Category: Patents

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Science Fiction Has Turned Into Medicine: How Ingestible and Injectable Digital Tech is Changing Healthcare

At first glance, it reads like the plot of a classic sci-fi movie or a big-screen blockbuster: micro-technology inside the human body.

Well, the future has arrived.

Computers no larger than a pill are now being designed for the human body. These digital devices can map the gut’s microbiome, track pharmaceutical delivery in real time, stream wireless telemetry to a doctor’s mobile phone, and—at the precise right moment—completely dissolve.

Here is a look at how ingestible and injectable medical computers are currently being deployed, along with some intellectual property strategies for the innovators building them.

Current Real-World Ingestible & Injectable Medical Computers

  1. Diagnostic Imaging & Sensing Capsules

Ingestible camera capsules now traverse the gastrointestinal tract to capture high-resolution imagery where traditional endoscopes cannot easily reach. Next-generation capsules—such as gas-sensing and hydrogel-sampling pills—measure internal pH, hydrogen, and methane levels to map the gut microbiome without invasive procedures.

  1. Digital Medicine & Adherence Tracking

Ingestible sensor systems utilize microchips made of food-grade minerals. Activated by stomach acid, the chip broadcasts a brief signal confirming the exact time a patient ingested their medication. In the “bullpen” are bioresorbable RFID capsules that track drug adherence and then biodegrade completely.

  1. Injectable & Bioresorbable Implants

While some of these computing devices are still in the development stage (like a trip to Mars) their widespread arrival is inevitable. Examples include injectable bioresorbable electronic devices (such as temporary cardiac pacemakers), nerve stimulators for chronic pain relief, and tissue-oxygen sensors. By utilizing micro/nano-technology silicon membranes and magnesium interconnects, these devices dissolve after a predetermined clinical window—eliminating the need for surgical removal.

Strategic Patent & Legal Takeaways for MedTech Innovators

  • File Early—Separate Patent Timelines from FDA Timelines: Patent rights depend on technological novelty, not regulatory approval. You can secure patent protection for an ingestible device years before entering human clinical trials.
  • Document Human Contributions: Maintain rigorous laboratory engineering records that log human modifications, testing, and iteration—particularly if AI tools assisted in early design phases.
  • Build a Multi-Layered Portfolio: Protect the entire ecosystem by drafting separate claim sets for the physical capsule architecture, the chemical bioresorbable substrate, and the operational methods for internal data transmission.
  • Prioritize Regulatory Compliance Early: FDA certification is necessary to commercialize your device. Start the process as soon as possible, as regulatory clearance will likely require more time than securing your first patent grant.
  • Understand the “Distance from the Patient” Rule: In medical IP, a general rule of thumb applies: the farther away from the patient a medical invention is, the less economic value the patent tends to command. (And, of course, the closer a medical patent gets to its expiration date, the less value it retains.)

Ask Us Anything… About Intellectual Property!

Business Patent Law, PLLC is headquartered between Louisville and Lexington, Kentucky, serving a diverse range of clients—from innovative startups to successful companies with decades of market presence whose business interests span across seventeen time zones.

If you have a topic or legal question you would like our editorial staff to address in an upcoming feature, please contact us. Business Patent Law, PLLC provides comprehensive intellectual property and business counsel to safeguard your technological breakthroughs.

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What is This Intangible to Tangible Thing About Patents?

  • Tangible can be defined as, “a physical thing.”
  • Intangible can be defined as, “something without physical substance.”

A fundamental paradox at the heart of intellectual property law is that part of it is controlled by the physical laws of the natural world, while another part exists purely in an invisible space.

Intellectual property is much more than just an abstract idea floating around in that invisible space.

For a patent to be granted, that ethereal idea must be transformed into enforceable “metes and bounds.” Like it or not, an inventor usually needs a lawyer to stand up in federal court and argue that someone is trespassing on those invisible boundaries (the alleged infringement). This unique combination of the abstract and the concrete creates one of the cornerstones that ultimately benefits “We the People.”

The Limited Patent Monopoly

The limited patent monopoly gives the first to market an upper hand on the competition. Without patent rights, technological advancement would grind to a halt. Many argue against the patent system, but do we really want to go back to riding horses and bathing once every few months? Most people would think that stinks!

