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 .
DETAILED ACTION
Claims 1, 2, 5, 8-11, 13, 14, 16, 17, 24, 26, 27, 35, 36, 38, 40, 52 and 58 are currently pending in amendments filed 06/03/2026. In addition, applicant filed a rule 1.132 Declaration.
Withdrawn rejections:
Applicant's amendments/arguments and a Declaration filed 06/03/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Objection/Rejections --- as necessitated by amendment
Claim Objection
Claims 13 and 14 are objected to minor informalities.
Each of claims 13 and 14 is not written in a proper Markush-type claim format where the Markush-type claim should recite alternatives in a format such as "selected or chosen from the group consisting of A, B, and C." Alternatively, the format “selected or chosen from A, B or C” can be used. (see MPEP 2111.03 –II and 2117 and MPEP 2173.05(h)).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 38 reciting “the active agent comprises an anti-infective agent, an anesthetic agent, an analgesic agent, a diuretic, an anti-inflammatory agent, a coagulant or an anti-coagulant, a chemotherapeutic agent, an agent for the treatment of incontinence, an agent for treating kidney stones, or a combinations thereof. However, the languages of “comprises” and “the said bold type agents” in dependent claim 38 are broader than base claim 35 reciting “the active agent is selected from the group consisting of an anti-infective agent, an anesthetic agent, an analgesic agent, an anti-inflammatory agent, a chemotherapeutic agent, an agent for the treatment of incontinence, and an agent for treating kidney stones. That is, the active agent of base claim 35 is limited to the recited Markush format agents, while the scope of dependent claim 38 is broader than that of base claim 35. Therefore, it may not be said that dependent claim 38 further limits base claim 35 in a proper manner.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 5, 8-11, 13, 14, 24, 27, 35, 36, 38, 40, 52 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Ottoboni et al. (US 6,039,967A).
Applicant claims the below claims 1 and 35 filed on 06/03/2026:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Ottoboni discloses intravesical drug delivery system (title); the bio-erodible sustained release preparations comprises a pharmaceutically active ingredient and a bio-erodible pharmaceutically acceptable carrier being capable of sustained delivery within the bladder of said active ingredient wherein the said active ingredient is controllably released from the said carrier (e.g., abstract and claim 1 of prior art), and the carrier materials containing or impregnated with the drug may have a specific gravity less than or equal to that of urine, which is normally about 1.005 gm/ml to 1.033 gm/ml at 25° C, which allows the device to be neutrally buoyant or float in the urine of the bladder to minimize the occurrence of blockage of the urethra (col. 3, lines 27-39), and the said gravity overlaps the claimed range of less than 1.03 gm/ml. Please see MPEP 2144.05 I. OVERLAP OF RANGES In the case where the claimed ranges “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), and the carrier materials include natural products and synthetic polymers (e.g., col. 2, lines 34-46); for example, the polymer carrier/drug blend is extruded into a 0.5 mm (=500 microns) diameter (e.g., Example 7); the drug includes oxybutynin, imipramine, dicyclomine, desmopressin, estrogen, terodiline, propantheline, doxepin, and flavoxate (for treating incontinence), doxorubicin, bacillus calmette-guerin, and mycobacterium (for treating bladder cancer), DMSO or anesthetic agent (for treating interstitial cystitis), and any drug may be utilized for the treatment of any condition related to the bladder or urethral tract, including urge incontinence, cancer, infections, inflammation, and the like. (e.g., abstract, col. 5, lines 14-29, and claims 1 and 3 of prior art) which reads on the claimed active agent, and the Examples including Examples 5-7 disclose microparticles (=microsphere) of drug/polymer carrier (instant claim 1, in part and instant claim 2); the carrier provides for controlled release of the active agent (e.g., bridging para. at col. 2-3) (instant claim 5); the drug is dispersed in a carrier such as microsphere matrix, polymer matrix, etc. (e.g., col. 3, lines 40-48) (instant claim 8); the device can contain coating (e.g., Fig. 2) (instant claim 9); the carrier is readily dissolved, eroded, or is subjected to degradation in the bladder (e.g., e.g., col. 2, lines 23-26) (instant claim 10); the carrier materials include triglycerides, fatty acids, lipids, latexes, the derivatives of PEG, polysaccharide, phospholipid, fatty alcohol, collagen, etc. (e.g., col. 2, lines 34-46) (instant claims 11 and 13); although this applied art does not expressly teach species of triglyceride of instant claim 14, they would be obvious variation because the claimed species have equivalent function as triglyceride and selection of species would be a matter of choice or design (instant claim 14); the preparation contains surfactant such as Pluronic F-69 and F-127 (Examples 6 and 9)(instant claim 16, in part); the sustained delivery of the drug into the bladder will be for an extended period, longer than about three days, and preferably at least about one week (e.g., col. 3, lines 28-30) that is within the instant range of 2 hours to six months. MPEP 2144.05 noted above (instant claim 24); the preparation further comprises viscosity adjusting agent such as gellan gum (Example 8), phosphate buffer (Example 10), etc. (instant claim 27); the said preparation containing active agent including oxybutynin, doxorubicin, etc., and carrier is intravesically administered in controlled release manner including sustained release manner to treat any condition related to the bladder or urethral tract including interstitial cystitis, cancer, incontinence, inflammation and infection (e.g., col. 5, lines 26-29 and claims 3 and 24-29 of prior at) (instant claims 35 and 58, in part and claims 38, 40 and 52); and the preparation has a specific gravity less than that of urine which is normally about 1.033 gm/ml at 25C (col. 3, lines, 27-36) that overlaps or is identical to the instant range of 1.03 gm/ml. MPEP 2144.05 noted above (instant claim 36).
