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 .
Priority
This Application filed on 01/24/2023, claims priority to U.S. provisional application No. 63/072,661 filed on 08/31/2020, and PCT/US2021/048218 filed on 08/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/24/2023, 10/28/2024 and 03/25/2026, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
Applicant’s amendment and arguments filed on 03/25/2026, have been received and have been fully considered.
Claims 1, 8, 17, 20, 26, 29 and 37-38, claim 7 was cancelled, and claims 11-13, 15-16, 18-19, 23-25, 27-28, and 31-36 were previously cancelled. Claims 1-6, 8-10, 14, 17, 20-22, 26, 29-30, and 37-39 are pending.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim 26 recites “wherein the ratio of the maximum concentration of dopamine in the brain to the maximum concentration of dopamine in the systemic plasma is greater than 100:1; …”. There is inherent antecedent basis support for the recited ratio because there must be a maximum concentration of dopamine in the brain and a maximum serum concentration of dopamine (i.e., systemic plasma concentration). It will be understood that the ratio is calculating after administering levodopa because Parkinson’s disease is known to be characterized by low level of dopamine in the brain. Thus, the claim 26 ratio is interpreted to be calculated after administering levodopa.
Rejection Maintained/Modified/Added in view of the Amendment
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 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.
§ 103 Rejection over Yacoby in view of Nedorubov and Shahaf
Claims 1-6, 8-10, 14, 17, 20-22, 26, 29-30, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over O. Yacoby et al. (US PG PUB. 2017/0196828 A1, 07/13/2017, “Yacoby” cited in the PTO-892 dated 10/30/2025) in view of Nedorubov A., et al. (Open Access Maced J Med Sci. 2019 Aug 30;7(21):3509-3513. “Nedorubov” cited in the PTO-892 dated 10/30/2025), and D. Shahaf et al. (US PG-PUB 2018/344951 A1, 12/06/2018, “Shahaf” cited in the PTO-892 dated 10/30/2025).
Yacoby teaches a method for treatment of Parkinson's disease comprising substantially continuously administering to a patient in need thereof a therapeutically effective amount of a formulation comprising a levodopa or salt thereof [0013]. Yacoby teaches that substantially continuously administering include subcutaneous, transdermal, intranasal, intramuscular. [0037]. Yacoby teaches that the formulation includes levodopa salt with a basic amino acid selected from the group consisting of arginine, lysine, and histidine, for example, a liquid formulation comprising arginine and levodopa. [0051]. Yacoby also teaches that the formulation is a liquid or gel formulation comprising levodopa and arginine. [0009]. Yacoby teaches the delivery of dopamine to the brain by administering levodopa, and that levodopa transforms to dopamine. [0003], [0004], [0018].
In view of the foregoing, Yacoby teaches the method of claim 1, except that one of ordinary skill would need to specifically select administering the levodopa and amino acid composition intranasally, more specifically into the olfactory region of the nose. Yacoby does not teach selectively delivers a therapeutically effective amount of dopamine to the brain of the patient.
In the same field of Parkinson’s disease treatment using levodopa, Nedorubov teaches intranasal administration of levodopa (L-dopa). [Title]. Nedorubov teaches that “the most important feature of the medical products intranasal delivery is the opportunity to penetrate them directly into the central nervous system without entering the blood circulatory system. The medical products transportation from the nasal cavity to the central nervous system is implemented without the mucous participation. It is done using an extracellular tract through the epithelial barrier in the course trigeminal and olfactory nerves. Nedorubov teaches that the intranasal L-dopa administration leaves sympathetic nerves and arrives in the arterial and venous system, which supplies extremities, head, heart, adrenal glands and intestines with the blood” [Pg. 3509, col. 1, 2nd para.]. Nedorubov teaches that transport of L-dopa from the nasal cavity to the central nervous system is performed without the involvement of the mucosa, extracellularly along the trigeminal and olfactory nerves. [Pg. 3512, col. 2, 2nd para.]. Nedorubov teaches that L-dopa penetrates the brain only from the olfactory region, where there is a possibility of extra - and intracellular penetration of drugs through the epithelial barrier and getting not into the bloodstream, but directly to meninges. [Pg. 3512, col. 2, 2nd para.]. Nedorubov teaches that the use of nasal delivery method improves pharmacokinetic parameters of the drug in comparison with oral administration. [Pg. 3512, col. 2, 3rd para.]. Nedorubov teaches that levodopa is the “immediate metabolic predecessor of dopamine, which unlike dopamine is able to cross the blood-brain barrier and compensate dopamine deficiency in the brain that underlies many clinical manifestations of Parkinson's disease. L-Dopa is captured by the endings of remaining dopaminergic nigrostriatal neurons, undergoes decarboxylation in them, turns into dopamine, which is released into the synaptic cleft, thus maintaining an adequate functional state of the neurons of the striatum and other basal ganglia.” [Pg. 3510, col. 1, 1st para.].
