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 .
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.
Election/Restrictions
Applicant’s election of Group I, claims 1-9 and 12-20 in the reply filed on 14 April 2026 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Claims 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 14 April 2026.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 1-9 and 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 12 recite the phrase “homogeneous emulsification.” As best understood by the examiner, emulsification entails the mixing of two phases that are not soluble in each other; as such, emulsification is by definition heterogeneous rather than homogeneous. As such, it is unclear how the term “homogeneous” further modifies the term “emulsification.”
For the purposes of examination under prior art, the examiner will proceed with examination with the understanding that the “homogeneous emulsification” is the same as “emulsification.”
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the phrase “spray solution.” This phrase is unclear for at least the following reasons.
Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. With that being said, until the meaning of a term or phrase used in a claim is clear, a rejection under 35 U.S.C. 112(b) is appropriate. See MPEP 2173.05(a)(III). With that being said, in this case, it is unclear if the term “solution” is being used in accordance with its ordinary meaning or whether the term “solution” has been redefined by applicant. The ordinary meaning of the term “solution” is a homogeneous, single-phase mixture in which a solute is mixed in with a solvent. The skilled artisan would have understood an emulsion to have been other than a solution because an emulsion is a heterogeneous, multi-phase mixture of phases that are not miscible. In the case of claim 1, it is unclear whether the term “solution” is being used in accordance with its ordinary meaning or whether the term “solution” has been redefined to include an emulsion.
This rejection does not apply to claim 12 and claims dependent thereon. This is because, in the case of claim 12, it appears that the term “solution” has been redefined within the claim to include an emulsion. An applicant is entitled to be their own lexicographer and may rebut the presumption that claim terms are to be given their ordinary and customary meaning by clearly setting forth a definition of the term that is different from its ordinary and customary meaning(s) in the specification at the relevant time. See MPEP 2111.01(IV)(A). In the case of claim 12, it appears that applicant has redefined the term “solution” to include emulsions within the claim scope.
For the purposes of examination under prior art, the examiner will proceed with the understanding that an emulsion is within the scope of the claim term “solution.”
Claim Interpretation
The instant claims recite the phrase “spray solution.” This phase is not understood to require spray drying. Regarding claim 1, the examiner understands that S03, which is drying the emulsified spray solution, is not limited to any particular method of drying and is not limited to spray drying.
The examiner also notes here that the claim 1 does not appear to require an active agent. With that being said, in view of the claim language “comprising”, an active agent does not actually appear to be excluded by claim 1. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03(I). This analysis is not intended to apply to claim 12 or claims dependent thereon.
Claimed Invention Appears Not Useful for Protein/Peptide Drug Delivery
Based upon the examiner’s review of the instant claims and specification, it is the examiner’s best understanding that the product made by the claimed method would not appear to be useful for the purpose intended by the instant specification. The examiner presents the following arguments in support of this position.
Specification Potentially Indicates Invention is Useful for Protein/Peptide Delivery: As an initial matter, the examiner notes that a review of the instant specification may indicate the that the invention is intended to deliver protein and peptide drugs. See the instant specification on page 2, relevant text reproduced below with annotation by the examiner.
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As such, it appears that the instant specification indicates that polylactic acid (PLA) microspheres have been used for the delivery of peptides and proteins. The specification appears to indicate that the instantly claimed invention is to be used for delivery of peptides and proteins.
(In contrast, the above-cited portion of the specification may also be interpreted here as disclosing that PLA microspheres have in the past as a carrier for peptide and protein drugs even if that is not their intended purpose in the instant invention. Regardless, the examiner will proceed in this analysis with the assumption that the specification is disclosing that PLA microspheres in the instant invention or being made by the instantly claimed method are being used for protein or peptide drug delivery).
Instant Claims do not Recite Protein or Peptide: A review of the instant claims appears to indicate that the claims do not recite a protein or peptide as an active agent to be delivered. Said protein or peptide does not appear to be recited as an optional ingredient or in a dependent claim, let alone in an independent claim.
The examiner notes that the instant claims recite macromolecular substances. See e.g. instant claim 6, which is reproduced below with annotation by the examiner.
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As such, the instant claims recite macromolecular substances, one of which can be whey protein. However, looking to the specification, it appears that the recited macromolecular substances are intended as excipients. See the instant specification on pages 10-11, paragraph 0115. See relevant text reproduced below from page 11 of the instant specification.
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This would appear to indicate that the purpose of the macromolecular substances is as an excipient to affect degradation rate rather than as an active agent or model active agent.
