Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 08/27/2025, wherein the Amendment amended claims 2, 12-13, and 16.
Claims 1-16 are pending and examined on the merits herein..
Priority
This applications claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(b)
Applicant’s amendments to claims 2, 12-13, and 16 are sufficient to overcome these rejections.
Double Patenting
The Double Patents rejections are overcome by the terminal disclaimer filed on 08/27/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent Nos. 9,555,020 and 11,925,609, has been reviewed and is accepted. The terminal disclaimer has been recorded.
REJECTIONS-MAINTAINED & NEW
Claim Objections
(New) Claims 12-13 are objected to because of the following informalities:
Claims 12 and 13 recite “an amount” followed by a range of concentrations of “the topical analgesic.” However, an amount of the topical analgesic cannot be discerned from a concentration unless the specific volume of the solution is known (i.e., mL).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
Claim 16 is 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.
This is a new matter rejection.
Claim 16 recites “wherein the analgesic agent comprises a hydroxyl group.” A careful review of the originally filed disclosure does not provide support for this limitation. While the instant specification does teach capsaicin and resiniferatoxin as analgesic agents ([026] and [055]), wherein both these compounds contain hydroxyl groups, the specification does not teach analgesic agents, in general, as comprising “a hydroxyl group.”
Moreover, Applicant does not point to support for this limitation in the instant response.
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.
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.
(Maintained) Claims 1, 6, 7, 9, 11-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0012154 to Pasricha (published 2009, IDS of 08/15/2024), as evidenced by Giridharan (Microbiota-gut-brain axis in the Alzheimer’s disease pathology-an overview, Neuroscience Research, published 2022, PTO-892) and Fish (Physiology, Small Bowel, National Library of Medicine, published 01/31/2024, PTO-892).
Pasricha teaches a method of treating obesity by localized ablation of vagal afferent nerves in the stomach or other regions of the gastrointestinal tract (pg. 3, claim 9). The ablation is achieved by desensitization of the transient receptor potential vanilloid 1 expressed on the vagal afferent nerves, by locally administering resiniferatoxin (analgesic agent) or its derivatives, wherein endoscopic spraying is taught as form of local administration (pg. 3, claims 10-12). It is noted that endoscopic spraying is a topical application.
Pasricha teaches the small bowel as a region of the gastrointestinal tract (pg. 3, claim 14; pg. 4, claim 22).
Pasricha additionally teaches this method for reducing insulin resistance for the treatment of diabetes (pgs. 3-4, claims 17 and 24).
Regarding claim 1, while Pasricha teaches a method of treating obesity and diabetes by ablation of vagal afferent nerves in the gastrointestinal tract by endoscopically spraying resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach targeting the duodenum.
As evidenced by [043], the duodenum is a specific segment of the gastrointestinal tract.
As evidenced by Fish, the small bowel is divided into 3 sections, the duodenum, jejunum, and ileum (pg. 1, “Introduction,” 1st paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the duodenum as the targeted region of the gastrointestinal tract, in the method of Pasricha, to arrive at the instantly claimed method. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Pasricha teaches its methods for use in the small bowel portion of the gastrointestinal tract, and the duodenum is a specific segment of the gastrointestinal tract.
As such, an artisan of ordinary skill would have been motivated to target the duodenum since it is a part of the small bowel.
Further regarding claim 1, Pasricha specifically teaches ablation of vagal afferent nerves, but does not teach targeting a sensory nerve. However, Pasricha also teaches administration by endoscopic spraying. As evidenced by Giridharan, the vagus nerve is a mixed nerve consisting of 80% sensory afferent and 20% motor efferent fibers (pg. 18, Col. 1, “4. Vagus nerve”). Thus, local administration by endoscopic spraying of the duodenum would predictably target the vagal sensory nerve.
Regarding claims 6 and 7, Pasricha teaches administering the resiniferatoxin by endoscope spraying, and for the reasons stated above, it would have been obvious to endoscopically spray the duodenum.
Regarding claim 9, Pasricha teaches treating diabetes.
Regarding claim 11, Pasricha teaches treating obesity.
Regarding claims 12, Pasricha teaches administering a pharmacologically effective amount of resiniferatoxin to desensitize the TRPV1 receptor to treat obesity and diabetes ([0018], [0019]; pg. 3, claims 11 and 19).
