GlaxoSmithKline vs. Dudas: An Attempt to Stop Implemention of PTO Prosecution Rules

The U.S. Patent Office does not have substantive rulemaking authority.  Thus, the office cannot change the meaning of “novelty” or “obviousness” even through a formal process of notice and comment rulemaking. The Office does, however, have the power to make rules that govern procedures within the office that are “not inconsistent with [the] law.” 35 USC 2.

GlaxoSmithKline has now sued the Patent Office to stop implementation of two new sets of PTO rules — arguing that the scope and effect of the new rules extend well beyond the PTO’s limited rulemaking authority. The main thrust of the rules is to limit the number of follow-on applications that can be filed that somehow relate to an original patent application and to limit the number of claims filed in each patent application.

Glaxo can easily show that these rule changes will harm its business — especially because the rules retroactively impact the UK company’s already pending patent applications.

The rules hit innovator pharmaceutical companies especially hard. Pharmaceutical companies typically file large original patent applications early in the drug development process. Those original applications typically disclose many variations of a class of drug along with various methods of manufacturing and using the drug. As development continues, follow on continuation applications are used to specify and claim particular subgroups. The continuations also typically include further information to prove utility and nonobviousness of the particular subgroups.  These rule changes will severely limit GSK’s ability to file these continuations and, as a consequence, will hurt its position.

GSK notes that the PTO’s exceptions to the rule is primarily mythical because it requires a strict “could not have” limitation.

• Read the Complaint
• The complaint was filed by my old firm of Kirkland & Ellis. This is perhaps odd since Kirkland does no patent prosecution.

Comments

[johng]

I guess you've never been subjected to an "incremental" search, where the least relevant documents are cited first (just good enough to meet the claim features) and each action thereafter reveals prior art incrementally more relevant that follow the claim amendments.

Finally, in the sixth or seventh action, you get the document that should have been cited in the first action. This is one of the chief problems causing churning and backlog.

[Lionel Hutz]

Johng articulates my primary concern with the new rules.

I have had to file 2 RCEs in cases where the Examiner started out with references that when combined could arguably (but laughably) cover theinitial claim language and then with each amendment, better art is produced. I should say that some Examiners have been good and issued multiple nonfinal actions, but most rely upon the Applicant's amendment as an excuse to issue a final rejection with a new reference.

An applicant should always have the right to an RCE or a Continuation where the Examiner introduces a new reference on final.

[Lazarus Long]

Johng & Lionel Hutz,

You are right that the examiner will often just use art that is "good enough" to reject the initially filed claims. While we instruct them to find "the best art" all too many and all too often examiners will stop the search when they find art that is good enough to reject the claims.
Part of that is human nature. I am not trying to defend or justify it; just to explain it. If you have to get "X" many more cases done in a very limited amount of time, you need to cut some corners somewhere. Having art that is good enough to reject the (often way too broad) claims is often rationalized as a reason to stop the search, write it up & move on to a new case.
Yes, you can (& should) complete the search & maybe find better art or art that "might" apply to some future amendment. And, in the long run you will be better off doing a complete search for the 1st action. However, if you need more counts for the PP/quarter/FY, self-interest (getting those counts & keeping your job) is a lot stronger incentive than what "might" make things easier in the future or doing things "by the book".

Now, who/what is to blame for this. Part is the production system & the way it is set up. Part is the hrs/bd. And a big part is the applicant/lawyer (sorry, guys). If you want the best art in the case for what you REALLY INVENTED, make sure that at least a few of your claims are specific enough to actually read on what you invented. All too often, the original claims (as well as a few iterations) do not really recite what the invention is but some excessively broad version of the invention. This contributes an awful lot to the issue of "close enough" art being applied & just incrementally better art being added thereafter.

Doesn't the MPEP still indicate (suggest?) that the applicant file claims that vary in scope from the "broadest they think that they are entitled to on to the most narrow that they are willing to accept" (paraphrase, not a direct quote). If you all actually did this, there would be a whole lot less of the problems you are talking about here. Why do you not file claims along these lines?

thanks,

LL

[johng]

LL, we are now limited to 5/25 claims (and a limited number of continuations), making it even more difficult to compose claims as you suggest. With the RCE's of the past, we complained a little (: , but we could live with the incremental rejections. Now, we are left to speculate and gamble, which is not good for our clients and dangerous for ourselves.

