美國實務／如何善用「固有性」作為答覆策略，成功取得美國專利

問題

想像一下你的美國專利申請案，正面對一個顯而易見性的核駁理由，你已經提供證據說明該發明具有無法預期之結果，並且盡可能地將申請專利範圍限縮至商業上可接受的程度；然而，審查官仍然核駁了你的申請案。

那些想要採用「發明具有無法預期結果」作為答辯策略來克服核駁理由的人，都會發現這個策略的弱點在於其所考量的因素及必須達到的標準是非常主觀的，甚至，過於固執的審查官還會輕易地抱持著這樣的立場：在申請人已經窮盡一切方法舉出證據後，繼續主張申請人的證據是不夠的！。

 

解決方法

為了避免上述這種過於主觀的判斷方法，得依靠一種較為客觀且可預測性的「固有性」分析方法 （Inherency Doctrine analysis）。以下的提案便說明如何以固有性來克服此種困難的狀況，但該提案需要有著看起來像是完全違反直覺的思考。

 

問題說明

基於固有性的可預見性或顯而易見性核駁，最常發生於申請人所請求的一個性質或功能係伴隨於其結構或組成物的狀況。即便先前技術未能教示所請求的性質或功能，然而，在該性質或功能為結構或組成物本身所固有的情況下（亦即，所請求的性質或功能總是發生於所請求的結構時），「固有性」是允許審查官對該請求項作出核駁決定的。

編按：請參閱美國專利審查程序指南（MPEP 2112）：「先前技術引證之明示的（Express）、隱含的（Implicit）及固有的（Inherent）揭露，得作為可預見性或顯而易見性的核駁依據」

固有性與無法預期之結果實質上包含著相同的成分，兩者皆在爭辯請求項具有特定之性質，而是否應該具有可專利性。它們的主要差異在於：「未包含特定性質的請求項，需要顯現出無法預期之結果；而包含特定性質的請求項，則僅需證明該性質並非所請求的結構或組成物所固有。」相較之下，後者更具有可預測性且在多數情況下較容易被滿足。

審查官對於固有性的使用，通常可見於兩個層面：

1. 用以建立可預見性或顯而易見性的初步表面證據（Prima Facie case）
2. 用以評估申請人所提出的反駁證據

第一個層面，若先前技術缺乏請求項的某一項技術特徵（通常是性質或功能），則審查官可以使用固有性來說明該技術特徵係固有於其他技術特徵之中（通常是結構或組成物），當然，審查官需要負擔舉證責任！例如，提供某些證據或科學理由來建立該功能性限制為先前技術之固有特性的論點。

第二個層面，為當審查官提出合理的證據或解釋後，舉證責任便轉移至申請人身上，申請人須證明所請求的功能性限制，實際上不是所請求的結構或組成物所固有。從審查官有關固有性的核駁理由中，來找出性質與結構之間不具備固有性，藉以作為反駁證據，是相當有邏輯性的答覆策略！因為固有性要求該性質「總是或必然（編按：即不能僅是可能會發生或存在）」呈現於結構或組成物之中。因此，僅需要找到該結構或組成物不具有該性質的一個突破口，必然能證明該性質事實上並非該結構或組成物所固有！

 

答覆策略說明

第二個層面是上述顯而易見性核駁問題的關鍵。具體操作策略便是：「在說明書已經包含充足證據的前提下，透過有意地促使審查官發出基於固有性的顯而易見性核駁，並進而就初步表面證據提出反駁」。此策略適用於多數說明書包含範例與至少一反例的情況（實務上十分常見）。

以下便提供一個案例來說明：

案例：

　原請求項1：
　　一組成物，包括：
　　　　40%-60%的成分A
　　　　30%-50%的成分B

申請過程中，申請人提供資料顯示，這樣的組成物具有無法預期的性質X。然而，審查官認為現有證據不足以證明具有無法預期之結果，因而並未採信（編按：即不核准本申請案，發出審查意見或核駁審定等）。

資料：申請人所遞交的說明書中提供有實施例，顯示當組成物具有40%-60%的成分A時，性質X發生。然而，說明書也提供一個反例，顯示當組成物具有65%的成分A時（即便成分B於所請求的範圍內），性質X不發生。

答覆策略：所提策略係違反直覺地擴大了原請求項的範圍，進而包括說明書中的反例，並於請求項中再加入性質X的限制，具體修改如下：

　修改後請求項1：
　　一組成物，包括：
　　　　40%-60%40%-65%的成分A
　　　　30%-50%的成分B；以及
              其中，該組成物具有性質X

