35 U.S.C. 112, Sixth Paragraph As Applies To Biotechnology

1
35 U.S.C. 112, Sixth ParagraphAs Applies
ToBiotechnology Chemical Practice

• Ram R. Shukla, Ph.D.
• SPE AU 1632 1634
• Technology Center 1600
• 571-272-0735
• Ram.shukla_at_uspto.gov

2
MPEP 2181-2185(MPEP (Rev 3, August 2005))

• 2181 Identifying a 35 U.S.C. 112, Sixth
  Paragraph Limitation
• 2182 Scope of Search Identification of the
  Prior Art
• 2183 Making a Prima Facie Case of Equivalence
• 2184 Determining Whether an Applicant Has Met
  the Burden of Proving Nonequivalence After a
  Prima Facie Case is Made
• 2185 Related Issues Under 35 U.S.C 112, First
  or Second Paragraphs

3
35 U.S.C. 112, Sixth Paragraph

• An element in a claim for a combination may
  be expressed as a means or step for performing a
  specified function without recital of structure,
  material, or acts in support thereof and such
  claim shall be construed to cover the
  corresponding structure, material, or acts
  described in the specification and equivalents
  thereof.

4
Invoking 35 U.S.C. 112, Sixth Paragraph

• During examination, a three prong analysis is
  used to determine if 35 U.S.C. 112, sixth
  paragraph is being invoked.
• MPEP 2181

5
The First Prong must use the phrase means for
or step for

• The words means and for need not be
  immediately adjacent to each other, e.g., means
  for.
• A claim element not using means for or step
  for will not be considered to invoke 35 U.S.C.
  112, Sixth Paragraph.

6
The First Prong (cont.)

• If an applicant does not use means for or step
  for, yet wishes to have the claim limitation
  treated under 35 U.S.C. 112, Sixth Paragraph,
  applicant must either
• (A) amend the claim to include the phrase
  means for or step for or (B) show that the
  claim limitation is written as a function to be
  performed and does not provide sufficient
  structure, material, or acts which would preclude
  application of 35 U.S.C. 112, Sixth Paragraph.
• MPEP 2181

7
The Second Prong

• means for or step for must be modified by
  functional language
• For example
• -Means for treating
• -Step for treating

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The Third Prong
the phrase means for or step for must not be
modified by sufficient structure, material or
acts for achieving the specified function.
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Do the following expressions meet the third prong?

1. means for hybridization
2. means for hybridization, said means comprising
   high GC content

10
Analysis by Examiner

• Three prong analysis is applied for each means
  for or step for limitation in each claim.
• A statement will be made in the office action
  regarding elements in the claims that are being
  treated under 35 U.S.C. 112, Sixth Paragraph.

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35 U.S.C. 112, First Paragraph (Written
Description) Analysis

• The structure, material or acts corresponding to
  a means/step plus function limitation must be
  described so that one skilled in the art will
  understand what structure, material or acts will
  perform the recited function.
• MPEP 2181 (II)

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35 U.S.C. 112, First Paragraph (Written
Description) Analysis (cont).

• The disclosure may be implicit or inherent IF it
  would have been clear to one of skill what
  structure, material or acts will perform the
  recited function.
• MPEP 2181 (II)

13
35 U.S.C. 112, First Paragraph (Written
Description) Analysis (cont).

• If no explicit disclosure of structure, acts or
  function is present

• -The examiner may require applicant to amend the
  written description to expressly recite the
  implicit or inherent structure, material or acts
• or
• -The examiner may state on record what
  structure, materials, or acts perform the
  function recited in the means for or step for
  limitation.
• MPEP 2181(IV)

14
35 U.S.C. 112, First Paragraph (Written
Description) Analysis in relation to 35
U.S.C.112, Second Paragraph Analysis

• Whether a claim reciting an element in means-
  (or step-) plus-function language fails to comply
  with 35 U.S.C. 112, second paragraph, because the
  specification does not disclose adequate
  structure (or material or acts) for performing
  the recited function is closely related to the
  question of whether the specification meets the
  description requirement in 35 U.S.C. 112, first
  paragraph. (MPEP 2181) Therefore, when a 112
  second paragraph issue arises for this reason
  (lack of adequate structure), then a 112, 1st
  paragraph rejection should also be made.

