data/2100/s2103.html.txt

[
# 2103 Patent Examination Process [R-10.2019]

**I.** **DETERMINE WHAT INVENTION IS SOUGHT TO BE PATENTED**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, examiners 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, examiners and patent reexamination specialists should
 indicate how rejections may be overcome and how problems may be resolved. Where a
 rejection not based on prior art is proper (lack of adequate written description,
 enablement, or utility, etc.) such rejection should be stated with a full development of
 the reasons rather than by a mere conclusion. A failure to follow this approach can lead
 to unnecessary delays in the prosecution of the application.
 


The examination of reissue applications is covered in
 **[MPEP Chapter
 1400](mpep-1400.html#d0e134581)**, reexamination proceedings are covered in
 **[MPEP Chapters
 2200](mpep-2200.html#d0e220689)** (*ex parte*) and **[2600](mpep-2600.html#d0e249708)** (*inter
 partes*), and supplemental examination is covered in **[MPEP Chapter
 2800](mpep-2800.html#ch2800_d1fea8_279ab_9)**. 
 


Prior to focusing on specific statutory requirements,
 examiners must begin examination by determining what, precisely, the inventor or joint
 inventor has invented and is seeking to patent, and how the claims relate to and define
 that invention. Examiners 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)).
 


Examiners 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). Note that the
 concept of a "practical application" in the evaluation of utility is different from
 the concept of whether a judicial exception is integrated into a "practical
 application" in the evaluation of subject matter eligibility. 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 §
 2106](s2106.html#d0e197244)** for subject matter eligibility guidelines and
 **[MPEP §
 2107](s2107.html#d0e198469)** 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, examiners 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.
 Examiners 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."). 
 


Examiners 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. 
 


Examiners should then 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
 examiners correctly interpret each claim limitation in light of the specification. 
 


The subject matter of a properly construed claim is
 defined by the terms that limit the scope of the claim when given their broadest
 reasonable interpretation. It is this subject matter that must be examined. As a
 general matter, grammar and the plain meaning of terms as understood by one having
 ordinary skill in the art used in a claim will dictate whether, and to what extent,
 the language limits the claim scope. See **[MPEP § 2111.01](s2111.html#d0e200409)** for more information
 on the plain meaning of claim language. Language that suggests or makes a feature or
 step optional but does not require that feature or step does not limit the scope of a
 claim under the broadest reasonable claim interpretation. The following types of
 claim language may raise a question as to its limiting effect:
 


* (A) statements of intended use or field of use,
 including statements of purpose or intended use in the preamble,
* (B) "adapted to" or "adapted for" clauses,
* (C) "wherein" or "whereby" clauses,
* (D) contingent limitations,
* (E) printed matter, or
* (F) terms with associated functional
 language.


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,*
 285 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"). For more information about these types of claim language and
 how to determine whether they have a limiting effect on claim scope, see
 **[MPEP §§
 2111.02](s2111.html#d0e200689)** through **[2111.05](s2111.html#ch2100_d1b148_1ea0c_2c0)**.
 


 Examiners are to give claims their broadest
 reasonable interpretation in light of the supporting disclosure. See
 **[MPEP §
 2111](s2111.html#d0e200352)**. Disclosure may be express, implicit, or inherent.
 Examiners are to give claimed means- (or step-) plus- function limitations their
 broadest reasonable interpretation consistent with all corresponding structures (or
 materials or acts) described in the specification and their equivalents. See
 *In re Aoyama,* 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed.
 Cir. 2011). Further guidance in interpreting the scope of equivalents is provided in
 **[MPEP §§
 2181](s2181.html#d0e219279)** through  **[2186](s2186.html#d0e220631)**. 
 


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. See **[MPEP §
 2111.01](s2111.html#d0e200409)**, subsection II. As explained in
 **[MPEP §
 2111](s2111.html#d0e200352)**, giving a claim its broadest reasonable interpretation
 during prosecution will reduce the possibility that the claim, when issued, will be
 interpreted more broadly than is justified.
 


Finally, when evaluating the scope of a claim, every
 limitation in the claim must be considered. Examiners 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](mpep-9015-appx-l.html#d0e302376)**, 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 for
 patentability, examiners are expected to conduct a thorough search of the prior art. See
 **[MPEP §§
 904](s904.html#d0e115569)** through  **[904.03](s904.html#d0e115840)** for more information about how
 to conduct a search. In many cases, the result of such a search will contribute to
 examiners 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)](mpep-9015-appx-l.html#al_d1d85b_2ae7b_ec)** and
 **[MPEP §
 2181](s2181.html#d0e219279)** through **[MPEP § 2186](s2186.html#d0e220631)**.
 

**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](mpep-9015-appx-l.html#d0e302376)** 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](mpep-9015-appx-l.html#d0e302376)** has been interpreted as imposing four requirements: (i)
 only one patent may be obtained for an invention; (ii) the inventor(s) must be
 identified in an application filed on or after September 16, 2012 or must be the
 applicant in applications filed before September 16, 2012; (iii) the claimed
 invention must be eligible for patenting; and, (iv) the claimed invention must be
 useful (have utility). 
 


