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 .
DETAILED ACTION
1. This office action is in response to the filing of the application on 08/17/2023. Since the initial filing, no claims have been amended, added, or canceled. Thus, claims 1-20 are pending in the application. Claims 1-5 and 10-12 are being examined on the merits, while claims 6-9 and 13-20 are withdrawn from consideration.
Priority
2. Acknowledgement is made of applicant’s claim for benefit of priority for 18/451,664 (filing date of 08/17/2023) which claims benefit of 63/339,528 (filing date of 08/19/2022). 63/339,528 provide sufficient support for the subject matter of claims 1-5 and 10-12. Therefore, the current application will be assigned the effective filing date of 08/19/2022.
Election/Restrictions
Applicant elected Species I (FIGS. 5-8; Claims 1-5 and 10-12) directed to the stabilizing member comprises a core (296) and ribs (297) configured to facilitate stabilization without traverse on 07/01/2026. Therefore, claims 1-5 and 10-12 will be examined on the merits, with claims 6-9 and 13-20 being withdrawn from consideration.
Drawing Objection
3. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
The claimed “first lumen” (Claim 10, In 3, 4, 6), “second lumen” (Claim 10, In 3, 4, 8), “first end” (Claim 10, In 3), and “second end” (Claim 10, In 5) are not identified in the drawings. Since these features are necessary for an understanding of claimed subject matter, the drawings should be amended to clearly identify the claimed first lumen, second lumen, first end, and second end.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification Objection
4. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
• The terms “first lumen” and “second lumen,” as recited in claim 10, are not clearly associated with corresponding structure in the detailed specifications. While specifications generally refer to lumens associated with coaxial tubing and tubing (240c, 245c), the specification does not clearly identify which disclosed lumen corresponds to the claimed “first lumen” and which disclosed lumen corresponds to the claimed “second lumen.” Appropriate correction is required to clearly identify the first lumen and second lumen and its corresponding structure in the specifications.
The applicant is required to amend the specification and drawings to provide consistent reference character identification throughout the application. No new matter should be entered.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
5. 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.
6. 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:
“a stabilizing member” (claim 1, In 7)
“a stabilizing component” (claim 10, In 10)
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The following is the corresponding structure for these limitations:
“a stabilizing member” – a ring in the first port, a ring extending distally from the core into the first port, a strap and strap connector, a slot extending between the outer surface of the device coupling member and the second port, an actuator and retention component, and/or a rigid outer member and engaging members, as described in the specification.
“a stabilizing component” – a ring in the first port, a tab extending transverse to an axis of the first lumen at the first end, an elbow joint between the first end and the second end, and/or a retention component configured to engage a component of an endoscope system, as described in the specification.
The term "stabilizing member" recited in claims 2, 4, and 5 should not be interpreted under 35 U.S.C. 112(f) because these claims provide sufficient structure, namely, a ring. Similarly, the term "stabilizing component" recited in claim 11 should not be interpreted under 35 USC 112(f) because sufficient structure is provided, namely, a ring.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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
7. 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.
Claims 1, 4, and 10 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. Specifically:
Regarding claim 1, the limitation reciting “gas/lens wash tubing” (In 3) is indefinite because the use of the slash (/) renders unclear whether “gas/lens” refers to gas or lens, gas and lens, or gas and/or lens. Accordingly, the metes and bounds of the claimed “gas/lens wash tubing” cannot be determined with reasonable certainty. For purposes of examination, the term “gas/lens washing tubing” is interpreted as tubing configured for gas and/or lens.
Regarding claim 4, the limitation reciting “a ring” (In 1) is indefinite because it is unclear whether “a ring” refers to the ring previously introduced in claim 2 or introduces a separate ring. Accordingly, the identity of the claimed ring, and thus the metes and bounds of the claim cannot be determined with reasonable certainty. For purposes of examination, “a ring” is interpreted as referring to the ring previously introduced in claim 2.
Regarding claim 10, the claim directed to “a connector” (In 1) but positively recites “a first lumen and second lumen, the second is coaxial with the first lumen” (In 3-4). It is unclear whether the positively recited first and second lumens constitute structural components of the claimed connector or instead refer to lumens of tubing coupled to the connector. Although the specification describes coaxial tubes (240c, 245c) [0046], these tubes do not appear to constitute portions of the connector itself. Accordingly, the structural relationship of the positively recited first and second lumens to the claimed connector is unclear, and the metes and bounds of claim 10 cannot be determined with reasonable certainty. For purposes of examination, the claim is interpreted such that the recited coaxial first and second lumens are not included as part of the claimed connector.
Claim Rejections - 35 USC § 102
8. 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.