Ottoboni does not expressly teach the claimed mean particle size of instant claims 1 and 35; and the amounts of active ingredient and carrier of instant claims 1, 35, and 52.
However, Ottoboni teaches 500 microns (=0.5mm) of particle size, and the amounts of active ingredient and carriers (the Examples). Further, the claimed amounts of active agent and carrier materials are general ranges, not specific and significant ranges. Therefore, one of the ordinary artisan would optimize those parameters with the claimed ranges, in the absence of criticality evidences. In this regard, please see MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05(III)(A): “.)("[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant did not show the criticality of the claimed ranges (instant claims 1, 35 and 58 – parameters of active agent and carrier and particle sizes thereof).
In light of the foregoing, instant claims 1, 2, 5, 8-11, 13, 14, 24, 27, 35, 36, 38, 40, 52 and 58 are obvious over Ottoboni.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ottoboni et al. (US6,039,967A) in view of van Hemelrijck (US2018/0243273A1).
Ottoboni was discussed above.
However, Ottoboni does not expressly teach the surfactant of instant claim 16. The deficiency is cured by van Hemelrijck.
van Hemelrijck discloses composition for intravesical administration for treating bladder pain (title); and the composition comprises active agent (API) and excipients enhancing solubility ([0018]) such as surfactant having antioxidant properties including sodium lauryl sulfate (SLS) ([0069] and [0082]) (instant claim 16).
It would have been obvious to further define or replace the surfactant of Ottoboni with SLS surfactant in order to enhance the solubility of API as taught by Van Hemelrijck.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Ottoboni et al. (US6,039,967A) in view of Cima et al. (US2009/0149833A1).
However, Ottoboni does not expressly teach zero order release of instant claim 26. The deficiency is cured by Cima.
Ottoboni was discussed above.
Cima discloses treatment of the bladder using implantable device for controlled drug delivery (e.g., abstract), and the device may include a floatation features by use of the low density materials (e.g., [0019]) and the device provides zero order release of API (e.g., Example 1).
It would have been obvious to modify the composition of Ottoboni with zero order release of Cima in order to provide constant release rate as taught by Cima.
Claims 1, 5, 8-11, 13, 14, 24, 26, 27, 35, 38, 40, 52 and 58 remain rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., “Long-term floating control-released intravesical preparation of 5-fluorouracil for the local treatment of bladder cancer”, Drug Development and Industrial Pharmacy, 2017, vol. 43, no. 8, pp. 1343-1350 (IDS of 10/04/2023) in view of Ottoboni et al. (US6,039,967A).
