幾天前PTAB指定一個判決先例（precedential），此案關係解釋專利範圍時使用最廣且合理解釋原則（BRI）的條件，面對方法請求項中判斷式的描述方式，僅一個條件符合就以BRI原則解釋專利範圍 - Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016)。
Ex parte Schulhauser資訊：
訴願編號：Appeal2013-007847
申請號：12/184,020
緣起系爭案在USPTO審查階段遭遇Final Rejection (09-14-2012)後提出訴願，訴願中PTAB的APJ提出新的證據或新的審查意見（此例是引入BRI解釋的審查意見），依照規定，這樣讓申請人決定是否修正專利範圍或是請求複審，不能直接作為最終決定。此為根據37C.F.R.41.50(b)給予申請人/上訴人新的機會回應新的核駁意見的規定，這時，申請人可以修正專利範圍與答辯；或是請求複審（rehearing），以指出APJ錯誤或誤判。
系爭專利關於使用最低限度入侵式移植裝置以偵測心臟等生理問題的醫療裝置，請求項1界定使用移植裝置感測心髒問題的方法，方法包括收集生理資料、比對、警報、判斷事件水平、判斷是否低於門檻、比對組織資料與發出警報等。
collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data;
comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;
triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria;
determining the current activity level of the subject from the activity level data if the electrocardiac signal data is within the threshold electrocardiac criteria;
determining whether the current activity level is below a threshold activity level;
comparing the tissue perfusion data with a threshold tissue perfusion criteria for indicating a strong likelihood of a cardiac event if the current activity level is determined to be below a threshold activity level;
triggering an alarm state if the threshold tissue perfusion data is not within the threshold tissue perfusion criteria; and
triggering an alarm state if the threshold tissue perfusion data is within the threshold tissue perfusion criteria and the heart sound data indicates that S3 and S4 heart sounds are detected,
wherein if an alarm state is not triggered, the physiological data associated with the subject is collected at the expiration of the preset time interval.
引證案：
面對根據美國專利法第103條作出的核駁意見，申請人常見就是逐一比對先前技術後，認為引證案之個別或是組合並未揭示或是教示系爭案請求項發明，如本案為方法請求項的步驟，但理由都不被接受。
案件進入PTAB，APJ不同意申請人答辯意見，產生本次討論議題「Broadest Reasonable Interpretation, BRI」（"these arguments are not persuasive because they are not commensurate with the broadest reasonable interpretation of claim 1"）。本案在PTAB審理中，APJ以符合說明書內容的BRI原則解釋專利範圍，雖申請人不服，對此，PTAB的理由是，在審查過程中使用BRI並沒有不公平，因為申請人仍有機會修正專利範圍，使得有適當的限縮；另一理由是，如果專利權人拿著這份專利權去主張侵權告訴，仍會以最廣而合理的解釋原則來解釋專利範圍，因此此時用BRI來檢驗專利範圍應為合理的解釋。
"Construing claims broadly during prosecution is not unfair to the applicant ... because the applicant has the opportunity to amend the claims to obtain more precise claim coverage."
"A proper interpretation of claim language, under the broadest reasonable interpretation of a claim during prosecution, must construe the claim language in a way that at least encompasses the broadest interpretation of the claim language for purposes of infringement."
