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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on April 28, 2025. Claims 1-2, 4-7, 9-10, 12-16, 19, 22, 28, 37-41, 46, 49, 56-63 have been withdrawn. Claims 3, 8, 11, 17-18, 20-21, 23-27, 29-36, 42-45, 47-48, 50-55, 64-66, and 68-71 have been canceled.
The requirement for restriction between Groups I-IV was previously made FINAL. Applications election of Group IV, drawn to a method of differentiating one or a plurality of stem cells into one or a plurality of enteric neuronal cells in a culture vessel comprising a solid substrate said method comprising: contacting one or a plurality of stem cells with the solid substrate, applying a first cell medium into the culture vessel for a time period sufficient to differentiate the one or plurality of cells into one or a plurality of neural crest cells, removing the first cell medium, applying a second cell medium into the culture vessel for a time period sufficient to differentiate the neural crest cells into enteric neurons, was acknowledged.
Therefore, claims 67 and 72-73 are currently under examination.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2019/068447 filed on December 23, 2019. Applicants' claim the benefit of a prior-filed application parent provisional application 62/783, 795, filed on December 21, 2018 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c).
Thus, the earliest possible priority is December 21, 2018.
Withdrawn Objections- Specification
In view of the concurrent submission of a specification amendment, the objections to the specification have been withdrawn.
Withdrawn Claim Rejections - 35 USC§ 103
In view of Applicants’ amendment to the instant claim set, the rejections under 35 U.S.C. 103 to claims 67 and 72-73 as being unpatentable over Fattahi et al. (Nature. 2016 Mar 3;531(7592):105-9. Epub 2016 Feb 10.), in view of Studer et al. (WO 2017/112901 Al), and further in view of Thermofisher (Thermo Fisher Scientific, "Culturing Pluripotent Stem Cells (PSCs) in Essential 8th Medium" https://tools.themofischer.com/contenl/sfs/manuals/
feeder_free_PSCs_in_essential_mediumpdf; pp.1-9; of record IDS filed on 12/13/2022, No.35), Clevers et al. (US 2014/0243227 A1) and Kida et al. (US 2018/0155682 A1).
New Claim Objection
Claim 67 is objected to because of the following informalities: CHIR 9902 or an analog thereof, should be recited as CHIR 99021, according to the specification. Appropriate correction is required.
New Claim Rejections - 35 USC § 112(a)
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 67, and 72-73 by dependence, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SB431542 and CHIR99021, does not reasonably provide enablement for any analog thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims. This is a new rejection necessitated by Applicants’ amendments to the claims in the response filed on April 28, 2025.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
While determining whether a specification is enabling, one considers whether the claimed
invention provides sufficient guidance to make or use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC § 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skills of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
Claim 67 recites induction of enteric neuronal cells using a media comprising SB431542 “or an analog thereof” and CHIR99021 “or analog thereof.” The breath of the claims this covers SB431542 and CHIR99021 or analogs thereof. The specification defines analogues as follows:
“"Analogues" of the compounds disclosed herein are pharmaceutically acceptable salts, prodrugs, deuterated forms, radio-actively labeled forms, isomers, solvates and combinations thereof. The "combinations" mentioned in this context are refer to derivatives falling within at least two of the groups: pharmaceutically acceptable salts, prodrugs, deuterated forms, radio-actively labeled forms, isomers, and solvates. Examples of radio-actively labeled forms include compounds labeled with tritium, phosphorous-32, iodine-129, carbon-11, fluorine- 18, and the like. The compounds described herein may be present in the form of pharmaceutically acceptable salts. For use in medicines, the salts of the compounds described herein refer to non-toxic "pharmaceutically acceptable salts." Pharmaceutically acceptable salt forms include pharmaceutically acceptable acidic/anionic or basic/cationic salts. Suitable pharmaceutically acceptable acid addition salts of the compounds described herein include e.g. salts of inorganic acids (such as hydrochloric acid, hydrobromic, phosphoric, nitric, and sulfuric acids) and of organic acids (such as, acetic acid, benzenesulfonic, benzoic, methanesulfonic, and p-toluenesulfonic acids). Examples of pharmaceutically acceptable base addition salts include e.g., sodium, potassium, calcium, ammonium, organic amino, or magnesium salt. As used herein, the term "salt" refers to acid or base salts of the compounds used in the methods of the present disclosure. Illustrative examples of acceptable salts are mineral acid (hydrochloric acid, hydrobromic acid, phosphoric acid, and the like) salts, organic acid (acetic acid, propionic acid, glutamic acid, citric acid and the like) salts, quaternary ammonium (methyl iodide, ethyliodide, and the like) salts (pg.17-18, bridging para.).”
