Patent Baristas

Another lawsuit has been filed in federal court against the United States Patent and Trademark Office (PTO) looking to block implementation of the new claims and continuation rules that are to go into effect on November 1, 2007 (Final Rules; 72 Federal Register 161 at 46716). This time, the plaintiff is pharmaceutical giant SmithKline Beecham Corporation (d/b/a GlaxoSmithKline).

In the suit filed October 9, 2007, in the United Stated Federal District Court for the Eastern District of Virginia, GSK is asking the court to preliminarily and permanently enjoin the PTO from implementing the Final Rules on November 1, 2007 or thereafter as the Final Rules were promulgated without proper legal authority. They also contend that the Final Rules are vague, arbitrary and capricious, and prevent GSK (not to mention everyone else) from fully prosecuting patent applications and obtaining patents on one or more of its inventions.

Believing that the PTO engaged in ultra vires rulemaking in limiting an applicant’s ability to file continuing applications by restricting an applicant to two such applications before the applicant is required to file a petition “showing that the amendment, argument, or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application.”

GSK gets to the heart of the matter in that the “could not have” standard poses a Hobson’s choice under the PTO’s rules of professional conduct, which bars a practitioner from knowingly making a false statement of law or fact. Violations may result in reprimand, suspension, or exclusion of practice before the PTO.

Because the PTO construes the term “could not have” in its ordinary sense of meaning, i.e., that one could not have physically presented the amendment, evidence or argument, an applicant would be at risk of violating the rules of conduct by merely filing a petition.

This conflict renders compliance impossible because it is unclear how you satisfy both the applicable ethical obligations as well as the “could not have” standard. As a result, the PTO’s petition and showing effectively creates a trap.

In another suit, Triantyfyllos Tafas vs. John Dudas and the United States Patent and Trademark Office, Plaintiff Tafas also alleged that the PTO’s promulgation of the Final Rules will cause him harm.

In filing a Partial Motion to Dismiss and a Memorandum in Support of Defendants’ Partial Motion to Dismiss, the PTO has taken the position that one may not be able to establish harm caused by the Final Rules except by demonstrating specific examples of harm caused to pending patent applications. GSK refutes this saying that it meets the two-part ripeness test established in Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), which permits pre-enforcement review of agency regulations where the questions presented are fit for judicial review and would pose a hardship to regulated parties.

Summing up the dispute, GSK squarely spells it out that “an inventor has a statutory entitlement to a patent unless the invention that is the subject of the application for the patent is not new or is obvious. 35 U.S.C. §§ 102-03. To obtain a patent, an inventor must file a written application that contains a specification, an oath and ‘one or more’ claims. 35 U.S.C. §§ 111-12.”

In addition, the Final Rules apply retroactively to pending applications. Since everyone has prosecuted these pending applications under well-established rules and tailored its business accordingly, applicants have filed multiple continuations, continuations-in-part, and RCEs relying on these well-established rules. By forcing applicants to play by these new rules in the middle of the game, the retroactive application of Final Rules will cause irreparable harm.

GSK lists the following causes of action in the case:

The final rules’ various restrictions on patent application rights are all ultra vires because the PTO lacks the authority to issue substantive rules in this area.

The PTO especially lacks the authority to impose the final rules’ new restrictions concerning continuation applications.

The final rules are beyond the PTO’s power because they retroactively change the legal consequences of already filed continuation applications and patent prosecution strategies.

The PTO lacks the authority to restrict the number of claims that can be presented in a patent application.

Restrictions in the final rules on the rules for continued examinations are contrary to the patent act.

The final rules are procedurally defective in various respects for failure to provide a required notice and a comment opportunity before the proposed regulations were amended in ways that could not reasonably have been anticipated.

The final rules are vague and do not put GSK on sufficient notice of how to comply

The final rules work an unconstitutional, ultra vires, and arbitrary and capricious taking of GSK’s patent and patent application property rights.

