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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the species listed below in the reply filed on 6/2/2026 is acknowledged.
The following species were elected by Applicant:
Biologically active agent – azacitidine;
Metal oxide – Mixture of zinc and aluminum oxides;
Anti-inflammatory agent – indomethacin; and
Extended release component - Mixture of zinc and aluminum oxides.
Claims 1, 16, 20, 29-30, 39-42 and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 2. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim 36 recites “an injection or infusion means”. The specification provides the structure of “syringe with a needle for injection, a catheter.”
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 24 and 36 are objected to because of the following informalities:
Claim 24 recites “salts of any of these active ingredients,” this should recite “salts thereof”.
Claim 36 recites multiple instances of “which particles” or “which formulation” these should recites “wherein the particles” and “wherein the formulation” so they properly refer back to the claimed particles and formulation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 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 36 recites “associated with, an injection or infusion means” the use of “associated with”renders the claim indefinite because it is unclear what “associated with” means. For example, “associated with” could mean that the reservoir is directly connected to the injection/infusion means, or it could be indirectly connected or it could simply need to be capable of being connected, thus rendering the metes and bounds of the claim unclear. For purposes of examination, any interpretation will be deemed to read on the claim.
Claims 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 are rejected in view of their dependency on claim 32 as they do not cure its deficiencies and thus are deficient for the same reasons.
Claim 36(c) recites “to which an extended-release component is also applied…” the phrase “is also applied” renders the claim indefinite as it implies that an extended-release component was already applied to a different part of the formulation, however this is not recited nor required by the claim. While claim 36(b) recites a coating, this coating isn’t limited to an extended-release coating, thus rendering the metes and bounds of the claim indefinite. For purposes of examination, the only extended release component required is for the anti-inflammatory component as recited by instant claim 36(c).
Claims 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 are rejected in view of their dependency on claim 32 as they do not cure its deficiencies and thus are deficient for the same reasons.
Claim 38 recites the active method steps of “wherein the coated particles and the carrier are housed separately…admixing…” The use of active method steps in a product claim renders the metes and bounds of the claim indefinite as claim 38 depends from claim 36 which requires the formulation to comprise the particles suspended in a carrier present in a reservoir, thus it’s unclear how the particles can both be suspended in the carrier in a reservoir, while also being housed separately. For purposes of examination, the claim will be examined as reciting an intended use of the composition (i.e. it only needs to be capable of being housed separately and mixed together prior to administration).
Claim 4 recites “the extended-release components for an extended release of said…” There is insufficient antecedent basis for this limitation in the claim as claim 36 does not require the biologically active agent to have an extended release component.
Claim 6 recites “the coating material” There is insufficient antecedent basis for this limitation in the claim as claim 36 recites “at least one coating material” and it’s unclear if “the coating material” is referring back to one, more than one or all the coating materials.
Claim 7 is rejected in view of its dependency on claim 6 as it does not cure its deficiencies and therefore is deficient for the same reasons.
Claim 8 recites “the coating material” There is insufficient antecedent basis for this limitation in the claim as claim 36 recites “at least one coating material” and it’s unclear if “the coating material” is referring back to one, more than one or all the coating materials.
Claim 8 recites “separate mixture of zinc oxide…” the use of “separate” in combination with “mixture” renders the claim indefinite as a mixture implies a combination of two distinct components, but separate implied the opposite of a mixture. For purposes of examination, a mixture of Zinc oxide and metal/metal oxide in the same layer or coating will be deemed to read on the claim as well as the presence of Zinc oxide and metal/metal oxide in distinct layers/coating.
Claim 23 recites “or a related substance”, this render the metes and bounds of the claim indefinite as its unclear how far one can deviate from acetic acid without the “related substance” being so far removed as to be a completely different compound. The specification fails to provide a limiting definition of this phrase.
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) 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (WO 2014/187995) and Lichtenberger (US 2005/0058699). Carlsson is cited on the 11/4/2024 IDS.