Isomers are broadly defined as molecules of identical atomic compositions, but with different bonding arrangements of atoms or orientations of their atoms in space i.e., isomers are two or more different substances with the same molecular formula, including constitutional, configurational, and conformational, for example see Chhabra et al. (Int J Appl Basic Med Res. 2013 Jan-Jun;3(1):16–18). Additionally, the prodrugs can vary significantly before undergoing biotransformation prior to exhibiting their pharmacological effects, well understood in the field.
Thus, the scope of the claims is exceedingly broad and encompasses numerous compounds for which there are no enabling disclosure. Although the specification includes a general discussion of “analogues”, and the analogs must necessarily be able to perform the requisite function recited in the claims, it provides specific support only for SB431542 and CHIR99021. Therefore, while defined functionally, with regard to structural identify, the phrase “analogs thereof” is not structurally meaningfully limited. Since there is no disclosed structural-functional relationship, the claims must be construed to require that any analog perform the specific function recited, inducing differentiation in the desired cell differentiation. However, the specification provides no guidance or data supporting that other analogs beyond SB431542 and CHIR99021 are capable of doing so.
The scope of the claims is extremely broad and encompasses numerous compounds for which there is no disclosure in the specification. While the instant specification broadly defines “analogues” (pg.17-18, bridging para.), it only provides support for SB431542 and CHIR99021, see pg. 41 and pg. 57, Day 0 and Day 2. The claims also do not limit the nature or mechanism by which such analogs are expected to function or define what constitutes an acceptable analog. The breath of the claims is thus extremely broad.
The nature of the invention is chemical-compound-based cell differentiation, specifically involving the administration of small molecules (e.g., SB431542 and CHIR99021) to direct stem cells through neural crest intermediates into enteric neurons. While these molecules were known in the art for certain signaling effects, there was no evidence at the time of the invention that undefined analogs of either compound would be effective in this specific context of enteric neuronal differentiation. The bound of the claims are not limited to the disclosed small molecules, and no further limitations are provided to restrict the analogs to those known or tested.
At the time the invention was made, the structural and functional requirements for molecules capable of inducing human pluripotent stem cells into neural crest or enteric neuronal fates were not well known. While SB431542 and CHIR99021 had known specific cellular differentiation activity as an inhibitor of TGF-β signaling pathways and GSK3β inhibitor/Wnt activator respectively. The specification provides no evidence that structural analogs, many of which could differ significantly, would have the same effect. In fact, the ordinary artisan would be aware that small changes in molecular structure can lead to substantial differences in biological activity and target interactions, which are still unpredictable. The disclosure of Liao et al. (Application of Artificial Intelligence In Drug-target Interactions Prediction: A Review. npj Biomed. Innov. 2, 1 (2025).) evidence that even with the most advanced technology, there are still several challenges that need to be overcome, such as insufficient integrity of data set. Similarly, the disclosure of Pinheiro et al. (Pharmaceuticals (Basel). 2023 Aug 15;16(8):1157.) evidence that small changes, such as a methyl group, can demonstrate profound changes in either pharmacodynamic or pharmacokinetic properties. The specification broadly defines:
However, there is no indication that any such analogs were even synthesized or tested by applicants.