As such, none of the claims recite a protein or peptide intended as an active agent such as a therapeutic agent, diagnostic agent, or a model therapeutic agent.
With that being said, in view of the claim language “comprising”, an active agent does not actually appear to be excluded by claim 1. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03(I).
Prior Art Indicates that Double Emulsion is Needed to Deliver Protein/Peptide Drugs with PLA Microsphere: The examiner’s review of the prior art indicates that PLA microspheres have been successfully used to deliver protein and peptide drugs. In support of this position, the examiner cites Iqbal et al. (International Journal of Pharmaceutics 496 (2015), pages 173–190). Iqbal et al. (hereafter referred to as Iqbal) is a review article drawn to double emulsions for delivery of protein and peptide drugs, as of Iqbal, page 173, title and abstract. Iqbal cites a variety of references indicating successful formation of PLA microspheres. See the following examples reproduced below from page 176 of Iqbal.
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With that being said, the examples of Iqbal are all drawn to water-in-oil-in-water (w/o/w) double emulsions. These entail an inner water phase emulsified into an oil phase to form a water-in-oil primary emulsion, which is then emulsified into a secondary water phase to form a water-in-oil-in-water emulsion. As such, the primary water phase is present in the smallest volume, the oil phase is present in an intermediate volume, and the outer water phase is present in the largest volume. The method of loading with a double emulsion appears to be critical to successful encapsulation of hydrophilic substances. In support of this position, see the following text reproduced from Iqbal, page 173, abstract.
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Also see text reproduced below from page 174, right column of Iqbal.
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It is the examiner’s understanding that the majority of proteins and peptides are generally hydrophilic molecules. This is because proteins and peptides are made from amino acids, which are polymerized together to include amide functional groups having a carbonyl oxygen that engages in hydrogen bonding with hydrogen atoms from water molecules. Additionally, the majority of amino acids have hydrophilic side chains. Although some proteins and peptides can include hydrophobic regions, often intended as transmembrane regions, it is still the case that the skilled artisan would have understood proteins and peptides to have been generally hydrophilic. As such, for encapsulation of proteins into PLA microspheres, the skilled artisan would have had a reasonable expectation that the double emulsion technique would have been successful in encapsulating proteins and peptides but would not have had a reasonable expectation that the single emulsion technique would have been successful in encapsulating proteins and peptides.
Further in support of this position, the examiner notes Lassalle et al. (Macromolecular Bioscience, Vol. 7, 2007, pages 767-783), which is drawn to the formation of PLA microparticles. Lassalle appears to provide a similar teaching as of page 776, right column, top paragraph, relevant text reproduced below.
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As such, the teachings of Lassalle appear to be similar to those of Iqbal.
Instant Claims Do Not Recite Double Emulsion: Looking at the instant claims, it does not appear that the instant claims recite a double emulsion. In fact, instant claim 12 appears to be specifically drawn to a single emulsion. See the following text reproduced below.
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The above-reproduced text appears to indicate a single oil phase and a single aqueous phase. This appears to be a single emulsion rather than a double emulsion.
With that being said, the examiner will proceed in examination with the understanding that claim 1 does not exclude a double emulsion. See the section above entitled “Claim Interpretation.”
Examples in Specification Do Not Disclose Double Emulsion: Additionally, the examiner reviewed the examples in the instant specification and noted that the examples do not appear to be drawn to double emulsions. See e.g. embodiment 3 on page 6 of the specification, which is reproduced below.
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This example does not include an internal water phase separate from an internal oil phase and therefore does not appear to be drawn to a double emulsion.
Specification Does Disclose Albumin Addition After Particle Formation However This is Not Recited by Claims: The instant specification does appear to disclose addition of bovine serum albumin (BSA) to an already-formed particle. See the instant specification on pages 12-14, Experimental Example 3, wherein text is reproduced in part below.
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Later data on page 13 of the specification indicates that BSA does successfully adsorb to the particles formed by the recited method.
With that being said, based upon the above-reproduced text, it is unclear if Experimental Example 3 of the instant specification is intended to be drawn to loading of BSA for drug delivery, or is intended to model the effects of the particle after in vivo administration with BSA in the experiment acting as a model for blood plasma or another naturally occurring substance in the body. As such, given this lack of clarity, it is unclear as to whether the specification actually discloses successful loading of a protein after formation of the particle. Additionally, this feature is not actually recited by the instant claims.
