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The presence or absence of "a substantial new question of patentability" determines whether or not reexamination is ordered. The meaning and scope of the term "a substantial new question of patentability" is not defined in the statute and must be developed to some extent on a case-by-case basis, using the case law to provide guidance as will be discussed in this section.
If the prior art patents and printed publications raise a substantial question of patentability of at least one claim of the patent, then a substantial new question of patentability is present, unless the same question of patentability has already been decided by (1) a final holding of invalidity by a Federal Court, or (2) by the Office in a previous examination of the patent. A "previous examination of the patent" is: (1) the original examination of the application which matured into the patent; (2) the examination in a reissue application that has resulted in a reissue of the patent; or (3) an earlier concluded reexamination. The answer to the question of whether a "substantial new question of patentability" exists, and therefore whether reexamination may be had, is decided by the Commissioner, and, as 35 U.S.C. 303 provides, that determination is final, i.e., not subject to appeal on the merits of the decision. See In re Etter, 756 F.2d 852, 225 USPQ 1 (Fed. Cir. 1985). But see Heinl v. Godici, 143 F.Supp.2d 593, 596-98 (E.D.Va. 2001) (35 U.S.C. 303 addresses only USPTO decisions to deny a request for reexamination and does not bar review of USPTO decisions to grant reexamination requests. However, a decision to grant a reexamination request is not a final agency decision and is not ordinarily subject to judicial review.).
A prior art patent or printed publication raises a substantial question of patentability where there is a substantial likelihood that a reasonable examiner would consider the prior art patent or printed publication important in deciding whether or not the claim is patentable. In making a determination whether to reexamine a patent based on a request, the examiner should consider the prior art patents and/or printed publications to determine if there is a substantial likelihood that a reasonable examiner would consider them important. If the prior art patents and/or publications would be considered important, then the examiner should find "a substantial new question of patentability" unless the same question of patentability has already been decided as to the claim in a final holding of invalidity by a Federal court or by the Office in a previous examination. For example, the same question of patentability may have already been decided by the Office where the examiner finds the additional prior art patents or printed publications are merely cumulative to similar prior art already fully considered by the Office in a previous examination of the claim.
For "a substantial new question of patentability" to be present, it is only necessary that: (1) the prior art patents and/or printed publications raise a substantial question of patentability regarding at least one claim, i.e., the teaching of the (prior art) patents and printed publications is such that a reasonable examiner would consider the teaching to be important in deciding whether or not the claim is patentable; and (2) the same question of patentability as to the claim has not been decided by the Office in a previous examination of the patent or in a final holding of invalidity by the Federal Courts in a decision on the merits involving the claim. It is not necessary that a "prima facie" case of unpatentability exist as to the claim in order for "a substantial new question of patentability" to be present as to the claim. Thus, "a substantial new question of patentability" as to a patent claim could be present even if the examiner would not necessarily reject the claim as either fully anticipated by, or obvious in view of, the prior patents or printed publications. As to the importance of the difference between "a substantial new question of patentability" and a "prima facie" case of unpatentability see generally In re Etter, 756 F.2d 852, 857 n.5, 225 USPQ 1, 4 n.5 (Fed. Cir. 1985).
In order to further clarify the meaning of "a substantial new question of patentability" certain situations are outlined below which, if present, should be considered when making a decision as to whether or not "a substantial new question of patentability" is present.
A "substantial new question of patentability" is not raised by prior art presented in a reexamination request if the Office has previously considered (in an earlier examination of the patent) the same question of patentability as to a patent claim favorable to the patent owner based on the same prior art patents or printed publications. In re Recreative Technologies, 83 F.3d 1394, 38 USPQ2d 1776 (Fed. Cir. 1996).
In determining the presence or absence of "a substantial new question of patentability," the consideration to be given to prior art patents and printed publications cited in an earlier examination is controlled by In re Portola Packaging Inc., 110 F.3d 786, 42 USPQ2d 1295 (Fed. Cir. 1997).
See the guidelines below for reviewing requests for reexaminations and ongoing reexaminations for compliance with the Portola Packaging decision. Note also In re Hiniker Co., 150 F.3d 1362, 1367, 47 USPQ2d 1523, 1527 (Fed. Cir. 1998) (Court held the reexamination proceeding was supported by a substantial new question of patentability where the rejection before the court was based on a combination of art that had been before the examiner during the original prosecution, and art newly cited during the reexamination proceeding.).