See **[MPEP §
 2104](s2104.html#ch2100_d1b13f_1b012_1f4)** for a discussion of the four requirements,
 **[MPEP §
 2106](s2106.html#d0e197244)** for a discussion of eligibility, and
 **[MPEP §
 2107](s2107.html#d0e198469)** for the utility examination guidelines.
 


The patent eligibility inquiry under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**
 is a threshold inquiry. Even if a claimed invention qualifies as eligible subject
 matter under **[35
 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**, it must also satisfy the other conditions and
 requirements of the patent laws, including the requirements for novelty
 (**[35 U.S.C.
 102](mpep-9015-appx-l.html#d0e302383)**), nonobviousness (**[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**), and adequate
 description and definite claiming (**[35 U.S.C. 112](mpep-9015-appx-l.html#d0e302824)**). *Bilski
 v. Kappos,* 561 U.S. 593, 602, 95 USPQ2d 1001, 1006 (2010). Therefore,
 examiners should avoid focusing on only issues of patent-eligibility under
 **[35 U.S.C.
 101](mpep-9015-appx-l.html#d0e302376)** to the detriment of considering an application for
 compliance with the requirements of **[35 U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**, **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**,
 and **[35 U.S.C.
 112](mpep-9015-appx-l.html#d0e302824)**, and should avoid treating an application solely on the
 basis of patent-eligibility under **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)** except in the most
 extreme cases. 
 

**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)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** contains two separate and distinct requirements: (A)
 that the claim(s) set forth the subject matter the inventor or a joint inventor
 regards 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)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** when evidence
 outside the application as filed, e.g., admissions, shows that the inventor or a
 joint inventor regards the invention to be different from what is claimed (see
 **[MPEP §
 2171](s2171.html#d0e217389)** - **[MPEP § 2172.01](s2172.html#d0e217526)**). 
 


An application fails to comply with the second
 requirement of **[35 U.S.C. 112(b)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** 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 limitation that invokes
 **[35
 U.S.C. 112(f)](mpep-9015-appx-l.html#al_d1d85b_2ae7b_ec)** is defined as the corresponding structure or
 material set forth by the inventor in the written description and equivalents thereof
 that perform the claimed function. See **[MPEP § 2181](s2181.html#d0e219279)** through
 **[MPEP §
 2186](s2186.html#d0e220631)**. See **[MPEP § 2173](s2173.html#d0e217564)***et seq.* for a discussion of a variety of issues pertaining to the
 **[35
 U.S.C. 112(b)](mpep-9015-appx-l.html#al_d1d85b_2ae65_215)** 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)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)** contains 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](s2163.html#d0e213583)** 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 routinely engages in such
 experimentation. 
 


See **[MPEP § 2164](s2164.html#d0e215224)***et seq.* for detailed guidance with regard to the enablement
 requirement of **[35 U.S.C. 112(a)](mpep-9015-appx-l.html#al_d1d85b_2ae60_3d5)**.
 

**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 in such a manner that a
 person of ordinary skill in the art could practice the best mode.


See **[MPEP § 2165](s2165.html#d0e216924)***et 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 1801, 1804-05 (Fed. Cir.
 1997). 
 

**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](mpep-9015-appx-l.html#d0e302383)** and **[35 U.S.C.103](mpep-9015-appx-l.html#d0e302450)** begins with a
 comparison of the claimed subject matter to what is known in the prior art. See
 **[MPEP §§
 2131](s2131.html#d0e202959)** -  **[2146](s2146.html#d0e213206)** and **[MPEP §§
 2150](s2150.html#ch2100_d2002f_22805_16e)** - **[2159](s2159.html#ch2100_d20034_1dc34_1dd)** for specific guidance on
 patentability determinations under **[35 U.S.C. 102](mpep-9015-appx-l.html#d0e302383)** and **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**. 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](mpep-9015-appx-l.html#d0e302383)**. 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 to one of ordinary skill in
 the art. If not, the claimed invention satisfies **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**.
 

**VI.** **CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS AND THEIR BASES**Once examiners have completed the above analyses of the
 claimed invention under all the statutory provisions, including **[35 U.S.C. 101](mpep-9015-appx-l.html#d0e302376)**,
 **[35 U.S.C.
 112](mpep-9015-appx-l.html#d0e302824)**, **[35 U.S.C. 102](mpep-9015-appx-l.html#d0e302383)**, and **[35 U.S.C. 103](mpep-9015-appx-l.html#d0e302450)**,
 they should review all the proposed rejections and their bases to confirm that a
 *prima facie* case of unpatentability exists. 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.
 


EXAMINERS SHOULD USE THE APPLICABLE FORM PARAGRAPHS IN
 OFFICE ACTIONS TO STATE THE BASIS FOR ANY OBJECTIONS OR REJECTIONS TO REDUCE THE CHANCE
 OF A MISUNDERSTANDING AS TO THE GROUNDS OF OBJECTION OR REJECTION. 
 


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