Patent Law

For all those who have been confused and/or down right frustrated by a restriction requirement or two … (Haven’t we all?) … the United States Patent and Trademark Office will be accepting written public comments on restriction practice until August 13, 2010. Click  here to access the Federal Register Notice announcing the request.

Interestingly, the Notice is titled “Request for Comments on Proposed Changes to Restriction Practice in Patent Applications.” However, upon further review, it is clear that that the PTO is not proposing any actual rule changes at this time — just floating some ideas.

Here is a summary of the 6 areas the Office outlined for discussion:

1. What should be included in an Office action that sets forth a restriction requirement?

• Examiners may be required to set forth actual reasons why the inventions are independent or distinct and why there would be a serious burden in the absence of a restriction.

• Support for a “serious burden” might also come from an examination burden (and thus could be supported by non-prior art issues, e.g., under §101 and/or §112, first paragraph).

2. How might the process for traversing or requesting reconsideration of a restriction requirement be improved?

3. What exactly is necessary in order to restrict between related product inventions or related process inventions?

• For such restrictions not otherwise addressed in MPEP §§ 806 through 806.05(j), a restriction would require two-way distinctness (see MPEP § 802.01) and a serious burden on the examiner.

• Where claims define the same essential characteristics of a single invention, e.g., the claims vary only in breadth (ranging from broad to narrow), the examiner could not require restriction between such claims.

4. How could the Office modify Markush practice?

• If an elected species is found allowable, the examination of the Markush-type claim would be extended to the extent necessary to determine the patentability of the claim, i.e., to determine whether any nonelected species is unpatentable for any reason (35 U.S.C. 101, 102, 103, or 112, or nonstatutory double patenting). If a nonelected species is determined to be unpatentable, the Markush-type claim would be rejected, and the search and examination would not be extended to cover all nonelected species.

• For amended Markush-type claims, whether an Office action may be made final would be determined by whether the conditions in MPEP § 706.07 for making a second or subsequent Office action final are met and would not be dependent upon whether the examiner previously required a provisional election of species.

• The Office is exploring situations where restriction would be proper between a subcombination and a combination when a subcombination sets forth a Markush grouping of alternatives.

5. How might the process for determining which claimed inventions are eligible for rejoinder be simplified?

6. What other areas of restriction practice are in need of improvement?

So if you’ve ever wanted to give your 2 cents on how restriction practice can be improved, please remember to submit your written comments to the Patent Office by August 13, 2010. All indications are that rule changes are on the way. We will keep you posted on any developments in this area.

The preceding discussion is intended for informational purposes only and should not be construed as legal advice. Please contact one of our attorneys to learn more about restriction practice or any other aspect of intellectual property law.

Occasionally, a patent practitioner will become aware of a prior art reference after the issue fee has been paid, and the question becomes—will the examiner consider the reference at this late stage?

The short answer is “yes”.  But as you probably guessed, it requires a little more than a simple phone call to the examiner.  Instead, the applicant will need to file a petition under 37 CFR 1.313(c) to have the patent application withdrawn from issue.  This includes payment of the fee set forth in § 1.17(h) and a showing of good and sufficient reasons why the withdrawal is necessary.

While there are three distinct ways to accomplish a withdrawal under 37 CFR 1.313(c), in our experience, it is usually preferable to proceed under section (2) which involves filing a Request for Continued Examination (RCE) under § 1.114 (including payment of the separate RCE fee set forth in 37 CFR 1.17(e)).

In brief, when proceeding under 1.313(c)(2), the newly-discovered reference will be included in an Information Disclosure Statement (IDS) which will qualify as the RCE submission.  Once the RCE and petition are filed (preferably electronically), it is advisable to call the Office of Petitions to notify them of the filing.  (In some cases, it might even be a good idea to call them before filing the petition to make sure you are doing everything correctly.)

Calling the Office of Petitions is a key step since you want to verify immediately that the petition was received and that, if the petition can be granted, it will be granted before the patent issue date.  As MPEP §1308 warns, “… while a petition to withdraw an application from issue may be granted as late as one day prior to the patent issue date, to avoid publication and dissemination, the petition decision must be granted at least 3 weeks prior to the issue date.”

As mentioned previously, there are two other ways to accomplish a withdrawal under 37 CFR 1.313(c).  Under section (1), the applicant can provide an “unequivocal statement that one or more claims are unpatentable, an amendment to such claim or claims, and an explanation as to how the amendment causes such claim or claims to be patentable.”  While we can envision circumstances under which this approach might be appropriate, we would generally avoid it since making such statements can open a Pandora ’s Box of issues including alleged inequitable conduct.

