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Archived updates for Tuesday, July 31, 2007

USPTO Proposes Administrative Appellate Practice Changes

In an effort to avoid the predicted bottleneck at the Board of Patent Appeals and Interferences (BPAI) due to USPTO's upcoming patent continuation practice changes, the Office proposed rule changes on July 30, 2007 that are designed to help the Board “continue to resolve ex parte appeals in a timely manner.” According to the proposal's summary,

The proposed rules seek to provide examiners and Office reviewers with a clear
and complete statement of an appellant’s position at the time of filing an
appeal brief so as to enhance the likelihood that appealed claims will be
allowed without the necessity of further proceeding with the appeal, minimize
the pendency of appeals before the Office, minimize the need for lengthy patent
term adjustments in cases where claims become allowable as a result of an action
by the Board in an appeal, provide uniform treatment of requests for an
extension of time filed after an appeal brief is filed, and make the
decision-making process more efficient. . . . Written comments must be received
on or before September 28, 2007. No public hearing will be held.

. . . The Board is currently experiencing a large increase in the number of ex
parte appeals. In FY 2006, the Board received 3,349 ex parte appeals. In FY
2007, the Board expects to receive more than 4,000 ex parte appeals. In FY 2008,
the Board expects to receive over 5,000 ex parte appeals. These rules are proposed to change procedures in such a way as to allow the Board to continue to resolve ex parte appeals in a timely manner. The proposed rules do not propose to change any of the rules relating to inter partes reexamination appeals. Nor do the proposed rules propose to change any of the rules relating to contested cases. In some instances, the rules propose to adopt practices similar to those of the Court of Appeals for the Federal Circuit. For example, an appendix would be required, page limits would be
set, and a table of contents and a table of authorities would be required in briefs.

Professor Wegner predicts "The new rules, if enacted, will frustrate attempts to use the appeals route in lieu of filing unlimited continuing applications under the final continuing applications rules that are expected as early as the week of August 13, 2007 (and which will have a 60 day period from the publication date until they become effective)."

"The general tenor is consistent with the other rule packages - applicants must do all the work, and must spend pages and pages explaining peripheral stuff that has no relation to any issue in controversy. Paradoxically, the rule proposes to impose a page limit," adds David E. Boundy of Cantor Fitzgerald LP

Read the (over 22,000-word) proposed rule change here.
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Archived updates for Wednesday, July 18, 2007

Predictable Use of Prior Art Elements Requires Minimal Obviousness Analysis

In Ex Parte Smith (BPAI, June 25, 2995, per curium), the Board considered two, post-KSR obviousness issues.

The first was whether Appellant had shown that the Examiner erred in rejecting claims 1-9, 11-13, 16-18, and 32-24 under 35 U.S.C. § 103(a) as unpatentable over Wyant in view of Dick. That issue turned on whether it would have been obvious to glue two separate sheets to form a continuous two-ply seam, as taught by Dick, rather than folding one sheet to create a seam along the folded edge, as taught by Wyant.

According to the precedential opinion,

The question is whether one of ordinary skill in the art starting with Wyant’s two-ply pocket would have found it obvious at the time the invention was made to modify Wyant's pocket insert to include a continuous two-ply seam as taught by Dick for providing a more secure pocket. In considering the teaching of Wyant and Dick, we have found that (1) each of the claimed elements is found within the scope and content of the prior art; (2) one of ordinary skill in the art could have combined the elements as claimed by methods known at the time the invention was made; and (3) one of ordinary skill in the art would have recognized at the time the invention was made that the capabilities or functions of the combination were predictable. Furthermore, neither Appellant’s Specification nor Appellant’s arguments present any evidence that cutting the folded edge of Wyant and gluing the resulting separate pocket sheet and base sheet along the cut edge to form a continuous two-ply seam as taught by Dick was uniquely challenging or difficult for one of ordinary skill in the art. The substitution of the continuous, two-ply seam of Dick for the folded seam of Wyant thus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement." KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1396. Therefore, it would have been obvious at the time the invention was made to modify Wyant's pocket insert to attach a separate pocket sheet to a base sheet to form a pocket insert with continuous two-ply seams as taught by Dick.

