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 .
Response to Amendment
The amendment filed June 9, 2026 in response to the Office Action of December 10, 2025 has been acknowledged and entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: Claim limitation “a control unit…adapted to determine” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “adapted to determine” without reciting sufficient structure to achieve the function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “a control unit” refers to the Specification as filed, Page 54, Paragraph 2, refer to a computing circuit or device for controlling operation of mechanical and/or electrical components of the capsule.
See MPEP 2181.II.A. The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claims 1-2, 4, 8, 10-12, 17, 20, 22, and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Shimura (WO 2016035634) in view of Shohat (US 20090318841) (previously cited).
Regarding claim 1, Shimura teaches a gastrointestinal treatment system for treatment of a disorder in a gastrointestinal tract of a subject (Page 2, lines 25-33, Page 5, paragraph 4, a circadian rhythm inspection system to estimate gastrointestinal function) comprising an input source (inspection apparatus 100) providing input relating to a characteristic of a circadian cycle of the subject (Page 4, paragraphs 3-4 of Machine Translation, apparatus 100 comprises imaging device 104 that captures a plurality of skin images over a plurality of time points); a control unit (150), functionally associated with said input source, said control unit adapted to determine a user-specific time of day based on the input relating to the characteristic of the circadian cycle of the subject (Page 5, paragraphs 2-5).
However, Shimura does not teach “a gastrointestinal capsule for vibrating in the gastrointestinal tract of the subject following ingestion of said gastrointestinal capsule, said gastrointestinal capsule comprising: a housing; a vibrating agitator adapted such that, in a first vibrating mode of operation, said housing exerts vibrations on an environment surrounding said capsule; a power supply disposed within said housing and adapted to power said vibrating agitator; and a controller adapted, in response to receipt of an activation input from the control unit, to activate said vibrating agitator to operate in said first vibrating mode of operation at the user-specific time of day, wherein operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating.”
Shohat, in a related field of endeavor, teaches a gastrointestinal treatment system (Figs. 1-3) comprising a gastrointestinal capsule (Fig. 1, capsule 10) for vibrating in the gastrointestinal tract of the subject (Paragraph [0007] vibrating the gastrointestinal walls) following ingestion of said gastrointestinal capsule, (Paragraph [0007], [0009]) said gastrointestinal capsule (10) comprising: a housing (Paragraph [0010]; Fig. 1, shell segments 16, 20); a vibrating agitator (Paragraph [0011]; Fig. 1, spring 14, shaft 12, solenoid 18) adapted such that, in a first vibrating mode of operation, (Paragraph [0011] when an electrical current is intermittently and repeatedly applied on both terminals of solenoid 18 by an electric battery) said housing (Fig. 1, 16, 20) exerts vibrations on an environment surrounding said capsule (Paragraph [0011]); a power supply (Paragraph [0011] electric battery housed in the GIC) disposed within said housing and adapted to power said vibrating agitator (Paragraph [0011]); and a controller (Paragraph [0009] electric circuitry embedded in the GIC provides for synchronizing the activation of a GIC … as well as for time profiling its agitation) adapted, in response to receipt of an activation input from the control unit, to activate said vibrating agitator to operate in said first vibrating mode of operation at the user-specific time of day, (Paragraph [0009]), wherein operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating (Paragraph [0012] the gastrointestinal capsule is suitable to treat constipation; Paragraph [0017] gastroparesis).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura to incorporate “a gastrointestinal capsule for vibrating in the gastrointestinal tract of the subject following ingestion of said gastrointestinal capsule, said gastrointestinal capsule comprising: a housing; a vibrating agitator adapted such that, in a first vibrating mode of operation, said housing exerts vibrations on an environment surrounding said capsule; a power supply disposed within said housing and adapted to power said vibrating agitator; and a controller adapted, in response to receipt of an activation input from the control unit, to activate said vibrating agitator to operate in said first vibrating mode of operation at the user-specific time of day, wherein operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating” as taught by Shohat. Doing so enables therapeutic intervention for gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 2, Shimura teaches wherein the input source comprises a user interface adapted to receive input from the subject or from a caretaker of the subject. (Fig. 10b; Page 28, paragraph 4, button 622 described as “Regist Patient” is a button for causing the display 101 to display an input screen of a profile of the user.)