8. Claims 1, 2, 4, 5 and 10-12 are rejected under 35 U.S.C. 102 as being unpatentable over Jacobs et al. (20140031627).
Regarding claim 1, Jacobs discloses a connector (100) for connecting a gas/lens wash tubing to fluid lines of an endoscope, the connector (100) comprising: a core (101) configured to couple to the gas/lens wash tubing; a device coupling member (109) coupled to the core (101), the device coupling member (109) defining a first port (see, annotated FIG. 1A) configured to couple with a first fluid port of an endoscope and a second port (see, annotated FIG. 1A) configured to couple with a second fluid port of an endoscope; and a stabilizing member (first section 104) configured to facilitate securing the device coupling member (109) to the endoscope (Jacobs discloses a connector (100) comprises a compliant interface (109) overmolded onto a rigid Y-connector (101), wherein the first and second channels (114, 115) terminate at distal ends (104b, 102b) that fits around respective ports of the endoscope. Jacobs further discloses that the first section (104) is physically adhered to a first channel (114), and the distal end of the first channel fits around the first port of an endoscope [0031-0035]). See Annotated FIG. 1A
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Regarding claim 2, Jacobs discloses a connector (100), wherein the stabilizing member (first section 104) comprises a ring (O-ring 108) in the first port (see, annotated FIG. 1A) (Jacobs discloses that first section (104) associated with first channel (114) and having O-ring (108), wherein the O-ring (108) provides a sealing interface with corresponding endoscope port). See Annotated FIG. 1A Above.
Regarding claim 4, Jacobs discloses a connector (100), wherein the stabilizing member (first section 104) includes a ring and extends distally from the core (101) into the first port (see, annotated FIG. 1A) (Jacobs discloses that first section (104) extending distally relative to the core (101) and defining a distal end/aperture (104b) associated with the first channel (114) [0031].
Regarding claim 5, Jacobs discloses a connector (100), wherein the core (101) and the stabilizing member (first section 104) are a unitary component and the device coupling member (109) extends over a portion of the unitary component (Jacobs discloses that compliant interface (109) is overmolded onto a rigid y-connector (101), wherein the first section/port (104) is physically adhered to first channel (114) by virtue of the overmolding process [0031].
Regarding claim 10, Jacobs discloses a connector (100) for connecting tubing to fluid ports of a medical device, the connector (100) comprising: a first end (Y-connector 101/110) configured to couple with the tubing; a second end including: a first port (see, annotated FIG. 1A) configured to engage a first fluid port of the medical device; and a second port (see, annotated FIG. 1A) configured to engage a second fluid port of the medical device; and a stabilizing component configured to facilitate securing the second end (120) to the medical device when the first port engages the first fluid port (see, annotated FIG. 1A) (Jacobs alternatively discloses the claimed stabilizing component as (1) O-ring (108), which provides a seal between the connector (100) and the corresponding port of the endoscope to securely attach the connector thereto, or first section (104), which fits around the corresponding port of the endoscope and is physically adhered to first channel (114) [0031-0035]). See Annotated FIG. 1A Above.
Regarding claim 11, Jacobs discloses a connector (100), wherein the stabilizing component is configured as a ring (O-ring 108) in the first port (see, annotated FIG. 1A) and the ring (108) is configured to center the first fluid port within the first port (see, annotated FIG. 1A) and the second fluid port in the second port (see, annotated FIG. 1A) (Jacobs discloses that the respective distal ends fit around the corresponding ports of the endoscope, wherein the dual O-ring seals maintain sealing engagement between the connector and endoscope ports [0028-0029; 0032; 0034-0034]. Furthermore, in FIG 3. Jacobs depicts ring (305) centrally disposed within first port (304) and corresponding ring (303) centrally disposed within port (302), wherein the respective rings define the apertures configured to receive the corresponding endoscope ports [0046-0048]; FIG. 3). See Annotated FIG. 1A Above.
Regarding claim 12, Jacobs discloses a connector (100), wherein the ring (first section 104) is formed from a rigid material (rigid Y-connector (101), providing flexible/resilient interface)and the first port (see, annotated FIG. 1A) and the second port (see, annotated FIG. 1A) are at least partially formed from a resilient material (compliant interface 109) (Jacobs discloses that the rigid Y-connector (101) comprises first section (104), mapped to the claimed ring, thereby establishing first section (104) as part of the rigid portion of connector (100). Jacobs further discloses a flexible portion including compliant interface (109) overmolded onto the rigid Y-connector (101), thereby providing flexible/resilient interface at the endoscope-engaging portions of the connector [0030-0031]).
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs et al. (20140031627) in view of Shuji (JPH09262205A) as applied to the rejection of claim 1 above.
Regarding claim 3, Jacobs discloses connector(100), wherein the ring (O-ring 108) has an inner surface and a first port (see, annotated FIG. 1A).
Jacobs does not disclose that the inner surface tapers toward a central axis of a first port.
However, Shuji discloses a ring-shaped connecting member (23) having a tapered cylindrical body (27), wherein the tapered cylindrical body (27) has an inner peripheral surface (27a) that continuously varies in diameter toward an end thereof and is configured to receive a corresponding tapered portion (21a), thereby providing mating engagement between the connecting member (23) and connection pipe (21).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the O-ring of Jacobs to include the tapered inner surface as taught by Shuji to facilitate insertion, centering, and mating engagement of the corresponding fluid port within the first port.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Aizenfeld (WO2017204873), Bryne (6485412), Savitt et al. (5133336), Ohshima (0082950) discloses connectors having multiple fluid channels/ports configured for connection with an endoscope;
Bendele (WO2012051436) discloses a connector having a tapered inner surface configured to engage and form a seal with a mating component.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEROME PRATT whose telephone number is (571)272-8454. The examiner can normally be reached on Mon - Fri 7:00-4:00. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached on 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LDP/
Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
