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 with traverse of Group I, claims 1-2, 4-7, 9, 16, 18-23, 27, and 30-32 and DOTAP as the permanently cationic lipid in the reply filed on 04/27/2026 is acknowledged.
The traversal is on the grounds that the pending claims are linked by a common special technical feature. Applicant argues that the lipid nanoparticle has a diameter of from about 160 nm to about 900 nm and the common size limitation constitutes a special technical feature that confers novelty and inventiveness over the cited art.
The Examiner disagrees that the diameter of the particles is a special technical feature that confers novelty. Ramunas discloses a polynucleotide encapsulated in a lipid nanoparticle administered by intravenous injection to deliver polynucleotides to the lung of a subject (abstract; claim 1). Ramunas discloses that the particle diameter of the lipid membrane structures are 10-500 nm [0256].
Groups I-III lack unity of invention, and do not make a contribution to the art, in view of Ramunas (WO 2022/212576 A1) (nor in view of Patil et al. WO 2022/132926 A1 – discussed below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 33, 35, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 2 is objected to because of the following informality:
Claim 2 recites “The lipid nanoparticle claim 1” and should recite “The lipid nanoparticle of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
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 6-7, 9, 16, 18, and 22 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 6, 7, and 9 recite the limitation “the permanently cationic lipid". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claims can each depend from claim 2 where “a permanently cationic lipid” is introduced or “a permanently cationic lipid” can be incorporated into the subject matter of claim 1.
Claims 16 and 18 recite the limitation “the ionizable lipid". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claims can each depend from claim 2 where “an ionizable lipid” is introduced or “an ionizable lipid” can be incorporated into the subject matter of claim 1.
Claim 22 recites the limitation “the steroid". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claim can depend from claim 21 where “a steroid” is introduced or “a steroid” can be incorporated into the subject matter of claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-7, 9, 19-22, and 27 are rejected under 35 U.S.C. 102 as being as being anticipated by Patil et al. (WO 2022/132926 A1).
Claim 1 is anticipated because Patil discloses in Table 2 (pg. 59) a lipid nanoparticle (DOE-7) with a particle size of 184.9 nm and a positive surface charge (17.3 mV).
If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03.
Further regarding claim 1, the limitation “for use in delivering or expressing a therapeutic agent in the lung of a subject, wherein the lipid nanoparticle is administered intravenously, intraarterially, or intraperitoneally to a subject” is interpreted as an intended use of the lipid nanoparticle and does not carry patentable weight.
Claim 4 is anticipated because lipid nanoparticle has a diameter of 184.9 nm (DOE-7, Table 2, pg. 59).
Claim 5 is anticipated because lipid nanoparticle has a zeta potential of 17.3 mV (DOE-7, Table 2, pg. 59).
Claim 6 is anticipated because the lipid nanoparticle contains a permanently cationic lipid (DOTAP) in an amount of 25 mol % (DOE-7, Table 2, pg. 59).
Claim 7 is anticipated because the permanently cationic lipid is DOTAP (DOE-7, Table 2, pg. 59), which has a pKa of greater than about 10.
Claim 9 is anticipated because the lipid nanoparticle contains the permanently cationic lipid, DOTAP (DOE-7, Table 2, pg. 59).
Claim 19 is anticipated because the lipid nanoparticle contains the phospholipid, DOPC (DOE-7, Table 2, pg. 59).
Claim 20 is anticipated because the lipid nanoparticle contains the phospholipid, DOPC, in an amount of 10 mol % (DOE-7, Table 2, pg. 59).
Claim 21 is anticipated because the lipid nanoparticle contains the steroid, cholesterol (DOE-7, Table 2, pg. 59).
Examiner’s Note: The instant specification states that “in general, the term "about" can modify a numerical value above and below the stated value by a variance of, e.g., 10 percent, up or down (higher or lower).” [0055].
Claim 22 is anticipated because the lipid nanoparticle contains the steroid, cholesterol, in an amount of 64.75 mol % (DOE-7, Table 2, pg. 59), which is about 60 mol %.
Claim 27 is anticipated because a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a lipid nanoparticle with the same components (e.g., lipid components and amounts) (DOE-7, Table 2, pg. 59), the properties the applicant discloses and/or claims (pKa of greater than about 7) are necessarily present.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-7, 9, 19-23, and 27 are rejected under 35 U.S.C. 103 as being as being obvious over Patil et al. (WO 2022/132926 A1).
Patil et al. is believed to be anticipatory as described above, but in the interest of completeness of prosecution, purely arguendo, and for the purposes of this ground of rejection only, Patil will be interpreted as if it is not anticipatory.
