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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16) in the reply filed on 01/08/26 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 17-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-16 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 09/12/24 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Claim Objections
Claim 9 is objected to because of the following informalities: In claim 9, line 1, the active agent “xybutynin” should be corrected to recite “oxybutynin.” 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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claims 5-7 are 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. Claims 5-7 are dependent on claim 1 but only recite properties which are inherently associated with the polymer carrier (in claims 5 and 6) and with the microsphere (in claim 7) and do not further limit claim 1. There are no further or additional components or an arrangement of the components recited. Claims 5-7 do not further limit claim 1. 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.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Na et al. (CA 3 167 978 A1 – “Na”).
Instant claim 1 is drawn to a microsphere for controlled long-term sustained delivery of an active agent, comprising the active agent and a polymer carrier that encapsulates the active agent, wherein the polymer carrier comprises polylactide (PLA), polyglycolic acid (PLG), poly(lactide-co-glycolide) (PLGA), polyethylene glycol-PLA, PLA-polycaprolactone (PCL), a polyorthoester, a polyphosphazene, a polyphosphoester, or a combination thereof.
Na teaches a pharmaceutical composition including sustained-release microspheres containing the active agent semaglutide and a biodegradable polymer (Abstract, claims 1-7). The encapsulated amount of the semaglutide ranges from 4.08 (Example 03) to 13.7% by weight (Example 22) (Pages 27-28 - Table 3). The biodegradable polymer is one or more selected from the group consisting of polylactide (PLA), polyglycolide (PGA), polylactide-co-glycolide (PLGA), and polyorthoester (Page 8, 3rd ¶, Page 25 – Example 29, and claim 2).
Regarding instant claim 1, the limitation of a microsphere for controlled long-term sustained delivery of an active agent, comprising the active agent and a polymer carrier that encapsulates the active agent is anticipated by the pharmaceutical composition including sustained-release microspheres containing semaglutide and a biodegradable polymer (Abstract, claims 1-7) and the encapsulated amount of the semaglutide which ranges from 4.08 (Example 03) to 13.7% by weight (Example 22) (Pages 27-28 - Table 3), as taught by Na. The limitation of the polymer carrier comprising PLA, PLG, PLGA, polyethylene glycol-PLA, PCL, a polyorthoester, or a combination thereof is anticipated by the biodegradable polymer which is one or more selected from the group consisting of polylactide (PLA), polyglycolide (PGA), polylactide-co-glycolide (PLGA), and polyorthoester (Page 8, 3rd ¶, Page 25 – Example 29, and claim 2), as taught by Na.
Regarding instant claim 2, the limitation of PLGA, PLA, or a combination thereof is anticipated by the biodegradable polymer which is one or more selected from the group consisting of PLA, PLGA (Page 8, 3rd ¶, Page 25 – Example 29, and claim 2), as taught by Na.
Regarding instant claim 3, the limitation of a diameter of from about 8 µm to about 75 µm is anticipated by the particle size range of 60 µm to 70 µm, 20 µm to 70 µm, 20 µm to 60 µm, 30 µm to 60 µm, 40 µm to 70 µm, 40 µm to 50 µm, 30 µm to 40 µm, 20 µm to 30 µm, 50 µm to 30 µm, 5 µm to 20 µm, 10 µm to 20 µm, or 5 µm to 10 µm, which lie within the claimed range (Page 10, 1st full ¶), as taught by Na. Please see MPEP § 2131.03(I).
Regarding instant claim 4, the limitation of the microsphere comprising from about 4% (w/w) to about 50% (w/w) of the active agent by weight of the microsphere is anticipated by the encapsulated amount of the semaglutide which includes 4.08% by weight (Example 03) and 13.7% by weight (Example 22) (Pages 27-28 - Table 3), as taught by Na. Please see MPEP § 2131.03(I).
