Full Text
HIGH COURT OF DELHI
C.A.(COMM.IPD-PAT) 10/2022 DR. SAPNA NANGIA .... Appellant
Through: Mr. Gaurav Barathi, Adv.
Through: Mr. Harish Vaidyanathan Shankar, CGSC, Mr. Srish Kumar Mishra, Mr. Sagar Mehlawat and Mr. Alexander Mathai Paikaday, Advs.
JUDGMENT
22.02.2023
1. This appeal under Section 117A of the Patents Act, 1970 impugned order dated 29th January 2021 passed by the learned Assistant Controller of Patents and Designs, whereby Application NO. 201911010599 dated 19th March 2019, filed by the appellant for registration of a patent claiming a “device and process for obtaining individualised tactile feedback replicating breath hold of patient” was rejected by the learned Assistant Controller.
2. Mr. Gaurav Barathi, learned Counsel for the appellant submits that the impugned order is unreasoned.
3. Consequent to the filing of the aforesaid application by the appellant, First Examination Report (FER) dated 10th February 2020 was issued by the Controller of Patents in which it was alleged that the patent, for which the appellant had applied, lacked inventive step within the meaning of Section 2(1) (ja)1 of the Patents Act, as the claims in the patent were obvious from prior art. Two documents, D 1 and D 2 were cited as prior art by the Controller of Patents. The objection as contained in the FER may be reproduced thus: “1. The document D[1] discloses a device which is Installed on the upper treatment table 5 of the radiation devices in radiation surgery the position verifying apparatus for verifying the position of the patient on said treatment table 5, the treatment table 5 is installed to be secured to the upper side and the well connected to a pair of upper ends of the side plate 20 and the, side plates 20, the pair being a predetermined interval apart in a patient either side of the box as well as the upper side of the patient configured as a fixed top plate 30 are spaced intervals frame 10; is installed on the frame (10), radiation surgery, the patient position verifying apparatus characterized in that comprises a distance measuring means 40 to measure the distance between the frame 10 and the patient. Further; D[1] also discloses a method of recording a patient's position at the time of the step treatment plan, first, there is thereby secured to the frame (10) on the upper side the treatment table 5 the patient is lying, that here the frame 10 to the pelvic side of the patient it is preferable to position at a position. Then, each recording the distance measured by each of the distance measuring bars 45 to measure the distance between the frame 10 and the patient to the plurality of distance measuring bar (45). At this time, the convenience without an error when recording the measured distance to each distance measuring bar 45, when a serial number to the through hole 41 of each of the distance measuring bar 45 and the frame 10 Do. Of course, the position coordinates are recorded along the meshing contact point is displayed in terms of the scale and the treatment table 5 is shown the lower end of the frame (Whole Document). (ja) “inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;
2. The document D[2] discloses In block 210, an optional breath hold can be requested from the patient. At block 212, acquisition of a new image (eg, 3DUS) is triggered. This occurs when the success parameter is appropriate. At block 214, the newly acquired image (eg, 3DUS) is registered on the baseline image. The operator then obtains a breath hold from the patient, acquires a live 3DUS of the tumor in the current view, and triggers motion compensation using the acquired 3DUS. At block 216, the registration result obtained at block 214 is employed to update the registration with the previous US image. The system performs motion compensation by aligning the live 3DUS with the baseline 3DUS and using the registration results to update the fused image. At block 218, the quality of the fusion is determined. If the quality is good, the path ends and the operator can then use the updated fusion image to visualize the tumor or perform an intervention (such as a needle insertion). If not, the path returns to block 204 and tries to update the fused image again. Referring to FIG. 3, the figure shows the overlap of ultrasound images to illustrate the calculation of success parameters in the pose analyzer unit 132 of FIG. Image overlap and relative pose can be calculated as success parameters (shown in 2D for simplicity in FIG. 3) (Figures 2-3 and its relevant description).
3. D[1] and D[2] in combination disclose the independent claim 1, of alleged Invention. Therefore the claim 1, is lack of inventive step over D[1] in combination with D[2] and hence not allowable u/s 2 (1) (j) of The Patent Act, 1970.
4. Dependent claims 2-8 do not contain any features which, in combination with the features of any claim to which they refer, meet the requirements of the inventive step as per section 2(1)(j) of The Patents Act,1970.”
