CTNF 18/933,684 CTNF 82403 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non- structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “valve interface mechanism” in claims 1 and 14. “[M]echanism” is a substitute for means; the term is modified by functional language (here, this is a means for interfacing with the valve); and the term is not modified by sufficient structure to perform the claimed function. Disclosed as 126 or 226. “biasing members” in claims 1 and 14. “[M]embers” is a substitute for means; the term is modified by functional language (here, the members position the user interface mechanism in the first or second states); and the term is not modified by sufficient structure to perform the claimed functional language (“biasing” is not a structural term). Disclosed as various springs, baffles, dampers, or clips (see Paragraph 0035 and Figs. 14-16; also disclosed as pressure differentials). “user interface mechanism” in claims 1 and 14. “[M]echanism is a substitute for means; the term is modified by functional language (operable between…); and the term is not modified by sufficient structure to perform the claimed function. Disclosed as an interface, an interface member, a user interface, a housing, a linkage, a knob, a lever, a rocker switch, a push/pull switch, a knob, a button, a diaphragm switch, a toggle switch, and the like (see Paragraph 0035). Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim limitation “biasing members” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure indicates that a biasing member may include a pressure differential between the atmosphere and the atmospheric channel. As a structural member, the Examiner does not consider a natural phenomenon to be properly claimed as such. Applicant can refer to multiple components that are configured to react or function in response to natural phenomenon (for example, a gravity fed system for fluids would be permissible), the way the claim is drafted, the phenomenon itself appears to be claimed. This is improper because the phenomenon is not a structural feature. Pressure differentials exist, but they are not structures. Second, to the extent the claim does include a natural phenomenon as a structural element that would run into 35 USC 101 problems. 07-34-23 The Examiner recommends amending the claims to remove the 112f invocation and amending claim 6 so that the valves are configured to response to a pressure differential as claimed, but the biasing members are not a pressure differential. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(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. 07-12-aia AIA (a)(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. 07-15-aia AIA Claim s 1-6 are rejected under 35 U.S.C. 102 a1/a2 as being anticipated by Saiga (US 2019/0350444) . Regarding Claim 1 , Saiga discloses: A medical device, comprising: a valve set (Figs. 4-5) including a primary control valve (91) , an air input valve (932) , and an atmospheric valve (952 and the user’s finger) , the primary control valve configured to control flow between a water input channel (67) , a water output channel (63) , and a balloon channel (64) of a valve well (7) , the air input valve configured to control flow through an air input channel (66) of the valve well, and the atmospheric valve configured to control flow through an atmospheric channel (9111) ; and a valve interface mechanism (9) including one or more biasing members (96/97) and a user interface mechanism (95) , the user interface mechanism operable between a first state and a second state, the first state comprising the valve set configured to place the air input channel in fluid communication with the atmospheric channel (see Fig. 42 when a finger is not blocking the opening) , the second state comprising the valve set configured to place the air input channel in fluid communication with an air output channel (see Fig. 42 when a finger is blocking the opening) , wherein the one or more biasing members positions the user interface mechanism in the first state when user input is absent (see Fig. 42) and the atmospheric valve seals the atmospheric channel when user input adjusts the user interface mechanism from the first state to the second state (the user places a finger over the opening of 952, which is part of 95, to initiate the second state) . Regarding Claim 2 , Saiga further discloses wherein the one or more biasing members prevent the atmospheric valve from blocking flow through the atmospheric channel when user input is absent (see Fig. 42 showing the biasing members keeping the valve open without user input) . Regarding Claim 3 , Saiga further discloses wherein the one or more biasing members prevent the air input valve from blocking flow through the air input channel when user input is absent (see Fig. 42 showing the biasing members keeping the valve open without user input) . Regarding Claim 4 , Saiga further discloses wherein the one or more biasing members position the primary control valve to block flow between the water input channel and the water output channel when user input is absent (see Fig. 42 showing the biasing members keeping the valve closed without user input such that water does not flow from 723 to 711) . Regarding Claim 5 , Saiga further discloses wherein the one or more biasing members position the primary control valve to block flow between the water input channel and the balloon channel when user input is absent (see Fig. 42 showing the biasing members keeping the valve closed without user input such that water does not flow from 723 to 722) . Regarding Claim 6 , Saiga further discloses the one or more biasing members comprise a pressure differential between a portion of the atmospheric valve and the atmospheric channel created by configuring the valve set to place the air input channel in fluid communication with the atmospheric channel (the springs create a pressure differential between the valves in that the springs apply pressure on the valves to keep them open as shown in Fig. 42) . 