Delhi High Court
Aethlon Medical, Inc vs Controller General Of Patents, Designs ... on 26 September, 2025
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment delivered on: 26.09.2025
+ C.A.(COMM.IPD-PAT) 251/2022
AETHLON MEDICAL, INC .....Appellant
versus
CONTROLLER GENERAL OF PATENTS, DESIGNS AND
TRADEMARKS & ANR. .....Respondents
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.
CORAM:
HON'BLE MR. JUSTICE TEJAS KARIA
JUDGMENT
TEJAS KARIA, J
INTRODUCTION
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, non-
patentability 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:
"1. Pursuant to previous order of this Court dated 12th January,
2024, appellant had filed an auxiliary request of proposed amended
set of claims.
Counsel for appellant states that these proposed amendments were
necessitated to embody the limitation which was granted along with
the patent by European Patent Office ['EPO']. The proposed
amendments are, therefore, to deal with the issues of prior art which
had also been cited by the EPO and the limitations assigned to the
patent. Therefore, these are also being proposed as amendments to
the subject application. The other issue, he states, relates to Section
3(i) of the Patents Act, 1970, in that, the subject application involves
a method of treatment."
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 Earlier Claims Auxiliary Claims filed before
No. this Court
1. A medical device configured A medical device configured for
for extracorporeal removal of extracorporeal removal of
immune suppressive immune suppressive
microvesicular particles from microvesicular particles from
whole blood or a component whole blood or a component
thereof, said device thereof, said device comprising:
comprising: a. an intake conduit through
a. an intake conduit which whole blood or a
through which whole component thereof is
blood or a component taken from the subject ;
thereof is taken from the b. a matrix comprising an
subject ; agent capable of binding
b. a matrix comprising an immune suppressive
agent capable of binding microvesicular particles
immune suppressive found within said blood or
microvesicular particles component thereof,
found within said blood wherein said agent
or component thereof, comprises a lectin and
wherein said agent said agent is configured
comprises a lectin and for contacting said blood
said agent is configured or component thereof; and
for contacting said blood c. a system for
or component thereof; reintroduction of
c. a system for contacted blood or
reintroduction of component thereof into a
contacted blood or subject, whereby said
component thereof into a contacted blood or
subject, whereby said component thereof is
contacted blood or reintroduced under
component thereof is physiologically acceptable
reintroduced under conditions, said contacted
physiologically blood or component
acceptable conditions, thereof containing
said contacted blood or substantially fewer
component thereof immune suppressive
containing substantially microvesicular particles
fewer immune compared to the whole
suppressive blood or component
microvesicular particles thereof that is taken from
compared to the whole the subject through the
blood or component intake conduit; and
thereof that is taken from d. an additional agent
the subject through the capable of binding
intake conduit. immune suppressive
microvesicular particles
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 Deleted
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.
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:
"29. Therefore, it would have to be considered whether an
amendment can be allowed at the stage of appeal or not.
30. There is no provision in the Act, which specifically bars the
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:
"15. Thus, it is evident that amendments in claims are allowed, even
at the appellate stage, with the rider that the amended claims are
not inconsistent with the earlier claims. This Court notes that the
appellant, by way of the amendments, seeks to reduce the scope of
the earlier claims. Further, the auxiliary claim set does not
introduce any new matter which was not already disclosed in
substance in the originally filed specification. The claims, as
amended by the appellant, fall wholly within the scope of the
originally filed claims, and the same have been narrowed to a
process.
16. It is a well-settled position in law that amendments that narrow
down or restrict the scope of the claims to address objections raised
by the Patent Office, or facilitate grant, are permissible, if the
amendments are within the scope of the patent specification, and the
originally filed claims. [See: Nippon A & L Inc. Versus Controller
of Patents 2022 SCC OnLine Del 1909 and W R Grace and Co.
Conn. Versus Controller of Patents 2023 SCC OnLine Del 5456]"
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'