Shahaf teaches nasal delivery device for delivering active ingredient/drug including levodopa. [0004]-[0006]. Shahaf teaches a system and method for delivering substance to a nasal cavity. [0045]. Shahaf teaches that the device is used to deliver Parkinson's disease treatment including levodopa. [0582]. Shahaf teaches the nasal delivery device on figures 10, 11 and 12. Shahaf teaches that the delivery system improved delivery of to the olfactory epithelium in the nasal cavity and enhanced absorption at that area for better delivery to a desired tissue (such as the brain). [0309]. Shahaf teaches that the nasal delivery delivers the drugs through the nasal cavity to the central nervous system including the brain, spinal cord and associated nerves. [0326].
With regard to administering levodopa and amino acid intranasally, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer Yacoby’s levodopa and amino acid composition to the olfactory region of the nose for treating Parkinson's disease in view of the teachings of Nedorubov. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Nedorubov teaches that intranasal delivery though olfactory nerves penetrate levodopa directly into the central nervous system without entering the blood circulatory system; intranasal levodopa administration directly supplies extremities, head, heart, adrenal glands and intestines with the blood; the use of nasal delivery method improves pharmacokinetic parameters of levodopa in comparison with oral administration; and because Nedorubov teaches that levodopa penetrates the brain only from the olfactory region. Therefore, claims 1 are 14 are obvious over Yacoby and Nedorubov.
With regard to selectively delivers a therapeutically effective amount of dopamine to the brain, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to administer levodopa and amino acid composition into the olfactory region of the nose of a Parkinson’s disease patient using the nasal delivery device taught by Shahaf. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Shahaf teaches nasal delivery device for delivering Parkinson's disease treatment including levodopa, wherein the device improved delivery of to the olfactory epithelium in the nasal cavity; enhanced absorption in the olfactory region for better delivery to the brain; and that the delivery device provides dose control and method provide delivery accuracy, drug storage, and treatment with multiple medications. Shahaf teaches that the device is more suitable for Parkinson’s disease patients. [0004]. Therefore, one of ordinary skill in the art would have been motivated to utilize Shahaf’s nasal delivery device in a method of delivering the levodopa and the positively charged amino acid to the olfactory region of the nose to treat Parkinson’s disease. The delivery of a therapeutically effective amount of dopamine to the brain of the patient is met because Yacoby and Nedorubov teach that levodopa delivers dopamine to the brain of the patient, [(see claim interpretation above)]; [Yacoby, [0003], [0004], [0018]; [Nedorubov, pg. 3510, col. 1, 1st para.]. moreover, the combination of Yacoby, Nedorubov and Shahaf teaches a method of treating Parkinson’s disease by administering levodopa and amino acid to the olfactory region of the nose of a patient in need thereof. The combination of Yacoby, Nedorubov and Shahaf is silent on the selective delivery of a therapeutically effective amount of dopamine to the brain of the patient but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting therapeutically effective amount of dopamine is inherently delivers to the brain of the patient. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Therefore, the combination of Yacoby, Nedorubov and Shahaf meet each and every limitation of claims 1, 30, 37 and 38.
Regarding claims 2, 3, 4, 5, 6, 8 and 9, Yacoby teaches the preparation of levodopa arginine salt in Example 7, wherein levodopa was weighed in a suitable container with L-arginine (at molar ratio of 1:1.8) and a 0.2% sodium bisulfite solution in water was added to obtain a final concentration of 4.4% L-Dopa. The mixture was heated to 65±10° C. with constant stirring. When the solids were completely dissolved, solution was filtered using 0.45 μM nylon membrane. The filtered solution was immediately frozen in dry ice and subsequently subjected to lyophilization. Off-white crystals were obtained and subsequently subjected to MS analysis. Water meets the term “nasally acceptable vehicle” as described by instant specification [0045]. Yacoby Example 7 reads on claims 2, 3, 4, and 5 because the vehicle is an aqueous solution and levodopa and arginine dissolved in the aqueous solution; reads on claims 7, and 8 because the amino acid is arginine; and reads on claim 9 because the formulation does not comprise a decarboxylase inhibitor.
Regarding claim 6, Yacoby teaches that the formulation of levodopa and amino acid is a lyophilized powder that can be administered by continuous administration using any suitable route [0063], wherein Yacoby teaches that continuous administration includes intranasal administration. [0037]. Moreover, Nedorubov teaches that the levodopa used in the intranasal method of administration is L-DOPA-PC, nasal drops, is an original pharmaceutical composition containing L-DOPA as an active ingredient, distributed in the polymer matrix based on a biodegradable copolymer of lactic/glycolic acids (polylactic glycolic acid, PLGA) [Pg. 3509, col. 2, 2nd para.]. The teaching of Nedorubov reads on claim 6 particle because the instant specification recites that “solid particles may comprise an excipient, including a polymer (e.g., polylactic glycolic acid)” [0048]. Therefore, because the compatibility of levodopa with PLGA is taught by Nedorubov’s nasal drop, one of ordinary skill in the art would have been motivated to prepare Yacoby’s levodopa and arginine with PLGA, and therefore reads on claim 6.
