J&J Seeks Ridiculously Broad Patent on Method of Treating Pain

By Gene Quinn
March 29, 2013

Perhaps you have noticed, but over the past several months we have been trying to increasingly focus coverage on the patent activities of some of the more innovative and interesting companies in the technology sector. This started with our coverage of Apple Patent Activity and buoyed by the interest that was generated we have recently started following Google Patents Activity, IBM Patent Activity and will soon add Microsoft Patent Activity. Stay tuned for other companies to be added to our list of periodic updates.

In any event, I was searching to see what companies we might be able to periodically follow outside the “tech sector” and took a look at a fairly recent list of top patenting companies. I saw Johnson & Johnson on the list so I figured I would take a look. With all the Johnson & Johnson companies there has to be some interesting patent activity, right?

It didn’t take long to find a patent application being pursued by Johnson & Johnson that made me scratch my head. On March 21, 2013, U.S. Patent Application No. 2013/0072575 was published. The title is Method and Composition for Treating Pain. Knowing that so many suffer from chronic pain I was immediately intrigued and had to take a look. Rather than finding something that looks like a potentially exciting innovation I found a bunch of claims that should have absolutely no chance of ever being patented.

The Claim: Apply Cold Topical Analgesic

First, although the title of the application suggests that the patent seeks coverage for a composition, all of the published claims relate to a method. Claim 1 is illustrative of the method and seeks to cover the following:

1. A method of treating pain by topical application of an analgesic composition to the skin of a patient comprising a) placing an analgesic composition in an environment with a temperature of less than 10° Centigrade, b) keeping said analgesic composition in said environment for a period of time sufficient to reduce the temperature of said composition c) removing said composition from said environment, and d) applying said composition topically to the region of pain.

So, essentially you take a topical analgesic, cool it, remove it from the cooling environment and then apply. If this claim gets patented it will be extraordinarily embarrassing for the USPTO. But what exactly was Johnson & Johnson thinking when they tried to obtain coverage with this ridiculously broad claim? It is a violation of USPTO rules to seek a claim that you know you are not entitled to receive. Is there anyone that could possibly rationalize in any intellectually honest way seeking a claim that covers applying a cooled, unspecified analgesic to the region of pain?

For crying out loud, analgesic is defined as a “[d]rug that relieves pain without blocking nerve impulse conduction or markedly altering sensory function.” Topical analgesic compounds are not new, and the claim Johnson & Johnson is seeking is not based on any particular new or improved analgesic. Isn’t it fairly well known already that the application of a topical composition known to relieve pain would, in fact, relieve pain?

Isn’t if also fairly well known that placing something cold on an area that is irritated will reduce swelling, which in turn will reduce pain? YES! Of course it is well known.

Thus, in a post-KSR era where so much is obvious wouldn’t it be the epitome of obvious to cool a topical analgesic before application? Is cooling an analgesic before application an innovation? I am at a total loss as to how there could be any potential hope to obtain a patent on a claim this broad. If the USPTO ever does issue a patent on these claims they will have a lot of explaining to do!

Concern Over Specious Claims in Patent Litigation

Earlier this month Philip Johnson, who is Senior Vice President and Chief Intellectual Property Counsel at Johnson & Johnson, testified before the House Subcommittee on Courts, Intellectual Property, and the Internet regarding the need for legislation to address patent assertion entities. In his prepared statement he explained:

To enhance the objective of maximizing R&D investment and its attendant creation of jobs, it is incumbent on the courts to effectively enforce meritorious patents against those who are infringing them, while weeding out specious claims that act as drags on the system.

I agree with that statement, and I agree with much of Johnson’s testimony, which in my opinion was thoughtful and balanced. He understands the need to offer protections for those innovators who are not manufacturing, but recognizes the truth that there are bad actors in the patent system that are holding up companies with specious claims of patent infringement.

At a time when Johnson & Johnson is seeking legislative help to deal with patent shakedowns, should they be filing patent applications themselves that seek claims that are on their face absurd? How is it at all reasonable to be complaining about “specious claims that act as drags on the system,” while at the same time be seeking specious claims? In all likelihood the USPTO will never issue claims that are so ridiculously broad, but doesn’t asking for such claims simply waste precious Patent Office resources? Of course it does.

What can be Learned?

Aside from poking fun at this obviously ridiculous set of patent claims, pointing out that USPTO resources will be wasted during the examination and a bit of irony over the concern relating to specious patent claims, I’d like to try and turn this into a teaching moment of a substantive nature. As with virtually any patent application or issued patent, there are things worth learning from the drafting of this patent application even if the “innovation” is dubious. So allow me a moment to focus on a teaching point that deals with ranges and the definiteness of the term “about.”