GSK asks for judgment against Defendants as follows:

Maintain the status quo and grant a preliminary and permanent injunction enjoining and staying implementation of the Final Rules pending resolution of this lawsuit.Grant a permanent injunction enjoining Defendants from issuing new regulations limiting the number of continuing applications, requests for continued examination, and the number of claims that may be filed with the PTO that are deficient in any of the ways described in this complaint, or otherwise infringes GSK’s rights in the manner described in this complaint.

Enter a declaratory judgment that the Final Rules are, in the respects denoted above, vague, arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law (including but not limited to the Patent Act), contrary to constitutional right, power, privilege or immunity, and in excess of statutory jurisdiction, authority or limitations.

Vacate the Final Rules as arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law (including but not limited to the Patent Act), contrary to constitutional right, power, privilege or immunity, and in excess of statutory jurisdiction, authority or limitations.

Issue any writs of mandamus necessary to compel the PTO to perform neglected or unlawfully unperformed duties.

See the complaint here:  gsk-pto-suit.doc

See Gene Quinn’s take on the suit at the PLI blog here.

See also: Do the New Rules Exceed USPTO Rulemaking Authority?

The United States Patent and Trademark Office (USPTO) published Examination Guidelines to help examiners make decisions regarding the obviousness (or lack thereof) of claimed inventions in light of the Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).

Teleflex v. KSR

In Teleflex Inc. v. KSR Int’l Co., the Supreme Court reaffirmed the framework for determining obviousness as set forth in Graham v. John Deere Co., but stated that the Federal Circuit had erred by applying the teaching-suggestion-motivation (TSM) test in an overly rigid and formalistic way.

Specifically, the Supreme Court stated that the Federal Circuit had erred in four ways: (1) ‘‘By holding that courts and patent examiners should look only to the problem the patentee was trying to solve;’’ (2) by assuming ‘‘that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem;’’ (3) by concluding ‘‘that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘obvious to try;’’’ and (4) by overemphasizing ‘‘the risk of courts and patent examiners falling prey to hindsight bias’’ and as a result applying ‘‘[r]igid preventative rules that deny fact finders recourse to common sense.’’

In KSR, the Supreme Court reaffirmed that ‘‘[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.’’ When considering obviousness of a combination of known elements, the operative question is thus ‘‘whether the improvement is more than the predictable use of prior art elements according to their established functions.’’

Graham v. John Deere Co.

An invention that would have been obvious to a person of ordinary skill at the time of the invention is not patentable. As reiterated by the Supreme Court in KSR, obviousness is a question of law based on underlying factual inquiries. The factual inquiries enunciated by the Court are as follows:

(1) Determining the scope and content of the prior art;

(2) Ascertaining the differences between the claimed invention and the prior art; and

(3) Resolving the level of ordinary skill in the pertinent art.

Objective evidence relevant to the issue of obviousness must be evaluated by examiners. Such evidence, sometimes referred to as ‘‘secondary considerations,’’ may include evidence of commercial success, long-felt but unsolved needs, failure of others, and unexpected results.

In making a determination of obviousness, the key question factor is what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge.

Other factors will apply

Once the Graham factual inquiries are resolved, examiners must determine whether the claimed invention would have been obvious to one of ordinary skill in the art. KSR noted that:

“The obviousness analysis cannot be confined by … overemphasis on the importance of published articles and the explicit content of issued patents … . In many fields it may be that there is little discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends.”

Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations; however, examiners must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The ‘‘mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.’’

Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap between the prior art and the claimed invention. The USPTO states that in determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.

Rationales To Support Obviousness Rejections

The new Guidelines provide rationales that outline reasoning that may be applied to find obviousness in such cases.

If the USPTO determines that an invention is obvious using the Graham factors show that an obviousness rejection may be made using the familiar teaching-suggestion-motivation (TSM) rationale, then such a rejection using the TSM rationale can still be made.

Examiners are then directed to also consider whether one or more of the other rationales (as set forth below) support a conclusion of obviousness.

Combining prior art elements according to known methods to yield predictable results;

Simple substitution of one known element for another to obtain predictable results;

Use of known technique to improve similar devices (methods, or products) in the same way;

Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;

‘‘Obvious to try’’ – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;

Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art;

Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.