This conclusion is consistent with the line of case from the Federal Circuit and its predecessor court. See, e.g., In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 8-9 (CCPA 1975) (holding that the claimed manner in which an electrical contact was made, i.e. by "metallic wrapping," that provided no novel or unexpected result over the metallic connections used in the applied references was an obvious choice within the skill of the art) (cited with approval in In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094 (Fed. Cir. 1995)). In the present case, the disputed claim limitation of "continuous two-ply seams" and the function it performs—to create a pocket—are identical between the claimed invention and the prior art. Thus, the selection of the continuous two-ply seam of Dick over the folded seam of Wyant represents an obvious choice within the skill of the art, i.e., a choice between known viable alternatives.

Appellant argues that Wyant and Dick teach away from each other (Substitute Br. 14-18). The Examiner believed otherwise, finding that Wyant and Dick do not teach away from each other, and that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Wyant's pocket insert with a separate pocket sheet attached to a base sheet to form a pocket insert as taught by Dick (Answer 5-6).

In particular, Appellant argues that Wyant and Dick teach away from each other because combining Dick with Wyant would render Wyant inoperable for its primary purpose—namely providing tabs that selectively can be folded outward of the edge of the card (Substitute Br. 11). The Examiner correctly found that if the base sheet and pocket sheet were attached along the perimeter edge as disclosed in Dick, it would still be possible to fold back the tabs of Wyant near its attached perimeter edge (Answer 6). Appellant argues that the only way the tabs of Wyant can be formed is by forming the tab yielding sheet and the base sheet from a single piece of material to form a folded line (Substitute Br. 11). Although this method is consistent with an embodiment disclosed in Wyant, there is nothing in Wyant that requires or suggests that this is the only way to attach tabs that can be selectively folded outward, much less to teach away from the use of a pocket constructed on one side surface of a base sheet, the element for which the Examiner relies on Dick (Answer 5).

Where, as here, art is silent on the capabilities or function of any particular item, that is not teaching away from its use. Further, the Court in KSR noted that "[a] person of ordinary skill is also a person of ordinary creativity, not an automaton." 127 S.Ct. at 1742, 82 USPQ2d at 1397. It would take no more than ordinary creativity for a person of ordinary skill to adapt Wyant to form tabs with the base sheet and pocket sheet attached along the perimeter edge as disclosed in Dick.

Appellant’s claims 1-9, 11-13, 16-18, and 32-34 were combinations which only unite old elements with no change in their respective functions and which yield predictable results. Thus, the claimed subject matter likely would have been obvious under KSR. In addition, neither Appellant’s Specification nor Appellant’s arguments present any evidence that the modifications necessary to effect the combination are uniquely challenging or difficult for one of ordinary skill in the art. Because this is a case where the improvement is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1396, no further analysis was required by the Examiner. KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1396. Under those circumstances, the Examiner did not err in holding that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Wyant's pocket insert with a separate pocket sheet attached to a base sheet to form a pocket insert as taught by Dick for providing a more secured pocket.


The second obviousness issue was whether Appellant has shown that the Examiner erred in rejecting claims 10, 14, 15, 19-21, and 36 under 35 U.S.C. § 103(a) as unpatentable over Wyant in view of Dick, and further in view of Ruebens. That issue turned on whether it would have been obvious to improve a pocket insert by creating two pockets from a single pocket using an additional line of adhesive.

The Examiner relies on Ruebens to show a pocket sheet that is adhered to a base sheet along the base sheet's perimeter edge and along a strip or inner portion, which separates the pocket sheet into two pockets (Answer 5). One of skill in the art would have been able to combine the adhesive strip of Ruebens with the combination of Wyant and Dick asserted by the Examiner in the preceding rejection using methods known at the time the invention was made in the bookbinding art. Moreover, each of the elements of Wyant, Dick, and Ruebens combined by the Examiner performs the same function when combined as it does in the prior art. Thus, such a combination would have yielded predictable results. See Sakraida, 425 U.S. at 282, 189 USPQ at 453.

