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 .
Claim Status
Claims 1-9 are pending.
Claims 1-9 are examined on the merits herein.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 28-Jul-2023. It is noted, however, that applicant has not filed a certified copy of the CN202310947993.2 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 02-Jan-2025 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 59, “400 mbarr” should be 400 mbar.
Appropriate correction is required.
The use of the term “Tween”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The use of the term “Span”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The term “semi-cured” in claim 1 is a relative term which renders the claim indefinite. The term “semi-cured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the term semi-cured cannot be ascertained since no definition is given in the specification and the degree of the microsphere being cured to constitute "semi-cured" cannot be reliably determined.
Claim 7 contains the trademark/trade name “Tween”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polysorbate 20, 40, 60, 80, etc. and, accordingly, the identification/description is indefinite.
Claim 7 contains the trademark/trade name “Span”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe sorbitan monolaurate, monopalmitate, monostearate, monooleate, etc. and, accordingly, the identification/description is indefinite.
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.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia (CN114588115A, Patent Published: 07-Jun-2022), and further in view of Cabana et al (WO2011112576, Published 15-Sep-2011) and Cook (US20060228414A1, Published: 12-Oct-2006).
In regards to Claim 1, Xia teaches a preparation method of PLGA and drug substance released from microspheres comprising: dissolving polylactic acid-glycolic acid copolymer is dissolved in an organic solvent to form a clear and transparent solution to obtain an oil phase (Page 2), stirring the oil phase solution prepared in step a and add drug particles or drug aqueous solution, and continue stirring to obtain a uniform drug emulsion or drug particle suspension system (Page 2), transferring the resultant suspension to an aqueous phase and performing emulsification with a phase inversion mechanism to form a semi-cured microsphere (Page 2), and transferring the semi-cured microsphere solution to a curing phase solution, followed by heating and vacuuming to remove solvent and obtain the cured and drug loaded PLGA microsphere (Page 2).
In regards to Claim 2, Xia teaches that the molar ratio of lactic acid and glycolic acid of the polylactic acid-glycolic acid copolymer in the present invention is 50:50-85:15 (Page 3).
In regards to Claim 3-4, Xia teaches that the organic solvent used to dissolve the PLGA is selected from one or more of ethyl acetate, ethyl formate, methyl formate, methyl acetate, butanone, tetrahydrofuran, acetone, acetonitrile, dimethyl sulfoxide, dichloromethane, and chloroform (Page 2).
In regards to Claim 5, Xia teaches that the aqueous solutions contains functional additives dissolved in water, including polyvinyl alcohol, poloxamer, and metal salts such as sodium chloride (Page 3).
In regards to Claim 6, Xia teaches that the mass volume percentage of the polylactic acid-glycolic acid copolymer in the oil phase is 10%-70% . Preferably it is 40%-70% (Page 3).
In regards to Claim 7, Xia teaches that the surfactant in the curing phase is selected from one or more of Tween, Span, PVA, and Poloxamer (Page 3).
In regards to Claim 8, Xia teaches that the preparation method achieves a drug loading rate of over 50% and a drug encapsulation rate of over 90% (Page 4).
In regards to Claim 9, Xia teaches process excipients such as lactose, sucrose, and glucose (Page 4) incorporated as a part of the aqueous phase formulation.
However, Xia does not teach octreotide acetate and dissolving octreotide acetate into a separation organic solvent to form oil phase 2 of claim 1. Xia does not teach the PLGA molecular weight or intrinsic viscosity of 12,000-36,000 Daltons and 0.15-0.45 dL/g of claim 2. Xia does not explicitly teach the use of dimethyl sulfoxide specifically as the solvent to dissolve octreotide acetate of claim 4. For this reason, Cabana and Cabana are added.
Cabana teaches an octreotide acetate loaded PLGA microsphere composition with the PLGA polymer units each weighing between 5 kDa and 25 kDa (Page 3, line 20-22) and a viscosity of 0.1 to 0.24 dl/g (Page 20, line 37-38).
Cook teaches PLGA microspheres loaded with octreotide acetate prepared by dissolving PLGA with a molecular weight of 24,000 Daltons into ethyl acetate, and to separately dissolve octreotide acetate into benzyl alcohol to be added to the polymer solution phase to yield a homogenous organic phase prior to emulsification (Page 10, Example 3, Paragraph 117).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xia’s drug loaded PLGA microsphere process by substituting the drug with octreotide acetate as taught by Cabana and Cook. Xia’s process is expressly disclosed as a process to accommodate drug particles or drug aqueous solutions without limitations to a specific active pharmaceutical ingredient, and octreotide acetate is a known candidate for PLGA microsphere formulation.
Further, it would have been obvious to form a second discrete oil phase 2 rather than adding the octreotide acetate directly to the PLGA oil phase as in Xia because Cook teaches preparing the peptide in a separate organic phase prior to emulsification, which improves peptide dispersion and attenuates peptide degradation (Page 10, Example 3, Paragraph 116). This represents a simple substitution of one known technique for another according to their established methods to yield predictable results with a reasonable expectation of success.
Furthermore, it would have been obvious to select a PLGA molecular weight and intrinsic viscosity within the claimed ranges since Cabana discloses overlapping molar ratio of lactic acid and glycolic acid, molecular weight ranges, and inherent viscosity values corresponding to suitable PLGA grades for sustained release octreotide microspheres for the process of Example 1, and represents routine optimization of a result-effective variable known in the arts to affect polymer degradation and drug release kinetics. For the foregoing reasons, Claims 1-9 are rendered obvious by the teachings of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.L./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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