Edmund C. Rogers, a well-known patent attorney in St. Louis, and a past president of the AIPLA, would often muse at lunch, “when does meat tenderizer stop working?”  A similar question might be posed about any of the qualifying language we lawyers pack into our applications and other legal writings.  In two cases this year, the Federal Circuit addressed to what the qualifications “in the preferred embodiment” and “the present invention” apply.

In Howmedica Osteonics Corp. v. Zimmer, Inc., 822 F.3d 1312 [119 USPQ2d 1290] (Fed. Cir. 2016), the Federal Circuit (O’Malley, Plager and Wallach) rejected Stryker’s arguments that the introductory clause “in the preferred embodiment” applies to not only to the sentences in which it is located, but also to the entirety of the passage. Thus it is error to import the “essentially midway” language from the specification in the claim.  The Federal Circuit disagreed, finding that “context reveals that such introductory clauses limit only the sentences in which they are located in this case.”

In Unwired Planet, LLC v. Apple Inc., 119 USPQ2d 1517 (Fed. Cir. 2016), the Federal Circuit (Moore, Bryson and Reyna), rejected the District Court’s determination that details in a paragraph of the description following a sentence that began “The present invention” became mandatory claim limitations to be read into the claims.  The Federal Circuit disagreed that “the second sentence in the summary of the invention constitutes a disclaimer that limits the scope of every claim.”

The lesson from these cases is that when you use qualifying language, you have to be clear when it applies and when it doesn’t.  You need to be clear what is part of the preferred embodiment and what isn’t.  Likewise, if you can’t resist the temptation to use “the present invention,” you have to control to when, it applies and when it doesn’t.

Controlling language is within our power, meat tenderizer on the other hand . . .

§112(f) allows a patent applicant to claim an element by the function it performs, however functionally claimed elements using §112(f) are limited to what is disclosed in the specification and equivalents.  The classic form of a 112(f) claim element is:

means for + [GERUND]

for example “means for fastening.”  However, many prosecutors, attempting to free themselves from the bounds of the structures disclosed in their specifications, attempt to claim an element by the function it performs.]

However, it is not possible to write a truly functional claim that avoids 112(f).  A claim element that does not use the word “means” is presumed to not invoke §112(f), but if it fails to recite “sufficiently definite structure” or recites “function without reciting sufficient structure for performing that function,” then that element will nevertheless be construed under 112(f).  The standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure.  Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1346 [115 USPQ2d 1105] (Fed. Cir. 2015).

If the functional term is found to have  a sufficiently definite meaning as the name for structure, the prosecutor has succeeded in broadly claiming the invention, while if it is not found to have a sufficiently definite structural meaning, then 112(f) applies, whether or not that is what the prosecutor intended.

While converting the gerund “fastening” in the example above, to “fastener” would seem to be safe, one cannot be completely certain that the selected term conveys a sufficiently definite structural meaning. See Advanced Ground Info. Sys., Inc. v. Life360, Inc., 119 USPQ2d 1526 (Fed. Cir. 2016)(symbol generator) ; Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, [116 USPQ2d 1144, 1148] (Fed. Cir. 2015)(compliance mechanism); Williamson v. Citrix Online, LLC, 792 F.3d 1339 [115 USPQ2d 1105, 1112 (Fed. Cir. 2015) (distributed learning control module). Thus, whenever a claim element is named functionally, the prosecutor should make sure that specification broadly discloses corresponding structure, in case the courts decide to construe the element under 112(f).

In Affinity Labs of Texas v. Amazon.com, Inc., [2015-2080] (September 23, 2016) the Federal Circuit affirmed judgment on the pleadings that U.S. Patent No. 8,688,085 on a System and Method to Communicate Targeted Information was directed to unpatentable subject matter.