Claims 10, 14, 15, 19-21, and 36 were combinations which only unite old elements
with no change in their respective functions and which yield predictable results. Thus, the claimed subject matter likely would have been obvious under KSR. In addition, neither Appellant’s Specification nor Appellant’s arguments present any evidence that the separation of one pocket into two pockets using an additional line of adhesive is uniquely challenging or difficult for one of ordinary skill in the art. Moreover, the separation of one pocket into two pockets using an additional
line of adhesive is a technique that has been used to improve one device (the
photo album of Ruebens), and one of skill in the art would recognize that it
would improve similar devices in the same manner. Because Appellant has not
shown that the application of the Ruebens technique to the combination of Wyant
and Dick would have been beyond the skill of one of skill in the art, we find
using the technique would have been obvious. Under those circumstances, the
Examiner did not err in holding that it would have been obvious to one having
ordinary skill in the art at the time the invention was made to modify Wyant's
and Dick's pocket insert with an adhesive strip, as taught by Ruebens, for the
purpose of defining a plurality of pockets to hold numerous articles. Because
this is a case where the improvement is no more than the predictable use of
prior art elements according to their established functions, no further analysis
is required by the Examiner. KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1396.

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More Post-KSR Combination Obviousness at the USPTO

In Ex Parte Catan (BPAI, July 3, 2007, per curium), the sole difference between Appellant's claim 5 and the teachings of Nakano was the use of bioauthentication in place of Nakano’s password authentication. Harada showed that it was known in the art at the time of the invention to use a bioauthentication device on a remote control to provide the bioauthentication information.

According to the precedential opinion,

Since each individual element and its function, as described in claim 5, are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and that of the prior art rests not on any individual element or function but in the very combination itself; that is, in the substitution of Harada’s bioauthentication device for Nakano’s manual authentication means. Where, as here "[an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result," KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1395 (citing United States v. Adams, 383 U.S. 50-51, 148 USPQ 479, 483 (1966)). In that regard, Appellant has provided no evidence that replacing Nakano’s manual authentication means with Harada’s known bioauthentication means yields an unexpected result or was beyond the skill of one having ordinary skill in the art.

The Appellant’s own Specification only generally describes the idea of incorporating a bioauthentication device, such as a fingerprint sensor, into a consumer electronics device and the matching function needed to compare the scanned bioauthentication information with the stored bioauthentication information (e.g., Specification 6:6-7 and 6:17-7:2). The Specification does not provide a detailed description of the implementation in hardware or software of the bioauthentication device. Furthermore, Appellant’s Specification as well as Appellant’s arguments do not present any evidence that including the bioauthentication device into the consumer electronic device was uniquely challenging or difficult for one of ordinary skill in the art.

As in Leapfrog, the device defined by claim 5 is an adaptation of an old invention (Nakano) using newer technology that is commonly available and understood in the art (Harada). Adding bioauthentication to the Nakano device does no more to Nakano’s device than it would do if it were added to any other device. The function remains the same. Predictably, bioauthentication adds greater security and reliability to an authorization process (FF 12). This variation on Nakano’s device, whereby the manual authentication means of the Nakano device is replaced with Harada’s bioauthentication means, appears to present no unexpected technological advance in the art. One of ordinary skill in the art of consumer electronic devices would have found it obvious to update the Nakano device with the modern authentication components of the Harada bioauthentication means and thereby gaining, predictably, the commonly understood benefits of such adaptation, that is, a secure and reliable authentication procedure (FF 12).

Appellant argues that the Examiner has failed to provide sufficient reasoning to reach a conclusion of obviousness based on the prior art (Appeal Br. 11-20). Appellant repeatedly argues for application of the teaching, suggestion, motivation (TSM) test, stating that "[t]here must be some suggestion or motivation, either in the references themselves, or in the knowledge generally available to one of ordinary skill in the art, to modify a reference or to combine reference teachings" (e.g., Appeal Br. 11). The Supreme Court noted in KSR that although the TSM test "captured a helpful insight," an obviousness analysis "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art
would employ." 127 S.Ct. at 1741, 82 USPQ2d at 1396.

