Patent Baristas

We are pleased to announce that Frost Brown Todd has been selected both by Working Mother magazine and the Flex-Time Lawyers organization as one of the 50 Best Law Firms for Women.

Law firms throughout the United States were evaluated on their workforce profiles, family-friendly benefits and policies, flexibility, leadership, compensation, and their advancement and retention of women, among other factors.

“This award further underlines the progress our Diversity and Women’s Initiative programs have made over the last eight years.  As a law firm, we go beyond talking points.  Our commitment is demonstrated through actions.  And, it is because of our actions that we have achieved this important award.”

On September 15, 2009 the firm will receive this award at the Gala Award Luncheon in New York, NY for the 2009 Best Law Firms. Click here to view the complete article from Working Mother magazine.

(Prepared Remarks)

David Kappos
Swearing In Ceremony
August 13, 2009
USPTO

Thank you Secretary Locke for your support, for joining today and for your focus on the USPTO and the American IP system.

I also want to thank President Obama for appointing me to this position.

And thanks to all of you who came out today during your lunch hour to participate in this event. What a wonderful welcome!

I also want to thank the senior management team at the USPTO, particularly for their leadership during a time of great challenges for the agency. And I especially thank John Doll for his service leading the agency for the latest 7 months.

Thanks, also, to the former directors who are here today. I look forward to working with you in my new capacity.

Finally, I want to thank my wife, Leslie, and friends joining today for their support and encouragement. I’m very thankful you could be here. I am tremendously pleased and honored to be joining your team at the USPTO.

As a longtime patent practitioner and trademark advisor, I understand both the importance and the difficulty of the work done by USPTO employees.

I have some understanding—and will be learning a lot more in the coming months—about the challenges, and indeed the impediments, you face in doing your jobs.

My pledge to you is that I will listen, and I will work with every single USPTO employee as part of your team to understand these issues and address them so that you can reach your maximum effectiveness and achieve everything you want in your careers.

For example, I know many of you have concerns about the count system. We’re going to address the count system.

I know many of you who telework or want to telework have concerns about travel requirements We’re going to address that issue. This is a Trademarks issue; it is a Patents issue; it’s an agency issue.

I know many of you are concerned about the time your managers are able to spend helping you learn the refinements of the patent laws and guiding you in applying 35USC, 37CFR and the MPEP in your work. We’re going to address those issues too.

I also recognize that Trademarks has very different challenges from Patents as Trademarks seeks to maintain its low pendency and high quality while retaining its highly skilled employees in a time when application filings have been decreasing.

The list goes on and on, as you all know better than I do. I’m here to address the whole list.

Let me reiterate—I’m HERE to address YOUR issues.

Secretary Locke has asked me to devote my personal attention to improving—and indeed remaking in some areas—the operations of the USPTO so that you can succeed at doing high-quality work, so that – in turn – we can succeed at serving the best interests of our country.

This will include reducing the backlog of unexamined patent applications, cutting pendency dramatically, working off the mounting appeals backlog and improving re-exam processing—all while maintaining high quality standards.

To meet Secretary Locke’s direction to me, I will be HERE at the USPTO. I will minimize overseas travel, and focus domestic travel on listening to the U.S. innovation community and discussing our agenda with them.

Most importantly, I plan to focus my energies on understanding issues here at the USPTO and addressing them aggressively.

There’s one other specific point I’d like to address before concluding–Our financial condition at the USPTO and its impact on you.

2009 has been a very tough year for the USPTO financially, as it has been for our country generally.

2010 is also likely to be difficult; it certainly will start that way.

I’m going to make a very high priority of moving the USPTO to more sustainable footing both in the short term—fiscal year 2010—and in the longer term.

Nobody wants to put USPTO employees in a position of worrying about job security.

And despite the swift and effective work that was recently done to make Trademark funds available on a loan basis to the Patent team—nobody wants to actually USE that authority if there is a way to avoid it.

It is my job not only to ensure that you have the resources needed to do your jobs, but also to ensure the USPTO is placed on a financial footing that ensures resources will be available in future years so that your work and the mission of the Office is not vulnerable to economic cycles.

