(Summary: Finding a very similar patent on a dosing device with a time scale is probably the most interesting news. Second is a change to slightly more aggressive tactics, to appeal the rulings of the patent office.)

Patents and licensing

            OptiDose - US patent progress. 

            You can now see our application online.

                        Google method:

                                    Type in “uspto”

                                    Click: Databases: Patent Grant and Patent Application ...

                                    (then see below)

                        Link or typing URLs method:

                                    (use patent office link on bottom of last page)

                                    On the applications side (right column) click “Quick search”

                                    Type in two terms "medicine dropper" and "body weight"

                                    You should get 20020010429  Dose by weight medicine dropper

                                    (This is CIP 6, they should have our more recent one up soon.)

            A very good break for us is a contemporary invention by Chanoch, 1997, US patent number 5,645,534. He put a time scale on an insulin injector so that the patient could set it as a reminder of the time of the last injection. (You can see it online, sort of like above, except on the issued patents side. The title is “Time of last injection indicator for medication delivery pen”.) This patent gives me a model to follow when writing the next edition.

            The most recent action was this last August 8, 2003. I filed our first appeal brief. Here is the meat of it if you want to pick through it. (Skip next 4 pages if you don’t.)

Appeal Brief

(1) Real party in interest:  Jack R. Grogan, Jr.

(2) Related appeals and interferences:  None.  A Continuation in part application has been filed,  CIP 7 (10/453087 filed 05/31/03). The new CIP has a new claim 6 for a body surface area scale.

(3) Status of claims: Claims 1-5, all pending and all appealed.

(4) Status of amendments: Amendment K(3) filed after final rejection. Unknown status. K(3) did not attempt to amend claims.

(5) Summary of invention (taken verbatim from abstract):

DOSE BY WEIGHT MEDICINE DROPPER

            A dose dispensing device such as a medicine dropper is improved by putting a dosing scale such as a body weight scale directly on the dose dispensing device. This improved device is used to simultaneously calculate and measure an exact dose of liquid medicine, based on the body weight of the patient.

(6) Issue: Newness.

(7) Grouping of claims. All the claims may be grouped together.

(8) Argument.

(i) (No rejections under 35 U.S.C. 112, first paragraph.)

(ii) (No rejections under 35 U.S.C. 112, second paragraph.)

(iii) For each rejection under 35 U.S.C. 102, the argument shall specify the errors in the rejection and why the rejected claims are patentable under 35 U.S.C. 102, including any specific limitations in the rejected claims which are not described in the prior art relied upon in the rejection.

Rejection:

The 102 (b) rejection is that my invention is unpatentable by George 4,693,709 and Swartwout 4,416,381. George teaches a medicine dropper with a volume scale. Swartwout teaches a medicine cup with a volume scale.

The Examiner says, “This scale can be used as a body weight scale because the user can measure out the specific amount of medicine appropriate for the body weight of the user.” (Source: Office Action, 12-31-02.)

Errors in the rejection:

I am going to answer this on three levels.

1.      The prior art does not contain my unique element, the body weight scale.

2.      The Examiner’s “can be used as” method requires an extra step and part.

3.      The implied statement that my claims are poorly constructed is worth exploring.

1.      Unique element. The law is quite clear: “…for anticipation under 35 U.S.C. 102, the reference must teach every aspect of the claimed invention either explicitly or impliedly” [my emphasis]. (From MPEP 706.02(a).) My unique element is the body weight scale, and this is simply not shown in any way, shape, or form.

2.      Can be used as. It is true that ordinary medicine droppers have long been used to dose by body weight. However, this use requires both a part – something like a dosage table or a set of dosage instructions – and a step – finding or calculating the dose for the weight of your patient. 

Similarly, the Examiner says, “…the scale of the prior art can represent both bodyweight and age by assigning a number on the scale a specific weight and/or age…” (Source: Advisory Action, 5-21-03.)

The similar error here is that this assigning is a step of some kind, and the assigned weights had to have come from somewhere.

3.      Claims structure. The issue could be that in a well-drafted claim the key descriptive words are separated out as separate elements to allow for easy analysis. If the issue is something like this, then the original error is mine for lousy claim drafting.

Looking through some of the relevant prior art, I see that scales seem to be broken apart.

