DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species A (Figs. 2-4) in the reply filed on 29 Dec 2025 is acknowledged. Claims 8-9 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claim(s) 7 is/are objected to because of the following informalities:
Claim 7, Ln. 2 recites “the another” which should read “the other”
Appropriate correction is required.
Claim Interpretation - 35 USC § 112(f)
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.
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: “blocking fluid guide element” in claims 1, 12 and 18, “first connecting fluid guide element” in claims 1, 12 and 18, “second connecting fluid guide element” in claims 1, 12 and 18, “clamping components” in claims 1, 12 and 18, “mechanical connection element” in claim 3, “guiding elements” in claim 6, “locking unit” in claim 10, “first fluid guide unit” in claim 12, “second fluid guide unit” in claim 12 and “patient-side coupling unit” in claims 13 and 19.
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.
The corresponding structure for the “blocking fluid guide element” is best understood from the specification as at least: hose 7.1 (e.g. Figs. 2-4).
The corresponding structure for the “first connecting fluid guide element” is best understood from the specification as at least: patient-side connecting fluid guide element 3 (e.g. Figs. 2-4).
The corresponding structure for the “second connecting fluid guide element” is best understood from the specification as at least: device-side connecting fluid guide element 4 (e.g. Figs. 2-4).
The corresponding structure for the “clamping components” is best understood from the specification as at least: jaws 8.1, 8.2 (e.g. Figs. 2-4).
The corresponding structure for the “mechanical connection element” is best understood from the specification as at least: one of web 5.1, 5.2 (e.g. Figs. 2-4).
The corresponding structure for the “guiding elements” is best understood from the specification as at least: holders 11.1, 11.2 (e.g. Figs. 2-4).
The corresponding structure for the “locking unit” is best understood from the specification as at least: hooks 12.1, 12.2 (e.g. Figs. 2-4).
The corresponding structure for the “first fluid guide unit” is best understood from the specification as at least: patient-side hose system 18 (e.g. Fig. 1).
The corresponding structure for the “second fluid guide unit” is best understood from the specification as at least: device-side hose system 21 (e.g. Fig. 1).
The corresponding structure for the “patient-side coupling unit” is best understood from the specification as at least: endotracheal tube or a tracheal cannula or a catheter 26 (e.g. Fig. 1).
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 –
(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.
(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.
Claim(s) 1-6, 12-13, 15-16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fiorenza (U.S. Pub. 2022/0241544).
Regarding claim 1, Fiorenza discloses a clamp (Figs. 1-4; ¶¶017-0018) for selectively releasing or blocking a fluid connection (e.g. Fig. 3 by operation of #60, 62; ¶0018), the clamp comprising: a clamping tube (Figs. 1-3 #25, 30, 65), the clamping tube comprising: a blocking fluid guide element (Fig. 3 #65; ¶0018); a first connecting fluid guide element (Fig. 1 #30; ¶0017); and a second connecting fluid guide element (Fig. 1 #25; ¶0017), wherein the blocking fluid guide element is fluid-tightly connected to the first connecting fluid guide element and is fluid-tightly connected to the second connecting fluid guide element (Fig. 1; ¶0018); and a clamping unit (Fig. 3 #35; ¶0018) comprising two clamping components (Fig. 3 #55, 57; ¶0018), wherein the blocking fluid guide element is located between the two clamping components (Fig. 3), wherein the clamping unit is configured to selectively be brought into a releasing state (Fig. 3 with #60, 62 not compressing #65; ¶0018) or into a blocking state (Fig. 3 with #60, 62 compressing #65; ¶0018), wherein with the clamping unit being in the releasing state, the blocking fluid guide element establishes a fluid connection between the first connecting fluid guide element and the second connecting fluid guide element (Fig. 1; ¶0017 – allow airflow), and wherein with the clamping unit being in the blocking state, the two clamping components prevent a flow of fluid through the blocking fluid guide element or reduce a flow of fluid through the blocking fluid guide element by at least 80% compared to the releasing state and thereby interrupt or at least limit the fluid connection between the first connecting fluid guide element and the second connecting fluid guide element with the clamping unit in the blocking state (¶0018 – airflow prevented when inner tube 65 fully compressed). It is noted that alternately the clamping components could be read as only pressure members 60, 62 instead of all of first and second tabs 55, 57 (Fig. 3).
