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 .
Receipt is acknowledged of Amendments and Remarks filed on 11/15/23 and an IDS filed on 08/29/23. Claims 97, 106-115, 119-120, 124-125 and 129 have been amended, claims 105 and 136-147 have been cancelled and new claims 148-151 have been added. Claims 97-104, 106-135 and 148-151 are pending. Claims 119, 123 and 129-135 are withdrawn. Accordingly, claims 97-104, 106-118, 120-122, 124-128 and 148-151 are under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Response to Amendment
The reply filed on 11/15/23 is not fully responsive to the prior Office action because of the following omission(s) or matter(s): the limitation added to claim 97 was previously in withdrawn claim 120 due to containing a non-elected species. See 37 CFR 1.111.
However, in the interest of compact prosecution, Examiner has expanded the species election to include the polymer comprising a polymetacrylate based polymer. As such previously withdrawn claims 120 and new claims 148-151 will be examined.
The reply filed on 11/15/23 is also non-responsive because withdrawn claims 119-120, 123 and 129 were not properly identified as withdrawn.
Claim Objections
Claim 124 is objected to because of the following informalities: certain general and chemical names are capitalized.
Claim 128 is objected to for reciting an abbreviation without providing its full description at least once in the claim set.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 110, 148-149 and 151 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 110, 148-149 and 151 contain descriptions and/or formulas for the recited lipids (identified only with their tradenames) that are not supported by the Specification. For example, the Specification does not provide the structure or formulas for DLinDMA, DLin-KC2-DMA, HGT4003, cKK-E12, ICE. It is also not clear if the said compounds have correctly been identified. As evidenced by Cayman product information (Attached), OF-02 has the same formula as cKK-E12.
This is a new matter rejection.
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 124, 149 and 151 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 124 contains terms that are trademark/trade names such as Triton X-100. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim 149 recites the limitation "the one or more cationic lipid" in the dry powder formulation of claim 120. There is insufficient antecedent basis for this limitation in the claim. However, claim 120 lacks any support for a cationic lipid.
Claim 151 recites the limitation "the one or more cationic lipid" in the dry powder formulation of claim 150. There is insufficient antecedent basis for this limitation in the claim. However, claim 150 lacks any support for a cationic lipid.
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 97-104, 106-118, 121-122, 124-128 and 148-151 are rejected under 35 U.S.C. 103 as being unpatentable over Almarsson et al (WO 2016118725 or US 20180085474) (citations from the US document) in combination with Brito et al (US 20110077284) and Van de Wetering et al (Structure-Activity Relationships of Water-Soluble CationicMethacrylate/Methacrylamide Polymers for Nonviral Gene Delivery).
Almarsson et al’s Application is titled lipid nanoparticle compositions and relates to nanoparticle compositions including an mRNA and a lipid component and methods of using the same (See Title and Abstract).
Almarsson et al disclose the following:
-nanoparticle composition including (i) a lipid component including a phospholipid, a PEG lipid, a structural lipid, and a compound of formula (I) and (ii) an mRNA encoding a polypeptide (See [0006]).
-a PEG lipid of a nanoparticle composition selected from the group consisting of a PEG-modified phosphatidylethanolamine, a PEG-modified phosphatidic acid, a PEG-modified ceramide, etc, (See [0015]).
- a phospholipid moiety including, phosphatidyl glycerol, 1,2-dilinoleoyl-sn-glycero-3-phosphocholine (DLPC), 1,2-dimyristoyl-sn-glycero-phosphocholine (DMPC), or a cationic and/or ionizable lipid such as 1,2-dilinoleyloxy-N,N-dimethylaminopropane (DLin-DMA), 2,2-dilinoleyl-4-(2-dimethylaminoethyl)-[1,3]-dioxolane (DLin-KC2-DMA), etc (See [0017], [0019] and claim 31).
-Lipid component: that component of a nanoparticle composition that includes one or more lipids, which includes one or more cationic/ionizable, PEGylated, structural, or other lipids, such as phospholipids (See [0140]).
-a structural lipid of a nanoparticle composition selected from the group consisting of cholesterol, ergosterol, etc, and preferably cholesterol (See [0016]).