Regarding instant claims 5 and 6, the limitations of the polymer carrier that is biodegradable and biocompatible (instant claim 5) and the polymer carrier having a degradation half-life of at least 2 months under physiological conditions (instant claim 6) are inherent properties of the polymer carrier and is inseparable from it. Nevertheless, these limitations are anticipated by the biodegradable polymer which is one or more selected from the group consisting of PLA, PGA, PLGA, and polyorthoester (Page 8, 3rd ¶, Page 25 – Example 29, and claim 2), as taught by Na. Please see MPEP 2112.01. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Regarding instant claim 7, the limitation of the microsphere having a zero-order release when contacting with an aqueous phase is an inherent property of the microsphere and is inseparable from it. Na teaches the same microsphere comprising the same active agent and the same biodegradable polymer. Instant claims do not provide any component, concentration, or arrangement ot distinguish over the microsphere taught by Na. Please see MPEP 2112.01. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product. Furthermore, the recitation of “when contacting with an aqueous phase” (emphasis added) is a future intended use which is not given patentable weight.
Regarding instant claim 8, the limitation of the microsphere maintaining a controlled and sustained release for a period from 1 week to 6 months is anticipated by the continuous release of the drug for 5 weeks or more after administration of the microsphere (FIG. 3, Examples 4 and 6-8, Page 33, last ¶), as taught by Na. Please see MPEP § 2131.03(I).
Regarding instant claim 11, the limitation of a composition comprising the microsphere of claim 1 is anticipated by the pharmaceutical composition including sustained-release microspheres containing the active agent semaglutide and a biodegradable polymer (Abstract, claims 1-7), as taught by Na.
Regarding instant claim 12, the limitation of at least one anti-cryogenic agent is anticipated by the sorbitol (Page 13, 1st ¶, line 2), as taught by Na.
Regarding instant claim 13, the limitation of an excipient is anticipated by the excipient (¶ bridging Pages 12 and 13), as taught by Na.
Claims 1-2, 4-11, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders et al. (US 2002/0147236 A1 – “Sanders”).
Sanders teaches compositions for oxybutynin while minimizing the incidence and or severity of adverse drug experiences associated with oxybutynin therapy (Abstract, Example 2 – [0097]-[0099], and claims 19-36). Example 2 discloses an oxybutynin biodegradable microsphere depot injection for sustained-release ([0097]-[0099]). The microspheres comprise 12,000 molecular weight poly-d,l lactic acid (PLA) and oxybutynin free base ([0098]). The resultant microspheres can be injected either intramuscularly or subcutaneously to provide a prolonged systemic release of oxybutynin ([0099]).
Regarding instant claim 1, the limitation of a microsphere for controlled long-term sustained delivery of an active agent, comprising the active agent and a polymer carrier that encapsulates the active agent is anticipated by the oxybutynin biodegradable microsphere depot injection for sustained-release (Example 2 - [0097]-[0099]), wherein the microspheres comprise 12,000 molecular weight PLA and oxybutynin free base ([0098]), and the resultant microspheres can be injected either intramuscularly or subcutaneously to provide a prolonged systemic release of oxybutynin ([0099]), as taught by Sanders.
Regarding instant claim 2, the limitation of PLGA, PLA, or a combination thereof is anticipated by the PLA (Example 2 - [0098]), as taught by Sanders.
Regarding instant claim 4, the limitation of the microsphere comprising from about 4% (w/w) to about 50% (w/w) of the active agent by weight of the microsphere is anticipated by the 4% by weight of oxybutynin free base in the microsphere (Example 2 - [0098]), as taught by Sanders. Please see MPEP § 2131.03(I) and (II). The concentration taught by Sanders, i.e., 4% by weight, lies within, touches, and therefore anticipates the range of about 4% (w/w) to about 50% (w/w).