So to conclude:

Thank you for taking time on your lunch hour to listen today. I’m tremendously pleased to be joining your team. I’m committed to making changes to help you propel your work and your careers. And, finally, I look forward to meeting each of you and working with you to advance our mission on behalf of the American people. Thank you and have a great afternoon.

Exergen sued Wal-Mart, CVS, and several thermometer makers (including SAAT) for infringement of three patents covering infrared detecting thermometers. The U.S. Court of Appeals for the Federal Circuit ruled that one of the patents was invalid because it is inherently anticipated, and the other two were not infringed. See Exergen, Corp. v. Wal Mart Stores.

The thermometers measure the emitted infrared radiation off a human body to get the surface temperature. Typical measurement points are the eardrum and the forehead. The body’s internal temperature is then calculated from the surface temperature and displayed on the digital readout of the thermometer.

The three patents at issue were: 5,012,813 (“the ’813 patent”), No. 6,047,205 (“the ’205 patent”), and No. 6,292,685 (“the ’685 patent”). The ‘813 and ‘205 patents disclose measuring the surface temperature of the eardrum, and the ‘685 patent is directed to measuring the surface temperature of the skin on the forehead that covers the temporal artery. Only two terms were in dispute during the claim construction.

The District court construed that “biological surface tissue” means “a living layer of external human tissue having a temperature that can be measured,” and that “internal temperature” means the “temperature of the region existing beneath the surface of the biological tissue targeted for measurement.”

At the jury trial, SAAT was found to have willfully infringed two of the patents and actively induced infringement of the third, with damages totaling more that $2.5 million. SAAT moved for JMOL, and Exergen moved for enhanced damages. Both were denied, both appealed.

SAAT challenged the jury finding that the ‘205 patent was not anticipated by U.S. Patent No. 4,602,642 (“O’Hara”). The independent claim of ‘205 recites:

1. A method of detecting temperature of biological tissue comprising: providing a radiation detector for sensing infrared radiation from an external target; sensing radiation from multiple areas of the biological tissue with the radiation detector; and electronically detecting the peak radiation from the multiple areas to obtain a peak temperature signal.

The O’Hara reference discloses a thermometer handheld probe unit that is used to sense infrared emissions from the ear canal. When the unit is removed from the base (chopper unit), it takes radiation measurements seven times per second, storing the maximum reading. After the SCAN button is pressed, the maximum reading from the moment the unit was removed from the base is displayed. Exergen argued that O’Hara only measures radiation from one location, not multiple ones as required by the claims. Unfortunately, Exergen’s own expert testified that O’Hara inherently anticipates this limitation:

Q. While you’re moving this probe unit from the chopper unit, is it — what is it measuring?
A. It’s measuring infrared radiation.
Q. And you have to move it along the side of the patient’s face to get to the ear, don’t you?
A. Yes.
Q. During the period that you’re moving along the side of the patient’s face, what’s it measuring? What’s it doing?
A. It’s measuring radiation.

A user of O’Hara’s thermometer would measure radiation from the patient’s face, outer ear, and inner ear at a rate of seven times per second, inherently sensing radiation from multiple areas and anticipating Exergen’s claim.

SAAT also challenged the jury’s finding of direct infringement of the ‘813 patent. The claim which was found to be infringed was:

7. A radiation detector comprising:

• a thermopile mounted to view a target of biological surface tissue;
• a temperature sensor for sensing ambient temperature;
• an electronic circuit coupled to the thermopile and temperature sensor and responsive to the voltage across the thermopile and the temperature sensed by the sensor to provide an indication of an internal temperature within the biological tissue adjusted for the ambient temperature to which the surface tissue is exposed; and
• a display for providing an indication of the internal temperature.

SAAT argued that their thermometer, which targets the forehead, did not display an internal temperature, but an oral temperature. Exergen tried to alter the construed meaning of “internal temperature” to include an oral temperature, but had to retract it. The court was not too pleased with how Exergen’s counsel interpreted the record or the court’s ruling, suggesting that if Exergen had won this case, their counsel might have so prejudiced SAAT as to warrant a new trial.

