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 .
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.
DETAILED ACTION
This is the first action for application #17/928320, Tubing Support Device and Method of Manufacture, filed 11/29/2022, since the filing of a Request for Continued Examination on 7/25/25. Claims 1-3, 11, 12, 15-18, and 21 are pending.
Claim Rejections - 35 USC § 112
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.
Claim 15 is 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.
Regarding Claim 15, the subject matter regarding the ridges was already claimed in Claim 11 and is therefore redundant.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 11, 12, 15-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0003305 to Gagne et al. (hereinafter ‘Gagne’) in view of US 10,903,633 to Brouwer et al. (hereinafter ‘Brouwer’).
Regarding Claim 1, Gagne teaches a tubing support device for tubing of a drug manufacturing system (abstract), the tubing support device comprising:
a body (150; Figure 5; para [0086]) having a first end (left end), a second end (right end), and a plurality of projections (168,162, and unlabeled lower projections), the plurality of projections including a first projection (168 on the left) disposed at the first end (left end) and a second projection (168 on the right) disposed at the second end (right end), each of the first and second projections including an aperture (166) adapted to receive a fastener (164); and
a bore (channel to receive tubing created by each clamp half) extending from the first end (left end) to the second end (right end) of the body (150), the bore adapted to receive tubing such that the body reinforces the tubing, thereby allowing the tubing to contain fluids at high pressures and/or preventing kinking in the tubing (para [0006], teaching handling pressurized fluids; para [0080] teaching preventing kinking),
wherein the body includes an inside surface (bore surface that contacts the tubing).
Gagne does not specifically teach the inside surface having a plurality of ridges at the first and second ends of the body, the plurality of ridges adapted to contact the tubing for additional securement of the tubing within the body.
However Brouwer, which is also drawn to a tubing clamp with opposed halves (Figures 1, 2, 20), further teaches that an additional securement on an interior surface of the clamp halves could include either arrays of teeth (112; Figure 5) or could include a plurality of ridges (210; Figure 20) at each of the first and second ends of the body (depicted along entire longitudinal length which includes the first and second ends), the plurality of the ridges adapted to contact the tubing for additional securement of the tubing within the body (col 4, ln 60-64). Therefore, it would have been obvious before the effective filing date of the claimed invention to one of skill in the art with a reasonable expectation of success to include ridges as taught by Brouwer on the inside surface of the clamp halves of Gagne, as one type of additional securement that will prevent longitudinal movement of the tubing within the clamp.
Regarding Claim 2, Gagne and Brouwer combined teach the tubing support device of claim 1, and Gagne further teaches wherein the body (150; Figure 5) further includes a first body part (152) and a second body part (154) coupled to the first body part to form the body, the first body part (152) including a first projection (168 on left) and the second body part (154) including a first projection (unlabeled lower projection below 162 left), the first projections of the first and second body parts forming the first projection of the body (when in a closed position), and the first body part (152) including a second projection (168 right) and the second body part (154) including a second projection (unlabeled lower projection below 162 right), the second projections of the first and second body parts forming the second projection of the body (when in a closed position).
Regarding Claim 3, Gagne and Brouwer combined teach the tubing support device of claim 2, and Gagne further teaches where the second body part (154) is complementary in shape to the first body part (152; as depicted in Figure 5), such that the first and second projections (unlabeled lower projections) of the second body part (154) are aligned with the first and second projections (168/168) of the first body part (152) when the first and second body parts are coupled together. Figure 5 does not show apertures on each of the projections with opposing apertures aligned. However, Figure 5 shows friction fit fasteners 158/164 instead of apertures, and para [0023] teaches that other fasteners may be used for this embodiment, para [0079] teaches that the fastener can be a friction fit fastener or could include a screw or bolt, and para [0120] teaches that different attachment means between the two-part jackets can be substituted between the embodiments). Therefore, it would have been obvious before the effective filing date of the claimed invention to one of skill in the art with a reasonable expectation of success to use screws as taught by Gagne through aligned apertures in the projections, since this would allow the fasteners to securely attach the two halves and not accidently become disengaged or loosened if the friction attachment was overcome.
