The One Year Deadline for a PTAB Final Written Decision is more of a Guideline than a Rule (Oh, and the Written Description is more of a Rule than a Guideline)

In Purdue Pharma L.P., v. Collegium Pharmaceutical, Inc., [2022-1482] (November 21, 2023), the Federal Circuit affirmed the Final Written Decision of the PTAB that claims 1–17 of U.S. Patent No. 9,693,961 were unpatentable for lack of written description and anticipation.  The patent is titled “Pharmaceutical Formulation Containing Gelling Agent” and is meant to prevent or deter the abuse of opioid analgesics by the inclusion of at least one aversive agent.

Deadline for Final Written Decision

At the outset, the Federal Circuit rejected Purdue’s argument that the Board lacked authority to issue a Final Written Decision once the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) (one year plus the six-month extension) passed.

Written Description

On written description, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.  The Federal Circuit said it has required that the specification provide sufficient blaze marks to “guide a reader through the forest of disclosed possibilities toward the claimed compound.”  The issue was whether the ’961 specification adequately disclosed the claimed polyglycolyzed glycerides (“PGGs”) as an aversive agent. The Board found the claimed formulation was not disclosed, and the Federal Circuit concluded that substantial evidence supported the Board’s finding.

Although the ’961 claims on their face do not require an aversive agent, the specification makes clear that the claims require “inclusion of at least one aversive agent” and the parties agree that the claims require the use of an aversive agent.  PGGs are identified as a possible surfactant “useful in accordance with the present invention.”  While the specification discloses that some surfactants can be gelling agents and that gelling agents can satisfy the aversive agent requirement, the parties agree that not all surfactants are gelling agents.  The specification does not say that PGGs are gelling agents.  The only time PGGs are mentioned in the specification, they are described as a surfactant, and not as a gelling agent, and surfactants generally are described as “useful in accordance with the present invention.”  In other parts of the specification, the patent recognizes that surfactants can be used completely separate from and in addition to the gelling agent.

The Federal Circuit said that “[j]ust because the specification states PGGs are useful for the invention does not suggest how PGGs are gelling agents. The disclosure of the application does not reasonably convey to those skilled in the art that the inventor had possession of the claimed drug formula containing PGGs as a gelling agent (aversive agent). In other words, there are insufficient blaze marks.” Because the anticipation finding flowed from the lack of written description in the claimed priority application, the finding of anticipation was affirmed.

Co-owned, but Unrelated Application Cited in IDS Does not Inform the Meaning of the Claims

In Malvern Panalytical Inc., v. TA Instruments-Waters LLC, [2022-1439] (November 1, 2023), because the district court erred in construing “pipette guiding mechanism,” the Federal Circuit vacated the stipulated judgment of non-infringement of U.S. Patent Nos. 8,827,549 (“the ’549 patent”) and 8,449,175 and remanded for further proceedings.  These patents both disclose microcalorimeters, which are machines that measure the amount of energy absorbed or released during a chemical reaction between two compounds.

Malvern and Waters disputed whether the term “pipette guiding mechanism” encompasses only manual guiding mechanisms (Waters’s position) or covers both manual and automatic guiding mechanisms (Malvern’s position). The Federal Circuit agreed with Malvern that “pipette guiding mechanism” means a mechanism that guides the pipette assembly manually or automatically.

Starting with the claim language, the Federal Circuit concluded that “pipette guiding mechanism” has a plain and ordinary meaning—a mechanism that guides the pipette assembly.  It is appropriate to construe this term by looking to the words “pipette,” “guiding,” and “mechanism” individually.  Looking at the individual words in the claim, the immediately apparent meaning is that a “pipette guiding mechanism” is a mechanism that guides the pipette. The claim language contains no restrictions that would suggest that the “pipette guiding mechanism” is only manual. Instead, the broad claim language supports the conclusion that the “pipette guiding mechanism” encompasses both manual and automatic embodiments.