For a hat trick, SAAT challenged the jury’s finding of induced infringement of the ‘685 patent. Claim 1 of the patent reads:

1. A method of detecting human body temperature comprising: laterally scanning a temperature detector across a forehead; and providing a peak temperature reading from plural readings during the step of scanning.

The instructions for the thermometers included a drawing (the two circles were added during the trial):

The instruction state to scan the thermometer around the temple area, or to slowly slide upwards. SAAT argues that neither of these instructions, nor the drawing would induce a user to slide the thermometer laterally across the forehead. Exergen creatively compares lateral scanning to crossing the Charles river. Whether you are crossing it going east, west, north, or south you are still crossing it. The point of these instructions is to find the temporal artery. The Federal Circuit disagreed. Exergen expressly waived the doctrine of equivalents before trial. “Under a theory of literal infringement, to which Exergen was limited, no reasonable jury could have found that scanning within an oval pattern in the temple region on one side of the forehead meets the literal requirement of scanning ‘across a forehead.’”

In a similar way, the Federal Circuit looked at the literal meaning of claim 27, which reads:

27. A method of detecting human body temperature comprising measuring temperature of the temporal artery through skin.

The SAAT thermometer only reads the surface temperature of the skin which covers the temporal artery, not the actual temperature of the temporal artery. The court agreed.

Today’s post comes from Guest Barista Scott Conley, a registered patent agent in Frost Brown Todd’s Cincinnati office.

Take it for Pain. Take it for Life.
~ Bayer aspirin slogan

Drospirenone is a progestin that inhibits ovulation. While known in the art, Bayer patented formulations of drospirenone, one of the active ingredients in Yasmin® a daily oral contraceptive. Now, the U.S. Court of Appeals for the Federal Circuit has ruled that the patent is invalid because the formulations were obvious. Bayer Schering Pharma v. Barr Labs (08-1282).

Drospirenone is acid-sensitive so when exposed to low-pH (highly acidic) environments such as found in the human stomach, drospirenone “isomerizes” – that is, the acid catalyzes a reaction that rearranges drospirenone’s molecular structure while its molecular composition remains constant. The resulting isomer is non-antimineralocorticoidal, meaning it will not act as a diuretic, removing the desirable anti-bloating effect that sets drospirenone apart from other prior art progestins.

Drospirenone is also a poorly water soluble hydrophobic composition. Because it will not easily dissolve into a volume of liquid, its bioavailability is degraded. To combat this, pharmaceutical producers commonly employ a technique called “micronization,” where the drug’s particle size is reduced, increasing its overall surface area. All commercially available oral contraceptives use micronized progestins and/or estrogens, so this technique was well known in the art.

One method pharmaceutical companies use to overcome an acid-sensitivity problem is to use an enteric-coated pill. An enteric coating, a pH-sensitive film that protects the drug from stomach acid, also reduces the drug’s bioavailability. For five years, Bayer used this coated pill in its studies, even reconfirming in 1988 that drospirenone needed an enteric coating because it isomerized quickly in a pH 1 acidic solution.

Eventually, Bayer tested an unprotected (normal) drospirenone tablet and compared its bioavailability to that of the enteric-coated formulation — and fully expected to find that the normal pill would produce an even lower bioavailability than the enteric-coated tablet. Unexpectedly, they found that the normal pill and the enteric-coated pill resulted in the same bioavailability.

Being clever, Bayer developed drospirenone in a normal pill, the subject of U.S. Pat. No. 6,787,531. Bayer relied on the finding that drospirenone would absorb with a normal pill to overcome an obviousness rejection in the Patent and Trademark Office.

Barr Laboratories filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market a generic version of Yasmin®. Bayer promptly filed a patent infringement suit against Barr.

The district court ruled that the claims were invalid holding that under KSR International Co. v. Teleflex it would have been obvious to a person having ordinary skill in pharmaceutical formulation to try a normal pill in formulating drospirenone as an oral contraceptive.

The Federal Circuit looked to KSR, where the Supreme Court stated that an invention may be obvious if it would have been obvious to a person having ordinary skill to try a course of conduct:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

Finding the use of uncoated drug was obvious, the court stated:

First, an invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art. When “what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful” an invention would not have been obvious. O’Farrell, 853 F.2d at 903.

Second, an invention is not obvious to try where vague prior art does not guide an inventor toward a particular solution. A finding of obviousness would not obtain where “what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.”

Given the above, you’d have thought the court was heading in the direction of upholding the patent. You’d be wrong.  Even though Bayer — a company with over 10,000 employees and over EUR 10.704 billion in sales in 2008 — could not come up with the final solution through years of research, the court held that the formulations would have been obvious to “a person having ordinary skill in the art ” (a person who apparently does not work at Bayer) due to the limited number choices:

At this point, a person having ordinary skill in the art has reached a crossroads where he must choose between two known options: delivery of micronized drospirenone by a normal pill following the spirorenone analogy in the Krause series, or delivery of drospirenone by an enteric-coated pill following the Nickisch teaching that the drug needs to be protected from the stomach. This is a finite number of identified, predictable solutions. See KSR. 550 U.S. at 421. The prior art would have funneled the formulator toward these two options; he would not have been required to try all possibilities in a field unreduced by the prior art, thus avoiding the first pitfall of O’Farrell, 853 F.2d at 903. Additionally, the prior art was not vague in pointing toward a general approach or area of exploration, but rather guided the formulator precisely to the use of either a normal pill or an enteric-coated pill, thus avoiding the second pitfall of O’Farrell. Id. Because the selection of micronized drospirenone in a normal pill led to the result anticipated by the Krause series, the invention would have been obvious. See KSR, 550 U.S. at 421.

Circuit Judge Newman, dissenting, thought that the decision was a crock:

With all respect to my colleagues, I do not share their view that it would have been obvious to do that which was indisputably unobvious to the experienced formulation scientists whose assignment was to formulate the known product drospirenone. The evidence showed, without contradiction, that it was known that micronized drospirenone rapidly degraded at the acidity of stomach acid. The evidence showed, without contradiction, that the Bayer scientists working in this field believed that the product required an enteric coating in order to prevent degradation in the stomach, upon ingestion as an oral contraceptive. Yet my colleagues, employing their own expertise, hold that since the scientists working in this field turned out to be mistaken, it would have been obvious that it was not necessary to take steps to prevent acid degradation. The court discounts the testimony of the scientists themselves, ignores the knowledge concerning this product and its instability in acid, ignores the textbook teachings, and finds that this unlikely process obviously should have been tried. That is not the law of obviousness.

The statutory criterion is whether the invention would have been obvious to persons of ordinary skill at the time of the invention, not whether it is sufficiently simple to appear obvious to judges after the discovery is finally made, despite the years of contrary belief among the scientists charged with the project.

“Obviousness” requires that the subject matter was obvious to persons of ordinary skill in the field of the invention. The law does not hold it “obvious to try” experiments that contravene conventional knowledge, and that are not deemed reasonably likely to succeed. The evidence in this case is a better measure of obviousness than is the hindsight science of judges, for the scientists who eventually made this discovery testified, without dispute, that they did not believe an uncoated micronized product would meet the demanding criteria of contraceptive effectiveness.

Dealing with the Patent Office is a lot like standing in front of the airline ticket counter where the agent keeps typing in endless strings of random numbers and letters and politely explains that you can’t possibly make a change in your reservation because your ticket is a A389X-27-Purple ticket and not the B347L-Triple-Lindy ticket.

Although nonprecedential, the U.S. Court of Appeals for the Federal Circuit laid into the Patent Office this week for behaving in what it said was an ” arbitrary and capricious” manner after it cashed a payment that was $10 short and then promptly let the patent expire. See Taylor v. USPTO (CAFC 09-1133).

Jorge Taylor had a patent for a chemical sealant device for repairing flat tires (U.S. Pat. No. 5,178,701) and had to pay the seven-and-a-half-year maintenance fee of $1040. But, Mr. Taylor sent a check for $1030, rather than $1040, in the mail and used the wrong form for transmitting his payment, and sent it to the Applications Branch rather than the Maintenance Fee branch – sort of a hat trick of errors.

Mr. Taylor marked in capital letters at the top of his transmittal form:

“NOTE: IF THIS IS NOT THE CORRECT FORM, PLEASE MAIL THE CORRECT FORM TO THE RETURN ADDRESS ON THE CHECK.”

The PTO employee who processed the form may not have recognized this filing as an attempt to pay a maintenance fee, and may have just processed it as a regular application filing fee. Whatever the thinking, the PTO deposited the check in its account.

Fast forward several years later when Mr. Taylor called the Office in preparation for paying the required eleven-and-a-half-year maintenance fee and the PTO says “Oops, your patent went abandoned for failure to pay the seven-and-a-half-year maintenance fee.”

Taylor asked the PTO for reinstatement of his patent saying that he was “not an attorney but a pauper disabled living on a fixed income (SSI) who cannot pay $200 to petition your office.”

The PTO dismissed the case (for not including $200) also helpfully pointed out that Mr. Taylor’s original payment had not included a certificate of mailing. Thus, because the Office received the payment on January 17, 2001, five days had passed beyond the window for accepting maintenance payments with a surcharge.

Taylor then sued in district court, alleging that the PTO had “misappropriated” his $1030, and sought $1 billion in damages, his estimation of the worth of his intellectual property “in the U.S. and world market.”

The district court dismissed the complaint saying that PTO regulations do not provide a waiver of petition filing fees for indigent applicants and that Taylor had not shown that the PTO’s actions were “arbitrary and capricious” for purposes of making out a claim under the Administrative Procedure Act.

Mr. Taylor appealed to Federal Circuit, which seemed perturbed that the case had to go all the way to the appellate level and was not happy that that the PTO cashed Mr. Taylor’s check and still proceeded to consider his patent expired.

The court said that the PTO’s actions were arbitrary and capricious in accepting Mr. Taylor’s deficient payment on the one hand, while on the other hand expiring his patent without notifying him under MPEP § 2531 (Notice of Non-Acceptance of Patent Maintenance Fee) that his payment was inadequate.

The PTO tried to weasel out of the suit saying it would refund the $1030 and said that Taylor could still file a petition — along with $200, of course — to have his patent reinstated for unavoidable delay. But, the USPTO then mused that even if the failure to properly pay the 7.5-year maintenance fee could be overlooked, Mr. Taylor has now also failed to pay the 11.5 year maintenance fee, and has also missed the deadline for reinstatement based on “unintentional delay” of that payment.  Nice.

In the end, the Federal Circuit said that it wasn’t fair for the PTO to take Mr. Taylor’s payment without notifying him of the $10 shortfall and demanded an equitable remedy:

In this case, equity would counsel that the PTO should reinstate Mr. Taylor’s patent upon receipt of his payment for all outstanding maintenance fees. This relief will remedy, to this court’s best estimation, the PTO’s arbitrary and capricious actions.

While I feel bad for Mr. Taylor, the real issue here is why doesn’t the Patent Office put more procedures in place that make the application process more of a mutual partnership? Yes, Mr. Taylor paid the wrong amount. Yes, he used the wrong form. But, even very experienced attorneys make these kinds of mistakes.

The present case illustrated that the Patent Office needs to adopt more equitable rules and procedures for helping inventors correct mistakes in the first place so that valid patents issue. Shouldn’t the Patent Office be on the inventor’s side?

5th Annual Developing IP Strategies for Crystalline Forms is to be held November 09 – 11, 2009, at the Regus Conference Centre, 1 Broadgate Circus, London.

Now, Patent Baristas readers can get an extra 10% off by using discount code BLOG when registering and can access our free resource centre containing past presentations from the event at www.ipcrys.com.

New for 2009:

2009 confirmed speakers include:

• Bo Hammer Janssen, Senior Patent Counsel, Novozymes
• Nicolas Ruiz, Head of IP, Esteve
• Dr Mandar Kodgule, Head, Intellectual Property and Strategic Planning, Wockhardt Ltd
• Dr William Heggie, CSO, Hovione
• James Horgan, Assistant Counsel, Merck, Sharpe & Dohme Ltd
• Dr Thomas Weisbrod, Patent Examiner, European Patent Office
• Peter Roth, Senior Patent Counsel, Novartis
• Lisa Dixon, Senior Patent Counsel, Vertex Pharmaceuticals Incorporated
• Rekha Bansal, Patent Attorney, Amgen
• Alastair Wilson QC, Joint Head of Chambers, Hogarth Chambers
• George Moore, International Patent Counsel, Apotex
• Andre Bourgouin, Chief IP Officer, Ipsen
• Dr Filip Borkowski, DG Competition, European Commission
• Frank Burket, European Patent Attorney, Bayer Healthcare
• Lawrence Cullen, Deputy Director, UK IPO
• Marian Flattery, Global Head of IP, Syngenta Crop Protection
• Eric Ruhlmann, Senior Patent Counsel, Actelion
• Raymond R. Mandra, Partner, Fitzpatrick, Cella, Harper & Scinto
• William E. Solander, Partner, Fitzpatrick, Cella, Harper & Scinto

	Maximizing Polymorphic Wealth: Technical and Legal Issues – Dr. Mandar Kodgule
	Crystalline Forms – The Next Generation – Jeffrey A. Lindeman
	Impact of Indian Patent Law on Polymorph Patents – B. Vijayaraghavan
	Characterising and Protecting Non-Stoichiometric Hydrates and Solvates – Christian W. Lehmann
	The Brave New World After KSR! – Vineet Kohli
	Realising The Potential Of Chiral Discrimination Induced By Crystallisation As Novel Patentable Material РProf. Dr. G̩rard Coquerel

Congress is busy doing what it does best. That is, taking a massive, overly-convoluted piece of legislation and making it more complex with amendments. And so it is with the “America’s Affordable Health Choices Act of 2009” bill (H.R. 3200, 1018 pages and counting).

After adding in hundreds of amendments that never seem thoughtfully considered as to how they all fit together, the House of Representatives’ Energy and Commerce Committee voted 47-11 in favor of allowing 12 years of data exclusivity for biotech drugs. The change on data exclusivity follows the similar amendments by the Senate Health, Education, Labor and Pensions Committee.

Data exclusivity for biotech drugs is separate from patent protection and is the amount of time before other drug makers could receive market approval for generic versions of the drugs or drugs that are improvements that need to rely on the data of the original drug (see an overview at Patent Docs).

Biotechnology Industry Organization President and CEO Jim Greenwood issued a press release saying:

The strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow. The approved amendment, introduced by Representatives Anna Eshoo (D, CA), Jay Inslee (D, WA) and Joe Barton (R, TX), strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation.

The Generic Pharmaceutical Association (GPhA) released a statement from GPhA President and CEO Kathleen Jaeger stating:

We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs. The amendment passed tosses patient needs out the window.

Rep. Anna Eshoo (D-CA), sponsored the amendment that would provide a pathway for approval of generic biologics (biosimilars or follow-on biologics).  In total, the amendment to H.R. 3200 could provide for up to 12.5 years of exclusivity through an initial 12-year exclusivity period that may be extended with 6 months of pediatric exclusivity.

Meanwhile, Rep. Bobby Rush (D-IL) got an amendment approved, in a voice vote, which would ban “pay-for-delay” settlements between branded and generic drugmakers that are used to keep generic competitors out of the market. This got a high-five from Jon Leibowitz, chairman of the Federal Trade Commission (FTC), who is set against these deals.

The bill would amend Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) by adding at the end the following:

“(A) conduct prohibited.—It shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which—
“(i) an ANDA filer receives anything of value; and
“(ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales, for any period of time, of the drug that is to be manufactured under the AND A involved and is the subject of the patent infringement claim.”

Look for more tweaks when Congress gets back from its vacation.

After McNeil appealed obviousness rejections to the US Patent and Trademark Office Board of Patent Appeals and Interferences, the Board dismissed the whole business as filed in an untimely manner. McNeil took the case to the US Court of Appeals for the Federal Circuit who sided with them that the appeal was timely and the patent rejections were bogus. In re McNeil (08-1546).

McNeil owns U.S. Patent No. 6,310,269, which claims a tampon for feminine hygiene with a solid fiber core in which the core is denser than the radially projecting “ribs” and the ribs are narrower at their bases than their distal ends.

McNeil asked that the PTO reexamine its ‘269 patent (re-examination No. 90/006,467) based on an unexamined Japanese application by Tetsu Sasaki, No. 55-168330.  In light of Sasaki, the examiner rejected claims 1 and 3 as anticipated and claim 4 as obvious.

