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 .
Priority
The instant application was filed 09 November 2023 and is the continuation of 16/962,948 filed 17 July 2020 and the national stage entry of PCT/GB2019/050152. The Applicant claims priority to foreign application GB1800912.6 filed 19 January 2018. A copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 18 January 2019.
Election/Restrictions
Applicant’s election of Group I (claims 30-44, 47-49) in the reply filed on 19 December 2025 is acknowledged. Because applicant 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)).
Claims 45 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 19 December 2025.
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) 30-43, 47-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liggins et al. (US 2008/0124400 A1), as evidenced by Lau (Novel Particles Conferring Eradication of Deep Tissue Bacterial Reservoirs for the Treatment of Chronic Urinary Tract Infection, 2024) and Birk (Polymeric nano- and microparticulate drug delivery systems for treatment of biofilms, Advanced Drug Delivery Reviews, 2021).
Liggins teaches a microparticle composition (abs; entire teaching) for treatment of cancer or infections (para. 3) in different parts of the body, such as the urinary tract or genital tract (para. 31). The microparticle diameter size may be in the range of 0.5-1000 microns (para. 19). The microparticle may comprise drugs, such as antibiotics (para. 12) or anticancer agents (para. 76), and a polymer, such as PLGA (para. 7). The polymer matrix with the drug within the microparticle is interpreted as the drug dispersed within the polymer, addressing claims 30, 33, 42, 47, and 48. The composition may be administered through different routes, such as intraarticular, intraperitoneal, intravenous, intramuscular, in incisions, or into the urinary tract or genital tract. The delivery of certain anticancer agents (para. 107) is understood to affect patients on a cellular level, which is interpreted as intracellular delivery, addressing claim 31. The delivery of the composition can include a scaffold, such as catheters, grafts, stent-grafts, stents (para. 21), synthetic grafts (para. 173), tube grafts (para. 171), or implantable non-vascular stents or tubes (para. 293), which is interpreted as addressing synthetic conduit in claim 32. Antibiotic drugs in the composition include ciprofloxacin (para. 12) and the type of bacteria may be Staphylococcus (para. 267), addressing claims 33-37. The composition comprising PLGA is interpreted as addressing the polyester limitation in claim 38, as well as claims 39 (hydrolysis leads to lactic acid and glycolic acid) and 40. In some embodiments, BRIJ surfactants may be included (para. 138), which are known in the art as non-ionic surfactants, addressing claim 41. SEM is a common analytical and characterization tool known in the art (para. 65), and the average diameter and optimal and preferred size of the microparticles may be no more than about 5 or 10 microns (paras. 41, 42, 47, 211), partially addressing claim 43. Treatment of an infection in the biofilm due to better penetration of the drug would inherently or necessarily occur due to the encapsulated structure of the antibiotic and the small size of nanoparticles and microparticles used to deliver the drug (evidenced by Lau, abs and Birk, section 2.6), addressing claim 49.
Liggins does not specifically teach an exact combination of a polymer and medicament to treat a urinary tract disease with a particle size of 1-30 microns in claim 30. Liggins does not specifically teach at least 90% of particles with a particle size of 10 microns or less in claim 43.
In regards to selecting the combination of polymer, drug, particle size of 1-30 microns, “[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 combinations 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.”
Liggins teaches a microparticle composition (abs) for treatment of cancer or infections (para. 3) in different parts of the body, such as the urinary or genital tract (para. 31), whereas the claimed invention is directed toward a method of treating a urinary tract disease using a composition comprising a polymer, medicament, and with a particle size of 1-30 microns. Since Liggins 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.
In regards to claim 43, SEM is a common analytical and characterization tool known in the art (para. 65), and the average diameter and optimal and preferred size of the microparticles may be no more than about 5 or 10 microns (paras. 41, 42, 47, 211), partially addressing claim 43. Liggins also teaches d(0.5) in Table 14. That being said and in lieu of objective evidence of unexpected results, the particle size can be viewed as a variable that achieves the recognized result of successfully making the microparticle composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of particle sizes 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 particle size as nonobvious.
Furthermore, 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.
Claim(s) 30-44, 47-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liggins et al. (US 2008/0124400 A1) and Sridhar (Electrosprayed nanoparticles for drug delivery and pharmaceutical applications, Biomatter, 2013), as evidenced by Lau (Novel Particles Conferring Eradication of Deep Tissue Bacterial Reservoirs for the Treatment of Chronic Urinary Tract Infection, 2024) and Birk (Polymeric nano- and microparticulate drug delivery systems for treatment of biofilms, Advanced Drug Delivery Reviews, 2021).
In regards to claim(s) 30-43, 47-49, Liggins, as applied supra, is herein applied in its entirety for its teachings of a microparticle composition comprising a polymer and a drug.
Liggins does not specifically teach making the particles through electrohydrodynamic processing in claim 44.
Sridhar teaches electrospraying offers better encapsulation efficiency and production of more stable nanoparticles and microparticles (pgs. 3-4).
Since Liggins teaches spray drying (para. 328) but does not specifically teach electrospraying their microparticles in claim 44, one of ordinary skill in the art would have been motivated to use Sridhar’s teaching with a reasonable expectation of success. Liggins teaches that their microparticle composition should not degrade during storage or during administration (para. 273). Therefore, a skilled artisan would have recognized the importance of creating as stable of a microparticle as possible through electrospraying, as taught by Sridhar. A person of ordinary skill in the art would have had reasonable motivation to combine the teachings to arrive at the claimed invention.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613