DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed August 28, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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, 5-7, 9, 16, 18-23, 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).
Regarding claim 1, Patil discloses DOTAP (a permanently cationic lipid) lipid nanoparticles in the size range of 51-188 nm, with a surface charge between 0-26 mV (pg. 53, top). Patil teaches that the lipid particles of the disclosure may include a PEG-lipid conjugate, in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles (pg. 3, paragraph 3). 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). Patil teaches that the lipid nanoparticles are used for delivering nucleic acids as the therapeutic agent (abstract) (claim 1).
Patil does not disclose a working example with lipid nanoparticles in the size range of 180-900 nm and a PEG-lipid. However, the ordinarily skilled artisan would be motivated to include a PEG-lipid in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles as taught at pg. 3, paragraph 3.
Regarding the nanoparticle size, surface charge, and amount of pegylated lipid, 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.
Patil does not disclose that the lipid nanoparticles include an ionizable lipid.
Ramunas teaches a lipid nanoparticle with an ionizable lipid [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 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., ionizable lipids in lipid particles) 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 1, the claimed limitation of “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. 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 5 is rendered prima facie obvious because Patil the lipid nanoparticles have a surface charge between 0-26 mV (pg. 53, top). 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 nanoparticles include the permanently cationic lipid, DOTAP, in an amount of 20 mol % to 80 mol % (pg. 3, paragraph 2). 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 (pg. 53, top), 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 (pg. 53, top).
Regarding claims 16 and 18, 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 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 an amount of 10-50 mol %, because Ramunas teaches an ionizable lipid in this amount in a lipid nanoparticle for nucleic acid delivery. An ordinarily skilled artisan would be motivated to use an ionizable lipid, such as SS-OP, in the amount taught by Ramunas 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.
Claims 19 and 20 are rendered prima facie obvious because Patil discloses the lipid nanoparticles further include an additional lipid, such as the phospholipid DOPC, in an amount of 5 mol % to 20 mol % (pg. 4, paragraph 3). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 21 and 22 are rendered prima facie obvious because Patil discloses the lipid nanoparticles include the steroid, cholesterol in an amount of 10 to 20 mol.% (pg. 4, paragraph 2). A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 23, as previously discussed, Patil discloses that the lipid particles of the disclosure may include a PEG-lipid conjugate to inhibit aggregation of particles (pg. 3, paragraph 3). Patil discloses that the PEG-lipid conjugate may be DMG-PEG2000 (pg. 3, paragraph 3).
Regarding claim 27, 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 DOTAP (a permanently cationic lipid) lipid nanoparticles in the size range of 51-188 nm (pg. 53, top). Patil discloses the lipid nanoparticles include DOTAP in an amount of 20 mol % to 80 mol % (pg. 3, paragraph 2). Patil teaches that the lipid particles of the disclosure may include a PEG-lipid conjugate, in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles (pg. 3, paragraph 3). Patil teaches that the lipid nanoparticles are used for delivering nucleic acids as the therapeutic agent (abstract) (claim 1).
Patil does not disclose a working example with lipid nanoparticles in the size range of 51-188 nm and a PEG-lipid. However, the ordinarily skilled artisan would be motivated to include a PEG-lipid in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles as taught at pg. 3, paragraph 3.
Regarding the nanoparticle size and amount of lipids, 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.
Patil does not disclose that the lipid nanoparticles include an ionizable lipid in an amount of about 15 mol % to about 60 mol % of the total lipid present in the lipid nanoparticle 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 an amount of 10-50 mol %, because Ramunas teaches an ionizable lipid in this amount 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 a size range of 51-188 nm (pg. 53, top). A prima facie case of obviousness exists because of overlap, as discussed above. 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).
Response to Arguments
Applicant’s arguments filed 08/28/2026 have been fully considered but are not persuasive.
Applicant argues at pg. 11-12 that Patil fails to teach or suggest the claimed invention because none of the lipid nanoparticles containing a pegylated lipid have a particle size of about 180 to about 900 nm.
The Examiner disagrees. Patil discloses DOTAP lipid nanoparticles in the size range of 51-188 nm (pg. 53, top). Patil teaches that the lipid particles of the disclosure may include a PEG-lipid conjugate, in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles (pg. 3, paragraph 3). While Patil does not disclose a working example with lipid nanoparticles in the size range of 180-900 nm and a PEG-lipid, the ordinarily skilled artisan would be motivated to include a PEG-lipid in an amount of 0.01 to 2 mol.% to inhibit aggregation of particles as taught at pg. 3, paragraph 3.
