Full Text
JUDGMENT
NEERAJ GUPTA .....Appellant
Advocates who appeared in this case For the Appellant : Mr. Anirudh Bakhru, Ms. Anuradha Salhotra, Mr. Sumit Wadhwa, Ms.Aradhna
Laktakia & Mr. Amit Ramjan, Advocates.
For the Respondent : Mr. Ashish K. Dixit, CGSC with Mr. Shivam Tiwari, Mr. Umar Hashmi, Ms. Deepika Kalra & Ms. Urmila Sharma, Advocates.
1. The present Appeal has been filed under Section 117A of the Patents Act, 1970 (“Act”) by the Appellant challenging the Order dated 11.02.2021 (“Impugned Order”) and Order dated 06.01.2023 (“Appeal Order”) passed by the Assistant Controller of Patents and Designs (“Controller”) by which the Patent Application No. 201911036272 (“Subject Application”) was rejected under Section 15 of the Act.
FACTUAL MATRIX:
2. The Subject Application titled “An Intravenous Catheter Device” was filed before the Indian Patent Office (“Patent Office”) on 10.09.2019 and is related to a device used to infuse medication / fluids directly into a vein or draw blood samples from the subject for testing.
3. The Respondent issued the First Examination Report on 10.02.2020 (“FER”) raising objections on the ground of lack of novelty under Section 2(1)(j) of the Act in respect of Claims 1 to 14 based on the cited prior art D[1] (WO2018096549Al) and lack of inventive step under Section 2(1)(ja) of the Act in view of documents D[1] and D[2] (WO2015161294Al), to which the Appellant filed the Reply on 29.05.2020.
4. A Hearing Notice was issued by the Respondent on 17.07.2020, wherein the Appellant reiterated the stand on the objection of lack of inventive step under Section 2(1)(ja) of the Act. The Respondent issued a second Hearing Notice dated 14.08.2019, pursuant to which the Appellant attended the hearing. The Appellant thereafter filed written submissions on 04.09.2020.
5. Subsequently, by way of the Impugned Order, the Respondent refused the Subject Application. The Appellant, on 24.02.2021, filed a review petition before the Respondent seeking review of the Impugned Order. On 03.03.2022, the Respondent issued a Hearing Notice fixing the hearing for 24.03.2022. The Appellant, after the said hearing, filed post-hearing written submissions on 06.04.2022. By way of the Appeal Order, the Respondent dismissed the review petition. Hence, this Appeal.
SUBMISSIONS ON BEHALF OF THE APPELLANT:
6. The learned Counsel for the Appellant submitted that the Impugned Order is unreasoned, arbitrary and is liable to be set aside on the ground that the Respondent has not considered the submissions made by the Appellant and has further not disclosed why the said submissions are inapplicable while deciding the Subject Application. The Impugned Order does not deal with the detailed reply to the FER that was filed on behalf of the Appellant vide dated 29.05.2020.
7. The learned Counsel for the Appellant further submitted that the FER with detailed submissions and responses on how the objections raised by the Respondent have been overcome by the invention under the Subject Application. The Impugned Order failed to consider the explanations provided by the Appellant, overcoming the objections in the Impugned Order. The relevant extract from the Impugned Order wherein the Respondent has referred the Appellant’s reply to the FER is reproduced hereunder: “2. After considering the reply filed in response to the first examination Report by the applicant's agent and the report of the examiner on such reply, it was observed that the said patent application was not in order for grant. Keeping in view the provisions of the Patents Act, 1970 (as amended) and with a view to provide natural justice to the applicant, a hearing was offered to the agent of the applicant on 24/08/2020...”
8. The learned Counsel for the Appellant submitted that the Respondent, without considering the oral arguments made and the written submissions filed on behalf of the Appellant, has stated in the Impugned Order that it had been considered. Further, on this ground alone, the Impugned Order is liable to be set aside.