4. Certain other objections were also raised, relatable to Section 3(i) and Section 10(5) of the Patents Act. However, these objections do not form part of the grounds on which the Controller has rejected the appellant’s application.
5. The appellant filed its reply dated 29th July 2020 to the aforesaid FER, consequent on which notice of hearing dated 18th September 2020 was issued by the Controller. The objections which survived for consideration, as per the Controller, as set out in the hearing notice, may be reproduced thus: “Objections Clarity and Conciseness
1. 1. claims should be drafted clearly in a manner to understand the technical features for which the protection is being claimed. hence claims should be drafted more clearly.
2. principal claim should be in two part form. Invention u/s 2(1)(j)
1. In the view of the FER reply, D[1] and D[2] are retained and the new document (D3- US20090314960A[1] 24/12/2009) has cited. The document D[3] discloses the rhythmic pattern of the subject's breathing is determined, a signal is optionally delivered to the subject to more precisely control the breathing frequency. For example, a display screen is placed in front of the subject directing the subject when to hold their breath and when to breath. Typically, a breathing control module uses input from one or more of the breathing sensors. For example, the input is used to determine when the next breath exhale is to complete. At the bottom of the breath, the control module displays a hold breath signal to the subject, such as on a monitor, via an oral signal, digitized and automatically generated voice command, or via a visual control signal. Preferably, a display monitor is positioned in front of the subject and the display monitor displays at least breathing commands to the subject. Typically, the subject is directed to hold their breath for a short period of time, such as about one-half, one, two, or three seconds. The period of time the subject is asked to hold their breath is less than about ten seconds as the period of time the breath is held is synchronized to the delivery time of the proton beam to the tumor, which is about one-half, one, two, or three seconds. While delivery of the protons at the bottom of the breath is preferred, protons are optionally delivered at any point in the breathing cycle, such as upon full inhalation. Delivery at the top of the breath or when the patient is directed to inhale deeply and hold their breath by the breathing control module is optionally performed as at the top of the breath the chest cavity is largest and for some tumors the distance between the tumor and surrounding tissue is maximized or the surrounding tissue is rarefied as a result of the increased volume. Hence, protons hitting surrounding tissue is minimized. Optionally, the display screen tells the subject when they are about to be asked to hold their breath, such as with a 3, 2, 1, second countdown so that the subject is aware of the task they are about to be asked to perform. The proton delivery control algorithm is used to synchronize delivery of the protons to the tumor within a given period of each breath, such as at the bottom of a breath when the subject is holding their breath. The proton delivery control algorithm is preferably integrated with the breathing control module. Thus, the proton delivery control algorithm knows when the subject is breathing, where in the breath cycle the subject is, and/or when the subject is holding their breath. The proton delivery control algorithm controls when protons are injected and/or inflected into the synchrotron, when an RF signal is applied to induce an oscillation, as described supra, and when a DC voltage is applied to extract protons from the synchrotron, as described supra. Typically, the proton delivery control algorithm initiates proton inflection and subsequent RF induced oscillation before the subject is directed to hold their breath or before the identified period of the breathing cycle selected for a proton delivery time. In this manner, the proton delivery control algorithm can deliver protons at a selected period of the breathing cycle by simultaneously or near simultaneously delivering the high DC voltage to the second pair of plates, described supra, that results in extraction of the protons from the synchrotron and subsequent delivery to the subject at the selected time point. Since the period of acceleration of protons in the synchrotron is constant, the proton delivery control algorithm is used to set an AC RF signal that matches the breathing cycle or directed breathing cycle of the subject (Paragraphs 293-296).
2. D[1], D[2] and D[3] in combination disclose the independent claim 1 of alleged Invention. Therefore the claim 1 is lack of inventive step over D[1], D[2] in combination with D[3] and hence not allowable u/s 2 (1) (j) of The Patent Act, 1970.