The specification confirms the broader understanding of the “pipette guiding mechanism.” It discloses two embodiments of the guiding mechanism. The first embodiment is a guide arm that can move only by way of a guide rod where permitted by guide grooves.  The second is a guide arm that can only move where permitted by a coaxial guide sleeve.  The specification contains no language describing the invention as limited to a manual guiding mechanism, stating that “the present invention ‘is,’ ‘includes,’ or ‘refers to’” a manual guiding mechanism, or “expressing the advantages, importance, or essentiality” of a manual guiding mechanism.

The district court took a different view, concluding that “pipette guiding mechanism” is a coined term with no commonly understood meaning in the art.  On this basis, the district court concluded that “pipette guiding mechanism” “cannot be construed broader than the disclosure in the specification.”  The Federal Circuit said that it has sparingly applied this principle of construction in other cases.  The district court’s analysis predominantly addressed whether “pipette guiding mechanism” has a plain and ordinary meaning broadly in the art. The Federal Circuit said that this analysis, however, did not answer the question of what plain and ordinary meaning a term has in the context of a patent, which is the focus of the Federal Circuit’s analysis.  The Federal Circuit said that it discerns plain and ordinary meaning by examining the claims themselves, the specification, and the prosecution history.

The district court relied heavily on the co-owned, but unrelated ’782 patent prosecution history to limit the guiding mechanism to manual embodiments.  The Federal Circuit concluded that merely listing the ’782 patent office actions in the IDS of the patent supplemental examination was insufficient to inform the meaning of “pipette guiding mechanism” in the unrelated ’175 and ’549 patents.  On this basis, the Federal Circuit concluded that the district court erred when it used the ’782 patent prosecution history statements to limit “pipette guiding mechanism” to manual guiding mechanisms.  The Federal Circuit said:

“In the absence of an incorporation into the intrinsic evidence, this court’s precedent takes a narrow view on when a related patent or its prosecution history is available to construe the claims of a patent at issue and draws a distinct line between patents that have a familial relationship and those that do not.”

The amount of characterization of that reference in the IDS impacts how informative we consider that reference when evaluating a patent. For example, listing of references in an IDS does no more than admit “that references in the disclosure may be material to prosecution of the pending claims,” but it does not admit materiality.  Likewise, a patentee has not necessarily admitted that a listed reference’s characterization or use of a claim term bears on the proper construction of that term in the patent.

The Federal Circuit noted that although the ’782 patent applicant argued that the ’968 application discloses only a manual guiding mechanism, the examiner clearly stated its rejection of this argument several times.  In these circumstances, where an applicant abandons its unsuccessful argument, the Federal Circuit concluded that the prosecution history lacks the clarity necessary to establish prosecution disclaimer.

The Reference-Back “the” Language Takes its Meaning (Singular or Plural) from the Meaning of the Antecedent

ABS Global, Inc., Genus Plc, v. Cytonome/ST, LLC, [2022-1761] (October 19, 2023), the Federal Circuit reversed the Board’s finding of no unpatentability of claims 1 and 8 of U.S. Patent No. 10,583,439, and vacated the decision of no unpatentability of claims 2, 6, and 9.  The ’439 patent, titled “Hydrodynamic Focusing Apparatus and Methods,” describes and claims a microfluidic device for “particle” processing.

The Board determined that, as a matter of claim construction, “the sample stream” language in claim 1 had a singular-only meaning, not allowing a plurality of streams or a split stream.  The Board also rejected ABS’s obviousness challenges, and their reasoning depended on their claim construction that claim 1 required that there be only a single stream, precluding a split one.

The Federal Circuit rejected the PTAB’s construction, explaining that the specific claim language at issue is “a fluid focusing region configured to focus the sample stream.” The use of the definite article, “the,” means that the phrase “the sample stream” refers back to earlier language as an antecedent. The antecedent language is “a sample stream” in the preceding limitation, and it is the singular-only or plural- allowing meaning of that limitation which is determinative.  The reference-back “the” language takes its meaning from the meaning of the antecedent, so if “a sample stream” has a plural-allowing meaning, so does the reference-back “the sample stream” phrase.