The specification provides examples showing that SB431542 and CHIR99021 promote neural crest and enteric neuron differentiation, but the same is not shown or suggested for any analog. No working examples using analogs are provided. The claims encompass compounds far beyond what is taught in the specification. In total, the specification and prior art support that SB431542 and CHIR99021 may be used in the claimed methods. However, the claims recite use of undefined analogs of each compound, and the specification fails to provide adequate enablement for the full scope of those claimed. The scope of the claims is beyond what was known/expected based on the prior art and taught in the instant specification.
Taken together, given the state of the knowledge available to a person of ordinary skill in the art at the time of the invention, and in view of the breath of the claims, the undefined structural relationship of the claimed ‘analogs’ of SB431542 and CHIR99021 renders the claimed scope unpredictable. The specification fails to provide adequate guidance, working examples, or structural criteria by which such analogs could be identified or reasonably expected to induce the claimed stem cell differentiation. As such, the ability of the skilled artisan to practice the full scope of the claimed invention, including using undefined analogs to induce the required neural crest or enteric neuron differentiation, would require undue experimentation and exceeds the enablement provided in the disclosure. Therefore, the claims are not commensurate in scope with the supporting disclosure and fail to satisfy the enablement requirement of 35 USC § 112(a).
Claim interpretation
Claims 67 and 72-73 are interpreted according to the broadest reasonable interpretation (BRI) consistent with the specification, as would be understood by one of ordinary sill in the art.
Specifically, the claims chronologically require that the first media is limited in that it contains SB431542, CHIR 99021, and retinoic acid. The ‘second medium’ and ‘third medium’ are generically recited, with the ‘third’ subsequent to the ‘first,’ the ‘second’ subsequent to the ‘third,’ and with no structural limitation applied.
In claim 72, the neural crest cells are ‘exposed to the third medium before steps (c) and (d), where the ‘third medium’ is applied from 1-3 days, but is not limited by any structure or function. Thus, this step can be broadly interpreted simply as adding any liquid media with the additional of any new aliquot, the third media could even be a media refresh with the same components SB431542, CHIR 99021, and retinoic acid as the first.
Finally, in steps (c) and (d), the claims recite the first media is removed and a second media is applied, sufficient to terminally differentiate the cells. Again, there is no structural limitation upon the second cell medium. Thus, the second medium can be interpreted to be any media required to sustain cell growth, or even a simple media change, involving replacing or refreshing the first medium, again containing the required nutrients to sustain cell growth along with SB431542, CHIR 99021, and retinoic acid.
Thus, under BRI, the recited medias can reasonably encompass any liquid medium containing SB431542, CHIR 99021, and retinoic acid, including commonly used basal medium, complete medium or differentiation medium, such as materials are routinely used in cell culture between differentiation and terminal cell fate induction steps.
New Claim Rejections - 35 USC § 103
Claims 67 and 72-73 are rejected under 35 U.S.C.103 as being unpatentable over Fattahi et al. (Nature. 2016 Mar 3;531(7592):105-9. Epub 2016 Feb 10.), in view of Studer et al. (WO 2017/112901 A1)). This is a new rejection necessitated by Applicants’ amendments to the claims in the response filed on April 28, 2025.
Regarding claim 67 and 72-73, Fattahi teaches the efficient derivation and isolation of enteric nervous system (ENS) progenitors from human pluripotent stem (PS) cells and their further differentiation into functional enteric neurons. The teachings of Fattahi state,
“Here we demonstrate the efficient derivation and isolation of ENS progenitors from human pluripotent stem (PS) cells, and their further differentiation into functional enteric neurons (abstract).”