Regarding Claim 21, Gagne and Brouwer combined teach the tubing support device of claim 1, and Gagne further teaches where the body (150) includes an additively manufactured body comprising an additively manufactured first body part and an additively manufactured second body part coupled to the additively manufactured first body part (Figure 5; para [0118] teaching 3-D printing).
Regarding Claim 11, Gagne teaches a drug manufacturing system (para [0002]), comprising:
one or more manufacturing components (Figures 18A-18C; para [0110]-[0111]); and
one or more fluid lines (para [0111] ‘conduits’) fluidly coupled to the one or more manufacturing components, wherein the one or more fluid lines include tubing having a tubing support device (‘two-part jacket’), the tubing support device comprising:
a body (150; Figure 5; para [0086]) having a first end (left end), a second end (right end), and a plurality of projections (168,162), the plurality of projections including a first projection (168 on the left) disposed at the first end (left end) and a second projection (168 on the right) disposed at the second end (right end), each of the first and second projections including an aperture (166) adapted to receive a fastener (164); and
a bore (channel to receive tubing created by each clamp half) extending from the first end (left end) to the second end (right end) of the body (150), the bore receiving the tubing such that the body reinforces the tubing, thereby allowing the tubing to contain fluids at high pressures and/or preventing kinking in the tubing (para [0006], teaching handling pressurized fluids; para [0080] teaching preventing kinking),
wherein the body includes an inside surface (bore surface that contacts the tubing).
Gagne does not specifically teach the inside surface having a plurality of ridges at the first and second ends of the body, the plurality of ridges contacting the tubing for additional securement of the tubing within the body.
However Brouwer, which is also drawn to a tubing clamp with opposed halves (Figures 1, 2, 20), further teaches that an additional securement on an interior surface of the clamp halves could include either arrays of teeth (112; Figure 5) or could include a plurality of ridges (210; Figure 20) at each of the first and second ends of the body (depicted along entire longitudinal length which includes the first and second ends), the plurality of the ridges contacting the tubing for additional securement of the tubing within the body (col 4, ln 60-64). Therefore, it would have been obvious before the effective filing date of the claimed invention to one of skill in the art with a reasonable expectation of success to include ridges as taught by Brouwer on the inside surface of the clamp halves of Gagne, as one type of additional securement that will prevent longitudinal movement of the tubing within the clamp.
Regarding Claim 12, Gagne and Brouwer combined teach the system of claim 11, and Gagne further teaches wherein the body (150; Figure 5) further includes a first body part (152) and a second body part (154) coupled to the first body part to form the body, the first body part (152) including a first projection (168 on left) and the second body part (154) including a first projection (unlabeled lower projection below 162 left), the first projections of the first and second body parts forming the first projection of the body (when in a closed position), and the first body part (152) including a second projection (168 right) and the second body part (154) including a second projection (unlabeled lower projection below 162 right), the second projections of the first and second body parts forming the second projection of the body (when in a closed position).
Regarding Claim 15, as best understood, Gagne and Brouwer combined teach the system of claim 11, and Gagne further teaches wherein the body is a sleeve having a cylindrical shape (curved cylinder Figure 5; para [0086] teaching that it doesn’t have to be curved; para [0069] teaching that the bore can be straight or curved).
Brouwer further teaches that an additional securement on an interior surface of the clamp halves could include either arrays of teeth (112; Figure 5) or could include a plurality of ridges (210; Figure 20) at each of the first and second ends of the body (depicted along entire longitudinal length which includes the first and second ends), the plurality of ridges including a first plurality of ridges disposed on the inside surface near the first end of the body and a second plurality of ridges disposed on the inside surface near the second end of the body (depicted along the entire longitudinal length with a plurality of the ridges being disposed near one end and another plurality being disposed on the opposite end), each of the first and second plurality of ridges contacting the tubing for additional securement of the tubing within the body (col 4, ln 60-64).