Like all exercises involving determinations of what’s obvious (or not) the guidelines fall short in not providing clear guidance within the “rationales” that can be used. Unfortunately, the guidelines take an amorphous, hard-to-define test and add amorphous, hard-to-define rationales to it.

The Court in KSR rejected the rigid rule that ‘obvious to try’ is per se insufficient to show obviousness stating:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.

Thus, if the fact that something was obvious to try might be sufficient to prove obviousness, examiners may now be more likely to just take an “I know it when I see it” approach to every invention. There could then be a frightful battle over what was obvious to try and to whom was it obvious.

It remains to be seen how advances with “real innovation” are to be determined.

The Examination Guidelines can be found at the USPTO.

More on KSR here.

The United States Patent and Trademark Office (USPTO) published Examination Guidelines to help examiners make decisions regarding the obviousness (or lack thereof) of claimed inventions in light of the Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).

The USPTO announced the new guidelines saying:

[P]atent examiners will continue to consider (1) the scope and content of the prior art, (2) the differences between the claimed invention and the prior art, (3) the level of ordinary skill in the pertinent art, and (4) objective evidence relevant to the issue of obviousness.

The Guidelines also note that patent examiners must continue to explain the reasoning that leads to a legal conclusion of obviousness when rejecting claims on that ground. The reasoning may still include the established Court of Appeals for the Federal Circuit standard that a claimed invention may be obvious if the examiner identifies a prior art teaching, suggestion, or motivation (TSM) to make it.

However, the Guidelines explain that there is no requirement that patent examiners use the TSM approach in order to make a proper obviousness rejection. Furthermore, the Guidelines point out that even if the TSM approach cannot be applied to a claimed invention, that invention may still be found obvious.

To help patent examiners make obviousness rejections that are supported by appropriate facts and reasoning, the Guidelines identify a number of rationales suggested by the Supreme Court in the KSR decision. For each rationale, the Guidelines explain the underlying factual findings, and provide guidance about how to reason from the facts to the legal conclusion of obviousness.

The Examination Guidelines can be found at the USPTO.

More on KSR here.

On August 21, 2007, the USPTO published its final rules limiting continuation practice (72 Federal Register 161 at 46716, “Rules and Regulations Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent applications; Final Rule”).

USPTO’s assertion of statutory authorization would appear to be insufficient in this case

The question remains whether the USPTO has exceeded its statutory authorization.. The most relevant case on USPTO rule making power under the APA (5 U.S.C. § 500 et seq.) is Animal Legal Defense Fund v. Quigg, (932 F.2d 920 (Fed. Cir. 1991)) upholding the right of the USPTO under 5 U.S.C. § 553 to consider animals as patentable subject matter.

Central to the Federal Circuit’s reasoning in that case was that the USPTO action was merely upholding prior precedent, being consistent both with 35 U.S.C. § 101 and the Supreme Court’s interpretation of that statute in Diamond v. Chakrabarty. (447 US 303 (1980).) In reaching its decision, the court outlined the limits of USPTO rule making authority:

Courts interpreting section 553 generally speak in terms of “substantive” or “legislative” rules requiring notice and comment in contrast to the exempt “interpretative” rules of section 553(b) which do not. []A rule is “substantive” when it “effects a change in existing law or policy” which “affects individual rights and obligations.” see also Chrysler Corp. v. Brown, 441 U.S. 281, 302 (1979) (“affecting individuals’ existing rights and obligations”); Gosman, 573 F.2d at 39 (change existing law or policy). To be “substantive”, a rule must also be promulgated pursuant “‘to statutory authority . . . and implement the statute.'” Cubanski v. Heckler, 781 F.2d at 1426; see also Chrysler Corp., 441 U.S. at 302-03. In contrast, a rule which merely clarifies or explains existing law or regulations is “interpretative.” See American Hosp. Ass’n, 834 F.2d at 1045.