Regarding claim 2, Fiorenza discloses each connecting fluid guide element is or comprises a rigid tubular component (Fig. 1 #25, 30 are rigid and not flexible because they connect to further structures; ¶0017); and wherein each clamping component is mechanically connected to a respective connecting fluid guide element or the two clamping components are mechanically connected to the same connecting fluid guide element (Figs. 1 & 3). The connecting fluid guide elements in the instant claim do not invoke 35 U.S.C. 112(f).
Regarding claim 3, Fiorenza discloses the two connecting fluid guide elements are permanently mechanically connected to one another by at least one mechanical connection element (Figs. 1-2 #45, 47; ¶0017).
Regarding claim 4, Fiorenza discloses the blocking fluid guide element is flexible over its entire length or at least in one area (¶0018 – inner tube 65 compressible); and with the clamping unit being in the blocking state, the two clamping components clamp the blocking fluid guide element in the flexible area between the two clamping components, whereby the flow of fluid through the blocking fluid guide element is reduced by at least 80% in the blocking state compared to the releasing state (¶0018).
Regarding claim 5, Fiorenza discloses the two clamping components each comprise a respective jaw (Fig. 3 #55, 57); the two jaws are articulated to each other in a V shape or U shape configuration (Fig. 3 #55, 57)
Regarding claim 6, Fiorenza discloses the clamp comprises two guiding elements (Fig. 3 #70, 72; ¶0018); each jaw (Fig. 3 #55, 57; ¶0018) is associated with a respective one of the two guiding elements; and each of the two guiding elements is configured to guide the associated jaw during a movement of the jaw relative to the clamping tube (¶0018 – guided by way of manual manipulation).
Regarding claim 12, Fiorenza discloses a connection device (¶¶017-0018) for establishing a fluid connection between a first device (¶0017 – e.g. patient and/or patient interface) and a second device (¶0017 – ventilator), the connection device comprising: a first fluid guide unit (what is connected to Fig. 1 #30; ¶0017) being connectable with the first device; a second fluid guide unit (what is connected to Fig. 1 #25; ¶0017) being connectable with the second device; and a clamp (Figs. 1-4; ¶¶017-0018), the clamp comprising: a clamping tube (Figs. 1-3 #25, 30, 65), the clamping tube comprising: a blocking fluid guide element (Fig. 3 #65; ¶0018); a first connecting fluid guide element (Fig. 1 #30; ¶0017); and a second connecting fluid guide element (Fig. 1 #25; ¶0017), wherein the blocking fluid guide element is fluid-tightly connected to the first connecting fluid guide element and is fluid-tightly connected to the second connecting fluid guide element (Fig. 1; ¶0018); and a clamping unit (Fig. 3 #35; ¶0018) comprising two clamping components (Fig. 3 #55, 57; ¶0018), wherein the blocking fluid guide element is located between the two clamping components (Fig. 3), wherein the clamping unit is configured to selectively be brought into a releasing state (Fig. 3 with #60, 62 not compressing #65; ¶0018) or into a blocking state (Fig. 3 with #60, 62 compressing #65; ¶0018), wherein with the clamping unit being in the releasing state, the blocking fluid guide element establishes a fluid connection between the first connecting fluid guide element and the second connecting fluid guide element (Fig. 1; ¶0017 – allow airflow), wherein with the clamping unit being in the blocking state, the two clamping components prevent a flow of fluid through the blocking fluid guide element or reduce a flow of fluid through the blocking fluid guide element by at least 80% compared to the releasing state and thereby interrupt or at least limit the fluid connection between the first connecting fluid guide element and the second connecting fluid guide element (¶0018 – airflow prevented when inner tube 65 fully compressed), wherein the first connecting fluid guide element is fluid-tightly connected to the first fluid guide unit, and wherein the second connecting fluid guide element is fluid-tightly connected to the second fluid guide unit (Fig. 1; ¶0017). It is noted that alternately the clamping components could be read as only pressure members 60, 62 instead of all of first and second tabs 55, 57 (Fig. 3).
