DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 March 2026 has been entered, and the arguments presented therein have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
The examiner clarifies that albuterol and salbutamol are understood to refer to the same compound. See e.g. Greenway (US 2018/0055848 A1), paragraph 0011. Applicant does not appear to dispute this.
Claim 1 has been amended to require that the composition is formulated for oral, intravenous, intraperitoneal, or subcutaneous administration. The examiner presents the following explanation regarding how this limitation will be interpreted for the purposes of examination under prior art.
The examiner notes that apparatus claims cover what a device is, not what a device does. As such, a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114(II). The examiner understands the rationale in MPEP 2114(II) to apply to chemical composition claims in the manner that it applies to apparatus claims. Therefore, for the purposes of examination under prior art, the examiner understands that a composition that could have been administered orally, intravenously, intraperitoneally, or subcutaneously to have meet the requirements of the last two lines of claim 1 even if the prior art does not teach this mode of administration. See also MPEP 2111.02(II), 2112(I & II), 2112.01(I & II), and 2144(IV), which are also relevant to this matter.
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 1-4, 6-12, and 14-15 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 “methyl ether-block-poly(lactide-co-glycolide) (PLGA)” as of the third and fourth line of claim 1. It is unclear how the term “block” further limits the claimed polymer. The examiner notes that the term “block” is frequently used in polymer science to refer to a block copolymer. This is a copolymer that comprises at least two polymer blocks, wherein each polymer block is made from the polymerization of particular monomers. A block copolymer differs from a random copolymer in that a block copolymer comprises a unit made entirely of the polymer formed by the polymerization of the first monomer separate from a unit made entirely of the polymer formed by the polymerization of the second monomer. As such, if e.g. the first monomer is hydrophobic and the second monomer is hydrophilic, this leads to a polymer with a hydrophobic region and a separate hydrophilic region, which would not occur with a random copolymer. See e.g. Oda et al. (Biomacromolecules, Vol. 12, 2011, pages 3581-3591), which explains block copolymers and compares them to random copolymers, as of at least page 3582, left column, figure 1, reproduced below.
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With that being said, in this case, “methyl ether” is not a polymer; as such, a methyl ether polymer block cannot form. As such, it is unclear how the phrase “block” further limits the claim requirements drawn to a methyl ether block of a certain polymer given that methyl ether, not being a polymer, cannot form a polymer block. This rationale occurs to the occurrence of the term “methyl ether-block” in the third and fourth lines of claim 1.
In regard to claim 1, lines 7-10, the examiner additionally notes that since PLGA comprises ester groups, an end modification of PLGA with a methyl group would likely have formed a methyl ester rather than a methyl ether.
For the purposes of examination under prior art, the examiner will examine the claims with the understanding that the phrase “methyl ether-block” in the third and fourth lines of claim 1 as well as the seventh through tenth lines of claim 1 does not further limit the claim.
With that being said, the examiner clarifies that the limitation “poly(ethylene glycol) methyl ether-block-poly(lactide-co-glycolide)” in the 5th and 6th lines of claim 1 appears to be definite. This is because in this case, there is a block copolymer with a poly(ethylene glycol) block and a poly(lactide-co-glycolide) block. The term “methyl ether” in this case limits the terminus of the poly(ethylene glycol) block, but is not a block of the polymer itself, and is therefore definite and understood to further limit the claim.
Response to Arguments Regarding Indefiniteness Issue
Applicant disputes the indefiniteness rejection, as of applicant’s response on 27 March 2026 (hereafter referred to as applicant’s response). In applicant’s response, page 6, applicant takes the following positions.
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In response, the examiner notes that Example 1 discloses the following, which is reproduced below.
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Example 3 discloses the following, which is reproduced below.
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The document provided with applicant’s response discloses the following.
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The examiner notes that all of these indicated disclosures disclose poly(ethylene glycol) methyl ether block poly(lactide-co-glycolide). The examiner takes the position that the claim requirement drawn to poly(ethylene glycol) methyl ether block poly(lactide-co-glycolide) is acceptable and is not indefinite. This is because such a disclosure teaches a block copolymer comprising a block of poly(ethylene glycol) bound to a block of poly(lactide-co-glycolide). This is a well-known block copolymer. In this case, the term “methyl ether” indicates that the end of the poly(ethylene glycol) block that is not bound to the poly(lactide-co-glycolide) block. The examiner takes the position that this language is acceptable. Therefore, the claimed requirement of “poly(ethylene glycol) methyl ether-block-poly(lactide-co-glycolide)” on the 5th and 6th line of claim 1 is acceptable and is not subject to a rejection under 35 U.S.C. 112(b).