The Federal Circuit said two familiar aspects of claim-construction analysis strongly support the plural-allowing meaning here. First, “at least in an open-ended ‘comprising’ claim,” like claim 1 of the ’439 patent, “use of ‘a’ or ‘an’ before a noun naming an object” requires that the phrase be construed to mean “‘one or more’ unless the context sufficiently indicates otherwise.”  Second, the specification here states: “[F]or the purposes of the present disclosure, the term ‘a’ or ‘an’ entity refers to one or more of that entity. As such, the terms ‘a’ or ‘an’, ‘one or more’ and ‘at least one’ can be used interchangeably herein.”

The Federal Circuit found no sufficient basis for rejecting the plural-allowing meaning of “a sample stream” here. The prosecution history has not been shown, or even meaningfully argued, to do so. Nor does anything in the specification supply a clear and manifest disavowal of that meaning, or totally negate it.  In particular, the singular only meaning is not demanded by the specification’s embodiments, described as nothing more than examples.

Independence Day 2023

July 4 is arguably the most important date in the history of the U.S. John Adams had some specific thoughts on how the day should be celebrated: “It ought to be solemnized with pomp and parade, with shows, games, sports, guns, bells, bonfires, and illuminations, from one end of this continent to the other, from this time forward forevermore.” And inventors have long obliged the Founding Father with tech for the celebration.

IN 1923 Arthur Dean received U.S. Patent No. 1,513,536 on a Toy Mortar suitable for Independence Day celebrations.

In 1902, Edward Howard received U.S. Patent No. 716,547 on a Toy Gun for celebrating Independence Day:

In 1931 Harold Barnes received U.S. Patent No, 1,809,825 on a safety cracker for celebrating Independence Day, and hopefully saving little patriots’ fingers.

In 1962 George Eddy received U.S. Patent No. 3,034,786 on an Action Toy for celebrating Independence Day:

In 2001, a group lead by Michael Sullivan, received U.S. Patent No. 3,034,786 on a Thermochromic Candle.

So go ahead and celebrate with pomp and parade, with shows, games, sports, guns, bells, bonfires, and illuminations, but be careful!

How Many?

An often critical issue in determining patent infringement is how many of a specified claim element are required by the claim. This issue can arise in a variety of ways:

A or An

The general rule is that “a” or “an” means one or more. In KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351 (Fed. Cir. 2000), the Federal Circuit observed:

an indefinite article “a” or “an” in patent parlance carries the meaning of “one or more” in open-ended claims containing the transitional phrase “comprising.” … Unless the claim is specific as to the number of elements, the article “a” receives a singular interpretation only in rare circumstances when the patentee evinces a clear intent to so limit the article. … Under this conventional rule, the claim limitation “a,” without more, requires at least one.

See, also  Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338 (Fed. Cir. 2008).

However, the Federal Circuit indicated that there are situations where “a” or “an” can mean “only one.” See, for example, Harari v. Lee, 656 F.3d 1331 (Fed. Cir. 2011), and Insituform Techs., Inc. v. CAT Contr., Inc., 99 F.3d 1098, 1106 (Fed. Cir. 1996).

How can the careful prosecutor ensure the interpretation he or she wants? One way is to provide a definition in the specification. Thousands of patents do.

  1.  As used herein, “a” or “an” or “the” can mean one or more than one. For example, “a” widget can mean one widget or a plurality of widgets. See, e.g., U.S. Patent No. 1082263.9
  2. As used herein, “a” or “an” may mean one or more than one. See, e.g., U.S. Patent No. 10525082.
  3. Unless otherwise indicated or the context suggests otherwise, as used herein, “a” or “an” means “at least one” or “one or more.” See, e.g., U.S. Patent No. 10546223.
  4.  As used herein, “a” or “an” means “at least one” or “one or more” unless otherwise indicated. See, e.g., U.S. Patent No.7465758.
  5. As used herein, “a” or “an” means at least one, unless clearly indicated otherwise. See, e.g., U.S. Patent No.11275080.
  6. As used herein, “a” or “an” means one or more unless otherwise specified. See, e.g., U.S. Patent No. 9540312.

