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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 16-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1, there is no specification support for a calculating of an escape time. Rather, the specification sets forth that an escape time is adapted which means, for example, that concentration of the bacteria is adjusted. This does not indicate that the escape time is actually calculated. In claims 16-25, there is no support that an injecting uses the escape time. While it appears injecting can influence an escape time, it does not use an escape time.
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 1-10 and 16-25 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.
In claim 1, it is unclear how a calculation (of an escape time) can “increase targeting”.
In claim 10, it appears ‘an’ and ‘a’ should be ‘the’.
In claims 16-25, it is unclear how an injection can ‘use’ the escape time.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Kotakadi et al (“Therapeutic Applications of Magnetotactic Bacteria and Magnetosomes: A Review Emphasizing on the Cancer Treatment” -cited by applicant) in view of Martel et al (US 9,905,347 -cited by applicant).
Re claim 1: Kotakadi discloses a method of improving targeted delivery of at least one of a treatment agent, an imaging agent and a diagnostic agent attached to magneto-aerotactic-responsive bacteria adapted to self-locomote while subject to a magnetic field, the magneto-aerotactic-responsive bacteria depositing the at least one of a treatment agent, an imaging agent and a diagnostic agent at hypoxic zones in a patient, comprising:
calculating a total bolus escape time of a bolus of a solution of the magneto-aerotactic responsive bacteria when injected into the patient in order to influence the targeting of a target zone with hypoxic zones in the patient (Abstract, page 1; see the magnetotactic bacteria MTB that are manipulated by external magnetic fields and are driven to hypoxic areas; page 6 column 2 remote modification via the magnetic field for delivery to a target with modifies an escape time, page 7 column 1 see the “varying dosages of MC-1” which modifies/calculates escape time, page 8 column 2 see the “use of BMs to transport drug nanocarriers is linked to changes in their biological membranes, which change their properties in tissues, such as their stability and dispersibility”, page 9 column 1 see the changing of field strength and shape (“creation of dense clusters…of varied geometric form”), page 9 column 2 see the adapting/calculating based on the change in absorbance from the light beam, page 10 column 1-2 see the adapting/calculating based on which sites are conjugated/binding which changes the escape time).
Kotakadi discloses all features except for determining a distance between an injection location and a hypoxic target zone for the patient, determining an activity decay in velocity post injection of the bacteria when exposed to an environment of the patient, and calculating the escape time using the distance and the activity decay to increase targeting. However, Martel teaches of a method for control of magneto-responsive entities including determining a distance between an injection location and a hypoxic target zone for the patient, determining an activity decay in velocity post injection of the bacteria when exposed to an environment of the patient, and calculating the escape time using the distance and the activity decay to increase targeting (col 6 lines 28-35, col 14 lines 13-47; see the targets and initial position of each SSPE and the observation thereof which corresponds to determining a distance; also see the observation of velocity of each SSPE which corresponds to determining an activity decay of velocity, wherein the distance and activity decay are used to adapt/calculate the escape time to increase targeting). It would have been obvious to the skilled artisan to modify Kotakadi, to determine features of the target and of the bacteria as taught by Martel, in order to improve targeting efficacy.
Re claim 2: Kotakadi discloses the total bolus escape time is adapted by adjusting one or more of: a concentration of the magneto-aerotactic-responsive bacteria in the solution; a volume of the bolus: a viscosity of the solution; and a surface of the bolus exposed to a north of the magnetic field when the magneto-aerotactic-responsive bacteria are north-seeking, or a surface of the bolus exposed to a south of the magnetic field when the magneto-aerotactic-responsive bacteria are south-seeking (see at least page 6 column 2 with the delivery to a target via magnetic fields which exposes the bolus to a north or south).
Re claim 3: Kotakadi discloses the total bolus escape time is adapted by dividing, during injection, the bolus into smaller boluses injected into the patient in order to lower a bolus-volume as the individual volumes of each of the smaller boluses is less than the volume of the bolus (page 7 column 1; see the varying dosages which includes delivery of smaller sized boluses).
Re claim 4: Kotakadi discloses increasing the total bolus escape time is achieved by heating the solution in the injection device prior to introduction into the patient (page 5 column 2; see the heating ability of the bolus).
Re claim 5: Kotakadi discloses increasing the total bolus escape time is achieved by reducing the rate of volume of injection into the patient (page 7 column 1; see varying dosages of MC-1 which includes reducing the injection rate).
Re claim 6: Kotakadi discloses the total bolus escape time is adapted by adjusting the shape of the bolus (page 9 column 1; see the creation of dense clusters of varied geometric form).
Re claim 7: Kotakadi discloses decreasing the total bolus escape time is in order to enable access to a portion of a tumor that is inaccessible by the injection device, necessitating the travel of the magneto-aerotactic-responsive bacteria from the injection point to the portion of the tumor (page 9 column 1; see the adapting from varying the field strength which allows delivery to a target).
Re claim 8: Kotakadi discloses the total bolus escape time is adapted by influencing a shape of the bolus through a selection of an appropriate injector (page 9 column 1; see injected bolus such that the particular injector used will influence the shape).
Re claim 9: Kotakadi discloses the total bolus escape time is decreased by increasing the surface to volume ratio of the injected bolus (page 10 column 1-2 see the adapting based on which sites are conjugated/binding which changes the escape time and see the surface to volume ratio).
Re claim 10: Kotakadi discloses an increase in total bolus escape time is favoured when targeting of hypoxic zones closer to the injection site is sought (page 9 column 1; see the adapting from varying the field strength which allows delivery to a target, wherein escape time is increased as the delivery time/distance to a target is less).
Re claims 16-25: Kotakadi discloses injecting the bolus at the injection location uses the total escape time (abstract; see that the bolus of magneto-aerotactic-responsive bacteria are injected and this modifies an escape time).
Response to Arguments
Applicant’s arguments with respect to claims 1-10 and 16-25 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.
The prior 112f interpretation and 112 rejections are withdrawn due to amendments.
Conclusion
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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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797