In that case, Patil could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention because Patil does not explicitly state that DOE-7 is “for use in delivering or expressing a therapeutic agent in the lung of a subject, wherein the lipid nanoparticle is administered intravenously, intraarterially, or intraperitoneally to a subject”. As discussed above, this is interpreted as an intended use of the lipid nanoparticle, nevertheless, Patil discloses that the particles are used for delivering a therapeutic agent to the lung of a subject (abstract) and may be delivered by intravenous injection (pg. 22, paragraph 2).
Claim 1 is rendered prima facie obvious because Patil discloses in Table 2 (pg. 59) a lipid nanoparticle (DOE-7) with a particle size of 184.9 nm and a positive surface charge (17.3 mV). Patil discloses that the particles are used for delivering a therapeutic agent to the lung of a subject (abstract) and may be delivered by intravenous injection (pg. 22, paragraph 2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 4 is rendered prima facie obvious because Patil discloses the lipid nanoparticle has a diameter of 184.9 nm (DOE-7, Table 2, pg. 59). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 5 is rendered prima facie obvious because Patil discloses the lipid nanoparticle has a zeta potential of 17.3 mV (DOE-7, Table 2, pg. 59). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 6 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains a permanently cationic lipid (DOTAP) in an amount of 25 mol % (DOE-7, Table 2, pg. 59). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 7 is rendered prima facie obvious because Patil discloses the permanently cationic lipid, DOTAP (DOE-7, Table 2, pg. 59), which has a pKa of greater than about 10.
Claim 9 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains the permanently cationic lipid, DOTAP (DOE-7, Table 2, pg. 59).
Claim 19 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains the phospholipid, DOPC (DOE-7, Table 2, pg. 59).
Claim 20 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains the phospholipid, DOPC, in an amount of 10 mol % (DOE-7, Table 2, pg. 59). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 21 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains the steroid, cholesterol (DOE-7, Table 2, pg. 59).
Examiner’s Note: The instant specification states that “in general, the term "about" can modify a numerical value above and below the stated value by a variance of, e.g., 10 percent, up or down (higher or lower).”
Claim 22 is rendered prima facie obvious because Patil discloses the lipid nanoparticle contains the steroid, cholesterol in an amount of 64.75 mol % (DOE-7, Table 2, pg. 59), which is about 60 mol %. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 23, Patil does not disclose that embodiment DOE-7 includes a pegylated lipid. However, Patil does teach that the lipid particles of the disclosure may include a PEG-lipid conjugate to inhibit aggregation of particles (pg. 3, paragraph 3). The ordinarily skilled artisan would have been motivated to include a pegylated lipid within embodiment DOE-7 to inhibit aggregation of the particles.
Claim 27 is rendered prima facie obvious because a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art discloses a lipid nanoparticle with the same components (e.g., lipid components and amounts) (DOE-7, Table 2, pg. 59), the properties the applicant discloses and/or claims (pKa of greater than about 7) are necessarily present.
Claims 2, 16, 18, 27, and 30-32 are rejected under 35 U.S.C. 103 as being as being obvious over Patil et al. (WO 2022/132926 A1) in view of Ramunas et al. (WO 2022/212576 A1).
The 35 U.S.C. 103 rejection over Patil was previously discussed.
Additionally, Patil teaches that the lipid nanoparticles are used for delivering nucleic acids as the therapeutic agent [abstract] [claim 1].
Patil does not disclose that the lipid nanoparticles further include an ionizable lipid as recited in claim 2, wherein the amount of ionizable lipid is from about 15 mol % to about 60 mol % as recited in claim 16, wherein the ionizable lipid has a pKa of from about 7 to about 13 as recited in claim 18.
Ramunas teaches a lipid nanoparticle with an ionizable lipid in an amount of 10-50 mol % [abstract] (pg. 108, Table 6C). Specific examples of the ionizable lipids include SS-OP (pKa of about 6.4) (pg. 108, Table 6A) [0175]-[0218]. Ramunas teaches a nucleic acid can be introduced into a cell by encapsulating the nucleic acid in the lipid membrane structure containing an ionizable lipid and bringing it into contact with the cell [0248]. Ramunas teaches that a nucleic acid forms an electrostatic complex with the ionizable lipid and this LNP can be used as a drug delivery system for selectively delivering a nucleic acid or the like into a specific cell [0255].
Since Patil generally teaches a lipid nanoparticle for delivering therapeutic agents, such as nucleic acids, it would have been prima facie obvious to include an ionizable lipid, such as SS-OP, in the amount taught by Ramunas, because Ramunas teaches an ionizable lipid in a lipid nanoparticle for nucleic acid delivery. An ordinarily skilled artisan would be motivated to use an ionizable lipid because Ramunas teaches a nucleic acid can be introduced into a cell by encapsulating the nucleic acid in the lipid membrane structure containing an ionizable lipid and bringing it into contact with the cell [0248]. Ramunas teaches that a nucleic acid forms an electrostatic complex with the ionizable lipid and this LNP can be used as a drug delivery system for selectively delivering a nucleic acid or the like into a specific cell [0255].
Additionally, generally, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., cationic and ionizable lipids in lipid particles; ionizable lipid, such as SS-OP, in an amount of 10-50 mol %) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a lipid nanoparticle) to one of ordinary skill in the art. MPEP 2143.A.
Further regarding claim 18, specific examples of the ionizable lipids include SS-OP which has a pKa of about 6.4. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Regarding claim 27, an apparent pKa of greater than about 7 would reasonably be expected to be necessarily present in embodiment DOE-7 of Patil as discussed above, nevertheless, it would have been obvious to arrive at the claimed pKa value with the combined teachings of Patil and Ramunas through routine experimentation. Ramunas teaches that the lipid membrane may have a pKa from 5.5 to 7.2 and that the pKa can be adjusted by the composition of the components of the lipid membrane structure [0258]. Ramunas teaches that the pKa affects the charge of the lipid nanoparticle which affects the cellular uptake and delivery of nucleic acids [0219] [0257]. 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 condition of the pKa of the lipid nanoparticle has been taught by the prior art (Ramunas) and is known to be results effective (affects surface charge/cellular uptake and delivery of nucleic acids); as such, it would not have been inventive for the skilled artisan to have discovered the optimum pKa via routine experimentation.
Regarding claim 30, Patil discloses in Table 2 (pg. 59) a lipid nanoparticle (DOE-7) with DOTAP in an amount of 25 mol % and a particle size of 184.9 nm (DOE-7, Table 2, pg. 59).
Patil does not disclose that the lipid nanoparticles further include an ionizable lipid wherein the amount of ionizable lipid is from about 15 mol % to about 60 mol %, as recited in claim 30.
Ramunas teaches a lipid nanoparticle with an ionizable lipid in an amount of 10-50 mol % [abstract] (pg. 108, Table 6C). Ramunas teaches a nucleic acid can be introduced into a cell by encapsulating the nucleic acid in the lipid membrane structure containing an ionizable lipid and bringing it into contact with the cell [0248]. Ramunas teaches that a nucleic acid forms an electrostatic complex with the ionizable lipid and this LNP can be used as a drug delivery system for selectively delivering a nucleic acid or the like into a specific cell [0255].
Since Patil generally teaches a lipid nanoparticle for delivering therapeutic agents, such as nucleic acids, it would have been prima facie obvious to include an ionizable lipid in the amount taught by Ramunas, because Ramunas teaches an ionizable lipid in a lipid nanoparticle for nucleic acid delivery. An ordinarily skilled artisan would be motivated to use an ionizable lipid because Ramunas teaches a nucleic acid can be introduced into a cell by encapsulating the nucleic acid in the lipid membrane structure containing an ionizable lipid and bringing it into contact with the cell [0248]. Ramunas teaches that a nucleic acid forms an electrostatic complex with the ionizable lipid and this LNP can be used as a drug delivery system for selectively delivering a nucleic acid or the like into a specific cell [0255].
Furthermore, generally, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results, as discussed above.
Claim 31 is rendered prima facie obvious because Patil discloses a population of lipid nanoparticles with an average diameter of 184.9 nm (DOE-7, Table 2, pg. 59).
While Patil does not explicitly disclose that the particles are measured via dynamic light scattering, it is nevertheless, prima facie obvious to determine these values empirically, through methods known in the art such as DLS.
Claim 32 is rendered prima facie obvious because Patil discloses the particles are formulated with a pharmaceutically acceptable carrier (claim 14).
Claims 1-2, 4-7, 9, 16, 18-23, 27, and 30-32 are rejected under 35 U.S.C. 103 as being as being obvious over Ramunas et al. (WO 2022/212576 A1).
Regarding claim 1, Ramunas discloses lipid nanoparticle formulations with a cationic lipid, such as DOTAP [claim 39], in an amount between 20-80 mol %, an ionizable lipid in an amount of 10-50 mol %, a structural lipid, such as the phospholipid, DOPC [claim 44], in an amount of 0-15 mol %, the steroid, cholesterol, in an amount of 0-40 mol %, and an insulator lipid, such as a PEGylated lipid [0173] (pg. 108, Table 6C). Ramunas discloses that the particle diameter of the lipid membrane structures are 10-500 nm [0256] and that the surface charge may be positive, for example, + 5 mV [0257].
