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 .
This is the first office action in response to the above identified patent application filed on 10/13/2023. Claims 1-7, 9-19, 22 and 59 are currently pending and being examined.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested:
CATHETER TUBE INSERTION DEVICE HAVING A ROTATABLE MECHANISM FOR ADVANCING A NEEDLE, PROBE AND THE CATHETER TUBE
Claim Interpretation
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.
In Claims 11-17, 22 and 59 the recitation "a drive mechanism" has been treated as a broad limitation including any structure capable of performing the recited function and thus was not treated under 35 U.S.C. l12(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the specification does not contain a clear corresponding structure of the generic placeholder. Hence, the recitations have been interpreted as mere broad limitations.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-7, 9-19, 22 and 59 are rejected under 35 U.S.C. 102a1 as being anticipated by Avneri et al. (US 2013/0281787).
In regards to Independent Claim 1, and with particular reference to Figures 2A-2E and equivalent Figures 42A-D, Avneri discloses a device 2500 for inserting a tube 2512 into a body cavity (110 in figures 2A-2E; shown but not labeled in figure 42A-D) of a patient, the device comprising:
a tube (2512 in figure 42A-D; equivalent to element 20 in figures 2A-2E);
a probe 12; and
a needle 11 configured to enter the body cavity 110 (as shown in figure 2A-2C), and to enable entry of the tube (20, 2512) and the probe 12 into the body cavity,
wherein the device 2500 is configured such that the needle 11, the tube (20, 2512) and the probe 12 distally advance in the body cavity 110 after entry of the probe 12 into the body cavity 110, with the probe 12 advancing distally beyond the needle 11 (as shown in figures 2A-2E; par. 151, pars. 218-220).
Regarding dependent Claim 2, Avneri discloses wherein the device is configured such that, when the needle 11 is inserted through a region of body tissue 100 prior to entry into the body cavity 110, the tube 20 and the probe 12 move with the needle 11, as shown in figures 2A, 2B.
Regarding dependent Claim 3, Avneri discloses wherein the device is configured to apply a biasing force (via springs 201, 202; figures 42A-D) to the probe (2512, 20) during insertion of the needle 11 through the region of body tissue100, where in the biasing force causes the probe (2512, 20) to advance distally beyond the needle 11 after entry of the probe (2512, 20) into the body cavity 110, refer to figures 2E, 42A-D.
Regarding dependent Claim 4, Avneri discloses wherein the device 2500 is configured such that the probe 12 advances at a first rate causing distal advancement of the probe 12 relative to the tube 20 after entry of the probe 12 into the body cavity 110 (as shown in figure 2D, the probe 12 advances distally of the tube 20 at a rate, that rate interpreted as the first rate), and subsequently advances at a second rate causing distal advancement of the tube relative to the probe (as shown in figure 2E, the tube advances at a rate “second rate” and the distance between the advancement of the probe 12 and the tube is reduced).
Regarding dependent Claim 5, Avneri discloses wherein the device is configured such that the tube 20 advances distally relative to the needle 11 after entry of the probe 12 into the body cavity 110 (figure 2E shows the tube 20 advances distally relative to the needle 11).
Regarding dependent Claim 6, Avneri discloses wherein the device is configured such that the tube 20 advances distally beyond the probe 12 (Figure 2F) after distal advancement of the probe 20 beyond the needle 11 (Figure 2E).
Regarding dependent Claim 7, Avneri discloses wherein the device is configured to permit retraction of the needle 11 and/or the probe 12 after insertion of the tube 20 into the body cavity 110 (shown in figure 2F), or wherein the device is configured to retract the needle 11 and/or the probe 12 after insertion of the tube 20 into the body cavity 110 (shown in figure 2F).
Regarding dependent Claim 9, Avneri discloses wherein the device is configured to permit decoupling of the tube 20 from the device after insertion of the tube 20 into the body cavity 100 (figure 2F shows the tube 20 decoupled/disconnected from the rest of the device).
Regarding dependent Claim 10, Avneri discloses wherein the tube 20, the probe 12 and the needle 11 are arranged concentrically (refer to figure 2C).
Regarding dependent Claim 11, Avneri discloses further comprising a drive mechanism (in figure 42A-C, all the components/mechanisms responsible for allowing the displacement of the needle 11, probe 12, and tube 20/2512) configured to distally advance the needle 11, the probe 12 and the tube 20.
