Introduction

A patent is a form of intellectual property protection that gives the inventor the exclusive right to make, use, and sell an invention for a certain period.  It is a way for inventors to safeguard their ideas and prevent others from profiting from their hard work.

In the medical field, patents are crucial in protecting medical inventions.  With the increasing demand for innovative and effective medical solutions, inventors must secure their intellectual property through a patent.  This protects their ideas and helps spur innovation and advancement in the field of medicine.

The patent process can seem overwhelming, but understanding the steps involved can make the process more manageable.  This article will outline the steps involved in obtaining a patent for a medical device.  These steps include keeping your invention confidential, determining if your invention is patentable subject matter,  determining if you need a patent, selecting the type of patent you need, conducting a patent search, preparing and submitting your application, responding to Office Action rejections, paying the Issue Fee, and making Maintenance Fee payments.

Keep Your Invention Confidential

Keeping your invention confidential is essential because if it is made public longer than a Grace Period specified by each country, it may no longer be eligible for patent protection.

The U.S. has a ‘Grace Period’ allowing for disclosure of the novel aspects of the invention up to one year before filing a patent application.  If the patent application is filed even a day after the one-year deadline, all patent rights are lost and cannot be recovered.  This deadline is non-extendable.

If an Inventor needs to work with other people, such as an electrical engineer or a plastics extrusion expert, to complete the invention, a Non-disclosure Agreement (N.D.A.) or Confidentiality Agreement is recommended.  Disclosures made under these agreements to complete or modify your invention are not considered ‘public disclosures’ and do not start the Grace Period clock or forfeit your rights in certain countries.

Determine If Your Invention is Patentable Subject Matter

A patent is effectively a ‘legal monopoly’ on an invention, restricting use to the general public and only allowing use by the patent owner.  Under public policy, it makes sense to allow the general public to benefit from certain subject matter.  Therefore, due to public policy under 35 U.S.C. Sect.  101, certain subject matter cannot be patented for the good of society overall.

One such category of subject matter is medical procedures.  It was determined that medical procedures which would benefit patients would be allowed to be used by all, for the good of society.  Therefore, medical procedures fall under 35 U.S.C. 101, are not patentable subject matter, and cannot be restricted with patents.

However, it was determined that unique medical devices used in medical procedures could be patented.  Medical devices often are used in combination with medical procedures.  Therefore, one must first determine if it is worth patenting a medical device if the procedure cannot be patented.

For example, years ago, a vascular surgeon had to remove portions of varicose veins manually.  Existing scalpels and forceps would shred the veins requiring them to be removed in many sections.  This procedure became very labor-intensive and time-consuming.  A vascular surgeon designed a spoon-shaped tool with blunt edges that could remove large portions of the veins without breaking or shredding the vein.  The device was new.  He began making these devices for other surgeons and patented them.  However, the procedure was not patentable.

Determine if You Need a Patent

Before applying for a patent, it’s important to determine if you need a patent at all.  Obtaining a patent is an agreement between the Inventor(s) and the Federal Government.  The Inventor(s) agree to teach ‘… one of ordinary skill in the art to make and use the invention’.  In return, the Federal Government will grant the Patent Owners a monopoly on the invention described in the granted claims for a maximum of 20 years (from the filing date).

The first part of this agreement requires the Inventor(s) to disclose their invention in detail in the patent application.  These patent applications are published 18 months after filing.  However, the U.S. patent only protects the invention in the U.S. and its territories.  The Inventor will also need a patent in all other countries where he/she would like to protect his/her invention.  It can get costly to file and prosecute patent applications in numerous countries.  Other entities are free to make, use, sell, and import your invention into all countries where the Inventor did not file for patent protection.  Therefore, you have enabled (with the published patent) entities to make, use, sell, and import your invention globally but have only filed for protection in a few countries.  The result is that other entities can make, use, and sell your invention in all countries where you have not filed patent applications.    Since we live in a global economy, one can see how Trade Secrets can be useful in protecting certain inventions instead of patents.

For some types of inventions, such as software inventions, chip designs, and other inventions that cannot be easily reverse-engineered, Trade Secrets may provide better protection.

Types of Patents

Three types of patents are available for submission: a) Design Patents, b) Utility Patents, and c) Plant patents.

1. Design Patents

Design Patents cover the aesthetic look of a device or object.  They do not cover the functioning of the device.

Some medical devices have a unique shape or visual design.  If the Inventor would like to stop others from making, using, selling, or importing products that have a shape or design similar to that of the Inventor’s medical device(s), the Inventor should consider filing a Design patent application.

