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Examination Instructions and Guidelines Referenced Items (228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248)
(248)                  Guidance on Treatment of Product
                 and Process Claims in light of In re Ochiai,
                      In re Brouwer and 35 U.S.C. 103(b)

   The purpose of this Notice is to provide guidance to Patent and
Trademark Office personnel and to the public on the proper consideration
of certain claims in light of In re Ochiai, 71 F. 3d 1565, 37 USPQ2d
1127 (Fed. Cir. 1995) and In re Brouwer, ** F.3d **, 37 USPQ2d 1663
(Fed. Cir. 1996) and the passage of 35 U.S.C. § 103(b), which became
effective November 1, 1995. Ochiai, Brouwer and § 103(b) relate to how
process claims directed to making or using nonobvious products are to be
   The Court in Ochiai and Brouwer addressed the issue of whether an
otherwise conventional process could be patented if it were limited to
making or using a nonobvious product. In both cases, the Federal Circuit
held that the use of per se rules is improper in applying the test for
obviousness under the 35 U.S.C. § 103. Rather, § 103 requires a highly
fact-dependent analysis involving taking the claimed subject matter as a
whole and comparing it to the prior art. To support a rejection under
103, the collective teachings of the prior art must have suggested to
one of ordinary skill in the art that, at the time the invention was
made, applicant's claimed invention would have been obvious. In applying
this test to the claims on appeal, the Court held that there simply was
no suggestion or motivation in the prior art to make or use the
nonobvious products to which the claims were limited and consequently
overturned the rejections based upon § 103.
   Interpreting a claimed invention as a whole requires consideration of
all claim limitations. Thus, language in a process claim which recites
making or using a nonobvious product must be treated as a material
limitation, and a motivation to make or use the nonobvious product must
be present in the prior art for a § 103 rejection to be sustained.
   In light of Ochiai and Brouwer, Office personnel will consider all
claim limitations when analyzing process claims which make or use
nonobvious products under § 103. Office personnel will focus on
treating claims as a whole and follow the analysis set forth in Graham
v. John Deere, 383 U.S. 1, 148 USPQ 459 (1966).
   Accordingly, to facilitate examination under § 103, where product
and process claims are presented in the same application, applicant may
be called upon under 35 U.S.C.    121 to elect claims to either the
product or process. The claims to the non-elected invention will be
withdrawn from further consideration. However, in the case of an elected
product claim, rejoinder will be permitted when a product claim is found
allowable and the withdrawn process claim depends from or otherwise
includes all the limitations of an allowed product claim. Withdrawn
process claims not commensurate in scope with an allowed product claim
will not be rejoined. In the event of rejoinder, the rejoined process
claims will be fully examined for patentability in accordance with 37
CFR 1.104 - 1.106. If the application containing the rejoined claims is
not in condition for allowance, the subsequent Office action may be made
final, or, if the application was already under final rejection, the
next Office action may be an advisory action.
   35 U.S.C. § 103(b) is applicable to biotechnological processes only.
Section 103(b) precludes a rejection of process claims which involve the
use or making of certain nonobvious biotechnological compositions of
matter under § 103(a). Section 103(b) requires that:

   1. the biotechnological process and composition of matter be contained
in either the same application or in separate applications having the
same effective filing date;

   2. both the biotechnological process and composition of matter be owned
or subject to an assignment to the same person at the time the process
was invented;

   3. a patent issued on the process also contain the claims to the
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composition of matter used in or made by the process, or, if the process
and composition of matter are in different patents, the patents expire
on the same date;

   4. the biotechnological process falls within the definition set forth
in § 103(b); and

   5. a timely election be made to proceed under the provisions of

   In view of the Federal Circuit's decisions in Ochiai and Brouwer, an
applicant's need to rely upon § 103(b) should be rare. Consequently,
the Patent and Trademark Office will treat § 103(b) elections on a
case-by-case basis by way of petition under 37 CFR 1.182. That petition
must establish that all the requirements set forth in § 103(b) have
been satisfied. An election will normally be considered timely if it is
made no later than the earlier of either (1) the payment of the issue
fee, or (2) the filing of an appeal brief in an application which
contains a composition of matter claim which has not been rejected under
35 U.S.C.§ 102 or 103.
   In an application where at least one composition of matter claim has
not been rejected under 35 U.S.C. § 102 or 103, a § 103(b) election
may be made by submitting the petition and an amendment requesting entry
of process claims which correspond to the composition of matter claim.
   For applications pending on or after November 1, 1995, in which the
issue fee has been paid prior to the date of this Notice, the timeliness
requirement for an election under § 103(b) will be considered satisfied
if the conditions of 37 CFR 1.312(b) are met. However, if a patent is
granted on an application entitled to the benefit of § 103(b) without
an election having been made as a result of error without deceptive
intent, patentees may file a reissue application to permit consideration
of process claims which qualify for § 103 (b) treatment.
   Any questions, comments or suggestions regarding petitions under 37
CFR 1.182 filed pursuant to this Notice should be directed to the
Special Program Law Office, attention: Hiram Bernstein, Senior Legal
Advisor. All other questions, comments or suggestions regarding this
Notice should be directed to the Solicitor's Office, attention: Craig
Kaufman, Associate Solicitor.

February 28, 1996                                           BRUCE A. LEHMAN
                                        Assistant Secretary of Commerce and
                                     Commissioner of Patents and Trademarks

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