Fattahi teaches a chemically defined method for differentiating human pluripotent stem cells into functional enteric neurons via a vagal neural crest cell intermediate (pg. 105-106, bridging para.). The method includes culturing stem cells on Matrigel-coated dishes (solid substrates), applying a first medium comprising dual SMAD inhibitors, specifically SB431542 and CHIR99021 to induce neural crest cells, and subsequently applying a second medium (e.g., containing retinoic acid) to promote enteric neuronal differentiation. The protocol also includes removal and replacement of media between stages, and results in enteric neurons identified by characteristic expression patterns (see Methods Section, para. 1-2). The use of CHIR99021 and SB431542 is explicitly taught from day 0, where the newly recited CHIR99021 is taught in the methods for neural crest induction and in vitro differentiation of ENC to enteric neurons. (Fig 1.; Methods section, para 1-2 and Sections: Neural crest induction & In vitro differentiation of ENC to enteric neurons). The method of claims 67, 72, and 73 recites “said method comprising
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”. The phrase “comprises” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The claimed steps are rendered obvious by Fattahi alone because a person of ordinary skill in the art would have found it obvious to have cultured cells in a medium containing SB431542, CHIR 99021, and retinoic acid to obtain neural crest cells and differentiation of ENC to enteric neurons, as taught by Fattahi. Thus, prior to the effective filing date, the ordinary artisan would have had a reasonable expectation of success in achieving the desired fate performing the recited sequence of directed differentiation steps, using SB431542, CHIR99021, and retinoic acid, in a solid substrate-based culture system.
Furthermore, the ordinary artisan would have recognized that methodologies of differentiating stem cells into enteric neuronal cells along with neural crest induction using SB431542, CHIR99021, and retinoic acid were well known in the prior art, further in view of the teachings of Studer. Studer further teaches in vitro methods of inducing differentiation of stem cells into enteric neural crest lineage cells, and enteric neural crest lineage cells (claim 1), where the method comprises culturing where the cells are in contact with the claimed chemical compounds (pg. 5, para. 4-6; Claim 1-6, 12, 15-23, 32-34, 51, 62, 74-75, 113, 116, 124).
Moreover, as per MPEP § 716.02, [a]ny differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Fattahi teaches the application of CHIR99021 and SB431542 from days 0-11, and there is no indication that cellular differentiation is made distinctive or unique by exposure to a ‘second’ or ‘third cell medium’ for 1-3 days with no recited structural differences to that of the first.
Regarding the specific steps, such as the cells being exposed to a generic ‘third medium’ a person of ordinary skill in the art would have recognized that during the process of cell culturing the selection of components, parameters, and techniques, such as passaging cells, media refreshments, media changes, or adding media, removing supernatant, all fall within conventional and established activities to maintaining cell viability and is considered standard in the field. These activities are regarded merely a matter or judicious selection, well within the purview of the skilled artisan, in light of the prior art and references such as Fattahi and Studer. Together, these references teach sufficient methodological context from which the skilled artisan would reasonably execute the common procedural steps without requiring undue experimentation.
Response to Applicants’ arguments as they apply to the rejection of Claims 67 and 72-73 under 35 USC § 103
Applicant's arguments filed April 28, 2025, have been fully considered but they are
not persuasive.
At pages 12-15 of the remarks filed on April 28, 2025, Applicants essentially argue the following:
Applicant argues “Fattahi teaches initiation of differentiation by culturing in medium containing LDN193189 and SB431542 and then application of retinoic acid for differentiation into enteric NC cells. Fattahi, Pg. 110. To differentiate cells into cranial NC cells, a completely different cell, Fattahi teaches introduction of CHIR 99021. Id." Hence, applicant argues Fattahi teaches away from introduction of CHIR99021 for enteric NC cells.
The argument is not persuasive because the cited art does not teach away from the claimed combination. The evidenced demonstrates that Fattahi taught neural crest induction and CNC induction with the treatment of CHIR99021, SB431542, and retinoic acid. It appears Applicant incorrectly stated Fattahi only taught LDN193189, SB431542, and retinoic acid.
In response, the Examiner respectfully submits that patents are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). With that, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, even nonpreferred embodiments. See MPEP § 2123: Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989); Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). In the instant case, Fattahi expressly states ENC differentiation involves the culturing in CHIR99021, SB431542, and additional treatment with retinoic acid (Methods Section, para. 2, Neural crest induction).
