NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1436
(Re-examination No. 90/007,785)
IN RE NATURES REMEDIES, LTD.
John J. Marshall, Drinker Biddle & Reath LLP, of Berwyn, Pennsylvania, argued
for appellant. With him on the brief was Kathryn R. Doyle, of Philadelphia,
Pennsylvania.
Robert J. McManus, Associate Solicitor, Office of the Solicitor, United States
Patent and Trademark Office, of Arlington, Virginia, argued for the Director of the United
States Patent and Trademark Office. With him on the brief was Shannon M. Hansen,
Associate Solicitor. Of counsel was Raymond T. Chen, Solicitor.
Appealed from: United States Patent and Trademark Office
Board of Patent Appeals and Interferences
NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2008-1436
(Re-examination No. 90/007,785)
IN RE NATURES REMEDIES, LTD.
Appeal from the United States Patent and Trademark Office, Board of Patent Appeals
and Interferences.
__________________________
DECIDED: March 12, 2009
__________________________
Before MICHEL, Chief Judge, MAYER and DYK, Circuit Judges.
PER CURIAM.
Natures Remedies, Ltd. (“Remedies”) appeals a decision of the Board of Patent
Appeals and Interferences of the United States Patent and Trademark Office affirming
the rejection of claim 2 of U.S. Patent No. 5,945,107 (the “’107 patent”) as unpatentable
under 35 U.S.C. § 102(b). We affirm.
I.
Remedies manufactures and distributes herbal products. In 1999, it obtained the
’107 Patent, entitled “Compositions and Methods for Weight Reduction.” Claim 2, as
amended, provides:
2. A composition which produces weight loss in a patient comprising a
combination of selected herbal extracts wherein said combination
comprises at least one herbal extract capable of inhibiting gastric
emptying and one herbal extract which increases metabolic rate in a
patient, wherein the combination of selected herbal extracts comprises
Guarana, Damiana and Paraguay.
The board affirmed the rejection of claim 2 as anticipated by a reference entitled
“The Effect of Medi-Tab Capsules on the Ventricular Emptying Time” (the “Medi-Tab
Application”). The Medi-Tab Application, which was submitted to the Scientific-Ethical
Committee of Copenhagen in Denmark (the “Copenhagen Committee”), sought
approval for clinical testing of Medi-Tab capsules on the emptying time of the human
stomach, and was dated April 10, 1996, more than a year prior to the December 8,
1997, priority date of the ’107 patent. Appendix I to the Medi-Tab Application states that
Medi-Tab capsules contain three herbal extracts: Guarana, Damiana and (Yerbe) Maté,
which is another term for the herb Paraguay.
In determining that claim 2 of the ’107 patent was anticipated by the Medi-Tab
Application, the board relied upon the declaration of Unna Scherer, who served as
Secretary for the Copenhagen Committee. Scherer explained that the task of the
Copenhagen Committee “is to ensure the protection of trial patients in biomedical
clinical trials” and that all clinical trials were required to obtain committee approval prior
to their start. Scherer further stated, based upon her “personal knowledge,” that:
3. The Notification of the Scientific Ethical Committee for the
project Effect of Medi-Tab Capsules on Gastric Emptying, with the
attached Study Protocol and Project Description (“Notification and Study
Protocol”), has been kept in the files of the Scientific Ethical Committee of
Copenhagen County since 10 April 1996. . . .
4. As required by the Danish Open Files Act, the Notification and
Study Protocol is a public record, and has been open to inspection by the
2008-1436 2
public since 10 April 1996 in accordance with the rules in the Danish Open
Files Act. . . .
5. The Scientific Ethical Committee of Copenhagen County
maintains an index of the notifications of clinical trials that are submitted.
The index is also open to inspection by the public. In April 1996, the
Notification and Study Protocol was assigned reference no. KA 96085g,
and listed in this index.
The board determined that the Scherer declaration was “impartial evidence”
sufficient to establish a prima facie case that the Medi-Tab Application was “publically
available” and therefore a “printed publication” under 35 U.S.C. § 102(b). In an effort to
rebut this prima facie showing, Remedies submitted the declaration of Henrik B.
Sanders, a Danish attorney. Sanders stated:
The purpose of article 12(1), 2° in The Danish Open File Act is to prevent
companies from suffering significant economical losses as a result of the
right of access to documents. Since the formulation for the Slimming
Product disclosed in the [Medi-Tab] Application would be regarded as
information on technical plan or processes or on operation or business
procedures or the like, the [Medi-Tab] Application is covered by the
exception in article 12(1), 2° of The Danish Open File Act, and would not
have been available to the public before the effective filing date of [the]
U.S. Patent Application.