Currently, the United States of America is a semi-regulated capitalistic country. It must be this way; unregulated capitalism historically results in a very few owning almost everything while everyone else is left poor. Our history from the 19th and early 20th centuries showed us exactly what happens without smart regulations. Patents are a key part of that balanced framework.

Rights Become Tangible When Enforced

When a third party creates a physical product or process that too closely resembles your patent claims, a judge or jury will determine if there is an infringement. Armed with a successful judgment, you can legally stop that third party from:

  • Manufacturing your invention
  • Selling or offering it for sale
  • Using it in commerce
  • Importing it into the United States

The power to stop an infringer, paired with the payment of damages, can be the biggest dog in the room for advancing your company to the next level. A court-ordered injunction and cash settlement are real, physical results flowing directly from an intangible patent.

The Tangible Value of the Patent Outside the Courtroom

You don’t always have to go to court to feel the physical power of a patent. In the daily business world, that intangible asset creates tangible value in three distinct ways:

  1. The License

Upfront fees, milestones, and royalties are just a few of the financial perks. They can be sliced and diced however the parties agree. With or without your own manufacturing or distribution facility, a patent allows you to create a very real, very physical revenue stream.

  1. Investment Capital

In return for selling equity to investors, hard capital is deposited directly into your corporate treasury in exchange for shares—without a bank collecting interest on a loan. However, your Securities and Exchange Commission (SEC) filings must be pristine. Without one or more patents defending your market position, it is highly unlikely sophisticated investors will back the future of your company.

  1. Collateral for Corporate Growth

Sometimes, the “just right” patent portfolio is sufficient collateral to secure a major loan. Public bankers, private bankers, investment bankers, and even insurance companies generate loans backed by intellectual property. Without the patent(s), this type of cash influx is often impossible.

  1. Sale

The patent’s intangible rights can be sold to a third party. This also generates tangible cash in the hand of the former owner.

The Takeaway

In the business world, things we cannot see, touch, hear, taste, or smell can become extremely valuable. Of course, they may not—it all depends on how you protect them.

From our experience, when companies are acquired, those with robust Intellectual Property portfolios realize significantly more cash than those without. That very tangible increase in cash for the seller is the direct result of those intangible patent claims.

Ask Us Anything… about Intellectual Property!

Business Patent Law, PLLC is headquartered between Louisville and Lexington, Kentucky, serving a diverse range of clients—from innovative startups to successful companies of several decades whose business interests cause BPL’s practice to span across seventeen time zones.

If you have a topic or question you would like our editorial staff to address, please send us an email. Business Patent Law, PLLC provides intellectual property and business counsel. If you need assistance, contact us today.

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I Invented a Box Containing Hot Air: Shoot the Moon or File 13?

I Invented a Box Containing Hot Air: Shoot the Moon or File 13?

Similar to the public’s verdict about 1800s’ snake oil salesmen, the colloquialism “selling hot air” generally voices a negative connotation. But until Congress changes Title 35 of the U.S. Code, the ultimate arbiters of patentability are statutory requirements—not public opinion.

To understand how the United States Patent and Trademark Office (USPTO) evaluates an invention, let’s look at four different examples of “a box” to see what lands in the trash can (File 13) and what gets a shot at a patent (Shoot the Moon).

  1. The Unpatentable Box

The Setup: A sealed cardboard box containing nothing other than ambient air at 100 degrees Fahrenheit.

The Verdict: High probability of File 13.

Standard cardboard boxes have been available for hundreds of years, and the statutes dictate that Natural Phenomena—such as ambient air—are not patentable. Simply trapping hot air in a standard container doesn’t cut it.

  1. The “Something Different” 

The Setup: An open-close box containing air, a cushion liner on the inside of the box, and a location tracker.

The Verdict: Possible, but likely File 13.

Under some narrow circumstances, this might be patentable if it features a brand-new location tracker that measures travel speed and position connected to the Cloud. However, there are already numerous tracking devices used by international carriers to move boxes around the globe. Without an additional search of the prior art, this one faces a steep uphill battle.

