Madras High Court
Navya Network Inc vs The Controller Of Patents & Designs on 27 February, 2025
Author: Senthilkumar Ramamoorthy
Bench: Senthilkumar Ramamoorthy
2025:MHC:538
IN THE HIGH COURT OF JUDICATURE AT MADRAS
Judgment reserved on 06.02.2025
Judgment pronounced on 27.02.2025
CORAM:
THE HON'BLE MR. JUSTICE SENTHILKUMAR RAMAMOORTHY
CMA (PT) No.13 of 2024
Navya Network Inc.
108, Trowbridge Street,
#1 Canbrudgem N/a 02138,
United States of America
Through its Authorized Representative
Ms.Gitika Srivastava,
CEO of Navya Network Inc.
108, Trowbridge Street, #1 Cambridge
MA 02138 – USA ... Appellant
v.
The Controller of Patents & Designs,
Patent Office,
IPR Buildings, SIDCO Plot
GST Road, Guindy,
Chennai-600 032. ... Respondent
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PRAYER: This Civil Miscellaneous Appeal filed under Section 117 A
of the Patents Act, 1970, to allow the appeal, set aside the impugned
order dated 13th March 2023 passed by the Respondent in Indian
Patent Application No.951/CHENP/2013 and grant the subject
Patent in favour of the Appellant.
For Appellant : Mr.Kapil Kumar
and Mr.K.Muthu Selvam
for M/s K and S Partners
For Respondent : Ms.R.Durga Rani, CGSC
Ms.Himanshi Kharb, Controller
JUDGMENT
This appeal is directed against the order dated 13.03.2023
dismissing Patent Application No.951/CHENP/2013. The said
application was filed by the appellant herein for grant of patent for
an invention titled “TREATMENT RELATED QUANTITATIVE
DECISION ENGINE”.
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2. Upon request by the appellant, the respondent issued a First
Examination Report (FER) dated 21.11.2019. In the FER, objections
were raised inter alia on grounds of lack of novelty, lack of inventive
step, exclusion under Section 3(k), lack of clarity and conciseness
under Section 10(5) of the Patents Act, 1970 (the Patents Act). The
appellant responded to the FER on 21.08.2020 and submitted
amended claims. Pursuant to hearing notice dated 13.12.2021, the
appellant submitted written submissions on 22.02.2022 by enclosing
current claims 1 to 28. These claims were rejected by the order
impugned order herein.
3. Learned counsel for the appellant submitted that the
impugned order erroneously concluded that the appellant's claims
relate to an algorithm or computer programme per se or business
method in terms of Section 3(k) of the Patents Act. By referring to the
judgment of the Delhi High Court in Microsoft Technology Licensing v.
Assistant Controller of Patents and Designs, 2023 SCC OnLine Del 2772,
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particularly paragraph 47 thereof, learned counsel contended that
claims cannot be rejected solely on the ground that the claims relate
to computer executable instructions or algorithms that are performed
on a general purpose computing device. He also submitted that the
Delhi High Court concluded that if the claims are in respect of a
computer programme which results in a technical effect that
improves the computer system's functionality and effectiveness, it
cannot be rejected as being a computer programme per se.
4. He next submitted that the rejection on the ground that it is a
business method is completely erroneous. By referring to paragraph
74 of the Delhi High Court in Open TV Inc. v. The Controller of Patents
and Designs, 2023:DHC:3305, learned counsel submitted that an
invention would be excluded as being a business method only if it is
intended primarily to enable conduct or administration of a
particular business and if the purpose of the invention is for claiming
exclusivity or monopoly over a manner of doing business. He also
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relied upon the judgment of this Court in Priya Randolph v. Deputy
Controller of Patents, 2023:MHC:5450, to contend that the monopoly
claim is not in respect of a method of conducting business.
5. As regards the conclusion that the claimed invention lacks an
inventive step, the first submission of learned counsel was that the
respondent committed an error in the identification of the persons
skilled in the art (PSITA). According to him, in view of the nature of
the invention, a PSITA team should have been formed by including
a medical expert therein. With regard to prior art documents D1 and
D3, learned counsel contended that the claimed invention would not
be obvious to PSITA from either of these prior arts. He distinguished
D3 by pointing out that D3 involves patient interaction whereas the
claimed invention does not. As regards prior art D2, he contended
that prior art D2 is limited to grading and providing scores for
alternative medicines. By contrast, he submitted that the claimed
invention is more complex and even provides for grading of the
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experts, whose opinion is sought and relied upon for purposes of
generating a report for the patient. Therefore, he concluded his
submissions by reiterating that the claimed invention would not be
obvious to PSITA on the basis of cited prior arts.