For an example with a body weight scale, Ausman first says his dosage calculator has “scale indicia” and then that the indicia “includes two scales,

one representing weight and the other dosage”. (4,308,450 claim 10)

For an example with a time scale on a dosing device, Chanoch first lists a “plurality of indicia” and then says that each of the indicia “represent a day of a week”. (5,645,534 claim 1)

I have no objection to such good claim drafting. I would be happy with the terms above, or any of the slight variations below, or any other reasonable descriptions. (And as long as we are moving forward I can absorb the cost and effort of another CIP.)

Suggested claim variations:

Var 1:  A dose by weight medicine dropper for dispensing a medical fluid, comprising:

a tube;

                        a flexible bulb attached to one end of said tube;

an opening at the other end of said tube, and

a scale marked on said tube,

said scale comprising a plurality of discrete numerical points in a series,

said points comprising body weight indicia,

whereby dosing by body weight is quickly and easily performed by filling said tube with said medical fluid to a patient’s body weight.

Var 2:  A dose by weight medicine dropper for dispensing a medical fluid, comprising:

a tube;

                        a flexible bulb attached to one end of said tube;

an opening at the other end of said tube, and

a scale marked on said tube,

said scale comprising a series of marks used for measuring,

wherein said marks are body weight indicia,

whereby dosing by body weight is quickly and easily performed by filling said tube with said medical fluid to a patient’s body weight.

Even though the main error was mine for not writing a good claim, there was also an error in not giving me any instructions or chances to correct the claim wording. The Examiner suffered a lengthy illness, which is no one’s fault. But for me, all I got was that my invention was “unpatentable”. My request for the Examiner to write an acceptable claim fell through the cracks. My half-dozen phone calls to the Examiner yielded no chance to discuss claims.

(A call to the Supervisor did yield something along the lines of, “a body weight scale reads on all scales”, and that did eventually lead me to now propose better claim structure. But I was told he could not discuss my case, that that had to be done with the Examiner.)

I am also sympathetic about the sheer volume of work examiners are expected to process. When I worked at our university’s patent office, my full-time job was helping about 3 inventors, and I had unlimited access to attorneys. My understanding is that you folks have about 100 times this load. Given all the givens the US Patent Office does a heck of a job.

Why the rejected claims are patentable under 35 U.S.C. 102: 

The main reason that adding a body weight scale to a medicine dropper is patentable is that it saves both a part (such as a dosage table) and a step (such as looking at the dosage table to find your dose). From a “newness” point of view (35 U.S.C. 102), there is no question that it is new relative to the prior art relied upon. These regular medicine droppers only show volume scales, such as ml. There is nothing remotely like body size or weight even mentioned. (There is some much closer prior art in the application, such as Zimecterin, described at the bottom of page 7. If we are going with the issue being faulty claims drafting, I will need to add a clause about the direction of the scale for the oral syringe embodiment.)

The specific limitations in the rejected claims which are not described in the prior art relied upon in the rejection:

The limitation is “body weight”.

(iv) (No rejections under 35 U.S.C. 103.)

(End of appeal brief)

(back to OptiDose patent story from 4 pages ago)

            Earlier in the summer I did the usual thing, which was to file yet another edition of the application (CIP 7, filed 5-31-03). This one has the “language” of Chanoch, which gives us a way to go. (But I may end up with one more CIP just to get all the claims worded just right.) I also explicitly claimed our “BSA” dropper. (See below in Paul’s license.)

            We may be down to almost splitting hairs. As in me wrongly saying hairbrush instead of brush, hair. (My only brush with this was in the Navy. Instead of saying scrub brush or toothbrush, their official lists would always put the noun first, adjective second. Like brush, scrub and brush, tooth.) In my claims I always say “body weight scale”. I think they want me to say “scale, body weight”.

            Resolution of old issues (from the earlier history way below). Objections from CIP 5, like obviousness and the Janssen prior art, seem to have been put away. (They never actually say you are right, they just go on to say you are wrong in other areas and quit carping about the original objections.) And we got the patent application reincarnated after I bungled that check. (Cost us $660 in the short run and will cost us the last 22 months of our patent’s life, which could be boodles of way way future royalties.)

            In between issues (CIP 6, filed 5-17-01). Not much interesting happened this go round, which was the main reason I ended up appealing.