Thus, in Animal Legal Defense Fund the court found that substantive rule making authority must be pursuant to statutory authority. Unlike the specific statutory support and Supreme Court precedent in Animal Legal Defense Fund, the present USPTO proposal to restrict Continuations is supported only by its general rule making authority under 35 U.S.C. § 2(b)(2), which states:

(2) [The Office] may establish regulations, not inconsistent with law, which—

(A) shall govern the conduct of proceedings in the Office;

(B) shall be made in accordance with section 553 of title 5.

35 U.S.C. § 2(b)(2) would appear to be insufficient to allow the USPTO to make the substantive changes to Continuation practice.

First, this law is simply support for general rule making authority, not a specific statutory support for substantive rules that dramatically affect an Applicant’s rights. Moreover, the new rules would appear to contradict, not support, prior interpretations of the law, contrary to Animal Defense Fund. The Federal Circuit has affirmed the plain meaning of 35 U.S.C. § 120 and refused to limit an Applicant’s rights under 35 U.S.C. § 120, except in particular cases of abuse. Recent attempts to limit Continuations via amendments to the statutes have not succeeded in Congress.

The fact that such amendments were considered and then withdrawn from later language indicates that the Congressional intent, at present, does not favor limitations on Continuations. The plain meaning of 35 U.S.C. § 120, its construction in comparison to other sections of Title 35, the Congressional record, and the case law, all point to a more generous interpretation of 35 U.S.C. § 120 than may be applied by the USPTO. If so, USPTO limits on Continuation practice might be held to limit its rule making authority under 35 U.S.C. § 2.

See Part 1 here.

See Part 2 here.

On August 21, 2007, the USPTO published its final rules limiting continuation practice (72 Federal Register 161 at 46716, “Rules and Regulations Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent applications; Final Rule”).

Constraints on the USPTO’s ability to limit continuations

In both the proposed rules and the final rulemaking, the USPTO acknowledges the right to continuations under 35 U.S.C. § 120, but counters that “[n]othing in 35 U.S.C. 120 or its legislative history suggests that the Office must or even should permit an applicant to file an unlimited number of continuing applications without any justification.” The USPTO noted that the changes in the final rules do not set a per se limit on the number of continuing applications, nor are the changes intended to address extreme cases such as Lemelson or Bogese (discussed below).Whether or not one believes that USPTO is constrained by the plain language of 35 U.S.C. § 120 or its legislative history, these are not the only factors to consider. As argued below, the new rules appear to run counter to other factors, including the judicial constructions of 35 U.S.C. § 120.

Attempted Statutory Limitations have not been enacted, or been rejected, by Congress, indicating Congressional intent to preserve current Continuation practice.

35 U.S.C. § 120 provides that “[a]n application for patent for an invention . . . in an application previously filed . . . shall have the same effect, as to such invention, as though filed on the date of the prior application.

Prior to the enactment of 35 U.S.C. § 120, Continuations were not limited. (See In re Henriksen, 399 F.2d 253 (CCPA 1968); Transco Prods, Inc. v Performance Contracting, Inc., 38 F.3d 551 (Fed. Cir. 1994) According to the Court of Customs and Patent Appeals (CCPA), the legislative history of 35 U.S.C. § 120 indicated that Congress sought to codify this prior practice. (Henriksen 399 F.2d at 256-258.) Congress has not sought to limit continuations despite other amendments to 35 U.S.C. § 120 (Amended Nov. 14, 1975, Public Law 94-131, § 9, 89 Stat. 691; Nov. 8, 1984, Public Law 98-622, § 104(b), 98 Stat. 3385; Nov. 29, 1999, Public Law 106-113, § 1000(a)(9), 113 Stat. 1501A-563 (S. 1948 § 4503(b)(1))) and other major reforms. (See, e.g., 1994 GATT Uruguay Round implementing legislation, Pub. L. No. 103-465; Pub. L. No. 106-113 (1999); Pub. L. No. 108-453 (2004); codified as various sections of 35 U.S.C.). For example, the “Patent Reform Act of 2005” (H.R. 2795, 109th Congress (June 8, 2005)) proposed addition of a new section, 35 U.S.C. § 123, which would have provided specific statutory authority for the new continuation rules. This provision was removed from the most recent versions, suggesting that Congress did not support such a limitation. (H.R. 2795, 109th Congress (September 1, 2005)). Thus, while the legislative history of 35 U.S.C. § 120 per se may not constrain the powers of the USPTO, there is a record showing that Congress chose not to grant to the USPTO the power to limit continuation practice.