-a nanoparticle composition including a lipid component with a neutral or near neutral charge which may subsequently deliver mRNA to hepatocytes including LDLRs in a targeted manner (See [0113]).
- a pharmaceutical composition suitable for pulmonary administration comprising dry particles which comprise the active ingredient and wherein the particles have a diameter in the range from about 0.5 nm to about 7 nm or from about 1 nm to about 6 nm. Such compositions are conveniently in the form of dry powders for administration using a device comprising a dry powder reservoir. Dry powder compositions may include a solid fine powder diluent such as sugar and are conveniently provided in a unit dose form (See [0095]).
- a nanoparticle composition including one or more mRNAs administered by inhalation; as an oral spray and/or powder, nasal spray, and/or aerosol (See [0118]).
-an mRNA included in a nanoparticle composition which may encode a therapeutic polypeptide and produce the therapeutic polypeptide upon contacting and/or entry into a cell. And, an mRNA included in a nanoparticle composition which may encode a polypeptide that may improve or increase the immunity of a subject (See [0104]).
-Diseases, disorders, and/or conditions characterized by dysfunctional or aberrant protein or polypeptide activity for which said compositions may be administered including genetic diseases (e.g., cystic fibrosis). A specific example of a dysfunctional protein is the missense mutation variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which produce a dysfunctional protein variant of CFTR protein, which causes cystic fibrosis (See [0115]).
-the encapsulation efficiency of an mRNA of a nanoparticle composition being at least 50%, at least 80% and preferably greater than 90% (See [0028], [0076] and [0133]).
-a nanoparticle composition administered by inhalation at a dose of about 0.001 mg/kg to about 10 mg/kg to a mammal (See [0029]).
- nanoparticle compositions which may include any substance useful in pharmaceutical compositions, including diluents, dispersion aids, binders, etc, such as lactose, sucrose, cellulose, mannitol, sorbitol, sodium chloride, powdered sugar, etc, (See [0060] and [0062]).
-a polymer included in and/or used to encapsulate or partially encapsulate a nanoparticle composition, which may be polyamines, polymethacrylates, polyamides, polyesters, sorbitan monostearate, TWEEN® 80, a poloxamer, etc (See [0056], [0058] and [0061]).
-the wt/wt ratio of the lipid component to the mRNA in the nanoparticle composition being from about 5:1 to about 50:1, such as from about 10:1 to about 40:1. The N:P ratio of the nanoparticle composition being from about 2:1 to about 8:1, from about 5.0:1, about 5.5:1, about 7.0:1 (See [0023]-[0024]).
Almarsson et al lack a specific disclosure on the powder being spray-dried or the amount of the polymer in the composition or the specific polymethacrylate based polymer. These are well known in the art as taught by Brito et al and van de Wetering et al.
Brito et al teach a dry powder formulation for delivery to a mammal by inhalation, the formulation comprising particles comprising a lipid, a carrier, and one or more double-stranded siRNA molecules (See abstract and claim 1).
Brito et al disclose the following:
-dry powder formulations may be prepared by spray drying and that active agents can be sprayed dried from an aqueous solution (See [0020] and [0114]-[0116]).
- the active agent in the aqueous phase is combined with an organic solution optionally containing lipids and polymers such as poly(lactide-co-glycolide) or PLGA. This mixture can be spray dried (See [0021]).
-pharmaceutical excipients useful in the said composition include peptides, proteins, non-biological polymers, biological polymers, simple sugars, etc. Sugars include mannitol, monosaccharides such as fructose, maltose, etc, (See [0105], [0109]).
- polymeric excipients/additives include polyethylene glycols, pectin, poly(lactide-co-glycolide) (PLGA), polyethylene imine (PEI), poly-L-lysine (PLL) and other cationic polymers (See [0112]).
-these excipients are generally present in the composition in amounts ranging from about 0.01% to about 95% percent by weight, and more preferably from about 0.5 to about 80% (See [0101]).