3. Dependent claims 2-8 do not contain any features which, in combination with the features of any claim to which they refer, meet the requirements of the inventive step as per section 2(1)(j) of The Patents Act,1970. Non-Patentability u/s 3
1. 1. Without prejudice to other objection the method steps of the diagnosis/treatment have been camouflaged and incorporated in the claims to alter the form of the claims in “system” format Claims 1-8 fall within the scope of clause (i) of section 3 of the Indian Patent Act 1970 as amended in 2005 for falling within the scope of a method of treatment/diagnosis. Hence, such claims are not allowed under section 3(i) of the Indian Patent Act 1970 as amended in 2005.
1. 1. The phrase "the end of the movable pencil does not touch the patient while in use" of claim 8 is not within the scope of the description, since the page 8; lines 14-15 of the description states that "The graduated pointer 118 is adjusted so that it touches the patient’s body and provides a15 tactile feedback to the patient, thus ensuring replicability of the deep inspiratory breath hold position". hence the same is not allowable as per section 10(4) (c) The Patent Act, 1970.”
6. The appellant was granted an opportunity of hearing by the Controller on 25th September 2020, whereafter the appellant filed further submissions before the Controller on 13th October 2020.
7. Thereafter the impugned order dated 29th January 2021 came to be passed, rejecting the appellant’s application for grant of patent. The reasoning and conclusion of the learned Assistant Controller, who has passed the impugned order, are entirely contained in the following passages: “DECISION After attending the hearing on the stipulated date as mentioned above, Applicant’s agent filed the written submission and relevant documents on date 25th September, 2020 regarding above mentioned objections. Having considered all the facts and submissions made by the Applicant/Agent in the written note of arguments as well as in view of all the documents on record and also on the basis of my analysis and findings, it is found that the amended claims of the instant application lacks INVENTIVE STEP u/s 2(1)(j) of the Patent Act, in view of the cited prior arts D1-D[3]. The citations when combined discloses a device and a process for obtaining individualized tactile feedback replicating breath hold of a patient. A person skilled in the art can reach the present alleged invention from the teaching of above documents D1-D[3]. Hence the subject matter of the amended claims is not inventive as per section 2(1)(j) of the Patent Act,1970.”
8. Mr. Barathi, learned Counsel for the appellant points out that there is no discernible consideration of the grounds urged by the appellant, though the written submissions of the appellant have been extracted practically in extenso.
9. On a reading of the impugned order, the submission is found to be correct. The decision of the learned Assistant Controller may not be entirely unreasoned, but is too perfunctory to sustain judicial scrutiny. Some amount of application of mind to the contentions advanced by the applicant in response to the FER as well as the written submissions advanced before the learned Controller was required to be manifested in the impugned order, inter alia, so that this Court would be in a position to assess for itself whether the grounds on which the learned Assistant Controller deemed it appropriate to reject the appellant’s application were sustainable in law.
10. Applications seeking a patent are sui generis. Grant, or rejection, of a patent, is an extremely serious matter. Intellectual property rights are priceless, and are required to be scrupulously safeguarded. The entire industry is affected by a decision either to grant, or to refuse, a patent, and, in either case, the commercial and financial ramifications are huge. Incisive examination of the objections in the FER, and the response of the patent applicant thereto, must be manifest from the order passed by the Controller. There is no scope for any short shrift in the matter. At the very least, application of mind to the objections contained in the FER, vis-à-vis the defence of the patent applicant thereto, must be manifest from the decision of the Controller.
11. The Court hopes and trusts that the Controller, or the officer who examines the patent application, the FER and the response thereto, would bear these principles in mind, so that the Court does not have, as in the present case, to remand the matter for de novo consideration. Valuable time, which eats into the residual life of the patent – were it to be granted – is lost in the process.
12. In view thereof, the impugned order is quashed and set aside. The appellant’s Application No. 201911010599 is remanded for reconsideration to the learned Controller or to any officer deputed by him. The reconsideration would start from the point where the opportunity of personal hearing was granted to the appellant. The de novo consideration would, therefore, be restricted to the objections contained in the notice dated 18th September 2020.
13. The appellant would be granted one more opportunity of hearing in the matter. The learned Controller, or other officer designated by him, is directed to pass a speaking order, dealing with the appellant’s contentions within a period of 8 weeks from receipt of a copy of this order.
14. This appeal stands allowed in the aforesaid terms.
15. Let this order be uploaded on the website of this Court within 24 hours.
C.HARI SHANKAR, J FEBRUARY 22, 2023