Regarding claim 10, Yacoby teaches that the liquid formulations have a physiologically acceptable pH, e.g. a pH of about 4.0 to 9.5, [0009], more preferable about 7 to about 9. [0042]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 17, Yacoby teaches that the liquid formulation includes at least 5% (w/v) and at least 10% (w/v) by weight levodopa. [0009].
Regarding claims 20 and 29, Yacoby teaches that the liquid formulation includes levodopa and arginine in a molar ratio of about 1:3.5. [0051].
Regarding claim 21, Yacoby teaches that the methods include additional administration of an effective amount of a composition comprising levodopa (for example, administering a composition e.g. a tablet, having levodopa as its sole active agent), or a composition that includes carbidopa and one or more other active agents. [0013].
Regarding to claim 22, one of ordinary skill in the art would have been motivated to use the nasal administration to treat off periods in the patient because Yacoby teaches that levodopa treatments may be associated with dopaminergic adverse events; continuous administration of levodopa or dopa agonists is still associated with off periods that are self-limiting; and Nedorubov teaches the advantages of intranasal administration as discussed above and teaches that the use of nasal delivery method improves pharmacokinetic parameters of the drug in comparison with oral administration. [Pg. 3512, col. 2, 3rd para.].
Claim 26 is met for the following reasons: Yacoby and Nedorubov teach a method of treating Parkinson’s disease comprises administering to the olfactory region of the nose of a patient a composition of levodopa and arginine. The combination of Yacoby and Nedorubov are silent on the maximum concentration of dopamine in the brain and in the systemic plasma but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting maximum concentration of dopamine in the brain vs. the maximum concentration of dopamine in the systemic plasma is inherently greater than 100:1. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Response to Arguments
Applicant argues:
Yacoby is directed to substantially continuous administration of levodopa and/or carbidopa or ester and/or salt thereof. (See Abstract of Yacoby.) By using the term "continuous administration", Yacoby envisions administration routes other than intranasal administration, stating that the "disclosure relates at least in part to the discovery that an ester or salt of levodopa or carbidopa can form a stable, liquid aqueous formulation, suitable for e.g., continuous subcutaneous, transdermal, intradermal, intravenous and/or intraduodenal administration, at a physiologically acceptable pH." (see "Summary" of the invention in para [0006] of Yacoby; emphasis added.) Though intranasal is listed among possible administration routes elsewhere (other than in the "Summary" of the invention section) in its lengthy disclosure, the primary teaching of Yacoby is to continuous subcutaneous or transdermal administration which would inherently result in systemic levels of levodopa and dopamine. Therefore, modifying the administration of Yacoby to be intranasal administration as alleged in the Action would render Yacoby unsatisfactory for its intended purpose of continuous systemic delivery. That is, Yacoby's objective of achieving sustained systemic plasma levels of levodopa is fundamentally different than Nedorubov's intranasal administration that delivers the drug without entering the blood circulatory system. "If [a] proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification." MPEP § 2143.01(V) (citing In re Gordon, 733 F.2d 900 (Fed. Cir. 1984)). Accordingly, Applicant submits that one of skill in the art would not have been motivated to modify the continuous administration of Yacoby to arrive at the claimed intranasal administration.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive for the following reasons. As provided in 2145 (D. 1.), the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) ("Although Oez [the prior art] used a white pigment with a cross-linking polymer, it does not discourage a skilled artisan from using the white pigment without a cross-linking polymer or lead the skilled artisan in a direction divergent from the path taken in the Appealed Patents. Thus, Oez's disclosure is substantial evidence that supports the Board's finding that Oez does not teach away from the proposed combination."
