United States

2.4 United States

On 16 March 2013, the US moved from a first-to-invent system to a first-inventor-to-file system in accordance with the America Invents Act (AIA). The transitional provisions mean that applications having a priority date earlier than 16 March 2013 will normally still operate under the old first-to-invent principle. As a result both systems are likely to be relevant for some years to come. However, this study guide now assumes that the post-AIA system is the norm.

At the time of writing the 2021 syllabus is unavailable, but is unlikely to change substantially from the 2020 syllabus. The 2020 syllabus requires knowledge of 35 USC 101-103, 112 and 119-121, and these are each discussed below before briefly discussing the old pre-AIA system where appropriate. For reference and comparison, a listing of the new and old legal provisions can be found together at https://www.uspto.gov/web/offices/pac/mpep/mpep-9015-appx-l.html.

35 USC 101 Patentable Inventions

The inventor or discoverer of any new and useful process, machine, manufacture or composition of matter or any new and useful improvement to any of these can have a patent to it, providing the following conditions are met.

Legal Notes

General • The US Manual of patent examining procedure (MPEP) section 2104 notes that there are four implicit requirements arising from 35 USC 101: – Double patenting is prohibited – ‘a patent’; – The inventor must be identified (and had to be the applicant before 16/03/13); – The subject matter must be eligible – within the listed categories, and not directed to a judicial exception; – The invention must have utility – ‘useful’.

See https://www.uspto.gov/web/offices/pac/mpep/s2104.html for more details. • Regarding judicial exceptions, there is no explicit list of exclusions in 35 USC 101, although as noted above it does specify patentable categories. Consequently, the US system has, at least in principle, fewer patentability exceptions and may be considered an alternative to

EP/UK filings for some subject matter. However, a number of exceptions do exist, and are established through case law (hence ‘judicial’ exceptions). – Within case law, the historical principle that ‘everything under the sun made by man’ could be patented (Diamond v Chakrabarty 447 U.S. 303 (1980)) has been narrowed significantly over recent years by successive Supreme Court decisions, and in particular Alice Corp. v. CLS Bank 134 S.Ct. 2347. As a result, the historic assumption that, compared

with UK and EP law and practice, certain subject matters such as business methods were more easily patentable in the US can no longer be made without qualification. – Regarding US method/process claims, the so-called ‘machine or transformation test’ has been used to greater or lesser degrees to determine patent-eligibility. The test ties a process to a particular machine or apparatus or requires that it transforms something into a different state or thing. However, the Supreme Court subsequently decided in

In re Bilski that the test is not the sole criterion for determining the patent-eligibility of process claims in the US, but it nevertheless remains an important indicator. – See https://www.uspto.gov/web/offices/pac/mpep/s2106.html for (a lot) more details. – The fluidity of US case law on patentability might militate against patentability being the focus of a question in FD1, though of course this cannot be guaranteed.

35 USC 102 Conditions for patentability

First Inventor to File: Introduction • The original US system was a first to invent system, effectively created by old 35 USC 102 (a), which stated that an applicant could have the patent unless it was known or published before being invented by the applicant. • The new First Inventor to File (FITF) system introduced by the AIA has been created by re-writing this definition of novelty in 35 USC 102. • The new §102(a) provides a novelty system similar to the first-to-file system found in the rest of the world. However, §102(b) then introduces exclusions to that system which provide some limited grace periods to the inventor, resulting in the ‘first inventor to file’ moniker. • The section comprises two threads to novelty relating to prior publications and earlier unpublished patent applications. Consequently the respective provisions and exclusions for each thread of 102(a) and (b) are collated below, before moving on to the rest of the section in (c) and (d):

§102(a)(1) and (b)(1) – Prior publications

§102(a)(1) – Anything publicly disclosed before the inventor’s effective filing date is prior art unless subject to a §102(b)(1) exception.

§102(b)(1)(A) The inventor has one year from his/her own patent or non-patent disclosure to file a US patent application without that disclosure being prior art.

§102(b)(1)(B) Any third party’s non-patent disclosure in the year between an inventor’s disclosure and filing a US application is not prior art.

§102(a)(2) and (b)(2) – Applications filed before but published after the effective filing date

§102(a)(2) – Any US patent or application filed before, but published after, the inventor›s effective filing date is prior art unless subject to a §102(b)(2) exception.

§102(b)(2)(A) The inventor›s own prior applications that have been filed, but not published, before the effective filing date are not prior art.

§102(b)(2)(B) Any US patent application effectively filed by a third party after the inventor’s earlier public disclosure (but see §102(b)(1)(A)), but before the inventor’s effective filing date is not prior art.

§102(b)(2)(C) Any patent application of a third party which is effectively filed before, but published after the inventor›s effective filing date, and is, as of the inventor›s effective filing date, commonly owned or under an obligation to assign, is not prior art.

§102(c) Common Ownership Under Joint Research Agreements

Inventions from two different inventors from otherwise different companies will be deemed to be commonly owned for the purpose of §102(b)(2)(C) if: (1) the invention was made by someone party to a joint research agreement in effect on or before the earliest effective filing date, (2) the invention was within scope of the agreement, and (3) the application names parties of the joint research agreement.

§102(d) Patents and Published Applications Effective as Prior Art

For the purpose of §102(a)(2) the effective filing date of a US application is: (1) the actual filing date, unless (2) the application is entitled to claim an earlier filing date under §119 – Convention priority claims & provisional filings, §120 – Continuations, §121 – Divisionals, or §365 – PCTs.

Legal Notes

Grace Period: • Note that the 12-month grace period is for filing in the US, not for an overseas priority document that leads to a later US filing (though a PCT(US) counts if filed in English). Note that in the US even confidential offers for sale (in the US) may be considered a disclosure. • §102(b)(1)(A) covers the inventor’s own patent and non-patent disclosures. This means that an inventor has one year from disclosing his invention to file an application, or a year from the publication of a prior application of his by a patent office to file an application. – NB: The USPTO interprets these provisions narrowly – the earlier disclosure must be identical in substance to the filed application to enjoy the grace period. A novelty-

style comparison may be envisaged. The USPTO examination guidelines state: “These examination guidelines maintain the identical subject matter interpretation of AIA 35 U.S.C. 102(b)(1)(B) and 102(b)(2)(B). However, these examination guidelines also clarify that there is no requirement that the mode of disclosure by an inventor or joint inventor (e.g., publication, public use, sale activity) be the same as the mode of disclosure of the intervening disclosure, and also does not require that the disclosure by the inventor or a joint inventor be a verbatim or ipsissimis verbis disclosure of the intervening disclosure. In addition, these examination guidelines also clarify that if subject matter of the intervening disclosure is simply a more general description of the subject matter previously publicly disclosed by the inventor or a joint inventor, the exception in AIA 35 U.S.C. 102(b)(1)(B) applies to such subject matter of the intervening disclosure.” (See https://www.uspto.gov/ sites/default/files/aia_implementation/FITF_Final_Guidelines_FR_2-14-2013.pdf). • As noted in the MPEP guidelines, this narrow interpretation also applies to §102(b)(1) (B). Consequently, in this case the inventor’s prior disclosure and the inventor’s eventual filing must again be identical in substance and this protects against the intervening third party disclosure to the extent that it is similarly identical in substance. – The most common scenario for this provision is, therefore, likely to be to protect the inventor from recirculation of his original disclosure by third parties during the 12-month grace period – though of course it does also protect the inventor from independent invention and disclosure of substantially the same idea by a third party. – Consequently in FD1, this provision is likely to crop up where an interest in a US application is mentioned in a case relating to either s2(4) UKPA disclosures, entitlement proceedings or where joint inventors fall out, as these are likely to result in near-identical disclosures or applications by different parties. – Bear in mind that these provisions only relate to US applications; a prior publication discounted for a US application may nevertheless be citable against a UK application claiming priority, unless the prior publication counts as abusive and meets the requirements of s2(4). • §102(b)(2)(A) and §102(b)(2)(B) are similarly narrowly interpreted by the USPTO, requiring the inventor’s prior disclosure, the subsequent third-party filing and the inventor’s eventual filing to all be identical in substance for these provisions to take effect. • These provisions invite careful consideration using a timeline since they can cause counter- intuitive outcomes. For example it is possible under the ‘First Inventor to File’ system for someone to lose out to a third party despite being both the first to invent and the first to file. This is illustrated by the example on the following page.