The claim is to a structure already known in the prior art that is altered by the mere substitution of one known element for another element known in the field for the same function. The facts themselves show that there is no difference between the claimed subject matter and the prior art but for the combination itself. "[T]he mere existence of differences between the prior art and an invention does not establish the invention's nonobviousness. The gap between the prior art and respondent's system is simply not so great as to render the system nonobvious to one reasonably skilled in the art." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976) (holding that claims directed to a machine system for automatic record keeping of bank checks and deposits were obvious in view of the use of data processing equipment and computer programs in the banking industry at the time of the invention in
combination with a prior art automatic data processing system using a programmed
digital computer for use in a large business organization). Appellant has presented no evidence that combining the Nakano device with the Harada bioauthentication means would have required anything more from one of ordinary skill in the art than to substitute one authentication means for a more advanced one. Accordingly, we hold that the subject matter of claim 5 would have been obvious to one of ordinary skill in the art given the teachings of Nakano and Harada.

Nonetheless, our holding is further buttressed by the teaching in Dethoff of the substitutability of a voice print authentication for a PIN authentication (FF 10). In particular, Dethloff teaches that it was known in the art at the time of the invention to substitute a PIN authentication with bioauthentication to enable a user to access credit (FF 10, 20).

Further, Harada provides sufficient motivation for one skilled in the art to use this bioauthentication information, such as a voice print or fingerprint, in lieu of a PIN in order "to prevent unauthorized tampering with [certain terminal setting] data by persons who may have access to the remote control apparatus," "to ensure that the type of service which is provided by a terminal apparatus to the users of its remote control apparatuses is selectively controlled in accordance with various different categories of uses, e.g.[,] adults and children," and "to reliably ensure that certain services which should be available only to a specific individual user … and which can be requested by operation of a remote control apparatus, will in fact be made available only to the appropriate individual, when a number of different individuals can use remote control apparatus to communicate with that same terminal apparatus" (FF 10). The use of a PIN code is not as reliable an identifier as bioauthentication information because the PIN can be stolen and used without the authorized user’s knowledge (FF 11). On the contrary, bioauthentication information, such as a fingerprint, unambiguously and reliably ensures that a specific authorized user is requesting the service (FF12). Further, use of a PIN code as an identifier is
not as desirable as bioauthentication information because the use of a PIN requires the user to remember the PIN code (FF 13).

Thus, one of ordinary skill in the art would have been motivated to combine
the bioauthentication device of Harada with the system of Nakano because Dethloff teaches that one can substitute bioauthentication information for PIN information, and Harada teaches that it was a common problem at the time of the invention to create a remote control that would reliably ensure that the appropriate person was given access to the system. The use of a fingerprint scanner, such as disclosed in Harada, was an obvious solution to provide a more reliable means of identification than the PIN code of Nakano.

. . . The decision of the Examiner to reject of claims 5-11 and 13-16 under 35 U.S.C. § 103(a) as obvious over Nakano, Harada, and Dethloff is affirmed.

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Foreseeable Surrender of Equivalents Objectively Determined from Original Claim Scope at Time of Amendment

In Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. (July 5, 2007), The Federal Circuit held that "foreseeability [under the Doctirne of Equivalents] does not require the applicant to be aware that a particular equivalent would satisfy the insubstantial differences test or the function/way/result test with respect to the claim as amended." Instead, “an equivalent is foreseeable if one skilled in the art would have known that the alternative existed in the field of art as defined by the original claim scope, even if the suitability of the alternative for the particular purposes defined by the amended scope were unknown.”

