Full Text
JUDGMENT
AETHLON MEDICAL, INC .....Appellant
Advocates who appeared in this case For the Appellant : Ms. Swati Mittal, Ms. Manisha Singh, Mr. Abhai Pandey, Ms. Preeti Tyagi, Ms. Shivani Singh, Mr. Manish Aryan & Mr. Gautam Kumar, Advocates.
For the Respondents : Mr. Manish Mohan, CGSC with Mr. Prakhar Vashisth, Advocates.
1. The present Appeal has been filed against the order dated 16.10.2017 (“Impugned Order”) passed by the Assistant Controller of Patents and Designs (“Controller” or “Respondent No. 2”) refusing the grant of Patent in respect of Indian Patent Application No. 8139/DELNP/2008 (“Subject Application”) on the grounds that the claimed invention falls within the scope of Section 3(i) of the Patents Act, 1970 (“Act”) and lacks novelty under Section 2(1)(j) of the Act. The invention of the present Application was filed in India as a national phase entry of the Patent Cooperation Treaty application PCT/US2007/006101 dated 09.03.2007 (“PCT Application”).
FACTUAL MATRIX
2. The invention titled “EXTRACORPOREAL REMOVAL OF MICRO VESICULAR PARTICLES” under the Subject Application relates to the field of medical devices, in particular to methods and devices for the extracorporeal removal of microvesicular particles from the blood or component.
3. The Appellant is a company existing under the laws of the State of Nevada, United States of America, with its Registered Office at 9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123, U.S.A.
4. The Appellant, through their agent, received a First Examination Report dated 16.09.2014 (“FER”) issued by the Patent Office. The objection raised in the FER was lack of Novelty under Section 2(1)(j) of the Act, nonpatentability under Sections 3(f) and 3(i) of the Act. Thereafter, the Appellant filed its response on 28.08.2015, along with the amended claims to address all the objections raised in the FER.
5. The hearing notice was issued by the Patent Office dated 22.05.2017 (“Hearing Notice”). The Hearing Notice contained the objections on the ground of lack of novelty (and inventive step) under Section 2(1)(j) of the Act and non-patentability under Section 3(i) of the Act.
SUBMISSIONS ON THE BEHALF OF THE APPELLANT
6. The learned Counsel for the Appellant submitted that the Respondent No. 2 erred both in law and facts in passing the Impugned Order and it was passed in violation of the principles of natural justice as Respondent No. 2 not only failed to appreciate the relevant facts as disclosed by the materials summitted by the Appellant during the proceedings but also failed to adequately consider the merits of the present case.
7. The learned Counsel for the Appellant submitted that the findings of Respondent No. 2 are erroneous both of fact and of law, which consequently affected the legality and validity of the decision.
8. The learned Counsel for the Appellant further submitted that the Impugned Order is erroneous in raising the objection under Section 3(i) of the Act and the interpretation of the said provision. Additionally, the Impugned Order does not clearly demonstrate findings of non-patentability of the claimed method under Section 3(i) of the Act.
9. The learned Counsel for the Appellant submitted that according to the Appellant, Respondent No. 2 in the Impugned Order has failed to discuss the established principles of law of novelty and inventive step.
10. The learned Counsel for the Appellant submitted that the Respondents have raised the question of drawings at the stage of replying to the Appeal and, therefore, cannot be allowed to introduce new grounds of refusal. The Appellant has relied on the following cases while making their submissions: Otsuka Pharmaceutical Co. Ltd v. The Controller of Patents, 2022 SCC OnLine Del 4982; Perkinelmer Health Sciences Inc vs Controller of Patents, 2023 SCC On Line Del 8590.
SUBMISSIONS ON THE BEHALF OF THE RESPONDENTS
11. The learned Counsel for the Respondents submitted that the Respondents in their Reply dated 31.07.2023 (“Reply”) submitted that there is no error in law and a narrow interpretation of Section 3(i) of the Act in disposing of the Subject Application. The Subject Application does not extend to any apparatus / device and is not supported by any drawing.
