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 .
Preliminary Amendment
Preliminary Amendment dated 02/05/2024 has been formally entered and claims 1-18 submitted with Preliminary Amendment dated 02/05/2024 are being examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
“…The present disclose is directed to a medical treatment cart or beds … in para.[0002] needs to be corrected. A suggested correction is -- The present [[disclose]] disclosure is directed to a medical treatment cart or beds --.
“…one or more guild rails…” in [0022] needs to be corrected. A suggested correction is --one or more [[guild]] guard rails--.
“In various aspects, the medical cart is configured to treat one or both ears of the patient, and is optimized for the patient's conform during the treatment procedure” in [0023] needs to corrected. A suggested correction is --In various aspects, the medical cart is configured to treat one or both ears of the patient, and is optimized for the patient's [[conform]] comfort during the treatment procedure --.
“…and may be may be administered…” in para. [0025] needs to be corrected. A suggested correction is --…and
“…FIGS. 4A-4B illustrate and aspect of the magnetic assembly comprising of multiple strong but smaller permanent magnets, rather than a single larger and stronger magnet…Additionally, the magnetic army may also be configured in an analogous N rows×N columns structure, such that the N×N structure provides a predetermined amount of magnetic force on the magnetic nanoparticles to sufficient to of the magnetic agent to across the ear drum…” in para. [0036] needs to be corrected. A suggested correction is --FIGS. 4A-4B illustrate [[and]] an aspect of the magnetic assembly comprising [[of]] multiple strong but smaller permanent magnets, rather than a single larger and stronger magnet…Additionally, the magnetic army may also be configured in an analogous N rows×N columns structure, such that the N×N structure provides a predetermined amount of magnetic force on the magnetic nanoparticles [[to]] sufficient for the magnetic agent to across the ear drum--.
“The medical cart is configured to patient to be moved from a first position to a second position and the guard mails may prevent the patient from falling of the cart during a position transition” in para. [0042] needs to be corrected. A suggested correction is --The medical cart is configured [[to]] for patient to be moved from a first position to a second position and the guard mails may prevent the patient from falling of the cart during a position transition--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Each of claims 11-18 line 1 “a magnetic agent to a patient” needs to be corrected. A suggested correction is – [[a]] the magnetic agent to [[a]] the patient – in light of its antecedent in claim 10 line 1 “a magnetic agent to a patient”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in each of line 11, line 12, line 16-17, line 18 and line 20 recite the term “the patient”. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 in line 3 recites the term “the caster”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear to claim 7 line 3 “the caster” is referencing which one among the “one or more casters” recited in claim 7 line 3.
Claim 16 in line 3 recites the term “the caster”. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear to claim 16 line 3 “the caster” is referencing which one among the “one or more casters” recited in claim 16 line 3.
Claim 4 recites “a first magnetic force is based on the right ear in the first administration position, a second magnetic force is based on the left ear in the first administration position, a third magnetic force is based on the right ear in the second administration position, and a fourth magnetic force is based on the left ear in the second administration position” which renders this claim unclear. More specifically, in the context used, it is unclear as what is meant by “based on” in the limitation-- magnetic force is based on respective ear-- i.e. a first magnetic force is based on the right ear, a second magnetic force is based on the left ear and so on and so forth. In what way is magnetic force based on the respective ear in the respective administration position.
Claim 10 in lines 3-4 recites “a magnetic therapeutic agent comprising magnetic nanoparticles attached to a therapy” which renders this claim unclear. More specifically, in the context used it is unclear as to what is meant by the clause “attached to a therapy” in this limitation. It is unclear as to whether “therapy” in this context refers to treatment or therapy or whether “therapy” in this context refers to magnetic nanoparticles attached to a therapeutic agent or something else.
Claim 13 recites “a first magnetic force is based on the right ear in the first administration position, a second magnetic force is based on the left ear in the first administration position, a third magnetic force is based on the right ear in the second administration position, and a fourth magnetic force is based on the left ear in the second administration position” which renders this claim unclear. More specifically, in the context used, it is unclear as what is meant by “based on” in the limitation-- magnetic force is based on respective ear-- i.e. a first magnetic force is based on the right ear, a second magnetic force is based on the left ear and so on and so forth. In what way is magnetic force based on the respective ear in the respective administration position.