In the U.S., the doctrine of "prosecution history estoppel limits the range of equivalents available to a patentee by preventing recapture of subject matter surrendered during prosecution of the patent." Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1579 (Fed. Cir. 1995). The burden is on the patentee to establish that the reason for the amendment was unrelated to patentability. Warner-Jenkinson, 520 U.S at 33. If the patentee fails to meet this burden, the court must presume that the patentee "had a substantial reason related to patentability for including the limiting element added by amendment." Id. If there is a substantial reason related to patentability "prosecution history estoppel would bar the application of the doctrine of equivalents as to that element." Id. However, in Festo VIII, 535 U.S. at 740, the Supreme Court held that the patentee may prove that the amendment did not surrender the particular equivalent by demonstrating that one of three exceptions is met, namelythat
  1. the equivalent was "unforeseeable at the time of the application,"
  2. "the rationale underlying the amendment [bears] no more than a tangential relation to the equivalent in question," or
  3. that "some other reason suggest[s] that the patentee could not reasonably be expected to have described the insubstantial substitute in question." Festo VIII, 535 U.S. at 740-41.
In a series of related decisions, the Supreme Court [in Festo VIII] established that the purpose of the amendments to the original claims of the application ultimately issuing as the ’125 patent was to overcome a Section 112 rejection, and therefore "the amendments were made for a reason relating to patentability." The Federal Circuit [in Festo X] also established that the "tangential" and "some other reason" exceptions are inapplicable. Therefore, the sole question in this case was whether the equivalent was "unforeseeable at the time of the application." Festo VIII, 535 U.S. at 740-41.

On remand from the Supreme Court, the Federal Circuit concluded that "unforeseeable at the time of the amendment" meant "whether the alleged equivalent would have been unforeseeable to one of ordinary skill in the art at the time of the amendment." Festo X, 344 F.3d at 1369. They noted that later-developed technology or technology that was not known in the pertinent prior art was "usually" not foreseeable. Id. However, they explained that "old technology, while not always foreseeable, would more likely have been foreseeable. Indeed, if the alleged equivalent were known in the prior art in the field of the invention, it certainly should have been foreseeable at the time of the amendment." Id.

During prosecution, amendements and a new independent claim were added for a “cylindrical sleeve made of a magnetizable material” and the term “sealing means” was replaced with “first sealing rings located axially outside said guide rings.” The accused device included a sleeve member made of a non-magnetizable material (aluminum alloy), with only one sealing ring.
The question then became whether the use of a non-magnetizable sleeve or a single sealing ring was known as an alternative in the prior art at the time of amendment. Because the Federal Circuit concluded that use of non-magnetizable sleeves (including aluminum sleeves) was foreseeable under the original broader claim, they did not determine whether use of a single sealing ring was foreseeable.

According to the Federal Circuit,

We disagree that the foreseeability test requires application of the function/way/result or insubstantial differences test. Rather, we find that
an alternative is foreseeable if it is disclosed in the pertinent prior art
in the field of the invention. In other words, an alternative is foreseeable
if it is known in the field of the invention as reflected in the claim scope
before amendment. We have no occasion here to determine in what other
circumstances an equivalent might be foreseeable. . . .

Even if we were to assume that Festo’s argument was consistent with the purpose of the doctrine of equivalents, we conclude that, contrary to Festo’s argument, the foreseeability requirement does not require the knowledge that the equivalent would satisfy the function/way/result test or the insubstantial differences test.

. . . Festo also offers no persuasive theory as to why the function/way/result test applied to the claims as amended should be used to determine foreseeability. To adopt Festo’s argument, in fact, makes no sense. First, the function/way/result or insubstantial differences test is designed to determine whether the alternative is sufficiently close to the claimed feature that the patentee should be able to capture the equivalent and bar its use by a competitor. The test is not designed to determine whether prosecution history estoppel applies as a result of a limiting amendment. Festo offers no rationale for importing a test designed for one purpose into an entirely different context.

. . .Finally, and most important, Festo’s test focuses on the wrong claim. The
question is not whether after the narrowing amendment the alternative was a
known equivalent, but rather whether it was a known equivalent before the
narrowing amendment. The purpose of an amendment typically is to avoid the prior
art. If at the time of the amendment, the equivalent was known in the pertinent
prior art, the applicant should not be able to recapture it simply by
establishing that a property of the equivalent—irrelevant to the broader claim
before amendment—was relevant but unknown with respect to the objectives of the
narrower amended claim. In other words, an equivalent that is foreseeable as an
alternative to the broader claimed feature does not become unforeseeable simply
because the claimed feature is narrowed. For example, if a claim before
amendment broadly claimed a metal filament for a light bulb but was later
amended to avoid prior art and to specify metal A because of its longevity, the
equivalent metal B, known in the prior art to function as a bulb filament, is
not unforeseeable even though its longevity was unknown at the time of
amendment.