No Rejection for Lack of Enablement for This Reason: The examiner notes that according to MPEP 2164.08(c), a feature which is taught as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112. With that being said, the presence of a hydrophilic drug does not actually appear to be critical because the description in the specification on page 1, paragraph 0004 appears to indicate that particles lacking drugs are useful for medical cosmetology and as dermal fillers. As such, the instant claims are not rejected for lacking enablement.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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.
Claim(s) 1 is is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panda et al. (US 2013/0259948 A1).
Panda et al. (hereafter referred to as Panda) is drawn to spray-dried powder formulations for vaccines, as of Panda, title and abstract. Panda teaches the following in one embodiment, as of Panda, pages 4-5, Example 1, partially reproduced below.
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Figure 1 is cited in the above-reproduced text and is reproduced below.
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As to claim 1, step S01, the solution of polymer in dichloromethane is understood to read on the required spray solution.
As to claim 1, step S02, the above-reproduced figure teaches emulsification.
As to claim 1, step S03, Panda teaches lyophilization at the end of paragraph 0105; this is understood to be a drying step.
The examiner notes here that Panda teaches a double emulsion, which is not recited by the instant claims. Nevertheless, claim 1 does not actually appear to exclude a double emulsion due to the “comprising” language in the claim. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03(I).
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lassalle et al. (Macromolecular Bioscience, Vol. 7, 2007, pages 767-783).
Lassalle et al. (hereafter referred to as Lassalle) is drawn to preparation of microparticles and nanoparticles made from poly(lactic acid), which Lassalle abbreviates as PLA, as of Lassalle, page 767, title and abstract. Lassalle teaches the following method on page 769, right column, bottom paragraph, relevant text reproduced below.
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As to S01, the solution of PLA in chloroform is understood to read on the requires spray solution.
As to S02, the step of adding PLA dissolved in chloroform with PVA dissolved in aqueous solution is understood to read on the required homogeneous emulsification.
As to S03, the drying step by stirring to evaporate chloroform is understood to read on the required drying step.
As to claim 5, Panda teaches 50 mg/mL PLA in dichloromethane, as of paragraph 0094. This is the same as 50 g/L PLA.
Claim Rejections - 35 USC § 103 – Obviousness
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) 1-5 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panda et al. (US 2013/0259948 A1) in view of Lassalle et al. (Macromolecular Bioscience, Vol. 7, 2007, pages 767-783).
Panda is drawn to formulation of PLA microparticles through an emulsion followed by spray drying. See the rejection above over Panda by itself.
For the purposes of this rejection, the examiner understands that Panda fails to teach the macromolecular substances (other than PLA) required by claim 2, and that the vaccine active ingredient of Panda does not read on the required macromolecular substance.
Lassalle et al. (hereafter referred to as Lassalle) is drawn to methods of preparation of microparticles and nanoparticles made from PLA, as of Lassalle, title and abstract. See the rejection above over Lassalle by itself. Lassalle teaches chitosan and polyvinyl alcohol as macromolecular substances to be used in addition to the PLA, as of Lassalle, page 778, right column, bottom paragraph.
Lassalle is not anticipatory with respect to claim 2 because Lassalle does not teach the ratio of the oil phase to aqueous phase.
It would have been prima facie obvious for one of ordinary skill in the art to have included the macromolecular substances of Lassalle in the method of Panda. Panda is drawn to the formation of PLA microparticles. Lassalle is also drawn to formulation of particles from PLA and/or PLGA, and teaches that use of polyvinyl alcohol and chitosan in the aqueous phase results in a more unimodal size distribution. As such, the skilled artisan would have been motivated to have incorporated the polyvinyl alcohol and chitosan of Lassalle into the aqueous phase in the method of Panda to have predictably increase the unimodality of the particle size distribution with a reasonable expectation of success. The examiner notes that although the example of Lassalle, page 778, right column, bottom paragraph applies to PLGA rather than PLA, the skilled artisan would have expected that results applicable to PLGA in the prior art would have also been applicable to PLA because of the similar chemistry between PLA and PLGA.
As to claim 2, the claim requires a particular range of amounts of oil phase and aqueous phase. Both Panda and Lassalle teach the combination of an oil phase and an aqueous phase; however, it is not clear if the ratio of these ingredients is taught by the references. Nevertheless, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of mixing an oil phase with a water phase has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of these ratios by routine experimentation. Additionally, it is prima facie obvious to optimize a result-effective variable. See MPEP 2144.05(II)(B). In this case, the prior art teaches both an oil in water (o/w) emulsion as well as a water-in-oil (w/o) emulsion that is being used as the primary emulsion in a water-in-oil-in-water (w/o/w) emulsion, as of Lassalle, page 769, right column. The skilled artisan would have been aware that in an o/w emulsion, the amount of water exceeds the amount of oil, whereas in a w/o emulsion, the amount of oil exceeds the amount of water. As such, the skilled artisan would have been motivated to have optimized the ratios of water to oil in order to have predictably formulated either an o/w emulsion or a w/o emulsion with a reasonable expectation of success.