15
A means-(or step-) plus function claim limitation
satisfies 35 U.S.C. 112, First Paragraph (written
description) and 112, Second Paragraph if

• (1) written description links or associates
  particular structure, material, or acts to the
  function recited in a means-(or step-) plus
  function claim limitation
• or
• (2) it is clear that one skilled in the art
  would have known what structure, material, or
  acts perform the function recited in the
  means-(or step-) plus function limitation.

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35 U.S.C. 112, Second Paragraph Analysis (cont.)

• The duty to link or associate structure or
  function is the quid pro quo for the convenience
  of using 35 U.S.C. 112, Sixth Paragraph.

• T 37 CFR 1.75(d)(1) can (and should) be used to
  require corresponding terminology. An examiner
  will use form paragraph 7.44 in the office action
  for such requirement.
• 7.44 Claimed Subject Matter Not in
  Specification
• The specification is objected to as failing to
  provide proper antecedent basis for the
• claimed subject matter. See 37 CFR 1.75(d)(1)
  and MPEP  608.01(o). Correction of the
  following is required 1
• No new matter may be added to the specification.

17
Scope of the Search and Identification of the
Prior Art

• The means or step plus function limitation
  should be interpreted in a manner consistent with
  the specification disclosure.
• -If the specification defines what is meant by
  the limitation for the purposes of the claimed
  invention, the examiner should interpret the
  limitation as having that meaning.
• -If no definition is provided, some judgment
  must be exercised in determining the scope of the
  limitation.
• (MPEP 2182)

18
In re Donaldson Co., 16 F.3d 1189, 29 USPQ2d 1845
(Fed. Cir. 1994)

• In this decision, the Federal Circuit stated
• the broadest reasonable interpretation that
  an examiner may give means-plus-function language
  is that statutorily mandated in paragraph six.
  Accordingly, the PTO may not disregard the
  structure disclosed in the specification
  corresponding to such language when rendering a
  patentability determination.

19
Prior Art Analysis Making a Prima Facie Case of
Equivalence(MPEP 2183)

• The examiner should ask the following questions
• (1) does the prior art element perform the
  function specified in the claim?
• (2) does any explicit definition provided in the
  specification exclude the prior art element as
  an equivalent?
• (3) is the prior art element an equivalent of
  the means-(or step) plus function limitation?

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Prior Art Analysis Factors Supporting a Prima
Facie Case of Equivalence (MPEP 2183)

• (A) The prior art element performs (or is
  capable of performing) the identical function in
  substantially the same way and produces
  substantially same result, or
• (B) Art Recognized Interchangeability, or
• (C) Insubstantial Differences between the prior
  art element and corresponding element shown in
  the specification, or
• (D) The prior art element is a structural
  equivalent Only one of the above noted factors
  need exist to support a finding of equivalence.
  Further, these examples are not an exhaustive
  list, see MPEP 2184 (II).
• The examiner should ensure that the record is
  clear why the prior art element, or step, is an
  equivalent.
• see, e.g. RCA Corp. v. Applied Digital Data
  Systems, Inc. at 221 USPQ 385, 388 (Fed. Cir.
  1984)

21
Prior Art Analysis Examiners Office Action

• If the examiner determines that the prior art
  element is equivalent to the structure, material,
  or acts described in the applicants
  specification, the examiner should conclude that
  the prior art anticipates the means-(or step-)
  plus-function limitation.
• Examiners should also make a 35 U.S.C. 103
  rejection where appropriate.
• Applicant then has the burden of proving
  nonequivalence.

22
Applicants Burden of Proving nonequivalence
after a prima facie case is made (MPEP 2184)

• Evidence of nonequivalence include
• Teachings in the specification that show that
  particular prior art is not equivalent
• Teachings in the prior art itself that may tend
  to show nonequivalence or
• - Evidence of facts provided in 37 CFR 1.132
  affidavits showing nonequivalence.