This conclusion is supported by comparing the language of 35 U.S.C. § 120 with others in Title 35. There are many statutes that expressly grant extensive discretion to the director (e.g. 35 U.S.C. §§ 135, 303). By comparison, 35 U.S.C.§ 120 notably fails to provide the Director the discretion sought here, suggesting that Congress did not intend to provide such discretion.

Prior USPTO attempts to limit Continuation have been rejected by the courts for exceeding statutory authority

The USPTO has repeatedly tried to limit Continuations, but, with the exception of two recent cases which can be distinguished on their facts, these attempts have been rejected by the courts.

The case of In re Henriksen (399 F.2d 253) is relevant to the current Rules. The Patent Office Board of Appeals had upheld an Examiner’s rejection of Henriksen’s Continuation application, ruling that 35 U.S.C. § 120 limited Applicants to three Continuations. The CCPA rebuffed this attempt, stating:

We hold here that under [35 U.S.C. § 120], in view of its long-standing interpretation by the Patent Office and the patent bar, there is no statutory basis for fixing an arbitrary limit to the number of prior applications through which a chain of copendency may be traced to obtain the benefit of the filing date of the earliest of a chain of copending applications, provided Applicant meets all the other conditions of the statute.

In reaching its holding, the Court analyzed the language of the statute and the legislative history and found no explicit support for limiting the number of Continuations. Indeed, operating in the previous laws in which term was calculated as 17-year from issuance, it found that the legislature had considered but rejected attempts to even limit the term of the Continuation, and that Congress intended 35 U.S.C. § 120 only to codify prior practice.

In reviewing such prior practice, the CCPA found that the Board of Patent Appeals had previously rejected limitations on Continuation practice, (Id. at 259, citing Ex parte Harris, 55 USPQ 329 (Pat. Off. Bd. App. 1942)) that early patent treatises had recognized unlimited Continuation practice, (Id. at 260) and that Supreme Court case law recognized at least the right of Continuations and did not indicate any limitations. (Id. at 260, citing Godfrey v. Eames, 68 U.S. 317 (1863), Crown Cork & Seal Co. v. Gutmann Co., 304 U.S. 159 (1938), and General Talking Pictures Corp. v. Western Electric Co., 304 U.S. 175 (1938)). Finally, the Court noted that any such imitations on Continuations could deny Applicants substantive rights and that such changes should be decided by the Congress, not the Patent Office: (Id. at 262.)

The action of the board is akin to a retroactive rule change which may have the effect of divesting Applicants of valuable rights to which, but for the change in Patent Office position brought about by the board’s decision, they were entitled. Nothing appears in the Patent Office Rules of Practice or the Manual of Patent Examining Procedure which sanctions such a result.

Finally, we would express the postscript to this opinion, as did the dissenting opinion of the board, that it is unfortunate that a patent should be granted on an application depending upon another application filed over 20 years ago. However, as the opinion of the board dissenters states, 154 USPQ at 61:

* * * but the cure for this deplorable state of affairs rests with Congress, not with us. If a restriction is to be imposed, it must be based upon law, legislatively or judicially expressed.

It is our view, as the judiciary, that it is for the Congress to decide, with the usual opportunity for public hearing and debate, whether such a restriction as sought by the board is to be imposed.