Pasricha additionally exemplifies administration of 250 ml of a 100nM solution of resiniferatoxin ([0022]). Since the molar mass of resiniferatoxin is 628.71g/mol and the solution comprises 100nM resiniferatoxin, 628.75g/mol times.0000001mol/g(M)=0.00006287g/250mL=0.00025mg/mL=0.25ug/m, meeting the limitation of instant claim 12.
Regarding claim 13, while Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach the claimed concentrations.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the concentration of resiniferatoxin in the method of Pasricha to about 10ug/mL to about 1 mg/mL, to arrive at instant claim 13. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because Pasricha teaches administering a therapeutically effective amount of resiniferatoxin to desensitize the TRPV1 receptor to treat obesity and diabetes, and "[W]here 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." MPEP 2144.05(II).
The optimization of concentrations for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 16, since resiniferatoxin comprises a hydroxyl group, this limitation is met.
Claims 1, 6, 7, 9, 11-13, and 16 are rendered obvious.
(Maintained) Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0012154 to Pasricha (published 2009, IDS of 08/15/2024), as evidenced by Giridharan (Microbiota-gut-brain axis in the Alzheimer’s disease pathology-an overview, Neuroscience Research, published 2022, PTO-892) and Fish (Physiology, Small Bowel, National Library of Medicine, published 01/31/2024, PTO-892), as applied to claims 1, 6, 7, 9, 11-13, and 16 above, and further in view of Leffler (The vanilloid receptor TRPV1 is activated and sensitized by local anesthetics in rodent sensory neurons, J Clin Invest. 208; 118(2), published 2008, PTO-829).
Pasricha, Giridharan and Fish are applied as discussed above and incorporated herein.
Regarding claims 2 and 3, while Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach lidocaine, an antinociceptive agent.
Pasricha teaches resiniferatoxin as a ligand for the TRPV-1 receptor, wherein TRPV-1 functions as a modulator of sensory nerve responses to stimuli. Pasricha teaches resiniferatoxin as an agonist of TRPV-1.
Leffler teaches that TRPV1 is activated and sensitized by local anesthetics (title). Leffler teaches lidocaine as an anesthetic that activates TRPV1 (abstract).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add lidocaine to the method of Pasricha, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because Pasricha teaches resiniferatoxin as an agonist of TRPV1 and Leffler teaches lidocaine as activating TRPV1, and "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06.
Thus, an artisan of ordinary skill would be motivated to make such an addition to predictably arrive at a method of treating obesity or diabetes that more potently targets the TRPV1 receptors of the sensory nerve.
Claims 1-3, 6, 7, 9, 11-13, and 16 are rendered obvious.
(Maintained) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0012154 to Pasricha (published 2009, IDS of 08/15/2024), as evidenced by Giridharan (Microbiota-gut-brain axis in the Alzheimer’s disease pathology-an overview, Neuroscience Research, published 2022, PTO-892) and Fish (Physiology, Small Bowel, National Library of Medicine, published 01/31/2024, PTO-892), as applied to claims 1, 6, 7, 9, 11-13, and 16 above, and further in view of Clark (Chemical Ablation of Liver Cancer, Techniques in Vascular and Interventional Radiology, published 2007, PTO-892).
Pasricha, Giridharan and Fish are applied as discussed above and incorporated herein.
Regarding claim 4, while Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach administration via a syringe.
Clark teaches a method of chemical ablation wherein the active agent is administered via an ultrasound guided syringe (pg. 58, final paragraph-pg. 59 first full paragraph, pg. 61, Figure 2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the endoscopic spraying of Pasricha with ultrasound guided syringe administration, to arrive at the instantly claimed method. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Pasricha is directed toward a method of chemical ablation and Clark teaches chemical ablation via ultrasound guided syringe administration.
Thus, an artisan of ordinary skill in the art would have been motivated to make such a substitution to predictably arrive at a less invasive method of performing chemical ablation that is more targeted.
Claims 1, 4, 6, 7, 9, 11-1,3 and 16 are rendered obvious.