6. Learned standing counsel made submissions in response to
the above by contending that the appellant's patent application was
rejected primarily on the ground of lack of inventive step. According
to the respondent, the claimed invention consists of two steps. The
first step involves collating relevant information from patients and
feeding such information into a medical information system
depending on the specified health condition by selecting guideline
treatment options. The second step involves the evaluation of
alternative guideline treatment options and selection of the most
appropriate treatment option. It was further submitted that both the
steps are anticipated by, or, at a minimum, obvious from claims 21
and 29 of prior art D3. Likewise, the respondent contended that
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grading and scoring is clearly anticipated by or at least obvious from
claim 33 of prior art D2.
Discussion, analysis and conclusion:
7. The complete specification sets out the title of the claimed
invention as “TREATMENT RELATED QUANTITATIVE DECISION
ENGINE”. The field of invention is described as relating to systems
and methods for facilitating medical decisions. The summary, in
relevant part, is as under:
“In accordance with one embodiment of the
invention, a system and method, for use with a
computer system, generate a report to help decide
among a plurality of treatment options for a
patient with a given medical condition. To that
end, the system and method receive patient
information related to the patient and the medical
condition, and query a treatment option database
to generate a plurality of potential treatment
options for the medical condition. In a
corresponding manner, the system and method
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also receive preference information indicative of
the patient's preference(s) for potential treatment
outcomes of the treatment options. The patient's
preference(s) are used to produce a preference
value. The system and method also analyze
indexed study data relating to the plurality of
treatment options to produce (e.g., at least in part
in a computer process), based on the analysis of
the indexed data, a study score for each of the
treatment options. Accordingly, for each
treatment option, the method and apparatus
produce a treatment score as a function of at least
the preference value and the study score, thus
permitting generation of a report listing the
treatment options and a) the treatment scores or
b) the information derived from the treatment
scores.”
The above paragraph discloses that the claimed invention envisages
a system and method for use with a computer system so as to
generate a report, which would help the patient to decide from and
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out of a plurality of treatment options. It further indicates that
quantitative scores are generated to enable the patients to pick the
most appropriate treatment option. The complete specification
further discloses that this method and system involves formulating
the medical question, quantitative representation of information
sources, providing for queries to experts for expert feedback,
literature analysis, reckoning patient preferences and risk tolerance
and evaluating outcomes on the basis of an outcome database and
machine learning so as to rank the treatment options and set out the
same in the report.
8. Therefore, it becomes necessary to examine whether all the
above mentioned features are found in the cited prior arts and, even
if not, whether such features would be obvious to PSITA from the
cited prior art. Prior art document D3 was referred to as the closest
prior art. D3 is patent literature bearing the title 'HEALTH CARE
MANAGEMENT SYSTEM'. After outlining the then existing prior art
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as enabling the evaluation of the recommended treatment from a pre-
defined treatment, D3 identifies the problem to be solved as a health
care management data processing system that could be used by
various health care participants at multiple stages of the health care
process. The summary of the invention recites inter alia as under:
“According to the present invention, there
is provided a processing unit and software-
implemented health condition treatment
guidelines. A user inputs an individual's health
data into a new or existing case file in response to
inquiries implemented in a health-condition
specific guideline. Through the interactive
guideline query-response process, a guideline-
recommended treatment (or treatments) is
obtained. The user may adopt or accept the
guideline-recommended treatment or input an
actual or proposed treatment that is different.
Discrepancies between actual/proposed and
guideline-recommended treatment are identified
and the user's choice is documented through
interactive queries. Once a treatment is selected,
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the case information is added to the data base and
an additional reviewer can analyze the file. The
case may be re-opened, and changes may be made
at any stage in the process to reflect new
conditions, or new or modified treatments.”
Thus, D3 provides for a diagnosis based guideline and discloses that
the application of such guideline to an individual's health condition
consists of four phases, namely, the entry phase, the question/data
collection phase, the assessment phase and final recommendation
phase. It further discloses that the guideline development process
involves 13 steps. These steps include identification of illness
category, the components of care, literature search, quantitative
analysis about a particular intervention, effectiveness, summary of
risks and benefits of interventions, etc. Independent claim 21 of prior
art D3 is as under:
“21. A medical information system for analyzing
health care treatment for individuals having a
specified health care condition to evaluate such
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treatment against specified health care guidelines
comprising:
(a) a central processing unit;
(b) at least one memory unit connected to said
central processing unit;
(c) means for defining one or more health care
conditions for which treatment exists;
(d) means for providing to the system one or more
diagnosis-based guidelines corresponding to each
of said one or more specified health care conditions
and including at least one guideline treatment
option; and
(e) means for interactively exchanging with the
system information for at least one or more
characteristics of the individual relevant to the
observed health care condition, said exchange
utilizing data collection nodes and conditional
branching in a diagnosis-based guideline, to
arrive at an endpoint selected from the group
consisting of: a guideline treatment option, an
indication to select another one of the diagnosis-
based guidelines, or an indication for further
clinical evaluation.”
