A Case for Filing Patent Applications Sooner Rather than Later

The expense of developing a new product can tempt innovators to wait for market proof before filing for patent protection. Waiting beyond the statutory bars of 35 U.S.C. 102 can be devastating to a patent, even if already issued. Specifically, these statutory bars prohibit obtaining a patent if priority is not established before one year after public disclosure, publication, sale, or offer for sale.

Helsinn Healthcare S.A. designed a drug with 0.25mg of palonosetron to treat chemo-induced nausea. Helsinn immediately began developing the market for the new product. Helsinn entered into several sales agreements for the new drug, although the dosage information remained undisclosed. Helsinn waited for several years after the after the agreements before applying for a patent.

Upon patent issue, Helsinn sued Teva Pharmaceuticals USA, Inc. for infringement. Teva argued that Helsinn’s patent was invalid due to the statutory bar in that the drug was “on sale” under 35 U.S.C. 102 for more than one year before Helsinn filed the patent application. Helsinn argued that the “on sale” bar was not applicable because the sales agreements did not publicly disclose dosage information. The district court agreed that the America Invents Act (AIA) changed the “on sale” bar to require public disclosure to invalid the patent. However, the Federal Circuit and the Supreme Court of the United States held that there was no Congressional intent to change the history of the “on sale” bar, which did not previously require public disclosure of every aspect of the product sold. See Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ___, 2019 WL 271945 (2019). Helsinn lost both the infringement claim and its patent.

Helsinn may have kept its patent and a monopoly on the market, if the patent application had been filed sooner. Generally, statutory bars to patentability under 35 U.S.C. 102 requires that a patent application be filed (or establishes priority through an earlier filing) before one year after the invention is publicly disclosed, sold, or offered for sale. However, filing the patent application as soon as possible can help reduce the validity of later challenges to the patent in court.

If you need help with your patents, trademarks, copyright, or trade secrets, please contact us.

Jeremy I. Maynard
Registered U.S. Patent Attorney
Troutman & Napier, PLLC
4740 Firebrook Blvd.
Lexington, KY 40513
Tel: 859-253-0991
Web: Troutman & Napier, PLLC
Originally Published at: Maynard.Law
Originally Published by: Maynard.Law

Obviousness: Responding to a Rejection to Your Patent Application under 35 U.S.C. 103

What is an obviousness rejection?

An obviousness rejection of your patent application is a substantive legal argument that your patent application is too similar to existing publications at the time of filing of your patent application. Unlike a procedural objection, you will have to overcome legal and factual arguments to distinguish your rejected claims from the cited prior art references.

What is the proper form of response?

Argument against an obviousness rejection can be filed as a response to a non-final office action in the case of the non-final rejection. If the rejection is final, argument can be presented with a Request for Continued Examination (RCE) or upon appeal to the Patent Trial and Appeal Board.

In the written response, remember to address every point made by the Examiner. At the most benign, the response may be deemed incomplete. An incomplete response can cause your application to become abandoned as the statutory deadline is not met without a complete response. At worst, your response may be deemed to concede unaddressed arguments in an appeal brief.

What is the standard for Obviousness?

35 U.S.C. 103: Conditions for patentability; non-obvious subject matter

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

How can you respond to an obviousness rejection?

These rejections are commonly addressed in a couple ways. The strongest argument is that the combination of prior art doesn’t teach every element of the claim rejected. A weaker, but sometimes worthwhile argument, is that there is no reason to combine the prior art references.

MPEP 2143.03 All Claim Limitations Must Be ConsidereD

“All words in a claim must be considered in judging the patentability of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970).

Many words in a claim, often including articles and prepositions, either define a new structure or modify a structure recited. For each of these words, the word itself defines a individual claim element. If an element or a word that shapes the scope of the claim can’t be found in the combination of cited prior art references, the rejection is not properly supported under MPEP 2143.03. A well-reasoned response using this argument shifts the burden to the Examiner to find different references to maintain the rejection or allow the patent to issue.

2143.01 Suggestion or Motivation To Modify the References

Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).

The Examiner has much more discretion when reconsidering claims accompanied by this type of response. However, there are some limits to the Examiner’s discretion. For example, the Examiner must provide some supporting reason that one of ordinary skill in the art would combine the references. Therefore, a strengthening argument could point out that the prior art references combine into a result that is not the claimed invention (e.g. that the combined result is tangential to the invention, rather than the invention itself). In more extreme cases, it can be proper to argue that the references “teach away” from the claimed invention. Be careful not to overplay the differences, as this can lose credibility with the Examiner. It can be important to maintain credibility in a discretionary situation.

As an example of the Examiner’s leeway -when teachings in the prior art conflict, the Examiner can weigh the suggestive power of each reference. Therefore, consider whether the teaching to reach the claimed invention is totally absent in the combination formed by the references, or whether multiple conflicting teachings could form several alternatives, including the claimed invention. Just because one of the alternatives seems disfavored doesn’t prevent the Examiner from maintaining a properly supported argument by the cited combination of references.

If you need help with your patents, trademarks, copyright, or trade secrets, please contact us.

Jeremy I. Maynard
Registered U.S. Patent Attorney
Troutman & Napier, PLLC
4740 Firebrook Blvd.
Lexington, KY 40513
Tel: 859-253-0991
Web: Troutman & Napier, PLLC
Originally Published at: Maynard.Law
Originally Published by: Maynard.Law

Correcting Priority Claims in Patent Applications

Why claim priority to a previous application?

U.S. non-provisional patent applications can claim priority to a previously filed application in order to establish an earlier effective date. Claiming priority and the earlier effective date can preclude an examiner from using publications dated after the initial filing date against your later-filed application, if the material is not new matter in the child application. This can increase the likelihood of overcoming rejections and ultimately obtaining an issued patent.

When can a priority claim be made on initial filing of the child application?

Priority to a provisional application can be claimed for up to twelve months after the filing date of the provisional. Priority can be claimed to a non-provisional application any time during the pendency of the parent non-provisional. Thus, the parent application cannot be issued or abandoned before the child application is filed.

What are some requirements for claiming priority to a parent application?

As of September 16, 2012, a specific reference to the priority application must be included in an application data sheet (ADS) of the child application. Otherwise, the filing receipt will likely reflect the priority date as the filing date of the child rather than the parent. The Examiner can cite prior art having a publication date after the effective date of the parent application.

Prior to September 16, 2012, the specific reference to the priority application could be included either in the ADS or in the first sentences of the specification. However, MPEP 211.02 encourages applicants to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed, if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material. Therefore, the specific reference to the priority claim should be included in both the ADS and the first sentences of the specification.

Furthermore, both the parent and child application must share at least one inventor in common to properly maintain a priority claim between the applications.

What is a proper specific reference to an parent application?

A proper specific reference must identify the application number and the relationship between the parent and child applications. For example, a common method is to state the the present application is a [identify relationship (e.g. continuation, continuation-in-part, divisional, etc.)] of [application number], which is a [identify relationship] of [application number]. This chain continues until the first application in the priority chain.

Can a priority claim be added or amended into a filed application after-the-fact?

When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b).

MPEP 211.02

This means that the specific reference to the priority application cannot be added to the specification after the fact. However, a forgotten priority claim in the ADS can be amended. Typically, the USPTO will require a petition under 37 CFR 1.78 and the petition fee, often several thousand dollars, to correct the claim if the correction is sought after expiration of the time period set in 37 CFR 1.78. Under 37 CFR 1.78(a)(4), the specific reference in the ADS must be submitted within the later of four months from the actual filing date of the later-filed application or sixteen months from the filing date of the prior-filed provisional application. After that deadline, a petition may be filed to restore priority with statement that the entire delay was unintentional with the proper fee.

Conclusion

When filing a patent application claiming priority, include a specific reference to the priority claim in the first sentences of the specification and also in the ADS. The specification cannot be amended to add the reference without introducing new matter. The ADS can be amended to include the specific reference within four months from the child application or sixteen months from the provisional application. Thereafter, a petition for unintentional delay with a fee of several thousand dollars will be required to correct the claim.


If you need help with your patents, trademarks, copyright, or trade secrets, please contact us.

Jeremy I. Maynard
Registered U.S. Patent Attorney
Troutman & Napier, PLLC
4740 Firebrook Blvd.
Lexington, KY 40513
Tel: 859-253-0991
Web: Troutman & Napier, PLLC
Originally Published at: Maynard.Law
Originally Published by: Maynard.Law