(Maintained) Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0012154 to Pasricha (published 2009, IDS of 08/15/2024), as evidenced by Giridharan (Microbiota-gut-brain axis in the Alzheimer’s disease pathology-an overview, Neuroscience Research, published 2022, PTO-892) and Fish (Physiology, Small Bowel, National Library of Medicine, published 01/31/2024, PTO-892), as applied to claims 1, 6, 7, 9, 11-13, and 16 above, and further in view of Holle (Myoelectric activity of small intestine after chemical ablation of myenteric neurons, American Physiological Society, published 1990, IDS of 08/15/2024).
Pasricha, Giridharan and Fish are applied as discussed above and incorporated herein.
While Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach administration following surgical exposure of the duodenum or administration on the serosal surface of the duodenum.
Holle teaches chemical ablation of the myenteric plexus by serosal application in the duodenum, jejunum and ileum (abstract). The serosal application is preceded by surgical exposure of the peritoneal cavity (pg. G519, Col. 2, “Methods,” 2nd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the endoscopic spraying of Pasricha, with serosal application via surgical exposure, to arrive at instant claims 5 and 8. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because both Pasricha and Holle are directed toward methods of chemically ablating the stomach and gastrointestinal tract, and Holle teaches serosal application via surgical exposure as a known and acceptable ablation technique.
Thus, an artisan of ordinary skill in the art would have been motivated to make such a substitution to predictably arrive at an alternative method of chemically ablating nerves cells on the duodenum that is effect for treating obesity and diabetes.
Claims 1, 5-9, 11-13, and 16 are rendered obvious.
(Maintained) Claims 10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0012154 to Pasricha (published 2009, IDS of 08/15/2024), as evidenced by Giridharan (Microbiota-gut-brain axis in the Alzheimer’s disease pathology-an overview, Neuroscience Research, published 2022, PTO-892) and Fish (Physiology, Small Bowel, National Library of Medicine, published 01/31/2024, PTO-892), as applied to claims 1, 6, 7, 9, 11-13, and 16 above, and further in view of US PG-PUB 2008/0275445 to Kelly (published 2008, IDS of 08/15/2024).
Pasricha, Giridharan and Fish are applied as discussed above and incorporated herein.
Regarding claim 10, while Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach type 2 diabetes mellitus.
Kelly teaches devices and methods for ablating tissue in the wall of various organs of the gastrointestinal tract of a patient to treat conditions such as obesity or type 2 diabetes mellitus (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select type 2 diabetes mellitus, as the diabetes of Pasricha, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Pasricha and Kelly both teach methods of treating diabetes through ablating tissue of the gastrointestinal tract, and Kelly specifically teaches the diabetes as type 2 diabetes mellitus.
Thus, an artisan of ordinary skill would have been motivated to make such a selection to predictably arrive at a method of treating type 2 diabetes mellitus.
Regarding claims 14-15, while Pasricha teaches a method of treating diabetes or obesity by endoscopically spraying the duodenum with resiniferatoxin, it differs from that of the instantly claimed invention in that it does not teach measuring oral glucose tolerance or body weight change of the subject.
Kelly teaches evaluating the success of ablation treatment for obesity, metabolic syndrome or diabetes by measuring absorption of nutrients, blood glucose levels, blood insulin levels, insulin resistance, body weight, or body mass index ([0014], [0104]-[0106]). Kelly specifically teaches the administration of oral glucose tolerance test to test blood glucose levels ([0107]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add measuring oral glucose tolerance and/or weight change of a subject, to the methods of Pasricha, to arrive at the instantly claimed method. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because Kelly teaches measuring oral glucose tolerance and weight change as a way to evaluate the success of ablation treatment for obesity or diabetes.
Thus, an artisan of ordinary skill would have been motivated to add these steps to predictably arrive at a means to evaluate the success of the ablation treatment in obese and/or diabetic patients.
Claims 1, 6, 7, and 9-16 are rendered obvious.
Response to Arguments
On pgs. 4-5, Remarks, Applicant argues that Pasricha fails to teach, suggest, or provide any apparent reason for targeting a sensory nerve in the duodenum of a subject with an analgesic agent and that Pasricha does not provide any enabling teaching to target the duodenum.
This argument has been fully considered, but is not found persuasive. Regarding the term “targeting,” in paragraph [047] of the specification, the specification states that “Such targeting can be accomplished, for example, by immunolabeling or other labeling techniques during the ablation procedure,” however, this is merely an example of “targeting,” and no limiting definition of “targeting” is provided. Thus, the methods of Pasricha, which teach localized administration, wherein localized administration is known in the art as administration of an active agent directly to a specific target site in the body, targets a sensory nerve in the duodenum. See MPEP 2111, “During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification.”