9. The learned Counsel for the Appellant further submitted that pursuant to the issuance of the Impugned Order, the Appellant had filed an application seeking review of the Impugned Order, but the same was disposed of vide̛ Appeal Order on the ground that there was no merit. The Respondent, in the Appeal Order, has merely reproduced the claims of the Subject Application and subsequently stated the following: “8.... The applicant's oral submission during the hearing and written submission dated 04.09.2020 in view of the objections cited in hearing notice regarding the inventive step in the alleged invention has been considered but is not fully persuasive. However, in this report document Dl-D[2] is retained for the detailed explanation of the obviousness of the amended application and hence the amended claims are not inventive under section 2(l)(ja) of IPA 1970 in view to prior documents D 1-D 2. All the features of claim 1 & 14 are disclosed in documents D1-D[2]...”
10. The learned Counsel for the Appellant submitted that the Impugned Order vitiates the doctrine of audi alteram partem as the Respondent failed to apply its mind while disposing of the Impugned Order.
11. The learned Counsel for the Appellant submitted that the Respondent does not disclose how a Person Skilled In The Art (“PSITA”) would arrive at the invention claimed under the Subject Application, merely by combining the prior arts cited or address the fact that the valve closure member of the present invention has not been disclosed in either of the prior arts and forms the inventive step in the present invention.
12. The learned Counsel for the Appellant submitted that the Respondent has merely resorted to mosaicing of prior arts D[1] and D[2] and has not examined the merits of the Subject Application.
13. The learned Counsel for the Appellant submitted that the learned Controller erroneously stated that all features of claims 1 and 14 are disclosed in prior arts D[1] and D[2], and the following said finding in Paragraph No. 8 of the Impugned Order is incorrect. “8. The cited prior arts:- D[1]: WO2018096549Al, and D[2]: WO2015161294Al. The applicant's oral submission during the hearing and written submission dated 04.09.2020 in view of the objections cited in hearing notice regarding the inventive step in the alleged invention has been considered but is not fully persuasive. However, in this report document Dl-D[2] is retained for the detailed hence the amended claims are not inventive under section 2(1)(ja) of IPA 1970 in view to prior documents D1-D[2]. All the features of claim 1 & 14 are disclosed in documents D1-D[2]. The applicant's agent argued that the characterizing part of claim 1 i.e a valve closure member (192) is the novel and inventive features and is not being disclosed in any of the cited documents. The argument of applicant's agent is not persuasive as a valve closure member (2) is disclosed in document DI at page 7 line 4-27, fig. 2 & 3, the same valve closure is also disclosed in document D[2] as well at para [0075] - [0077] fig. 2B. Therefore, the subject matter as claimed in claims is not inventive in view of D 1 with D[2] as a person skilled in the art can easily arrive at the invention from combining the features of D 1 and D[2]. The dependent claims 2-14 do not appear to contain any additional features which, in combination with the features of any claim to which they refer, meet the requirements of the 2(l)Ua) of Indian Patent Act 1970 with respect to inventive step in view of document DI in combination with D[2]. Hence the subject matter of claims does not meet the requirement of Section 2(1)(D of The Patents Act 1970.”
14. The learned Counsel for the Appellant submitted that the Impugned Order states that the valve closure member is disclosed in documents of the prior art D[1] is wrong as there is no such disclosure. The relevant reproduction from the Impugned Order is reproduced hereunder: “... The argument of applicant's agent is not persuasive as a valve closure member (2) is disclosed in document D 1 at page 7 line 4-2 7, fig. 2 & 3...”
15. The learned Counsel for the Appellant submitted that the learned Controller failed to acknowledge the fact that the cited prior art D[1] relied on the slits self-sealing on account of the elasticity or shape retention features of the material that is used to construct the valve (silicon or rubber). The materials eventually subside on account of wear and tear accruing on account of repeated opening and closing of the slit that results in a reduction of elasticity by the slits of the valve member of D[1], and would be unable to stop the backflow of the blood. On the other hand, the device under Subject Application on account of the valve closure member, the curved and hollowed portion whereof exerts pressure or force on the hemispherical surface of the valve member, and consequently, the slits that ensure no backflow of blood takes place when the needle is withdrawn.
16. The learned Counsel for the Appellant further submitted that the learned Controller has erroneously held that the invention claimed under the Subject Application can be arrived at by combining features of D[1] and D[2], and PSITA can easily arrive at the invention by combining the features of Dl and D[2]. Therefore, the learned Controller, based on combining the prior arts D[1] and D[2], has erroneously held that the invention claimed in the Subject Application does not contain any inventive step.
