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 action is in response to the RCE filed on 11/26/2025 and the amendment filed on 11/04/2025. Claims 1-8, 10, and 12-34 are pending. Claims 1, 18, and 30 are independent. Claims 18-32 have been withdrawn. Claims 9 and 11 are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
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.
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.
Claims 1-8, 10, 12-17, 33, and 34 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.
a) Claim 1 recites the limitation “wherein the first flexibility zone defines a first pressure drop per unit length and the second flexibility zone defines a second pressure drop per unit length that is at least 10% less than the first pressure drop per unit length.” The limitation is indefinite because the pressure drop per unit length for flow in a pipe depends on the fluid density and the mean flow velocity as described by the Darcy-Weisbach equation:
ΔP/L = f * (ρ * V² / (2 * D))
ΔP/L: Pressure drop per unit length
f: Darcy friction factor
ρ (rho): Fluid density
V: Mean flow velocity
D: Pipe internal diameter
Claim 1 positively recites the pressure drops or the differences between the pressure drops. However, the fluid and the fluid velocity (e.g. the blood and the blood flow or other fluids and fluid velocities) are not part of the delivery device. Therefore, it is unclear how “the first flexibility zone defines a first pressure drop per unit length and the second flexibility zone defines a second pressure drop per unit length that is at least 10% less than the first pressure drop per unit length” without the defining or reciting the fluid and fluid velocity through the flexibility zones (tubes). Applicant should also be noted that the blood and the blood flow are part of the human body and claims 1-8, 10, 12-17, 33, and 34 are the apparatus claims.
Secondly, based on the Darcy-Weisbach equation, the pressure drop per unit length increases from a larger pipe to a smaller pipe because pressure drop per unit length is directly proportion to the square of the mean flow velocity over the inner diameter of the pipe (V² / D). Based on the specification and the drawing (Fig. 4), the second flexibility zone 128 has a smaller diameter than first flexibility zone 126. The flow velocity would be larger in the second flexibility zone 128 because of the smaller diameter. Therefore, the second pressure drop per unit length defined by the second flexibility zone being at least 10% less than the first pressure drop per unit length (e.g. for the blood flow under physiological condition) is in conflicts with or not consistent with the fundamental physical laws which describe that a smaller pipe has a high pressure drop per unit length.
Claims 2-8, 10, 12-17, 33, and 34 are rejected because they depend on claim 1.
b) Claim 10 is depending on a canceled claim (claim 9). Claims 12-14 depend on claim 10.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 10, 12-17, 33, and 34 have been considered but are moot in view of new ground(s) of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771