Adopting this standard for foreseeability is not unfair when a reasonable
applicant at the time of the amendment would have been aware of the equivalent
as an alternative under the broader claim before the amendment. Under such
circumstances the applicant can properly be charged with surrender by narrowing
the claim to exclude the alternative. The Supreme Court noted that a surrender
is appropriate where "the inventor turned his attention to the subject matter in
question, knew the words for both the broader and narrower claim, and
affirmatively chose the latter." Festo VIII, 535 U.S. at 734-35.

We thus conclude that the function/way/result test or insubstantial
differences test is inapplicable to the question of foreseeability. An
equivalent is foreseeable if one skilled in the art would have known that the
alternative existed in the field of art as defined by the original claim scope,
even if the suitability of the alternative for the particular purposes defined
by the amended claim scope were unknown.

. . . The question then becomes whether the use of a non-magnetizable sleeve or a single sealing ring was known as an alternative in the prior art at the time of amendment. Because we conclude that use of non-magnetizable sleeves (including
aluminum sleeves) was foreseeable under the original broader claim, we need not determine whether use of a single sealing ring was foreseeable.

Dr. Stoll’s original claim 1 did not include a requirement for a magnetizable sleeve and the claimed sleeve (which could have been composed of any material) was not designed to shield the magnetic field but rather to enclose the magnets. . . .
In response to the examiner’s rejection and in light of the prior art, Dr. Stoll withdrew original claims 1 and 8 and filed a new amended claim that included a requirement for a magnetizable sleeve. A non-magnetizable sleeve was clearly known as available to perform the magnet-enclosing objectives of the claims before the amendment.

. . . We conclude that use of an aluminum alloy sleeve was foreseeable at the time of amendment because the pertinent prior art disclosed a non-magnetizable sleeve. Festo could have claimed use of a non-magnetizable sleeve but did not do so. Accordingly, we find that the equivalent was surrendered by amendment.

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Archived updates for Monday, July 02, 2007

Forum Choice Clause Requirements in European Licensing Disputes


According to the IPR Helpdesk, although Council Regulation (EC) No 44/2001 establishes an exclusive competence in matters related to validity and registration of IP rights, a dispute related to an IPR contract will seldom concern this issue as the main object of proceedings. Therefore, in order for European forum-choice clauses to be valid in an intellectual property license, certain requirements need to be complied with:
  1. they must fulfil certain formal requirements2;

  2. they must grant jurisdiction to the court(s) of a Member State;

  3. at least one of the parties to the contract has to be domiciled in a Member State;

  4. the object of the contract cannot be one for which exclusive competences are established3.

The forum-choice clause must have been agreed: a) in writing (or by electronic means which provides a durable record); (b) in accordance with the regular practices established between the parties; or (c) in a form with is widely use in that field of international trade and the parties are ought to have been aware of.

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Indefiniteness for Failure to Support Linkage of Elements

In Hyatt v. Dudas (June 28, 2006), the Federal Circuit held that an adequate prima facie case for rejection under the written description requirement exists where the Examiner asserts that the application fails to "provide support for the linkage of the claimed elements creating the embodiment:"
Here, we hold the examiner’s initial rejection complied with § 2163.04(I)(B), followed Alton, and accomplished the aims of the prima facie case. For example,
in rejecting application claim 163, the examiner explained that the written
description did not support the particular claimed combination of elements, even
listing each and every element of the allegedly unsupported combination. And the
examiner was explicit that while each element may be individually described in
the specification, the deficiency was the lack of adequate description of their
combination—he stated, "While each element may individually be discussed neither
the specification nor drawings clearly support the claimed embodiment as a
whole." Id. (emphasis added). He further indicated what Hyatt needed to address
his concern: "[I]t is not enough that applicant show where each claimed element
resides in the earliest filed application but [he] must also provide support for
the linkage of the claimed elements creating the embodiment." Id. (emphasis
added).