Applicant claims the below claims 1 and 35 filed on 06/03/2026:
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Determination of the scope and content of the prior art
(MPEP 2141.01)
Wang discloses treatment of bladder cancer comprising intravesical administering long-term preparations, e.g., mini-pellet preparations comprising 5-fluorouracil cancer drug which reads on the claimed chemotherapy active agent, and glyceryl tristearate (GTS) matrix which reads on the claimed controlled carrier matrix fatty acid ester, triglyceride, and the prepared long-term preparations could maintain an effective 5-fluorouracil concentration in the bladder for about one month, and furthermore, in this period the 5-fluorouracil concentration in blood was always far less than that in urine (abstract), and the pellet has a diameter of 2 mm (1344, left column, third paragraph: Preparation of mini-pellets); the mini-pellets contains 15%, 25% or 35% of 5-fluorouracil which is within the claimed range of 2.5 to 95% (Table 1 on page 1345). Although Wang does not expressly teach the amount of GTS matrix carrier, since Wang teaches the amount 15%, 25% or 35%of 5-fluorourasil, the relative amount of GTS would be determined without undue experimentation (instant claims 1 and 35 (in part), and instant claims 11, 13, 14, 24, 26, 38 and 40); the 5-flurorourasil is released from the GTS (page 1345, right column, third paragraph) (instant claim 5), and the 5-fluorourasil is dispersed into the GTS matrix (page 1344, left column, third paragraph: Preparation of mini-pellets) (instant claim 8); and the GTS coats around 5-fluorouracil particles and thus, 5-fluorouracil could not directly dissolve into water under GTS coat (page 1345, right column, the last second paragraph) (instant claim 9); the GTS slowed down the invading rate of water into the mini-pellets, and with the slow erosion of the GTS, the hydrophilic 5-fluorouracil would gradually expose to water medium and be dissolved, and in mini-pellets, GTS formed a continuous phase and slowed down the releasing rate of 5-fluorouracil (page 1345, right column, second paragraph)(instant claim 10); and the preparations have the greatest local therapeutic effect and the smallest systemic drug side effects, and therefore, the GTS based 5-fluorouracil floating long-term control-released intravesical mini-preparation prepared in this study is an ideal preparation for the treatment of bladder cancer (page 1349, left column, last paragraph), and the mini-pellet is more suitable for the using in long-term sustained release purpose (page 1345, right column, third paragraph) (instant claims 24, 26 and 52); and the intravesical administration improves local drug efficacy and reduction of systemic side effects (page 1348, right column); and 1.5 g of 5-fluorouracil was administered which reads on unit dose and the amount is within the claimed range of 60 mg to 5g (instant claim 58). MPEP 2144.05: “In the case where the claimed ranges “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).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
However, Wang does not expressly teach microparticles of instant claims 1 and 35; specific gravity of instant claims 2 and 36; and additional ingredients of instant claim 27. The deficiencies are cured by Ottoboni.
Ottoboni discloses intravesical drug delivery system (title); the bioerodible sustained release preparations comprises a pharmaceutically active ingredient and a bioerodible pharmaceutically acceptable carrier being capable of sustained delivery within the bladder of said active ingredient, and said active ingredient is controllably released from the said carrier (e.g., abstract and claim 1 of prior art), the polymer carrier/drug blend is extruded into a 0.5 mm (=500 microns) diameter (e.g., Example 7), and although Ottoboni does not expressly teach the claimed range of 1000-2000 microns, it would have been obvious to optimize the particle sizes of Ottoboni with the claimed ranges depending on the intended purpose, administration mode, etc. in the absence of criticality (instant claim 1, particle size); the carrier materials containing or impregnated with the drug may have a specific gravity less than or equal to that of urine, which is normally about 1.005 gm/ml to 1.033 gm/ml at 25° C, which allows the device to be neutrally buoyant or float in the urine of the bladder to minimize the occurrence of blockage of the urethra (col. 3, lines 27-39), wherein the gravity overlaps the claimed range of less than 1.03 g/ml. MPEP 2144.05 noted above (instant clam 2); the drug includes oxybutynin, imipramine, dicyclomine, desmopressin, estrogen, terodiline, propantheline, doxepin, and flavoxate (for treating incontinence), doxorubicin, bacillus calmette-guerin, and mycobacterium (for treating bladder cancer), DMSO or anesthetic agent (for treating interstitial cystitis), and any drug may be utilized for the treatment of any condition related to the bladder or urethral tract, including urge incontinence, cancer, infections, inflammation, and the like. (e.g., abstract, col. 5, lines 14-29, and claims 1 and 3 of prior art); the carrier provides for controlled release of the active agent (e.g., bridging para. at col. 2-3); the drug is dispersed in a carrier such as microsphere, etc. (e.g., col. 3, lines 40-48); the device can contain coating (e.g., Fig. 2); the carrier is readily dissolved, eroded, or is subjected to degradation in the bladder (e.g., e.g., col. 2, lines 23-26); the carrier materials include triglycerides, fatty acids, lipids, latexes, the derivatives of PEG, polysaccharide, phospholipid, fatty alcohol, collagen, etc. (e.g., col. 2, lines 34-46); the preparation further comprises viscosity adjusting agent such as gellan gum (Example 8), phosphate buffer (Example 10), etc. (instant claim 27); the said preparation containing active agent including oxybutynin, doxorubicin, etc., and carrier is intravesically administered in controlled release manner including sustained release manner to treat any condition related to the bladder or urethral tract including interstitial cystitis, cancer, incontinence, inflammation and infection (e.g., col. 5, lines 26-29 and claims 3 and 24-29 of prior at); and the preparation has a specific gravity less than that of urine which is normally about 1.033 gm/ml at 25C (col. 3, lines, 27-36) that overlaps the instant range of 1.03 (instant claims 2 and 36).