  1. The Box with Internal Climate Control

The Setup: On the outside, it looks like a standard cardboard box that can be opened, closed, and sealed (cardboard is a cheap insulator). On the inside, the ambient air is actively controlled by a thermal heating and cooling system built into the inner liner. Along with a small vent, the box includes a microcontroller/processor, a mini-heat pump, a voltage supply, a temperature sensor, and tracking module circuitry with a transceiver connected to the Cloud.

The Verdict: High probability of Shoot the Moon!

It’s an integrated system. You aren’t patenting the air or the cardboard; you are potential a novel, man-made utility system that manipulates the internal environment.

  1.  A Very Soft Malleable Blanket

The Setup: On the outside, a durable, protective shell capable of absorbing extreme external shock. On the inside is a harvested donor heart traveling 400-plus miles to a waiting patient. The heart rests in a sterilized, malleable blanket that conforms to its exact shape, preventing it from contacting anything else. The box’s vent includes a microfilter to block pathogens. Alongside the processor, mini-heat pump, voltage supply, and Cloud transceiver, the box includes a supply of saline, a mini-fluid pump, and a layer of graphene contacting each millimeter of the heart’s external surface area.

The Verdict: Ultimate Shoot the Moon!

This is a highly sophisticated, life-saving apparatus with clear, markedly different structural and functional characteristics from anything found in nature. (Note: While highly patentable, you will definitely need FDA certification before introducing it into commerce!)

The Takeaway

Never assume your idea is too simple or too strange to be patentable. As humans, we often lean toward keeping the old rather than embracing the new. We weren’t there, but based on human nature, when the first person put a wheel on a peg, his peers likely laughed at him.

Ironically, we recently watched a documentary about the ten greatest inventions in human history. The wheel did not make the top 10. Something doesn’t seem quite right about that!

At the end of the day, some of the most valuable innovations look like “hot air” to the public until a granted patent proves otherwise.

Ask Us Anything… about Intellectual Property!

Business Patent Law, PLLC is headquartered between Louisville and Lexington, Kentucky, serving a diverse range of clients—from innovative startups to successful companies of several decades whose business interests cause BPL’s practice to span across seventeen time zones.

If you have a topic or question you would like our editorial staff to address, please send us an email. Business Patent Law, PLLC provides intellectual property and business counsel. If you need assistance, contact us today.

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Prepared by the Business Patent Law, PLLC, editorial staff.

 

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Divisional: How One Filing Can Create Two Expiration Dates

Really? Two Expiration Dates? Yes.

The Usual Sequence

The patent examiner declares in the First Office Action that there is more than a single invention disclosed in the parent patent application which allows the filing of a divisional. Before further examination, the examiner requires that the Applicant select a first invention for examination. This is known as a Restriction Requirement.

The Statutory Combo: 35 U.S.C. § 154(b) (PTA) + the § 121 Divisional Safe Harbor

This combination of statutory law allows the extension of a divisional patent application’s term beyond the parent’s twenty-year legal monopoly.

  • 35 U.S.C. § 154(b): Governs Patent Term Adjustment (PTA). As a result of USPTO delays in examination that exceed three years, the PTA adds “bonus life” to the patent term. (Note: Over the years, Business Patent Law, PLLC has seen extensions of four years or more.)
  • 35 U.S.C. § 121: This provides the “Safe Harbor” for divisional applications. It states that a divisional application filed because of a restriction requirement cannot be rejected based on the parent patent for double patenting.

How PTA Calculations Work

The PTA is calculated independently for each application. Depending on the USPTO’s specific delays, the parent and the divisional patent applications are eligible for different PTAs. Upon filing a divisional, its own PTA clock begins.

When a divisional application is filed because the examiner issued a restriction requirement, the USPTO cannot use the parent patent as a reference to reject the divisional for double patenting (and vice-versa). Since you aren’t forced to file a Terminal Disclaimer, every single day of PTA belongs to the owner of the divisional patent.