In order for the Office to conduct reexamination, prior art must raise a "substantial new question of patentability." See 35 U.S.C. 304. In Portola Packaging, the Federal Circuit held that a combination of two references that were relied upon individually to reject claims during the prosecution of the application which matured into the patent does not raise a substantial new question of patentability in a subsequent reexamination of the patent. During the original prosecution of the application which led to the patent, the Office had rejected the claims separately based upon the Hunter and Faulstich references. However, the Office never applied the references in combination. During reexamination, Portola Packaging amended the patent claims, and for the first time the Office rejected the amended patent claims based upon the Hunter and Faulstich references in combination. Despite these facts, the Federal Circuit determined that the Office was precluded from conducting reexamination on those references, either alone or in combination. The Court explained that "a rejection made during reexamination does not raise a substantial new question of patentability if it is supported only by prior art previously considered by the PTO." 110 F.3d at 791, 42 USPQ2d at 1300.110 F.3d at 790, 42 USPQ2d at 1299. The Federal Circuit also held that an amendment of the claims during reexamination does not justify using old prior art alone to raise a substantial new question of patentability. 110 F.3d at 791, 42 USPQ2d at 1299.
If prior art was previously relied upon to reject a claim in a prior related Office proceeding, the Office will not order or conduct reexamination based only on such prior art. Prior related Office proceedings include the application which matured into the patent that is being reexamined, any reissue application for the patent, and any reexamination proceeding for the patent.
If prior art was not relied upon to reject a claim, but was cited in the record of a prior related Office proceeding, and its relevance to the patentability of any claim was actually discussed on the record, the Office will not order or conduct reexamination based on only such prior art. The relevance of the prior art to patentability may have been discussed by either the applicant, patentee, examiner, or any third party. However, 37 CFR 1.2 requires that all Office business be transacted in writing. Thus, the Office cannot presume that a prior art reference was previously relied upon or discussed in a prior Office proceeding if there is no basis in the written record to so conclude other than the examiner's initials or a check mark on a PTO 1449 form, or equivalent, submitted with an information disclosure statement. Thus, any specific discussion of prior art must appear on the record of a prior related Office proceeding. However, generalized statements such as the prior art is "cited to show the state of the art," "cited to show the background of the invention," or "cited of interest" would not preclude reexamination.
The Office may order and conduct reexamination based on prior art that was cited but whose relevance to patentability of the claims was not discussed in any prior related Office proceeding.
Office personnel must adhere to the following procedures when determining whether a reexamination may be ordered in compliance with the Federal Circuit's decision in Portola Packaging:
(A) Read the reexamination request to identify the prior art on which the request is based.
(B) Conduct any necessary search of the prior art relevant to the subject matter of the patent for which reexamination was requested. See 35 U.S.C. 303 ("On his own initiative, and any time, the Commissioner may determine whether a substantial new question of patentability is raised by patents and publication discovered by him. . . ."); see also MPEP § 2244 ("If the examiner believes that additional prior art patents and publications can be readily obtained by searching to supply any deficiencies in the prior art cited in the request, the examiner can perform such an additional search.").
(C) Read the prosecution histories of all prior related Office proceedings.
(D) Determine if the prior art in the reexamination request and the prior art found in any search was: (1) relied upon to reject any claim in a prior related Office proceeding; or (2) cited and its relevance to patentability of any claim discussed in a prior related Office proceeding.
(E) Deny the reexamination request if the decision to order reexamination would be based only on prior art that was, in a prior related Office proceeding, (1) relied upon to reject any claim, and/or (2) cited and its relevance to patentability of any claim discussed. See Portola Packaging, Inc., 110 F.3d at 790, 42 USPQ2d at 1299 (examiner presumed to have done his/her job). There may be unusual fact patterns and evidence which suggest that the examiner did not consider the prior art that was discussed in the prior Office proceeding. These cases should be brought to the attention of the Technology Center (TC) Director. For a discussion of the treatment of such cases, see section 5 below.
(F) Order reexamination if the decision to order reexamination would be based at least in part on prior art that was, in a prior related Office proceeding, neither (1) relied upon to reject any claim, nor (2) cited and its relevance to patentability of any claim discussed and a substantial new question of patentability is raised with respect to any claim of the patent. If not specified, a reexamination generally includes all claims. However, reexamination may be limited to specific claims. See 35 U.S.C. 304 (authorizing the power to grant reexamination for determination of a "substantial new question of patentability affecting any claim of a patent.") (emphasis added). Thus, the Commissioner may order reexamination confined to specific claims. However, reexamination is not necessarily limited to those questions set forth in the reexamination order. See 37 CFR 1.104(a) ("The examination shall be complete with respect both to compliance of the application or patent under reexamination with the applicable statutes and rules and to the patentability of the invention as claimed.").