For medical devices with a distinct design, such as a unique shape, it is possible to protect the distinct look with a Design Patent.  A Design patent will not allow the Patentee to stop another entity from making, using, selling, or importing a medical device that performs a specific function; however, it will allow the Patentee to stop another entity from making, using, selling or importing a medical device that has the same aesthetic look as shown in the Design Patent.

2. Utility Patents

Utility Patents are the most common type of patent application filed.  They are designated to cover the functioning of new and useful processes, machines, articles of manufacture, and compositions of matter.

Utility Patents cover how medical devices function or operate.  The vast majority of U.S. patent applications filed are Utility Patents.

Provisional Utility Patent Applications

Utility Patent can be filed as a 1) Provisional patent application or 2) a full Non-provisional Patent application.

A Provisional patent application functions as a ‘placeholder’ and is official evidence filed with the USPTO of what the Inventor knew when the Provisional patent application was filed.  Provisional patent applications are not examined and expire one year after being filed unless converted into a Non-provisional patent application.

If the Provisional is not converted or there are no other patent applications filed claiming reference to the Provisional patent application within one year, all patent rights will expire.  If the information was not made public more than one year ago, the Applicant could file another patent application but only receive the date it was filed and not the date of a prior-filed but expired Provisional patent application.

3. Plant Patents

Plant Patents cover asexually reproducing plants.  These are typically not used to protect medical devices and are outside the scope of this paper.

Determine if the Invention Is Known

If you decide to file a patent application, you may want to check what parts of your invention are already known.  Since many inventions begin as a solution to a problem, the Inventor or Patent Attorney should step back from an invention and try to determine the problem the invention is aimed at solving.

Next, the Inventor should learn what has been done in the past to correct or mitigate this problem.

One way to learn about prior attempts to solve this problem is to conduct a prior art search.  A search will uncover previous devices and methods directed at solving the same problem.

Typically, we break down the invention into elements.  For example, a dialysis catheter has elements being: an insertion end, a shaft with one or more lengthwise dividers that separate the internal lumen into multiple lumens.

There are inlet and outlet tubes, each connected to a different lumen.  The other end of each lumen has a connection piece that makes a liquid-tight connection to other tubes.  The shaft, lengthwise dividers, internal lumens, and connection pieces are all elements of this invention.

Determine Prior Art

Typically, an online search is done trying to find as many of the elements or structures similar to the elements of the invention in publications, presentations, papers, advertisements, published patent applications, patents, videos, or other disclosures of one or more elements of the current invention.  Collectively, these are referred to as “Prior Art References”.

The prior art search is not required to file a U.S. patent application and is optional.  There is Rule 56 (37 CFR 1.56), which requires the Applicant to report to the Examiner any Prior Art References found that are very relevant.

The Examiner may use these reported Prior Art References to reject your Patent Application.

A typical patent search involves an online search through existing publications and disclosures to determine what elements of your medical device are already known to the public.

Those elements available to the public cannot be considered “new” elements.  All elements may appear in a single Prior Art Reference which would cause an “Anticipation” rejection per 35 USC 102.

If some of the elements are found in one Prior Art Reference, and the others are found in one or more Prior Art References, and if it is obvious to combine the elements, then the claim may receive an “Obviousness” rejected under 35 USC 103.  This rejection is by far the most common.

Searching

Conducting a search before filing an application is important because you don’t want to waste time and money filing for a patent on an invention that has already been patented.  Searching before filing is for the Applicant’s benefit and is not required by the patent laws and regulations.  One of the first actions that the Examiner takes on a patent application is to perform an extensive, global search for technology similar to the aspects claimed in a patent application.  The closest references and an explanation of how they relate to the claims are written up as an Office Action and sent to the Applicant.  If the references are close enough to certain claims, they may be rejected based on the references found.  Typically, in the first Office Action, all claims are rejected based upon 2-3 references, usually U.S. patents or U.S. patent applications.  The Office Action is then sent to the Applicant.

Rule 56 Required Disclosure

As indicated above, Rule 56 requires an Applicant or his/her Counsel to submit close and relevant references to the USPTO, usually in the form of an Information Disclosure Statement (I.D.S.).  The Examiner reviews these and if close enough, can reject claims based on the references submitted in the I.D.S.  Therefore, please note that if the Applicant does an exhaustive search and finds very close references, the Applicant must submit them to the USPTO, and these references may be used to reject his/her patent application.

In a sense, a prior art search is beneficial, since it saves the Applicant a great deal of time and expense prosecuting a patent which would eventually be rejected or declared unenforceable, depending upon when the very relevant reference is found.