Regarding dependent Claim 12, Avneri discloses further comprising a support leg (2502 in figures 42A-C) configured to abut a body surface of the patient (body surface shown in figure 42D but not labeled; body surface receiving the probe 12, needle 11 and tube 2512) during entry of the needle 11 into the body cavity 110, wherein the support leg 2502 is configured to drive the drive mechanism as the tube 2512 advances distally relative to the support leg 2502 (refer to figures 42A-C showing the support leg 2502 connected to the drive mechanism; compare figures 42A to 42B showing how the support leg 2502 moves along with the drive mechanism; same applies for the comparison of figures 42C-D) .
Regarding dependent Claim 13, Avneri discloses wherein the drive mechanism comprises a rotatable element (just to name one rotatable element; 216 rotates about axis 220; compare the rotation of element 216 in figures 42A-B and in Figures 42C-D) coupled to each of the needle 11, the tube 2515/20 and the probe 12 via a respective mechanical linkage (For example, referring to figures 42 B and C, linkages/connections 202 connect the probe 12 to the rotatable element 216; linkages/connections 256/226/210/214/228 connect the needle 11 to the rotatable element 216; linkages/connections 2526/2502 connect the tube 2512 to the rotatable element 216).
Regarding dependent Claim 14, Avneri discloses wherein the rate of distal advancement (interpreted as the components/linkages in claim 13 above located farther from the reference point 220 advance “actuated” at a later time than the linkages closer to the refence point 220) of each of the needle 11, the tube 2512 and the probe 12 is determined by the distance (referring to figures 42B and C, the distances between the axle 220 of the rotatable element 216 and the linkages [refer to claim 13] are different; thus actuated at different times “different rates of advancement”, some earlier than others) between an end of its respective mechanical linkage (For example, referring to figures 42 B and C, linkages/connections 202 connect the probe 12 to the rotatable element 216; linkages/connections 256/226/210/214/228 connect the needle 11 to the rotatable element 216; linkages/connections 2526/2502 connect the tube 2512 to the rotatable element 216).
that is coupled to the rotatable element 216 and an axle 220 of the rotatable element.
Regarding dependent Claim 15, Avneri discloses wherein the drive mechanism (in figure 42A-C, all the components/mechanisms responsible for allowing the displacement of the needle 11, probe 12, and tube 20/2512) is operable to be driven in a first direction (into the body) to distally advance the needle 11, the probe12 and the tube 2512 “20”, refer to figures 2C-2E, Figures 42A-D.
Regarding dependent Claim 16, Avneri discloses wherein the drive mechanism (in figure 42A-C, all the components/mechanisms responsible for allowing the displacement of the needle 11, probe 12, and tube 20/2512) is operable to be driven in a second direction (direction removing the device, as shown in figure 2F) opposite to the first direction (Figures 2A-E, to retract the probe 12.
Regarding dependent Claim 17, Avneri discloses wherein the drive mechanism (in figure 42A-C, all the components/mechanisms responsible for allowing the displacement of the needle 11, probe 12, and tube 20/2512) is operable to be driven in the second direction (direction removing the device, as shown in figure 2F) to retract the needle.
Regarding dependent Claim 18, Avneri discloses further comprising a coupling element 2502 configured to couple the tube 2512 to the device 2500 and to permit decoupling (decoupling interpreted as separation/spacing in between) of the tube 2512 from the device 2500 after insertion of the tube (2512 or equivalent 20 in figure 2F) into the body cavity 110 (refer to figures 42A-B and figure 2F).
Regarding dependent Claim 19, Avneri discloses wherein the coupling element 2502 is configured to decouple (decoupling interpreted as separation/spacing in between) the tube (2512 or equivalent 20 in figure 2F) from the device 2500 after insertion of the tube into the body cavity 110 (refer to figures 42A-B and figure 2F).
Regarding dependent Claim 22, Avneri discloses a datum element (or support leg) 2502 for contacting the patient's skin 100 to maintain a spatial relationship between the body of the device and the patient, as shown in Figures 42B and 42D.
Regarding dependent Claim 59, Avneri discloses the datum element (or support leg) 2502 comprises a detachable component (ring 2510 is part of the component 2502; par. 223; in Figure 42B the ring 2510 detaches from the device 2500 so it is detachable), wherein the datum component (or support leg) 2502 engages (interpreted as connected to; 2502 is connected to the tube 2512) the tube 2512 in a fully deployed condition of the tube (as shown in figure 42B), and wherein the engaged datum component (or support leg) 2502 forms a wing or other element (whatever shape it forms in figures 42A-C) for fixing the tube 20 to the patient (as shown in figures 42B, 42D).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following reference(s) are also relevant for at least claim 1, 2 and 10.
Tal. (US 2003/0153874). Particularly refer to figures 9A-9C.
Belson et al. (US 2008/0300574). Particularly refer to figure 8.
Crawford (US 5,366,441). Particularly refer to figures 1-2.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741