23
Applicants Burden of Proving nonequivalence
after a prima facie case is made (cont.)

• Re-consider the factors which are used to
  establish a prima facie case of equivalence.
• Mere allegations of non-equivalence in
  applicants response are not sufficient.
• MPEP 2184(III) ..However, under no
  circumstance should an examiner accept as
  persuasive a bare statement or opinion that the
  element shown in the prior art is not an
  equivalent embraced by the claim limitation.
  Moreover, if an applicant argues that the "means"
  or "step" plus function language in a claim is
  limited to certain specific structural or
  additional functional characteristics (as opposed
  to "equivalents" thereof) where the specification
  does not describe the invention as being only
  those specific characteristics, the claim should
  not be allowed until the claim is amended to
  recite those specific structural or additional
  functional characteristics

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New Appeal Brief Criteria 35 U.S.C. 112, Sixth
Paragraph

• Appeal Brief must contain the following items
  (see 37 CFR 41.37(c)(1)(v))
• (Effective Date September 13, 2004)
• V. Summary of claimed subject matter (replacing
  summary of invention)
• A concise explanation of the subject matter
  defined in each of the independent claims
  involved in the appeal,
• Must refer to the specification by page and line
  number, and to the drawing, if any, by reference
  characters.
• For each independent claim involved in the appeal
  and for each dependent claim argued separately
• Every means plus function and step plus function
  must be identified, and
• The structure, material, or acts described in the
  specification as corresponding to each claimed
  function must be set forth with reference to the
  specification by page and line number, and to the
  drawing, if any, by reference characters.
• See MPEP 1205, 1205.02

25

• Examples

26
Example 1

• Claim 1
• A kit for screening a gene-specific drug
  therapy, the kit comprising
• a means for detecting a mutation in a gene.
• Claim 2
• A kit for screening a gene-specific drug
  therapy, the kit comprising
• a means for detecting a mutation in a gene,
  wherein the means for detecting comprises,
  mutation-specific primers and probes.

27
Three prong analysis of Example 1 (Claim 1 A
kit for screening a gene-specific drug therapy,
the kit comprising a means for detecting a
mutation in a gene.)

• 1- Does the claim recite the required means for
  ? Yes
• 2- Is there a link between the means for and a
  function? Yes
• 3- Is the means for NOT modified by sufficient
  structure, material or acts? Yes.
• Conclusion 35 U.S.C. 112, Sixth Paragraph is
  invoked for claim 1.

28
Three prong analysis of Example 1 (Claim 2 A
kit for screening a gene-specific drug therapy,
the kit comprising a means for detecting a
mutation in a gene, wherein the means for
detecting comprises, mutation-specific primers
and probes.)

• 1- Does the claim recite the required means for
  ? Yes
• 2- Is there a link between the means for and a
  function? Yes
• 3- Is the means for NOT modified by sufficient
  structure, material or acts? No.
• Conclusion 35 U.S.C.112, Sixth Paragraph is not
  invoked for claim 2.

29
Description in the Specification (Example 1)

• The specification provides general description
  for a kit for screening gene sequences. The
  specification also provides a general description
  of primers and probes in screening of gene
  sequences. A general description of relationship
  between mutations and diseases is also provided.
  No specific genes are set forth. No specific
  gene sequence-specific probes and primers are
  disclosed. No guidance is provided regarding
  which mutations would reasonably be correlated to
  disease. One skilled in the art would not have
  known what structure or material performs the
  function recited in the claim.

30
Do the claims in Example 1 meet 35 U.S.C. 112,
First and Second Paragraph requirements?
Claim 1 A kit for screening a gene-specific
drug therapy, the kit comprising a means for
detecting a mutation in a gene. Claim 2 A kit
for screening a gene-specific drug therapy, the
kit comprising a means for detecting a mutation
in a gene, wherein the means for detecting
comprises, mutation-specific primers and probes.
31
Do claims 1 and 2 meet 35 U.S.C. 112, First and
Second Paragraph requirements?(cont.)

• Does the specification define structure
  corresponding to the claimed means for
  detecting? No
• Would one skilled in the art have known what
  structure performs the function recited in the
  claims? No
• Note-This is a "single means" claim and would
  likely also be rejected as nonenabled (See MPEP
  2181(V) and 2164.08(a)).
• Conclusion
• 1- The claims do not meet 35 U.S.C. 112, First
  Paragraph requirements.
• 2- The claims also do not meet 35 U.S.C. 112,
  Second Paragraph requirements.