Requirements for Patentability

An invention must meet the requirements of Title 35 of the United States Code (U.S.C.), and Title 37 of the Code of Federal Regulations (C.F.R.) to be considered patentable.  Besides 35 U.S.C. 101, ‘Non-patentable Subject Matter described above, the major requirements are 35 U.S.C. sections:

102 novelty,

103 obviousness,

112 enablement,

112 clear specification, and

112 specifically claim the invention.

102 Novelty

If all of the elements of a claim are disclosed in a single reference, then the claim should receive a ‘Lack of Novelty’ or ‘Anticipation’ rejection.

103 Obviousness

If all the elements of a claim are disclosed in 2 or more references, and it is obvious to combine these references, then the claims should receive an ‘Obviousness-type’ rejection.

112 Clarity, Specificity

Patent protection of an Inventor’s invention is based upon an agreement between the U.S. Government and the Inventors.  The deal is that the Inventors must meet an ‘Enabling’ requirement.  Enabling means filing a patent application that describes their invention in sufficient detail such that “… one of ordinary skill in the art will be able to make and use the invention”.  The Invention is also required to be novel, non-obvious, and useful.

The Inventor or Applicant must submit a patent application having certain required elements.  There should be a written description that meets the Enabling Requirement above.  If the specification does not fully and clearly explain how to make and use the invention, it can be rejected under 35 U.S.C. paragraph 1 as being unclear.

If a claim does not specifically identify the invention, it can be rejected under 35 U.S.C. paragraph two as a failure to ‘… specifically claim the invention’.

Preparation Process – Utility Patent

Preparing to apply for a patent involves learning the current invention, its structure, and its function.  Next, the references found in the prior art search are compared to the current invention.  The differences in structures, functions, and advantages between the current invention, as claimed and the prior art references I determined.

If the structure and functions of the current invention differ in a substantial way from all the prior art references, it is possible to obtain a patent on the invention.

Explanation of Acceptable Forms

The USPTO has created forms that satisfy some of the requirements of the patent laws and rules.  However, these forms are applicable to a specific situation.  Other situations require a different forms.  For example, a Provisional Utility Patent Transmittal Form meets the requirements for the initial filing of a Provisional patent application, but not the initial filing of a Non-provisional patent application.

Minimum Requirements for a Complete Nonprovisional Utility Patent Application

As indicated above, a complete Non-provisional patent application must be a written description that explains the invention clearly to a degree of detail that enables one of ordinary skill in the art to make and use your invention.  (Drawings are very helpful but are not required.)

An Oath or Declaration is required in which the Inventor states that the named Inventors believe that he/she is the true and rightful Inventors of the Invention, and that he/she has not copied the novel aspects from another.

Some of the Information required to file a U.S. Patent Application is:

• the type of patent application, (Utility, Design, Plant),
• an indication of the patent application is provisional or non-provisional,
• a statement indicating if the Invention was funded by a government agency,
• a title of the invention,
• Inventor names,
• Inventor city and state of residence
• Inventor mailing address,
• Attorney Information,
• Correspondence address,
• Number of drawing sheets,
• Number of specification sheets,
• Calculation of the Basic Filing fee,
• Calculation of the Search Fee,
• Calculation of the Examination Fee,

Cost of Submitting a Patent Application

The majority of the costs are the Attorney’s fees.  It typically takes about 20 hours to draft a Non-provisional Utility patent application of average difficulty.  Patent attorneys typically charge $270 – $560 per hour to draft patent applications, resulting in estimated costs of approximately $5,600 – $11,200 + government fees.  The government fees for filing a Non-provisional US Utility Patent are currently $1,476 for a full-sized entity, $738 for a Small Entity, and $369 for a Micro Entity.

Benefits of Retaining a Patent Attorney

There is a steep learning curve for each of the steps of this process.  Since regulations and laws govern these steps, a firm understanding of the laws and regulations allows one to argue aspects in the ‘gray’ areas successfully.

Also, our legal system recognizes precedents and ‘stare decisis’.  If a specific fact pattern was decided a given way, a later case with a similar fact pattern should be decided in the same manner.

Therefore, it would be helpful to know previous cases and their outcomes.  An Applicant unfamiliar with previous caselaw could conceivably learn it and be effective in arguing against rejections.  However, most people will only go through the patent process a few times.  It is not economically feasible to spend the time to learn the regulations, laws, and caselaw only to use it a few times.

Retaining the services of a patent attorney can help ensure that your application meets all the requirements and can provide valuable guidance throughout the patent process.  Additionally, a patent attorney can provide legal representation in case of any disputes or infringement claims related to your patent.