Regarding claim 4, Shimura teaches wherein said input includes input relating to a sleep time or sleep schedule of the subject. (Page 5, paragraphs 2-4).
Regarding claim 8, Shimura does not teach “wherein said user-specific time of day at which said vibrating agitator operates in said first vibrating mode of operation is a user-specific mealtime”.
Shohat teaches wherein said user-specific time of day at which said vibrating agitator operates in said first vibrating mode of operation is a user-specific mealtime. (Paragraph [0009])
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura as modified to teach “wherein said user-specific time of day at which said vibrating agitator operates in said first vibrating mode of operation is a user-specific mealtime” as taught by Shohat. Doing so enables therapeutic intervention for gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 10, Shimura teaches wherein said control unit is adapted to provide said user-specific time of day, as part of said activation input (Page 5, paragraphs 2-5), but does not further teach “to said gastrointestinal capsule”.
Shohat teaches a gastrointestinal capsule. (Paragraph [0009]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura to incorporate “a gastrointestinal capsule” as taught by Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 11, Shimura teaches wherein said control unit is adapted to incorporate said user-specific time of day, (Page 5, paragraphs 2-5), but does not further teach incorporation of said user-specific time of day “into a vibration protocol and to program said gastrointestinal capsule with said vibration protocol”.
Shohat teaches a vibration protocol and to program said gastrointestinal capsule with said vibration protocol. (Abstract; Paragraphs [0009]-[0011], [0019]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura to further teach incorporation of said user-specific time of day “into a vibration protocol and to program said gastrointestinal capsule with said vibration protocol”, as taught by Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 12, Shimura teaches a method of treating a gastrointestinal condition of a subject, (Page 2, lines 25-33, Page 5, paragraph 4, a circadian rhythm estimation system to estimate gastrointestinal function) the method comprising: receiving input (via inspection apparatus 100) relating to a characteristic of a circadian cycle of the subject (Page 4, paragraphs 3-4 of Machine Translation, apparatus 100 comprises imaging device 104 that captures a plurality of skin images over a plurality of time points); determining a user-specific time of day (via control unit 150) based on the input relating to the characteristic of the circadian cycle of the subject (Page 5, paragraphs 2-5).
However, Shimura does not teach “programming a gastrointestinal capsule being adapted to transit a gastrointestinal tract of the subject, with said user-specific time of day, said gastrointestinal capsule having: a housing; a vibrating agitator, the vibrating agitation mechanism adapted such that, in a first vibrating mode of operation, said housing exerts vibrations on an environment surrounding said gastrointestinal capsule; a power supply disposed within said housing and adapted to power said vibrating agitator; and a controller adapted to activate said vibrating agitator to operate in said first vibrating mode of operation; following ingestion of said gastrointestinal capsule by the subject, and when said gastrointestinal capsule is in an operative state, activating said vibrating agitator to operate in said first vibrating mode of operation said user-specific time of days wherein the operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating.”
