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2103    Patent Examination Process [R-11.2013]

I.   DETERMINE WHAT APPLICANT HAS INVENTED AND IS SEEKING TO PATENT

It is essential that patent applicants obtain a prompt yet complete examination of their applications. Under the principles of compact prosecution, each claim should be reviewed for compliance with every statutory requirement for patentability in the initial review of the application, even if one or more claims are found to be deficient with respect to some statutory requirement. Thus, USPTO personnel should state all reasons and bases for rejecting claims in the first Office action. Deficiencies should be explained clearly, particularly when they serve as a basis for a rejection. Whenever practicable, USPTO personnel should indicate how rejections may be overcome and how problems may be resolved. A failure to follow this approach can lead to unnecessary delays in the prosecution of the application.

Prior to focusing on specific statutory requirements, USPTO personnel must begin examination by determining what, precisely, the applicant has invented and is seeking to patent, and how the claims relate to and define that invention. USPTO personnel will review the complete specification, including the detailed description of the invention, any specific embodiments that have been disclosed, the claims and any specific, substantial, and credible utilities that have been asserted for the invention.

After obtaining an understanding of what applicant invented, the examiner will conduct a search of the prior art and determine whether the invention as claimed complies with all statutory requirements.

A.   Identify and Understand Any Utility for the Invention

The claimed invention as a whole must be useful. The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world” value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).

USPTO personnel should review the application to identify any asserted utility. The applicant is in the best position to explain why an invention is believed useful. Accordingly, a complete disclosure should contain some indication of the practical application for the claimed invention, i.e., why the applicant believes the claimed invention is useful. Such a statement will usually explain the purpose of the invention or how the invention may be used (e.g., a compound is believed to be useful in the treatment of a particular disorder). Regardless of the form of statement of utility, it must enable one ordinarily skilled in the art to understand why the applicant believes the claimed invention is useful. See MPEP § 2107 for utility examination guidelines. An applicant may assert more than one utility and practical application, but only one is necessary. Alternatively, an applicant may rely on the contemporaneous art to provide that the claimed invention has a well-established utility.

B.   Review the Detailed Disclosure and Specific Embodiments of the Invention To Understand What the Applicant Has Invented

The written description will provide the clearest explanation of the applicant’s invention, by exemplifying the invention, explaining how it relates to the prior art and explaining the relative significance of various features of the invention. Accordingly, USPTO personnel should continue their evaluation by

(A) determining the function of the invention, that is, what the invention does when used as disclosed (e.g., the functionality of a programmed computer); and

(B) determining the features necessary to accomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparing applications that clearly set forth these aspects of an invention.

C.   Review the Claims

The claims define the property rights provided by a patent, and thus require careful scrutiny. The goal of claim analysis is to identify the boundaries of the protection sought by the applicant and to understand how the claims relate to and define what the applicant has indicated is the invention. USPTO personnel must first determine the scope of a claim by thoroughly analyzing the language of the claim before determining if the claim complies with each statutory requirement for patentability. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the claim.”).

USPTO personnel should begin claim analysis by identifying and evaluating each claim limitation. For processes, the claim limitations will define steps or acts to be performed. For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter.

USPTO personnel are to correlate each claim limitation to all portions of the disclosure that describe the claim limitation. This is to be done in all cases, regardless of whether the claimed invention is defined using means- (or step-) plus- function language. The correlation step will ensure that USPTO personnel correctly interpret each claim limitation.

The subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. The following are examples of language that may raise a question as to the limiting effect of the language in a claim:

(A) statements of intended use or field of use,

(B) “adapted to” or “adapted for” clauses,

(C) "wherein" clauses, or

(D) “whereby” clauses.

This list of examples is not intended to be exhaustive. The determination of whether particular language is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). See also MPEP §§ 2111.02 and 2111.04.

USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. See MPEP § 2111. Disclosure may be express, implicit, or inherent. USPTO personnel are to give the claimed means- (or step-) plus- function limitations their broadest reasonable interpretation consistent with all corresponding structures or materials described in the specification and their equivalents including the manner in which the claimed functions are performed. See Kemco Sales, Inc. v. Control Papers Company, Inc., 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. 2000). Further guidance in interpreting the scope of equivalents is provided in MPEP § 2181 through MPEP § 2186.

