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 .
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 1-4, 10-13, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US 20090318841) in view of Rink (US 20150087894).
Regarding claim 1, Shohat 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]).
However, Shohat does not teach “an input source providing input relating to a characteristic of a circadian cycle of the subject; a control unit, 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”.
Rink, in a related field of endeavor, teaches apparatus for monitoring sleep (Fig. 1) that may be incorporated into an ingestible capsule. (Paragraph [0061]). Rink teaches an input source (Paragraph [0116], sensor 102) providing input relating to a characteristic of a circadian cycle of the subject (Paragraph [0116] information obtained from one or more sensors monitoring various sleep parameters such as sleep stage, user motion, time of sleep onset); a control unit (electronic controller 106), 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 (Paragraph [0062], the electronic controller can evaluate the sensed sleep parameter to determine a target awakening time).
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 gastrointestinal treatment system of Shohat to incorporate “an input source providing input relating to a characteristic of a circadian cycle of the subject; a control unit, 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” as taught by Rink. Doing so enables one or more therapeutic devices to automatically apply a therapeutic intervention to the user at the target awakening time. (Paragraph [0117]).
Regarding claim 2, Shohat does not teach “wherein the input source comprises a user interface, adapted to receive input from the subject or from a caretaker of the subject”.
Rink teaches wherein the input source comprises a user interface (108), adapted to receive input from the subject or from a caretaker of the subject. (Paragraph [0052]).
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 gastrointestinal treatment system of Shohat to teach “wherein the input source comprises a user interface, adapted to receive input from the subject or from a caretaker of the subject” as taught by Rink. Doing so allows real-time feedback with the user. (Paragraph [0116]).
Regarding claim 3, Shohat does not teach “wherein the input source comprises a sensor, adapted to sense a characteristic relating to the circadian cycle of the subject and to provide the input”.
Rink teaches wherein the input source comprises a sensor (102), adapted to sense a characteristic relating to the circadian cycle of the subject and to provide the input. (Paragraph [0053] detection of sleep stage).
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 gastrointestinal treatment system of Shohat to teach “wherein the input source comprises a sensor, adapted to sense a characteristic relating to the circadian cycle of the subject and to provide the input” as taught by Rink. Doing so enables detection of various sleep parameters such as sleep stage, user motion, time of sleep onset, etc. (Paragraph [0116]).
Regarding claim 4, Shohat does not teach “wherein said input includes input relating to a sleep time or sleep schedule of the subject”.
Rink teaches wherein said input includes input relating to a sleep time or sleep schedule of the subject. (Paragraph [0116]).
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 gastrointestinal treatment system of Shohat to teach “wherein said input includes input relating to a sleep time or sleep schedule of the subject” as taught by Rink. Doing so enables treatment and/or improvement of a number of sleep-related disorders. (Paragraph [0048]).
Regarding claim 10, Shohat teaches wherein said control unit is adapted to provide said user-specific time of day, to said gastrointestinal capsule, as part of said activation input. (Paragraph [0009]).
Regarding claim 11, Shohat teaches wherein said control unit is adapted to incorporate said user-specific time of day into a vibration protocol and to program said gastrointestinal capsule with said vibration protocol. (Abstract; Paragraphs [0009]-[0011], [0019]).
Regarding claim 12, Shohat teaches a method of treating a gastrointestinal condition of a subject, (Paragraph [0009] treating obesity) the method comprising: 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]).
However, Shohat does not teach “receiving input relating to a characteristic of a circadian cycle of the subject; determining a user-specific time of day based on the input relating to the characteristic of the circadian cycle of the subject”.
Rink, as previously discussed, teaches receiving input relating to a characteristic of a circadian cycle of the subject (Paragraph [0116], sensor 102; information obtained from one or more sensors monitoring various sleep parameters such as sleep stage, user motion, time of sleep onset); and, determining a user-specific time of day based on the input relating to the characteristic of the circadian cycle of the subject (Paragraph [0062], the electronic controller 106 can evaluate the sensed sleep parameter to determine a target awakening time).
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 method of treating a gastrointestinal condition of Shohat to incorporate the step of “receiving input relating to a characteristic of a circadian cycle of the subject; determining a user-specific time of day based on the input relating to the characteristic of the circadian cycle of the subject” as taught by Rink. Doing so allows the ability to automatically apply a therapeutic intervention to the user at the target awakening time. (Paragraph [0117]).
Regarding claim 13, Shohat does not teach “wherein said receiving input comprises receiving input relating to a sleep schedule of the subject”.
Rink teaches wherein said receiving input comprises receiving input relating to a sleep schedule of the subject. (Paragraph [0116]).
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 gastrointestinal treatment system of Shohat to teach “wherein said receiving input comprises receiving input relating to a sleep schedule of the subject” as taught by Rink. Doing so enables treatment and/or improvement of a number of sleep-related disorders. (Paragraph [0048]).
Regarding claim 17, Shohat does not teach “wherein said receiving input comprises receiving said input from the subject or from a caregiver of the subject.”
Rink teaches wherein said receiving input comprises receiving said input from the subject or from a caregiver of the subject. (Paragraph [0052]).
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 gastrointestinal treatment system of Shohat to teach “wherein said receiving input comprises receiving said input from the subject or from a caregiver of the subject” as taught by Rink. Doing so allows real-time feedback with the user. (Paragraph [0116]).
Regarding claim 18, Shohat does not teach “wherein said receiving input comprises receiving said input from a sensor”.
Rink teaches wherein said receiving input comprises receiving said input from a sensor (102).
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 gastrointestinal treatment system of Shohat to teach “wherein said receiving input comprises receiving said input from a sensor” as taught by Rink. Doing so provides a mechanism that enables detection of various sleep parameters such as sleep stage, user motion, time of sleep onset, etc. (Paragraph [0116]).
Regarding claim 20, Shohat teaches wherein said programming comprises providing the user-specific time of day to said gastrointestinal capsule as part of an activation input. (Paragraph [0009]).
Claims 5-8 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat in view of Rink, further in view of Axelrod (US 20170055871).
Regarding claim 5, Shohat as modified does not teach “wherein said input includes input relating to a meal time or meal 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 meal time or meal schedule of the subject. (Paragraph [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 gastrointestinal treatment system of Shohat as modified to teach “wherein said input includes input relating to a meal time or meal schedule of the subject” as taught by Axelrod. Doing so enables evaluating the response of a patient's resumption in motility within a stomach, a small intestine, and a colon of a patient following a surgical procedure. (Paragraph [0102]).
Regarding claim 6, Shohat as modified does not teach “wherein said input includes input relating to a time of defecation of the subject”.
Axelrod teaches an apparatus for detecting gastrointestinal motor activity which includes receiving patient input relating to a time of defecation of the subject. (Paragraph [0019] time of bowel movement).
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 gastrointestinal treatment system of Shohat as modified to teach “wherein said input includes input relating to a time of defecation of the subject” as taught by Axelrod. Doing so enables evaluating the response of a patient's resumption in motility within a stomach, a small intestine, and a colon of a patient following a surgical procedure. (Paragraph [0102]).
Regarding claim 7, Shohat as modified does not teach “wherein said input includes input relating to a vitality schedule of the subject”.
Axelrod 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 gastrointestinal treatment system of Shohat 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]).
Regarding claim 8, Shohat as modified does not teach “wherein said user-specific time of day is a user-specific mealtime”.
Axelrod teaches wherein said user-specific time of day is a user-specific mealtime. (Paragraph [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 gastrointestinal treatment system of Shohat as modified to teach “wherein said user-specific time of day is a user-specific mealtime” as taught by Axelrod. Doing so enables tracking of the change in activity level of each gastrointestinal organ during mealtimes. (Paragraph [0019]).
Regarding claim 14, Shohat as modified does not teach “wherein said receiving input comprises receiving input relating to a meal schedule of the subject”.
Axelrod, in a related field of endeavor, teaches wherein said receiving input comprises receiving input relating to a meal schedule of the subject. (Paragraph [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 gastrointestinal treatment system of Shohat as modified to teach “wherein said receiving input comprises receiving input relating to a meal schedule of the subject” as taught by Axelrod. Doing so enables evaluating the response of a patient's resumption in motility within a stomach, a small intestine, and a colon of a patient following a surgical procedure. (Paragraph [0102]).
Regarding claim 15, Shohat as modified does not teach “wherein said receiving input comprises receiving input relating to a time of defecation of the subject”.
Axelrod teaches wherein said receiving input comprises receiving input relating to a time of defecation of the subject. (Paragraph [0019] time of bowel movement).
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 gastrointestinal treatment system of Shohat as modified to teach “wherein said receiving input comprises receiving input relating to a time of defecation of the subject” as taught by Axelrod. Doing so enables evaluating the response of a patient's resumption in motility within a stomach, a small intestine, and a colon of a patient following a surgical procedure. (Paragraph [0102]).
Regarding claim 16, Shohat as modified does not teach “wherein said receiving input comprises receiving input relating to a vitality schedule of the subject”.
Axelrod teaches wherein said receiving input comprises receiving 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 gastrointestinal treatment system of Shohat as modified to teach “wherein said receiving input comprises receiving 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]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat in view of Rink, further in view of Benson (US 20150164409).
Regarding claim 9, Shohat as modified does not teach “a computer readable memory adapted to store a subject profile for the subject, the subject profile including subject data received as said input”.
Benson, in a related field of endeavor, teaches a sleep monitoring system comprising a computer readable memory adapted to store a subject profile for the subject, the subject profile including subject data received as said input. (Paragraph [0264] user profile may be input to the sleep system 100 using an input interface. After this information is input, it may be stored in memory 372 associated with the sleep system or device.)
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 gastrointestinal treatment system of Shohat to teach “a computer readable memory adapted to store a subject profile for the subject, the subject profile including subject data received as said input”. Doing so provides a database of to track users over time.
Regarding claim 19, Shohat as modified does not teach “storing said input in a subject- profile associated with the subject”.
Benson, as previously discussed, teaches a sleep monitoring system comprising a computer readable memory adapted for storing said input in a subject- profile associated with the subject. (Paragraph [0264] user profile may be input to the sleep system 100 using an input interface. After this information is input, it may be stored in memory 372 associated with the sleep system or device.)
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 gastrointestinal treatment system of Shohat to teach “storing said input in a subject- profile associated with the subject”. Doing so provides a database of to track users over time.
Conclusion
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
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791