Regarding claim 13, Fiorenza discloses the connection device according to claim 12 as part of a ventilation system (¶0017), the ventilation system further comprising: a ventilator (¶0017); and a patient-side coupling unit configured to be at least temporarily positioned in, or positioned on, or positioned at a body of a patient (e.g. ¶0006 – endotracheal tube), wherein the first fluid guide unit is fluid-tightly connected to the patient-side coupling unit, wherein the second fluid guide unit is fluid-tightly connected to the ventilator, and wherein the ventilator is configured to cause a fluid to be conveyed through the connection device to the patient-side coupling unit (¶¶0003-0006, 0017 – ventilators provide fluid-tight connections to ensure proper gas delivery to the patient). It is noted that the ventilation system is read as positively recited by the instant claim.
Regarding claim 15, Fiorenza discloses the blocking fluid guide element is flexible over its entire length or at least in one area (¶0018 – inner tube 65 compressible); and with the clamping unit being in the blocking state, the two clamping components clamp the blocking fluid guide element in the flexible area between the two clamping components, whereby the flow of fluid through the blocking fluid guide element is reduced by at least 80% in the blocking state compared to the releasing state (¶0018).
Regarding claim 16, Fiorenza discloses the two clamping components each comprise a respective jaw (Fig. 3 #55, 57); the two jaws are articulated to each other in a V shape or U shape configuration (Fig. 3 #55, 57)
Regarding claim 18, Fiorenza discloses a process comprising: providing a clamp (Figs. 1-4; ¶¶017-0018) for selectively releasing or blocking a fluid connection (¶0018), the clamp comprising: a clamping unit (Fig. 3 #35; ¶0018) comprising two clamping components (Fig. 3 #55, 57; ¶0018); and a clamping tube (Figs. 1-3 #25, 30, 65), the clamping tube comprising: a blocking fluid guide element (Fig. 3 #65; ¶0018); a first connecting fluid guide element (Fig. 1 #30; ¶0017); and a second connecting fluid guide element (Fig. 1 #25; ¶0017); locating the blocking fluid guide element between the two clamping components (Fig. 3; ¶0018); fluid-tightly connecting the blocking fluid guide element to the first connecting fluid guide element and to the second connecting fluid guide element (Fig. 1; ¶0017); selectively bringing the clamping unit into a releasing state (Fig. 3 with #60, 62 not compressing #65; ¶0018) or into a blocking state (Fig. 3 with #60, 62 compressing #65; ¶0018); with the clamping unit being in the releasing state, the blocking fluid guide element establishing a fluid connection between the first connecting fluid guide element and the second connecting fluid guide element (Fig. 1; ¶0017 – allow airflow); and with the clamping unit being in the blocking state, the two clamping components preventing a flow of fluid through the blocking fluid guide element or reducing a flow of fluid through the blocking fluid guide element by at least 80% compared to the releasing state and thereby interrupting or at least limiting the fluid connection between the between the first connecting fluid guide element and the second connecting fluid guide element (¶0018 – airflow prevented when inner tube 65 fully compressed). It is noted that alternately the clamping components could be read as only pressure members 60, 62 instead of all of first and second tabs 55, 57 (Fig. 3).
Regarding claim 19, Fiorenza discloses the clamp is provided as a component of a connection device (Fig. 1), wherein the connection device establishes or is at least capable of establishing at least from time to time a fluid connection between a medical device (¶0017 – ventilator) and a patient-side coupling unit (¶0017 – at patient being treated). It is noted that the connection device, as claimed, does not need to encompass any structure other than the clamp.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiorenza (U.S. Pub. 2022/0241544).
Regarding claim 14, Fiorenza discloses the second connecting fluid guide element is detachably connected to the second fluid guide unit (¶0017 – removal or replacement of components).