Shohat teaches programming a gastrointestinal capsule being adapted to transit a gastrointestinal tract of the subject, with said user-specific time of day, (Paragraphs [0007], [0009]) said gastrointestinal capsule having: a housing (Paragraph [0010]; Fig. 1, shell segments 16, 20); a vibrating agitator, the vibrating agitation mechanism (Paragraph [0011]; Fig. 1, spring 14, shaft 12, solenoid 18) adapted such that, in a first vibrating mode of operation, said housing exerts vibrations on an environment surrounding said gastrointestinal (Paragraph [0011]) ; a power supply (Paragraph [0011] electric battery housed in the GIC) disposed within said housing and adapted to power said vibrating agitator (Paragraph [0011]); and a controller adapted to activate said vibrating agitator to operate in said first vibrating mode of operation (Paragraph [0009] electric circuitry embedded in the GIC provides for synchronizing the activation of a GIC … as well as for time profiling its agitation); (d) following ingestion of said gastrointestinal capsule by the subject, and when said gastrointestinal capsule is in an operative state, activating said vibrating agitator to operate in said first vibrating mode of operation said user-specific time of day, (See Paragraph [0009]), wherein operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating (Paragraph [0012] the gastrointestinal capsule is suitable to treat constipation; Paragraph [0017] gastroparesis).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection method of Shimura to teach the steps of “programming a gastrointestinal capsule being adapted to transit a gastrointestinal tract of the subject, with said user-specific time of day, said gastrointestinal capsule having: a housing; a vibrating agitator, the vibrating agitation mechanism adapted such that, in a first vibrating mode of operation, said housing exerts vibrations on an environment surrounding said gastrointestinal capsule; a power supply disposed within said housing and adapted to power said vibrating agitator; and a controller adapted to activate said vibrating agitator to operate in said first vibrating mode of operation; following ingestion of said gastrointestinal capsule by the subject, and when said gastrointestinal capsule is in an operative state, activating said vibrating agitator to operate in said first vibrating mode of operation said user-specific time of days wherein the operation of said gastrointestinal capsule in said first vibrating mode of operation at the user-specific time of day is efficacious for the treatment of the disorder in the gastrointestinal tract of the subject, the disorder being selected from the group consisting of constipation, gastroparesis, diarrhea, a sensation of straining while defecating, and a sensation of gastric bloating” as taught by Shohat. Doing so enables therapeutic intervention for gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 17, Shimura teaches wherein said receiving input comprises receiving said input from the subject or from a caregiver of the subject. (Fig. 10b; Page 28, paragraph 4, button 622 described as “Regist Patient” is a button for causing the display 101 to display an input screen of a profile of the user.
Regarding claim 20, Shimura teaches wherein said control unit is adapted to provide said user-specific time of day, as part of said activation input (Page 5, paragraphs 2-5), but does not further teach “to said gastrointestinal capsule”.
Shohat teaches a gastrointestinal capsule. (Paragraph [0009]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura to incorporate “a gastrointestinal capsule” as taught by Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 22, Shimura does not teach “wherein said controller is configured to activate said vibrating agitator to operate in said first vibrating mode of operation for a cumulative duration in the range of one hour to 12 hours”.
Shohat teaches wherein said controller is configured to activate said vibrating agitator to operate in said first vibrating mode of operation for a cumulative duration in the range of one hour to 12 hours. (Paragraph [0009]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein said controller is configured to activate said vibrating agitator to operate in said first vibrating mode of operation for a cumulative duration in the range of one hour to 12 hours” as taught by Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 24, Shimura does not teach “wherein the capsule is devoid of sensors for sensing an environment thereof.”
Shohat teaches wherein the capsule is devoid of sensors for sensing an environment thereof. (Paragraphs [0012], [0014] discuss a gastrointestinal capsule with sensing modes and sensing cycles, but not specifically sensors).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein the capsule is devoid of sensors for sensing an environment thereof” as taught by Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of costly sensors.
Regarding claims 25 and 28, Shimura does not teach “wherein said first vibrating mode of operation at the user-specific time of day being efficacious for successful treatment of constipation.”
Shohat teaches wherein said first vibrating mode of operation at the user-specific time of day being efficacious for successful treatment of constipation. (Paragraphs [0009], [0012]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein said first vibrating mode of operation at the user-specific time of day being efficacious for successful treatment of constipation” as taught by Shohat. Doing so enables therapeutic intervention for gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 26 and 29, Shimura does not teach “wherein said first vibrating mode of operation at the user-specific time of day being efficacious for promoting peristaltic movement and/or increasing a number of spontaneous bowel movements (SBMs) of the subject.”
