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 .
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.
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: ‘securing mechanism’ in claims 1-14.
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 § 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 1-11, 13-26, 28, & 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fain et al. (US Pub. No. 2025/0360303 A1).
Regarding claim 1, Fain et al. disclose a device (Fig. 3B) for gripping a portion of a catheter 203 of a catheter assembly (NOTE: the catheter/catheter assembly are not considered to be positively recited as part of the claimed invention since they are recited in an intended use phrase), the device comprising: a longitudinal axis; a housing 211 (Fig. 3B) comprising a proximal end and a distal end, the housing 211 extending along the longitudinal axis from the proximal end to the distal end of the housing 211 (Fig. 3B), wherein the housing 211 is configured to receive the catheter (see NOTE above) through an interior of the housing 211; a securing mechanism 257 (Fig. 3B; paragraph [0278]) configured to be selectively engaged to restrict or permit movement of the catheter 206 through the housing 211 (paragraph [0278]); and a grippable handle 224 (Fig. 3B) comprising a proximal end, a distal end, an exterior surface, and an interior surface defining an interior lumen, wherein the grippable handle 224 extends along the longitudinal axis from the proximal end to the distal end of the grippable handle 224, wherein the interior lumen extends along the longitudinal axis and is configured to receive the portion of the catheter 203 (Fig. 3B), wherein the distal end of the grippable handle 224 is rotatably coupled to the proximal end of the housing such that the grippable handle 224 is rotatable relative to the housing 211 about the longitudinal axis, and wherein the grippable handle 224 is configured to deform in response to a compression force applied to the grippable handle 224 such that the interior surface (seal 254 – paragraph [0278]) grips the portion of the catheter 203 to permit the grippable handle 224 to transfer a torque force to the portion of the catheter 203 (paragraph [0278]).
Regarding claim 2, Fain et al. further disclose wherein the grippable handle 224 is configured to deform in response to a compression force applied to the exterior surface of the grippable handle 224 (via actuator 214; paragraph [0278]).
Regarding claim 3, Fain et al. further disclose an actuator 214 (rotation to 214 imparts rotation to actuator 258 which compresses the seal 257 within the grippable handle 224 – Fig. 3B; paragraph [0278]) configured to apply the compression force to the grippable handle 224.
Regarding claim 4, Fain et al. further disclose wherein the distal end of the housing 211 is configured to couple with a fixation device that is attachable to a patient (paragraph [0263]; NOTE: the fixation device is not positively recited as part of the claimed invention).
Regarding claim 5, Fain et al. further disclose wherein the distal end of the housing 211 is configured to couple with the fixation device via a hemostasis valve (hemostatic valve usage is discussed throughout the disclosure, in particular in paragraph [0267]) disposed between the housing and the fixation device. (paragraph [0263]; NOTE: the fixation device is not positively recited as part of the claimed invention)
Regarding claim 6, Fain et al. further disclose wherein the distal end of the housing 211 includes a cavity configured to receive a proximal portion of the hemostasis valve (hemostatic valve usage is discussed throughout the disclosure, in particular in paragraph [0267]).
Regarding claim 7, Fain et al. further disclose wherein the distal end of the grippable handle 224 is coupled to the proximal end of the housing 211 such that the grippable handle 224 is translatable relative to the housing 211 along the longitudinal axis (Fig. 3B).
Regarding claim 8, Fain et al. further disclose wherein, when the grippable handle 224 is translated along the longitudinal axis and the interior surface grips the portion of the catheter 203 (see NOTE in claim 1 regarding the catheter), the grippable handle 224 is configured to transfer a push or a pull force to the catheter.
Regarding claim 9, Fain et al. further disclose a first coupling mechanism 222 configured to rotatably couple the distal end of grippable handle 224 to the proximal end of the housing 211.
Regarding claim 10, Fain et al. further disclose wherein the first coupling mechanism 222 is configured to couple the distal end of the grippable handle 224 to the proximal end of the housing 211 such that the grippable handle is translatable relative to the housing along the longitudinal axis.
Regarding claim 11, Fain et al. further disclose a second coupling mechanism 214 (Fig. 3B) configured to rotatably couple the proximal end of the grippable handle 224 to a protective sleeve of the catheter assembly 203 (214 is capable of rotatable coupling).