The Federal Circuit found that the district court’s conclusion was consistent with its
approach to the “abstract idea” step in prior cases, including In re TLI Communications LLC Patent Litigation, which involved a patent on a method for uploading digital images from a cellular telephone to a server, which would then classify and store the images.  The Federal Circuit further found that the idea of the ‘085 patent was “even broader and more abstract” than the idea in Ultramercial, where a process of allowing
a consumer to receive copyrighted media in exchange for watching a selected advertisement was found to be an abstract idea.

The Federal Circuit rejected the argument that ’085 patent embodied a concrete
technological innovation, noting the purely functional nature of the claim, which confirms that it is directed to an abstract idea, not to a concrete embodiment of that idea.  The Federal Circuit said that claims thus do not go beyond stating the relevant functions in general terms, without limiting them to technical means for performing the functions that are arguably an advance over conventional computer and network technology.

The Federal Circuit concluded that In sum, the ‘085 patent was not directed to the
solution of a “technological problem,” nor was it directed to an improvement in computer or network functionality.  It claims the general concept of streaming user-selected content to a portable device. The addition of basic user customization features to the interface did not alter the abstract nature of the claims and does not add an inventive component that renders the claims patentable.

There are a number of ways that a patent applicant can end up with less than the patent applicant appeared to claim:

No. 10 Disclaiming claim scope during prosecution of the application.  However, this disclaimer must be clear and unmistakable.  Omega Engineering, Inc, v. Raytek Corp., 334 F.3d 1314, 1325-26 (Fed. Cir. 2003).

No. 9 Distinguishing the prior art.  See, SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187 [108 U.S.P.Q.2d 1001] (Fed. Cir. 2013)(excluding the use of beads from the claimed three dimensional culturing based upon statements distinguishing the prior art).

No. 8 Criticizing the prior art.  See, Chicago Board Options Exchange Inc. v. International Securities Exchange LLC, 677 F3d 1361 [102 USPQ2d 1683] (Fed. Cir. 2012)(limiting scope of claims based upon characterization of prior art as “antiquated,” and having “inherent inadequacies,” and “deficiencies.”); Scimed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337 [58 USPQ2d 1059] (Fed. Cir. 2001)(limiting claims to “coaxial lumen configuration” based, in part, criticisms of the dual lumen prior art in the Background Of the Invention.); Astrazeneca AB v. Mutual Pharmaceutical Co., 72 USPQ2d 1726 [72 USPQ2d 1726, 1730] (Fed. Cir. 2004)(limiting the meaning of solubilizer because of criticisms of prior art).

No. 7 Identifying “Objects” of the Invention.  See, The Gentry Gallery Inc. v. The Berkline Corp., 45 USPQ2d 1498 (Fed. 1998)(liming the location of controls so that the claimed invention meets the objects).

No. 6 Failing to describe more than one embodiment.  See, Wang Laboratories, Inc. v. America Online Inc., 197 F3d 1377 [53 USPQ 1161] (Fed. Cir. 1999)(determining that the claims were properly limited to the “only embodiment described.”); General American Transportation Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 770, 772, [39 USPQ2d 1801, 1803, 1805-06] (Fed.Cir. 1996)(limiting the claims to the disclosure which was “not just the preferred embodiment of the invention; it is the only one described”); Watts v. XL Systems Inc., 232 F3d 877, 56 USPQ2d 1836 (Fed. Cir. 2000)(limiting sealingly connected because the specification “ only describes one method in which ‘tapered external threads [are] dimensioned’ to achieve the sealing connection.”); Modine Mfg. Co. v. United States Int’l Trade Comm’n, 75 F.3d 1545, 1551 [37 USPQ2d 1609, 1612] (Fed. Cir. 1996)(claimed limited to disclosed embodiment because “when the preferred embodiment is described in the specification as the invention itself, the claims are not necessarily entitled to a scope broader than that embodiment.”).

No. 5 Using i.e. instead of e.g.  See Edwards Lifesciences LLC v. Cook Inc., 582 F3d 1322 [92 USPQ2d 1599] (Fed. Cir. 2009)(limiting the construction of the term malleable, because “the specification’s use of “i.e.” signals an intent to define the word to which it refers.”); see, also, Abbott Laboratories v. Novopharm Ltd., 323 F3d 1324 [66 USPQ2d 1200] (Fed. Cir. 2003).

