Question 1

How should an applicant respond to a rejection based on questioned test results?

Accepted Answer

When an applicant faces a rejection based on questioned test results, they have several options for response. According to MPEP 707.07(l):

The applicant must reply to the rejection, for example, by providing the results of an actual test or example which has been conducted, or by providing relevant arguments that there is strong reason to believe that the result would be as predicted.

The applicant can:

Provide additional test results or examples to support their claims
Present arguments explaining why the original results should be considered valid
Offer evidence that strongly suggests the predicted results would occur

It's crucial that any new information provided does not introduce new matter into the application, as this could lead to further rejections.

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Question 2

What action should a patent examiner take if they question test results in a patent application?

russ.krajec@blueironip.com · Accepted Answer

If a patent examiner questions the test results in a patent application, they should reject the relevant claims based on insufficient disclosure. The MPEP 707.07(l) provides clear guidance:

If the examiner questions the results, the appropriate claims should be rejected as being based on an insufficient disclosure under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112.

This rejection is based on the written description and enablement requirements of 35 U.S.C. 112. The examiner should provide a clear explanation of why they believe the disclosure is insufficient to support the claimed invention.

To learn more:

35 U.S.C. 112

Question 3

What are the written description and enablement requirements related to test results in patent applications?

russ.krajec@blueironip.com · Accepted Answer

The written description and enablement requirements are crucial when considering test results in patent applications. The MPEP 707.07(l) references these requirements:

See MPEP §§ 2161 - 2164.08(c) for a discussion of the written description and enablement requirements of 35 U.S.C 112.

These requirements, found in 35 U.S.C. 112(a), mandate that the patent application must:

Written Description: Clearly describe the invention in sufficient detail that one skilled in the art can recognize that the inventor had possession of the claimed invention.
Enablement: Provide enough information for a person skilled in the art to make and use the invention without undue experimentation.

Test results play a crucial role in meeting these requirements, as they can demonstrate that the invention works as claimed and provide guidance on how to make and use it.

To learn more:

35 U.S.C. 112

Question 4

What is the relationship between questioned test results and operability or utility rejections?

Accepted Answer

When test results in a patent application are questioned, it may raise concerns about the operability or utility of the invention. The MPEP 707.07(l) addresses this connection:

If questions are present as to operability or utility, consideration should be given to the applicability of a rejection under 35 U.S.C. 101. See MPEP § 2107 et seq.

This means that if doubts about test results lead to concerns about whether the invention actually works (operability) or has a useful purpose (utility), the examiner should consider rejecting the application under 35 U.S.C. 101. This statute requires inventions to be useful and operable to be patentable. Examiners should refer to MPEP § 2107 for guidance on utility rejections.

To learn more:

35 U.S.C. 101

Question 5

What is the 'critical element test' for unexpected results in patent applications?

Accepted Answer

The 'critical element test' is an important consideration when evaluating whether unexpected results are commensurate in scope with the claimed invention. MPEP 716.02(d) states:

To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.

This test involves:

Identifying the critical element or range in the claims
Providing data that demonstrates unexpected results within the claimed range
Showing that the results are significantly different outside the claimed range

If the applicant can demonstrate that the claimed range or element is critical to achieving unexpected results, it can help establish that the results are commensurate in scope with the claims.

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Question 6

What file formats are acceptable for submitting biological sequence listings?

Accepted Answer

The acceptable file formats for submitting biological sequence listings in patent applications are:

ASCII text files
PDF files (for submissions up to 100MB)

MPEP 608.05(c) states: "Sequence listings may be submitted in electronic form via EFS-Web or PatentCenter as ASCII text files or PDF files up to 100 megabytes."

It's important to note that ASCII text format is preferred and required for larger submissions. PDF format is acceptable only for smaller submissions up to 100MB. When submitting on read-only optical discs for files over 100MB, the sequence listing must be in ASCII text format.

Ensure that the sequence listing complies with the requirements set forth in 37 CFR 1.821-1.825 regardless of the file format used.

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How should an applicant respond to a rejection based on questioned test results?

What action should a patent examiner take if they question test results in a patent application?

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What are the written description and enablement requirements related to test results in patent applications?

What is the relationship between questioned test results and operability or utility rejections?

What is the ‘critical element test’ for unexpected results in patent applications?

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What file formats are acceptable for submitting biological sequence listings?