32
Analysis of Prior Art

• Claim 1
• A kit for screening a gene-specific drug
  therapy, the kit comprising
• a means for detecting a mutation in a gene.
• Claim 2
• A kit for screening a gene-specific drug
  therapy, the kit comprising
• a means for detecting a mutation in a gene,
  wherein the means for detecting comprises,
  mutation-specific primers and probes.

33
Analysis of Prior Art (cont.)

• A reference teaching a relationship between a
  drug and a mutation in a gene sequence and
  describing primers that can be used to detect the
  gene or parts of the gene will anticipate the
  claim(s).

34
Examiners Office Action

• The examiner will acknowledge and explain that
  35 U.S.C. 112, Sixth Paragraph has been invoked
  for claim 1, but not for claim 2.
• The examiner will also explain why the claims do
  not meet the requirements under 35 U.S.C. 112,
  First and Second Paragraphs.

35
Examiners Office Action (cont.)

• The examiner will explain how the prior art
  cited anticipates the claimed limitations
  examined under 35 U.S.C. 112, Sixth Paragraph.

36
Example 2

• Claim 1 An apparatus comprising
• - a first means for heating a sample and
• - a second means for holding the sample.
• Claim 2 An apparatus comprising
• - a first means for heating a sample and
• - a second means for holding the sample,
• wherein said second means has a conical bottom.

37
Three Prong Analysis of the Claims in Example 2

• 1- Do the claims recite means for? Yes
• 2- Is there a link between the means for and a
  function? Yes
• 3- Is the means for NOT modified by sufficient
  structure, material or acts Claim 1-Yes Claim
  2-first means for- yes second means for-No.
• Conclusion 35 U.S.C. 112, Sixth Paragraph is
  invoked for Claim 1 and first means for of
  claim 2, but not for second means for of Claim
  2.

38
Description in the Specification

• The specification defines the first means for
  as an electrical heater wire and the second
  means for as a chamber block that holds
  reaction tubes. The specification describes that
  reaction tubes can be of different sizes. The
  specification also describes that the chamber
  block could have holes/recesses with different
  shape bottoms, including a conical bottom, to
  hold tubes with different shape bottoms.

39
Examiners Office Action

• The examiner will acknowledge that 35 U.S.C. 112,
  Sixth Paragraph has been invoked for claim 1 and
  the first means for limitation in claim 2.
• The examiner will also explain how 35 U.S.C. 112,
  Sixth Paragraph has not been invoked for the
  second means for limitation in claim 2 (since
  it fails to meet the third prong).

40
Examiners Office Action (cont.)

• The examiner will also explain how the cited
  prior art anticipates the claimed means.

41
Example 3

• Claim 1 A method for determining
  anti-inflammatory response comprising
• a system for measuring an anti-inflammatory
  response in a sample before and after treatment
  and,
• comparing the measurements.
• (Note A "system" can be a method or an
  apparatus, thus this claim may be indefinite.)

42
Three Prong Analysis of the Claim in Example 3

• 1- Does the claim recite means for or step
  for? No
• 2- Is there a link between the means for and a
  function? Yes
• 3- Is the means for NOT modified by sufficient
  structure, material or acts? Yes.
• Conclusion 35 U.S.C. 112, Sixth Paragraph is not
  invoked.

43
Example 3 (cont.)

• In the first office action on merits, the
  examiner will not consider the claim under 35
  U.S.C. 112, Sixth Paragraph.
• If applicant wishes to have the claim limitation
  treated under 35 U.S.C. 112 Sixth Paragraph,
  applicant must either(1) amend the claim to
  include the phrase means for or step for
  or(2) show that the claim limitation is written
  as a function to be performed and does not
  provide sufficient structure, material, or acts
  which would preclude application of 35 U.S.C.
  112, Sixth Paragraph.

44
Thank you

• Ram Shukla
• 571-272-0735
• ram.shukla_at_uspto.gov

• Acknowledgement
• Betty Forman, Ph.D.
• Primary Examiner, AU 1634