It would have been obvious to modify the teachings of Wang with specific particle size, specific gravity, and additives of Ottoboni because specific particle size and gravity makes the composition buoyant in the urine, and additives enhance the properties of active agent as taught by Ottoboni. Although Ottoboni teaches 500 microns (=0.5mm) of particle size, the applied art does not teach the claimed range of 1000-2000 microns. However, one of the ordinary artisan would optimize the particle size with the claimed ranges, in the absence of criticality evidence. In this regard, please see MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05(III)(A): “.)("[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant did not show the criticality of the claimed range.
It would have been obvious to modify the mini-pellets of Wang with microparticles having encapsulated therapeutic agent of Ottoboni for the same treatment of cancer, e.g., bladder cancer. One of the ordinary artisan would have been motivated to do so because microparticles drug delivery provides controlled and localized delivery of the encapsulated agents to a targeted tissue of a patient by releasing encapsulated agent into bladder in a controlled rate of release without significantly inhibiting biological activity of the encapsulated agent, as taught/suggested by Ottoboni. Further, it would have been obvious to add additional polymer dispersant of Ottoboni to the composition of Wang in order to enhance the release properties of the composition.
In light of the foregoing, instant claims 1, 2, 5, 8-11, 13, 14, 24, 26, 27, 35, 36, 38, 40, 52 and 58 are obvious over Wang in view of Ottoboni.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., “Long-term floating control-released intravesical preparation of 5-fluorouracil for the local treatment of bladder cancer”, Drug Development and Industrial Pharmacy, 2017, vol. 43, no. 8, pp. 1343-1350 (IDS of 10/04/2023) in view of Ottoboni et al. (US6,039,967A) and further in view of Ashton et al. (US2003/0170286A1).
However, Wang in view of Ottoboni does not expressly teach surfactant of instant claim 16. The deficiency is cured by Ashton.
Ashton discloses treatment of genitourinary tract disorders comprising administering an active agent such as 5-FU ([0037]) as particles ([0051]), carrier, excipient, surfactant, dispersant, etc. ([0050] and claim 12 of prior art) for the treatment of cancer e.g., bladder cancer, wherein the surfactant includes sodium lauryl sulfate ([0236]).
It would have been obvious to further add surfactant such as SLS of Ashton to the composition of Wang in view Ottoboni in order to enhance the drug delivery, solubility and stability properties of the composition, as taught by Ashton.
In light of the foregoing, instant claim 16 is obvious over Wang in view of Ottoboni and Ashton.
Response to Arguments
Applicant’s arguments and a rule 1.132 Declaration have been fully considered, but are not persuasive.
Applicant argues that Wang is non-enabled due to catheter physics impossibilities and density/buoyancy mathematical impossibilities, and specifically, 4.0mm catheter (Wang at 1344) has a wall thickness of approximately 1.0 mm, yielding an inner lumen of approximately 2.0mm and it is not physically possible to deliver a rigid 2.0mm spherical pellet through a 2.0 mm lumen, and pellets of Wang cannot be buoyant in urine because of apparent densities greater than 1.0g/ml and Wang reports densities below the pure GTS density of 0.95 g/ml at every loading-physically impossible for a composite material composed of GTS and a denser drug (Tables on paras. 20-23 of Declaration); and Wang’s in vivo data show identical error-bar magnitudes across all time points, contrary to expected biological variability in animal urine production and voiding.