因為先前技術未能教示具有性質X的組成物，此修改的結果引發固有性的核駁。然而，當審查官主張性質X為固有時，申請人可簡單地指出，「說明書的反例已明確地呈現當成分A為組成物的65%時，性質X並不存在」。這是證明性質X並非固有的明確證據（固有性係一事實問題，而不是如無法預期之結果的法律問題）。若審查官無法在先前技術的類似組成物中找到性質X時（多數情況下審查官無法找到），則需撤回此前案核駁。

 

這個策略如何影響請求項範圍

這個策略對於請求項範圍具有最小的影響。雖然請求項範圍看似藉由修正組成比例而被擴大，但也增加了具有特定性質或功能的限制而有所限縮。對於請求項範圍的整體影響為，該申請案在具有對請求項實際範圍的最小更動下，從不具有無法預期之結果的不具可專利性，轉變為固有性之下的具可專利性。

對於商用價值在於存在某些有需求或價值的功能或性質上的發明，使用上述策略能夠提供實務上可行使的專利權（侵權產品必須具有該有價值的性質才可與之競爭），因而實際上並不會減縮請求項範圍。

 

在固有性分析方面，審查官表現並不佳

上圖顯示基於固有性的核駁案件的反轉率，其係透過統計分析美國專利審查暨訴願委員會自2016年12月1日至2018年12月1日間，所作出包括有「固有性」字樣之決定而所獲得的數據，接著，每個決定內容都被仔細的審視，藉以決定該案是否真正對固有性的議題產生了爭議，並將實際上有爭議的案件作紀錄。

此資料係以技術中心（編按：各技術中心代號的說明請見此），以及核駁內容是屬於以可預見性（102 reversed）或顯而易見性（103 reversed）來作區分。再者，此資料接著與可預見性及顯而易見性核駁類型的一般反轉或確定比率（非基於固有性核駁）加以比較。

 

如何應對表現不佳的審查官

在評估基於固有性的核駁中的反駁證據時，審查官最常犯的錯誤就是令人啼笑皆非地採用無法預期之結果的標準（編按：了解更多，可參閱智慧財產月刊，《「固有之結果」與「無法預期之結果」的區別及論辯》）。幸虧這樣的錯誤可以藉由請願被糾正。具體來說，申請人可用這樣理由來提出請願：「審查意見使用無法預期之結果標準，來回應申請人所提出之不具有固有性的證據，並未具體回應（non-responsive）申請人的答覆！」

作者個人在2019年間提出了五件這樣的請願，並有著百分之百的成功機率。在各個案例中，審查官被強迫要撤回審查意見並採用正確的標準發出新的審查意見。此外在這些案例中，一旦改為採用正確的標準時，其結果是前案核駁事由被撤回，全案得以核准。

 

結論

固有性的策略不僅能用以有效克服顯而易見性核駁（尤其是面臨不具有無法預期之結果的情況），對於多樣化的發明組合也是有用的。換句話說，相比於傳統架構性的請求項策略，這種請求項策略是提供發明保護的一種替代或額外手段。

 

本文係美國專利律師 Rayn Pool 基於其所發表之題目為《The Inherency Doctrine: A Performance Review》的論文所改編，該論文發布於專利商標局學會期刊（Journal of the Patent and Trademark Office Society, JPTOS）最新一期，JPTOS是美國專利商標局的智財權法期刊。

本文經作者授權編譯
翻譯／李春霖 專利師，廣流智權事務所
編輯／馬克斯 專利師
Image by fancycrave1 from Pixabay

 

原文如下：

The Inherency Doctrine and How You Can Use it to Obtain Patents

Problem

Imagine you are faced with an obviousness rejection in the US.  You have presented your best evidence of unexpected results and narrowed your claims as much as is commercially acceptable.  However, the Examiner is still rejecting your application.

Everyone who has relied on an unexpected results strategy to overcome a rejection will eventually realize that the weakness with the strategy is that the factors in consideration and the standards which must be met are very subjective.  A stubborn Examiner can easily take the position that anything less than infinite evidence is insufficient.

 

Solution 

Avoid this subjective analysis completely in favor of the objective and predictable Inherency Doctrine analysis.

The following proposal uses the Inherency Doctrine to overcome this difficult situation but requires what can, at first, seem like a counter intuitive strategy.

 

Explanation of the Problem

An anticipation or obviousness rejection based on the Inherency Doctrine most commonly occurs when applicants claim a property or function along with their structure or composition.  The Inherency Doctrine allows the Examiner to reject the claims even when the prior art fails to teach the claimed property or function under the condition that the claimed property or function is inherent in the claimed structure.  That is, the claimed property or function always occurs in the claimed structure.

An Inherency Doctrine analysis and an unexpected results analysis contain essentially the same components.  Both are arguing that the claims should be patentable because they possess a particular property.  The main difference is that claims which do not include the property must rely on a showing of unexpected results, while claims which do include the property must merely prove that the property is not inherent to the structure/composition of the claim.  The latter being much more predictable and, in most cases, easier to satisfy.

Use of the Inherency Doctrine has essentially two phases:

1. Construction of a Prima Facie case of anticipation or obviousness using the doctrine;
2. Evaluating rebuttal evidence by the applicant under the doctrine.

In the first phase, the Examiner may use inherency to supply a missing claim limitation but bears the burden of providing, for example, some evidence or scientific reasoning to establish the reasonableness of the Examiner’s belief that the functional limitation is an inherent characteristic of the prior art.

In the second phase, the burden shifts to Applicants to provide proof that the claimed functional limitation is not, in fact, inherent to the claimed structure or composition.   Rebuttal evidence in the context of inherency is merely one example where the claimed property does not appear in the claimed structure/composition.  This is entirely logical as inherency requires that the property is always/inevitably present in the structure/composition.  Therefore, a single example showing the structure/composition without the property, definitively proves the property is not, as a matter of fact, inherent.

 

Explanation of the Solution

It is this second phase which is the key to addressing the difficult obviousness situation discussed above.  The strategy relies on intentionally provoking an obviousness rejection based on inherency where the specification already contains sufficient evidence to rebut the prima facie case.  This will be applicable in most cases where the specification contains examples and at least one counter example (which in practice is very common).

To best explain the strategy an illustrative example will be used:

Illustrative Example:

Original Claim 1:
A composition comprising:
　　　　　40%-60% component A
　　　　　30%-50% component B

During prosecution, the applicant provides data showing that such compositions possess the unexpected property X.  The Examiner is not convinced and rejects the unexpected results evidence as insufficient.

Data: Applicants specification has examples which shows that when the composition has 40%-60% of component A the property X occurs.  However, the specification also has a counter example that shows that when the composition has 65% of A (even when B is present within the claimed range), property X does not occur.

Inherency Doctrine: The proposed strategy is to counterintuitively broaden the structural portion of the claim to encompass the counter example in the specification while also claiming property X in the claim.  The resulting amendment is as follows:

Claim 1. (Amended)
　　　A composition comprising:
　　　　　40%-60% 40% – 65% component A
30%-50% component B, and
　　　　　wherein the composition possesses property X

The effect of this amendment to provoke a inherency rejection because the prior art fails to teach a composition having property X.  However, when the Examiner alleges that property X is inherent, applicants can simply point to the counter example in the specification which definitively shows that the when A is 65% of the composition, property X does not occur.  This is definitive proof (inherency is a matter of fact, not law like unexpected results) that the property X is not inherent.

If the Examiner can not find property X in a similar composition in the prior art (most of the time they cannot) they must withdraw the prior art rejection.

 

How does this Strategy Effect the Claim Scope?

The strategy has minimum effect on the scope of the claims.  Although the claim scope is broadened by the amendments to the structure, it is similarly reduced by the added requirement that the claims possess a particular property of functional limitation.  The total effect is that the application goes from unpatentable under the unexpected results analysis to patentable under the Inherency Doctrine analysis with minimum change in the actual scope of the claims.

The above is largely what makes the strategy so useful.  For inventions whose commercial value is that it possesses some function or property which is desirable or valuable, using the above strategy offers a claim which is just as enforceable (infringing product must have the valuable property to be competitive) without a reduction in claim scope.

 

Examiner’s are Bad at the Inherency Doctrine Analysis

The graph below shows the reversal rates for rejections based on inherency.  The data below was acquired by reviewing every PTAB decision from December 1, 2016 to December 1, 2018 which included the word “Inherency.”  Each decision was reviewed to determine whether the Inherency Doctrine was actually at issue.  In the cases where the Inherency Doctrine was at issue, the decision of the case was recorded.

The data is separated by Technology Center and by whether the rejection was made in the context of anticipation or obviousness.  This data is then compared to the general rates (non-inherency-based rejections) of reversal/affirmance of anticipation and obviousness rejection types.

 

How to Deal with Bad Examiner’s

The most common error made by Examiners when evaluating rebuttal evidence in an inherency-based rejection is to ironically apply the standards used for unexpected results.  Thankfully, this error is correctable by petition.  Specially, applicants can petition that an Office Action which responds to submitted evidence of non-inherency by applying the unexpected results standard is non-responsive.

This author has personally filed five such petitions in the year of 2019 with a 100% success rate.  In each case the Examiner was forced to withdraw the Office Action and issue a new Office Action applying the correct standard.  Additionally, in each of these cases when the correct standard was applied the case resulted in a withdrawal of the prior art rejections.

 

Conclusion

The above Inherency Doctrine strategy is useful not only for overcoming obviousness rejections where unexpected results have failed, but also for diversifying and increasing portfolio coverage for inventions.  That is, this claim strategy is an alterative or additional way to provide protection of an invention compared to the typical structural claim strategy.