However, claim 1 also recites “methyl ether-block-poly(lactide-co-glycolide)” on the third and fourth line of claim 1. This is not disclosed in either examples 1 or 2 and is not disclosed in the additional documents provided with applicant’s response. As such, applicant’s arguments do not make the case that “methyl ether-block-poly(lactide-co-glycolide)” is definite.
Additionally, the examiner took the following position on page 4 of the office action mailed on 13 February 2026.
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This position, which relates to the 7th through 10th lines of claim 1, does not appear to have been addressed by applicant in applicant’s arguments.
As such, applicant’s arguments are not persuasive. The examiner has made a clarification in the text of the above-applied indefiniteness rejection that the portion of claim 1 rejected is the requirement of “methyl ether-block-poly(lactide-co-glycolide)” in the third and fourth line of the claim.
Withdrawn Anticipation Rejection
Previously in the prosecution history of the instant application, the examiner rejected the instant claims as being both anticipated by and obvious over Beck-Broichsitter et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 23, No. 1, 2010, pages 47-57). The examiner has decided to withdraw the anticipation rejection over this reference. The examiner presents the following reasons in support of this position.
Beck-Broichsitter et al. (hereafter referred to as Broichsitter) is drawn to biodegradable salbutamol-loaded nanoparticles, as of Broichsitter, page 47, title and abstract. The nanoparticles described in the examples of Broichsitter, page 48, right column, as being made from poly(D,L-lactide-co-glycolide) (PLGA). The particular PLGA used by Broichsitter is known by the trade name “Resomer® RG 502 H” as of Broichsitter, page 48, right column, “Materials” section.
The examiner notes that the chemical identities of the “Resomer®” PLA/PLGA polymers have been set forth as of Sigma-Aldrich (http://www.sigmaaldrich.com/materialsscience/polymerscience/resomer.printerview.html accessed 25 October 2015), wherein relevant text has been reproduced below with annotation by the examiner.
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Briefly, Resomer RG 502H is a PLGA polymer with a 50/50 lactide/glycolide ratio, a molecular weight of between about 7000-17,000 Daltons, and which is carboxylic acid terminated as opposed to ester terminated. As best understood by the examiner, the nomenclature of Resomer polymers is such that in RG 502H, the “50” refers to a 50/50 lactide/glycolide ratio, the “2” refers to the molecular weight, (with higher numbers being higher molecular weights), and the “H” refers to carboxylic acid termination rather than ester termination.
As such, Broichsitter is no longer anticipatory at least because the molecular weight of the RG 502H PLGA of Broichsitter is slightly lower than the 20,000 Dalton molecular weight claimed.
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) 1-4, 8-12, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck-Broichsitter et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 23, No. 1, 2010, pages 47-57) in view of Varshosaz et al. (Research in Pharmaceutical Sciences, 12(3), June 2017, pages 222-232).
Beck-Broichsitter et al. (hereafter referred to as Broichsitter) is drawn to biodegradable salbutamol-loaded nanoparticles, as of Broichsitter, page 47, title and abstract.
As to claim 1, the claim requires nanoparticles comprising a polymer and a β2-adrenergic agonist. Broichsitter teaches salbutamol, which reads on the β2-adrenergic agonist, as well as poly(D,L-lactide-co-glycolide) (PLGA) in one embodiment, which reads on the required polymer, as of page 47, abstract.
Broichsitter does not teach the required molecular weight of the PLGA polymer. This is because Broichsitter teaches RG 502H, which has a molecular weight from 7000-17,000 Daltons, which is less than the 20,000 Daltons required by the instant claims
Varshosaz et al. (hereafter referred to as Varshosaz) is drawn to PLGA loaded nanoparticles comprising tadalafil, as of Varshosaz, page 222, title and abstract. These nanoparticles are intended to be delivered via dry powder inhaler, as of Varshosaz, page 222, title and abstract. Varshosaz teaches PLGA with a molecular weight of 24,000 to 38,000, as of Varshosaz, page 223, right column, section entitled “Materials.”
Varshosaz does not teach a β2-adrenergic agonist; also, the PLGA molecular weight in Varshosaz is slightly higher than what is claimed.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the PLGA of Broichsitter to have had characteristics taught by Varshosaz. Broichsitter is drawn to PLGA nanoparticles intended for delivery via inhalation. Varshosaz is also drawn to PLGA nanoparticles intended for delivery via inhalation. As such, the skilled artisan would have been motivated to have optimized the PLGA of Broichsitter to have had characteristics taught by Varshosaz in order to have rendered the PLGA suitable for inhalation with a reasonable expectation of success.
