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First, circle the independent claims, which will illustrate here with parentheses, e.g., (1) means claim 1 is independent (it always is, BTW).

Second, use an arrow aft

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

er a dependent claim to show what claim it is dependent from.

Third, use the PTO check mark and equal signs (from the file wrapper claim chart format) to indicate reje

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ted or allowed claims. "=" means allowed, "./" (the closest can get to a check mark here) means rejected.

Fourth, draw the claim chart veritcally on the inside of the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

file wrapper (in the margin) – this way you get a road map of the claims during reviewing the case.

Miscellaneous notations might be added to remind you about the scop

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of the claims or other notes. e.g., "A" for apparatus, "M" for method, "o" for objected to, etc.

Example: A ten claim case with 3 independent claims might have a ch

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

rt like this:

A (1) ./

2 -> 1 =

3 -> 1 ./

4 -> 3 =
M (5) =

6 -> 5 =

7 -> 6 =
A (8) ./

9 -> 8 o

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

10 -> 9 o

In day-to-day analysis of claims, people use the this type of claim tree as a way to visualize the analysis especially for complex claim structures.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

For example, in an application with 100+ claims and an extended prosecution history (e.g., with many canceled, revised, and newly added claims), a visual depiction of

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

he dependency structure of the claims (e.g. using a tree structure similar to Windows Explorer) can be invaluable. Some people take a further step of annotating the tr

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e structure to reflect the content of the claim and any references cited against the claim.

Another approach for making claim chart is a two-column table in every leg

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

timate patent infringement analysis. In the left column are each and every limitation of the patented invention. In the right column is either a "yes" or "no" answer

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s to whether that limitation is present in the accused device or method. For example, an accused device and a claim chart are presented below:

Robert's validity chart

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

is not only useful for 102 analyses, but also 103 analyses, particularly the combining references type. Consider

Claim 1

Reference 'A’

Reference ‘B’

A widget appar

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tus, comprising:

1) a frobosinator,

2) a pixilator, and

3) a green cogscreen

Widget apparatus:

Yes (col 1, line 10)

Yes (col 1, line 12)

No (but there is a blue

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

cogscreen at col 7, line 10)

Widget subassembly

No.

No.

Yes (col 9, line 12)

This chart supports a rejection of claim 1 as obvious over ‘A’ in view of 'B’.

The m

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

st useful automating tool that I have found is the shareware program that takes a draft specification and produces reports of the numbered items referred to in the clai

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s and produces reports with respect to the same. It saves time in producing a Sec. 112 check. For the most part, I have found analysis of claims not to be terribly di

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ficult to do with human eyeball, but can see massive problems in trying to do them automatically, making it a project unsuitable for automation, because the cost/benefi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ratio seems unfavorable. On the other hand, while this is certainly true for novelty searches, where you compare the claims of your application with the teachings of

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

he prior art, where you pretty much ignore the claims, it may not be so true for a validity search, where you compare the claims of many patents with the accused device

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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