            OptiDose - USA licensing progress.  Paul from pharmics may a casual request for a license for a new infant iron product. We wrote back and forth a few times, Drs. G & P threw in some dosage pointers, etc. (Now – 11-04, this seems to be on everyone’s back burner.)

            OptiDose - Swiss licensing progress. 

            Abbott's request for a license seems to have faded away. *SIGH*  (During that time, like 1998, I was not very supportive. No annual report to say rah, rah, rah. No funding. Heinz and the Abbott guys are busy people. What they probably needed most was a well-drafted license, in German, ready to sign.) Earlier Heinz and I talked about giving Janssen a free license since they are the actual inventors. So just the other day I went ahead and did that. The continuing presence of Abbott and the other 2 "infringers" is clearly an issue we should do something about. We will probably give them a license that we could cancel in 3 months if someone else wanted more exclusivity. 

            OptiDose - South African licensing progress.  We may be dead there now?

            Osteo - US patent progress.  I finally dropped our application to use fluoride to prevent birth defects, as of 12-12-02. Many of you helped, like with finding good papers, but 16 tons of circumstantial evidence was not enough. What I was missing was hard evidence that fluoride will prevent birth defects (like a real clinical trial). Without that, the claims can not be definite (“prevent 10% of heart defects”). If I make the claims wishy-washy, like “make the best possible attempt”, then I get hit with the objection that the claim is indefinite. I could have kept it alive just by doing another CIP for another $600. That would have lasted about a year and a half, or about $30-$40 a month. I had already played this gamble (that sooner or later I would somehow find proof or find a way to write the claims) for 7 applications over the course of 11 years. I enjoyed it and learned a lot, but to me it was time to drop it.

            The loss of “osteo” in and of itself is not important to us financially. However, it does take a little wind out of my most far-fetched dream sails. Working on osteo got me into how matrix molecules affect early fetal development and then, years later, everything from the shape of teeth (Dr. Glenn’s pits and fissures) to the “identity” of cells. I had some hope that I could figure out a way to target cells that had identity problems that lead to cancer. As I saw it, these trouble areas, like the pits and fissures of teeth, emerge later, and then their lack of identity allowed cancer cells to colonize. Maybe we could have designed a hybrid molecule that would have been a blockbuster drug. It could have been taken once a month or so, with one end seeking the emerging identity pits, and the other end of the molecule protecting the site somehow. It was a wild dream, and we only had a zillion to one chance that it was possible and that an amateur like me could have been first to find it. And, we still could, but I try to resist now, and stay focused on OptiDose and other more likely things.

            (This application was just before the patent office started pubbing online. I put parts of it on a little web site, and I still fiddle with it. So far it is just the basic birth defect parts. Number one on my wish list of experiments is looking at prematurity – following Dr. Glenn’s nose – and pits and fissures – and then the cancer part. The closure of the pits area of the first permanent molars is right at the time of birth. It may be that the closure is some part of the “switch” that begins the birth cascade. Dr. Glenn’s findings on lower prematurity and lack of pits and fissures with prenatal F beg someone to look at the first permanent molars of premature infants. Are their molars closing at birth also, even though they are way early? Could this be developed into a precise way to forecast prematurity and birth dates? If true, the interest in how this worked may spin off into the cancer area. Is there an animal model for pits and fissures so we can start playing with the variables? Like a step in developing the hybrid molecule would be to find something that would target teeth pits and fissures. If we had an animal model, we could give an injection of radioF right near birth and that would show up as a line, outlining the pits and fissures target. Then later, probably as the teeth start moving but before they emerge into the mouth, try various molecules and timing, etc. to see if we could get something to stick inside the target. If you ever see somebody doing work like this, please let me know.)

            Trademark issues.  New users (see more in the earlier history). None of these are in our area (dosing devices) and we are in peaceful co-existence.

GE Medical Systems’ use of the OptiDose trademark is for CT scan devices, computer hardware and software.

CDS Dose Checker (OptiDose). The OptiDose is a clinical decision support software module.

Optidose, as it refers to a product developed at Zoomedia, is a software application about dosing for Parkinson’s disease.

Other news

            New web sites. (Our old ones melted down with some dot.com startups. The new infant fluoride one is quite popular on Google, etc.)