DETAILED ACTION
Notice of Pre-AIA or AIA Status
This office action is intended to supersede the previously issued Office Action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application was filed 08 December 2022 and is the national stage entry for PCT/IB2021/055116 filed 10 June 2021. The Applicant claims priority to provisional application filed 11 June 2020. Therefore, the effective filing date of the instant application is 11 June 2020.
Examiner’s Note
The Applicant's amendments and arguments filed 09 October 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
and/or objections not reiterated from previous office actions are hereby withdrawn. The
following rejections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application. In the Applicant’s response, filed
09 October 2025, it is noted that claim 14 has been canceled, claim 44 has been newly added, and no claims have been amended. Support for the new claim(s) can be found [0089] of the instant specification. No new matter has been added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-5, 9-10, 13, 18, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanes et al. (WO 2017/075565 A1; cited in IDS) and Guo et al. (Impacts of particle shapes on the oral delivery of drug nanocrystals: Mucus permeation, transepithelial transport and bioavailability, Journal of Controlled Release, 2019).
Hanes et al. teach mucus penetrating particles (MPP) (entire teaching, abs) that may comprise anti-cancer agents (pg. 17, ln. 24). The MPPs may be formulated for enteral administration, such as a capsule (pg. 31, lns. 26-28). The composition comprises an active agent incorporated or encapsulated using a coating with a polymer matrix (pg. 8, lns. 17-21). The nanoparticles may be any shape, including non-spherical shapes (pg. 7, lns. 30-32), partially addressing claim 1. The coating is interpreted as the outer layer, addressing claims 2 and 4. The capsules may be in the form of sustained release (pg. 8, ln. 19) and delayed release (pg. 32, ln. 6-14). The capsules may be designed to delay the release of the contents after passing the stomach (pg. 32, lns. 15-16), which is interpreted as addressing claim 3. The composition comprising anti-cancer drugs addresses claim 5. The matrix may comprise PLGA and other biocompatible polymers (pg. 9, lns. 17-32), addressing claims 9 and 10. The composition comprising surface-modifying agents, such as PEG (pg. 5, lns. 1-7), is interpreted as functionalized with a mucoadhesive agent, addressing claim 18. Particle sizes may range from 1 to 500 nm (pg. 7, lns. 24-28) or have a hydrodynamic diameter of 50-500 nm (claim 11), addressing claim 44.
Hanes does not specifically teach a vertex shape for the particle in claim 1. Hanes does not teach an exact combination of the MPPs with an API and particles shaped with at least one vertex in claim 1.
Guo teaches a higher mucus permeation value for flake-shaped nanoparticles over traditional spherical nanoparticles (pg. 67, 3.2). Flake-shaped nanoparticles are interpreted as having an edge or point. The limitation of the particle configured to penetrate tissue in claim 1 is interpreted as an inherent property of nanoparticles with a sharp shape or edge.
In regards to selecting the combination of MPPs, PLGA, anticancer agents, capsule, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Hanes et al. teach mucus penetrating particles (MPP) (entire teaching, abs) that may comprise anti-cancer agents (pg. 17, ln. 24), whereas the claimed invention is directed towards a drug delivery device comprising an enteric capsule, API, matrix, wherein the particles have at least one vertex. Since Hanes teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Hanes does not specifically teach a vertex shape for the particle in claim 1, one of ordinary skill in the art would have been led to use Guo’s teaching of flake-shaped nanoparticles for better mucus penetration or permeation. A person of ordinary skill in the art would have been led to combine the teachings because Hanes teaches mucus penetrating particles with any spherical or non-spherical shape and Guo teaches that nanoparticles with a pointed shape or edge may increase the mucus better than spherical nanoparticles.
Claim(s) 1-5, 9-10, 13, 15-18, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanes et al. (WO 2017/075565 A1; cited in IDS), Guo et al. (Impacts of particle shapes on the oral delivery of drug nanocrystals: Mucus permeation, transepithelial transport and bioavailability, Journal of Controlled Release, 2019), Gentile et al. (An Overview of Poly(lactic-co-glycolic) Acid (PLGA)-Based Biomaterials for Bone Tissue Engineering, Int. J. Mol. Sci., 2014), Demir et al. (Characterization of Polymeric Microneedle Arrays for Transdermal Drug Delivery, PLoS One, 2013), and Arora et al. (Micro-scale Devices for Transdermal Drug Delivery, Int J Pharm, 2008).
In regards to claim(s) 1-5, 9-10, 13, 18, 44, Hanes and Guo, as applied supra, is herein applied in its entirety for its teachings of mucus penetrating particles (MPP) that may comprise anti-cancer agents.
Hanes does not specifically teach values for the elastic modulus, axial failure, and sharpness in claims 15-17.