In the instant case, Yacoby teaches a method substantially continuously administering of a therapeutically effective amount of levodopa and amino acid to a patient in need thereof [0013], with substantially continuously administering include subcutaneous, transdermal, intranasal, intramuscular [0037]. Nedorubov would provide motivation to one of ordinary skill in the art to specifically pick internasal administration to the olfactory region of the nose from Yacoby’s administration route because Nedorubov teaches that intranasal delivery though olfactory nerves penetrate levodopa directly into the central nervous system without entering the blood circulatory system; intranasal levodopa administration directly supplies extremities, head, heart, adrenal glands and intestines with the blood; the use of nasal delivery method improves pharmacokinetic parameters of levodopa in comparison with oral administration; and because Nedorubov teaches that levodopa penetrates the brain only from the olfactory region. Thus, Applicant’s argument “Yacoby's objective of achieving sustained systemic plasma levels of levodopa is fundamentally different than Nedorubov's intranasal administration”, is not persuasive. Moreover, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, the combination of Yacoby and Nedorubov teaches a method of treating Parkinson's disease by administering to the olfactory region of the nose of a patient in need thereof a composition of levodopa and amino acid e.g., arginine. Furthermore, as provided in MPEP 2144 (IV). the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). In the instant case, Yacoby already teach internasal administration as one of the levodopa route of administration to treat for treating Parkinson's disease, and Nedorubov provides the motivation to administer levodopa intranasally to olfactory region of the nose because Nedorubov teaches the effectiveness of intranasal administration of levodopa for treating Parkinson's disease.
Applicant argues:
Moreover, even if one of skill in the art were to make the alleged modifications, there would be no reasonable expectation of success at arriving at the claimed invention. Nedorubov teaches a nanosomal form of levodopa, "L-DOPA-PC," which is a pharmaceutical composition containing L-DOPA distributed in a polymer matrix based on biodegradable copolymer of lactic/glycolic acids, PLGA. Nedorubov found that this specific nanotechnology-based drug delivery system was able to have improved bioavailability while being administered intranasally. In contrast, the claimed invention includes a composition comprising levodopa and a positively charged amino acid. Nedorubov fails to teach or suggest including any amino acid, let alone one as claimed. Rather, Nedorubov's improved pharmacokinetics were attributed to the specific PLGA nanosomal formulation, and not merely the route of administration. Nedorubov teaches that its nasal drops formulation achieved 244.4% relative bioavailability compared to oral Madopar® (levodopa/benserazide) specifically because of the nanoparticle delivery system. There is no teaching or suggestion that a levodopa-arginine salt as taught by Yacoby would achieve similar results when administered to the olfactory region. Thus, one of skill in the art would have no reasonable expectation of success when combining these references to arrive at the claimed invention.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive for the following reasons. The claimed composition of levodopa and positively charged amino acid for treating Parkinson’s disease is taught by Yacoby, the internasal administration of the levodopa composition is taught by Yacoby as one of the administration route, and the internasal administration to the olfactory region of the nose is what incorporated from Nedorubov teachings. Nedorubov brought in to provide skilled artisan with the requisite motivation to pick the internasal administration of levodopa and amino acid due to the effectiveness of intranasal administration for levodopa for treating Parkinson’s disease. See the above obviousness rationale. As provided in the MPEP 2145, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Regardless of levodopa formulation, Nedorubov is incorporated to teach the internasal route increase penetrate of levodopa directly into the central nervous system without entering the blood circulatory system, and that nasal delivery method improves pharmacokinetic parameters of levodopa and because Nedorubov teaches that levodopa penetrates the brain only from the olfactory region.
Applicant argues:
Furthermore, neither Yacoby nor Nedorubov, alone or in combination, teach or suggest "wherein said method selectively delivers a therapeutically effective amount of dopamine to the brain of the patient." The claimed selective delivery of dopamine to the brain is a specific functional result achieved by the claimed method. The specification demonstrates this selective delivery through experimental data showing that following intranasal dosing of L-Dopa with arginine, the average Cmax of dopamine in brain tissue was 105.7 + 7.2 ng/mL, while all dopamine concentrations in plasma were below the limit of quantitation. This selective delivery of dopamine to the brain while maintaining undetectable plasma levels is not taught or suggested by the prior art combination.
Examiner action:
Applicant's arguments have been fully considered but they are not persuasive for the reasons stated above. That is, the combination of Yacoby, Nedorubov and Shahaf teach a method of treating Parkinson's disease by administering to the olfactory region of the nose of a patient in need thereof a pharmaceutical composition comprising levodopa and a positively charged amino acid. The combination of Yacoby, Nedorubov and Shahaf while teach the claimed method of administering levodopa and amino acid, is silent on the selective delivery of a therapeutically effective amount of dopamine to the brain of the patient but otherwise teaches a substantially identical method as claimed. As such, it is reasonable to presume that the resulting therapeutically effective amount of dopamine is inherently delivers to the brain of the patient, and that the Cmax of dopamine in brain tissue is inherently 105.7 + 7.2 ng/mL. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112. Note that Yacoby and Nedorubov teaches that levodopa delivers dopamine to the brain of the patient, [Yacoby, [0003], [0004], [0018]; [Nedorubov, pg. 3510, col. 1, 1st para.] (see claim interpretation above).
Conclusion
Claims 1-6, 8-10, 14, 17, 20-22, 26, 29-30, and 37-39 are rejected. No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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