Submit the Application

Protecting your medical device begins with submitting a complete application to the USPTO website and supporting forms, commonly referred to as Formal Papers.  The formal papers are used to fulfill the requirements of U.S. Patent law.  For example, the Applicant must swear that he/she is the first and original inventor of the subject matter in the patent application being filed.  This requirement can be fulfilled by filling out and submitting an executed ‘Declaration’ form.  Other requirements are fulfilled by completing and filing an ‘Information Disclosure Statement (I.D.S.)’, a ‘Certification of Micro Entity Status’, a ‘Power of Attorney’ document, etc.

The submission requires converting the specification, figures, and formal papers into the proper format.  The converted files are then uploaded to the USPTO website.  It also requires paying the required government fees.   These can be paid online with a credit card.

USPTO Review of a Filed Application

Several departments of the USPTO review the non-substantive aspects of your patent application right after it is filed.  For example, one division examines your patent application to determine if you have all the parts of an application and sends you a notice to provide missing parts.

Another determines if the proper fee has been paid.  There are additional charges for applications over 100 pages, more than 20 total claims, more than three independent claims, fees for late submission of the Declaration, etc.

Some departments verify that the names of the Inventors are precisely the same as those on an Application Data Sheet, if there is a Power of Attorney, if the Power of Attorney gives power to the proper entity, or Attorney filed by the Applicants if there is a properly executed Certification of Micro Entity Status form, and that they payments are consistent with the type of entity.

A group works with the Examiner to provide a global search of features similar to those claimed.

Examiner Assigned

After submitting your patent application, it will be assigned to a group art unit handling the subject matter of the patent application.  An Examiner in that Group Art Unit will be assigned to examine your patent application to determine if it meets the patentability requirements.

The Examiner is a USPTO representative assigned to review your patent application and is tasked with examining your patent application.  He/she can reject it if it is determined that it does not meet the requirements of patentability.  The Examiner notifies the Applicant through Office Actions.

Office Actions

The Examiner will review the references found in the search and compare the claims of the pending patent application with elements disclosed in the references.  The Examiner will then send an Office Action reporting on the search and examination.  Usually, these have rejections of claims and reasons for the rejections.

Responses

The Applicant is then allowed to respond to the Office Action.  Typically, the Applicant is given three months to respond.  The Applicant can amend the claims and make legal arguments against the rejections.  After the Response is filed, the Examiner can respond with another Office Action considering the amended claims and the legal arguments.  There may be two to three Office Actions sent in a case.  After this, the Examiner will send a Final Office Action or an Allowance.

Final Office Action

A Final Office Action contains final rejections.  The Applicant can file a ‘Request for Continued Examination’ (RCE), pay the required fee, and be allowed to continue prosecution with another Response and one or two more Office Actions.  Some patent claims are never allowed, and the Applicant must finally drop them.  However, some may be allowed.

Allowance

If the Applicant successfully amends and argues over the rejections of the Office Actions, the Examiner will send a Notice of Allowance.  The Notice of Allowance lists the fees required to be paid before the issuance of your patent, including the issue and publication fees, and the patent will be issued upon payment of these fees.  It also indicates that a patent will issue on the patent applications, provided that the Issue Fee is paid within the time set for payment.

Issue Fee

The Issue Fee is required to be paid before the patent issues.  It keeps the patent in force for the first four years.

Patent Issue Notification

A patent is issued after the U.S. Patent and Trademark Office determines that the invention meets the requirements for patentability, and the inventor pays the issue and publication fees.

Maintain Your Patent

Maintenance Fees are required on U.S. Patents at 3.5, 7.5, and 11.5 after issuance of the patent.  Failure to pay these required Maintenance fees will cause your patent to be unenforceable.

Conclusion

Obtaining a patent for a medical device is a time-consuming but worthwhile process.  The general steps involved in the patent process include keeping your invention confidential, determining if your invention is patentable subject matter, determining if you need a patent, selecting the type of patent you need, conducting a patent search, preparing and submitting your application, responding to Office Action rejections, paying the Issue Fee, and making Maintenance Fee payments.

The rewards of obtaining a patent include the right to exclude others from making, using, offering for sale, or selling your invention in the United States or importing it into the United States.

Pursuing a patent application can be challenging, but the benefits of protecting your novel idea make it a worthwhile effort.

A US Patent is essentially a legal monopoly on your idea in the largest market in the world.

Reduces competition, makes your products unique, increases your selling price, and makes your company indispensable.