-the compositions can have good stability, with respect to both chemical stability and physical stability, i.e., aerosol performance, over time. With respect to chemical stability, the active agent contained in the formulation may degrade by no more than about 10% over a time course of 18 months. With respect to aerosol performance, compositions may exhibit a drop in emitted dose of no more than about 10%, or no more than about 5%, when stored under ambient conditions for a period of three months (See [0144]-[0145]).
Van de Wetering et al teach that almost all studied cationic methacrylate/methacrylamide polymers were able to condense the structure of plasmid DNA, yielding polymer/plasmid complexes (polyplexes) with a size of 0.1−0.3 μm and a slightly positive ζ-potential, which can be taken up by cells, e.g., via endocytosis. However, the transfection efficiency and the cytotoxicity of the polymers differed widely: the highest transfection efficiency and cytotoxicity were observed for poly[2-(dimethylamino)ethyl methacrylate], p(DMAEMA). It is concluded that “We therefore hypothesized that the superior transfection efficiency of p(DMAEMA) containing polyplexes can be ascribed to an intrinsic property of p(DMAEMA) to destabilize endosomes combined with an easy dissociation of the polyplex once present in the cytosol and/or the nucleus” (See abstract).
Van de Wetering et al disclose that “Figure 1 Chemical structure of (a) poly(2-(dimethylamino)ethyl methacrylate), p(DMAEMA); (b) poly(3-(dimethylamino)propyl methacrylate), p(DMAPMA); (c) poly(2-(dimethylamino)ethyl methacrylamide), p(DMAEMAm); (d) poly(3-(dimethylamino)propyl methacrylamide), p(DMAPMAm); (e) poly(2-(trimethylamino)ethyl methacrylate chloride), p(TMAEMA); (f) poly(2-(diethylamino)ethyl methacrylate), p(DEAEMA); and (g) poly(2-(dimethylamino)ethyl acrylate), p(DMAEA)” (See Page590, 1st Col.).
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Ven de Wetering et al further disclose Figure 6, which show the interaction between an adenine-thymine base pair (R = sugar/phosphate backbone) and adenine and (the carbonyl group of) the polymer.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Brito et al and van de Wetering et al with that of Almarsson et al to arrive at the claimed invention. It would have been obvious to do so because Almarsson et al teach dry powder formulations comprising nanoparticles comprising mRNA, one or more lipids and one or more polymers for inhalation. Almarsson et al teach that the said mRNA may be encoding a peptide and/or a therapeutically active protein such as CFTR. Almarsson et al also teach that the polymer may be polymethacrylate. While Almarsson et al do not expressly teach that the particles are spray-dried, it is known in the art that spray-drying is suitable and commonly used process for making dry powders. This is taught by Brito et al. Brito et al also teach that the polymer can be included in the composition is any suitable concentrations such as from 0.5 to 80%. With guidance from Brito et al, one of ordinary skill in the art is more than capable of optimizing the concentrations as necessary. Furthermore, van de Watering et al teach that polymethacrylate polymers including those with a positively charged tertiary amine are suitable for nanoparticles of lipids and DNA.
It would have been obvious t one of ordinary skill in the art to have looked in the art for specific polymethacrylate polymers for the disclosed nanoparticles of Almarsson et al as taught by van de Wetering et al with a reasonable expectation of success.
The prior art contains all the claimed limitations, with the only difference being the lack of actual combination in a single prior art reference. One of ordinary skill could have combined the elements by known methods, and that in combination, each element performs the same function as it does separately.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 97-104, 106-118, 120-122, 124-128 and 148-151 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 9,713,626; 9,181,321; 10,266,559; 10,822,368 in view of Almarsson et al (WO 2016118725 or US 20180085474) and Van de Wetering et al (Structure-Activity Relationships of Water-Soluble CationicMethacrylate/Methacrylamide Polymers for Nonviral Gene Delivery).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims. The examined claims would have been obvious over the reference claims in view of Almarsson et al and van de Wetering et al.
Specifically, the claims are not patentably distinct from each other because the Examined claims are drawn to a dry powder formulation for delivery of messenger RNAs (mRNAs) comprising a plurality of spray-dried particles, wherein each particle comprises: one or more lipid nanoparticles (LNPs) comprising one or more lipids, wherein the one or more LNPs encapsulate mRNA encoding a protein or a peptide; and one or more polymers, wherein the one or more polymers comprise a polymethacrylate based polymer having a positively charged tertiary amine group with a methacrylic back bone.