While it is appropriate to use the specification to determine what applicant intends a term to mean, a positive limitation from the specification cannot be read into a claim that does not itself impose that limitation. A broad interpretation of a claim by USPTO personnel will reduce the possibility that the claim, when issued, will be interpreted more broadly than is justified or intended. An applicant can always amend a claim during prosecution to better reflect the intended scope of the claim.

Finally, when evaluating the scope of a claim, every limitation in the claim must be considered. USPTO personnel may not dissect a claimed invention into discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered. See, e.g., Diamond v. Diehr, 450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) (“In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.”).

II.   CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

Prior to evaluating the claimed invention under 35 U.S.C. 101, USPTO personnel are expected to conduct a thorough search of the prior art. Generally, a thorough search involves reviewing both U.S. and foreign patents and nonpatent literature. In many cases, the result of such a search will contribute to USPTO personnel’s understanding of the invention. Both claimed and unclaimed aspects of the invention described in the specification should be searched if there is a reasonable expectation that the unclaimed aspects may be later claimed. A search must take into account any structure or material described in the specification and its equivalents which correspond to the claimed means- (or step-) plus- function limitation, in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and MPEP § 2181 through MPEP § 2186 .

III.   DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101

A.   Consider the Breadth of 35 U.S.C. 101 Under Controlling Law

Section 101 of title 35, United States Code, provides:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. 101 defines four categories of inventions that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define “things” or “products” while the first category defines “actions” (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) (“The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.”).

The subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention is limited to abstract ideas, laws of nature and physical phenomena. Bilski v. Kappos, 561 U.S. ___, ___, 130 S. Ct. 3218, 3225, 95 USPQ2d 1001, ___ (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)). While this is easily stated, determining whether an applicant is seeking to patent an abstract idea, a law of nature or a physical phenomenon has proven to be challenging. These three exclusions recognize that subject matter that is not a practical application of an idea, a law of nature or a physical phenomenon is not patentable. See, e.g., Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507 (1874) (“idea of itself is not patentable, but a new device by which it may be made practically useful is”); Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86, 94, 40 USPQ 199, 202 (1939) (“While a scientific truth, or the mathematical expression of it, is not patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.”).

The courts have also held that a claim may not preempt abstract ideas, laws of nature or physical phenomena; i.e., one may not patent every “substantial practical application” of an abstract idea, law of nature or physical phenomenon. This is because such a patent would “in practical effect be a patent on the [abstract idea, law of nature or physical phenomenon] itself.” Gottschalk v. Benson, 409 U.S. 63, 71-72, 175 USPQ 673, 676 (1972). The concern over preemption was expressed as early as 1852. See Le Roy v. Tatham, 55 U.S. 156, 175 (1852) (“A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.”).

The Supreme Court in Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), underscored that the text of 35 U.S.C. 101 is expansive, specifying four independent categories of inventions eligible for protection, including processes, machines, manufactures, and compositions of matter. As stated by the Court, "[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.") (quoting Diamond v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, 197 (1980)). The Court also made clear that business methods are not "categorically outside of § 101’s scope," stating that "a business method is simply one kind of ‘method’ that is, at least in some circumstances, eligible for patenting under § 101." Examiners are reminded that 35 U.S.C. 101 is not the sole tool for determining patentability; where a claim encompasses an abstract idea, 35 U.S.C. 112 , 35 U.S.C. 102 , and 35 U.S.C. 103 will provide additional tools for ensuring that the claim meets the conditions for patentability. As the Court made clear in Bilski:

The § 101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy ‘‘the conditions and requirements of this title.’’ § 101. Those requirements include that the invention be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112.

Therefore, examiners should avoid focusing on issues of patent-eligibility under 35 U.S.C. 101 to the detriment of considering an application for compliance with the requirements of 35 U.S.C. 112, 35 U.S.C. 102, and 35 U.S.C. 103, and should avoid treating an application solely on the basis of patent-eligibility under 35 U.S.C. 101 except in the most extreme cases.