12. The learned Counsel for the Respondents submitted that the functional features of the medical device that are claimed in the claims and the constructional features of the device are not defined, which renders the scope of the claims as a method of treatment, hence, falls under Section 3(i) of the Act.
13. The learned Counsel for the Respondents further submitted that in their Reply, there is no error in observing the facts, principles of law of novelty and inventive step under Section 2(1)(j) of the Act and the patentability has been clarified in detail in the Impugned Order.
ANALYSIS AND FINDINGS
14. The invention under the Subject Application relates to a medical device for extracorporeal removal of microvesicular particles from whole blood for reversing immune suppression in a subject in need through extracorporeal means. The medical device as claimed in the Subject Application comprises of the following three constructional components: a.Intake conduit b.Matrix c.System for reintroduction
15. The independent claim of the Subject Application is reproduced hereunder: “Claim 1
1. A medical device configured for extracorporeal removal of immune suppressive microvesicular particles from whole blood or a component thereof, said device comprising: a) an intake conduit through which whole blood or a component thereof is taken from the subject; b) a matrix comprising an agent capable of binding immune suppressive microvesicular particles found within said blood or component thereof, wherein said agent comprises a lectin and said agent is configured for contacting said blood or component thereof; and c) a system for reintroduction of contacted blood or component thereof into a subject, whereby said contacted blood or component thereof is reintroduced under physiologically acceptable conditions, said contacted blood or component thereof containing substantially fewer immune suppressive microvesicular particles compared to the whole blood or component thereof that is taken from the subject through the intake conduit.”
16. Vide Order dated 12.01.2024, this Court allowed the Appellant to file Auxiliary Claims as under: “Counsel for the appellant states that without prejudice to the rights and contentions of the appellant in this petition, they may be given liberty to file auxiliary request for proposed amended claims before this Court.”
17. Thereafter, this Court vide Order dated 21.03.2024 has recorded reasons for the Auxiliary Claims, hereunder:
18. According to the Appellant, the independent Claim 1 in the corresponding European Patent (“EP”) and of the Subject Application are similar, and since the Patent is granted in EP, the Appellant proposed to file the Auxiliary Claims before this Court. The Appellant, in the Written Submissions has submitted that ‘Medical Device’ Claims have been granted in the corresponding EP No. 1993600, as the device was explained sufficiently throughout the specification.
19. The Claims 1 and 3 submitted by the Appellant dated 28.06.2017, after the hearing that were considered in the Impugned Order and Auxiliary Claims are given hereunder: Claim No. Earlier Claims Auxiliary Claims filed before this Court
1. A medical device configured for extracorporeal removal of immune suppressive microvesicular particles from whole blood or a component thereof, said device comprising: a. an intake conduit through which whole blood or a component thereof is taken from the subject; b. a matrix comprising an agent capable of binding microvesicular particles found within said blood or component thereof, wherein said agent comprises a lectin and said agent is configured for contacting said blood or component thereof; c. a system for reintroduction of contacted blood or component thereof into a subject, whereby said component thereof is reintroduced under physiologically acceptable conditions, said contacted blood or component thereof A medical device configured for extracorporeal removal of microvesicular particles from whole blood or a component thereof, said device comprising: a. an intake conduit through which whole blood or a taken from the subject; b. a matrix comprising an agent capable of binding found within said blood or component thereof, wherein said agent comprises a lectin and said agent is configured for contacting said blood or component thereof; and c. a system for reintroduction of component thereof into a subject, whereby said reintroduced under physiologically acceptable conditions, said contacted blood or component thereof containing substantially fewer containing substantially fewer immune suppressive compared to the whole thereof that is taken from the subject through the intake conduit. compared to the whole thereof that is taken from the subject through the intake conduit; and d. an additional agent capable of binding selected from a group consisting of a) an antibody; b) a protein; c) an aptamer; d) a surface that selectively restricts microvesicles from passage; and e) a surface with selective adhesion to microvesicles.
