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What if surgical, therapeutic or diagnostic method claim rejected?
A method of surgery, therapy or diagnosis of humans is excluded from patentability
as an industrially inapplicable invention in Japan, and a claim directed
to such a method will be rejected in an official action by the Patent Office
examiner during substantive examination proceedings, although products
such as a medical device, apparatus, and substances for use in such a method
are patentable subject matter. Then, what response, particularly amendment,
could be made to address such an official action? Options would be as follows.
1. Limitation to a method claim relating to surgery, therapy or diagnosis of animals
A method for treatment (surgery or therapy) or diagnosis of animals is not excluded from patentability in Japan. Accordingly, a surgical, therapeutic or diagnostic method claim could be limited by amendment to a method claim for treatment or diagnosis of animals in response to an official action. In this connection, it is important to make it clear that the method is directed not to human beings, but only to animals, such as by "a method for curing disease X of animals, excluding humans, ..." or the like.
2. Redrafting into a claim relating to a product such as a device, apparatus or the like
A surgical, therapeutic or diagnostic method claim could be redrafted to define a product such as a device, apparatus or the like to address an official action rejecting the method claim.
Methods for surgery, therapy or diagnosis of humans are NOT excluded from
patentability in the United States, we understand, and, for the sake of
convenience, an example of a claim relating to such a method is cited below
from the United States Patent and Trademark Office (http://www.uspto.gov),
which, as is being discussed herein, would not be patentable in Japan because
of its surgical, therapeutic or diagnostic nature.
- Quoted -
A method for measuring temperature at a site
within a patient during a medical procedure comprising the steps of:
providing a medical device having a position
sensor;
placing the medical device within the patient
and positioning the position sensor at the site;
providing a temperature measurement signal to
the position sensor;
measuring voltage at the position sensor;
determining a resistance value based on the
temperature measurement signal and the voltage; and
determining a temperature value based on the
resistance value.
Under the Japanese patent law and practice, of these features recited in this claim, at least the feature of "placing the medical device within the patient and positioning the position sensor at the site" would be considered as a step requiring the presence of a medical practitioner or an act of his or an action of an apparatus on the human body. Thus, unlike in the United States, the claimed invention would not be patentable subject matter as it is in Japan for its surgical, therapeutic or diagnostic nature on the human body.
An easiest way of reformulating the claim into a product claim to adapt to the Japanese patent law and practice would be such as given below.
- Revised for adaptation in Japan -
A system for measuring temperature at a site
within a patient during a medical procedure comprising:
a medical device having a position sensor;
the medical device being placed within the patient
and the position sensor being positioned at the site;
means for providing a temperature measurement
signal to the position sensor;
means for measuring voltage at the position
sensor;
means for determining a resistance value based
on the temperature measurement signal and the voltage; and
means for determining a temperature value based
on the resistance value.
This revised claim no longer defines a method for treatment or diagnosis of humans and would be patentable in Japan, provided that it is found by the examiner to have novelty and non-obviousness (inventive step).
3. Redrafting into a method claim for controlling a product such as a device, apparatus or the like
The third option is to redraft a surgical, therapeutic or diagnostic method claim to define a method for controlling or operating a product such as a device, apparatus or the like in response to an official action rejecting the first-mentioned method claim. In this way, the rejected method claim could be maintained as a method claim in a different form.
The following examples A to C are cited from the Examination Guidelines for Patent and Utility Model by the Japan Patent Office (English translation by Kogo Patent Office), of which the first one represents a surgical, therapeutic or diagnostic method which is excluded from patentability in Japan, and the second and third ones are methods for controlling a medical device (pacemaker) into which the first one could be reformulated to get around a surgical, therapeutic or diagnostic method.
- Quotation A -
A method for electrical stimulation by a pacemaker
comprising the steps of:
using a control means of a pacemaker to compare
a heart rate detected by a detector unit with a threshold value stored
in a memory; and, if the heart rate is lower than the threshold value,
reading out an average steady-state heart rate
from the memory;
calculating a difference between the average
heart rate and the detected heart rate; and
setting a value of intervals at which pulses
are generated in accordance with the difference,
wherein a pulse generator unit generates pulses
at the set pulse generation intervals to give stimuli to a heart ventricle
and maintain the heart rate.
The Examination Guidelines states that the feature of "give stimuli to a heart ventricle and maintain the heart rate" requires an action of the medical device on the human body, and that the claimed method including such a feature falls under a surgical, therapeutic or diagnostic method (specifically, therapeutic method) excluded from patentability in Japan.
- Quotation B -
A method for controlling a pacemaker comprising
the steps of:
using a control means of a pacemaker to compare
a heart rate detected by a detector unit with a threshold value stored
in a memory; and, if the heart rate is lower than the threshold value,
reading out an average steady-state heart rate
from the memory;
calculating a difference between the average
heart rate and the detected heart rate; and
setting a value of intervals at which pulses
are generated in accordance with the difference.
- Quotation C -
A method for controlling a pacemaker comprising
the steps of:
using a control means of a pacemaker to compare
a heart rate detected by a detector unit with a threshold value stored
in a memory; and, if the heart rate is lower than the threshold value,
reading out an average steady-state heart rate
from the memory;
calculating a difference between the average
heart rate and the detected heart rate;
setting a value of intervals at which pulses
are generated in accordance with the difference, and
using a pulse generator unit to generates pulses
for stimulating a heart ventricle at the set pulse generation intervals.
The claimed methods B and C each recite the functioning of the pacemaker itself, do not include a step requiring an act of a physician or an action of the medical device on the human body, and are deemed to be subject matter that could be patentable. The last paragraph of the method C includes the feature of the pacemaker generating pulses directed from the inside thereof towards the outside, but this feature is considered not to mean to the extent of giving stimuli to the ventricle. Moreover, the "pulses for stimulating a heart ventricle" in the same paragraph is deemed to indicate the status or nature of the pulses generated by the pulse generator unit and should be differentiated from giving stimuli to the ventricle. Thus, both the latter two methods are considered to fall outside a method for treatment or diagnosis of humans excluded from patentability.
4. Other options
Method claims relating to surgery, therapy or diagnosis of humans could be cancelled in response to an official action to have the patent application allowed with the other claims. Additionally, the patent application could be allowed to go abandoned by filing a notice to that effect at the Japan Patent Office or by not responding to the outstanding official action.
References:
(1) Examination Guidelines for Patent and Utility Model by the Japan Patent
Office
(2) Manual of Patent Examining Procedure (USPTO)
(3) Guidelines for Examination in the European Patent Office
(4) Others
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