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9. Prior art D3 therefore appears to disclose most features of the
claimed invention with the exception of quantitative analysis by
grading or scoring.
10. Turning to prior art D2, this is also patent literature bearing
the title “Method and System for Patient Preference Determination
for Treatment Options”. The publication date is 28.08.2003, which is
subsequent to the publication date of prior art D3, being 06.01.1994.
Paragraph [0003] of the complete specification of prior art D2 is as
under:
“[0003] The present invention relates to a method
and system for matching patient preference data
with products, such as drugs and other
pharmaceuticals, and in particular to a
computerized method and system for receiving
preference data on patients and using this data
with a therapeutic product and other treatment-
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related information to determine a treatment
preference for each patient.”
11. The summary of the invention, at paragraph [0012], is as
under:
“[0012] The present invention provides a method
and system for determining treatment preference
information. In one embodiment, individuals are
queried for such data as demographic information,
preference factors, and trade-off selections. The
preference factors include, for example, relief from
symptoms, cost of treatment, side effects of
treatment, frequency of treatment required, and
mode of administration of treatment. In one
embodiment, input patient preference data are
used with repositories (e.g., databases) of
treatment related information, and then treatment
preferences are refined via use of selectable options
for tradeoff preferences. In one embodiment,
treatment options are then ranked or otherwise
compared.”
As in the case of prior art D3, prior art D2 also discloses the
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evaluation of received treatment preference information using a
repository of treatment option information to determine at least one
preferred treatment option.
12. Significantly, it also provides for the ranking and scoring of
treatment options, including medications. Claims 17, 18 and 33 are as
under:
“17. The method of claim 16, wherein
evaluating the received treatment preference
information using a repository of treatment option
information to determine at least one preferred
treatment option for the user further includes:
ranking each of the plurality of medications
applicable to the treatment condition.”
“18. The method of claim 17, wherein
ranking includes:
producing a weighted comparison of the
received treatment preference information and the
medication specific information for each of the
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plurality of medications applicable to the
treatment condition.”
.. .. ..
“33. A method for determining medication
preference information for a patient, the method
comprising:
receiving a selection of a treatment of
interest, the treatment of interest having a
plurality of associated medications;
receiving the demographic information;
receiving a plurality of preference factor
selections from the patient, the plurality of
preference factor selections including at least one
selected from a group consisting of valuation of
relief from symptoms, cost of medication, side
effects of medication, frequency of treatment, and
mode of administration;
analyzing the plurality of associated
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medications with respect to the plurality of factor
selections, wherein analyzing includes comparing
pairs of the received plurality of preference factor
selections and assigning a score for each of the
plurality of preference factor selections based on a
predetermined comparison threshold;
determining at least one tradeoff option for
the plurality of associated medications, each of the
at least one tradeoff option being identified from
a repository of option information;
receiving a tradeoff selection for each of the
at least one tradeoff option; and
scoring each of the plurality of associated
medications, wherein scoring includes applying
the score for each of the plurality of preference
factor selections and a score applied for each of the
received tradeoff selections;
wherein ranking includes weighting each of
the plurality of associated medications based on
the received preference factors information and the
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received tradeoff selection for each of the at least
one tradeoff option.”
Claims 17, 18 and 33 clearly disclose that prior art D2 recites ranking
and assigning a score in respect of medication, received treatment
preference information, preference factor selections and received
tradeoff selections. In effect, prior art D2 also involves quantitative
analysis by way of ranking and scoring.
13. In a similar vein, prior art D1 titled 'AN INTERACTIVE
TREATMENT PLANNING SUPPORT SYSTEM AND METHOD
THEREOF' provides inter alia, for an ontology of hierarchical
treatment options by constructing and sorting a treatment method
and treatment information, defining a treatment method class
corresponding to the treated disease and the patient's condition;
providing detailed information on the best treatment method
selected based on the relative preference input provided by the
patient. If the best method presented is not the final selection,
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feedback is received to find a suitable treatment method. Thus, it can
be seen that D1 discloses a method of ranking treatment options in a
hierarchy and presenting it to the patient.