Turning a Restriction into an Enhanced Asset

  • Multiple Monopolies: In the IP world, distinct but similar inventions are a preferred way of doing business.
  • Stepped Expirations: Staggered expiration dates provided by a divisional make it much more difficult for competitors to “design around” or wait out your protection.
  • Mutually Beneficial: When innovation and engineering are symbiotic, we can precisely select which inventions should be maximized by the PTA and include several of those into the parent application to trigger the divisional process.
  • Too Much Of A Good Thing: Being overzealous can be detrimental if there are too many inventions flowing from the parent application.
  • Management’s Wisdom: Just because you can, does not mean you should. The “good ole days” of “submarine patents” are a vapor in time, but the divisional patent PTA is the law of the land today.

Business Patent Law, PLLC can assist your company with the strategic architecture of parent and divisional patent applications.

Ask Us Anything… about Intellectual Property!

Headquartered between Louisville and Lexington, Kentucky, Business Patent Law, PLLC serves a diverse range of clients—from innovative startups to successful clients of several decades. Our clients’ business interests means BPL’s practice spans across seventeen time zones.

Business Patent Law, PLLC provides intellectual property and business counsel. If you need assistance, please contact us today.

Stay up-to-date with news that impacts your business and intellectual property—sign up for Business Patent Law’s Monthly Mailer™ newsletter. If you have a topic or question you would like the editorial staff to address, please reach out.

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I Know It’s Worth A Million!

I Know It’s Worth A Million!

Occasionally, a first-time inventor sits down with Business Patent Law, PLLC (BPL) to discuss a new mechanical or electromechanical invention. Before the hour ends, the excitement usually peaks: “Let me tell you, it’s worth a million!”

It’s an inspiring sentiment, but as a firm that has spent decades in the trenches of intellectual property, a million-dollar idea is only the first brick. To turn that “worth” into “wealth,” you need a foundation that can hold the weight of a business.

The Legal Foundation: The Patent

Before any money is made from your invention, there must be a patent.

  • The Industry Standard: The USPTO’s current allowance rate for mechanical-type applications is approximately 65-70%.
  • The BPL Advantage: Fortunately, BPL’s clients consistently maintain a higher allowance rate than the national average.

However, a granted patent is not a check; it is a legal monopoly right – it means you hold the exclusive rights to make, use or sell. To be “in the money,” the patent must be used in a manner that creates value that can be reduced to cash.

The Million?: Sales vs. Licensing

Once you have the patent, you have two primary paths to your “million”:

  1. Licensing or Selling: This is the path where you rent or sell your rights to a third party. In my 38 years as a patent attorney, only three times, have I seen a third party offer to buy a mechanical invention based solely on the patent only. And, to my knowledge, none of those resulted in a viable commercial deal.
  2. Building the Business: The clients who created truly valuable patents were generally persistent ones. They didn’t wait for a buyer; they started an LLC and began selling the device themselves.

The most successful inventors didn’t just invent a product; they built a customer base. When an LLC reaches a “magic number” in annual sales—proving the market exists—that is when an acquiring company steps in to pay an impressive Return on Investment (ROI).

“Born to Invent”: The 1.5%

Why is the invention path so difficult? Because the innovation “gene” is a rare human trait. Statistics suggest that roughly 1.5% of the population creates the vast majority of inventions. These individuals are a necessary cylinder of our economic engine, but they often face lopsided odds.

While some look to Venture Capitalists (VCs) to bridge the gap, the numbers are sobering. Only about 5-10% of VC deals generate a worthwhile ROI for both the founder and the VC, especially in the high-cost manufacturing world of tangible consumer devices.

The One In A Million Longshot

For a first-time inventor, the “million-dollar” dream is, statistically, a longshot. But world-changing technologies generally start that way. In its earliest days, few people were interested in cell phones—they were bulky, expensive, and lacked the clarity of a landline.

Success requires more than a better idea; it requires serendipity and a legal team you are comfortable with. BPL can write the patent application, suggest architecture for your business, and answer your questions when they arise.

Ask Us Anything… about Intellectual Property!

Business Patent Law, PLLC is headquartered in Nicholasville, Kentucky, serving a diverse range of clients from innovative startups in Lexington and established industry leaders in Louisville, to businesses across the United States and the world.

If you have a topic or question you would like the editorial staff to address, please send us an email.