No. 4 Incorporating definitions or limitations “by reference.”  X2Y Attenuators, LLC v. Int’l Trade Comm’n, 757 F.3d 1358 [111 USPQ2d 1607, 1610 (Fed. Cir. 2014)(claims limited by statements incorporated by reference).

No. 3 Failing to Identify described matter as “preferred.”  See Honeywell International Inc. v. ITT Industries Inc., 452 F3d 1312 [79 USPQ2d 1294, 1299] (Fed. Cir. 2006)( limiting “fuel injection system component” to a fuel filter because a fuel filter was not merely discussed as a preferred embodiment); see, also, Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328 [56 USPQ2d 1208](Fed. Cir. 2000)(Claims limited to use of citric acid where “preferably” language separated by a comma, and thus did not apply.).

No. 2 Use of unnecessarily narrow language.  For example “very important” (Inpro II Licensing, S.A.R.L. v. T-Mobile USA, Inc., 450 F.3d 1350 [78 USPQ2d 1786, 1788] (Fed. Cir. 2006)(limiting claims because of “very important” feature described in specification.)); “important feature,” (SafeTCare Manufacturing Inc. v. Tele-Made Inc., 497 F3d 1262 [83 USPQ2d 1618] (Fed. Cir. 2007)(limiting claims because of an “important feature of the present invention” described in specification).);  “critical,” (harmacia & Upjohn Co. v. Mylan Pharm., Inc., 182 F.3d 1373 [50 USPQ2d 1033, 1037] (Fed. Cir. 1999)(limiting the claims because the specification indicated that “the use of spray-dried lactose is a critical feature of the present invention.”).) “necessary,” (Atofina v. Great Lakes Chemical Corp., 441 F.3d 991 [78 USPQ2d 1417, 1421](Fed. Cir. 2006)(Statement in specification that “it is necessary to have a catalyst to have a catalyst containing solely chromium” limited claims).); “solely,” (Atofina v. Great Lakes Chemical Corp 441 F.3d 991 [78 USPQ2d 1417, 1421]( (Fed. Cir. 2006) (Statement in specification that “it is necessary to have a catalyst to have a catalyst containing solely chromium” limited claims).); “essential,” (X2Y Attenuators v. ITC, [110 USPQ2d 1707, 1610] (Fed. Cir. July 7, 2014)(limiting claims to sandwich configuration because of description in specification that the sandwich configuration is “an essential element among all embodiments”).)  “requires,” (Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1367 [81 USPQ2d 1545, 1549] (Fed. Cir. 2007)(limiting the claims because of a statement in the specification that successful manufacture “requires” a particular step).);  and “universal” (X2Y Attenuators v. ITC, [110 USPQ2d 1707, 1610] (Fed. Cir. July 7, 2014)(limiting claims to sandwich configuration because of description in specification that the sandwich configuration is a “feature [] universal to all the embodiments”).)

No. 1 Describing “the invention” rather than embodiments of the invention.  See, Honeywell International Inc. v. ITT Industries Inc., 452 F3d 1312 [79 USPQ2d 1294, 1299] (Fed. Cir. 2006)(limiting “fuel injection system component” to a fuel filter because at least four times the specification described it as “this invention” or “the present invention”); Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021 [113 USPQ2d 1859, 1862] (Fed. Cir. 2015)(noting that “the present invention includes …” or “the present invention is …” or “all embodiments of the present invention are ….” limits the claims); Scimed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1447 [58 USPQ2d 1059] (Fed. Cir. 2001)( limiting claims to “coaxial lumen configuration” based, in part, on description of “the invention” and “the present invention.”); Watts v. XL Sys., Inc., 232 F.3d 877 [56 USPQ2d 1836, 1840] (Fed. Cir. 2000)(limiting claims to use of misaligned taper angles based on description of “the present invention”); Astrazeneca AB v. Mutual Pharmaceutical Co., 384 F.3d 1333 [72 USPQ2d 1726, 1730] (Fed. Cir. 2004)(limiting claims to solubilizers suitable according to the invention).