Regarding claim 13, Fain et al. further disclose wherein a diameter of the interior lumen is larger than an outer diameter of the catheter 203 when the grippable handle 224 is not compressed (paragraph [0278]).
Regarding claim 14, Fain et al. further disclose wherein the device is slidable over the exterior of the catheter 203 when the grippable handle 224 is not compressed and the securing mechanism 257 (Fig. 3B; paragraph [0278]) is engaged to permit movement of the catheter through the housing.
Regarding claim 15, Fain et al. disclose a catheter assembly, comprising: a catheter 203 (Fig. 3B); and a gripping device 214 (Fig. 3B) comprising a proximal end, a distal end, an exterior surface, and an interior surface defining an interior lumen (Fig. 3B), the interior lumen extending from the proximal end to the distal end, wherein the interior lumen is configured to receive a portion of the catheter 203, and wherein the gripping device 214 is configured to deform in response to a compression force applied to the exterior surface of the gripping device (paragraph [0278]) such that the interior surface 257 grips the portion of the catheter 203 to permit the gripping device to transfer a torque, push, and/or pull force to the portion of the catheter 203 (paragraph [0278]).
Regarding claim 16, Fain et al. further disclose wherein the gripping device 214 is configured to deform (interior seal 257 compresses/deforms – paragraph [0278]) in response to a compression force applied to the exterior surface of the gripping device 214 (paragraph [0278]).
Regarding claim 17, Fain et al. further disclose a sleeve 224 disposed over the catheter 203 (Fig. 3B).
Regarding claim 18, Fain et al. further disclose wherein the sleeve 224 and the portion of the catheter 203 extend through the interior lumen such that the gripping device 214 is disposed over the sleeve 224 (Fig. 3B – disposed over a distal extension of 214).
Regarding claim 19, Fain et al. further disclose wherein the gripping device 214 is coupled to the sleeve 224 (via 255).
Regarding claim 20, Fain et al. further disclose wherein the gripping device 214 is joined to the sleeve (via distal extension extending inside of 224 – Fig. 3B).
Regarding claim 21, Fain et al. further disclose wherein gripping device 214 is coupled to one of a proximal end or a distal end of the sleeve (via distal extension extending inside of 224 - Fig. 3B).
Regarding claim 22, Fain et al. further disclose wherein the gripping device 214 is coupled to a portion of the sleeve between a proximal end and a distal end of the sleeve (214 extends distally from the proximal end of the sleeve 224 so it couples to a length of the sleeve that is distal of the proximal end, therefore, meeting ‘coupled to a portion of the sleeve between a proximal end and distal end – Fig. 3B).
Regarding claim 23, Fain et al. further disclose wherein the gripping device 214 is disposed interior to the sleeve 224 and exterior to the catheter 203 (Fig. 3B).
Regarding claim 24, Fain et al. further disclose wherein the interior lumen is dimensioned such that that gripping device 214 is slidable over the exterior of the catheter 203 (Fig. 3B).
Regarding claim 25, Fain et al. further disclose wherein the interior lumen is dimensioned such that the gripping device 214 is slidable over the exterior of the catheter 203 when the gripping device is not compressed (paragraph [0278]).
Regarding claim 26, Fain et al. further disclose wherein the exterior surface of the gripping device 214 has an ergonomic shape (Figs. 3A-B).
Regarding claim 28, Fain et al. further disclose wherein the catheter assembly is an intracardiac blood pump assembly (paragraph [0263]).
Regarding claim 29, Fain et al. further disclose a blood pump 2 (Fig. 3B – paragraph [0263]) comprising a proximal end and a distal end, wherein a distal end of the catheter 203 is coupled to a proximal end of the blood pump 2 (Fig. 3B).
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 (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 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, 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 12 & 27 are rejected under 35 U.S.C. 103 as being unpatentable over Fain et al. (US Pub. No. 2025/0360303 A1) in view of O’Connell et al. (WO 2012/158152 A1).
Regarding claims 12 & 27, Fain et al. fail to further disclose wherein the grippable handle/gripping device is made of a rubber or silicone material.
However, O’Connell et al. teach providing a strain relief component to a handle portion, wherein the material providing the strain relief is chosen from a group including rubber and silicone. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize rubber or silicone for the grippable handle/device of Fain et al. for the purpose of providing strain relief to the element. Such materials are considered well known in the art for this purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 12, 2026
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