The use of the claimed components for stem cell differentiation was indeed well known in the field. The following reference is cited as evidence without relying on the rejection, as further evidence to this fact, see Qi et al. (Nat Biotechnol. 2017 Feb;35(2):154-163. doi: 10.1038/nbt.3777. Epub 2017 Jan 23.). Here, Qi taught combined small-molecule inhibition accelerates the derivation of functional cortical neurons from human pluripotent stem cells, specifically disclosing the utility of WNT agonist CHIR99021 in steps of differentiation (Fig. 1 and 4; pg. 161, column 1, para. 2), as well as SB431542 (pg. 154, para. 1; Fig. 2, Fig. 6; Online Methods Section).
***
While the method recites exposing the cells in culture to CHIR99021, SB431542, and retinoic acid, it appears the applicant is also arguing Fattahi teaches an alternative intended use. In response to applicant's argument that Fattahi teaches the same steps for different intended uses, being the differentiation of cranial nerve cells, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, while the references may contain context-specific teachings, they do indeed teach the use of CHIR99021, SB431542, and retinoic acid for enteric NC derivation. While
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applicants argue Fattahi teaches CHIR99021 for differentiation of cranial NC cells, Fig. 1 of Fattahi explicitly recites: for deriving enteric NC (ENC) cells in the second line and teaches are directed to both CNS and CNC precursors. Moreover, applicant has not acknowledged that Studer also explicitly teaches the utility of CHIR99021 and SB431542 in neural induction protocols, and the selection of such factors is well within the routine capabilities of one of ordinary skill seeking to optimize differentiation protocols. As such, the references provide complementary teachings that would have led the skilled artisan to the claimed combination with a reasonable expectation of success.
Applicant argues the references merely invite mixing and matching of unrelated steps or compositions, which cannot render the claim obvious.
Applicant is correct in that the teachings of Thermofisher, Clevers and Kida, while present in the “Response to Applicants arguments” section of the reply to restriction traverse, were not repeated in the content of the 103. However, Applicants’ recitation of the new limitation requiring CHIR99021, have been responded to with a new ground of rejection. The arguments pertaining to Thermofisher, Clevers and Kida are moot, in view of the new grounds of rejection. The relevant disclosures are made of record in a PTO-892 Form to complete the record.
Applicant argues the results of obtaining enteric neural crest cells and then enteric neurons is unexpected and thus rebut a prima facie case of obviousness.
This argument is not persuasive because the alleged unexpected results are not sufficiently substantiated with comparative data or evidence that the claimed method yields results that deviate from what would have been expected based on the prior art. Fattahi and Studer both demonstrate the derivation of neural crest cells and neuronal linages using the same recited media containing CHIR99021, SB431542, and retinoic acid. As referenced above, please see Fattahi, Methods, Section: Neural crest induction, ‘ENC differentiation involves additional treatment with retinoic acid’. The claims also recite the media can further comprise retinoic acid. There is nothing unexpected here.
Furthermore, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. Here, the assertion of unexpected results is conclusory and does not overcome the prima facie case.
References made of record in a PTO-892 Form to complete the record
Thermofisher (Thermo Fisher Scientific, "Culturing Pluripotent Stem Cells (PSCs) in Essential 8th Medium" https://tools.themofischer.com/contenl/sfs/manuals/feeder_free_PSCs_in_essential_mediumpdf; pp.1-9; of record IDS filed on 12/13/2022, No.35)
Teaches general cell culture media and protocol procedures for PSCs, including passaging and differentiation.
Clevers et al. (US 2014/0243227 A1)
Specifically teaches the optimized the culture conditions for culturing stem cells including SB431542, CHIR99021, and retinoic acid as compounds (Abstract; [0718]; [0090-0092]; Table 4; Example 7).
Kida et al. (US 2018/0155682 A1)
Teaches method for inducing differentiation of neural crest cells into neurons of the autonomic nervous system, including SB431542 and CHIR99021 ([0006]; [0123]).
Conclusion
Claims 67 and 72-73 are rejected. No claims are allowed.
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.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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