Office personnel must adhere to the following procedures when determining whether any current or future ongoing reexamination should be terminated in compliance with the Federal Circuit's decision in Portola Packaging:
(A) Prior to making any rejection in an ongoing reexamination, determine for any prior related Office proceeding what prior art was (1) relied upon to reject any claim or (2) cited and discussed.
(B) Base any and all rejections of the patent claims under reexamination at least in part on prior art that was, in any prior related Office proceeding, neither (1) relied upon to reject any claim, nor (2) cited and its relevance to patentability of any claim discussed.
(C) Withdraw any rejections based only on prior art that was, in any prior related Office proceeding, previously either (1) relied upon to reject any claim, or (2) cited and its relevance to patentability of any claim discussed.
(D) Terminate reexaminations in which the only remaining rejections are entirely based on prior art that was, in any prior related Office proceeding, previously (1) relied upon to reject any claim, and/or (2) cited and its relevance to patentability of a claim discussed. The Commissioner may conduct a search for new art to determine whether a substantial new question of patentability exists prior to terminating any ongoing reexamination proceeding. See 35 U.S.C. 303. See also 35 U.S.C. 305 (indicating that "reexamination will be conducted according to the procedures established for initial examination," thereby suggesting that the Commissioner may conduct a search during an ongoing reexamination proceeding).
The Office recognizes that each case must be decided on its particular facts and that cases with unusual fact patterns will occur. In such a case, the reexamination should be brought to the attention of the TC Director who will then determine the appropriate action to be taken.
Unusual fact patterns may appear in cases in which prior art was relied upon to reject any claim or cited and discussed with respect to the patentability of a claim in a prior related Office proceeding, but other evidence clearly shows that the examiner did not appreciate the issues raised in the reexamination request or the ongoing reexamination with respect to that art. Such other evidence may appear in the reexamination request, in the nature of the prior art, in the prosecution history of the prior examination, or in an admission by the patent owner, applicant, or inventor. See 37 CFR 1.104(c)(3). The following examples are intended to be illustrative and not inclusive.
For example, if a textbook was cited during prosecution of the application which matured into the patent, the record of that examination may show that only select information from the textbook was discussed with respect to the patentability of the claims. The file history of the prior Office proceeding should indicate which portion of the textbook was previously considered. See 37 CFR 1.98(a)(2)(ii) (an information disclosure statement must include a copy of each "publication or that portion which caused it to be listed") (emphasis added). If a subsequent reexamination request relied upon other information in the textbook that actually teaches what is required by the claims, it may be appropriate to rely on this other information in the textbook to order and/or conduct reexamination. However, a reexamination request that merely provides a new interpretation of a reference already previously relied upon or actually discussed by the Office does not create a substantial new question of patentability.
Another example involves the situation where an examiner discussed a reference in a prior Office proceeding, but did not either reject a claim based upon the reference or maintain the rejection based on the mistaken belief that the reference did not qualify as prior art. For example, the examiner may not have believed that the reference qualified as prior art because: (i) the reference was undated or was believed to have a bad date; (ii) the applicant submitted a declaration believed to be sufficient to antedate the reference under 37 CFR 1.131; or (iii) the examiner attributed an incorrect filing date to the claimed invention. If the reexamination request were to explain how and why the reference actually does qualify as prior art, it may be appropriate to rely on the reference to order and/or conduct reexamination. For example, the request could: (i) verify the date of the reference; (ii) undermine the sufficiency of the declaration filed under 37 CFR 1.131; or (iii) explain the correct filing date accorded a claim. See e.g., Heinl v. Godici, 143 Supp.2d 593 (E.D.Va. 2001) (reexamination on the basis of art previously presented without adequate proof of date may proceed if prior art status established).
Another example involves foreign language prior art references. If a foreign language prior art reference was cited and discussed in any prior Office proceeding but the foreign language prior art reference was never completely and accurately translated into English during the original prosecution, Portola Packaging may not prohibit reexamination over a complete and accurate translation of that foreign language prior art reference. Specifically, if a reexamination request were to explain why a more complete and accurate translation of that same foreign language prior art reference actually teaches what is required by the patent claims, it may be appropriate to rely on the foreign language prior art reference to order and/or conduct reexamination.