The claims of the said patents recite a composition comprising of: an MRNA-loaded nanoparticle, wherein the MRNA is an in vitro transcribed MRNA and has a coding sequence at least 80% identical to SEQ ID NO: 3, and wherein the mRNA encodes a human cystic fibrosis transmembrane conductance regulator (CFTR) protein comprising the amino acid sequence of SEQ ID NO:1 (see US 9,713,626 at claim 1), wherein the composition is administered to the lung by aerosolization, wherein the one or more organic cations are selected from the group consisting of polyethyleneimine (PEI), protamine, PEGylated protamine, poly- L-lysine (PLL), PEGylated PLL, a cationic lipid and combinations thereof.
The differences between instant application and the patented claims are that the examined claims recite the inclusion of a polymethacrylate polymer while reference claims do not. This is however rendered obvious over the teachings of Almarsson et al and van be Wetering et al, which teach the inclusion of a polymethacrylate polymer in the particles and wherein the said polymethacrylate polymer has a positively charged tertiary amine and a methacrylate back bone.
Also, patent claims include additional limitations. The Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 97-104, 106-118, 120-122, 124-128 and 148-151 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 9-11 of copending Application No. 17/472,622 (US 20220249699) in view of Almarsson et al (WO 2016118725 or US 20180085474) and Van de Wetering et al (Structure-Activity Relationships of Water-Soluble CationicMethacrylate/Methacrylamide Polymers for Nonviral Gene Delivery).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims. The examined claims would have been obvious over the reference claims in view of Almarsson et al and van de Wetering et al.
Specifically, the claims are not patentably distinct from each other because the Examined claims are drawn to a dry powder formulation for delivery of messenger RNAs (mRNAs) comprising a plurality of spray-dried particles, wherein each particle comprises: one or more lipid nanoparticles (LNPs) comprising one or more lipids, wherein the one or more LNPs encapsulate mRNA encoding a protein or a peptide; and one or more polymers, wherein the one or more polymers comprise a polymethacrylate based polymer having a positively charged tertiary amine group with a methacrylic back bone.
Although the claims at issue are not identical, they are not patentably distinct from each other because the applications recite a pharmaceutical composition comprising at least one mRNA encoding a polypeptide and a lipid carrier. The differences between instant application and the patented claims are that the examined claims recite the inclusion of a polymethacrylate polymer while reference claims do not. This is however rendered obvious over the teachings of Almarsson et al and van be Wetering et al, which teach the inclusion of a polymethacrylate polymer in the particles and wherein the said polymethacrylate polymer has a positively charged tertiary amine and a methacrylate back bone.
Also, reference claims include additional limitations. The Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the reference claims and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claims 97-118, 121, 122 and 124-128 have been considered but are moot because the rejections have been modified based on the amendments.
Applicant’s main argument is that “the present claims are nonobvious over Almarsson in combination with Brito for at least the following reasons. Almarsson does not disclose, teach or suggest spray-dried particles including a polymer comprising “a polymethacrylate based polymer having a positively charged tertiary amine group with a methacrylic back bone” as recited in the present claims. Brito fails to remedy the deficiencies of Almarsson and similarly provides no teaching regarding a polymethacrylate based polymer having positively charged tertiary amine group with methacrylic back bone. Accordingly, Almarsson in combination with Brito does not teach or suggest the claimed methods” (See remarks, pages 10-11).
The argument is not sufficient to place the claims in condition for allowance because the newly cited reference, van de Wetering et al teach the claimed polymer in a lipid nanoparticle comprising a protein active agent and as such renders the added limitation obvious.
Applicant makes analogous argument regarding the rejections under obviousness type double patenting (See Remarks, page 11).
The arguments are not persuasive for the same reason as stated above.
Claims 97-104, 106-118, 120-122, 124-128 and 148-151 are rejected and claims 119, 123 and 129-135 are withdrawn.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights