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.

In Allied Erecting v. Genesis Attachments, LLC, [2015-1533](June 15, 2016), the Federal Circuit affirmed the PTAB’s decision in IPR2014-001006 that claims 1–21 of U.S. Patent No. 7,121,489, were obvious.

Allied first challenged the motivation to combine the references,  arguing that the proposed combination would would entail design and structural changes. However, the Federal Circuit said that it is not necessary that the reference be physically combinable to render the claimed invention obvious.  The criterion is not whether the
references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.  The Federal Circuit added that the fact that a modification has simultaneous advantages and disadvantages does not necessarily obviate motivation to combine.

Allied also argued that the references teach away from the combination.  The Federal Circuit disagreed that the reference taught away from the combination, saying that teaching away is when a person of ordinary skill would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the patentee.  The Federal Circuit noted that the reference did not teach away from the combination because the reference did not address the structure of the second reference.

In Ruckus Wireless, Inc. v. Innovative Wireless Solutions, LLC, [2015-1425, 2015-1438] (May 31, 2016), the Federal Circuit affirmed the district court’s claim construction and resulting judgment of non-infringement.

At issue was whether U.S. Patent Nos. 5,912,895, 6,327,264, and 6,587,473 directed to for providing access to a local area network (LAN) from a relatively distant computer, and more particularly whether “communications path” is these patents was limited to wired paths, or whether communications path also included wireless paths.

The Federal Circuit first confirmed that the district court relied only on intrinsic evidence to construe the term “communications path,” and thus its review of that construction was de novo.

The Federal Circuit found no intrinsic or extrinsic evidence to support IWS’s
assumption that a person of ordinary skill at the time of invention would have understood the plain and ordinary meaning of “communications path” to include wireless communications.  The Federal Circuit observed:

1. The title of the patents indicates that they are directed to “Communicating Information Packets Via Telephone Lines.”
2. The specification describes “[t]his invention” as one “particularly
   concerned” with “two wire lines such as telephone
   subscriber lines.”
3. Every embodiment described in the specification utilizes a telephone
   wire, and when the specification clarifies that the full breadth of the invention is not limited to the expressed embodiments, it declares only that the patents may also
   reach any wired connection.
4. IWS did not present—nor did the district court consult—any extrinsic evidence, such as dictionaries, trade literature, expert testimony, or any other evidence showing that “communications path” was a term of art or otherwise understood to include wireless communications at the time of invention.

The Federal Circuit also found IWS’s claim differentiation arguments unpersuasive, because they did not necessarily broaden the independent claims to include wireless, as opposed to other forms of wired connections.

Finally, the Federal Circuit turned to the “canons” of claim construction, and in particular to the cannon that, “[i]f, after applying all other available tools of claim construction, a claim is ambiguous, it should be construed to preserve its validity.”  Applying this canon, the Federal Circuit noted that if the claims were not limited to wired communication paths, it would “would likely render the claims invalid for lack of written description.”  The Federal Circuit thus concluded that canon favoring constructions that preserve claim validity therefore counsels against construing “communications path” to include wireless communications.

The Federal Circuit thus affirmed the district court’s claim construction and its judgment of non-infringement.

On May 30, 1978, U.S. Patent No. 4,833,729 issued to Nelson C. Fox. Rosetta H.V.G. Fox on Shark Protector Suit.

In Diamond Coating Tech. v. Hyundai Motor, [2015-1844, 2015-1861] (May 17, 2016), the Federal Circuit affirmed the dismissal of a patent infringement action for lack of standing.

The Federal Circuit agreed that Diamond did not possess sufficient rights to make, use, on sell the patented invention, because its assignor Sanyo retained a right and license to make, use, and sell products covered by the patents-in-suit.  The assignment and transfer agreement did not even grant Diamond a right to practice the patents, limiting Diamond’s rights to the prosecution, maintenance, licensing, litigation, enforcement, and exploitation of the patents.

The Federal Circuit said that unless Diamond received all substantial rights in the patents-in-suit at the time it filed suit in the District Court, it was not a “patentee,” and it could not bring suit by itself.  The Federal Circuit said that Sanyo retained significant control over Diamond’s enforcement and litigation activities, and thus Diamond did not receive all substantial rights.

While Diamond and Sanyo executed nunc pro tunc agreements to purportedly clarify the parties’ original intent, the Federal Circuit held that its precedent (Alps South, LLC v. Ohio Willow Wood Co.) prevented nunc pro tunc assignments from conferring confer retroactive patentee status.

Often the appearance of an article is attributable to the nature of the surface as much as its shape.  Reflective surfaces are often depicted in design patent drawings as parallel lines, as in U.S.Patent No. D754125:

The test completes the disclosure: “The oblique shade lines in the Figures show a transparent, reflective, or shiny surface, and not surface ornamentation” (emphasis added).  Sometimes the surface is not reflective as much as the material is reflective.  This is commonly handled withing shading, and again an explanation in the text, as in U.S. Patent No. D733,397::”United States Patent: D733397 The stipple shading represents claimed reflective piping” (emphasis added).