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Date of Judgment: September 26, 2025
Case: C.A. (COMM.IPD-PAT) 29/2023 – Neeraj Gupta v. The Controller of Patents and Designs
Court: High Court of Delhi at New Delhi
Bench: Hon'ble Mr. Justice Tejas Karia
Overview of the Dispute:
The Appellant, Neeraj Gupta, filed a patent application (No. 201911036272) titled "An Intravenous Catheter Device" on September 10, 2019, before the Indian Patent Office. The invention relates to a medical device used for infusing medication or fluids directly into a vein or drawing blood samples for testing. It addresses a common drawback in over-needle intravenous catheters: blood spillage from the catheter hub upon needle withdrawal, due to an open channel for blood flow.
The Assistant Controller of Patents and Designs (Respondent) issued a First Examination Report (FER) on February 10, 2020, objecting on grounds of lack of novelty under Section 2(1)(j) of the Patents Act, 1970 (citing prior art D1: WO2018096549A1) and lack of inventive step under Section 2(1)(ja) (citing D1 and D2: WO2015161294A1). The Appellant responded to the FER on May 29, 2020, addressing these objections.
Subsequently, the Respondent issued a Hearing Notice on July 17, 2020, reiterating the inventive step objection. A second Hearing Notice followed on August 14, 2020 (noted as 2019 in the judgment, likely a typographical error). The Appellant attended the hearing and filed written submissions on September 4, 2020. On February 11, 2021, the Respondent passed the Impugned Order, refusing the application under Section 15 of the Act.
The Appellant filed a review petition on February 24, 2021. After a hearing on March 24, 2022, and post-hearing submissions on April 6, 2022, the Respondent dismissed the review via the Appeal Order dated January 6, 2023. Aggrieved, the Appellant appealed to the Delhi High Court under Section 117A of the Act, challenging both orders as arbitrary, unreasoned, and violative of natural justice principles.
The core dispute revolved around whether the invention possessed an inventive step, particularly the role of a "valve closure member" in preventing blood backflow, and whether the Controller's rejection orders adequately addressed the Appellant's submissions and prior arts.
Core Litigation Issues:
The appeal raised several pivotal issues under patent law, focusing on substantive and procedural aspects:
1. Lack of Reasoned Order and Violation of Natural Justice: The Appellant argued that the Impugned Order was arbitrary and unreasoned, failing to consider detailed responses to the FER, oral arguments, and written submissions. It merely stated that submissions were "considered but not fully persuasive" without explaining why. This, the Appellant contended, violated the doctrine of audi alteram partem (hear the other side) and the requirement for the Controller to apply its mind. The Appeal Order similarly reproduced claims and dismissed the review without merit-based analysis.
2. Assessment of Inventive Step under Section 2(1)(ja): The primary substantive issue was whether the invention involved a technical advance or economic significance, making it non-obvious to a Person Skilled in the Art (PSITA). The Appellant highlighted the "valve closure member" (192) as the novel feature, which exerts force on the valve member's prongs (172) to close slits (170), preventing indefinite blood backflow. The Controller claimed all features of claims 1 and 14 were disclosed in D1 and D2, and a PSITA could combine them to arrive at the invention. The Appellant accused the Controller of "mosaicing" prior arts without examining merits or explaining how a PSITA would combine them.
3. Misinterpretation of Prior Arts (D1 and D2):
- D1 (WO2018096549A1) discloses a self-activating catheter with a cylindrical valve relying on material elasticity (e.g., silicon/rubber) for self-sealing slits, which degrades over time due to wear and tear.
- D2 (WO2015161294A1) claims a multi-use blood control catheter with a resilient septum (38) and flow channels (39), preventing blood exit "at least for some period of time" based on intermolecular forces.
The Appellant argued that neither prior art discloses the valve closure member, and D1/D2's limitations (temporary efficacy, reliance on elasticity/forces) are overcome by the invention's mechanical force application, providing superior, long-term backflow prevention.