SUBMISSIONS ON BEHALF OF THE RESPONDENT:
17. The learned Counsel for the Respondent submitted that the Respondent, in its reply, submitted that the present invention under the Subject Application lacks an inventive step in view of the cited prior arts D[1] and D[2].
18. The learned Counsel for the Respondent submitted that the Appellant’s argument that the characterising part of claim 1, that is a valve closure member (192) is the novel and inventive feature, as the same has it is not been disclosed in any of the cited documents, is not persuasive, as a valve closure member (2) is disclosed in document D[1]. The relevant paragraph from page 3 of the document D[1] is reproduced hereunder: “The main aspect of present invention 1s to provide a catheter device having selfactivating mechanism comprising; a catheter hub ( 1) having a proximal end and a distal end, the catheter hub including a substantially co-axial recess with an undercut towards proximal end that allows a one way cylindrical valve (2) made of flexible material to be held in place 25 towards proximal end in the recess ( 10) with first end of the cylindrical valve abutting the undercut (7) and the second end abutting against reduced diameter (8) within the recess ( 10) in the catheter hub towards distal end; the first end of valve being open and the second end of valve being closed, having a slit (9) on the second end; the cylindrical valve having a co-axial recess, the recess having a ring protruding on inner surface towards distal end;”
19. The learned Counsel for the Respondent submitted that it is clear from the above-mentioned disclosure that recess and reduced diameter correspond to the valve closure member as in the present invention, which the Appellant argues to be Novel and Inventive.
20. The learned Counsel for the Respondent submitted that the Respondent, in its reply, further submitted that the valve closure member is also disclosed in document D[2]. The septum flange (40) of the document D[2] corresponds to the valve closure member of the device under Subject Application. The relevant paragraph of the document D[2] is reproduced “[0075] A pre-slit resilient septum 38 is positioned in the channel 28 and functions as a valve that forms a fluid-tight seal and selectively admits fluid to or from the flexible catheter tube 18. In other words, the valve selectively permits or blocks the flow of fluid through the flexible catheter tube 18. The septum 38 may be seated against a septum flange 40 to limit distal movement. Protrusions or other internal structure may form an interference fit with the septum 38 to retain it in place or limit its proximal movement. As best shown in Figure 2B, the septum 38 has one or more pre-formed openings or slits 42 designed to selectively prevent unwanted fluid flow through the septum 38. The septum 38 preferably has three intersecting slits 42 forming three flaps that open when engaged by a valve actuator or a septum actuator (hereinafter actuator). [0076] The septum 38 further includes a plurality of axial flow channels 39. The flow channels 39 are disposed on an outer circumference of the septum 38. Eight flow channels 39 equidistant from each other are illustrated, although various quantities and positions are contemplated. The flow channels 39 have an appropriate width and depth so that when the septum 38 is not opened, blood can enter and air can escape the space distal of the septum 38 in the front portion of the catheter hub 14. At the same time, the flow channels 39 are sized small enough to prevent the blood from exiting past the septum 38 (at least for some period of time). Such a configuration is possible because the intermolecular forces in the blood are greater than the intermolecular forces in air. [0077] The septum 38 shown in Figure 2B may be used in any of the embodiments discussed herein. Other septum configurations may be used as would be understood by one of ordinary skill in the art. When the catheter tube 18 is initially inserted into a patient, and the introducer needle 12 is removed, the septum 38 prevents blood from flowing through the channel 28 and out of the distal end. The septum 38 is made of an elastic material to form the valve, for example silicone rubber. Other elastic materials may be used and non-elastic materials may be incorporated in the septum 38 as needed.”
21. The learned Counsel for the Respondent submitted that it is obvious and of common general knowledge to PSITA to arrive at the present invention under the Subject Application from the combined teaching of documents D[1] and D[2] and common general knowledge in the field.
22. The learned Counsel for the Respondent further submitted that D[1] provides the same design as the Subject Application, and D[2] provides functionality of stopping the blood. In D[2], there is no spillage of blood. Additionally, the invention under the Subject Application solves the same problem as D[2], but in a different way, which renders the claimed invention under the Subject Application obvious.