As to claim 1, the claim requires that the PLGA have a molecular weight of 20,000 [Daltons]. The PLGA of Broichsitter has a molecular weight of 7000-17,000 Daltons. The PLGA of Varshosaz has a molecular weight of 24,000 to 38,000 Daltons. These values overlap with the claimed value of 20,000 Daltons, resulting in a prima facie case of obviousness. 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). This overlap of range may be disclosed in multiple references; see MPEP 2144.05(I), last paragraph in section.
In the alternative as to claim 1, 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 PLGA nanoparticle for delivery of drugs via inhalation 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 range of molecular weight via routine experimentation.
As to claim 1, the claim requires that the composition is formulated for oral, intravenous, intraperitoneal, or subcutaneous administration. The examiner notes that Broichsitter teaches pulmonary administration, as of the reference title. This is different from the recited forms of administration. Nevertheless, the form of the composition of Broichsitter appears to be an aqueous liquid with nanoparticles suspended therein that is administered via inhalation, as of Broichsitter, paragraph bridging pages 48-49. This could have been administered via oral, intravenous, intraperitoneal, or subcutaneous administration even if this was not the method used by Broichistter, and is therefore sufficient to meet the claimed requirement. Composition claims are understood to cover what the composition is, not what the composition does. See MPEP 2114(II), wherein the rationale provided in the MPEP regarding apparatus claims is also understood to be relevant in regard to chemical composition claims. As the composition of Broichistter could have been administered via the required mode of administration, the composition of Broichsitter is understood to render the instantly claimed invention prima facie obvious for the reasons set forth above. See the section above entitled “Claim Interpretation” where this issue is discussed in greater detail. See also MPEP 2111.02(II), 2112(I & II), 2112.01(I & II), and 2144(IV), which are also relevant to this matter.
As to claim 2, as best understood by the examiner, the salbutamol would have been interspersed with the polymer in the composition of Broichsitter.
As to claim 3, the salbutamol of Broichsitter reads on the required albuterol of claim 3. As best understood by the examiner, salbutamol and albuterol refer to the same compound.
As to claim 4, the PLGA of Broichsitter is biodegradable and biocompatible.
As to claim 8, Broichsitter appears to teach spherical particles, as of Broichsitter, page 51, right column, figure 2, reproduced below.
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As to claim 9, Broichsitter teaches particle sizes of about 137 nm, as of Broichsitter, page 52, Table 2, reproduced below.
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As to claim 10, Broichsitter teaches that the active agent in the composition is capable of being released under physiological conditions, as of Broichsitter, page 53, figure 4, reproduced below.
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As to claim 11, the claim requires a particular concentration of active agent, as measured in the mass of the active agent per milligram of nanoparticles. Broichsitter measures drug loading as a percentage value, as of Broichsitter, page 51, Table 1 at top of page, wherein a value of 1.3% is measured at the top of the page. This would appear to be 13 micrograms of active agent per 1000 micrograms (i.e. 1 mg) of nanoparticle. This appears to exceed the claimed amount. Nevertheless, 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. See MPEP 2144.05(II)(A). In this case, there does not appear to be evidence that the concentration is critical. 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 PLGA nanoparticle encapsulating β-adrenergic agent have 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 the particles via routine experimentation.
As to claim 12, Broichsitter teaches the nanoparticles present in PBS (i.e. phosphate buffered saline) at pH 7.4, as of Broichsitter, page 54, left column, paragraph entitled “In vitro release studies.”
As to claims 14-15, Broichsitter teaches a method of making the particles that differs from the recited method. This is because Broichsitter the method used by Broichsitter on page 48, right column, bottom paragraph uses acetone and water, which are miscible solvents and do not form an emulsion. Nevertheless, product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. See MPEP 2113(I). In this case, the structure of Broichsitter appears to be the same as the claimed structure because it contains polymer nanoparticles comprising the required drug. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). In this case, the examiner has provided a rationale tending to show that the PLGA nanoparticle of Broichsitter is the same or similar to that of the claimed invention. This is sufficient to shift the burden to applicant in accordance with MPEP 2113(II).
Claim(s) 1-4, 6-12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller et al. (US 2018/0243227 A1) in view of Schnellmann et al. (US 2014/0024677 A1).
Heller et al. (hereafter referred to as Heller) is drawn to a drug nanoparticle for targeting the proximal tubules of the kidneys, as of Heller, title and abstract. The drug nanoparticle of Heller may be made from PLGA-mPEG, as of Heller, paragraph 0176. Heller teaches PLGA-PEG-COOH in paragraph 0164
Heller does not teach a β-adrenergic agent.