Ramunas is not believed to be anticipatory because Ramunas could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose to formulate the lipid nanoparticle to have a diameter of 10-500 nm as taught at paragraph [0256] and a positive surface charge, for example, + 5 mV as taught at paragraph [0257].
Nevertheless, claim 1 is rendered prima facie obvious over the teachings of Ramunas, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., lipid components, particle size, and surface charge) were known in the prior art (e.g., Ramunas) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a lipid nanoparticle) to one of ordinary skill in the art. MPEP 2143.A.
In regards to the diameter of the particles, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Further regarding claim 1, the limitation “for use in delivering or expressing a therapeutic agent in the lung of a subject, wherein the lipid nanoparticle is administered intravenously, intraarterially, or intraperitoneally to a subject” is interpreted as an intended use of the lipid nanoparticles, nevertheless, the particles appear to be capable of meeting the intended use because Ramunas discloses the compositions are used to deliver therapeutic agents to the lung of a subject (abstract) and are delivered intravenously [0276].
Claim 2 is rendered prima facie obvious because Ramunas discloses the lipid nanoparticles include a permanently cationic lipid, such as DOTAP [claim 39], and an ionizable lipid (pg. 108, Table 6C).
Claim 4 is rendered prima facie obvious because Ramunas discloses that the particle diameter of the lipid membrane structures are 10-500 nm [0256]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 5 is rendered prima facie obvious because Ramunas discloses that the surface charge may be positive, for example, + 5 mV [0257]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 6 is rendered prima facie obvious because Ramunas discloses a cationic lipid, such as DOTAP [claim 39], in an amount between 20-80 mol % (pg. 108, Table 6C). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 7 is rendered prima facie obvious because Ramunas discloses the cationic lipid, DOTAP [claim 39], which has a pKa of greater than about 10.
Claim 9 is rendered prima facie obvious because Ramunas discloses the cationic lipid, DOTAP [claim 39].
Claim 16 is rendered prima facie obvious because Ramunas discloses an ionizable lipid in an amount of 10-50 mol % (pg. 108, Table 6C). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 18 is rendered prima facie obvious because Ramunas discloses specific examples of the ionizable lipids include SS-OP (pKa of about 6.4) (pg. 108, Table 6A) [0175]-[0218]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Claims 19 and 20 are rendered prima facie obvious because Ramunas discloses a structural lipid, such as the phospholipid, DOPC [claim 44], in an amount of 0-15 mol % (pg. 108, Table 6C). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 21 is rendered prima facie obvious because Ramunas discloses the lipid nanoparticles include the steroid, cholesterol (pg. 108, Table 6C).
Claim 22 is rendered prima facie obvious because Ramunas discloses the lipid nanoparticles include the steroid, cholesterol, in an amount of 0-40 mol % (pg. 108, Table 6C). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 23 is rendered prima facie obvious because Ramunas discloses the lipid nanoparticles include an insulator lipid, such as a PEGylated lipid [0173] (pg. 108, Table 6C).
Claim 27 is rendered prima facie obvious because Ramunas discloses the lipid nanoparticles have a pKa of 5.5 to 7.2 [0258]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 30, Ramunas discloses lipid nanoparticle formulations with a cationic lipid, such as DOTAP [claim 39], in an amount between 20-80 mol %, an ionizable lipid in an amount of 10-50 mol %, a structural lipid, such as the phospholipid, DOPC [claim 44], in an amount of 0-15 mol %, the steroid, cholesterol, in an amount of 0-40 mol %, and an insulator lipid, such as a PEGylated lipid [0173] (pg. 108, Table 6C). Ramunas discloses that the particle diameter of the lipid membrane structures are 10-500 nm [0256].
Ramunas is not believed to be anticipatory because Ramunas could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose to formulate the lipid nanoparticle to have a diameter of 10-500 nm as taught at paragraph [0256].
Nevertheless, claim 30 is rendered prima facie obvious over the teachings of Ramunas, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results, as discussed above.
In regards to the amount of the lipid components and the diameter of the particles, a prima facie case of obviousness exists because of overlap, as discussed above.
Claim 31 is rendered prima facie obvious because Ramunas discloses lipid particles with a particle diameter of 10-500 nm [0256], the particles are measured via dynamic light scattering [0564]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 32 is rendered prima facie obvious because Ramunas discloses the compositions include a pharmaceutically acceptable carrier [0290].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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