Subsequent attempts by the USPTO to limit other substantial rights that flow to a Continuing application have also been rejected. In In re Hogan (559 F.2d 595 (CCPA 1977)) the CCPA affirmed the right of an Applicant to rely on the enablement of a prior-filed application, stating that the Board had, in making its rejection, “[disregarded]entirely the statutory right of appellants under 35 U.S.C. § 120,” (Id. at 603.) and noted that the very substantive statutory rights had been upheld in prior cases. (Id. at 603-604.). In In re Bauman (683 F.2d 405 (CCPA 1982).) the CCPA affirmed the right of an Applicant to rely on the filing date of an abandoned prior application, and that “[a]cceptance of the PTO’s position [that the Applicant was not entitled to the right] would require recognition of a nonstatutory exception to the clear language of section 120.” (Id. at 407.)

Next, in Transco, the Federal Circuit overturned a district court finding that a patent was invalid for failing to update the best mode in a Continuation application. (Transco, 38 F.3d 551.) In doing so, the court expounded upon the statutory and common law support for Continuation practice and its long recognition by the courts. The court further stated that Continuations were often forced upon Applicants for the administrative convenience of the USPTO and that limitations on Continuations would be an unfair burden on Applicants. (Id. at 557-558.)

Accordingly, the Federal Circuit and its predecessor court have long interpreted 35 U.S.C. § 120 as granting broad rights to file Continuations. Two more recent decisions have modified this view, but only have been applied in extreme situations.

In Symbol Technologies (277 F.2d 1361 (2002)) the Federal Circuit found that the dormant doctrine of prosecution laches was available to Symbol Technologies in its defense against an infringement suit brought by assignees of the famous submarine patentee, Jerome Lemmelson, who were seeking to enforce recently issued patents that had claimed priority to applications filed in 1954 and 1956. In doing so, the court was careful to note that the laches doctrine was supported by prior Supreme Court precedent and had not been invalidated by the enactment of 35 U.S.C. § 120. Even so, Judge Newman dissented, arguing that any limitations on Continuation practice should be decided by Congress and not the courts.

In In re Bogese (303 F.3d 1362 (Fed Cir 2002) the Federal Circuit applied the doctrine of prosecution history laches to bar the right to file a Continuation. In that case, the Applicant had filed an application in June 14, 1978, and had continuously filed File Wrapper Continuations (A total of eleven file wrapper Continuations were filed in eight years) rather that narrow his claims, despite two appeals to the Board and two to the Federal Circuit. At the final round of prosecution, the Examiner had warned the Applicant that failure to narrow the claims or otherwise advance prosecution would result in rejection of the application. The next Continuation was rejected accordingly. The Federal Circuit found that this action was not an abuse of discretion under the Administrative Procedures Act, 5 U.S.C. § 706. (Bogese 303 F.3d at 1366-1370.) In construing the prior law, the two judge majority court carefully distinguished Henriksen, noting in a footnote:

In this case the PTO did not adopt a mechanical rule based on a misconstruction of the statutory requirements. Nowhere does Henriksen suggest or imply that the PTO must allow dilatory tactics in the prosecution of applications or that the PTO lacks inherent power to prohibit unreasonable delay in prosecution. (Id. at 1368.)

While these recent cases suggest that some limitations may be placed on Continuations, both Symbol and Bogese involved extreme cases that clearly rose to the level of abuse. The Federal Circuit and it predecessor court have long recognized the statutory right of Applicants to Continuations, have rejected any attempts to limit those rights, have determined that such rights are necessary to avoid unfairness upon the Applicant, and have stated that any change must be sought through the legislature. On balance, therefore, the case law suggests that Continuation limitations are the extremely rare exception, to be decided on a case-by-case basis. That the courts have limited Continuations only in rare cases shows that present laws are sufficient to curb abuse of the system.

See Part 1 here.

See Part 3 here.

On August 21, 2007, the USPTO published its final rules limiting continuation practice (72 Federal Register 161 at 46716, Tuesday, August 21, 2007 “Rules and Regulations Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent applications; Final Rule”).

The original proposed rules (71 Federal Register 1 at 48. Tuesday, January 3, 2006) (published eighteen months earlier) elicited an unprecedented amount of comments, and were roundly criticized by many practitioners. The limitations on continuation practice in the final rules are less onerous than those originally proposed. However, the rules might still be challenged under the Administrative Procedures Act (APA).

The new rules: a solution or just new problems?

