases such as cardiovascular disease (page 51, lin. 28-35). The dosage form comprises various ranges and concentrations form the components such as GLP1 receptor present about 5-50 mg (page 35, lin. 20-25); the SNAC or NAC present about 150 mg (page 35, lin. 18-30); sodium caprate about 150 mg as the medium-chain fatty acid (page 36, lin. 15-20); and variations thereof (page 40, lin. 5-30).
While the formulation of Jensen discloses an oral dosage form comprising a GLP-1 formulation comprising SNAC, histidine, solubilizers and other excipients like permeation enhancers. The formulation can be used to treat conditions such as diabetes. While the reference discloses the use of fatty acids and permeation enhancers, the reference is silent to the specific fatty acids of the instant claims. The use of these compounds in combination with oral polypeptides is known in the art as seen in the Shenoy.
Shenoy discloses an oral polypeptide formulation comprising semaglutide, present about 1-25 mg [0020-0022]. The formulation comprises amino acids including histidine, arginine and tryptophan [0031-0032, 0151]. The formulation comprises permeation enhancers including medium chain fatty acids like sodium caprate and other compound like polyethylene glycol [0035]. The formulation includes absorption enhancers like SNAC [0036]. The components are associated with one another non- covalently [0051]. The formulation can be used to treat various conditions including Crohn's disease, various cancers, and metabolic conditions [0265-0266]. It would have been obvious to include the excipients, including medium chain fatty acids of Shenoy into the formulation of Jensen as they solve similar problems and treat similar conditions.
Regarding the specific ranges and concentrations of the instant claims, it is the position of the Examiner that such limitations do not distinguish over the prior art. The combination of Jensen and Shenoy provide the same components arranged in the same way, in similar concentrations such that the general conditions of the claims have been met. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable formulation useful for treating various chronic conditions. It would have been obvious to include the enhancers and stabilizers of Shenoy into the formulation Sassene in order to properly solubilize the active components. It would have been obvious to combine the components as they have similar active components and treat similar conditions. One of ordinary skill in the art would have been motivated to combine the prior arty with an expected result of stable means of treating diabetes and other chronic conditions.
Response to Arguments
Applicant’s arguments, see Amendment, filed 3/10/26, with respect to the rejection(s) of claim(s) 1-21 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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