In regards to claims 15-17, the elastic modulus, axial failure, and sharpness can vary depending on the components of the product and the intended use. However, Gentile teaches that PLGA used in drug delivery may be around 2.0 GPa (Table 1), Demir et al. teach that PLGA may have an axial failure force of around 1 N (Table 2) in their drug delivery system, and Arora et al. teach that sharpness in drug delivery products designed to penetrate skin or tissue may be around 1-25 um (pg. 7, para. 4). Furthermore, “products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”). Additionally, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
In regards to claims 15-17, the ranges for elastic modulus, axial failure force, and sharpness can be viewed as a variable that achieves the recognized result of successfully making the drug particle composition. The optimum or workable range for the elastic modulus, axial failure force, and sharpness can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized ranges of elastic modulus, axial failure force, and sharpness as nonobvious.
Claim(s) 1-6, 9-10, 13, 15-18, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanes et al. (WO 2017/075565 A1; cited in IDS), Guo et al. (Impacts of particle shapes on the oral delivery of drug nanocrystals: Mucus permeation, transepithelial transport and bioavailability, Journal of Controlled Release, 2019), Gentile et al. (An Overview of Poly(lactic-co-glycolic) Acid (PLGA)-Based Biomaterials for Bone Tissue Engineering, Int. J. Mol. Sci., 2014), Demir et al. (Characterization of Polymeric Microneedle Arrays for Transdermal Drug Delivery, PLoS One, 2013), Arora et al. (Micro-scale Devices for Transdermal Drug Delivery, Int J Pharm, 2008), and Haggag et al. (Polymeric nano-encapsulation of 5-fluorouracil enhances anti-cancer activity and ameliorates side effects in solid Ehrlich Carcinoma-bearing mice, Biomedicine & Pharmacotherapy, 2018).
In regards to claim(s) 1-5, 9-10, 13, 15-18, 44, Hanes, Guo, Gentile, Demir, and Arora, as applied supra, is herein applied in its entirety for its teachings of mucus penetrating particles (MPP) that may comprise anti-cancer agents.
Hanes does not teach a specific anti-cancer agent in claim 6.
Haggag et al. teach that encapsulation of 5-fluorouracil in PLGA nanoparticles enhanced the anti-cancer activity of the drug and improved sustained release (entire teaching, abs).
Since Hanes does not teach a specific anti-cancer agent but does teach using anti-cancer agents in their nanoparticle drug delivery system in claim 6, one of ordinary skill in the art would have been motivated to use Haggag’s teaching of encapsulating 5-fluorouracil (interpreted as a small molecules) in PLGA nanoparticles with a reasonable expectation of success. A person of ordinary skill in the art would have been reasonably motivated to use these teachings because Haggag’s composition shows improved sustained release and enhanced anti-cancer activity when encapsulated in a nanoparticle system for oral delivery (pg. 215, right column).
Response to Arguments
Applicant's arguments filed 09 October 2025 have been fully considered but they are not persuasive.
The Applicant asks for clarification for the rejection of claims 1-5, 9-10, 13-18 over Hanes, Gentile, Demir, and Arora (Remarks, pg. 6).
Claims 1-5, 9-10, 13, 18, 44 are now rejected over Hanes and Guo alone.
The Applicant argues that Hanes does not teach particles with a vertex (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. Guo teaches a higher mucus permeation value for flake-shaped nanoparticles over traditional spherical nanoparticles (pg. 67, 3.2). Flake-shaped nanoparticles are interpreted as having an edge or point.
Since Hanes does not specifically teach a vertex shape for the particle in claim 1, one of ordinary skill in the art would have been led to use Guo’s teaching of flake-shaped nanoparticles for better mucus penetration or permeation. A person of ordinary skill in the art would have been led to combine the teachings because Hanes teaches mucus penetrating particles with any spherical or non-spherical shape and Guo teaches that nanoparticles with a pointed shape or edge may increase the mucus better than spherical nanoparticles.
The Applicant argues that Hanes does not teach particles with a physical feature that penetrates tissue (Remarks, pg. 7).
Applicant’s argument is not found persuasive. Guo teaches a higher mucus permeation value for flake-shaped nanoparticles over traditional spherical nanoparticles (pg. 67, 3.2). Flake-shaped nanoparticles are interpreted as having an edge or point. A person of ordinary skill in the art would have been led to combine the teachings because Hanes teaches mucus penetrating particles with any spherical or non-spherical shape and Guo teaches that nanoparticles with a pointed shape or edge may increase the mucus better than spherical nanoparticles. The limitation of the particle configured to penetrate tissue in claim 1 is interpreted as an inherent property of nanoparticles with a sharp shape or edge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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, Brian-Yong Kwon can be reached at (571)272-0581. 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.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613