Business Patent Law, PLLC provides intellectual property and business counsel. If you need assistance, please contact us today.

Stay up-to-date with news that impacts your business and intellectual property—sign up for Business Patent Law’s Monthly Mailer™ newsletter.

Prepared by the Business Patent Law, PLLC, editorial staff.

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Patent Applications Unlock Innovation

💡 Patent Applications Unlock Innovation

Patent applications unlock innovation and are one of the most crucial steps an innovator can take to protect an invention and secure its commercial future. It’s more than just paperwork; it’s a strategic business asset that offers significant advantages to individuals and companies alike.

🛡️ Patent Applications Unlock Future Exclusionary Rights

The primary and most powerful benefit of a patent is the exclusive right it grants to the inventor/owner for a limited time. In the United States, that time is 20 years from the first nonprovisional patent application.

  • Preventing Infringement: A granted patent allows you to stop others from making, using, selling, offering for sale, or importing the invention without your permission. This legal monopoly is the bedrock for successful commercialization.
  • Controlling the Market: You gain the power to set prices and control the supply of your patented product or process in the marketplace, which can lead to substantial financial returns.

💰 Patent Applications Unlock Potential Value

A patent transforms an idea into a tangible, valuable business asset that can be leveraged for growth. Some patent applications are exceptional and have value before the patent is granted. Multiple patent applications can unlock the next generation of assets.

  • Licensing and Royalties: You can license the patent to others, generating a steady stream of royalty income without having to manufacture or market the product yourself.
  • Attracting Investment: Patents signal to investors and venture capitalists that your technology is novel and legally protected, making your company a safer and more attractive investment opportunity.
  • Standalone Sale: The owner of the patent can sell to patent to the highest bidder.
  • Increased Company Valuation: For startups and established firms, a robust patent portfolio increases the company’s net worth and provides a stronger position during mergers and acquisitions (M&A).

🚀 Strategic and Competitive Edge

Beyond immediate financial gain, a patent provides a vital competitive advantage in the business landscape.

  • Competitive Deterrent: The existence of the patent can deter competitors from entering your market space, saving costs and headaches of future litigation.
  • Defensive Protection: Patents can also be used defensively. If a competitor sues for infringement, your company’s patents can be used as counter-leverage in negotiations.
  • Public Recognition: The patent document provides public recognition of inventorship, enhancing your company’s reputation as a leader in innovation and technology.

The Takeaway

Don’t leave valuable innovation exposed! Filing a patent application is an essential investment that secures enforceable rights, enhances financial prospects, and a businesses potential for long-term success.  And exceptional patent applications unlock royalty streams before the patent issues.

Ask Us Anything…about Intellectual Property!

If you or your business are in the greater Cincinnati, Indianapolis, Lexington, or Louisville standard metropolitan statistical areas and have a topic or question you would like Business Patent Law, PLLC to address in the blog, please send us an email.

Business Patent Law, PLLC provides intellectual property and business counsel for businesses and companies.  If you need assistance, please contact Business Patent Law, PLLC.

If you would like to stay up-to-date with news that impacts your business and intellectual property, sign up for Business Patent Law’s Monthly Mailer™ newsletter.

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Public Use Bar

Public Use Bar: A Cautionary Tale for Innovators

For anyone in the world of Patents, the terms “public use” and “public disclosure” are critical—and often misunderstood. 35 U.S.C. § 102 defines these terms and their implications for patentability.

Grace Period

A key point to remember:  the U.S. has a unique one-year grace period for filing a patent application after a public disclosure. In most other countries, any public disclosure can immediately bar you from obtaining a Patent. This is a crucial distinction that can make or break your intellectual property.

Defining the Public Use Bar

What exactly constitutes “public use bar”?  Can a use be “public” even when it’s hidden from the public eye?

The U.S. Supreme Court’s 1881 decision in Egbert v. Lippmann (104 U.S. 333) provides a fascinating and enduring lesson. The inventor in this case created improved corset steels in 1855, giving them to a single individual to use. Even though the steels were never publicly seen, the Court ruled that this was a public use. The inventor’s subsequent patent, filed years later, was therefore invalidated.