A problem with definitions is that the prosecutor has to commit to a meaning, and do so by the time of filing. In the examples above definitions #1 and #2 aren’t really definitions at all – they merely state a possible meaning. No options are foreclosed, buy no certainty is achieved. Definitions #3 expresses a preference, but there is still some uncertainty. Definitions #4 – #6 provides a definition that is only superseded by an “indication” or a “specification” otherwise.

More certainty is obtained by specifying “one” or “at least one” when the element is described and claimed.


The simple word “or” has multiple, inconsistent meanings. In some contexts, “or” can express exclusive alternatives. In these cases “A or B” means either A and not B, or B and not A. See, Kustom Signals, Inc. v. Applied Concepts, 264 F.3d. 1326 (Fed. Cir. 2001). In other contexts, “or” can express non-exclusive alternatives. In these cases “A or B” means just A, A and B, or just B. Brown v. 3M, 265 F.3d 1349 (Fed. Cir. 2001).

As discussed above, definitions can help provide some certainty. There are numerous examples:

  1. The term “or” as used in this disclosure is to be understood to refer a logically inclusive or not a logically exclusive or, where for example the logical phrase (if A or B) is satisfied when A is present, when B is present or where both A and B are present (contrary to the logically exclusive or where when A and B are present the if statement is not satisfied). See, e.g., U.S. Patent No. 9747910.
  2. As used herein, “or” is understood to mean “inclusively or,” i.e., the inclusion of at least one, but including more than one, of a number or list of elements. In contrast, the term “exclusively or” refers to the inclusion of exactly one element of a number or list of elements. See, e.g., U.S. Patent No. 10639598.

The examples above provide definitions of an inclusive “or,” but also provide a template of how to define an exclusive “or.”

Alternatively, the careful prosecutor can be more precise in the specification and claims. One way is to claim “A and/or B” for an inclusive “or”, and “either A or B” for an exclusive “or.”


“And” has also caused problems for patent owners.  In Super Guide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 885-86 (Fed. Cir. 2004), the patent owner and the accused infringer disagreed over the effect of “and” in the claim limitation “first means for storing at least one of a desired program start time, a desired program end time, a desired program service, and a desired program type.” The patent owner argued that this language required at least one of any of the four list categories. The accused infringer argued that this language required at least one from each of the four listed categories. The Federal Circuit agreed with the accused infringer, noting that the phrase “at least one of” preceded a series of categories of criteria, and the patentee used the term “and” to separate the categories of criteria, which connotes a conjunctive list. The Federal Circuit cited William Strunk, Jr. & E.B. White, The Elements of Style 27 (4th ed. 2000). The TTAB has reached a similar result in Ex Parte Jung, Appeal 2016-008290 at 2 (P.T.A.B. Mar. 22, 2017).

Thus when enumerating a list, the careful prosecutor must be mindful choosing whether to join the list with “and” or “or”


If “or” and “and” can cause problems, it would seem that “and/or” can likewise cause problems. As Wikipedia notes, “and/or” has come under criticism in the courts. Judges have called it a “freakish fad”, an “accuracy-destroying symbol”, and “meaningless”. In Ex Parte Gross, Application No. 11/565,411, the Examiner rejected claim 1 as indefinite based upon the use of “and/or.” However, the PTAB reversed – finding that “A and/or B” does have a meaning and that meaning is A alone, B alone, or A and B together. The Board noted the “preferred verbiage” should be more simply “at least one of A and B.”

While not popular with legal purists, “and/or” may be the best choice to get the intended claim scope.

Protection for Non-Literal Portions of Code Filtered Out by the Abstraction-Filtration-Comparison Test

SAS Institute, Inc., v. World Programming Limited, [2021-1542] (April 6, 2023), the Federal Circuit affirmed the district court’s determination that SAS failed to establish the copyrightability of its software.

SAS creates and sells a suite of software used for data access, data management, data analysis, and data presentation.  Users of the SAS System write commands in a SAS programming language .  World Programming Limited (“WPL”) created a competing system that uses the SAS programming language to allow users to complete analytics tasks.