4. Procedural Fairness in Patent Examination: The Appellant invoked the Delhi High Court's precedent in Agriboard International LLC v. Deputy Controller of Patents and Designs (2022 SCC OnLine Del 940), requiring Controllers to discuss: (i) invention in prior arts, (ii) invention in the application, and (iii) how it would be obvious to a PSITA. The Impugned Order was alleged to fall short of this standard.
The Respondent countered that the invention lacked inventive step, as the valve closure member was disclosed in D1 (as recess/reduced diameter) and D2 (as septum flange), and a PSITA could combine teachings with common general knowledge. They argued D1 provides design, D2 functionality (no spillage), solving the same problem.
Key Findings of the Hon’ble High Court:
The Hon’ble High Court allowed the appeal, setting aside the Impugned Order (February 11, 2021) and Appeal Order (January 6, 2023), remanding the matter to the Patent Office for fresh consideration. Key findings include:
1. Understanding the Invention: The Hon’ble Court detailed the invention's structure—a catheter hub (102), needle (116), valve member (158) with curved portion (162) and slits (170), actuator (176), and valve closure member (192). The inventive feature is the valve closure member, which closes prongs (172) to prevent blood flow from the distal (136) to proximal (134) end of the hub, overcoming blood spillage upon needle withdrawal.
2. Analysis of Prior Arts:
D1: Aims to prevent reverse blood flow via a self-activating valve with slits, but relies on material elasticity, leading to degradation. The Hon’ble Court found no valve closure member; the Controller's reference to a "valve closure member (2)" in D1 (page 7, lines 4-27) was incorrect, as it describes a cylindrical valve, not the claimed feature.
D2: Involves a septum (38) with slits (42) and flow channels (39), preventing blood exit temporarily via intermolecular forces. The Hon’ble Court distinguished it: valve shape (concave in invention vs. flat in D2), reliance on forces (temporary in D2 vs. indefinite in invention), and absence of a valve closure member (septum flange limits movement but does not exert force like the claimed member).
The Hon’ble Court noted the Controller failed to discuss D2's limitation ("at least for some period of time") and functional differences, rendering the obviousness conclusion flawed.
3. Failure to Follow Agriboard Precedent: The Impugned Order discussed the invention (step 1) and prior arts (step 2) but omitted step 3—explaining how the invention would be obvious to a PSITA. No reasoning on combining D1/D2 or functional similarity between septum flange (D2) and valve closure member.
4. Economic Significance as Technical Advance: Citing Ramanujam's Patent Law (Page 225), the Hon’ble Court observed that overcoming D1/D2's limitations (e.g., wear/tear, temporary efficacy) provides economic significance, a subset of technical advance under Section 2(1)(ja).
5. Procedural Lapses: The orders were unreasoned, ignoring submissions and violating natural justice. The Controller erroneously stated all features were disclosed and combinable without evidence.
The matter was remanded for fresh hearing within six months, uninfluenced by the Hon’ble Court's observations. The judgment was to be notified to the Controller General for administrative action.
Key Takeaways:
1. Reasoned Orders Mandatory: Patent Controllers must provide detailed reasoning when rejecting applications, especially on inventive step. Mere assertions of "considered but not persuasive" without addressing submissions violate natural justice and invite judicial intervention.
2. Rigorous Inventive Step Analysis: Follow the Agriboard three-step test: compare prior arts, the invention, and obviousness to PSITA. Avoid mosaicing without explaining combinations or functional equivalences.
3. Distinguishing Prior Arts: Hon’ble Courts emphasize precise comparisons—structural, functional, and temporal limitations (e.g., temporary vs. indefinite efficacy) can establish inventive step, even if solving similar problems.
4. Economic Significance in Medical Devices: Inventions improving efficiency, durability, or cost (e.g., reducing wear in catheters) qualify as technical advances, broadening Section 2(1)(ja)'s scope.
5. Strategic Advice for Applicants: Addresses novel features clearly (e.g., valve closure member) and challenge procedural lapses via reviews/appeals. For Controllers, this reinforces training on reasoned decision-making to reduce remands.
This judgment strengthens procedural safeguards in India's patent regime, promoting innovation in healthcare devices.
Prepared by : Nitin Patel
Designation: Patent Attorney
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