ANALYSIS AND FINDINGS:
23. The invention under the Subject Application deals with the intravenous catheter devices that are used to infuse medication / fluids directly into a vein or draw blood samples for testing. The drawback associated with the use of over-needle intravenous catheters is that while the needle is withdrawn from the catheter, there is an open channel for the blood to flow through the catheter that spills out of the catheter hub. Further, to analyse the Impugned Order and to address the arguments submitted by the Parties, it is important to understand the claimed invention under the Subject Application. The Invention
24. The inventive feature of the Subject Application is a valve closure member (192) which is adapted to close the plurality of prongs (172) of the valve member (158) thereby closing the passage (204) for the fluid flow which prevents the blood flow from the punctured vein of the patient from the distal end (136) of the catheter hub (102) towards the proximal end (134) of the catheter hub (102). The catheter device (100) is structured with a catheter hub (102) and a needle (116). The catheter device is reproduced below in Figure I:
25. A cross-sectional view of the device (100) reproduced below shows the intravenous catheter device that includes the catheter hub and has a proximal end and a distal end, along with a co-axial recess with an annular stopper (152) disposed at the proximal end.
26. The independent claim 1 under the Subject Application is reproduced “1. An intravenous catheter device (100) comprising: a catheter hub (102) having a proximal end (134) and a distal end (136), a co-axial recess (148) with an annular stopper (152) disposed at the proximal end (134) of the catheter hub (102), and an undercut portion (15 6) provided towards the distal end (136) of the catheter hub (102); a valve member (158) being adapted to be disposed inside the co-axial recess (148) of the catheter hub (102), a valve member (158) being defined by a cylindrical portion (160) and a curved portion (162) disposed at one end of the cylindrical portion (160), a co-axial recess (168) extending from the cylindrical portion (160) to the curved portion (162), the curved portion (162) being provided with one or more slits (170) defining a plurality of prongs (172), wherein the slits (170) configured to allow a needle (116) to pass through the slits (170) to puncture a vein of a patient; a flashback chamber (124) adapted to be disposed at the proximal end (134) of the catheter hub (102), wherein a blood flow into the flashback chamber (124) confirms puncturing of the vein by the needle (116); an actuator member (176) having an axial bore (186), the actuator member (176) being adapted to be disposed within the coaxial recess (168) of the valve member (158), wherein the actuator member (176) is being displaced axially in a direction (DJ) towards the distal end (136) of the catheter hub (102) thereby opening the plurality of prongs (172) of the valve member (158) to form a passage (204) for a fluid flow from the proximal end (134) of the catheter hub (102) to the distal end (136) of the catheter hub (102), when a luer lock member (206) is removably connected at the proximal end (134) of catheter hub (102) abutting the actuator member (J 76); characterized by a valve closure member (192) comprising a first surface (194) at a proximal end (196), a second surface (198) at a distal end (200) and a through hole (202) extending between the proximal end (196) and the distal end (200), the valve closure member (192) being disposed inside the catheter hub (102) such that the first surface (194) of the valve closure member (192) abuts the undercut portion (156) of the catheter hub (102) and the second surface (198) of the valve closure member (192) abuts the curved portion (162) of the valve member (158), wherein the valve closure member (192) is adapted to close the plurality of prongs (172) of the valve member (158). thereby closing the passage (204) for the fluid flow and preventing blood flow from the punctured vein of the patient from the distal end (136) of the catheter huh (102) to the proximal end (134) of the catheter huh (102). when the luer lock member (206) abutting the actuator member (17 6) is removed.”