Still a further alternative is section (3) which involves filing a continuing application under 37 CFR 1.53(b) and then expressly abandoning the earlier application.  The usual “RCE vs. CON” factors will come into play when evaluating this option.  However, for a host of reasons—expense being a major one—starting over with an entirely-new application is often undesirable.

Not only is filing a continuation application more expensive than an RCE, but importantly, if the applicant withdraws the application under 1.313(c)(2) by filing an RCE and the application is again found allowable, it is possible to “reapply” the previously-paid issue fee toward the subsequent issue fee.  See MPEP § 1306.  Conversely, if the applicant expressly abandons the earlier application in conjunction with 1.313(c)(3), the previously-paid issue fee is lost.

The preceding discussion is intended for informational purposes only and should not be construed as legal advice.  Please contact one of our attorneys to learn more about this or any other aspect of intellectual property law.

Clients and prospective clients are often eager to obtain patent protection even though their new product (invention) is still “under development”. They often ask: “When should I file a patent application?” and “What type of application should I file?”

If the core of your invention is fairly well established but you are still making improvements, you should strongly consider filing a U.S. provisional patent application.

A U.S. provisional patent application expires 12 months after it is filed. While a provisional application, as such, is never examined by the U.S. Patent and Trademark Office (and thus will not mature into an issued U.S. patent), a provisional application can form the basis for U.S. and non-U.S. patent protection if the proper steps are taken. (Essentially, to retain the benefit of the “provisional” filing date, the provisional application must be converted into a regular, non-provisional U.S. application and/or an International [PCT] application before the end of the 12-month period.)

Thus, in a situation where the product is fairly well developed but refinements are still being made, filing a provisional application would allow the applicant to “lock in” an early effective filing date for the core inventive concept while still leaving opportunities to supplement the original filing during the 12-month period.

This approach highlights some of the major benefits of starting with a provisional application when the core inventive concept, while mostly complete, is still being “fine tuned”. Any time during the 12-month period, you would be able to supplement the first provisional with one or more additional provisional applications—for example, to cover any newly-added features, improvements, modifications, etc. (Typically, the sum total of all provisional disclosures is converted into a regular application during the 12-month period of the first provisional application so as to retain the early effective filing date of the first provisional.)

Additionally, at the time of converting the provisional application(s) to a regular, non-provisional application, you would again have the option to supplement the provisional disclosure.

The preceding discussion is intended for informational purposes only and should not be construed as legal advice. Please contact one of our attorneys to learn more about filing U.S. provisional patent applications or any other aspect of intellectual property law.

The Court of Appeals for the Federal Circuit (CAFC) recently issued on en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., essentially leaving the written description requirement intact.  In that case, Ariad filed a patent application relating to NF-kB and its involvement in activating gene expression underlying the body’s immune response to infection.  Once issued, Ariad and others sued Lilly for infringement, and the district court found that Lilly did indeed infringe some of the claims.  The district court also determined that the patent was not invalid for anticipation, lack of enablement or lack of written description.  On appeal, the CAFC reversed this decision, holding the Ariad patent invalid for lack of written description.  Ariad then petitioned for en banc review, which the CAFC granted.  Relying on the language in the statute, Supreme Court precedent and policy considerations, the en banc court ruled that the written description requirement was indeed separate and independent from the enablement requirement and affirmed that the Ariad patent is invalid for lack of written description. 

In his public blog, Director Kappos provided comments in response to this decision.  He suggests that some of the principles noted by the majority when analyzing whether or not the written description is met were also discussed in the USPTO’s 2001 Written Description Guidelines and exemplified in the 2008 Revised Written Description Training Materials.  He states that one of these principles involves considering “whether the specification discloses a representative number of species, sufficient structure, and/or a sufficient correlation of function to structure.”  Director Kappos suggests that although the written description requirement may not be used in a vast majority of cases, it is nevertheless an important tool for Examiner’s to use when a patentee is attempting to claim more than what he/she has invented.  He specifically mentions the usefulness of written description as it is applied to claims reciting functional language, for example, when a genus claim uses functional language to define what species are encompassed by the claim.

 The Ariad case demonstrates a common problem in the chemical and biotechnology arts.  Typically, an invention is discovered at an early stage, at which point a patent application is filed.  If the invention shows promise, further research is performed, and additional information that may not have been disclosed in the initial patent application is now trying to be claimed.  As noted by Director Kappos, this can occur where a compound is disclosed but a claim directed to a broad genus encompassing the compound is pursued.  Such a claim may be rejected for lack of written description.  To the extent possible, it is generally good practice to include any relevant experimental information showing multiple species in the context of the invention at the time of initial filing of a patent application.