Schnellmann et al. (hereafter referred to as Schnellmann) is drawn to the treatment of acute kidney disease, as of Schnellmann, title and abstract. Schnellmann teaches formoterol for this purpose, as of the abstract, as well as paragraphs 0142-0143.
Schnellmann does not teach the required drug delivery vehicle.
It would have been prima facie obvious for one of ordinary skill in the art to have delivered formoterol, as of Schnellmann, to the kidney using the drug delivery vehicle of Heller. Schnellmann teaches that formoterol has therapeutic effectiveness in treating various kidney disease, and appears to suggest treating the kidneys with formoterol as of paragraph 0089. Heller is drawn to a drug delivery vehicle intended for delivery of therapeutic agents to the kidney. As such, the skilled artisan would have been motivated to have used the PLGA-PEG drug delivery vehicle of Heller to have predictably delivered the formoterol of Schnellmann to the kidney in order to have predictably treated kidney disease with a reasonable expectation of success.
As to claim 1, the claim requires PLGA with a molecular weight of 20,000 [Daltons]. Heller teaches PLGA with a molecular weight of 7 kDa (i.e. 7000 Daltons) to 54 kDa (i.e. 54,000 Daltons) in paragraph 0012. This overlaps with the claimed molecular weight of 20,000 Daltons (i.e. 24 kDa). 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).
As to claim 1, the claim recites various modes of administration. Heller teaches intravenous, oral, subcutaneous, and peritoneal administration in paragraph 0039.
As to claim 2, Heller teaches that the active agent is interspersed with the polymer.
As to claim 3, Schnellmann teaches formoterol, as of the abstract.
As to claim 4, the skilled artisan would have expected the PLGA-mPEG of Heller to have been biodegradable.
As to claims 6-7, Heller teaches PEG with a molecular weight of from 4 kDa to 7 kDa in paragraph 0012. These molecular weights overlap with the claimed molecular weights. 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).
As to claim 8, Heller teaches spherical morphology as of paragraph 0125 and figure 5.
As to claim 9, Heller teaches a particle size from 200 nm to 1000 nm in paragraph 0011.
As to claim 10, data in the figures of Heller such as figure 5B would appear to indicate that the active agent is released under physiological conditions.
As to claim 11, Heller teaches measuring the encapsulation efficiency of the particles, though it is unclear what the encapsulation efficiency measured by Heller actually is. With that being said, as best understood by the examiner, the encapsulation efficiency would have correlated with the amount of active agent per milligram of nanoparticle. 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 PLGA-PEG nanoparticle encapsulating active agent have 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 the amount encapsulated via routine experimentation.
As to claim 12, Heller teaches a pharmaceutically acceptable carrier as of paragraph 0043.
As to claims 14-15, Heller teaches a method of making particles as of paragraph 0165 of Heller; however, this method appears to occur via nanoprecipitation rather than via emulsion. Nevertheless, product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. See MPEP 2113(I). In this case, the structure of Heller appears to be similar to the claimed structure (with the exception of the drug) because it contains polymer nanoparticles made of the same polymer as in the claimed invention. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). In this case, the examiner has provided a rationale tending to show that the PLGA-PEG nanoparticle of Heller is the same or similar to that of the claimed invention. This is sufficient to shift the burden to applicant in accordance with MPEP 2113(II).
Response to Arguments Regarding Obviousness Rejections
Applicant has provided arguments regarding applicant’s response on 27 March 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
Arguments Regarding the Broichsitter and Varshosaz Reference Combination: Regarding the previously applied rejection over Broichsitter in view of Varshosaz, applicant argues that the prior art fails to teach a composition formulated for oral, intravenous, intraperitoneal, or subcutaneous administration, as of page 7 of applicant’s response.
In response, the examiner does not dispute that Broichsitter teaches pulmonary administration, which differs from the modes of administration recited by the last two lines of claim 1. Nevertheless, the examiner takes the position that this difference is insufficient to overcome the applied rejection. This is because the composition of Broichsitter could have been administered via oral, intravenous, intraperitoneal, or subcutaneous administration even if this was not the mode of administration intended by Broichistter. As best understood by the examiner, the composition of Broichsitter appears to be in the form of nanoparticles suspended in an aqueous medium. This could have been administered orally, as many drugs are administered orally in the form of an aqueous liquid. This could have also been administered via modes of injection such as intravenous, intraperitoneal, or subcutaneous administration as aqueous suspensions can be administered in this manner. For greater details regarding this issue, see the above section entitled “Claim Interpretation.” See also MPEP 2111.02(II), 2112(I & II), 2112.01(I & II), and 2144(IV), which are also relevant to this matter and which were cited in the above section entitled “Claim Interpretation.”