Regarding Claim 16, Gagne teaches a method of manufacturing a tubing support device for a drug manufacturing system, the method comprising:
forming a body (150; Figure 5) including a bore (curved portion in each body half forms bore when folded closed) and a plurality of projections (162/168), the bore extending along the length of the body (as depicted in Figure 5) and adapted to receive tubing of a drug manufacturing system for reinforcing the tubing and preventing kinking of the tubing during high pressure operations (abstract; para [0002], [0006], [0077], [0080], [0111]); and
forming an aperture (160/166; Figure 5) in at least one projection of the plurality of projections, the aperture adapted to receive a fastener (158/164; Figure 5),
wherein forming the body including a bore and a plurality of projections comprises forming a body having an inside surface (surface of bore that contacts the tubing).
Gagne does not specifically teach wherein forming the inside surface with a first plurality of ridges disposed near a first end of the body and a second plurality of ridges disposed near a second end of the body.
However, Brouwer, which is also drawn to a tubing clamp with opposed halves (Figures 1, 2, 20), further teaches that an additional securement on an interior surface of the clamp halves could include either arrays of teeth (112; Figure 5) or could include a plurality of ridges (210; Figure 20) near each of the first and second ends of the body (depicted along entire longitudinal length which includes the first and second ends), the plurality of ridges including a first plurality of ridges disposed on the inside surface near the first end of the body and a second plurality of ridges disposed on the inside surface near the second end of the body (depicted along the entire longitudinal length with a plurality of the ridges being disposed near one end and another plurality being disposed on the opposite end) (col 4, ln 60-64). Therefore, it would have been obvious before the effective filing date of the claimed invention to one of skill in the art with a reasonable expectation of success to include ridges as taught by Brouwer on the inside surface of the clamp halves of Gagne, as one type of additional securement that will prevent longitudinal movement of the tubing within the clamp.
Regarding Claim 17, Gagne and Brouwer combined teach the method of claim 16, and Gagne further teaches wherein forming a body including a bore and plurality of projections comprises forming a body including a bore and a plurality of projections having an aperture in at least one projection using an additive manufacturing technique (Figure 5; para [0118] teaching 3-D printing).
Regarding Claim 18, Gagne and Brouwer combined teach the method of claim 16, and Gagne further teaches wherein forming a body including a bore and a plurality of projections comprises:
forming a first body part (152) having a first end (left end), a second end (right end), a first projection (168 on left) disposed on the first end (left end) of the first body part (152), and a second projection (168 on right) disposed on the second end (right end) of the first body part (152), the first body part (152) being a first half of the body (150; Figure 5); and
forming a second body part (154) having a first end (left end), a second end (right end), a first projection (unlabeled lower projection on left) disposed on the first end (left end) of the second body part (154), and a second projection (unlabeled lower projection on right) disposed on the second end (right end) of the second body part (154), the second body part (154) being a second half of the body (150; Figure 5);
forming the first projection of the body using the first projections (168 on left and lower unlabeled project on left) of the first and second body parts (when in a closed position the first projections align); and
forming the second projection of the body using the second projections (168 right and unlabeled lower projection on right) of the first and second body parts (when in a closed position the second projections align).
Response to Arguments
In response to Applicant’s prior art arguments, the Examiner has fully considered the arguments but they are moot due to new grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prior art has been listed in the PTO-892 form.
In addition to the prior art previously listed having ridges within the bore, the following references additionally teach a plurality of ridges at first and second ends of the bore: US 10,197,190 (Neff), US 2019/0036314 (Toll et al.), US 2017/0227141 (Toll et al.), US 2013/0099070 (Chirpich et al.).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to INGRID M WEINHOLD whose telephone number is (571)272-8822. The examiner can normally be reached on Monday-Tuesday 7:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terrell McKinnon can be reached on 571-272-4797. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/INGRID M WEINHOLD/
Primary Examiner, Art Unit 3632