27. The valve closure member is disposed inside the catheter hub of the catheter device such that the first surface (194) of the valve closure member is next to the curved portion (162) of the valve member while the second surface (200) of the valve closure member is situated next to the undercut portion (156) of the catheter hub and the first surface of the valve closure member exerts force on the prongs (172) of the valve member that close the slits (170) provided on the curved portion (162) of the valve closing the fluid path (204). The three important components are (i) actuator; (ii) valve member; and (iii) valve closure member. The highlighted features of the principal claim 1 are reproduced below:
28. The Appellant submitted that the sealing of slits in the invention claimed under the Subject Application is due to the presence of the valve closure member ahead of the slits on the curved valve member, and the valve closure member forces the slits. The Impugned Order
29. The Appellant has submitted that the Impugned Order is unreasoned, arbitrary and is liable to be set aside on the ground that the Respondent has not considered the submissions made by the Appellant. Therefore, it is important to examine whether the learned Controller has provided the reasoning for retaining the objection under Section 2(ja) of the Act and to examine the arguments raised by the Appellant regarding the Impugned Order. The relevant part of the Impugned Order is reproduced hereunder: “8. The cited prior arts:- D[1]: WO2018096549Al, and D[2]: WO2015161294Al. The applicant's oral submission during the hearing and written submission dated 04.09.2020 in view of the objections cited in hearing notice regarding the inventive step in the alleged invention has been considered but is not fully persuasive. However, in this report document Dl-D[2] is retained for the detailed hence the amended claims are not inventive under section 2(1)(ja) ofIPA 1970 in view to prior documents D1-D[2]. All the features of claim 1 & 14 are disclosed in documents D1-D[2]. The applicant's agent argued that the characterizing part of claim 1 i.e a valve closure member (192) is the novel and inventive features and is not being disclosed in any of the cited documents. The argument of applicant's agent is not persuasive as a valve closure member (2) is disclosed in document DI at page 7 line 4-27, fig. 2 & 3, the same valve closure is also disclosed in document D[2] as well at para [0075] - [0077] fig. 2B. Therefore, the subject matter as claimed in claims is not inventive in view of D 1 with D[2] as a person skilled in the art can easily arrive at the invention from combining the features of D 1 and D[2]. The dependent claims 2-14 do not appear to contain any additional features which, in combination with the features of any claim to which they refer, meet the requirements of the 2(l)(ja) of Indian Patent Act 1970 with respect to inventive step in view of document DI in combination with D[2]. Hence the subject matter of claims does not meet the requirement of Section 2(1)(j) of The Patents Act 1970.
09. The oral argument and the written submission of the agent of the applicant have been carefully considered However without prejudice, although the hearing submissions have attempted to address the other requirements, yet the substantive requirements of the Patents Act, 1970 ie. requirements of sections 2(I)(ja) are not found complied with. Hence, in view of the above and unmet requirements, this instant application is not found in order for grant.
10. Therefore, keeping in view the above facts, the submissions of the agents during hearing and subsequently through the written submissions, as well as the outstanding official requirements, instant application no. 201911036272 dated 10/09/2019 does not comply with the requirements of The Patents Act, 1970 (as amended). I, therefore, hereby order that the grant of the application for patent for application no. 201911036272 is refused under the provisions of Section 15 of The Patents Act, 1970 (as amended).
11. This is to be noted that the aforesaid observations, and decision thereof, are based solely on the electronically uploaded documents to date.” [Emphasis supplied]
30. The important question here is whether the learned Controller has followed the required procedure and provided reasoning while rejecting the Subject Application under Section 2(1)(ja) of the Act in the Impugned Order. The Court in Agriboard International LLC v. Deputy Controller of Patents and Designs, 2022 SCC OnLine Del 940 has discussed the requirement to be followed by the patent office while rejecting the application on the ground of Section 2(1)(ja) of the Act. The judgment mandates that the controller must discuss the cited prior arts and the invention disclosed in the patent application. Thereafter, the order should discuss the manner in which the invention in question would be obvious to the PSITA. The relevant paragraph of the decision is reproduced hereunder:
31. Therefore, the documents D[1] and D[2] should be analysed to examine the Impugned Order. The primary object of the invention under D[1] is to provide an intravenous catheter to avoid the reverse flow of blood. The object of the D[1] is reproduced hereunder: “OBJECT OF THE INVENTION The main object of present invention is to provide an intravenous catheter to avoid reverse flow of blood. Another object of present invention is to provide an intravenous catheter with a novel 15 one way valve design which is responsible for prevention of reverse flow of blood. Another object of present invention is to provide a mechanism for preventing reverse flow of blood that may be applied to a variety of other devices.”
32. The abstract of D[1] discusses about a catheter device having a selfactivating mechanism, in which the self-activating catheter assembly is comprised of a catheter hub (I), cylindrical valve (2), actuator (3), needle (13) and a flash back chamber (18) having a one-way valve design preventing reverse blood flow. The abstract is reproduced hereunder: “57) Abstract: Present invention discloses a catheter device having self-activating mechanism. The self- activating catheter assembly comprises, a catheter hub (I), cylindrical valve (2), actuator (3), needle (13) and a flash back chamber (18). The intravenous catheter of present invention having a novel one-way valve design which prevent of reverse flow of blood.”