Regarding instant claims 5 and 6, the limitations of the polymer carrier that is biodegradable and biocompatible (instant claim 5) and the polymer carrier having a degradation half-life of at least 2 months under physiological conditions (instant claim 6) are inherent properties of the polymer carrier and is inseparable from it. Nevertheless, these limitations are anticipated by the biodegradable polymer which is PLA (Example 2 - [0098]), as taught by Sanders. Please see MPEP 2112.01. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Regarding instant claim 7, the limitation of the microsphere having a zero-order release when contacting with an aqueous phase is an inherent property of the microsphere and is inseparable from it. Sanders teaches the same microsphere comprising the same active agent and the same biodegradable polymer. Instant claims do not provide any component, concentration, or arrangement ot distinguish over the microsphere taught by Sanders. Please see MPEP 2112.01. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product. Furthermore, the recitation of “when contacting with an aqueous phase” (emphasis added) is a future intended use which is not given patentable weight.
Regarding instant claim 8, the limitation of the microsphere maintaining a controlled and sustained release for a period from 1 week to 6 months is anticipated by the sustained release over a period of about 6 weeks ([0068] and FIGS. 4 and 5), as taught by Sanders. Please see MPEP § 2131.03(I).
Regarding instant claims 9 and 10, the limitations of the active agent comprising oxybutynin (instant claim 9) and a free base of oxybutynin (instant claim 10) are anticipated by the oxybutynin free base containing biodegradable microsphere depot injection for sustained-release (Example 2 - [0097]-[0099]), as taught by Sanders.
Regarding instant claim 11, the limitation of a composition comprising the microsphere of claim 1 is anticipated by the oxybutynin biodegradable microsphere depot injection for sustained-release (Example 2 - [0097]-[0099]), as taught by Sanders.
Regarding instant claim 13, the limitation of an excipient is anticipated by the methylene chloride (Example 2 - [0098]-[0099]), as taught by Sanders.
Regarding instant claim 16, the limitation of an implant is anticipated by the implantable composition (claims 19 and 32), as taught by Sanders.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 2002/0147236 A1 – “Sanders”), as applied to claims 1-2, 4-11, 13, and 16 above, in view of Bielski et al. (US 2019/0125687 A1 – “Bielski”) and Dash et al. (Journal of Pediatric Surgery 51 (2016) 2025-2029 – “Dash”).
Instant claim 14 is drawn to the composition of claim 13, further comprising an additional therapeutic agent.
The teaching of Sanders are discussed above.
Sanders does not expressly teach an additional therapeutic agent.
Bielski teaches microcapsules including active pharmaceutical ingredients (API) that belong to different classes, including anticonvulsants such as gabapentin, and drugs for treatment of urinary tract infections such as oxybutynin ([0268]).
Dash teaches that gabapentin is used with oxybutynin as an add-on therapy for management of neurogenic bladder (Abstract - Conclusion). Results show that maximal improvement of symptom score was with combination of drugs at 1 year (Abstract – Results, Page 2026 – section “2. Results”). Dash teaches that gabapentin acts by blocking the voltage gated calcium channels distributed throughout the peripheral and the central nervous system (Page 2027, Col. 1, section “3. Discussion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising microspheres containing the biodegradable polymer PLA and oxybutynin as an active ingredient, as taught by Sanders, in view of the microcapsules that contain APIs that belong to different classes, including oxybutynin and gabapentin, as taught by Bielski, based on the improved management of neurogenic bladder by using gabapentin as an add-on therapy with oxybutynin, as taught by Dash, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references are drawn to microspheres or microcapsules that encapsulate APIs and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have had a reasonable expectation of success in combining the oxybutynin with the additional APIs taught by Bielski ([0268]), particularly the gabapentin, which is an α2δ subunit calcium channel modulator (Instant Specification – Page 6, lines 24-28), and improves management of neurogenic bladder as an add-on therapy, as taught by Dash (Abstract).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 14 and 15, the limitations of the additional therapeutic agent (instant claim 14) which is an α2δ subunit calcium channel modulator would have been obvious over microcapsules including APIs that belong to different classes, including anticonvulsants such as gabapentin, and drugs for treatment of urinary tract infections such as oxybutynin ([0268]), as taught by Bielski, and the use of gabapentin with oxybutynin as an add-on therapy for management of neurogenic bladder (Abstract), as taught by Dash.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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