Regarding claim 36: Carlsson teaches solid nanoparticles (NPs) with inorganic coatings. The NPs have a solid core comprising a biologically active substance, said core being enclosed by an inorganic coating (Abs). Carlsson teaches that the NPs can be administered parenterally in the form of a sterile injectable or infusible preparation, for example as a sterile aqueous or oleaginous suspension of the NPs (pg. 23). However, Carlsson does not teach the formulation to be contained within a reservoir.
Lichtenberger discloses sterile preparations comprising anti-inflammatory agents which are administered via injection. Lichtenberger teaches an injection apparatus including a reservoir including a volume of a composition of this invention sufficient to cause a desired pharmacological effect, a plunger operably connected to the reservoir and a needle operably connected to an other end of the reservoir, where the volume is injected through the needle when the plunger is depressed (Abs and [0016]).
It would have been prima facie obvious to modify the teachings of Carlsson with those of Lichtenberger and house the injectable formulation of Carlsson in the injection apparatus of Lichtenberger, reading on surgical administration apparatus connected to an injection means, as Lichtenberger teaches that this is a known way to administering an injectable formulations and its prima facie obvious for a skilled artisan to pursue the known options within his or her technical grasp to administer an injectable formulations.
Regarding claims 36a and 13: Carlsson teaches NPs (i.e. reading in a plurality of particles), comprising the solid core comprising a biologically active substance and any inorganic coating(s) (i.e. reading on coating material), to have a size, expressed as the diameter of the particle ranging from 1-10nm to about 50µm (pg. 8), the form can be spherical but any other form is possible. For a non-spherical particle, the size may be indicated as the size of a corresponding spherical particle of e.g. the same weight, volume or surface area (pg. 9). While Carlsson does not teach the diameter to be weight-, number- or volume-based mean diameter, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claims 36a and 15: Carlsson teaches the that the coating layers are preferably applying via atomic layer deposition (i.e. gas phase deposition technique).
Regarding claim 36b: As discussed above, Carlsson teaches suspending the NPs in an aqueous suspension (i.e. carrier system comprising a pharmaceutically acceptable carrier).
Regarding claim 36c: Carlsson teaches that the formulation can comprise NPs of different active ingredients and/or different release profiles (pg. 22). Carlsson also teaches that anti-inflammatory agents are suitable for use in the NPs (pg. 10) and teaches that the inorganic coating layer totally encapsulates the drug and the thickness of the layer can be varied and controlled, meaning that the drug release can be controlled with layer thickness (pg. 2) and teaches the drug release may be extended (pg. 21), thus it would have been prima facie obvious for a skilled artisan to formulate a set of NPs to have an anti-inflammatory agent along with NPs comprising a distinct biologically active agent and optimize the coating to achieve a desired release profile, for example, extended release.
Regarding claim 36d: While the prior art is silent to the formulation “forming a depot…” this is a resultant property of the claimed composition that occurs after administration of the composition. The prior art makes obvious the structure of the claimed formulation and dosage form and teaches that the formulation can be administered subcutaneously or intramuscularly (pg. 23), as such upon injection in the manner claimed the composition of Carlsson would be expected to form a depot as a composition and its properties are inseparable.
Regarding claim 38: As discussed above, Carlsson teaches adding the NPs to an aqueous suspension for create an injectable composition, as such the NPs of Carlsson and the carrier would be expected to be capable of being housed separately and mixed together prior to use.
Regarding claim 4: As discussed above, Carlsson teaches that the inorganic coating layer totally encapsulates the drug and the thickness of the layer can be varied and controlled, meaning that the drug release can be controlled with layer thickness (pg. 2) and teaches the drug release may be extended (pg. 21). Carlsson also teaches that the NPs can have different release profiled and/or different active agents and teaches that the first release profile may overlap with the second release profile or they don’t have to overlap, suggesting that the NPs can have the same or different release profiles and a skilled artisan would have been motivated to optimize the coating layers of each set of NPs to obtain a desired release profile for each population of NPs.
Regarding claim 6-7: Carlsson teaches that the inorganic coating comprises one or more metals of metal containing compounds (i.e. metal oxides) (pg. 11) and this includes zinc oxide (pg. 13).