33. The main aspect of the document D[1] is to provide a catheter device having a self-activating mechanism comprising a catheter hub having a proximal end and a distal end, where the catheter hub has a substantially coaxial recess with an undercut towards the proximal end, allowing a one-way cylindrical valve made of flexible material. The claimed device is reproduced below in Figure I: The device has a valve where the first end of the valve is open and the second end of the valve is closed and has a slit (9) on the second end; the cylindrical valve has a co-axial recess; the recess has a ring protruding on the inner surface towards the distal end. The catheter device has a tubular actuator having a closed end and an open end, and the actuator has a cylindrical outer surface with a circular depression (12) towards the distal end. The actuator arranged within the recess of the cylindrical valve, with the protruding ring 5 (11) within the recess of the cylindrical valve mating with the circular depression of the actuator. Additionally, other embodiments of the invention claimed under D[1] are as follows: • A slit (9) that may be of any shape, preferably Y-shaped slit, or Xshaped slit. • Actuator (3), which is made of a rigid plastic material or metal. • The flashback chamber (18) has a porous filter (19) / cover (20) allowing the air to escape and blood to flow inside the flash back chamber (18).
34. The Impugned Order states that all the essential features of the Subject Application are present in the document D[1]. On the other hand, the valve closure member, which is an essential feature under the Subject Application, is not present in document D[1].
35. Therefore, the observations in the Impugned Order that all the features of the present invention under the Subject Application are disclosed, cannot be accepted.
36. The functionality of D[2] to understand the reasoning provided under the Impugned Order. The prior art document D[2] claims a multi-use blood control safety catheter assembly. The background of D[2] states that the catheters may be used to infuse fluids into a patient in need of such treatment. Additionally, catheters also enable the removal of fluids from the circulatory system and the monitoring of conditions in the vascular system of the patient. The abstract of the D[2] is as reproduced hereunder: “(57) Abstract: A catheter assembly comprises a catheter (18), a needle (12) having a sharp distal tip disposed within the catheter (18), a catheter hub (14) connected to the catheter (18) having the needle (12) passing therethrough, the catheter hub (14) including a valve (38) that selectively permits or blocks a flow of fluid through the catheter (18), a valve actuator (54) that moves between a first position and a second position, and a return member (56) that returns the valve actuator (54) from the second position to the first position, and a needle protection member (l 76) that encloses the sharp distal tip of the needle (12).” As the wedge (34) is inserted into the catheter tube, the catheter tube expands, creating an interference fit between the catheter tube, the wedge, and the inner surface (24) of the catheter hub. A wedge flange may be formed on the inner surface to create a limit for distal movement of the wedge. A similar shoulder, tab, or groove may limit the distal movement of the wedge. A pre-slit resilient septum functions as a valve and forms a fluidtight seal and selectively permits or blocks the flow of fluid through the flexible catheter tube (18). The septum has pre-formed openings or slits designed to selectively prevent unwanted fluid flow through the septum. The septum preferably has three intersecting slits forming three flaps that open when engaged by a valve actuator or a septum actuator. Once the catheter tube is initially inserted into a patient, and the introducer needle is removed, the septum prevents blood from flowing through the channel (28) and out of the distal end. Figure 2A below depicts an exemplary embodiment of an actuator (44) that has an actuator barrel (46) surrounding an internal passage (46A).
37. As shown below in Figure 2B, the septum further includes a plurality of axial flow channels. Because of the appropriate width and depth of flow channels, when the septum is not opened, blood can enter and air can escape the space distal of the septum in the front portion of the catheter hub (14). Additionally, the flow channels (39) are small in size and prevent the blood from exiting past the septum (at least for some period of time). The greater intermolecular forces in the blood than the intermolecular forces in air make the configuration possible. Figure 2B of the document D[2] is hereunder:
38. The Subject Application and the document D[2] can be distinguished as follows: a. Contrary to the shape of the valve in D[2], the valve under the Subject Application is of a concave shape. b. Document D[2] solves the problem of backflow by the elasticity / selfsealing property of the valve member, coupled with the flow channel of the septum relying on the difference between intermolecular forces while the Subject Application does not rely on the difference between intermolecular forces to perform its function. c. The efficacy of solving the problem of backflow of blood lasts for some period of time in the device claimed under the document D[2], while the Subject Application does not have such a limitation.