Mr Able

Invents X

Applies for patent to X

Publishes X Mr Baker

Invents X (independently)

Publishes X

1 Y ear or le ss

Applies for patent to X

In this example: – Mr Able is the first to devise the invention and reduce it to practice. – Independently, Mr Baker later devises the same invention, and then publishes it. – Mr Able then files a US patent application, and subsequently publishes the invention. – Finally, within a year of his own publication, Mr Baker files a US patent application. • Under the first-to-file (FTF) system found in Europe and the rest of the world, Mr Baker’s initial voluntary publication is fully citable prior art for both Mr Able and Mr Baker’s applications, and as a result neither would be granted a patent. • If evaluated under the old US first-to-invent (FTI) system, Mr Able would be allowed to

‘swear behind’ Mr Baker’s publication to the earlier date at which he devised the invention and reduced it to practice, meaning that he could eventually get the patent. • However, if evaluated under the new US first-inventor-to-file (FITF) system, Mr Able would not get the patent, despite being both the first to invent and the first to file. Instead,

Mr Baker would get the patent because his publication counts as fully citable prior art for Mr Able’s application under new §102(a)(1), whereas this publication does not count against Mr Baker’s own application due to the grace period of new §102(b)(1)(A). But in addition, Mr Able’s application does not count against Mr Baker’s application due to new §102(b)(2)(B), and similarly Mr Able’s publication also does not count against it either due to new §102(b)(1)(B). As a result, Mr Baker’s application can proceed to grant.

Old 35 USC 102 – Notes

• Only a few pending US cases will still under be the old system and as such it is relatively unlikely to appear in the current FD1 exam.

Old 35 USC 102 An applicant can have the patent unless: a) the invention was known or used by others in the US, or was patented or published overseas, before being invented by the applicant, b) the invention was patented or published anywhere or used in the US more than one year before the date of the current application, c) they abandon the application, d) the invention was first patented by the applicant overseas more than one year ago, e) the invention was described in another applicant’s US application or US patent before invention by the applicant, provided that where such an application or patent was via the

PCT it designated the US and was published in English, f) they are not the inventor, or g)1)2) someone else proves during interference proceedings that they invented it first (provided they did so within a North American Free Trade Agreement state or a WTO state).

General • Old 35 USC 102(a) does not use absolute novelty, instead favouring domestic inventors over foreign inventors. Subsections (b), (d) and (g) were similarly partisan. • Old 35 USC 102(b) meant that even if first to invent, you still needed to file your own application in good time. – This subsection also provided a 12-month grace period following the publication of any disclosure. • Old 35 USC 102(f) was why the inventor had to be the applicant in the US. • Old 35 USC 102(e),(g) were novelty-only in certain limited circumstances.

35 USC 103 Inventive Step

A patent won’t be granted if the differences between the claimed invention as a whole and the prior art would be obvious before the effective filing date of the claimed invention to a person skilled in the art.

Legal Notes

General: • Obviousness is with respect to the state of the art immediately preceding the effective filing date of the invention, in a similar manner to the rest of the world.

• Hence for the purposes of FD1, one can treat inventive step as the same as for UK or EP prosecution. • However, note that applications filed before yours but published after can still be cited for novelty and inventive step in the US system; i.e., there is no concept of ‘novelty only’ prior art. • There is no separate search and examination – citations are introduced during examination, and all can be cited for inventive step.

Old 35 USC 103 General • Obviousness was with respect to the time the invention was made, as befits first to invent. • The section included joint development issues now moved to § 102. • The section included protections for common ownership now moved to § 102. • The section included a biotech method exception that no longer exists.

In certain limited circumstances outlined in old 35 USC 103 (b) and (c) the US effectively set the bar for inventive step lower if the prior art (and hence the inventive source) was from the same applicant. Old 35 USC 103 (c) could be useful where a client’s previous application was cited as prior art against their later application, but is not available under the new AIA scheme.