Hyatt was clearly notified of what exactly the examiner felt was missing by way of written description. . . .

We hold that an examiner, by complying with MPEP § 2163.04(I)(B) and thus our decision in Alton, sets forth a sufficient prima facie basis for a rejection due to lack of written description. The decision of the district court that compliance with § 2163.04(I)(B) is insufficient to establish a prima facie case and shift the burden to the applicant must therefore be

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Negative Properties of Closest Compound in Broad Selection Not Obvious to Try

In Takeda Chemical Industries, LTD., et al. v. Alphapharm PTY., LTD., et al. (June 28, 2006), the Federal Circuit held that "in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound:"

Rather than identify predictable solutions for antidiabetic treatment, the prior art disclosed a broad selection of compounds any one of which could have been selected as a lead compound for further investigation. Significantly, the closest prior art compound (compound b, the 6-methyl) exhibited negative properties that would have directed one of ordinary skill in the art away from that compound. Thus, this case fails to present the type of situation contemplated by the Court when it stated that an invention may be deemed obvious if it was "obvious to try." The evidence showed that it was not obvious to try.

Similarly, Alphapharm’s reliance on Pfizer fares no better. In Pfizer, we held that certain claims covering the besylate salt of amlodipine would have been obvious. The prior art included a reference, referred to as the Berge reference, that disclosed a genus of pharmaceutically acceptable anions that could be used to form pharmaceutically acceptable acid addition salts, as well as other publications that disclosed the chemical characteristics of the besylate salt. Pfizer, 480 F.3d at 1363. Noting that our conclusion was based on the "particularized facts of this case," we found that the prior art provided "ample motivation to narrow the genus of 53 pharmaceutically-acceptable anions disclosed by Berge to a few, including benzene sulphonate." Id. at 1363, 1367. Here, the court found nothing in the prior art to narrow the possibilities of a lead compound to compound b. In contrast, the court found that one of ordinary skill in the art would have chosen one of the many compounds disclosed in Sodha II, of which there were over ninety, that "did not disclose the existence of toxicity or side effects, and to engage in research to increase the efficacy and confirm the absence of toxicity of those compounds, rather than to choose as a starting point a compound with identified adverse effects." Thus, Pfizer does not control this case.

Based on the record before us, we conclude that the district court’s fact-findings were not clearly erroneous and were supported by evidence in the record. Moreover, we reject the assertion that the court failed to correctly apply the law relating to prima facie obviousness of chemical compounds. Because Alphapharm’s obviousness argument rested entirely on the court making a preliminary finding that the prior art would have led to the selection of compound b as the lead compound, and Alphapharm failed to prove that assertion, the court did not commit reversible error by failing to apply a presumption of motivation. We thus conclude that the court did not err in holding that Alphapharm failed to establish a prima facie case of obviousness.


Circuit Judge Lourie also noted that the "test for prima facie obviousness for chemical compounds is consistent with the legal principles enunciated in KSR" v. Teleflex:

We have held that "structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness." Dillon, 919 F.2d at 692. In addition to structural similarity between the compounds, a prima facie case of obviousness also requires a showing of "adequate support in the prior art" for the change in structure. In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985).

We elaborated on this requirement in the case of In re Deuel, 51 F.3d 1552, 1558 (Fed. Cir. 1995), where we stated that "[n]ormally a prima facie case of obviousness is based upon structural similarity, i.e., an established structural relationship between a prior art compound and the claimed compound." That is so because close or established "[s]tructural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds." Id. A known compound may suggest its homolog, analog, or isomer because such compounds "often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties." Id. We clarified, however, that in order to find a prima facie case of unpatentability in such instances, a showing that the "prior art would have suggested making the specific molecular modifications necessary to achieve the claimed invention" was also required. Id. (citing In re Jones, 958 F.2d 347 (Fed. Cir. 1992); Dillon, 919 F.2d 688; Grabiak, 769 F.2d 729; In re Lalu, 747 F.2d 703 (Fed. Cir. 1984)).

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