The Manual of Patent Examining Procedure (MPEP) explains that with respect to numerical range limitations, analysis must take into account the ranges one skilled in the art would consider supported by the specification. See MPEP 2163.05. Thus, filing an application that has support for a variety of ranges is important.

Here is what this particular Johnson & Johnson patent application discloses in terms of ranges:

  • “The analgesic composition may be stored in an environment with temperatures of less than about 10° C., or less than about 0° C., or less than about ?10° C., or less than about ?20° C. or in a range from less than about 10° C. to less than about ?20° C.”
  • “The temperature of the composition should be lowered to about 15 ° C. to about ?30 ° C. or from about 10° C. to about ?10 ° C. or from about 5° C. to about ?5 or about 0° C.”
  • “The time period between removal of the analgesic composition and the topical application of it to the region of pain is less than about 10 minutes, or less than about 5 minutes, or less than about 1 minute, or less than about 30 seconds, or less than about 10 seconds, or less than about 5 seconds, or less than about 2 seconds or from less than about 2 seconds to less than about 10 minutes.”

The term “about” has a specific meaning in the patent laws. The term “about” is considered definite if the context of the term as it is used in the specification is clear. See MPEP 2173.05(b). The term “about” also provides additional coverage beyond the specific range identified. For example, the Federal Circuit in the case of In re Woodruff explained that prior art that disclosed a range of “about 1-5” covered a little more than 5. See also MPEP 2144.05. Of course, the term “about” is relative and has to be driven by the technology, although the Supreme Court in their infinite wisdom has found that a PH of 5 may be equivalent to a PH of 6, see Warner Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), and they have also stated that manganese is equivalent to magnesium, See Graver Tank & Mfg. Co. v. Linde Air Products, Co., 339 U.S. 605 (1950), which has to make you wonder about their technical, scientific prowess.

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and founder of IPWatchdog.com. Gene is also a principal lecturer in the PLI Patent Bar Review Course and an attorney with Widerman Malek. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 10 Comments comments.

  1. patent leather March 30, 2013 1:33 am

    Claim 1 looks like it might be this product:

    http://www.bengay.com/

    Do you remember the old Flintstones episode where Fred got a black eye and Wilma took a steak out of the ice-box so Fred could put it over his eye? Assuming raw meat has some type of analgesic property, there’s a 102 on claim 1 right there. I hope the Examiner watched the Flintstones as a kid.

  2. Mark Summerfield March 30, 2013 2:50 am

    Hi Gene,

    I’ll grant you the independent claim does seem fairly broad, but then I’m no expert in this technology area.

    As you say, if cooling the analgesic prior to application produces a result that is no different from what you would expect from separate application of ice and uncooled analgesic, then you would think the claim would be invalid for obviousness. But, you never know, there may be some unexpected synergy! This is at least something that J&J could legitimately debate with the Examiner.

    It is also possible that creating a composition that actually functions at low temperature may involve problems requiring inventive solution. After all, an analgesic gel is useless if it is frozen solid! And while that might be of little assistance to J&J in getting claim 1 allowed in the US (since there is surely no way it is enabled across the scope of all analgesics) the situation may be different elsewhere. For example, under the current Australian law (until 15 April 2013) it is sufficient for the specification to teach just one embodiment falling within the scope of the claim (assuming it is also valid over the prior art).

    It is therefore relevant that the US application is claimed for priority in PCT/US12/055979. The broad claim really needs to be in the priority document if J&J wants to ensure entitlement to the original filing date in other jurisdictions.

    Of course, it is probably also relevant that the International Search Report (drawn up by the EPO) cites numerous X and Y documents, as well as the ‘Bengay Zero Degrees’ website as a T document!

    Also in J&J’s defence, filing borderline claims to build dense patent thickets is rife in this industry. Until and unless P&G, SCA, and other competitors are willing to stand down also, it would be poor strategy for J&J to unilaterally alter its practice, even supposing it is genuinely ready to do so.

    Mark

  3. Mike Zall March 30, 2013 9:07 am

    Gene:
    One day you need to write an article on how you write your articles. Because I (also) enjoy writing, I have had on my docket,probably for at least 20 years, that I will write an article on some IP topic In which I am interested. To date, the silence is deafening. Work, family, sleep, and just goofing off for about a half hour a week have killed all my time. The best I can usually offer is a “comment” at the end of some interesting article.
    Mike

  4. Steve M March 30, 2013 12:03 pm

    I’m with you, Mike.

    Gene’s a content machine.