35 USC 112 Specification

(a) The specification contains a written description of the invention and the manner and process of making and using it (including a best mode for carrying out the invention), which is clear enough that a person skilled in the art can also make and use the invention. (b)-(d) The specification contains one or more claims; claims can be dependent or independent as applicable. (e) A multiple dependent claim (‘any one of claims X to Y’) cannot depend from another multiple dependent claim. (f) A claim can describe the performance of a function without recital of supporting structures, but is interpreted in light of the supporting structures found in the description and their equivalents.

Legal Notes

• For the purposes of various rules & fees, claims having multiple dependencies are counted as a corresponding number of singly dependent claims and hence can add up fast. • It is no longer necessary to specifically identify a best mode. For UK / EP originating applications, their requirements for an enabling description providing support for the claims are deemed sufficient.

35 USC 119 Benefit of earlier filing date (Priority)

a) You can claim priority within 12 months from an overseas regular national filing. b) 1) Declare priority (App No, Country, filing date) within four months of filing or 16 months from priority (37 CFR §1.55(a)(1)(i)). 2) May file declaration late with surcharge if unintentional (37 CFR §1.55(c)). 3) USPTO may require a certified copy. c) (As per s5(3) UKPA & PC Art4(4)) – A subsequent filing in the same overseas country may be a basis for priority if the earlier filing was not published and left no rights outstanding. d) One can also claim priority from inventor’s certificates. e) 1)2) A US or PCT(US) application that was previously disclosed in a provisional US application can have the original filing date if filed within 12 months of the provisional application and it makes reference to the provisional, providing the filing fee for the provisional application was paid. 3) The 12 months is extended if it falls on a closed day. f)g) Plant breeder’s rights filed in a WTO or UPOV country can also claim priority according to subsections a)-c) above.

Legal Notes

• The US allows provisional filings, continuations (not adding matter) and continuations in part (adding matter with a second priority date). – Therefore, be careful to check that a particular US application is a valid basis for priority under s5(3) UKPA.

35 USC 120 Claiming the Benefit of an earlier filing date (Continuations)

A new patent application that names the same inventor(s) as a prior application can have the same priority date as the prior application if the new application is filed before grant or loss of the prior application, and provided the new application contains a specific reference to the prior application, or is amended to do so during prosecution.

Legal Notes

General: • The prior application must be a non-provisional US application or PCT application designating the US. • Notably 35 USC 120 enables but does not mention the filing of divisional, continuation and continuation-in-part applications.

Continuation applications: • These are a re-filing of the prior application that does not add subject matter. Notably therefore, only the claims can be substantively amended. A common use for continuation applications is when an examiner will allow a subset of the claims on file in an application; one may then restrict the application to the allowed claims, whilst filing the remainder as a continuation application for further prosecution without putting the allowed claims at risk. • Whilst the prior application has to be pending, this need not be the original application.

Hence chains of continuations are possible even after the original application has been granted or lost. • The continuation application is treated as having the same priority date as the parent application. Note that among other benefits, this prevents abusive extension of the effective term of protection using continuation chains. • Note that because it is not the first application comprising the subject matter, a continuation application cannot be used as a priority document itself. See s5 UKPA, ‘Valid priority documents’ earlier in this book for details.

Continuation-in-part applications: • These are similar to continuations, but are a re-filing of the prior application that does add subject matter. The majority of the application will typically be the same as the prior application, but include specific additional material. A common use for continuation-in-part applications is when an inventor has substantially improved upon an invention, and so the new subject matter is closely related to that of the prior application. • Claims relating to the original subject matter are still entitled to the original priority date, whilst claims incorporating the new subject matter are entitled to the date of filing the CIP application itself. • Note that only the new subject matter can be used as the basis for a subsequent priority claim. See s5 UKPA, ‘Valid priority documents’ earlier in this book for details.

35 USC 121 Divisional Applications

If two or more distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions. If the other invention is filed as a divisional application complying with the requirements of 35 USC 120, then it will have the priority date of the original application. The original application is not citable against the divisional and vice-versa.

