DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/29/2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/294666, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. With respect to claim 4, the prior art filed application does not provide support for the peptide having a molecular weight of up to two million Daltons. With respect to claim 11, the prior art filed application does not provide support the use of “about” with respect to the range 20-63 microns. As such claims 4 and 11 are awarded an effective filing date of 1/13/2011.
Response to Arguments
All of Applicant’s arguments filed 9/29/2025 have been fully considered.
The amendments filed 9/29/2025 were sufficient to overcome the prior art rejections presented in the office action mailed 3/28/2025 as such Applicant’s arguments against these rejections are moot.
Allowable Subject Matter
Claims 2, 5, 10, 12, 54 and 55 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
New Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 6, 8, 14-16, 53, 57 and 59 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Sopohcleous (A new class of inhibitors of peptide sorption and acylation in PLGA, available 3/24/2009), as evidenced by Sopohcleous (Mechanistic Investigation of Peptide Sorption and Acylation in Poly(lactic-co-glycolic acid, available 1/7/2010). Sopohcleous 2010 was previously cited.
Sopohcleous 2009 discusses peptide absorption and acylation in PLGA (Title). The sorption of model peptides to PLGA was tested by incubating aqueous solutions of peptides in the presence of polymer particles or films (pg. 30).
Sopohcleous 2009 teaches that solutions of octreotide (reading on instant claim 53) in HEPES buffer (pH 7.4) were added to PLGA (Resomer 502H) particles and incubated (37°C). For sorption inhibition studies, chloride salts of divalent cations (1-50mM) or NaCl (50 mM) were added to octreotide solutions prior to incubation. HEPES buffer was necessary to solubilize the divalent cations, which can precipitate with conventionally used phosphate buffer ions. The amount of octreotide sorbed was determined by the loss of octreotide from solution. Mass balance was performed at 1hr and 24hr (reading on instant claim 6) The total amount of octreotide recoverable at 1 and 24hr was 99+/-1% and 92+/-%, respectively (reading on claim 59). It was concluded that virtually all sorbed octreotide was non-covalently bound to PLGA, with the likelihood that a small fraction had become covalently bound to the polymer or otherwise decomposed (pg. 41-42, section 4.2.8).
As discussed above, both the polymer matrix as claimed (PLGA having no peptide disposed within the matrix structure) and the aqueous solution of peptide were admixed via a rotary shaker at 37°C, this mixture reads on the admixing step, which results in the peptide being sorbed into the microparticles, thus forming a suspension of particles having the particles disposed within the matrix structure.
While the art is silent to the peptide being fully or partially encapsulated in the matrix structure, the art teaches the peptide to be sorbed into the matrix structure, therefore as the peptide is inherently partially or fully encapsulated into the structure.
Regarding the PLGA having ionized carboxylate end groups, as evidenced by Sopohcleous 2010 the presence of ionized carboxylates is a necessary prerequisite to octreotide sorption (pg. 77) and studies showed the critical role of ionized PLGA acid end-groups during the absorption pathway (pg. 103), Sopohcleous 2010 teaches using Resomer 502H, therefore the PLGA used in the method above would necessarily have ionized carboxylate end groups.
Regarding claim 8: Sophocleous anticipates method of making the claimed solid delivery system, therefore, the resultant system of Sophocleous and the claimed system would necessarily have the same properties of release.
Regarding claim 14: The method above does not comprise organic solvents.
Regarding claim 15: Sophocleous teaches the PLGA to be Resomer 502H which is a 50/50 copolymer of lactic acid and glycolic acid (pg. 180).
Regarding claims 16 and 57: Sophocleous teaches the PLGA particles were which were loaded or sorbed with octreotide were dissolved in methylene chloride, this suggest that the PLGA particles were isolated and removed from the aqueous solution prior to their dissolution in the methylene chloride.
New 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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sopohcleous (Mechanistic Investigation of Peptide Sorption and Acylation in Poly(lactic-co-glycolic acid, available 1/7/2010). Reference was previously cited.
Sopohcleous discusses peptide absorption and acylation in PLGA (Title). The sorption of model peptides to PLGA was tested by incubating aqueous solutions of peptides in the presence of polymer particles or films (pg. 30).
Sopohcleous teaches that solutions of octreotide in HEPES buffer were added to PLGA particles and incubated (37°C). For sorption inhibition studies, chloride salts of divalent cations (1-50mM) or NaCl (50 mM) were added to octreotide solutions prior to incubation. HEPES buffer was necessary to solubilize the divalent cations, which can precipitate with conventionally used phosphate buffer ions. The amount of octreotide sorbed was determined by the loss of octreotide from solution. The total amount of octreotide recoverable at 1 and 24hr was 99+/-1% and 92+/-%, respectively. It was concluded that virtually all sorbed octreotide was non-covalently bound to PLGA, with the likelihood that a small fraction had become covalently bound to the polymer or otherwise decomposed (pg. 41-42, section 4.2.8).