[Malcolm Mooney]

"You are right that the examiner will often just use art that is "good enough" to reject the initially filed claims. While we instruct them to find "the best art" all too many and all too often examiners will stop the search when they find art that is good enough to reject the claims."

Give me a break. How the frick is an Examiner supposed to find the "best art" to invalidate claims that have NOT YET BEEN PRESENTED? Is the Examiner supposed to read the Applicants mind to determine every possible amendment/argument that the Applicant could make?

Please, let's try to keep it real. Applicants do play lawyerly games when they file applications. If an Examiner has art that anticipates the claims, then they should argue invalidity under that art.

Of course it goes without saying that Applicants should be able to prosecute claims until allowance or rejection. The cost of doing so -- whether it be through filing of RCEs or some other procedure -- is a rather simple policy calculation. Denying applicants the opportunity to present claims describing their invention when they have prosecuted in good faith up to the point of final rejection is, simply, wrong.

[Malcolm Mooney]

"If you want the best art in the case for what you REALLY INVENTED, make sure that at least a few of your claims are specific enough to actually read on what you invented. All too often, the original claims (as well as a few iterations) do not really recite what the invention is but some excessively broad version of the invention."

And why is that? Because the clients are told by VCs who are told by investors that the picture claims which cover the actual invention are not valuable.

Isn't that interesting?

Here's how this strange situation came about: the US patent office back in the "good old days" routinely issued stupidly absurdly broad claims. Patent prosecutors and the clients LOVED those claims. And the clients and their "investors" loved going around and whacking people over the head with those claims. In response, the people who got their heads whacked in decided to get their own bats, which were duly issued.

Now the price of getting a bat has gone up. The bats are rare. All the bullies are crying and who wants to invest in a soaking wet bully holding a limp stick? Hardly anybody. So what is an investor to do? Why he's going to put his money elsewhere! Where is he/she going to put it? In less risky ventures. What sort of less risky ventures? For starters, in ventures where the invention is much more likely to be valuable and has solid patent protection.

Of course, that is a small fraction of all inventions. Only the smartest inventors and patent attorneys will survive.

That's really bad news for the bullies.

[johng]

MM:"Give me a break. How the frick is an Examiner supposed to find the "best art" to invalidate claims that have NOT YET BEEN PRESENTED? Is the Examiner supposed to read the Applicants mind to determine every possible amendment/argument that the Applicant could make?"

That is the excuse examiners use often. I was a primary examiner and I know a "better" reference when I see it. It is because I had read the specification and had that in mind while searching. Also, much of what happens when making a rejection involves interpretation and stretching it to "make a referenct fit" into the terms of the claims. The better reference is usually spot on (i.e., no mincing of words).

Some judge once said something like "it is hard to define pornography, but I know it when I see it." The same is true when considering references. It is especially true when you consider that the better reference supplied with the sixth action could have been used to reject the originally filed claim.

[Malcolm Mooney]

"That is the excuse examiners use often. I was a primary examiner and I know a "better" reference when I see it. It is because I had read the specification and had that in mind while searching."

My specifications are loaded up with enough support to enable to me go in multiple directions, depending on what art the Examiner presents. In fact, if I can, I will often go down two paths simultaneously, in different claims, to make it even more difficult for the Examiner to figure out the nature of my game.

[johng]

Okay Malcolm, you win. But I restricted a lot, which helped to narrow the search and possible issues. I had very few RCE's near the end.

[Jeff Spangler]

The Manbeck dec is not deficient for failure to explicitly state the usual language of "in my professional opinion as an expert". The Court will not exalt form over substance, and no one is seriously in doubt about what his expert opinion is. With the AIPLA amicus entry, I see better than even odds for a PI.

[Jeff Spangler]

P.S.: If these rules are enjoined, heads should roll at the PTO, specifically the Chrome Dome of Doll, and his boss DudeArse. Instead, Bush will probably give them the Medal of Freedom-- freedom from neverending-continuations, excessively-claimed, patentably-indistinct, and otherwise pesky patent applications. The pending IDS rules should also be the target of similar litigation.

The PTO is the editor-in-chief and judge for a unique law quasi-judicial agency with exclusive jurisdiction over the most difficult type of legal writing, and it requires a patent attorney in that job. Lehman was a non-Registrant copyright attorney, and Dudas was counsel to some Committee on the Hill. In recent history, only Todd Dickinson fit the bill.

Just my opinion.