    Don’t know how he does it. I wouldn’t want to even try.

    Very thankful he’s willing to share his gift with all of us.

    The patent/IP ecosystem is better informed because he does so.

  5. MD March 31, 2013 5:54 am

    With the clear and convincing standard once again refreshed, I would suggest that the most effective way to blunt the effect of USPTO issuance of claims that are an affront to commonsense (and potentially a shake-down threat, even for J&J) is yourself to file them and carry them through to A (or WO) publication so that they exert their full prior art effect, in the USA, 18 months before they are so published.

    China has over recent years filed hundreds of thousands of PCT applications, taking them to WO publication then dropping them. Why might that be then?

    For half a century Japan has been assiduously running stuff through the USPTO for defensive reasons. They do this to keep the way ahead clear, rather than with any thought to assert their issued patent rights through the courts of the USA.

    So what is so bizarre about J&J copying the Asians. J&J is pretty smart, right? It must think (perhaps borrowing a trick from L’Oreal) “because I’m worth it”.

  6. Anon March 31, 2013 8:20 am

    MD, I will assume that you are MaxDrei from the blog Patently-O, and I have to say that your posts here, as there, continue to baffle me. I am once again left wondering what point you are attempting to make.

    Much like your postings on the other blog, I am left scratching my head – from start to finish.

    I find nothing you say to come close to being on point. Your randomness is perplexing.

    First, MaxDrei, this article has absolutely nothing to do with the clear and convincing standard, so your choice to lead in with the comment immediately puts me on guard as to what point you are trying to convey. You are aware that this claim has not issued, right?

    Second, as to any type of defensive worth of such an extremely broad claim, you are also aware that merely including such in a patent application does not automatically inure the benefit of clearing the path, right? You need enablement and not mere speculation. Elsewise, the examining corps could just visit the science fiction section of any library and find a treasure trove of material to curtail “excessive” patenting.

    Finally, I would ask on what basis do you jump to the conclusion that J&J is copying the Asians. Do you have some inside information that no one else is privy to? Or are you just making things up? And for the life of me, how do you tie the L’Oreal line into this situation? If anything, the emptiness of value exemplified by this overbroad claim is the opposite of the line you chose to use.

  7. Stan E. Delo March 31, 2013 2:02 pm

    Gene-

    Like yourself, I found their claim to be pretty strangely obvious, especially when they don’t specify any particular analgesic compound. They must have some reason I suppose, which Mark and anon allude to, if not just the practice of asking for as much territory as you think you Might be able to get away with.

    Stan~

  8. John Spevacek April 1, 2013 1:20 pm

    Gene,

    I’m not a lawyer, but a PHOSITA. Like most people here I suspect, for an issued patent, I jump straight to the claims. The specification I might read later if there are specific issues, but I’m pretty much just a claims guy. (The Cult of the Claim I believe it has been called.)

    But with applications, I seldom get fired up about any claims. To me, they are like a wish list to Santa Clause. “I want a pony and a playhouse and…” “Shut up kid and you’ll maybe get a Barbie (TM) doll.

    I’m surprised no one actually read the spec. It’s plenty short and mentioned a lot of issues with cooling analgesics – phase separation, still being able to dispense the material when it just came out of the freezer, packaging that enables said dispensing… there’s some good stuff there. Not revolutionary, but few patents are.

    Now why none of that made it in the claims, I’ll never know. We can speculate all we want (others here seem to have a great imagination) but unless there is some specific prior art covering the technical issues I raised above, it seems to me that this application will issue some day. Can we expect a follow up some day on this? In fact Gene, following this patent through the various office actions could supply you with lots of fodder for the blog. I’d be interested in seeing you comments as things progress.

  9. Gene Quinn April 1, 2013 2:02 pm

    John-

    I will try and follow this through and see what happens. I would like to do more of that type of “under the hood” review of applications for teaching/learning purposes.

    I usually don’t write about pending patent applications, unless it is something cool or particularly interesting. I know that a lot of patent applications just get filed with very bad claims. I think what rubbed me the wrong way is how Johnson & Johnson complains about patent trolls and specious claims. I know I am conflating a bit, or at least comparing apples to oranges, but if you are going to complain about gaming the system and abuse then why not start at home? If nothing else the first action in this case will be a complete and total waste of examiner resources. As was suggested earlier in the comment chain by patent leather, Claim 1 could be rejected based on an episode of the Flintstones.

    Incidentally, I wish I had thought of that Flintstones reference!

    Cheers.

    -Gene

  10. John Spevacek April 1, 2013 3:07 pm

    I do too!

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