As discussed above, both the polymer matrix as claimed (PLGA having no peptide disposed within the matrix structure) and the aqueous solution of peptide were admixed via a rotary shaker at 37°C, this mixture reads on the admixing step, which results in the peptide being sorbed into the microparticles, thus forming a suspension of particles having the particles disposed within the matrix structure.
While the art is silent to the peptide being fully or partially encapsulated in the matrix structure, the art teaches the peptide to be sorbed into the matrix structure, therefore as the peptide is inherently partially or fully encapsulated into the structure.
Regarding the PLGA having ionized carboxylate end groups, Sopohcleous discloses that the presence of ionized carboxylates is a necessary prerequisite to octreotide sorption (pg. 77) and studies showed the critical role of ionized PLGA acid end-groups during the absorption pathway (pg. 103), therefore the PLGA used in the method above would have ionized carboxylate end groups.
Sopohcleous teaches that the PLGA particles prepared are microsphere which are porous and these microspheres typically have a size ranging from 1-100 microns which overlaps with the claimed range and overlapping ranges are prima facie obvious (pg. 12), therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use PLGA microparticles having a size range of 1-100 microns in the method described above, as microparticles are contemplated by Sopohcleous.
Claim 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sopohcleous (Mechanistic Investigation of Peptide Sorption and Acylation in Poly(lactic-co-glycolic acid, available 1/7/2010), Schwendeman (US 2008/0131478) and Schwendeman (US 2002/0009493). Both Schwendeman references are previously cited.
Sopohcleous discusses peptide absorption and acylation in PLGA (Title). The sorption of model peptides to PLGA was tested by incubating aqueous solutions of peptides in the presence of polymer particles or films (pg. 30).
Sopohcleous teaches that solutions of octreotide (reading on positively charged peptide having a MW of less than 2million) in HEPES buffer were added to PLGA particles and incubated (37°C). For sorption inhibition studies, chloride salts of divalent cations (1-50mM) or NaCl (50 mM) were added to octreotide solutions prior to incubation. HEPES buffer was necessary to solubilize the divalent cations, which can precipitate with conventionally used phosphate buffer ions. The amount of octreotide sorbed was determined by the loss of octreotide from solution. The total amount of octreotide recoverable at 1 and 24hr was 99+/-1% and 92+/-%, respectively. It was concluded that virtually all sorbed octreotide was non-covalently bound to PLGA, with the likelihood that a small fraction had become covalently bound to the polymer or otherwise decomposed (pg. 41-42, section 4.2.8).
As discussed above, both the polymer matrix as claimed (PLGA having no peptide disposed within the matrix structure) and the aqueous solution of peptide were admixed via a rotary shaker at 37°C, this mixture reads on the admixing step, which results in the peptide being sorbed into the microparticles, thus forming a suspension of particles having the particles disposed within the matrix structure.
While the art is silent to the peptide being fully or partially encapsulated in the matrix structure, the art teaches the peptide to be sorbed into the matrix structure, therefore as the peptide is inherently partially or fully encapsulated into the structure.
Regarding the PLGA having ionized carboxylate end groups, Sopohcleous discloses that the presence of ionized carboxylates is a necessary prerequisite to octreotide sorption (pg. 77) and studies showed the critical role of ionized PLGA acid end-groups during the absorption pathway (pg. 103), therefore the PLGA used in the method above would have ionized carboxylate end groups.
Sopohcleous teaches that the PLGA particles prepared are microsphere which are porous and these microspheres typically have a size ranging from 1-100 microns which overlaps with the claimed range and overlapping ranges are prima facie obvious (pg. 12), therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use PLGA microparticles having a size range of 1-100 microns in the method described above, as microparticles are contemplated by Sopohcleous.
Sopohcleous does not teach the peptide to be micronized.
Schwendeman’478 discloses a method for encapsulating a biomacromolecule in a pore-containing polymer (Schwendeman’478 - claim 1). Schwendeman’478 teaches that micronization of proteins and polynucleic acid before encapsulation can destabilize the biomacromolecules [0007-0008], therefore it would have been prima facia obvious to use non-micronized octreotide in Sophocleous as the use of micronized biomolecules can cause destabilization. One of skill in the art would have a reasonable expectation of success as both Sopohcleous and Schwendeman’478 teaches encapsulating a biomacromolecules in a pore-containing polymer.
Sopohcleous does not teach the peptide to be present in a concentration of 1 mg/mL or less in the aqueous solution.
Schwendeman ‘493 teaches methods for stabilizing biologically active agents encapsulated in biodegradable controlled-release polymers. Schwendeman ‘493 teaches the polymer solution to comprise 0.1-20% of the biologically active agent and teaches that low amounts of the active due to cost, toxicity, etc. [0014], therefore, it would have been prima facie obvious to optimize the amounts of peptide used in Sopohcleous based on the cost or toxicity of the active agent. One of skill in the art would have a reasonable expectation of success as both Sopohcleous and Schwendeman’493 teaches encapsulating a biomacromolecules in a biodegradable polymers.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached on Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613