Another example of an unusual fact pattern involves cumulative references. To the extent that a cumulative reference is repetitive of a prior art reference that was previously applied or discussed, Portola Packaging may prohibit reexamination of the patent claims based only on the repetitive reference. For purposes of reexamination, a cumulative reference that is repetitive is one that substantially reiterates verbatim the teachings of a reference that was either previously relied upon or discussed in a prior Office proceeding even though the title or the citation of the reference may be different. However, it is expected that a repetitive reference which cannot be considered by the Office during reexamination will be a rare occurrence since most references teach additional information or present information in a different way than other references, even though the references might address the same general subject matter.
(A) If a request for reexamination is denied under 3(E) above in order to comply with the Federal Circuit's decision in Portola Packaging, the notice of reexamination denial should state: "This reexamination request is denied based on In re Portola Packaging, Inc., 110 F.3d 786, 42 USPQ2d 1295 (Fed. Cir. 1997). No patentability determination has been made in this reexamination proceeding."
(B) If an ongoing reexamination is terminated under 4(D) above in order to comply with the Federal Circuit's decision in Portola Packaging, the Notice of Intent to Issue a Reexamination Certificate should state: "This reexamination is terminated based on In re Portola Packaging, Inc., 110 F.3d 786, 42 USPQ2d 1295 (Fed. Cir. 1997). No patentability determination has been made in this reexamination proceeding."
(C) If a rejection in the reexamination has previously been issued and that rejection is withdrawn under 4(C) above in order to comply with the Federal Circuit's decision in Portola Packaging, the Office action withdrawing such rejection should state: "The rejection is withdrawn in view of In re Portola Packaging, Inc., 110 F.3d 786, 42 USPQ2d 1295 (Fed. Cir. 1997). No patentability determination of the claims of the patent in view of such prior art has been made in this reexamination proceeding." If multiple rejections have been made, the Office action should clarify which rejections are being withdrawn.
A prior decision adverse to the patentability of a claim of a patent by the Office based upon prior art patents or printed publications would usually mean that "a substantially new question of patentability" is present. Such an adverse decision by the Office could, for example, arise from a reissue application which was abandoned after rejection of the claim and without disclaiming the patent claim.
Any prior adverse final decision by the Commissioner, or the Board of Patent Appeals and Interferences, on an application seeking to reissue the same patent on which reexamination is requested will be considered by the examiner when determining whether or not a "substantial new question of patentability" is present. To the extent that such prior adverse final decision was based upon grounds other than patents or printed publications, the prior adverse final decision will not be a basis for determining whether or not a "substantial new question of patentability" is present.
While the Office would consider decisions involving substantially identical patents or printed publications in determining whether a "substantial new question of patentability" is raised, the weight to be given such decisions will depend upon the circumstances. For example, if the Office has used the same or substantially identical prior art to reject the same or substantially identical claims in another application or patent under reexamination, this would be considered as being controlling in making a determination. Similarly, if a foreign patent office or a foreign court has used the same or substantially identical prior art to reject or invalidate the same or substantially identical claims, this would be weighted heavily in making the determination. Likewise, if a United States Court has invalidated similar claims in another patent based on the same or substantially identical prior patents or printed publications, this would be considered as being controlling in making the determination. Favorable decisions on the same or substantially identical prior patents or printed publications in other cases would be considered but would not be controlling.
When the initial question as to whether the prior art raises a substantial new question of patentability as to a patent claim is under consideration, the existence of a final court decision of claim validity in view of the same or different prior art does not necessarily mean that no new question is present, because of the different standards of proof employed by the Federal District Courts and the Office. While the Office may accord deference to factual findings made by the district court, the determination of whether a substantial new question of patentability exists will be made independently of the court's decision on validity, because it is not controlling on the Office.
A nonfinal holding of claim invalidity or unenforceability will not be controlling on the question of whether a substantial new question of patentability is present.
A final holding of claim invalidity or unenforceability is controlling on the Office. In such cases, a substantial new question of patentability would not be present as to the claims finally held invalid or unenforceable.
As to A. - C. above, see Ethicon v. Quigg, 849 F.2d 1422,7 USPQ2d 1152 (Fed. Cir. 1988).
Any situations requiring clarification should be brought to the attention of the Office of Patent Legal Administration.
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