In The Medicines Company v. Hospira, Inc., [2014-1469, 2014,1504] (July 11, 2016), the en banc Federal Circuit reversed a panel decision finding that U.S. Patent Nos. 7,582,727 and 7,598,343 were invalid under the on-sale bar of §102(b), because of the sales activities of the patent owner’s contract manufacturer,

The Federal Circuit reviewed this history of the §102(b) bar, and the Supreme Court’s two-part Pfaff test, under which the challenger must show (1) the invention was subject to a commercial sale, and (2) the invention was ready for patenting.  Unlike most cases which focus on the second prong of the test, this case focused on the first prong.  The Federal Circuit clarified that the mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for an inventor does not constitute a “commercial sale” of the invention.  The Federal Circuit identified three reasons for its decision:

1. only manufacturing services were sold to the inventor — the invention was not;
2. the inventor maintained control of the invention –retaining title, and the manufacturer was not authorized to sell to third parties.
3. “stockpiling” inventory without more does not trigger the on-sale bar.

Even though this case applies to the pre-AIA version of §102, it will have relevance for many years until the last of the pre-AIA patents expire.

It seems that the majority of patent applications, including those that eventually issue as patents, face a “final” rejection at some point.  However, “final” does not not always mean final, and there are at least eight possible responses to a final rejection.

ABANDON APPLICATION

As much as patent prosecutors hate to admit it, every once in a while the Patent Examiner is right, and the only reasonable response to the Final Office Action is to abandon the application.

REQUEST RECONSIDERATION/AMENDMENT AFTER FINAL

Sometimes a Final Office Action will be premised on an a clear mistake of law or fact, which if pointed out the the Examiner, will result in the withdrawal of the finality of the action, and perhaps even an allowance.  37 CFR §§1.113 and 1.116 address responses after a Final Office Action.   37 CFR §1.116 limits amendment to three situations:

1. An amendment may be made canceling claims or complying with any requirement of form expressly set forth in a previous Office action
2. An amendment presenting rejected claims in better form for consideration on appeal may be admitted; or
3. An amendment touching the merits of the application or patent under reexamination may be admitted upon a showing of good and sufficient reasons why the amendment is necessary and was not earlier presented.

Generally, an Examiner will not permit an amendment unless it complies with 37 CFR §1.116.  Examiners have no incentive to give any substantial attention to a response after final, and they are rarely effective unless they fully comply with the requirements set forth in the Final Rejection.

FILE A REQUEST FOR CONTINUED EXAMINATION (RCE)

If an applicant wants to continue to prosecute the application, presenting additional arguments and evidence, or amending the claims, then the applicant can request continued examination under 37 CFR §1.114.  If an applicant timely files a submission and fee set forth in §1.17(e), the Office will withdraw the finality of any Office Action and the submission will be entered and considered.

RCE’s are a significant part of patent prosecution.  USPTO Statistics show taht approximately 30% of the applications waiting examination are applications in which an RCE has been filed:

The USPTO treatment of RCE’s has changed over time — in 2009 the USPTO changed the Examiner’s incentives to handle RCE, which resulted in a large backlog, but various changes in USPTO policies have resulted in a steady decline in pendency. 

FILE A CONTINUATION APPLICATION

An application is always free to restart the application process by filing a continuation application.  Unlike an RCE which keeps its original serial number and filing date, a continuation application is a new application, which is assigned a new serial number and filing date (although it claims priority to the parent application).  Continuation applications are put at the bottom of the examination pile, and are a good choice for an applicant who wants to keep the application alive, but is not in a position to provide a complete response to the final rejection, which would be required to file an RCE.