Arguments Regarding the Heller and Schnellmann Reference Combination: Regarding the previously applied rejection over Heller in view of Schnellmann, applicant argues that Heller is silent as to a nanoparticle comprising PLGA, PLGA-PEG, or any of the recited polymers, as of applicant’s response, page 8, top paragraph. The examiner disagrees. In support of this position, the examiner notes page 13 of the prior office action mailed on 13 February 2026, which is reproduced below.
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PLGA-mPEG and PLGA-PEG-COOH, as discussed in the above-reproduced paragraph, are species of PLGA-PEG. As such, contrary to applicant’s arguments, Heller teaches PLGA-PEG.
Applicant then makes the following arguments, as of page 8, relevant text reproduced below.
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Regarding Heller, it is the examiner’s position that Heller teaches nanoparticles, though the nanoparticles of Heller lack a β2-adrenergic agent. Regarding Schnellmann, it is the examiner’s position that Schnellmann teaches a β2-adrenergic agent, albeit not in the form of a nanoparticle. As such, the above-applied arguments appear to relate to Heller and Schnellmann by themselves rather than the combination of references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV).
Arguments Regarding Alleged Unexpected Results: Applicant makes arguments regarding alleged unexpected results, as of applicant’s response, page 8, end of first paragraph, relevant text reproduced below.
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In response, the examiner has reproduced a section of page 34 of the instant specification below.
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The above-reproduced text appears to be an admission that beneficial effects of 20,000 Dalton PLGA as compared with 55,000 Dalton PLGA were known in the art prior to the effective filing date of the instant application. As such, this would appear to support the idea that any improvement due to the use of 20,000 Dalton PLGA would appear to be an expected beneficial result. Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof. See MPEP 716.02(c)(II).
Regarding the specification on pages 36-37, these paragraphs appear to discuss particles made with 55,000 Dalton PLGA-PEG and particles made with 20,000 Dalton PLGA-PEG. These paragraphs appear to cite figures 13A and 13B of the application as well as Table 2 of the specification. These are reproduced below.
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An explanation of figure 13 is provided as of page 6 of the specification, wherein the relevant paragraph has been reproduced below.
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Nothing in the above-reproduced table, in figure 13, or in the explanation of figure 13 in the specification indicates that comparative testing has been conducted between PLGA of the claimed molecular weight as compared with PLGA having a molecular weight of 55,000 Daltons. As such, it is unclear that comparative testing has been conducted between PLGA of the claimed molecular weight as compared with PLGA of a molecular weight that differs from the claimed molecular weight. The burden is on applicant to establish that results are unexpected and significant, and applicant has the burden of explaining proffered data. See MPEP 716.02(b)(I & II). This burden has not been met by applicant because it is unclear as to what extent the data presented in the application actually relates to the claimed PLGA molecular weight.
Applicant also cited pages 49-50 of the specification as of page 8, top paragraph of applicant’s arguments. This portion of the specification cites figures 27 and 32. These figures are reproduced below.
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Explanations of these figures have also been provided by the specification on page 8, and are reproduced below.
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Nothing in figures 27 or 32 would appear to indicate that comparative testing has been conducted between PLGA of different molecular weights. As such, it is unclear that comparative testing has been conducted between PLGA of the claimed molecular weight as compared with PLGA of a molecular weight that differs from the claimed molecular weight. The burden is on applicant to establish that results are unexpected and significant, and applicant has the burden of explaining proffered data. See MPEP 716.02(b)(I & II). This burden has not been met by applicant because it is unclear as to what extent the data presented in the application actually relates to the claimed PLGA molecular weight.
Additionally, the examiner notes that in order to overcome a prima facie case of obviousness based upon unexpected results, the claimed invention must be compared with the closest subject matter that actually exists in the prior art. See MPEP 716.02(e). In this case, the PLGA particle of Broichsitter appears closer to the claimed invention than the comparative example. This is because the composition of Broichsitter has PLGA with a molecular weight of 7000-17,000 Daltons. This would appear to be closer to the claimed invention having a molecular weight of 20,000 Daltons than to the comparative example having a PLGA molecular weight of 55,000 Daltons. As such, the burden of comparing the claimed invention to the closest prior art does not appear to have been met by applicant.
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