Whether a particular component or element of a program is protected by a copyright depends on whether it qualifies as an expression of an idea, rather than the idea itself.  Other doctrines of copyright law detail what elements are not protectable, including scènes à faire elements, material in the public domain, factual material, and elements under the merger doctrine.  The literal elements of computer programs, for example: source and object codes, can be the subject of copyright protection, and as a general matter, and to varying degrees, copyright protection can extend beyond literal elements to nonliteral elements.

The appeal involves only nonliteral elements of the SAS System, i.e., those aspects that are not reduced to written code. These elements include the program architecture, structure, sequence and organization, operational modules, and user interface.  The Federal Circuit explained that using a literary novel as an analogy, the novel’s written words would be the literal elements (e.g., code) and the organization of the chapters, characters, and plot would be the nonliteral elements.  The Federal Circuit observed, that as one moves away from the literal elements to more general levels of a computer program, it becomes “more difficult” to distinguish between unprotectible ideas, processes, methods or functions, on the one hand, and copyrightable expression, on the other.

The Federal Circuit observed that the Second, Fifth, and Tenth Circuits, have adopted the abstraction-filtration comparison test, or method, to determine the scope of copyright protection for computer programs, including their nonliteral elements.  The abstraction-filtration-comparison method involves three steps: First, the court breaks down the allegedly infringed program into its constituent structural parts—abstraction. This step helps a court separate ideas and processes from expression and eliminate those portions of the work that are not eligible for protection.  Second, the court sifts out all non-protectable material—filtration.  The court examines the structural components at each level of abstraction” and “defining the scope of plaintiff’s copyright”.  Third, the trier of fact compares any remaining “core of protectable expression” with the allegedly infringing program to determine if there is in fact a substantial similarity—comparison. SAS contended that the district court legally erred in its application of the abstraction-filtration-comparison test.  The Federal Circuit rejected SAS’ argument that it satisfied its evidentiary burden once it demonstrated that the SAS System was covered by registered copyrights. The Federal Circuit also rejected SAS argument that the district court erred when it shifted the burden to SAS to establish that its asserted elements are protected by copyright law, noting that any plaintiff has to respond to any proof advanced by defendant.

Corroboration of Reduction to Practice Supported Under the Rule of Reason, Supported by Substantial Evidence.

In Dionex Softron GmbH v Agilent Technologies, Inc., [2021-2372] (January 6, 2023), the Federal Circuit affirmed the PTAB decision awarding priority to Agilent in an interference.

In the interference, the Board identified Dionex as the senior party and Agilent as the junior party, thereby requiring that Agilent prove priority by a preponderance of the evidence.

In its analysis, the Board applied the rule of reason and found that the testimony of Wolfgang Kretz, one of Agilent’s two co-inventors, was sufficiently corroborated by
two of his co-workers, Manfred Berndt and Martin Bäuerle, who had worked near Kretz during the relevant time. Berndt and Bäuerle testified that Kretz successfully tested
a prototype encompassing all limitations of the count by June 1, 2007.

Based on the foregoing, the Board entered judgment on priority for Agilent and against Dionex and refused Dionex’s claims. Dionex timely appealed.

The Federal Circuit said that the Board properly treated Agilent’s specification as
the “originating specification” for purposes of construing the disputed claim terms and evaluating the sufficiency of written description support for the claims. When a party
challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language.

The Federal Circuit said that the Board did not err in concluding that Agilent’s specification provided adequate written description support. Dionex’s arguments on this point depend entirely on our adopting Dionex’s proposed claim construction. In other words, Dionex contends there is not adequate written description support for its ordered steps construction of the claim, but we have rejected this proposed construction. Since the Federal Circuit affirmed the Board’s claim construction, Dionex’s written description arguments necessarily failed.

The Board did not err in awarding priority to Agilent. Substantial evidence supports the Board’s findings that Agilent’s actual reduction to practice was sufficiently corroborated
and occurred prior to Dionex’s earliest conception date. The Board’s finding of corroboration, under the rule of reason, is supported by substantial evidence.