See MPEP § 2106 for determining whether a claim is directed to patent-eligible subject matter, and MPEP § 2106.01 for further guidance regarding subject matter eligibility determinations during examination of process claims that involve laws of nature/natural correlations. Additionally, a claimed invention must be useful or have a utility that is specific, substantial and credible.

See MPEP § 2107 for a detailed discussion of the utility requirement.

IV.   EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

A.   Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph Requirements

35 U.S.C. 112(b) and the second paragraph of pre-AIA 35 U.S.C. 112 contains two separate and distinct requirements: (A) that the claim(s) set forth the subject matter applicants regard as the invention, and (B) that the claim(s) particularly point out and distinctly claim the invention. An application will be deficient under the first requirement of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph when evidence including admissions, other than in the application as filed, shows that an applicant has stated what he or she regards the invention to be different from what is claimed (see MPEP § 2171 - MPEP § 2172.01).

An application fails to comply with the second requirement of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph when the claims do not set out and define the invention with a reasonable degree of precision and particularity. In this regard, the definiteness of the language must be analyzed, not in a vacuum, but always in light of the teachings of the disclosure as it would be interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in light of the disclosure, must reasonably apprise a person of ordinary skill in the art of the invention.

The scope of a “means” limitation is defined as the corresponding structure or material set forth in the written description and equivalents thereof. See MPEP § 2181 through MPEP § 2186. See MPEP § 2173et seq. for a discussion of a variety of issues pertaining to the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph requirement that the claims particularly point out and distinctly claim the invention.

B.   Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(a) or 35 U.S.C. 112, First Paragraph Requirements

35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 contain three separate and distinct requirements:

(A) adequate written description,

(B) enablement, and

(C) best mode.

1.   Adequate Written Description

For the written description requirement, an applicant’s specification must reasonably convey to those skilled in the art that the applicant was in possession of the claimed invention as of the date of invention. See MPEP § 2163 for further guidance with respect to the evaluation of a patent application for compliance with the written description requirement.

2.   Enabling Disclosure

An applicant’s specification must enable a person skilled in the art to make and use the claimed invention without undue experimentation. The fact that experimentation is complex, however, will not make it undue if a person of skill in the art typically engages in such complex experimentation.

See MPEP § 2164et seq. for detailed guidance with regard to the enablement requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.

3.   Best Mode

Determining compliance with the best mode requirement requires a two-prong inquiry:

(1) at the time the application was filed, did the inventor possess a best mode for practicing the invention; and

(2) if the inventor did possess a best mode, does the written description disclose the best mode such that a person skilled in the art could practice it.

See MPEP § 2165et seq. for additional guidance. Deficiencies related to disclosure of the best mode for carrying out the claimed invention are not usually encountered during examination of an application because evidence to support such a deficiency is seldom in the record. Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1548-49, 41 USPQ2d at 1804-05.

V.   DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102 AND 103

Reviewing a claimed invention for compliance with 35 U.S.C. 102 and 35 U.S.C.103 begins with a comparison of the claimed subject matter to what is known in the prior art. See MPEP § 2131 - MPEP § 2146 and for specific guidance on patentability determinations under 35 U.S.C. 102 and 35 U.S.C. 103. If no differences are found between the claimed invention and the prior art, then the claimed invention lacks novelty and is to be rejected by USPTO personnel under 35 U.S.C. 102. Once differences are identified between the claimed invention and the prior art, those differences must be assessed and resolved in light of the knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one must determine whether the invention would have been obvious. If not, the claimed invention satisfies 35 U.S.C. 103.

VI.   CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS AND THEIR BASES

Once USPTO personnel have concluded the above analyses of the claimed invention under all the statutory provisions, including 35 U.S.C. 101, 35 U.S.C. 112, 35 U.S.C. 102, and 35 U.S.C. 103, they should review all the proposed rejections and their bases to confirm that they are able to set forth a prima facie case of unpatentability. Only then should any rejection be imposed in an Office action. The Office action should clearly communicate the findings, conclusions and reasons which support them.

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Last Modified: 03/27/2014 10:10:33