仔細看上述Claim 1內容，許多步驟是有條件的，如"if"之後的條件成立，才會執行相關步驟，這也常見於方法流程的專利中。其中，討論到專利範圍中"triggering..."與"determining...“兩個步驟在“comparing...“步驟之後，因此有可能在條件不符下不用執行triggering或determining步驟，甚至這兩個步驟是互相排斥的，如果在之前comparing步驟條件不符時，不會去triggering任何警報（有危險時），其餘步驟也不用執行了！反之，如果"if"之後的條件符合，才執行determining相關步驟以及之後的步驟。
這樣的專利範圍確實會有解釋上的困難，到底有沒有涵蓋"if"條件不符的情況的步驟？在PTAB解釋中，這樣的專利範圍包含了（至少）兩個方法，在此案中，符合某個條件，就要執行"triggering..."步驟，如果符合另一條件，就要執行"determining..."步驟。意見如下摘錄，看來經過PTAB裁定，BRI解釋後，專利範圍即"去蕪存菁"，其實是找到第一個符合某個判斷的條件的步驟，以此得到專利範圍解釋時會是最廣的幾個步驟，其他有例外或排斥情況的就被排除。
就考慮將來主張侵權時仍可能會以BRI解釋專利範圍，因此這裡採用BRI解釋原則為合理，也就是僅以兩種可能下（triggering, determining）第一個滿足條件而執行的動作/功能特徵來查驗，根據這些步驟來判斷是否顯而易見。因此PTAB的APJ同意USPTO審查時作出系爭案請求項發明不可專利的意見。其餘系爭請求項的答辯理由也都不被接受。
根據Claim 1的幾個判斷步驟，第一個"if"出現在"triggering an alarm state"步驟中，也就是當"if"後的條件符合，及執行triggering，後續步驟將不繼續進行，這樣，就在BRI原則下，認定系爭案的專利範圍中最廣的範圍就到第一次出現的"triggering..."為止。
當以最廣方式解釋Claim 1時，步驟僅前三個動作collecting, comparing, and triggering，判斷顯而易見性時，也就以此範圍為審查對象，PTAB判定在此最廣範圍下，系爭案請求項1發明為顯而易見。
由於PTAB的部分審查意見不同於USPTO審查意見，特別是解釋專利的方式，產生New Ground of Rejection，依照規定，仍提供申請人修正專利範圍的機會，但結論仍是系爭案請求項1（方法）不可專利，結論與USPTO一致，只是審查意見不同。
對於系爭案Claim 11，是系統範圍，APJ以一貫於Claim 1的態度來看Claim 11，但是卻不同於Claim 1所界定的方法步驟，也沒有當有一個條件符合才執行某動作的情況，因此APJ指出系統方法中的結構特徵（"structure"）執行了幾個步驟（功能），相對於有判斷條件的方法範圍，範圍較小，因此還指出了USPTO審查委員的兩點錯誤（沒有定義出發明中有限度數量的設置、錯誤引用前案），認為先前技術的組合並未涵蓋系統中為了取得心電資料的功能順序。因此PTAB否決專利局對Claim 11的核駁意見。
“the broadest reasonable interpretation of a system claim having structure that performs a function, which only needs to occur if a condition precedent is met, still requires structure for performing the function should the condition occur.”
訴願決定：
確認Claims 1-10顯而易見（103(a)）。
駁回Claim 11不具專利性的決定。
解釋專利範圍時，PTAB與USPTO審查委員不同，產生"NEW GROUNDS OF REJECTION"，因此給予申請人答辯與修正系爭案請求項的機會。
訴願決定後答辯與修正（給予發明人修改權利範圍的機會與期限）：
根據PAIR資料，申請人於04-28-2016做出訴願決定後，依照規定於06-28-2016提出修正，還新增了專利範圍，目的就是能避免以上BRI解釋時排除部分步驟的問題，並能有效與先前技術區隔，克服103顯而易見的審查意見。
這是申請人答辯內容，這裡提到修正後Claim 1已經刪除comparing步驟後的triggering動作，僅執行了在心電資料門檻內的determining步驟，使得請求項1的方法順序執行步驟determining..., in response to the electrocardiac signal data being within the threshold electrocardiac criteria, performing...等，與PTAB以BRI原則解釋專利範圍已經不同，同理也發生在新增範圍中，以triggering...步驟為限制。先前技術的組合已經無法教示修正後與新增請求項發明。
最後，經與先前技術比對這些步驟後，系爭案請求項範圍判定為可核准專利。
修正：
因應新的審查意見，Claim 1修改後：
修正與新增範圍分別主要描述determining與triggering的步驟：
修正時，Claim 1修改了以上所述因為"if"先決要件需要符合才執行triggering步驟的問題。新增範圍則是針對triggering步驟來描述，這樣可以避免BRI解釋上排除排斥的步驟而落於先前技術的組合中的問題。
新增範圍摘錄：
[相關法規]
35 U.S.C. 134 APPEAL TO THE PATENT TRIAL AND APPEAL BOARD
- (a) PATENT APPLICANT.— An applicant for a patent, any of whose claims has been twice rejected, may appeal from the decision of the primary examiner to the Patent Trial and Appeal Board, having once paid the fee for such appeal.