The final rules allow two Continuations and/or Continuations-in-Part (CIP) but only a single Request for Continued Examination (RCE). For every additional Continuation, CIP or RCE, the applicant must submit justification showing why the amendment, argument, or evidence sought to be entered via the Continuation, CIP or RCE could not have been previously submitted.

No guidance on what is a sufficient justification

It would be natural to expect that the nuances of what constitutes sufficient “evidence” will be worked out over time. However, the rules provide no guidance whatsoever as to what constitutes a sufficient “showing” to support an additional Continuation, CIP or RCE. Without such guidance, it is impossible to determine the extent to which the rules effectively limit current continuation practice.

Hardship in certain areas of technology

The continuation limitations might work excessive hardship on certain areas of technology, such as biotechnology and other medically-related fields in which experimentation may take significant periods of time (such as conducting experiments in animals, or clinical studies). In such an area, Continuations and/or RCEs are almost a standard step in patent prosecution.

Most importantly, Continuations are important for demonstrating enablement in these unpredictable arts. Under 35 U.S.C. § 112, the specification must enable a person of ordinary skill in the art to make and use the claimed invention, without undue experimentation. (See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988.). This objective standard does not require the existence of working examples, (See In re Wright, 27 USPQ2d 1510, 1561 (Fed. Cir. 1999); see also In re Borkowski, 422 F.2d 904, 908 (C.C.P.A. 1970); In re Long, 151 USPQ 640, 642 (C.C.P.A. 1966) so an application can be filed without experimental data.

However, if an Examiner rejects a claim as lacking in enablement, Applicants often can overcome the rejection with post-filing evidence demonstrating that “the disclosure was in fact enabling when filed,”(See In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995); see also Wands, 858 F.2d 731) such as experimental data showing that the teachings in the application were followed to obtain a successful result.

The fact that post-filing evidence is used to prove enablement indicates that an application can statutorily enable the claims, yet the Applicant is also required to meet an evidentiary standard of convincing the Examiner. The time and expense of obtaining such data may be extensive, especially in technologies requiring human or animal model data. Thus, in a family of Applications, claims to (say) a molecule might be prosecuted first, and claims to a method of treatment would be prosecuted later, as additional evidence supporting efficacy is obtained. Continuation practice permits the Applicant time to develop additional data to prove that the specification enables the claims.

Without Continuation practice, the Applicant may have difficulty obtaining the data necessary to prove enablement within the applicable time constraints. Thus, an Applicant’s statutory rights to a patent that satisfied the enablement requirement may be effectively denied by an inability to meet the Examiner’s evidentiary standard. (See, e.g., The Comments of the Biotechnology Industry Organization on the United States Patent & Trademark Office Proposed Rules Changes Concerning Continuation Practice and Claim Limitations, May 2, 2006, Biotechnology Industry Association, at pages 4-5. In that situation, denial of a continuation results in an effective denial of rights of the applicant.

See Part 2 here.

See Part 3 here.

The omnipotent, anonymous Editor-n-Chef of Blawg Review has started “Simply the Best”, a “meme” where he tags 10 blawgs as his favorites, and then asks each author to do the same on his/her blog, and so on, and so forth.

Patent Baristas was named as runner-up in the category of favorites by blogger Monica Bay, author of the Common Scold. Monica Bay is editor-in-chief of Law Technology News, a magazine about innovations in technology for the legal profession.

I’m not sure how one can narrow down the selection but it is interesting to see how people pull together different collections based on their own experiences.

Without further ado, he’s my off-the-cuff list:

Top 10

1. Adam Smith, Esq.
2. Fire of Genius
3. Go Fug Yourself (not a blawg but essential daily reading)
4. Invent Blog
5. morepartnerincome (I’m trying to earn myself a cycling jersey)
6. Orange Book Blog
7. Patent Docs Blog
8. Patently-O
9. Pharmalot
10. PHOSITA Patent Blawg

Runners up (because I ran out of room): Patent Infringement Updates, The Patent Prospector, Promote the Progress, Wired GC.