Dependent claims 2-9 and 11-18 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-9 and 11-18 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed [0022], and [0068-0083].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Contingently Allowable Subject-Matter
As per independent claims 1 and 10, independent claims 1 and 10 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-9 and 11-18, dependent claims 2-9 and 11-18 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-9 and 11-18, dependent claims 2-9 and 11-18 each is being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 1, the prior art of record fails to disclose or render obvious a magnetic agent delivery cart comprising… a magnetic assembly located under the upper bed platform, wherein the magnetic assembly is centered underneath the longitudinal axis of the upper bed platform and aligned at a proximal end of the magnetic agent delivery cart; one or more side fairings configured to hide the magnetic assembly, wherein the one or more side fairings is removable; a headrest located on top of the upper bed platform and positioned above the center of the magnetic assembly, the headrest further comprising: a first head contour and a second head contour, wherein the first head contour is configured for the patient in a first administration position and the second head contour is configured for the patient in a second administration position; and an alignment grid configured according to the first and second administration position and the location of the magnet assembly, wherein the alignment grid comprises a first position vertical line that corresponds to the sagittal plane of the patient in the first administration position, a second position vertical line that corresponds to the sagittal plane of the patient in the second administration position, and a horizontal line that corresponds to the transverse plane along the eyes of the patient including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 1.
As per independent Claim 10, the prior art of record fails to disclose or render obvious a system for delivering a magnetic agent to a patient through the ear canal, the system comprising: a magnetic therapeutic agent comprising magnetic nanoparticles … a medical cart comprising…a magnetic assembly located under the upper bed platform, wherein the magnetic assembly is centered underneath the longitudinal axis of the upper bed platform and aligned at a proximal end of the medical cart; one or more side fairings configured to hide the magnetic assembly, wherein the one or more side fairings is removable; a headrest located on top of the upper bed platform and positioned above the center of the magnetic assembly, the headrest further comprising: a first head contour and a second head contour, wherein the first head contour is configured for the patient in a first administration position and the second head contour is configured for the patient in a second administration position; and an alignment grid configured according to the first and second administration position and the location of the magnetic assembly, wherein the alignment grid comprises a first position vertical line that corresponds to the sagittal plane of the patient in the first administration position, a second position vertical line that corresponds to the sagittal plane of the patient in the second administration position, and a horizontal line that corresponds to the transverse plane along the eyes of the patient including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 10.
Prior art US 20150230810 A1 to Creighton et al. discloses systems and methods for facilitating introduction and external manipulation of magnetic particles (e.g., nanoparticles) within vasculature of a circulatory system for the treatment of various conditions. More specifically, Creighton discloses a system for external manipulation of magnetic nanoparticles in vasculature using a remotely placed magnetic field-generating stator. Creighton’s systems and methods relate to the control of magnetic nanoparticles in a fluid medium using permanent magnet-based or electromagnetic field-generating stator sources. Magnetic nanoparticles are provided having a non-specialized chemical coating facilitating association with a chemical composition by a user before infusion. Systems are provided for delivering a consistent infusion mass of magnetic nanoparticles to a patient. While Creighton discloses
Prior art US 20110144411 A1 to Sandhu et al. discloses systems and methods that provide magnetically-enhanced delivery of therapeutic agents to selected tissue. The systems and methods involve the use of carrier devices and release devices and two different magnetic fields to move magnetic particles into selected tissue. Movement of the magnetic particles (and any associated therapeutic agent) into the tissue may be assisted by both magnetic attractive forces as well as magnetic repulsive forces.
Prior art US 20060228421 A1 to Seeney et al. discloses a method and device for delivery of particles through membranes and tissue within a body. More specifically, Seeney discloses movement of magnetically responsive nanoparticles through a membrane using a varying magnetic field gradient. The magnetic field varies in intensity and/or direction and can be achieved by mechanically varying the position of a magnet with respect to the membrane, or by oscillating the strength of one or more electromagnets.