The board concluded that Sanders’ declaration failed to establish that the Medi-
Tab Application would have qualified for exemption from disclosure under Article 12(1)
of the Danish Open Files Act. In order to be exempt from disclosure under that
provision, information must be of such “material importance to the economy of the
person or enterprise” that a request for access to the information will be refused.
Sanders, however, failed to demonstrate that the information in the Medi-Tab
Application was of “material importance” to Remedies’ “economy.” The board noted,
moreover, that the Medi-Tab Application stated that the results of the Medi-Tab study
would be “published in an international gastro-enterological medical publication,” and
2008-1436 3
that this undercut Remedies’ assertion that information in the application was intended
to be kept confidential. Because it concluded that “the evidence of public accessibility .
. . outweigh[ed] . . . evidence that [the Medi-Tab Application] would not have been
accessible to the interested public,” the board affirmed the examiner’s rejection of claim
2 under 35 U.S.C. § 102(b).
Remedies then timely appealed to this court. We have jurisdiction under 28
U.S.C. § 1295 and 35 U.S.C. § 141.
II.
35 U.S.C. § 102 “serves as a limiting provision, both excluding ideas that are in
the public domain from patent protection and confining the duration of the monopoly to
the statutory term.” Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). It provides that:
“A person shall be entitled to a patent unless . . . the invention was patented or
described in a printed publication in this or a foreign country . . . more than one year
prior to the date of the application for patent in the United States.” This statutory “bar is
grounded on the principle that once an invention is in the public domain, it is no longer
patentable by anyone.” SRI Int’l, Inc. v. Internet Sec. Sys., 511 F.3d 1186, 1194 (Fed.
Cir. 2008) (citation and internal quotation marks omitted).
The parties do not dispute that the Medi-Tab Application teaches every element
of claim 2. Nor do they dispute that it was submitted to the Copenhagen Committee on
April 10, 1996, more than one year before the December 8, 1997, priority date of the
’107 patent. Rather, the narrow issue on appeal is whether the Medi-Tab Application
was accessible to the public and therefore a “printed publication” under 35 U.S.C.
§ 102(b).
2008-1436 4
“Accessibility goes to the issue of whether interested members of the relevant
public could obtain the information if they wanted to.” Constant v. Advanced Micro-
Devices, Inc., 848 F.2d 1560, 1568 (Fed. Cir. 1988). Thus, a reference will be deemed
“publicly accessible” if it:
has been disseminated or otherwise made available to the extent that
persons interested and ordinarily skilled in the subject matter or art,
exercising reasonable diligence, can locate it and recognize and
comprehend therefrom the essentials of the claimed invention without
need of further research or experimentation.
In re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981); see Bruckelmyer v. Ground Heaters,
Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006).
As the board correctly determined, the declaration of Unna Scherer, the
Secretary for the Copenhagen Committee, was sufficient to establish a prima facie case
that the Medi-Tab Application was publicly accessible more than one year prior to the
’107 patent’s critical date. Scherer stated, based upon her “personal knowledge” that
the Medi-Tab Application was a “public record” that had “been open to inspection by the
public” since April 10, 1996 “in accordance with the rules in the Danish Open Files Act.”
The public accessibility of the Medi-Tab Application was further supported by the
Copenhagen Committee’s indexing protocol. Scherer explained that the Committee
maintained “an index of the notifications of clinical trials” that was “open to inspection by
the public” and asserted that the Medi-Tab Application had been listed in this index
since April, 1996.
Because Scherer’s declaration established a prima facie case of public
availability, the onus was on Remedies to demonstrate that the Medi-Tab Application
was not accessible to interested members of the public. Remedies, however, failed to
2008-1436 5
carry its burden. The only piece of evidence it submitted to demonstrate lack of
accessibility was a declaration from Henrik Sanders, a Danish attorney. Sanders
attempted to establish that the information in the Medi-Tab Application would have been
exempt from disclosure under Article 12(1) of the Danish Open Files Act. That provision
states:
Exempt Information
12.-(1) The right of access to administration files shall not apply to . . . .
2° information on technical plant or processes or on operating or business
procedures or the like, provided it is of material importance to the
economy of the person or enterprise that grant of the request be refused.