07-15-aia AIA Claim s 16-20 are rejected under 35 U.S.C. 102 a1/a2 as being anticipated by Taniguchi (US 2019/0125167) . Regarding Claim 16 , Taniguchi discloses: A method, comprising: configuring a valve set to place an air input channel of a valve well in fluid communication with an atmospheric channel based on operation of a user interface mechanism to a first state (see Fig. 11 showing the atmospheric channel between 16 and 1641) ; configuring the valve set to place the air input channel in fluid communication with an air output channel of the valve well based on operation of the user interface mechanism to a second state (see Fig. 16 showing the input channel 68 now in communication with 61) ; configuring the valve set to place a water input channel of the valve well in fluid communication with a water output channel of the valve well based on operation of the user interface mechanism to a third state (see Fig. 19 showing 65 for water removal from a balloon; see also Paragraph 0075) ; and configuring the valve set to place the water input channel in fluid communication with a balloon channel of the valve well based on operation of the user interface mechanism to a fourth state (see Fig. 18 and Paragraph 0074 where tube 64 is configured to fill the balloon) . Regarding Claim 17 , Taniguchi further discloses configuring a first biasing member (165) to compress when the atmospheric channel is sealed with an atmospheric valve of the valve set (see Fig. 16) . Regarding Claim 18 , Taniguchi further discloses configuring a second biasing member (162) to compress when the air input channel is sealed with an air input valve of the valve set (see Paragraph 0191) . Regarding Claim 19 , Taniguchi further discloses configuring the second biasing member to compress when the water input channel is placed in fluid communication with the water output channel (see Fig. 19 showing 162 compressed when those channels are in fluid communication) . Regarding Claim 20 , Taniguchi further discloses configuring a third biasing member (133) to compress when the water input channel is placed in fluid communication with the balloon channel (see Fig. 15 and Paragraph 0204) . Allowable Subject Matter 07-43-01 AIA Claim s 7-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. For claim 7, the prior art fails to disclose the user interface mechanism comprising an interface, a hat including at least a portion of the air input valve, and one or more linkages, wherein a first linkage is coupled to the primary control valve. Neither Saiga nor Taniguchi have such features. In particular, the hat includes at least a portion of the air input valve. Saiga’s air input valve 932 does not have a hat. Claim 11 provides structural details of the biasing members in that they are bellows with a particular configuration and relative biasing forces. Saiga makes no mention of bellows or relative biasing forces of bellows. Claim 12 requires the atmospheric valve to be biased open due to pressure created by flow from the air input channel. Saiga’s atmospheric valve is open due to the springs and a lack of a user’s finger. Nothing is mentioned about it being open because of the pressure created by flow from the air input channel. Claim 13 requires wherein the valve set includes a flapper valve configured to open due to a pressure buildup when the atmospheric valve blocks flow through the atmospheric channel and the air input valve permits flow through the air input channel. Saiga does not have a flapper valve as claimed. The reference also lacks the claimed function. So, even if flapper valves are known, when combined with the function, the Examiner does not consider this an obvious limitation without some teaching in the prior art. Claim 15 is similar to claim 12 and overcomes the prior art for the same reason. For at least these reasons, these claims overcome the prior art and would be allowable if rewritten to overcome the 112b rejection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795 Application/Control Number: 18/933,684 Page 2 Art Unit: 3795 Application/Control Number: 18/933,684 Page 3 Art Unit: 3795 Application/Control Number: 18/933,684 Page 4 Art Unit: 3795 Application/Control Number: 18/933,684 Page 5 Art Unit: 3795 Application/Control Number: 18/933,684 Page 6 Art Unit: 3795 Application/Control Number: 18/933,684 Page 7 Art Unit: 3795 Application/Control Number: 18/933,684 Page 8 Art Unit: 3795 Application/Control Number: 18/933,684 Page 9 Art Unit: 3795 Application/Control Number: 18/933,684 Page 10 Art Unit: 3795 Application/Control Number: 18/933,684 Page 11 Art Unit: 3795 Application/Control Number: 18/933,684 Page 12 Art Unit: 3795
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