As to claim 2, the claim recites that the oil phase comprises PLA and an organic solvent. This is taught by both Panda and Lassalle. Lassalle teaches PLA dissolved in chloroform on page 769, right column, bottom paragraph, and Panda teaches PLA dissolved in dichloromethane in paragraph 0094.
As to claim 2, the claim requires a surfactant in the aqueous phase. Panda teaches mixing an emulsifier with the water phase in the primary emulsion in paragraph 0086; the examiner understands an emulsifier to be a surfactant. Lassalle also teaches surfactants in the aqueous phase, as of Lassalle, page 770, right column, section entitled “b) Surfactants” which is reproduced in part below.
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As to claim 2, the claim requires a macromolecular substance. The polyvinyl alcohol of Lassalle is understood to read on this requirement.
As to claim 2, the claim requires deionized water. Both Panda and Lassalle teach water for the aqueous phase; see e.g. Panda, paragraph 0124 and Lassalle, page 769, right column, first two paragraphs. The skilled artisan would have been motivated to have used deionized water in order to increase uniformity, as deionized water always lacks significant amount of salt whereas “regular” water may vary with regard to salt content and result in more inter-batch variability.
As to claim 3, the claim recites PLA with a molecular weight of 50,000 to 95,000 Daltons. Panda teaches PLA with a slightly lower molecular weight of 45,000 Daltons (which Panda writes as 45 kDa) as of Panda, paragraph 0094. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of forming an emulsion from PLA have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have optimized the molecular weight of PLA via routine experimentation.
As to claim 4, Panda teaches PLA dissolved in dichloromethane in paragraph 0094.
As to claim 5, Panda teaches 50 mg/mL PLA in dichloromethane, as of paragraph 0094. This is the same as 50 g/L PLA.
As to claim 7, this claim appears to further limit claim 2 by requiring ranges of ingredients of the surfactant and macromolecular substance. These features are taught by Panda and Lassalle, though the references do not appear to teach the required amounts of these ingredients. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence of criticality. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a method of making a PLA microsphere with a surfactant and polyvinyl alcohol (which is a macromolecular substance) has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of these ingredients via routine experimentation.
As to claim 8, Panda teaches treatment at 5000-10,000 rpm for 10 minutes, apparently at room temperature, as of paragraph 0105. The revolution speed and time appears to overlap with the claimed requirements. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). The temperature in the prior art appears to differ from the claimed temperature. Nevertheless, generally, differences in temperature between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such temperature is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided.
Claims Not Rejected Herein: This rejection does not apply to claim 6. This is at least because there would have been no motivation for the skilled artisan to have substituted a mixture of sodium alginate, whey protein, and β-glucose in the recited amounts in place of polyvinyl alcohol. This is because polyvinyl alcohol is a known stabilizer for the outer phase of water-in-oil-in-water double emulsions, as of Lassalle, at least page 770, left column, top paragraph. There would have been no reasonable expectation that a mixture of sodium alginate, whey protein, and β-glucose in the recited amounts would have had the ability to stabilize the outer phase of a w/o/w double emulsion in the same manner as polyvinyl alcohol.
This rejection does not apply to claim 9 as well as claim 12 and claims dependent thereon. This is because claim 9 recites the use of compressed air with a pressure higher than atmospheric pressure, as the minimum pressure recited by claim 9 is 0.3 MPa whereas atmospheric pressure is about 0.1 MPa. This is not recited by the prior art. Also, the required inlet and outlet temperatures are not recited by the prior art. This rationale also applies to the examiner’s decision not to reject claim 12 over prior art.
This rejection does not apply to claim 12 and claims dependent thereon. This is because claim 12 appears to be drawn to spray drying of a single oil in water emulsion rather than a double emulsion that is a water-in-oil-in-water emulsion. The skilled artisan would not have been motivated to have modified Panda to have been a single oil-in-water emulsion rather than a double emulsion. This is because Panda is drawn to delivery of a hydrophilic vaccine. The skilled artisan would have expected an oil-in-water emulsion to have been wholly unsuitable for delivery of a hydrophilic vaccine. See the section above entitled “Claimed Invention Appears Not Useful for Protein/Peptide Drug Delivery.”
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights