DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed [01/03/2025], in the matter of Application N° [18/060,766]. 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 .
Claims 32 and 35 are withdrawn. Claim 16 is cancelled. No claims have been added.
Claims 1, 3, 11, 15, 21-24, 26, 28-31, and 36-38 are pending.
No new matter has been added.
Applicants’ election of Group I, claims (1, 3, 11, 15, 21-24, 26, 28-31, and 36-38), without traverse, is acknowledged.
Applicants’ elections for Species A and B in the reply filed on [09/04/2024] is acknowledged. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP §818.01(a)).
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.
Claims 1, 3, 11, 15, 21-24, 26, 28-31, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Geschwind et al. (US20190328666) in view of Gudrun et al. (US2017087096)
Geschwind et al. disclose pharmaceutically acceptable compositions comprising ionic association complexes between an active pharmaceutical component and a carrier. Geschwind further teaches: the use of “pharmaceutically acceptable carriers” that “encapsulate or transport the active pharmaceutical substance”; that such complexes may be prepared as salts, microcapsules, or liposome based encapsulates; and importantly, that β-cyclodextrin is a suitable encapsulating agent forming an inclusion complex with active pharmaceutical ingredients, providing increased protection and stability (e.g. stability shown for 3-BrPA). Geschwind et al. expressly teaches that β-cyclodextrin forms inclusion complexes by encapsulating the active pharmaceutical ingredient within its hydrophobic internal cavity, which aligns with the well-established definition of host-guest inclusion complexes in the art. Although Geschwind may not provide a specific example where the active ingredient is first combined with a carrier and then encapsulated, the reference teaches the general applicability of β-cyclodextrin for encapsulating ionic association complexes and for stabilizing therapeutic agents. Under MPEP 2143 and 2144, a POSITA would recognize such encapsulation as a predictable variation. Thus, Geschwind provides the teaching that β-cyclodextrin can encapsulate a therapeutic compound, or a complex thereof, for stabilization and controlled delivery.
Gudrun et al. teach formulations of insulin with surfactants, including bile salts, and encapsulation approaches:
Gudrun et al. disclose pharmaceutical formulations comprising insulin peptides; compositions employing semi-polar protic solvents and non-ionic surfactants; incorporation of bile salts (e.g., sodium cholate, sodium deoxycholate, sodium glycocholate) as functional surfactant components; and specifically, encapsulation of insulin in nanocapsules, including protamine-based and surfactant-based systems.
Gudrun et al. explain the rationale for such encapsulation systems, namely to overcome the significant barriers associated with non-invasive (e.g., oral) insulin delivery, including enzymatic degradation and poor intestinal absorption. Thus, Gudrun clearly teaches formulations in which insulin is associated with bile salts, and encapsulated or entrapped within a carrier for improved delivery.
A person of ordinary skill in the art would have been motivated to combine the teachings of Geschwind et al. and Gudrun et al. because both references address the formulation challenges of delivering biologically active compounds, particularly in the context of stability and absorption issues. Gudrun teaches that encapsulation improves insulin stability and delivery, while Geschwind teaches β-cyclodextrin as a known encapsulating host molecule capable of stabilizing sensitize active agents. Bile salts taught by Gudrun function as surfactants and permeation enhancers in insulin formulations, and nothing in the art teaches that they are incompatible with β-cyclodextrin inclusion complexes. Substituting the carrier used in Gudrun for a well-known encapsulating excipient like β-cyclodextrin, as taught in Geschwind, represents a predictable design choice yielding expected improvements in stability and delivery. Under KSR, when two references are in the same field, address the same formulation challenges, and provide complementary solutions, a POSITA would have found it obvious to combine them to obtain the claimed composition.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (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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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615