This section covers rejections under pre-AIA 35 U.S.C. 103(a) using prior art under only pre-AIA 35 U.S.C. 102(e), (f), or (g). Pre-AIA 35 U.S.C. 103(c) applies only to consideration of prior art for purposes of obviousness under 35 U.S.C. 103. This section also discusses the subject matter that is disqualified as prior art under pre-AIA 35 U.S.C. 103(c) in applications filed prior to November 29, 1999, and granted as patents prior to December 10, 2004.

• Review Ed9 10.2019: 706.02(l)

This section covers how new matter filed in an application will lead to a rejection.

• Review Ed9 10.2019: 706.03(o)

This section covers what happens when an amendment contains a minor deficiency and is not fully responsive.

• Review Ed9 10.2019: 714.03

Affidavits or declarations, when timely presented, containing evidence of criticality or unexpected results, commercial success, long-felt but unsolved needs, failure of others, skepticism of experts, etc., must be considered by the examiner in determining the issue of obviousness of claims for patentability under 35 U.S.C. 103.

• Review Ed9 10.2019: 716.01(a)

This section discusses the probative value of objective evidence. To be of probative value, any objective evidence should be supported by actual proof. Attorney arguments cannot take the place of evidence. This section also discusses opinion evidence.

• Review Ed9 10.2019: 716.01(c)

This section discusses the criteria that commercial success must be derived from the claimed invention. The commercial success must flow from the functions and advantages disclosed or inherent in the specification description.

Establishing a nexus between commercial success and the claimed invention is especially difficult in design cases.

Lastly this section briefly touches upon the criteria that sales figures must be adequately defined.

• Review Ed9 10.2019: 716.03(b)

This section covers the long-felt need and failure of others. The claimed invention must satisfy a long-felt need which was recognized, was persistent, and was not solved by others. The long-felt need is measured from the date a problem is identified and efforts are made to solve it. Other factors contributing to the presence of a long-felt need must be considered.

• Review Ed9 10.2019: 716.04

Another form of secondary evidence which may be presented by applicants during prosecution of an application, but which is more often presented during litigation, is evidence that competitors in the marketplace are copying the invention instead of using the prior art. However, more than the mere fact of copying is necessary to make that action significant because copying may be attributable to other factors such as a lack of concern for patent property or contempt for the patentee's ability to enforce the patent.

• Review Ed9 10.2019: 716.06

Under certain circumstances an affidavit or declaration may be submitted which attempts to attribute an activity, a reference or part of a reference to the applicant to overcome a rejection based on pre-AIA 35 U.S.C. 102 prior art. If successful, the activity or the reference is no longer applicable. This section covers attribution affidavit or declaration to overcome a rejection under pre-AIA 35 U.S.C. 102 or 103. It also provides examples.

• Review Ed9 10.2019: 716.10

This section covers living subject matter, providing examples of what can be and cannot be patentable. For example, new minerals discovered in the earth are not patentable, but microorganisms produced by genetic engineering can be patented. In addition, it gives specifics on how no patent may issue on a claim directed to or encompassing a human organism, which was added in the America Invents Act (AIA).

• Review Ed9 10.2019: 2105

Useful inventions have a practical utility or specific utility without having to pursue further research to identify or reasonably confirm it. An applicant must identify why an invention is useful (unless it has a well-established utility), otherwise the claimed invention will be deficient under 35 U.S.C. 101 and 35 U.S.C. 112 first paragraph.

• Review Ed9 10.2019: 2107.01

Any evidence of a pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. This section covers special considerations for asserted therapeutic or pharmacological utilities.

• Review Ed9 10.2019: 2107.03

The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. This section covers the burden of proof for a rejection based on inherency.

This includes that something old does not become patentable upon the discovery of a new property. In addition, the inherent feature need not be recognized at the time of the invention. In addition there is a brief discussion how a rejection under 35 U.S.C. 102/103 can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. Finally, this section states that the examiner must provide rationale or evidence tending to show inherency.

• Review Ed9 10.2019: 2112

This section covers composition, product, and apparatus claims. For product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. For composition claims, if the composition is physically the same, it must have the same properties. For product claims, nonfunctional printed matter does not distinguish claimed product from otherwise identical prior art product.

• Review Ed9 10.2019: 2112.01

This section covers anticipation regarding 35 U.S.C. 102. Essentially, to anticipate a claim, the disclosure must teach every element of the claim.

• Review Ed9 10.2019: 2131

Normally, only one reference should be used in making a rejection under 35 U.S.C. 102.

However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:

• Prove the primary reference contains an “enabled disclosure;”
• Explain the meaning of a term used in the primary reference; or
• Show that a characteristic not disclosed in the reference is inherent. This section provides details on these instances.

• Review Ed9 10.2019: 2131.01

This section covers the scope and content of the prior art. Prior art available under 35 U.S.C. 102 is available under 35 U.S.C. 103. The content of the prior art is determined at the time the invention was made to avoid hindsight. This section also discusses the evidence required to show conditions of pre-AIA 35 U.S.C. 103(c) apply.

• Review Ed9 10.2019: 2141.01

This section discusses the differences between prior art and the claimed invention. During the examination the claimed invention as a whole must be considered. Distilling an invention down to the “gist” or “thrust” of an invention disregards the requirement of analyzing the subject matter “as a whole.”

A patentable invention may lie in the discovery of the source of a problem even though the remedy may be obvious once the source of the problem is identified. Applicants who allege they discovered the source of a problem must provide evidence substantiating the allegation, either by way of affidavits or declarations, or by way of a clear and persuasive assertion in the specification.

Obviousness cannot be predicated on what is not known at the time an invention is made, even if the inherency of a certain feature is later established. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention.

• Review Ed9 10.2019: 2141.02

This section provides examples of basic requirements of a prima facie case of obviousness including exemplary rationales.

• Review Ed9 10.2019: 2143

This section discusses supporting a rejection under 35 U.S.C. 103. Office personnel may invoke legal precedent as a source of supporting rationale when warranted and appropriately supported.

Rationale may be in a reference, or reasoned from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent. The expectation of some advantage is the strongest rationale for combining references.

Legal precedent can provide the rationale supporting obviousness only if the facts in the case are sufficiently similar to those in the application. In addition, a rationale different from the applicant's is permissible.

• Review Ed9 10.2019: 2144

“[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.”

• Review Ed9 10.2019: 2144.01

In certain circumstances where appropriate, an examiner may take official notice of facts not in the record or rely on “common knowledge” in making a rejection, however such rejections should be judiciously applied. This section covers the procedure for relying on common knowledge or taking official notice.

• Review Ed9 10.2019: 2144.03

This section covers obviousness of ranges. It includes a discussion on instances where there is an overlap of ranges, an optimization of ranges, and a rebuttal of prima facie case of obviousness.

• Review Ed9 10.2019: 2144.05

This section covers combining and substituting equivalents known for the same purpose. For example, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious.

• Review Ed9 10.2019: 2144.06

This section discusses consideration of applicant's rebuttal arguments. Rebuttal evidence and arguments can be presented in the specification, by counsel, or by way of an affidavit or declaration under 37 CFR 1.132. The types of evidence that may be used is covered in detail. An argument does not replace evidence where evidence is necessary.

This section also covers making certain types of arguments including arguing against references individually, arguing that prior art devices are not physically combinable, and many more argument types.

• Review Ed9 10.2019: 2145