Legal Notes

General: • A divisional is in effect a continuation application triggered by a restriction requirement issued by the USPTO.

Transitional Provisions

General: • The America Invents Act (AIA) introduced a raft of changes between 2011 and 2013, some of which were phased in, or depend upon what happens during the prosecution of a case.

For a list of all the changes, see http://www.uspto.gov/aia_implementation/aia-effective-dates.pdf. • Most of these provisions are now unlikely to be a topic in FD1, but are included for completeness. • US and PCT(US) applications filed before 16 March 2013 will stay under the old FTI system, and • US and PCT(US) applications with a priority date on or after 16 March 2013 will be under the new FITF system, but • US and PCT(US) applications claiming a priority date before 16 March 2013 from an earlier application, but filed after 16 March 2013, will qualify for the old FTI system, unless… the application contains, at any point in its existence, a claim that is not entitled to the priority… in which case the entire application is irreversibly re-classified as being under the new FITF system. • Hence one can easily envisage a case where, for example, an applicant has two priority applications GB1 and GB2 filed before 16 March 2013, and then files US applications US1 and US2 after 16 March 2013, where US2 claims additional subject matter with respect to

GB2. In this case, US1 is prosecuted under the old FTI system whilst US2 is prosecuted under the new FITF system. Consequently, the whole of US2 may be open to additional prior art, compared with US1. • Similarly one may envisage the case where US2 merely contains additional subject matter but does not claim it. Then something happens necessitating a claim amendment to include the new subject matter, so that US2 switches from FTI to FITF – which in turn may make a further piece of prior art now citable under the broader novelty provisions of new § 102. – However, the likelihood of this scenario being used in FD1 now is very small. • Note that if you do add subject matter as per the US2 example above, then you are required to notify the USPTO of the existence of such subject matter, and also whether it has been claimed, within four months of filing the application (or four months from national phase entry), and/or when an amendment creates such a claim during prosecution. Failure to notify results in loss of your priority claim. As noted elsewhere herein, however, the number of pending cases for which this could apply is becoming ever smaller.

Miscellaneous Changes by the AIA

Applicant: • The applicant no longer needs to be the inventor but can be the assignee. – An oath / declaration by the actual inventor(s) is still required to state that they are the inventor and authorise filing. File within the time provided by the Notice to File Missing Parts to keep the patent term adjustment (the additional patent term based on the time over 14 months before receiving the 1st OA or NoA).

Prior Use: • Since 16 March 2013, the previously restrictive US provisions on prior use were extended to any activity, and so for the purposes of FD1 can be treated as similar to s64.

Challenging validity: • This is not specifically on the FD1 syllabus for the US. However, it may be useful to note in passing the following: – You can file third-party observations, but are not allowed to state the relevance of any prior art you raise to the pending application. Given the presumption after grant of validity over reviewed prior art, this is, therefore, not such an attractive option. – The AIA introduced the ‘Post Grant Review’ that can be requested by third parties, and which is available for the nine months following grant of an application (i.e., similar to the opposition window for EP cases). However, it is probably good to note that the official fee is roughly 30 times more than the EP opposition fee at ~$27k. – Beyond nine months an ‘Inter Partes Review’ is available, akin to revocation proceedings; if you are a possible infringer, request this within 12 months of being sued for infringement.

Again, the official fee is very high, at ~$40k (but still much less than litigation in a US court). There is also a review scheme specific to covered business methods. – See https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/ aia-trial-types for more details.

Other notable points under the US patent system

• Co-owners can independently licence a patent / application, unlike the default position of s36 UKPA. • After grant, anyone can request re-examination of a patent in light of newly discovered art. However, there is a presumption of validity over any art already considered by the

USPTO, so if applicable consider waiting until court to raise new art in order to avoid such a presumption. – The AIA also introduced post-grant reviews and third-party observations. In addition, derivation proceedings (~entitlement) replaced interference proceedings (~inventorship). • Similarly, after grant it is possible to extend claim scope in the first two years with a

‘broadening reissue’. • The US is not a signatory to the reciprocal protection of unregistered designs. – Therefore, a US unregistered design has no protection in the UK and vice-versa.