/
Recent USPTO Developments on Subject Matter Eligibility Recent USPTO Developments on Subject Matter Eligibility

Recent USPTO Developments on Subject Matter Eligibility - PowerPoint Presentation

yoshiko-marsland
yoshiko-marsland . @yoshiko-marsland
Follow
380 views
Uploaded On 2018-11-09

Recent USPTO Developments on Subject Matter Eligibility - PPT Presentation

Presentation for Massachusetts Association of Technology Transfer Offices April 25 2018 Elizabeth Spar Sunstein Kann Murphy amp Timbers LLP 2018 Sunstein Kann Murphy amp Timbers LLP ID: 725187

acid subject nucleic abcd3 subject acid abcd3 nucleic expression prostate cancer sample disorder claims exception comprising cells anxiety female

Share:

Link:

Embed:

Download Presentation from below link

Download Presentation The PPT/PDF document "Recent USPTO Developments on Subject Mat..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.


Presentation Transcript

Slide1

Recent USPTO Developments on Subject Matter Eligibility

Presentation for

Massachusetts Association of Technology Transfer Offices

April 25, 2018

Elizabeth Spar

Sunstein Kann Murphy & Timbers LLP

©

2018

Sunstein Kann Murphy & Timbers LLPSlide2

USPTO Response to 101 Decisions

2

Since the Supreme Court decided Alice v. CLS Bank in June 2014, the USPTO regularly issues new memoranda explaining its implementation of

the §

101 framework.Slide3

3Slide4

USPTO Revisions to MPEP Incorporate Guidance from USPTO Memorandum

In late January, the USPTO incorporated each of its earlier memoranda into the MPEP.

The sections that the USPTO amended to include its Mayo/Alice guidance are in chapter 2100.

4Slide5

Updates to MPEP

The new cases and examples follow from the Mayo/Alice line of cases.

2106.04 repeats the guidance of the Enfish memo:

Examiners should accordingly be careful to distinguish claims that recite an exception (which require further eligibility analysis) and claims that merely involve an exception (which are eligible and do not require further eligibility analysis).

5Slide6

Patent Examiners are citing to these decisions

... mere physical

or tangible nature of

additional elements

such as the obtaining and

detecting steps

does not automatically confer eligibility on a claim directed to an abstract

idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).... this

type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo).... just as PCR was identified in Ariosa v. Sequenom as “well-known, routine and conventional” ... the methods encompassed by the instant claims are well-known, routine and conventional.

6Slide7

Recently Issued Diagnostic Claims U.S. 9,939,449 – Issued April 10, 2018

1. (

Original

) A method for diagnosing and treating an anxiety disorder in a female subject, comprising:

a.

analyzing

pituitary adenylate cyclase-activating polypeptide (PACAP) expression levels in a tissue sample collected from a female subject;

b. diagnosing

the anxiety disorder in the female subject having elevated tissue PACAP expression levels as compared to a control tissue sample obtained from a subject who does not have an anxiety disorder; andc. treating the anxiety disorder in the female subject diagnosed in (b). 7Slide8

The Office Action

... Step

(c) requires treating the disorder. However, for such treatment to add significantly more, it must practically apply the judicial exception

...

In this case, step (c) does not relate to the judicial exception. It does not require practically applying steps (a) and (b). Step (c) is no more than instructions to treat a disorder, including using known, conventional therapies.

Since step (c) is in no way reliant on the judicial exception, it does not add significantly more than the judicial exception.

8Slide9

U.S. 9,939,449- Claim Amendments

1

.

(

Amended

)

A method for diagnosing and treating

post traumatic stress disorder (PTSD) an anxiety disorder in a female subject, comprising:a. analyzing

pituitary adenylate cyclase-activating polypeptide (PACAP) expression levels in a tissue sample collected from a female subject; b. diagnosing PTSD the anxiety disorder in the female subject having elevated tissue PACAP expression levels as compared to a control tissue sample obtained from a subject who does not have PTSD an anxiety disorder

; andc. treating the anxiety disorder in administering to the female subject diagnosed in (b) a therapeutically effective amount of an antibody that binds specifically to an epitope at the carboxy-terminal end of PACAP.

9Slide10

The Office Action

The rejection under 101 is withdrawn in light of the amendments. The treatment step now practically applies the judicial exception and is considered to elevate the claim as a whole to significantly more than the judicial exception itself.

10Slide11

Recently Issued Diagnostic Claims

US

9,939,449 –

Issued

April 10,

2018

11

1. (

Original) A method of determining an increased likelihood of prostate cancer cells in a subject to metastasize, comprising detecting in a sample comprising prostate cancer cells from the subject over-expression of a nucleic acid of ABCD3 compared to expression levels of a nucleic acid of ABCD3 from a control, the over-expression of a nucleic acid of ABCD3 in prostate cancer cells being indicative of an increased likelihood of prostate cancer cells in the subject to metastasize.Slide12

The Office Action

The claims do not recite something “significantly more than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exceptions.

12Slide13

US 9,939,449 Claim Amendments

13

1. (

Amended

) A

method of

determining an

diagnosing and treating an increased likelihood of prostate cancer

cell metastasis in a subjectcells in a subject to metastasize, the method comprising: a. obtaining a sample comprising prostate cancer cells from a subject;

b.

detecting expression of a nucleic acid of

ABCD3

in the sample and determining whether the expression of a nucleic acid of

ABCD3

is overexpressed

in a sample comprising

prostate

cancer cells from the subject over expression of a nucleic acid of

ABCD3

compared to expression levels of a nucleic acid of

ABCD3

from a control

;

c. diagnosing the subject with

,

the overexpression of a nucleic acid of

ABCD3

in prostate

cancer cells

being indicative of

an increased likelihood of prostate cancer

cell

metastasis

when the nucleic acid

ABCD3

is overexpressed; and

d. administering an aggressive treatment of prostate removal, radiation, chemotherapy or a combination thereof to the subject

cells in the subject to metastasize

. Slide14

The Office Action

14

In an effort to expedite prosecution, it is noted the following amendment to claim 1 would obviate this rejection by adding a step that would result in a claimed combination of steps that would not be considered conventional or routine:” ...b. detecting expression of nucleic acid ABCD3 in the sample

by amplifying ABCD3 nucleic acid using a primer pair that specifically amplifies ABCD3 nucleic acid

and determining whether...Slide15

15

1

. (Amended) A method of diagnosing and treating an increased likelihood of prostate cancer cell metastasis in a subject, the method comprising:

a. obtaining a sample comprising prostate cancer cells from a subject;

b. detecting expression of a nucleic acid of

ABCD3

in the sample

by amplifying

ABCD3 nucleic acid using a primer pair that specifically amplifies ABCD3 nucleic acid and determining whether the expression of a nucleic acid of ABCD3 is overexpressed compared to expression levels of a nucleic acid of ABCD3 from a control; c. diagnosing the subject with an increased likelihood of prostate cancer cell metastasis when the nucleic acid ABCD3 is overexpressed; and d. administering an aggressive treatment of prostate removal, radiation, chemotherapy or a combination thereof to the subject.Slide16

Conclusion

There is some hope for diagnostic claims.

It may be useful to modify claim language based on claims that have been allowed, although there is inconsistency between examiners.

Take advantage of the Revised MPEP and use the

examples provided.

Interview.

16Slide17

Thank you.

Elizabeth N. Spar

espar@sunsteinlaw.com

17