The Egbert Court’s conclusions still stand as a stark warning:

  • A single public use is enough. You don’t need to have a crowd of people using your invention to trigger the bar.
  • Unrestricted use is public use. If you give or sell your invention to another person without any confidentiality agreements or restrictions, that use is considered public.
  • However, experimental use is an exception. A use that is open to public view but is made in good faith solely for testing and experimental purposes does not count as a public use.

Egbert serves as a powerful reminder: the definition of “public use” is far broader than most people realize.

Protect Your Innovation

Don’t let a seemingly private action become a public forfeiture.

35 U.S.C. 102, in part, reads:

(a)    Novelty; Prior Art.—A person shall be entitled to a patent unless—

           (1)     the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or

          (2)    the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

(b)    Exceptions.—

          (1)     Disclosures made 1 year or less before the effective filing date of the claimed invention.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—

                    (A)    the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

                    (B)    the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

Get Help With Your Invention

Ask Us Anything…about Intellectual Property!

If you or your business are in the greater Cincinnati, Indianapolis, Lexington, or Louisville standard metropolitan statistical areas and have a topic or question you would like Business Patent Law, PLLC to address in the blog, please send us an email.

Business Patent Law, PLLC provides intellectual property and business counsel for businesses and companies.  If you need assistance, please contact Business Patent Law, PLLC.

If you would like to stay up-to-date with news that impacts your business and intellectual property, sign up for Business Patent Law’s Monthly Mailer™ newsletter.

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66 Claims: A Tale of Patent Infringement

The 66 Claims

This is a tale of what happened to the 66 claims.

A, B and C were officers and engineers for ABC company located in Cincinnati. In 2022, A, B and C assigned their interests in their joint invention to ABC company. In 2022, ABC company filed the Patent Application in the United States Patent and Trademark Office (USPTO). The original ABC Patent Application had 66 claims.

What Happened With the 66 Claims

In 2024, A and B were playing a best ball golf tournament in Louisville. The other twosome happened to be X and Z, who were officers of XYZ company located in Indianapolis. Before starting the back nine, all players took a break at the clubhouse. By the thirteenth hole, A and B were talking about their joint invention.  X and Z listened closely.

In early 2025, ABC company became aware that XYZ company was selling an XYZ invention that appeared to be identical to the ABC company’s invention. ABC had yet to receive regulatory approval for use of its invention. Somehow, XYZ received regulatory approval and made it to market before ABC.

The 66 Claims of the ABC Company’s Application

In the summer of 2025, ABC received the First Office Action from the Examiner regarding the 66 claims. In the Office Action, the Examiner rejected the first 60 claims of the 66 claims but indicated that the last six claims were allowable if some of the language of those six claims was tweaked. Since A, B and C were engineers and not patent attorneys, A, B and C opted to seek legal assistance.

What Did the Law Firm Do With ABC’s Patent Application?

  • First – the firm determined what product XYZ sold.
  • Second – the firm tweaked the last six claims to make them allowable while at the same time ensuring that those six claims read on XYZ product.
  • Third – the firm filed a Response to the Office Action cancelling the first 60 claims and requesting the Examiner allow the last six claims to mature into a Patent.
  • Fourth – the firm prepared another five Patent Applications claiming priority/benefit to the first ABC Application. Each of those five Patent Applications contained 20 claims.  Three of the Applications were Continuations, and one of those included less structures to achieve the same result. Two of the Applications were Continuation-In-Part Applications that included additional structures that ABC had invented since the filing of the first ABC Company Application.

35 U.S.C. § 120 allows an Applicant to claim the benefit of an earlier Patent Application if the earlier Patent Application is still pending.

What Was the Outcome of the 66 Claims?

  • Before the first ABC Company Application was abandoned, the original first 60 claims morphed into five additional Patent Applications having a total of 100 claims.
  • Original claims 61-66 were the basis for the first Patent. ABC sued XYZ for infringement.
  • Before going to trial and because of the distinct possibility of intentional infringement and treble damages, XYZ agreed to allow ABC to select the infringement damages calculation, e.g., ABC’s losses, such as lost profits or a reasonable royalty, or an accounting of the infringer’s profits.
  • XYZ ceases to use, offer for sale, sale, or make ABC’s patented invention.