Avid Identification Sys. v. Crystal Import Corp., No. 09-1216 (April 27, 2010)

In Avid, Dr. Hannis Stoddard, who was the founder and president of the company, hired three engineers to develop a product based on his idea of identifying and processing recovered animals.  Dr. Stoddard was not an inventor on the patent that ultimately issued, but he did demonstrate an early version of the technology at a trade show more than a year prior to the filing date of the issued patent.  This demonstration was not disclosed to the PTO during prosecution of the patent, and Dr. Stoddard did not dispute that this information was withheld with specific intent to deceive the PTO for the purposes of obtaining a patent.  He argued that he was neither an inventor nor an attorney and therefore owed no duty of candor to the PTO; however, the district court disagreed and found Avid’s patent unenforceable for inequitable conduct committed by Dr. Stoddard

The regulations governing inequitable conduct are provided by 37 C.F.R. §1.56 (Rule 56), which imposes a duty to disclose information to the PTO when an individual is (1) associated with the filing and prosecution of a patent application, and (2) knows that the information in question is material.  For purposes of identifying who owes a duty of candor to the PTO, Rule 56 defines “individual(s) associated with the filing or prosecution of a patent application” as (1) each named inventor, (2) each attorney or agent that prepares or prosecutes the application, and (3) every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor or assignee.  37 C.F.R §1.56(c).

Dr. Stoddard is neither an inventor nor an attorney or agent involved in the preparation or prosecution of the patent, so the issue of whether or not he owed a duty to candor to the PTO involved an analysis of whether or not he was “substantially involved” in the preparation or prosecution of the patent, and whether or not the prior demonstration was material to patentability.

With respect to “substantially involved,” the CAFC identified a number of factors in affirming the ruling of the district court that Dr. Stoddard met this requirement.  Some of these factors included his position and responsibilities in the company, his involvement in hiring the engineers/inventors to develop the product, and his communication with the inventors during prosecution of the patent in Europe.

With respect to materiality, the CAFC dismissed Avid’s argument that the demonstration was not material to the patentability of the claims even though it would not have lead to a proper §102(b) rejection by the PTO.  Indeed, the demonstration involved a preliminary product that failed to contain all of the elements of the issued patent claims.  Moreover, an infringement jury was given information regarding the demonstration and still found the patent valid.  However, the court reasoned that the demonstration, while not invalidating, was the closest prior art and was thus material.  By doing so, the court relied on the “reasonable examiner” standard, which was written out of the old Rule 56 (i.e., prior to the 1992 amendments).  The current Rule 56 is much more objective and likely would have found this demonstration non-material to patentability.

The CAFC thus affirmed the lower court’s ruling that Avid’s patent was unenforceable for inequitable conduct committed by Dr. Stoddard.  This case seems to be a close call, and it certainly didn’t help that Dr. Stoddard purposefully withheld the information knowing that it would likely have some impact during prosecution.  If anything, this case serves as a reminder to submit any relevant information to the PTO even if the person aware of this information is only remotely involved in the preparation and prosecution of a patent application.

The United States Patent and Trademark Office (USPTO) is considering making a change to pendency of provisional patent applications.  The change, if adopted, would somewhat extend the existing 12‑month provisional application period to 24-months.  This change would be implemented through the missing parts practice common to nonprovisional applications. 

The proposal would benefit applicants by giving them additional time to determine if patent protection should be sought – enabling them to defer additional fees and enabling applicants to focus efforts on commercialization during this expanded provisional period.  

Currently applicants have a one-year period from the filing date of a provisional application to file a corresponding nonprovisional application in order to claim the benefit of the provisional application.  The proposed change would not alter this requirement but instead would provide applicants with more time to reply to a missing parts notice in a nonprovisional application that claims the benefit of a provisional application.

Under the proposal, applicants would be permitted to file a nonprovisional application with at least one claim within the 12-month statutory period after the provisional application was filed, pay the basic filing fee, and submit an executed oath or declaration.  In addition, the nonprovisional application would need to be in condition for publication and applicant would not be able to file a nonpublication request.  Applicants would be given a 12-month period to decide whether to pay the required surcharge and the additional required fees.

The USPTO is currently accepting comments on its proposal before considering it for implementation.  A copy of the USPTO Notice is available here.

Prior unsuccessful attempts to reform the U.S. patent system and rein in massive damages awards have sought to limit damages to the actual economic impact attributable to the claimed invention.  In its most recent bill, the U.S. Senate has shifted its focus from the methodology of the damages analysis, and now seeks to prevent a Plaintiff from presenting a more favorable damages theory absent sufficient evidence to justify its appropriateness. 