Fiorenza fails to explicitly disclose the first connecting fluid guide element is permanently connected to the first fluid guide unit.
However, Fiorenza discloses that flow interruption valve 10 is only intended to be used with a single patient such that it would not be disconnected, cleaned and reused for another patient (¶0017). Instead, the function of flow interruption valve 10 is to allow upstream change of components within an artificial ventilation system (¶0017). Thus, recognizing that Fiorenza only intends replacement of components upstream of flow interruption valve 10 one of ordinary skill in the art would have considered it prima facie obvious to permanently connect flow interruption valve 10 with its downstream components in order to avoid their possible disconnection during use.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Fiorenza the first connecting fluid guide element is permanently connected to the first fluid guide unit in order to provide the benefit of avoid their possible disconnection during use based upon the teaching in Fiorenza that only upstream components should be disconnected and replaced during use.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiorenza (U.S. Pub. 2022/0241544) in view of Ferreira Pasetto et al. (U.S. Pub. 2023/0181892).
Regarding claim 20, Fiorenza fails to explicitly disclose a computer program is provided with a non-transitory computer-readable medium; the computer program is executable on a computer; and the computer program is configured to actuate a 3D printer during the execution, wherein the actuation of the 3D printer causes the 3D printer to produce the clamp.
Ferreira Pasetto teaches an endotracheal tube clamp (Fig. 1) which can be made via 3D printing using a standard 3D printer (¶¶0005-0006). Pasetto teaches 3D printing as an easy manufacturing technique which can be performed wherever a 3D printer is available (¶¶0005-0006). One of ordinary skill in the art would obviously recognize that a 3D printer uses memory and a computer program in order to instruct the 3D printer on how to print a desired product.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Fiorenza a computer program is provided with a non-transitory computer-readable medium; the computer program is executable on a computer; and the computer program is configured to actuate a 3D printer during the execution, wherein the actuation of the 3D printer causes the 3D printer to produce the clamp in order to provide the benefit of supplying an easy manufacturing technique which can be performed wherever a 3D printer is available in view of Ferreira Pasetto.
Regarding claim 21, Fiorenza fails to disclose a 3D printer is provided, which 3D printer comprises a processor and a memory; a computer program is stored in the memory, which is a non-transitory computer-readable medium; and the processor is configured to execute the stored computer program and to actuate the 3D printer during the execution of the computer program such that the actuated 3D printer produces the clamp.
Ferreira Pasetto teaches an endotracheal tube clamp (Fig. 1) which can be made via 3D printing using a standard 3D printer (¶¶0005-0006). Pasetto teaches 3D printing as an easy manufacturing technique which can be performed wherever a 3D printer is available (¶¶0005-0006). One of ordinary skill in the art would obviously recognize that a 3D printer uses a processor, memory and a computer program in order to instruct the 3D printer on how to print a desired product.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Fiorenza a 3D printer is provided, which 3D printer comprises a processor and a memory; a computer program is stored in the memory, which is a non-transitory computer-readable medium; and the processor is configured to execute the stored computer program and to actuate the 3D printer during the execution of the computer program such that the actuated 3D printer produces the clamp in order to provide the benefit of supplying an easy manufacturing technique which can be performed wherever a 3D printer is available in view of Ferreira Pasetto.
Allowable Subject Matter
Claims 7 and 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, Fiorenza fails to disclose one of the two guiding elements has an elongated hole and the other of the two guiding elements comprises a fork; the clamping tube is passed through the elongated hole in each of the blocking state and the releasing state; and the fork encloses the clamping tube from two sides when the clamping unit being in the blocking state. The guiding elements in the instant claim do not invoke 35 U.S.C. 112(f). Fiorenza has no conception of the type of interaction between the two guiding elements recited by the instant claim.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 10, Fiorenza fails to disclose a locking unit configured to lock the two clamping components and to thereby hold the clamping unit in the blocking state. Fiorenza has no consideration for locking inner tube 65 in a compressed state.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785