Regarding the enabling disclosure, it is not clear what Applicant is referencing. Pasricha teaches locally administering, via topical application, an analgesic to the small bowel, wherein the duodenum is part of the small bowel. As such, it is not clear how the disclosure of Pasricha “does not provide any enabling teaching to target the duodenum.” Applicant is respectfully reminded that 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. See MPEP 716.01(c).
On pg. 5, Remarks, Applicant argues that Pasricha’s specific teachings are to reduce nausea by spraying the mucosal lining of the stomach and that it would not have been obvious to treat an area less dense of nerves because it would be less effective or would require a larger concentration of toxins like resiniferatoxin to have the same effect.
This argument has been fully considered, but is not found persuasive. This argument appears to be in reference to the two examples spanning paragraphs [0022]-[0023] of Pasricha. Applicant is respectfully reminded that patents are relevant as prior art for all they contain and “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994),” see MPEP 2123.
It is additionally respectfully pointed out, as discussed in the above rejection, that the claims of Pasricha claim a method of treating obesity, and claim a method for reducing insulin resistance for the treatment of diabetes, wherein these methods are claims as locally targeting the small bowel. Thus, Pasricha’s teachings and preferred embodiments are not limited to reducing nausea by spraying the mucosal lining of the stomach with a specific concentration of toxins like resiniferatoxin.
And regarding the arguments toward the concentration of resiniferatoxin, it is respectfully pointed out that independent claim 1 is not limited to any amount of analgesic.
On pg. 5, Remarks, Applicant argues that Pasricha teaches a localized ablation of the nerves, not a targeted ablation and that the endoscopic spraying of resiniferatoxin is to the gastric mucosa, which is not the duodenum.
This argument has been fully considered, but is not found persuasive. It is first respectfully pointed out that the instant rejection is not a 35 USC 102 anticipation rejection, but a 35 USC 103 obviousness rejection. As discussed above, Pasricha’s teaching of localized administration meets the limitations of “targeting.” And as discussed above, it is only Pasricha’s preferred embodiments that are limited to endoscopic spraying of gastric mucosa, and as discussed above, it would have been obvious to endoscopically spray the duodenum. Further, in [0018] of Pasricha, endoscopic spraying of the small bowel is specifically taught.
On pg. 5, Remarks, Applicant argues that Giridharan fails to teach, suggest, or provide any apparent reason for targeting a sensory nerve in the duodenum with an topical analgesic.
This argument has been fully considered, but is not found persuasive. Giridharan is relied upon as an evidentiary reference to show that the vagus nerve, as taught by Pasricha, is a mixed nerve consisting of 80% sensory afferent and 20% motor efferent fibers.
On pg. 6, Remarks, Applicant argues that encompassing the entirety of the sensory nerve is different from targeting the sensory nerve, and that localized spraying of a toxin simply means that the area is indiscriminately sprayed with the toxin.
This argument has been fully considered, but is not found persuasive. As discussed above, Applicant has not provided any definition of the term “targeting,” and as discussed above, the methods of Pasricha teach localized administration, which is known in the art as administration of an active agent directly to a specific target site in the body. Thus, the methods of Pasricha target a sensory nerve in the duodenum.
On pg. 6, Remarks, Applicant argues that Fish also fails to teach, suggest, or provide any apparent reason for targeting a sensory nerve in the duodenum with an topical analgesic.
This argument has been fully considered, but is not found persuasive. Fish is an evidentiary reference relied upon to show that the small bowel, as taught by Pasricha, is divided into three sections, the duodenum, jejunum, and ileum.
On pgs., 6-7, Remarks, Applicant argues that none of Leffler, Clark, Holle, or Kelly teach, suggest, or provide any apparent reason for targeting a sensory nerve in the duodenum with an topical analgesic.
These arguments have been fully considered, but are not found persuasive. Leffler, Clark, Holle, and Kelly are secondary references relied upon to meet the limitations of dependent claims, and are not relied upon to meet the limitations of instant claim 1.
For these reasons, Applicant’s arguments are not persuasive to overcome the 35 USC 103 rejections.
Conclusion
No claims are 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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/L.Q.W./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622