Prior art US 20070196281 A1 to Jin et al. discloses use of implantable magnetic particles and remotely applied magnetic fields to treat diseased tissues and cells. More specifically, Jin discloses treatment methods and articles that can be placed in a human or animal body to enable controlled destruction of diseased tissue. The methods include destruction of diseased cells and tissues by magnetically controlled motion and an externally controllable drug delivery process with a capability to start and stop the drug delivery at any time, for any duration. This invention provides two approaches to diseased cell destruction, (1) magneto-mechanical disturbance of cell structure (e.g. cancer cells) for cell lysis and (2) magnetically activated drug release at local regions (e.g. tumors) from a magnetic-particle-containing drug reservoir.
Prior art US 20080199400 A1 to Dyer et al. discloses otologic nanotechnology for diagnostic and/or therapeutic purposes. More specifically, Dyer discloses treating a human ear includes transporting a conjugated nanoparticle or a magnetically responsive nanoparticle into a human's middle or inner ear. Otologic nanophoresis includes electrically, magnetically or electromagnetically driving a nanoparticle through a membrane of the ear, including a tympanic membrane, a round window membrane, an oval window membrane, or a circulatory membrane. An otologic diagnostic device includes a nanoparticle conjugated with a material selected from the group consisting of lipids, proteins, growth factors, growth hormones, antioxidants, free radical scavengers, steroid preparations, and metabolically active substances; an otologic therapeutic device includes the same categories of substances and chemotherapeutic drugs.
Prior art US 20160038590 A1 to Li discloses compositions and methods in which magnetized nanoparticles are used to deliver therapeutic agents to anatomical targets that are difficult to access, such as the sinuses and middle ear. More specifically, Li discloses compositions and methods for targeted delivery of a therapeutic to a site accessible through the nose or mouth that may be difficult to effectively and efficiently treat otherwise (e.g., the middle ear, sinuses, or lung). The therapeutic agent is deposited onto a magnetic nanoparticle that is drawn through a passage or tissue that leads away from the nose or mouth by a magnetic field applied over the targeted site (e.g., by magnets within the ear canal or surrounding the ear).
Prior art US 20040011779 A1 to Krywiczanin et al. discloses therapeutic beds, and more particularly to an improved rotating bed capable of placing a patient in a prone position. More specifically, Krywiczanin discloses mechanism to support the head of a patient for therapeutic beds, including prone positioning therapeutic beds. A head restraint apparatus is provided comprising a casing having a closed bottom end, an open top end, and an open front end. The casing encloses a cavity for receiving a person's head resting in a supine position and substantially encompasses the back and sides of a person's head. A face piece removably attached to the open top end of the casing is configured to restrain at least a portion of the front of a person's head. In another embodiment, a head restraint is slidably mounted on a transversely oriented rail of the patient support platform. A manually operable clamp is provided to fix the position of the head restraint with respect to the rail.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in independent device claims 1 and 10 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 2-9 and 11-18 dependent claims 2-9 and 11-18 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20020147424 A1 to Ostrow et al. discloses a transdermal drug delivery system employing magnetic fields in singular or in combination with other methods to transport various substances of varying molecular weights and magnetic susceptibilities across the skin. More specifically, Ostrow discloses transdermal magnetic drug delivery system and method which can deliver multiple drugs in a controlled manner using a variety of methods including magnetophoreris, iontophoresis, sonophoresis, photophoresis and others. Ostrow is similar to that disclosed in terms of therapeutic use of nanoparticles that are responsive and navigable to externally applied magnetic field.
Prior art US 20180250183 A1 to Zwierstra et al. discloses a headset system including a headset configured to lay on top of a surface and to support a head of a subject when the subject is in a supine position or a reclined position, at least one probe adjustment mechanism, and a probe coupled to the at least one probe adjustment mechanism and configured to emit acoustic energy similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at http://www.uspto.gov/interviewpractice.
/SUNITA REDDY/Primary Examiner, Art Unit 3791