McNeil appealed to the Board, arguing that Sasaki did not disclose the relative densities or coarseness of the core and ribs on the tampon. McNeil also disputed that Sasaki disclosed ribs which were narrower at the base than at the proximal end.

The Board affirmed the examiner’s rejection so McNeil filed a request for rehearing, objecting to the Board making findings of fact in the first instance and arguing against the rejections on the merits. The Board denied the request saying they were a day late and a dollar short.

It turned out that the typed date on the face of the Board order denying McNeil’s request for rehearing was “May 30, 2008.” The mailing sheet for the order was dated June 2, 2008.  The online “Transaction History” for the reexam has two entries for May 30, 2008: “Mail BPAI Decision on Reconsideration – Denied” and “Dec on Reconsideration – Denied.”

The image file wrapper (“IFW”), which is also available online, lists the “Mail Room Date” of the decision as June 2, 2008. McNeil filed a notice of appeal on August 1, 2008. The Director responded that the appeal was untimely because it was filed more than sixty days after the Board made its final decision on May 30, 2008.  Hence, the Federal Circuit looked at the whole mess:

We address first, as we must, whether McNeil’s appeal is timely. Compliance with the PTO rules regarding the time for an appeal is required by statute, and while the Director can grant extensions of time, we cannot. See In re Reese, 359 F.2d 462, 463 (CCPA 1966) (per curiam).

Congress gave the Director some authority to set the time for filing an appeal:

When an appeal is taken to the United States Court of Appeals for the Federal Circuit, the appellant shall file in the Patent and Trademark Office a written notice of appeal directed to the Director, within such time after the date of the decision from which the appeal is taken as the Director prescribes, but in no case less than 60 days after that date.  35 U.S.C. § 142 (emphasis added).

The regulations promulgated under this statute provide, in pertinent part:

The time for filing the notice of appeal to the U.S. Court of Appeals for the Federal Circuit (§ 1.302) or for commencing a civil action (§ 1.303) is two months from the date of the decision of the Board of Patent Appeals and Interferences. If a request for rehearing or reconsideration of the decision is filed within the time period provided under § 41.52(a), § 41.79(a), or § 41.127(d) of this title, the time for filing an appeal or commencing a civil action shall expire two months after action on the request.  37 C.F.R. § 1 .304(a)(1).

The crux of the matter is what the phrase “the date of the decision” means. The second sentence of the regulation quoted above actually uses different phrasing to set the time to appeal from decisions on requests for reconsideration (i.e., “action on the request”), but the intent is that the same sixty-day rule (and not some shorter time period) applies after a denial of a request for reconsideration.

The PTO argued that both 35 U.S.C. § 142 and 37 C.F.R. § 1 .304(a)(1) state that the time to appeal runs from “the date of decision,” and the opinion says “Decided: May 30, 2008,” so it would be contrary to the language of the statute and the regulation for us to deem the date of decision to be the date the order was mailed.

The Federal Circuit felt sympathy in its heart that day:

While this argument has some superficial appeal, the inner workings of the agency are far more important than the PTO admits. Based on the evidence before us, it appears that only when an opinion is released to the public (or at least the parties) is it truly decided—until then, it is possible for the Board to decide to revise it.

Because we determine that McNeil’s appeal is timely, we reach the merits and, because the Board of Patent Appeals and Interferences findings about the disclosures of a prior art patent application are not supported by substantial evidence, we reverse the claim rejections.

Circuit Judge Dyk, dissenting, felt that the date on the face was clear:

The decision of the Board of Patent Appeals (“Board”) clearly states on its face that it was “Decided: May 30, 2008.” Because McNeil did not appeal until August 1, 2008, two days after the regulatory period for review from a decision of May 30, 2008, in my view this appeal was untimely filed and is beyond our jurisdiction to review. I respectfully dissent from the majority’s contrary conclusion.

The majority appears to hold that the “date of the decision” is not the date of decision as clearly written on the opinion, but is instead the date of mailing. In my view, this holding is contrary to the plain language of the regulation and precedent interpreting the nearly identical language of the predecessor rule.