The Intellectual Property Forum

Ooops.  If it "cures" surely it must "prevent"   

Gerd:  Prophylaxis in the pharma arts - like “for” in a preamble or “adapted/configured to” in a mechanical claim - always draws an Examiner’s scruitiny.  And prophylaxis is tougher to “prove” than treatment (utility, WD, and enablement).   And don’t forget the FDA and FTC.  If you can’t get labeling approved at the FDA or can't defend it before the FTC, fighting for allowance of the prophylaxis claim may be a “pyrrhic victory” (and a royal waste of client’s $).

In your case, the Examiner may or may not have a point.  As always, it depends on what “X” and “Y” are.  “A method of preventing cancer” is guaranteed to draw heavy fire.  There was a case a few years back (2005?) captioned In re Cruciferous Sprout Litigation that may be relevant.

Best I recall (case buried in a binder in office), eating cruciferous sprouts was claimed to “protect” against cancer (or something v. serious).  Because people had been eating cruciferous sprouts for ages, maybe for health benefits (Grandma - born in late 1800s -always said fish was “brain food”, long before the role of omega fatty acids in brain function was elucidated).  The claim was anticipated.  A hypo also comes to mind (patting self on back, it actually came to mind in this context years ago, before it appeared as a hypo in a CAFC case circa 1998). 

Folks have been taking Aspirin as an analgesic for a long time.  Somewhere along the line, it was discovered that Aspirin reduced platelet adhesion and reduced the risk of MI, at least in some population.  Anyone who, prior to this discovery, had taken Aspirin daily for pain associated with OA (a significant cohort) would have received this then-unknown benefit.  The rational of Cruceferous Sprout - if my memory is correct - would appear to apply.  But a secondary indication claim might be a different story. Sorry, I'm a bit rusty on inherent anticipation cases dealing with when the effect/result must have been "appreciated".  But if memory serves, appreciation of the effect is usu not required for inherency.  But I think I read some cases contra.   

“Definitive need” (i.e. known to be in need of prophyaxis) may be an approach; such as “a method of prophylaxis against breast cancer in a female carrying the [inherited] Brac-A(?) gene …”  This might be “proved” with clinical trials, if such could be conducted ethically.  Ditto for patients who have undergone lymphectomy, putting them at higher risk for edema, as you say is known in the art. 

In closing, FWIW I personally stick to the tried-and-true “a method of treating disease X in a {animal/mammal,/human} suffering from disease X comprising the step of administering to the {animal/mammal/ human} suffering from disease X a disease X treating amount of compound Y”.  And, if client insists on shooting for prophylaxis, I put such in a separate independent claim(s) to keep my PH as clean as possible in the (frequent) event that I have to strike prophy. 

Footnote:  There is another thread in which some posters don’t like “comprising the step of”.  I personally see no practical limiting effect of reciting “step”.  But need to consult case cited by Karen. 

If what you aspire to is to be at a strict prep-and-prosc only house in DC environs, probably not a huge plus.  But IMO it is always a plus. If you make law review and graduate Order of Coif and interview at a big IP botique and say "all I really want to do is draft and prosecute applications", absent a solid reason, you might be viewed with a a bit of skepticism.  With one exception I am aware of - and it surprised some partners - pep and prosec 'just pays the lights', litigation pays partner pay-out failed (prosec from one pharma client was 30%+ of all firm revenue for that year, and firm won 2 big ANDA cases).  What law firms would you like to work at?  Ones who file the most applications per year?  Ones who win most at the Board? Ones who win most at CAFC?  IMO value of law review depends on this putative "heirachy".  But if you can do it, do it.  Law review will never hurt your "employability".  This "cost-benefit" analysis re: law review can't be reduced to a mathematical formula. 

Invention:  Sorry if I am wrong, but I think you - or someone - floated this very idea before.  And, if I recall, it was met with much skepticism.  Why such a benefit?  Because you had a “brain fahrt” and think you have a real contribution the advancement of the useful arts?  Or because you think you are entitled to a few Krugerands?  A “submarine patent” may promote you personal profit.  But that is all.  This is not the reason we have patents in the US.  The body of international law - and I dare say the majority of opinion - is against the idea of “submarine patents”.  It took us decades to get rid of such in the US.  Doubt we would ever go back.  Why is the market not mature?  Easy answer.  You are simply not very good at marketing, haven’t created the need to fuel demand, or the better “mouse trap” you invented is not all that much better.  In any event, keep pushing your personal agenda.  This is your right.  Just don’t expect the US Congress, or most US practitioners, to pay it much mind.  It smacks of being self-serving, and I can't see how it in any way promotes the useful arts.  And you did not address "intervening rights".  In your view, should such not exist?   

MrSkippy:  Interesting and uncommon question.  The cite you provided appears to address “retainers”.  These always go into an “IOLTA” account, or whatever they are called in UR jurisdiction.  So, I draft and file an application for a new dental implant and choose to take my fee - after the fact - in reciprocal services from the DDM, where is the conflict or ethics issue?  I can't put a crown into an IOLTA account.  In NY and NJ, the “fee” should be commensurate with the value of services provided.  The IRS may have an opinion on this ‘swap of services” arrangement. 

It is a provisional rejection.  I type something like (all emphasis in argument):

“{blah blah statute / case law boilerplate …}  The claims of the present application have been provisionally rejected over the claims of commonly owned and co-pending application 12/123,456.  Because the final form of the claims of the pending ‘456 Application and the claims of the instant application have not been finally determined, Applicant respectfully defers filing a Terminal Disclaimer until the form of the claims of at least one of the applications has be finally determined and the claims of at least one application are otherwise in condition for allowance. 

If the provi DP is over a commonly owned issued patent, I’ve done essentially the same thing, tell me my pending claims are otherwise in condition for allowance, and I’ll file the TD.  Statutory DP can't be determined until claims are allowed/allowable and, as far as I am aware, statutory DP can't be overcome with a TD because, well, it's statutaory "same subject matter", not "obvious in view of" subject matter. 

If it’s a final w/ art rejections and I amend to otherwise put claims in condition for allowance, a second R116 w/ TD has always worked for me.  The examiner wants closure too. 

As a practical matter, if the lifetimes are close and not critical (would that I had clients who thought otherwise), the client says file the darn TD.  Of course, you can appeal and argue that the claims are NOT obvious in view of each other.

FWIW, I've never had a case where the Examiner didn't have a decent case for obv-type DP, or where the difference in scope was, in client's view, worth the fight. 

JAE:  Yep, done that (usu with less sophisticated client that didn't like to hear an honest "difficult" or "lower your expectations").  Realized that the initail set of (product) claims appeared DOA or too $$$ to fight.  Go for the process claims in a CON, the only option as you typed.  But "Examiner shopping" - there is some turnover - may have sometimes been a last ditch effort / motivation (OP said "almost" the same").  But a client's request to "drag-it out 'till we get more money" has come up.  Per others, RCE backlog makes this much less of a consideration.