3. The medical device of claim 1 or 2, further comprising an additional agent capable of binding immune suppressive microvesicular particles is selected from a group consisting of a) an antibody; b) a protein; c) an aptamer; d) a surface that selectively restricts microvesicles from passage; and e) a surface with selective adhesion to microvesicles. Deleted
20. In the Auxiliary Claims, the Appellant has deleted the dependent Claim 3 and merged it with the independent Claim 1. Accordingly, the inclusion of a paragraph in Claim 1 that states an additional agent capable of binding immune suppressive microvesicular particles selected from a specified group does not broaden the scope of the unamended claims.
21. The detailed description of the invention which discloses the additional agent capable of binding immune suppressive microvesicular particles as amended in Claim 1 is reproduced hereunder: “Agents capable of binding microvesicles contemplated for use herein are selected from the group consisting of one or more of the following: a) a singular or plurality of antibody species; b) a singular or plurality of proteins (e.g., lectins); c) a singular or plurality of aptamers, d) a surface that selectively restricts microvesicles from passage, and e) a surface with selective adhesion to microvesicles.”
22. Further, the detailed description of the invention also describes the antibody, protein, surface that selectively restricts microvesicles from passage and surface with selective adhesion to microvesicles given under the group from which the additional agent is selected. Additionally, the aptamers are discussed in Example 7 of the Specification. Therefore, the Auxiliary Claim 1 is acceptable as it complies with the condition provided under Section 59(1) of the Act.
23. In Societe Des Produits Nestle SA Versus Controller of Patents and Design and Another, 2023 SCC OnLine Del 582, this Court noted that there is no specific bar for the amendment even at the subsequent stage. The relevant paragraphs are reproduced hereunder:
amendment of a patent specification at the appellate stage. Amendment of patent applications and specifications are covered in Chapter X of the Act. Sections 57 to 59 of the Act are the provisions that govern the same.
31. A reference to Sub-Section 3 of Section 57 of the Act would show that an amendment application can be made even after the grant of patent.”
24. The above position was also reiterated in Albemarle Corporation v The Controller of Patents, 2025 SCC OnLine Del 4729, wherein this Court noted that the Court has the power to allow the amendment of claims at the appellate stage. The relevant paragraph is hereunder:
25. Therefore, the Auxiliary Claims are acceptable as they do not broaden the scope of the unamended claims, and the subject matter of the proposed amendment in the Auxiliary Claims is disclosed in the Specification.
26. On the objection raised under Section 3(i) of the Act, the Respondents, through their Reply, submitted that the Subject Application does not extend to any apparatus / device, also not supported by any drawing. The Respondents have submitted that the drawings have not been submitted by the Appellant. The relevant portion of the Reply is reproduced hereunder: “That the contents of para No. 4B to para No. 4C of the Appeal are denied and it is submitted that there is NO error in law and narrow interpretation of the section 3(i) the Patents Act, 1970 (as amended) in disposing the said application. Present application does not extend to any apparatus/Device, also not supported by any drawing. [Emphasis supplied]”
27. It is important to note that the Impugned Order does not raise any such objection. The issue regarding the requirements of drawings should have raised an objection at the time of issuance of the FER or at the time of issuance of the Hearing Notice. Since this ground is raised at a belated stage of Reply to this Appeal and, therefore, cannot be allowed.
28. It is further clarified that the merits of the case have not been examined. Accordingly, the matter is remanded back to the learned Controller General of Patents, Designs and Trademarks for reconsideration and is directed to consider the Subject Application in view of the proposed Auxiliary Claims.
29. Further, this Court directs that a fresh order be passed within a period of six months from the date of the receipt of this Order by the learned Controller. The Appellant shall be granted a hearing before deciding the matter afresh. Accordingly, the Appeal is disposed of with the aforesaid directions.
30. A copy of this Order also be brought to the notice of the learned Controller General of Patents, Designs and Trademarks for the necessary administrative action.
TEJAS KARIA, J SEPTEMBER 26, 2025 ‘KC’/‘N’