Shohat teaches wherein said first vibrating mode of operation at the user-specific time of day being efficacious for promoting peristaltic movement and/or increasing a number of spontaneous bowel movements (SBMs) of the subject. (Paragraph [0008], activated GIC mechanically excites the wall of the GI tract, to induce a peristaltic wave whereby the motor activity of this segment is stimulated).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection system of Shimura as modified to teach “wherein said first vibrating mode of operation at the user-specific time of day being efficacious for promoting peristaltic movement and/or increasing a number of spontaneous bowel movements (SBMs) of the subject” as taught by Shohat. Doing so enables therapeutic intervention for gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Regarding claim 27, Shimura teaches at least one timing mechanism, functionally associated with said controller (150), said at least one timing mechanism adapted to identify the occurrence of the user-specific time of day (Page 5, paragraphs 2-5), but does not teach that this timing mechanism is comprised in a “gastrointestinal capsule”.
Shohat teaches a gastrointestinal capsule. (Paragraph [0009]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the timing mechanism of the circadian rhythm inspection system of Shimura into “the gastrointestinal capsule” of Shohat. Doing so enables time-modulated therapeutic intervention for a patient with gastrointestinal issues without the use of medication, which have significant side effects. (Paragraph [0003]).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shimura in view of Shohat, further in view of Axelrod (US 20170055871) (previously cited).
Regarding claims 7 and 16, Shimura as modified does not teach “wherein said input includes input relating to a vitality schedule of the subject”.
Axelrod, in a related field of endeavor, teaches an apparatus for detecting gastrointestinal motor activity which includes receiving patient input relating to a vitality schedule of the subject. (Paragraph [0134] a user input indicating the presence or absence of an increase in heart rate at the time of a meal).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein said input includes input relating to a vitality schedule of the subject” as taught by Axelrod. Doing so allows assessment of the reaction of the myemeric plexus, which system may be involved in ileus and recovery. (Paragraph [0134]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shimura in view of Shohat, further in view of Shabbat (US 20150073315).
Regarding claim 21, Shimura as modified does not teach “wherein, in said vibrating mode of operation, said vibrating agitator is configured such that a net force exerted by the housing on the environment is in the range of 50 grams-force to 600 grams-force”.
Shabbat, in a related field of endeavor, teaches a gastrointestinal capsule wherein, in said vibrating mode of operation, said vibrating agitator is configured such that a net force exerted by the housing on the environment is in the range of 50 grams-force to 600 grams-force. (Paragraph [0024]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein, in said vibrating mode of operation, said vibrating agitator is configured such that a net force exerted by the housing on the environment is in the range of 50 grams-force to 600 grams-force” as taught by Shabbat. Doing so provides a preferred range of radial forces that stimulate a wall of the tract in order to treat intestinal constipation. (Paragraph [0006]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Shimura in view of Shohat, further in view of Ilan (US 20180185238).
Regarding claim 23, Shimura as modified does not teach “wherein, in said vibrating mode of operation, the vibrating agitator is configured to exert the forces on the housing to attain a vibrational frequency within a range of 100Hz to 650Hz”.
Ilan, in a related field of endeavor, teaches a gastrointestinal capsule wherein, in said vibrating mode of operation, the vibrating agitator is configured to exert the forces on the housing to attain a vibrational frequency within a range of 100Hz to 650Hz. (Paragraph [0024]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the circadian rhythm inspection estimation system of Shimura as modified to teach “wherein, in said vibrating mode of operation, the vibrating agitator is configured to exert the forces on the housing to attain a vibrational frequency within a range of 100Hz to 650Hz” as taught by Ilan. Doing so provides a capsule configured to vibrate at frequencies that may help modulate GI motility. (Paragraph [0020], [0088]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 6/9/2026, with respect to the rejections of claims 1-2, 4, 7-8, 10-12, 16-17 and 20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Shimura is relied upon for the amended feature.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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