39. It is important to note that the Impugned Order does not mention that the backflow of blood lasts for some period of time in the D[2], which is an important fact in this regard. Furthermore, the Impugned Order does not discuss that, unlike the functioning of the device under the Subject Application, document D[2] solves the problem of backflow by the elasticity or self-sealing property of the valve member, coupled with the flow channel of the septum relying on the difference between intermolecular forces.
40. The learned Counsel for the Appellant submitted that the valve closure member is not disclosed in D[2]. On the other hand, the learned Counsel for the Respondent submitted that the septum flange in document D[2] is performing similar functions as the valve closure member and therefore, the learned Controller in the Impugned Order is referring to the septum flange of document D[2] as the valve closure member. Under the Subject Application, the valve closure member is adapted to close the plurality of prongs of the valve member, thus, closing the passage for the fluid flow and preventing blood flow from the distal end of the catheter hub to the proximal end of the catheter hub. In other words, the valve closure member assists the valve member in functioning to prevent the blood flow. Therefore, the Impugned Order failed to explain / compare how there is functional similarity between the two.
41. Therefore, the submission on behalf of the Respondent that the Impugned Order refers to the septum flange in D[2] as a valve closure member while comparing it with the Subject Application, cannot be accepted as no explanation is provided.
42. The Impugned Order discusses the invention of the Subject Application in Paragraph No. 7, thereby complying with step 1 of Agriboard (supra). The prior Art D[1] and D[2] are discussed in Paragraph No. 8 of the Impugned Order, thereby complying with step 2 of Agriboard (supra). The third step requires the learned Controller to provide reasoning of how the present invention would be obvious to PSITA. However, the learned Controller has failed to discuss the three abovementioned differences between the document D[2] and the Subject Application. Additionally, the Impugned Order does not discuss the functional similarity between the septum flange in document D[2] and the valve closure member of the Subject Application. In the absence of this reasoning, it cannot be determined that document D[2] render the present invention claimed under the Subject Application obvious. Therefore, the learned Controller failed to comply with the third step of Agriboard (supra).
43. The limitation of making D[1] unable to stop the backflow of the blood after being used for a long time, due to the nature of the material used to construct the valve, is overcome by the Subject Application. Furthermore, the valve closure member is not present in document D[1].
44. Therefore, the ability of D[2] to prevent the blood from exiting past the septum is only for some time, and the claimed invention under the Subject Application does not have such a limitation.
45. According to Section 2 (1)(ja) of the Act, the economic significance itself is a subset of technical advancement. The Section 2 (1)(ja) of the Act is reproduced hereunder: “(ja) "inventive step" means a feature of an invention that involves a 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;”
46. In the book of Ramanujam’s Patent Law, Page 225, Paragraph 7 to 23 states that economic significance can itself be a subset of technical advancement. The relevant paragraph is reproduced hereunder: “A classic example would include inventions that increase the efficiency of industrial process, or reduce the cost of manufacturing a particular product, or result in lower consumption of raw materials etc. Arguably, such “economic significance” can itself can be a subset of “technical advance” as understood above, resulting in consequential reduction in product prices etc.”
47. Therefore, such limitations of documents D[1] and D[2] become important to discuss, which the learned Controller failed to consider while passing the Impugned Order.
48. Accordingly, in view of the above discussion, the Impugned Order dated 11.02.2021 and the Appeal Order dated 06.01.2023 passed by the learned Controller are set aside, and the matter is remanded back to the Patent Office for fresh consideration. The learned Controller shall afford a fresh opportunity of hearing to the Appellant before deciding the Subject Application.
49. It is made clear that the learned Controller shall decide the matter on the merits in accordance with the law, uninfluenced by any observations in this Order. The learned Controller shall reconsider the matter preferably within a period of six months from the date of this decision.
50. A copy of the Order also be brought to the notice of the learned Controller General of Patents, Designs and Trademarks for the necessary administrative action.
51. The Appeal is disposed of in the aforesaid terms.
TEJAS KARIA, J SEPTEMBER 26, 2025 ‘KC’/‘N’