The Examiner responds that Wang discloses 4.0mm catheter, and but does not expressly disclose wall thickness of about 1.0mm and inner lumen diameter of about 2.0mm, and it is noted that applicant’s assumption cannot replace evidence: see MPEP 716.01(c) II: The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). According to US 6,245,053B1, catheter size designation is based on an outer diameter, not an inner thickness and lumen diameter: 12F (12 French size) has an inner lumen typically having a diameter in the range from about 0.1mm to 3.6 mm (col. 5, lines 44-51), and therefore, a catheter labeled by size does not automatically specify the lumen or wall thickness. Further, Applicant’s calculation (para. 20 of Declaration) appears to be invalid even if applicant’s assumptions are correct. The calculation applicant used is not the general equation for the density of composite mixture. It would be only valid under restrictive assumptions, such as negligible volume change and when the weighting method is appropriate. The more fundamental calculation is: density (D) =mass (M)/volume (V). For a two-component mixture, D= (M1+M2)/(V1+V2) where Vi=Mi/Di, and thus, multiply each component's volume fraction by its density, then add them together: ρ{mix} = (V1 /V). ρ1 + (V2/V). ρ1. Use the inverse formula ρ{mix} = 1/[(Xa/Da) =(Xb/ Db)], where Xa and Xb are mass fractions. When calculation is made from ρ{mix} formula (Xa=0.85, Da=0.95, Xb=0.15, Db=1.55), ρ{mix} is about 1.01g/ml, not 1.04g/ml. Further, even 1.01g/ml may not prove the pellets cannot float because the calculation assumes a fully dense, non-porous solid. However, pharmaceutical pellets often contain internal pores, voids, or entrapped gas that reduce the effective density. In this regard, applicant’s calculation is based on a simplified theoretical density model and assumes a non-porous composite whose density is determined sorely by the densities and weight fractions of the constituent materials. Accordingly, it may not be said that Wang’s density data obtained by applicant’s calculation is incorrect. Applicant has not established that the used assumptions apply to the pellets discussed in the applied reference, and pharmaceutical pellets may exhibit internal porosity, entrapped gas, or other structural characteristics causing their effective density to differ from the theoretical density calculated from constituent materials alone. That is, applicant’s calculation does not demonstrate that the pellets disclosed in the Wang reference are incapable of exhibiting buoyance, nor does it establish that the applied reference is non-enabling. In this context, please see "[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). The burden thus shifts to Patent Owner to show that the reference is not enabling. Id. (“[I]t is procedurally convenient to place the burden on an applicant who is in a better position to show, by experiment or argument, why the disclosure in question is not enabling or operative. It would be overly cumbersome, perhaps even impossible, to impose on the PTO the burden of showing that a cited piece of prior art is enabling. The PTO does not have laboratories for testing disclosures for enablement.”). Here, applicant failed to show that Wang is non-enabling for the reasons as noted above.
In addition, Applicant’s arguments against Levisage and Tsubaki are moot because those references are removed in the current Action.
Lastly, please note that Ashton is relied on for disclosing species of surfactant, not for buoyancy and controlled release properties. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 8-11, 13, 14, 16, 17, 24, 26, 27, 35, 36, 38, 40, 52 and 58 provisionally remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-9, 17, 28, 29, 46 and 48-61 of copending application no. 18/858722.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a population of particles comprising an active agent and a carrier matrix in a controlled release manner over certain period of time for the treatment of urinary system disorder including cancer, overlapping amounts of agent and carrier, floating properties, various active agents, overlapping specific gravity of particles, and treating method using the population. The difference between them is that the claimed invention requires microparticles and size thereof while claim 1 of copending ‘722 remains silent. However, a plurality of particles of copending ‘722 embraces the claimed microparticles, in the absence of criticality evidence of the claimed range. Thus, the claimed invention would be obvious from copending ‘722 application.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Response to Arguments
For the reasons set forth above, this double patenting rejection has maintained as Applicants have deferred to rebut the rejection under Provisional Rejection, Obviousness Type Double Patenting.
Claims 1, 2, 5, 8-11, 13, 14, 16, 17, 24, 26, 27, 35, 36, 38, 40, 52 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of patent no. 11,242,538B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a population of particles comprising various active agents including anti-inflammatory agent (=antibacterial agent) and a carrier substance, floating properties in the urine so that the particles are retained in the urinary bladder, and treating method using the population. The difference between them is that the claimed invention requires diameter of particles, amounts of active agent and carrier. However, such dimensional parameters would be optimized depending on the intended purpose. Thus, the claimed invention would be obvious from patent ‘538.
Conclusion
The instant application is not in condition for allowance.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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