The Twelve Days of Christmas

There are more than 20000 patents that relate to or at least mention Christmas, but only one that mentions all of the gifts in the 1780 song The Twelve Days of Christmas: U.S. Patent No. 3,867,237, issued in 1972 on a Pear Tree Decoration . The pear tree has detachable branches and twelve numbered packages containing artificial miniature items corresponding to the items referred to in the Christmas carol.

The patent explains that:

The twelve days of Christmas start tomorrow, and run until the Epiphany on January 6. However, the ‘237 Patent suggests a different timing: “It is intended that the package No. 1 containing the pears and partridge will be opened on December l3. The package No. 2 will be opened on December 14th. The package No. 3 will be opened on December 15th, and so on with another package opened each day in numbered succession so that the package No. 12 will be opened on the 12th day after starting on December 13th. The kit invention 20 designed principally for the entertainment of children, with young children particularly enjoying the excitement of each day placing a new set of decorations or items in the package 30 onto the pear tree 21, starting on December l3th and ending on December 24th, Christmas Eve.

Christmas Tech

Patents are about solutions to problems, and the patent collection contains an interesting history of solving the problems with Christmas Tree Illumination. From 1867 unitl the advent of electric Christmas lights, a surprising amount of effort was devoted to making candles safe for Christmas trees:

U.S. Pnatent 69254 (1867) on Candlestick.
U.S. Patent No. 89,270 (1869) on Candle Holder.
U.S. Patent No. 133479 (1872) on Lantern
U.S. Patent No. 150572 (1874) on Decorative Lanterns
U.S. Patent No. 151055 (1874) Candlesticks for Christmas-Trees
U.S. Patent No. 152817 (1874) on Candle-Holders

U.S. Patent No. 155450 (1874) on Candle-Holders.
U.S. Patent No. 178603 (1876) on Christmas-Tree Bracket.
U.S. Patent No. 183573 (1876) Candle-Holders for Christmas Trees
U.S. Patent No. RE7652 (1877) on Candle-Holder
U.S. Patent No. 194421 (1877) on Illuminating-Devices for Christmas Trees
U.S. Patent No. 202342 (1878) on Candle-Holder
U.S. Patent No. 216628 (1879) on Candy Toy..
U.S. Patent No. 227088 (1880) on Candle-Holder for Christmas-Trees
U.S. Patent No. 227693 (1880) Candle-Holder for Christmas-Trees.
U.S. Patent No. 244045 (1881) Christmas Tree Candle Holder
U.S. Patent No. 266463 (1882) Candle Holder
U.S. Patent No. 270771 (1883) Candle Holder for Christmas Trees

U.S. Patent No. 286572 (1883) Candle Holder for Christmas Trees.

U.S. Patent No. 295182 (1884) Christmas Tree Candle Holder
U.S. Patent No. 298478 (1884) Reflector Support for Candles
U.S. Patent No. 347873 (1886) Candle Holder for Christmas Trees

U.S. Patent No. 373958 (1887) Lamp for Decorating and Illuminating Purposes

The Accidental History Library

The U.S. patent collection is a fabulous record of the history of innovation in the United States, and the rest of the world. But in recording the history of technology, that patent collection also captures glimpses of the broader history of society.

So, before December 7, 1941, there are several references to Pearl Harbor (in the Territory of Hawaii), but always as a place (the address of an inventor). See, for example, U.S. Patent No. US1677261, US1854268, and US2234109. After December 7, 1941, “Pearl Harbor” took on a new meaning as an event, rather than simply a place, reflecting the horrific events of that day, For example US2401521, filed in 1944, on a bomb site, references the “disaster” are Pearl Harbor:

US2471496 filed in 1945 on reclaiming scrap of natural rubber mixed with buna-s, references Pearl Harbor:

US2484051 refers to Pearl Harbor as a point of geographic and historical interest:

US6022637 identified the filing date of a prior art patent with reffe Eleven days after Pearl Harbor (Dec. 18, 1941), Bert Adams applied for a patent on his battery

US8584226 references Pearl Harbor, showing its impact

US8521512 even identifies Pearl Harbor as a “concept”:

US10300779 refers to a possible digital “Pearl Harbor” event:

It is interesting to hear the echo of historical events in the timeline of technology that is the USPTO patent collection.