Applicant argues that Patil does not suggest the effect of enhancing the lung delivery efficiency by increasing the particle size of the lipid nanoparticles and a person of ordinary skill in the art would not have been motivated to improve lung targeting efficiency by adjusting the particle size of the lipid nanoparticle in view of Patil. Therefore, Patil teaches away from the claimed invention.
The Examiner disagrees. Patil does not teach away from the claimed invention because Patil discloses particle sizes (51-188 nm; pg. 53, top) which overlap with the claimed range (180-900 nm), therefore a prima facie case of obviousness exists. For further discussion on the claimed particle size “enhancing lung delivery efficiency” see the following analysis of the alleged unexpected results.
Analysis of Alleged Unexpected Results
Applicant argues at pg. 14-15 that the inventors of the present application surprisingly found that lipid nanoparticles with a larger particle size (i.e., 180-900 nm) could significantly increase the specific delivery targeted to the lung, resulting in a significant increase of lung/liver ratio of delivery. The Examiner is directed to Tables 8 and 9 of the present application.
The Examiner has fully reviewed and considered the unexpected results alleged by the applicant at Tables 8 and 9 of the as-filed specification.
These tables provide data on lipid nanoparticles with either DOTAP or DOTMA as the permanently cationic lipid and “compound 46”, SM102, or MC3 as the ionizable lipid. The results show that entries 1-3 (300.67 nm), 1-4 (372.80 nm), 2-3 (258.07 nm), 2-4 (337.23 nm), and 4-2 (219.03 nm), which have particles sizes within the claimed range do show significantly better delivery to the lung vs. the liver (ratios of 20.76-116.5) compared to particles with sizes outside this range. These examples which have enhanced specific delivery to the lungs have either DOTAP or DOTMA as the permanently cationic lipid and “compound 46” or MC3 as the ionizable lipid.
The applicant has shown that lipid nanoparticles with either DOTAP or DOTMA as the permanently cationic lipid and “compound 46” or MC3 as the ionizable lipid with a lipid nanoparticle diameter from 219.03-372.80 nm exhibit better lung specific delivery compared to comparative compositions with smaller particle sizes, which is unexpected over the prior art.
However, the claims are not “commensurate in scope” with the showing. See MPEP § 716.02(d). The Applicant has demonstrated targeted lung delivery, but this has only been shown with the specific permanently cationic lipids, ionizable lipids, and particle sizes as stated above. The specific lipid components appear to have a large influence on the lung/liver expression ratio. For example, Entry 3-2 (DOTAP:SM102) has a particle size of 202.13 nm (which is within the claimed range) but only has a ratio of lung/liver of 13.20, whereas Entry 2-2 (DOTAP:“compound 46”) has a diameter lower than that claimed (173.5 nm), but a higher lung/liver ratio (15.67). It is not only the size of the lipid nanoparticles which has an influence on the targeting ratio, but also the components of the composition. Therefore, it is unclear whether a comparative composition containing these specific components would be reasonably representative of compositions containing other permanently cationic and ionizable lipids falling within the broader scope currently claimed. Furthermore, the specific delivery to the lung has been shown with a nanoparticle diameter from 219.03-372.80 nm, it is unclear that this diameter is reasonably representative of compositions containing larger diameters falling within the broader scope currently claimed (up to 900 nm).
Claim Rejections - 35 USC § 103 (Maintained)
Claims 1, 5-7, 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, in an amount of 0.2-6 mol % [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, the surface charge, and the amount of the lipid components, 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 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 an insulator lipid, such as a PEGylated lipid [0173] (pg. 108, Table 6C), with PEG-2000 ceramide disclosed as a PEGylated lipid [0230].
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, in an amount of 0.2-6 mol % [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].
Response to Arguments
Applicant’s arguments filed 08/28/2026 have been fully considered but are not persuasive.
Applicant argues that Ramunas only teaches examples of lipid nanoparticles having a particle size of 52-73 nm, therefore, Ramunas would not have motivated a person of ordinary skill in the art to arrive at a lipid nanoparticle containing a pegylated lipid and having a particle size of about 180 nm to about 900 nm.
The Examiner disagrees. Patents are relevant as prior art for all that they contain and nonpreferred or alternative embodiments constitute prior art. See MPEP 2123. Ramunas discloses a lipid nanoparticle size of 10-500 nm [0256], which overlaps with the claimed range of about 180 to about 900 nm. 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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