14. In order to determine whether the claimed invention would
be obvious to PSITA from the cited prior arts, it is necessary to set
out independent claims 1 and 14. The same are as under:
“1. A method, for use with at least one
processor on at least one computer, of generating a
report to help decide among a plurality of
treatment options for a patient with a given
treatable medical conditions, the method
comprising:
receiving (210), by a patient information
receiving module, patient information (110)
related to the patient and the medical condition;
querying (220), by querying module, a
treatment option database (235) to generate a
plurality of potential treatment options for the
medical condition;
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receiving (360), by a preference information
receiving module, preference information (120)
indicative of the patient's preference for potential
treatment outcomes of the treatment options to
produce a preference value;
analyzing (320), by an analysis module,
indexed study data (130) relating to the plurality
of treatment options by at least grading evidence
within the indexed study data (130), wherein the
indexed study data (130) is derived from scientific
studies, each of which evaluates an effect of a
different treatment option on different trial
subjects who have a similar medical condition as
the patient;
producing (420), by a study score
producing module, a study score for each of the
treatment options based on the analysis of the
indexed study data (130);
determining, a treatment scoring module,
for each distinc treatment option, a distinct
treatment score as a function of at least the
preference value and the study score
corresponding to the distinct treatment option;
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and
generating (370), by a reporting module, a
report (150) listing the treatment options and a)
the treatment scores or b) information derived
from the treatment scores.
14. A medical treatment recommendation
system for generating a report to help decide
among a plurality of treatment options for a
patient for a given treatable medical condition,
comprising:
a patient information receiving module that
receives patient information (110) related to the
patient and the medical condition;
a querying module that queries a treatment
option database (235) to generate a list of potential
treatment options for the medical condition;
a preference information receiving module
that receives patient information (120) indicative
of the patient's preference for potential treatment
outcomes of the treatment options to produce a
preference value;
an analysis module that analyzes indexed
study data (130) relating to the plurality of
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treatment options by at least grading evidence
within the indexed study data (130), wherein the
indexed study data (130) is derived from scientific
studies, each of which evaluates an effect of a
different treatment option on different trial
subjects who have a similar medical condition as
the patient;
a study score producing module that
produces a study score for each of the treatment
options based on the analysis of the indexed study
data (130);
a treatment scoring module that determines,
for each distinct treatment option, a distinct
treatment score as a function of at least the
preference value and study score corresponding to
the distinct treatment option; and
a reporting module that generates a report
(1500) listing the treatment options and a) the
treatment scores or b) information derived from
the treatment scores.”
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As is evident from the above, the claimed invention seeks monopoly
over the method involving the use of a processor on at least one
computer to generate a report to decide between plurality of
treatment options for a patient with a specific treatable medical
condition. The method comprises receiving patient information;
posing a query to the treatment option data base to generate a
plurality of the potential treatment options for such medical
condition; receiving information indicative of patient's preference for
potential treatment outcomes of the treatment options; analysing
index study data relating to plurality of the treatment options;
producing a study score for each treatment option; and thereafter
generating a report listing the treatment options and treatment
scores.
15. In addition, dependent claims 6, 7 and 8 provide for
receiving expert recommendations, recalculating and refining the
treatment score as a function of the expert score in addition to the
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preference value and study score based on patient input and
scientific studies respectively; the expert score is arrived at by taking
into account the expert's degree of success, ranking of the institution
that the expert is affiliated with and the like.
16. As is evident from the above discussion, except for the
quantitative analysis by providing for grading and scoring, all the
features of the claimed invention were present in prior art D3, which
additionally provides for patient interaction. Prior art D2 fills the gap
by providing for grading and scoring in addition to patient
interaction. Prior D1 provides for hierarchical ranking of treatment
options and also involves accounting for patient preferences. All
these cited prior arts are analogous since they share a common field
of invention with the claimed invention. There are clear cues in D3
that would lead the PSITA team to D2 and D1, and thereby to the
claimed invention.
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17. Learned counsel for the appellant contended that the
grading and scoring system disclosed in the claimed invention is
more sophisticated inasmuch as grading and scoring is provided for
even in respect of the literature analysed by the system and also
extends to the consulted experts.
18. Even proceeding on the basis that prior arts D1 and D2 do
not recite grading and ranking in respect of the experts, given the
fact that they provide for a grading and scoring system in respect of
medications and other treatment options, in my view, it would be
obvious to a PSITA team, consisting of a software engineer and a
medical expert, to arrive at the claimed invention on the basis of clear
pointers in the said prior arts. Mere refining of the treatment score
based on expert grading does not represent a technical advance over
the prior arts and, in any event, would be obvious from cited prior
arts to the PSITA team. Therefore, the claimed invention does not
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satisfy the requirements of Section 2(1) (ja) of the Patents Act. In view
of the above, it becomes unnecessary to examine whether the claimed
invention stands excluded from patent protection under Section 3(k)
of the Patents Act.
19. For reasons set out above, CMA(PT)No.13 of 2024 is
dismissed by confirming the order of the respondent. There will be
no order as to costs.
27.02.2025
Index : Yes/No
Internet : Yes/No
Neutral
Citation : Yes/No
kal
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SENTHILKUMAR RAMAMOORTHY J.
kal
Pre-delivery judgment in
27.02.2025
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