 The proposed bill would establish a Daubert like “gatekeeper” role, requiring the district court to exclude unjustified damages theories and evidence.  The proposed bill would mandate that the district courts conduct a thorough hearing on patent damages prior to trial. 

 The bill specifies that “the court shall consider whether one or more of a party’s damages contentions lacks a legally sufficient evidentiary basis” and that “[t]he court shall only permit the introduction of evidence relating to the determination of damages that is relevant to the methodologies and factors that the court determines may be considered in making the damages determination.”  Furthermore, the bill specifically requires that “[t]he court shall identify the methodologies and factors that are relevant to the determination of damages, and the court or jury, shall consider only those methodologies and factors relevant to making such a determination.”  Presumably, such an analysis would be guided by the well established Georgia-Pacific factors.  For a copy of the full version of the current Senate bill, click here.

The Federal Circuit has affirmed an ITC decision finding two asserted patents invalid because they did not satisfy the best mode requirement of 35 U.S.C. §112.

The two patents relate to improved methods of producing L-lysine using genetically modified E. coli.  (L-lysine is a dietary supplement in animal feed and has a multi-billion dollar market worldwide.)  The patent disclosed one method of creating the L-lysine producing E. coli.  However, before the patent applications were filed, the inventors created another, better strain.  (The evidence also established that the better strain was intentionally withheld from the patent applications.)

§112 requires that the inventor disclose the preferred embodiment of the invention and any preferences that materially affect the claimed invention, but only to the extent that information is known by the inventor when an application is filed.

The patentee unsuccessfully argued that the improvements in the better E. coli strain related to other, non-patentable, improvements that were not related to the “inventive aspects” of the claimed invention.

Here, the best mode requirement was not met due to the breadth of the claims.  The asserted claim recited the step of “cultivating a bacterium belonging to the genus [E. coli] … having mutation to desensitize feedback inhibition of L-lysine.”  Because the scope of the claimed invention included “cultivating a bacterium,” the failure to disclose the preferred, and in one case, only bacterial strain used by the patentee to practice the claimed invention the best mode requirement was not met and the asserted patents were held invalid.

See Ajinomoto Co., Inc. v. International Trade Commission (Fed. Cir. 2010).  Link http://www.cafc.uscourts.gov/opinions/09-1081.pdf

Thus, it is important to keep your attorney apprised of any modification to the invention, particularly if you believe the modification is preferred, up to the filing date your patent application.

Note: the current version of the Patent Reform Act of 2010 eliminates the invalidity defense for failing to disclose the best mode, which would likely have  flipped the verdict in a case such as this.

A pilot program of the Trilateral (EPO, JPO and USPTO) PCT-Patent Prosecution Highway began January 29, 2010 and is planned to run for two years.  The program fast-tracks patent examinations in the EPO, JPO and USPTO for PCT applications receiving a positive written opinion of the International Searching Authority or the International Examining Authority from the EPO, JPO, or USPTO.  Such a positive opinion must come in the form of: (i) a written opinion from the ISA; (ii) a written opinion from the IPEA; and/or (iii) an IPER from the IPEA. 

In effect, the work product from any of these patent authorities (acting in its PCT capacity) serves as the basis for a petition to make special in the USPTO.

US Applicants my request participation by filing the appropriate form (Form PTO/ SB/20PCT-EP or Form PTO/SB/20PCT-JP).  When filled via EFS-Web, the form is indexed as “Petition to make special under PCT-Patent Pros Hwy”.

On a related note, Applications may now be prepared in a Common Application Format (CAF) developed by the Trilateral Office.  This format streamlines direct filings in the EPO, JPO and USPTO where applications in this format are not subject to additional formality requirements.  For US applicants, the CAF goes beyond what is required in the US.  However, using the CAF can provide significant savings when nationalizing PCT applications in the EPO and JPO.  More information may be found at http://www.trilateral.net/projects/pct/CAF.html and http://www.wipo.int/pct/en/filing/caf_example.html.

The EPO has changed its rules for filing Divisional applications.  Previously, Divisional applications could be filed from any pending European application.  Now, the deadline for filing voluntary divisional applications is 24 months from the date of the first official communication by the Examining Division.  Note that search reports and search opinions do not trigger the 24 month period because they are issued by the Search Division, not the Examination Division.  Also note that a new unity of invention objection establishes a new 24 month period for filing a divisional application.

 For pending applications for which the 24 month period has expired or expires before October 1, 2010, the deadline for filing a Divisional application will be extended to October 1, 2010.  We suggest you review any pending applications well before the October 1, 2010 deadline to allow enough time to prepare and file any desired divisional applications before the deadline. 

 For more information see EPO Rule 36(1).

 Also see EPO Rules