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
Status of Prosecution
In view of the appeal brief filed on 5/4/26, PROSECUTION IS HEREBY REOPENED. A new group of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ANNE M KOZAK/ Supervisory Patent Examiner, Art Unit 3797
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7-8, 20, 30-31 and 34-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puleo et al. (US 2020/0054228).
Addressing claim 30, Puleo discloses a system for treating a metabolic disorder in a subject, the system comprising:
an energy application device comprising at least one ultrasound transducer configured to non-invasively target a tissue of the subject, wherein the tissue comprises at least a portion of a peripheral nerve pathway, and wherein the peripheral nerve pathway comprises at least a portion of a hepatoportal plexus or a superior mesenteric plexus (see Fig. 3, [0007], [0086], [0091] and [0096]; modulate nerve target site mesenteric plexus; mesenteric plexus include both superior mesenteric plexus and inferior mesenteric plexus);
a pulse generator configured to be connected to the at least one ultrasound transducer to stimulate the tissue using the at least one ultrasound transducer for a duration that is effective to activate late-response genes in the subject to thereby treat or alleviate the metabolic disorder (see Figs. 1-3, [0100-0101], [0119] and [0184]; change gene to treat diabetes; the claim is broadly claim ultrasound transducer stimulation for a duration that is effective to activate late-response genes in the subject to thereby treat or alleviate the metabolic disorder; Puleo discloses ultrasound stimulation of several minutes, 30 minutes to several hours; this is within the time frame disclose by applicant’s specification to effectively activate late-response genes (see applicant’s specification paragraphs [0058] and [0064]); activate late-response genes is a result of stimulation for a duration of time).
4 Addressing claims 7-8, 20, 31 and 34-41, Puleo discloses:
addressing claim 7, wherein the late-response gene comprises a fibroblast growth factor 1 (FGF1) gene (see Fig. 3, [0007], [0086], [0091], [0096] and [0100-0101]; examiner interprets the claim as stimulate gene/cell that has and responsible for producing FGF1; as see in applicant’s specification paragraphs [0052] and [0059], energy is directed to a target tissue (e.g., the hepatoportal plexus and/or superior mesenteric plexus) for a duration effective to activate late response genes (e.g., the FGF1 gene); FGF1 production is a result of apply energy to the target for a duration; Puleo discloses apply energy to the target for the same range duration as applicant therefore result in FGF1 production).
addressing claim 8, wherein the late-response gene modulates a protein kinase R (PKR)-like endoplasmic reticulum kinase (pERK) pathway (see Fig. 3, [0007], [0086], [0091], [0096] and [0100-0101]; modulates a protein kinase R (PKR)-like endoplasmic reticulum kinase (pERK) pathway is a result of activate late-response gene and activate late-response gene result from apply energy to the target for a duration of time; Puleo discloses apply energy to the target for a duration of time as applicant claim therefore result in activating late response gene which in turn modulates a protein kinase R (PKR)-like endoplasmic reticulum kinase (pERK) pathway).
addressing claim 20, wherein the late-response gene causes a-fibroblast-growth-factor 1 (FGFI) gene production of FGF1 (see Fig. 3, [0007], [0086], [0091], [0096] and [0100-0101]; as see in applicant’s specification paragraphs [0052] and [0059], energy is directed to a target tissue (e.g., the hepatoportal plexus and/or superior mesenteric plexus) for a duration effective to activate late response genes (e.g., the FGF1 gene); FGF1 production is a result of apply energy to the target for a duration; Puleo discloses apply energy to the target for the same range duration as applicant therefore result in FGF1 production).
addressing claim 31, wherein activating the late response genes comprises activating sustained expression of immediate early genes (see Fig. 3, [0007], [0086], [0091], [0096] and [0100-0101]; Puleo apply energy to the target region for a duration of time which result in sustained expression of immediate early genes).
addressing claim 34, wherein the tissue comprises more than one peripheral nerve pathway, wherein the peripheral nerve pathways are in communication with each other or with an integrating neuron or cell in the central nervous system (see [0004], [0007], [0086], [0091], [0177], [0186], [0188]).
addressing claim 35, wherein the integrating neuron is an interneuron (see [0004], [0007], [0086], [0091], [0177], [0186], [0188]; the stimulation tissue contain nerve that communicate to the brain, spinal cord, central nervous system that contain interneuron).
addressing claim 36, wherein the act of stimulating the tissue comprises activation of an ion channel selected from the TRP family of ion channels (see [0088] and [0091]; stimulate the tissue that modulate peripheral nerve to activate ion channel TRP).
addressing claim 37, wherein the ion channel selected from the TRP family of ion channels comprises TRPA1 (see [0088] and [0091]; stimulate the tissue that modulate peripheral nerve to activate ion channel TRPA1).
addressing claim 38, wherein the act of stimulating the tissue comprises mechanical displacement of peripheral nerve pathways (see [0069], [0071], [0099], [0108] and [0119]).
addressing claim 39, wherein the late response genes are in the hypothalamus of the subject (see Fig. 3, [0007], [0086], [0091], [0096], [0100-0101] and [0184]; Puleo disclose stimulate a duration that is effective to produce FGF1; FGF1 is produced in the hypothalamus; the stimulation effect genes and nerves in the hypothalamus).
addressing claim 40, wherein the late-response gene affects a concentration of glucose (see [0047] and [0181]; Puleo disclose stimulate to change concentration of glucose; the stimulate duration result in activating late response change that change concentration of glucose).
addressing claim 41, wherein the integrating neuron or cell connect neuropeptide Y (NPY) neurons and proopiomelanocortin (POMC) neurons (see [0058-0059] and [0184]; nerve pathways are in communication with NPY and POMC).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Puleo et al. (US 2020/0054228) and further in view of Azamian et al. (US 2013/0178910).
Addressing claim 42, Puleo does not disclose hepatoportal plexus and the superior mesenteric plexus. In the same field of endeavor, Azamian discloses the hepatoportal plexus and the superior mesenteric plexus (see [0080], stimulate mesenteric plexus in addition to nerve fibers in the hepatic plexus/hepatoportal plexus). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Puleo to stimulate superior plexus in addition to hepatic plexus because this help treat diabetes or metabolic conditions (see [0080]).
Response to Arguments
Applicant’s arguments, see pages 5-12, filed 05/04/26, with respect to the rejection(s) of claim(s) 7-8, 20, 30-31 and 34-42 under 112 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Puleo et al. (US 2020/0054228).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2024/0083903; US 2020/0113943; US 2016/0129012; US 2010/0268297 (see [0073]; stimulate mesenteric plexus and hepatic plexus); US 2016/0038769 (see [0018]; stimulate mesenteric plexus and hepatic plexus); US 2016/0128767 (see [0140]; stimulate hepatic plexus in addition to mesenteric plexus); US 2017/0312021 (see [0065]; stimulate mesenteric plexus and hepatic plexus); US 2017/0348049 (see [0181]; stimulate hepatic plexus in addition to mesenteric plexus) and US 2019/0069949 (see [0216]; stimulate hepatic plexus in addition to mesenteric plexus).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights