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 .
Prosecution History Summary
Claims 12-20 are cancelled.
Claims 1, 21, and 26 are amended.
Claims 1-11 and 21-27 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 21-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 21 recite the limitation “providing a treatment chaperone that imitate a natural setting.” Examiner is unable to determine how providing a chaperone imitates a natural setting and what exactly does it mean by a natural setting. The specification on pg. 21 states that it provides a treatment chaperone to be present in a setting to help the patient navigate feelings and emotions, which is not the same thing as providing a chaperone to imitate a natural setting. Examiner asks the Applicant for guidance.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-11 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. – CA 3082423A1 in view of Amidon et al. (U.S. Publication No. 2009/0272048).
As per claim 1, Becker teaches a method, comprising:
-determining a protocol dosage (Becker: pg. 50, para. 146; Physician sets the medical delivery protocols.) for treating a mental health disorder of a patient (Becker: pg. 98, 182) with ketamine in a treatment environment (Becker: pg. 1, para. 3);
-determining a diminished dosage for treating the mental health disorder with the ketamine (Becker: pg. 7-8; Plurality of dosing options include continuous infusion differences in dosage size, dosage rate, infusion duration, or any combination thereof.);
-determining a dosage progression comprising the diminished dosage, a first progressed dosage, a second progressed dosage, a third progressed dosage, a fourth progressed dosage, a fifth progressed dosage, a sixth progressed dosage, a seventh progressed dosage, an eighth progressed dosage, a ninth progressed dosage, and a target dosage (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.);
-performing a first therapy session comprising:
-administering the diminished dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a first inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the first progressed dosage of the ketamine at the end of the first inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a first inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a second therapy session comprising:
-administering the second progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a second inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the third progressed dosage of the ketamine at the end of the second inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a second inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a third therapy session comprising:
-administering the fourth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a third inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the fifth progressed dosage of the ketamine at the end of the third inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a third inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a fourth therapy session comprising:
-administering the sixth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a fourth inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the seventh progressed dosage of the ketamine at the end of the fourth inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a fourth inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a fifth therapy session comprising:
-administering the eighth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a fifth inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the ninth progressed dosage of the ketamine at the end of the fifth inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a fifth inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.); and
-performing a sixth therapy session comprising administering three of the target dosages of the ketamine, each target dosage separated by a sixth inter-dosage period (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.).
Examiner states that the system provides any amount of dosage period until optimum level for the patient is achieved (Becker: pg. 41; para. 114; pg. 113, para. 292).
Becker does not explicitly teach the following, however, Amidon teaches:
-configuring a treatment environment to be free from sharp corners and positioning padded surfaces at corners to reduce injury (Amidon: para. 2; Padded walls, floors, etc. to prevent patient from injuring himself.), comprising:
-locating the treatment environment (Amidon: para. 50; Locate the patient to administer medication in the seclusion room.); and
-providing a treatment chaperone that imitates a natural setting (Amidon: para. 50; Attendant or team of attendants for observing.).
One of ordinary skill in the art would have recognized that applying the known technique of Amidon would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Amidon to the teachings of Becker would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying a treatment environment with a chaperone to Becker teaching administration of treatment would have been recognized by those of ordinary skill in the art as resulting in an improved system that would keep patients safe (Amidon: para. 1-3).
As per claim 2, the method of claim 1 is as described. Becker further teaches further comprising administering to the patient at least one of an anti-nauseant medication, an anti-hypertensive medication, or an anti-anxiety medication (Becker: pg. 29, para. 71; Ketamine administration for treating physical, neurological, and psychiatric disorder.).
As per claim 3, the method of claim 1 is as described. Becker further teaches further comprising:
-determining a body mass of the patient (Becker: pg. 42-43, para. 119; Sensor detecting body mass.); and
-determining the target dosage to be 1.2 milligrams (mg) per kilogram (kg) of body mass of the patient (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.).
As per claim 4, the method of claim 1 is as described. Becker further teaches wherein determining the diminished dosage comprises selecting the diminished dosage to be less than 0.5 mg per kg of body mass of the patient (Becker: pg. 67, para. 214-215; pg. 7-8; Plurality of dosing options include continuous infusion differences in dosage size, dosage rate, infusion duration, or any combination thereof.).
As per claim 5, the method of claim 1 is as described. Becker further teaches further comprising: determining that a body weight of the patient is less than 140 pounds, wherein determining the dosage progression comprises selecting each successive progressed dosage to be 5 mg greater than the previous progressed dosage, based on the determination that the body weight of the patient is less than 140 pounds (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.).
As per claim 6, the method of claim 1 is as described. Becker further teaches further comprising: determining that a body weight of the patient is greater than or equal to 140 pounds, wherein determining the dosage progression comprises selecting each successive progressed dosage to be 10 mg greater than the previous progressed dosage, based on the determination that the body weight of the patient is greater than or equal to 140 pounds (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.).
As per claim 7, the method of claim 1 is as described. Becker further teaches wherein a duration of each of the first inter-dosage period, the second inter-dosage period, the third inter-dosage period, the fourth inter-dosage period, the fifth inter-dosage period, and the sixth inter-dosage period is selected based on a half-life of the ketamine (Becker: pg. 1-2, para. 4; Short half-life of ketamine requires continuous or frequent administration to maintain effective plasma concentration.).
As per claim 8, the method of claim 1 is as described. Becker further teaches wherein each of the first inter-session period, the second inter-session period, the third inter-session period, the fourth inter-session period, and the fifth inter-session period are of equal duration (Becker: pg. 113, para. 292; pg. 4-5, para. 11; The patient waits after the first treatment to determine if another treatment is needed. Patient waiting between time periods to determine treatment.).
As per claim 9, the method of claim 1 is as described. Becker further teaches further comprising:
-waiting for a threshold period during which the patient’s symptoms are improved after the sixth therapy session period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-in response to the patient’s symptoms returning after the threshold period, performing a seventh therapy session comprising administering three booster dosages of the ketamine, each booster dosage separated by a seventh inter-dosage period (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.).
As per claim 10, the method of claim 9 is as described. Becker further teaches wherein an amount of each booster dosage is equal to the target dosage of the ketamine (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.).
As per claim 11, the method of claim 1 is as described. Becker further teaches further comprising administering each dosage of the dosage progression using at least one of an intramuscular injection of the ketamine, a nasal spray containing the ketamine, or a ketamine troche (Becker: pg. 1, para. 3).
As per claim 21, Becker teaches a method, comprising:
-receiving, by a graphical user interface executing on a processing device, a first set of responses from a patient to a health questionnaire (Becker: pg. 75, para. 251; Selecting a disorder as a an input.);
-determining, by a processing device communicatively coupled with the processing device, a first score for the patient based on the first set of responses, wherein the first score exceeds a threshold indicating a mental health disorder of the patient (Becker: pg. 75, para. 251);
-administering, in a treatment environment, by a ketamine delivery mechanism for administering a ketamine dosage progression to the patient, to the patient a treatment for the mental health disorder (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation.), the treatment comprising:
-determining a protocol dosage for treating a mental health disorder of a patient with ketamine (Becker: pg. 50, para. 146; Physician sets the medical delivery protocols.);
-determining a diminished dosage for treating the mental health disorder with the ketamine (Becker: pg. 7-8; Plurality of dosing options include continuous infusion differences in dosage size, dosage rate, infusion duration, or any combination thereof.);
-determining a dosage progression comprising the diminished dosage, a first progressed dosage, a second progressed dosage, a third progressed dosage, a fourth progressed dosage, a fifth progressed dosage, a sixth progressed dosage, a seventh progressed dosage, an eighth progressed dosage, a ninth progressed dosage, and a target dosage (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.);
-performing a first therapy session comprising:
-administering the diminished dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.), wherein the diminished dosage is less than 0.5 mg per kg of body mass of the patient (Becker: pg. 67, para. 214-215; pg. 7-8; Plurality of dosing options include continuous infusion differences in dosage size, dosage rate, infusion duration, or any combination thereof.);
-waiting for a first inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the first progressed dosage of the ketamine at the end of the first inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a first inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a second therapy session comprising:
-administering the second progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a second inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the third progressed dosage of the ketamine at the end of the second inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a second inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a third therapy session comprising:
-administering the fourth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a third inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the fifth progressed dosage of the ketamine at the end of the third inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a third inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a fourth therapy session comprising:
-administering the sixth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a fourth inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the seventh progressed dosage of the ketamine at the end of the fourth inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a fourth inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.);
-performing a fifth therapy session comprising:
-administering the eighth progressed dosage of the ketamine (Becker: pg. 10, para. 14; pg. 35, para. 95; Drug delivery device with a pump mechanism for administering a drug formulation. Initiate with a small dosage that are less than the optimum dose.);
-waiting for a fifth inter-dosage period (Becker: pg. 39-40, para. 112; Pausing or canceling a dose for assessment.); and
-administering the ninth progressed dosage of the ketamine at the end of the fifth inter-dosage period (Becker: pg. 35, para. 95; Increase the dosage in small increments.);
-waiting for a fifth inter-session period (Becker: pg. 113, para. 292; The patient waits after the first treatment to determine if another treatment is needed.); and
-performing a sixth therapy session comprising administering three of the target dosages of the ketamine, each target dosage separated by a sixth inter-dosage period (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.), wherein:
-at least one of the target dosages is administered to the patient in a treatment environment during the first therapy session (Becker: pg. 1, para. 4; Ketamine is administered in the hospital or clinic.); and
-the target dosage is 1.2 mg per kg of body mass of the patient (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.);
-receiving, by the graphical user interface, a second set of responses from the patient to the health questionnaire after completion of the treatment (Becker: pg. 47, para. 137; Request pain ratings from the user at specified time with delivery of medication.);
-determining, by the processing device, a second score for the patient based on the second set of responses, wherein the second score is lower than the threshold (Becker: pg. 42, para. 118; Rank propensity for patient reactions and functionality like efficacy of treatment, responsiveness, etc..);
-calculating, by the processing device, a time interval during which the patient remained free from the mental health disorder (Becker: pg. 47, para. 137; Determine delivery information back to the doctor based on pain reduction requests at given intervals.).
Becker does not explicitly teach the following, however, Amidon teaches:
-configuring a treatment environment to be free from sharp corners and positioning padded surfaces at corners to reduce injury (Amidon: para. 2; Padded walls, floors, etc. to prevent patient from injuring himself.), comprising:
-locating the treatment environment (Amidon: para. 50; Locate the patient to administer medication in the seclusion room.); and
-providing a treatment chaperone that imitates a natural setting (Amidon: para. 50; Attendant or team of attendants for observing.).
One of ordinary skill in the art would have recognized that applying the known technique of Amidon would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Amidon to the teachings of Becker would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying a treatment environment with a chaperone to Becker teaching administration of treatment would have been recognized by those of ordinary skill in the art as resulting in an improved system that would keep patients safe (Amidon: para. 1-3).
As per claim 22, the method of claim 21 is as described. Becker further teaches wherein the psychoactive chemical comprises ketamine (Becker: pg. 2, para. 5).
Claim 23 recite substantially similar limitations as those already addressed in claim 3, and, as such, are rejected for similar reasons as given above.
As per claim 24, the method of claim 21 is as described. Becker further teaches wherein calculating the time interval further comprises:
-periodically receiving, by the graphical user interface, additional sets of responses from the patient to the health questionnaire (Becker: pg. 4-5, para. 11; pg. 47, para. 142; Real-time recording of pain status through self-reporting on a pain scale. Prompts given for data entry.);
-determining, by the processing device, respective additional scores corresponding to each of the additional sets of responses (Becker: pg. 47-48, para. 142; Determining a pain scale with a number associated with the level of pain.);
-identifying, by the processing device, an interval end time at which a respective one of the additional scores exceeds the threshold (Becker: pg. 48-49; para. 143); and
-determining, by the processing device, the time interval based on a time of completion of the treatment and the interval end time (Becker: pg. 35, para. 95; Dosage amounts and intervals adjusted individually to provide levels of administered treatment to be effective.).
As per claim 25, the method of claim 24 is as described. Becker further teaches further comprising:
-comparing, by the processing device, the time interval to a predetermined reference interval (Becker: pg. 4-5, para. 11; Comparing the pain scale to the maximum threshold of administering the drug within a time period.); and
-identifying, by the processing device, the treatment as successful based on a determination that the time interval meets or exceeds the predetermined reference interval (pg. 4-5, para. 11; Increasing the maximum dosage threshold for the time of day when patient’s pain survey indicates increased pain or discomfort.).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al. – CA 3082423A1 in view of Family et al. (WO 2021/183490).
As per claim 26, Becker teaches an apparatus, comprising:
-a ketamine delivery mechanism for administering a ketamine dosage progression to the patient (Becker: pg. 21, para. 21; Drug delivery device for administering ketamine), the ketamine dosage progression comprising:
-a diminished dosage (Becker: pg. 7-8; Plurality of dosing options include continuous infusion differences in dosage size, dosage rate, infusion duration, or any combination thereof.);
-one or more progressed dosages (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.); and
-a target dosage each administered to the patient in the treatment environment during one or more therapy sessions (Becker: pg. 9; Setting the continuous infusion with a dosage of 0.1mg/hour to 200 mg/hour and duration.), wherein:
-the diminished dosage is less than 0.5 mg per kg of body mass of the patient (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.); and
-the target dosage is 1.2 mg per kg of body mass of the patient (Becker: pg. 31-32, para. 84; pg. 54-55, para. 159; Therapeutic dosage determined based on age, weight, condition, etc.).
Becker does not explicitly teach the following, however, Family teaches:
-wherein the ketamine delivery mechanism comprises an embed or implanted administering device (Family: pg. 35, para. 3; Administered by implantation in dosage forms.).
One of ordinary skill in the art would have recognized that applying the known technique of Family would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Family to the teachings of Becker would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying implantable administering device to Becker teaching administration of treatment would have been recognized by those of ordinary skill in the art as resulting in an improved system that enhanced patient safety and efficient treatment (Family: pg. 1).
As per claim 27, the apparatus of claim 26 is as described. Becker further teaches wherein the ketamine delivery mechanism comprises at least one of a syringe for intramuscular injection of the ketamine, a nasal spray containing the ketamine, or a ketamine troche (Becker: pg. 1, para. 3).
Response to Arguments
Applicant’s arguments with respect to claims 1-11 and 21-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tang et al. – U.S. Publication No. 2021/0393544 -- Teaches a transdermal delivery of ketamine to treat various disorders.
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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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681
Prosecution Insights