Under Article 12(1), information is exempt from disclosure only if it is of “material
importance” to a company’s “economy.” Sanders, however, did not establish that the
information in the Medi-Tab Application was “of material importance” to Remedies’
financial interests. Thus, as the board correctly concluded, his declaration was
inadequate to demonstrate that the Medi-Tab Application would have been exempt from
disclosure under Article 12(1).
On appeal, Remedies argues that the board misinterpreted the Sanders
declaration. It contends that “[a]ny fair reading of the Sanders Declaration shows that
he is offering his opinion that the [Copenhagen] Committee would have regarded the
information on Remedies ‘Slimming Product’ to be of material importance, the
disclosure of which could cause significant economic loss.” Contrary to Remedies’
assertions, however, the Sanders declaration says nothing about the economic
importance to Remedies of the information contained in the Medi-Tab Application.
Instead, the only mention of “economic loss” in the Sanders declaration is his statement
2008-1436 6
that the purpose of the Article 12(1) exemption was “to prevent companies from
suffering significant economical losses as a result of the right of access to documents.”
The evidence of record simply does not establish that the disclosure of information
contained in the Medi-Tab Application would have caused economic loss sufficient to
warrant exemption from disclosure under Article 12(1).
Remedies also challenges the board’s determination that the Scherer declaration
was sufficient to establish a prima facie case of public accessibility. In Remedies’ view,
Scherer’s declaration only describes the procedure for obtaining documents under the
Danish Open Files Act, but does not establish “which, if any, of the contents of the
[Medi-Tab Application] would have been made available to a requestor before the
critical date.” We agree with Remedies that the Scherer declaration could have been
clearer and more comprehensive. Scherer did not discuss the Article 12(1) disclosure
exemption, or indicate whether it might have been possible for Remedies to use this
provision to block access to information regarding the formulation of the Medi-Tab
capsules.
We must accept the board’s factual determinations, however, if they are
supported by substantial evidence. See Kyocera Wireless Corp. v. Int’l Trade Comm’n,
545 F.3d 1340, 1350 (Fed. Cir. 2008) (This court must accord “substantial evidence
deference to the factual components of the determination” as to whether a reference
qualifies as a printed publication under 35 U.S.C. § 102(b)). Scherer stated: (1) that the
Medi-Tab application was a “public record,” (2) that it “ha[d] been open to inspection by
the public since 10 April 1996 in accordance with the rules in the Danish Open Files
Act,” and (3) that it was listed in an index of clinical trials which was “open to inspection
2008-1436 7
by the public.” Given these explicit statements as to the public availability of the Medi-
Tab Application, we conclude that substantial evidence supports the board’s
interpretation of the Scherer declaration as sufficient to establish a prima facie case of
public accessibility. See Bruckelmyer, 445 F.3d at 1379 (concluding that a reference
was publically available where it was “classified and indexed . . . providing the roadmap
that would [allow] one skilled in the art to locate [it]”); In re Hall, 781 F.2d 897, 899-900
(Fed. Cir. 1986) (holding that a single catalogued thesis in a German university library
was sufficiently accessible to the public).
The board’s determination as to public accessibility, moreover, is supported by
the fact that the Medi-Tab Application itself contains no restrictions on public
dissemination. To the contrary, the application states the results of the study would be
“published in an international gastro-enterological medical publication.” Furthermore,
the application indicates that volunteers participating in the study will be provided with
the project number of the clinical trial notification—presumably so that they could
access information about the study in the Copenhagen Committee’s index. The fact
that there is nothing in the Medi-Tab Application evidencing an intent to keep its
contents confidential serves to buttress the board’s determination that it was publically
available prior to the ’107 patent’s critical date. See Mass. Inst. of Tech. v. AB Fortia,
774 F.2d 1104, 1109 (Fed. Cir. 1985) (concluding that a paper orally presented at a
scientific meeting was publically accessible where written copies were distributed
“without any restrictions” to those requesting them); Garrett Corp. v. United States, 422
F.2d 874, 878 (Ct. Cl. 1970) (distributing documents “without restriction on use”
constitutes publication).
2008-1436 8
At oral argument, Remedies’ counsel asserted that his client did not intend to
disseminate information about the Medi-Tab study until after the study had been
completed and “all patent obligations had been satisfied.” Attorney argument, however,
cannot take the place of record evidence. See In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Here, the
evidence of record does not establish that Remedies intended to keep the formulation of
the Medi-Tab capsule confidential until after the study had been completed and a patent
application had been filed.
2008-1436 9