Ask Us Anything… about Intellectual Property!

If you or your business are in the greater Cincinnati Indianapolis, Lexington or Louisville standard metropolitan statistical areas and have a topic or question you would like Business Patent Law, PLLC to address in the blog, please send us an email.

Business Patent Law, PLLC provides intellectual property and business counsel for businesses and companies.  If you need assistance, please contact Business Patent Law, PLLC.

If you would like to stay up-to-date with news that impacts your business and intellectual property, sign up for Business Patent Law’s Monthly Mailer™ newsletter.

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Is a Medical Method Patent Enforceable? 

Sometimes. In the United States, medical method/process patents may be granted by the United States Patent and Trademark Office. For patent rights to exist, the patent must first be granted by the appropriate governmental authority.

When is a Medical Method Patent Not Enforceable?

Pursuant to 35 U.S.C. § 287(c), a medical method/process type patent is not enforceable as follows:

(1)    With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b), the provisions of sections 281, 283, 284, and 285 shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

Speaking generally, a medical method/process patent cannot be enforced against a medical practitioner or a related health care entity.

Medical method patent owners are not awarded damages when a medical practitioner or related health care entity infringes the patented medical method/or process.

When is a Medical Method Patent Enforceable?

Provision of pharmacy or clinical laboratory services related to the patented procedure are not exempt.

Definitions: Medical Practitioner or Related Health Care Entity

35 U.S.C. § 287(c) reads as follows:

(2)    For the purposes of this subsection:

                    (A)    the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

                    (B)    the term “medical practitioner” means any natural person who is licensed by a State to provide the 35 U.S.C. § 287(c) described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.

                     (C)    the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the 35 U.S.C. § 287(c) including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.

                     (D)   the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.

                     (E)    the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.

                     (F)    the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.

Ask Us Anything…about Intellectual Property!

If you or your business are in the greater Cincinnati, Indianapolis, Lexington, or Louisville standard metropolitan statistical areas and have a topic or question you would like Business Patent Law, PLLC to address in the blog, please send us an email.

Business Patent Law, PLLC provides intellectual property and business counsel for businesses and companies.  If you need assistance, please contact Business Patent Law, PLLC.

If you would like to stay up-to-date with news that impacts your business and intellectual property, sign up for Business Patent Law’s Monthly Mailer™ newsletter.

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Notice Requiring Inventor’s Oath or Declaration

The USPTO can issue a Notice Requiring Inventor’s Oath or Declaration that requires action by the Applicant. Failure of the Applicant to respond will cause the Patent Application to become abandoned.

Basic Requirements for a US Patent Application

An Inventor’s oath or declaration is one of the requirements for filing a US Patent Application. Basic minimum requirements for filing a US Patent Application include:

  • Specification
  • Drawings
  • At least one claim
  • Application Data Sheet
  • Inventor’s Oath or Declaration
  • USPTO fees – NOTE: It is less expensive to pay the required USPTO fees on the day the Application is filed

An Example of Oath/Declaration Problems

The given name of the inventor was William.  However, William generally used the name Will in his business.  Will also used the name Will on his federal income taxes.

With the filing of the Patent Application, in the Inventor’s Declaration, the name William was used.  However, in the Application Data Sheet, the name Will was utilized.

The Scenario that Unfolded

Will’s Patent Application was examined and approved by the Examiner. A Notice of Allowance was issued. Will was very happy he was going to be granted his first US Patent.

Several days after receiving the Notice of Allowance, Will received a USPTO Notice Requiring Inventor’s Oath or Declaration. Will contacted Business Patent Law about his dilemma.

The Solution to the USPTO Notice

  • William can file an amended Application Data Sheet indicating his name is William or
  • Will can file a substitute Inventor’s Declaration changing the name to William

Of course, the USPTO charges a small fee for making either one of these corrections.

The Takeaway

When comes to an inventor’s given name and surname, the USPTO demands precision.

Based on information provided to BPL by our IRS and Social Security affiliates, it appears it does not matter if William or Will is utilized for those agencies as long as the social security number is identical.

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