AFTER FINAL 2.0

Although a response after final generally won’t be considered, several years ago the USPTO created an After Final Consideration Pilot 2.0 that gives Examiner a limited additional amount of time (and thus an incentive) to consider compliant submissions under the pilot program.  The current version of the program, which expires September 30, 2016, requires that the applicant file:

1. A request for consideration under AFCP 2.0 (Form PTO/SB/434); and
2. A response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect.

In response to the AFCP submission, the applicant will receive an AFCP 2.0 response form (PTO-2323) that communicates the status of the submission. If the applicant requested an  interview, the the form will also be accompanied by an interview summary.

One can request an examiner interview after final in the ordinary course, but it is up to the discretion of the examiner as to whether to grant that interview request. Here, under the AFCP 2.0 program, the examiner is given additional time to search and/or consider the response, but also it gives applicants an additional opportunity to discuss the application with the examiner, if the response does not place the application in a condition for allowance. To date, the USPTO has not published statistics on the AFCP 2.0 program.

POST-PROSECUTION PILOT PROGRAM (P3) 

A new alternative for patent applications beginning July 11, 2016, and extending to January 12, 2017, is the Post-Prosecution Pilot Program or P3 Program.  The P3 Program provides for (i) an after final response to be considered by a panel of examiners (like the Pre-Appeal Brief Conference), (ii) an after final response to include an optional proposed amendment (like the AFCP 2.0), and (iii) an opportunity for the applicant to make an oral presentation to the panel of examiners (new).

The request for the P3 Program should include:

1. A transmittal form, such as form PTO/SB/ 444, that identifies the submission as a P3 submission and requests consideration under the P3 Program
2. A response under 37 CFR 1.116 comprising no more than five pages of argument; and
3. A statement that the applicant is willing and available to participate in the conference with the panel of examiners.
4. (Optionally) A proposed non-broadening amendment to a claim(s).

PRE-APPEAL BRIEF CONFERENCE

For applicants who have made all the amendments they are willing to make, and presented all of the arguments it has, the is one last stop before an full-blown appeal to the Patent Trials and Appeals Board: the pre-appeal brief conference.

The request must be filed with the Notice of Appeal, and can include up to five pages of reasons why the final rejection is incorrect.  The point of the pre-appeal conference is that the Examiner must discuss (hence “conference) the final rejection with at least two other Examiners.  The hope of applicants, of course, is that the two other Examiner’s will provide a voice of reason so that the final rejection will be withdrawn and the case allowed. However that is only one of the possible outcomes.

In 2015, IP  Watchdog posted the results of a FOIA request for data on the effectiveness of the Pre-Appeal Brief Conferences, the data showed that of the non-defective requests, only 6% resulted in an allowance.  61% of the time, the conference panel decided that there was an issue for appeal.  33% of the time, the conference resulted in a reopening of prosecution, which is at least a partial victory for the applicant.

Drilling down a little further, of the 61% of applications where the Pre-Appeal Brief Conference found an appealable issue, 58% of these applications eventually issued as patents.  Of the 33% of applications where the Pre-Appeal Brief Conference reopened prosecution, nearly 80% of these applications eventually issued as patents.  This data represented the ten years’ experience between when the program began in 2005 through 2015, although the trend since 2009 has been an ever-increasing percentage of Pre-Appeal Brief Conferences finding an appealable issue.

APPEAL

After all the amendments have been made and arguments presented, an applicant is left with no choice but to appeal,  The cost of an appeal is not insignificant, with a Notice of Appeal Fee, the cost of preparing the Brief on Appeal, and the Appeal consideration fee, an applicant can easily spent $8,000 to $12,000, before oral argument.  The time involved is also considerable — typically three to four years. The current (2016) success rate is about 40%, with Examiner being affirmed about 58.2% of the time, being reversed about 28.0% of the time, and partially reversed another 12.8% of the time.

i

In Amgen Inc. v. Apotex Inc., [2016-1308] (July 5, 2016), the Federal Circuit affirmed a preliminary injunction against Apotex from entering the market until 180 days after giving Amgen Notice after receiving its FDA license.

The Federal Circuit held that the commercial marketing provision of the Biologics Act was mandatory.