- (b) PATENT OWNER.— A patent owner in a reexamination may appeal from the final rejection of any claim by the primary examiner to the Patent Trial and Appeal Board, having once paid the fee for such appeal.
37 C.F.R. 41.50 DECISIONS AND OTHER ACTIONS BY THE BOARD
(b) New ground of rejection. Should the Board have knowledge of any grounds not involved in the appeal for rejecting any pending claim, it may include in its opinion a statement to that effect with its reasons for so holding, and designate such a statement as a new ground of rejection of the claim. A new ground of rejection pursuant to this paragraph shall not be considered final for judicial review. When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims:- (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart.
- (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought.
my two cents:
這是一個很好學習的功課。撰寫方法專利範圍時，若有判斷式，可以在一個發明概念下用不同的獨立請求項分別界定不同的步驟流程，否則，就僅針對發明核心的流程描述，捨棄判斷動作（除非判斷本身很重要，這應該是另一個情況），其他便視為例外或是一般習知技術而已。
看來，至少進入PTAB時，當「方法專利」中請求項描述的步驟有「if, else, whether or not」等判斷式時，審查單位會得出其中條件符合執行的步驟，進而判斷出一個進行102, 103審查的最廣與合理的專利範圍，如此例，審查單位就一步步檢驗，一旦步驟打住，就是完成方法。
對此，也可學習本案申請人的做法，根據PTAB意見修正專利範圍，使得專利請求項步驟不會因為某個步驟停止而就以此為最廣的範圍。
"Thus, the broadest reasonable interpretation encompasses a method
where only the steps of
"collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data,"
"comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event," and
"triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria" are performed. "
之後的步驟就被停住了，因為僅一個條件符合就完成此方法步驟，APJ就以這些步驟來審查其專利性。
"collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data,"
"comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event," and
"triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria" are performed. "
之後的步驟就被停住了，因為僅一個條件符合就完成此方法步驟，APJ就以這些步驟來審查其專利性。
原來進入訴願時的Claim 1，底線是被萃取出審查103的步驟：(updated on Oct. 12, 2016)
1. A method for monitoring of cardiac conditions incorporating an implantable medical device in a subject, the method comprising the steps of:
collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data;
comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;
triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria; (修正後此步驟被刪除，而保留在新增請求項中）
...
collecting physiological data associated with the subject from the implantable device at preset time intervals, wherein the collected data includes real-time electrocardiac signal data, heart sound data, activity level data and tissue perfusion data;
comparing the electrocardiac signal data with a threshold electrocardiac criteria for indicating a strong likelihood of a cardiac event;
triggering an alarm state if the electrocardiac signal data is not within the threshold electrocardiac criteria; (修正後此步驟被刪除，而保留在新增請求項中）
...
最高法院同意IPR程序中採用BRI原則 - Cuozzo v. Lee：
http://enpan.blogspot.tw/2016/06/iprbri-cuozzo-v-lee.htmlPTAB裁決：
https://app.box.com/s/ushzagxn6luwjx2z3blqeww7h81ru2k2
系爭案審查到訴願歷史資料：https://app.box.com/s/jnh67r34f03lt8b5516bm8fxfie1rmdq
Ron
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