Regarding claims 8-9: Carlsson teaches that each coating layer can comprise a mixture of two or more metal oxides, mixture of different metal oxides can be used to modify the properties of the layer and adapt it to specific demands. Suitable metal oxides for use include zinc oxide and aluminum oxide (selected from a finite number of options) (pg. 13, lines 10-11). Carlsson also teaches that if the coating layer comprises more than 1 layer, each layer can be composition of different metal oxides, thus it would have been prima facie obvious to formulate an NP having a layer of zinc oxide and one of aluminum oxide (reading on a 1:1 atomic ratio). A skilled artisan would have also been motivated to optimize the specific mixture and/or layers of different metal oxide as this is taught to affect the properties of the layers and would affect the final properties of the NPs.
Regarding claim 10: As discussed above, Carlsson makes obvious NPs comprising multiple layers of metal oxides (reading on discrete layers) and teaches that when more than one layer is applied to the core, one layer is applied, the core is agitated and a subsequent layer is applied, reading on sequentially.
Regarding claim 19: Carlsson teaches that suitable biologically active substances include chemotherapeutics (pg. 10).
Regarding claim 21: Carlsson teaches that a suitable biologically active substance for use include paclitaxel (pg. 11).
Regarding claims 23-24: Carlsson teaches that a suitable biologically active substance for use include ibuprofen (i.e. a non-steroidal anti-inflammatory agent) (pg. 11).
Regarding claim 27: As discussed above, Carlsson makes obvious NPs having a population of anti-inflammatory particles with a diameter ranging from 1-10nm to 50µm, which are coating with an inorganic coating material (i.e. a metal oxide) that be modified to alter the release of the active agent and formulate the particles to have extended release and a skilled artisan would have been motivated to optimize the coating layers of each set of NPs to obtain a desired release profile for each population of NPs.
Claim(s) 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (WO 2014/187995) and Lichtenberger (US 2005/0058699), as applied to claims 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 above, and further in view of Newell (US 8,071,645) and Qin (US 2014/0314664)
As discussed above, the prior art makes obvious the limitations of claims 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27, but do not teach the biologically active agent to be azacitidine as elected.
As noted above, Carlsson teaches that anti-cancer and chemotherapeutic agents can be used and teaches that the drug is poorly water soluble (pg. 10), a suitable active for use is paclitaxel.
Newell teaches method of treating cancer (abs) through injection, suitable chemotherapeutics for use include paclitaxel and azacitidine (Newell – claims 8 and 34).
Qin teaches azacitidine to be water insoluble or poorly water soluble (Qin – claim 7).
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 modify the teachings of the above reference with those of Newell and Qin and use azacitidine as an anti-cancer agents as Carlsson teaches that paclitaxel is a suitable agent for use and Newell and Qin shows paclitaxel and azacitidine to be art recognize equivalent anti-cancer agent which are poorly soluble in water and its prima facie obvious to substitute one art recognized equivalent for another.
Claim(s) 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (WO 2014/187995) and Lichtenberger (US 2005/0058699), as applied to claims 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27 above, and further in view of Maione (US 5,284,827) and Bellamy (US 2005/0169997)
As discussed above, the prior art makes obvious the limitations of claims 36, 38, 4, 6-10, 13, 15, 19, 21, 23-24 and 27, but do not teach the anti-inflammatory agent to be indomethacin as elected.
As noted above, Carlsson teaches that anti-cancer and chemotherapeutic agents can be used and teaches that the drug is poorly water soluble (pg. 10), a suitable active for use is ibuprofen or ketoprofen.
Maione teaches treating cancer (abs) via injection (Maione – claim 1) and teaches that indomethacin can be used as an anti-inflammatory agent along with ibuprofen or ketoprofen (col. 12, lines 60-67 to col. 13, lines 1-5).
Bellamy teaches indomethacin to be poorly water soluble (Bellamy – claim 3).
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 modify the teachings of the above reference with those of Maione and Bellamy and use indomethacin as an anti-inflammatory agents as Carlsson teaches that ibuprofen and ketoprofen are suitable agents for use and Maione and Bellamy shows ibuprofen, ketoprofen and indomethacin to be art recognize equivalent anti-inflammatory agents which are poorly soluble in water and its prima facie obvious to substitute one art recognized equivalent for another.
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 Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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