DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election without traverse of Group II, corresponding to claims 8-12, in the reply filed on 12 November 2025 is acknowledged. Claim(s) 1-20 is/are pending, with claims 1-7 and 13-20 withdrawn from consideration for being drawn to a non-elected invention and/or species.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), except as otherwise indicated in an Office action.
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 pre-AIA 35 U.S.C. 112, 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(s) 10 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 10 and claims dependent thereon, the limitation "the body is configured for physical and electrical coupling with an electronic device" is indefinite. It is unclear if said limitation requires the body to be configured in such a manner that any physical and electrical coupling can be achieved with an electronic device (e.g., the body is constructed in such a manner that physical and electrical couplings between an electronic device and the sensor(s) of the medical device can be achieved) or requires that the body is configured such that the body itself may be physically and electrically coupled with an electronic device (e.g., the body is constructed in such a manner that an electronic device may be physically and electrically coupled to said body). If the latter, it is further unclear in what manner the body is electrically coupled, as the body itself is neither claimed nor disclosed as being electronic.
Claim Rejections - 35 USC § 102
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.
Claim(s) 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0184912 A1 (Al-Ali).
Regarding claim 8, Al-Ali discloses a medical device (e.g., Figs. 2, 9, etc.) comprising:
a body (main valve body 220) defining a passage therethrough (lumen 218);
a first connector at a first end of the body (Luer lock nut 228 with an O-ring 230);
a valve at a second end of the body (threaded fitting 202 containing a compressible cylindrical gasket 204, wherein as the gasket 204 is axially compressed by the fitting applying a compressive axial force, it collapses around a microcatheter or guidewire 206 locking it in place and preventing blood or other fluids from backflowing through the access port 208, as described in, e.g., ¶ [0047]);
the body being configured to receive an elongated, flexible member (microcatheter or guidewire 206) through the valve and through the passage (e.g., Fig. 2; ¶ [0047]; etc.); and
at least one sensor configured to measure a parameter of a fluid contained within the body (pressure transducer 216, 216-I, or 216-M).
Regarding claim 9, Al-Ali discloses the sensor(s) includes a pressure sensor (pressure transducer 216, 216-I, or 216-M).
Regarding claim 10, Al-Ali discloses the body is configured for physical and electrical coupling with an electronic device (external device, such as a microcomputer or signal processing electronics) (e.g., ¶ [0063] body 220, or a sensor housing (housing 902) thereof, comprises an opening allowing for a wired connection to external electronics).
Regarding claim 11, Al-Ali discloses the first connector is configured as a Luer lock (Luer lock nut 228; ¶ [0051]; etc.).
Regarding claim 12, Al-Ali discloses the device further comprises at least one port in fluid communication with the passage (sidearm 210 and/or sidearm 212).
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of US 5,795,325 A (Valley).
Regarding claim 10, Al-Ali discloses the limitations of claim 10, as discussed above. In particular, Al-Ali discloses the body is configured for physical and electrical coupling with an electronic device (e.g., main valve body 220, or sensor housing 902 thereof, is constructed in such a manner that an external electronic device, e.g., microcomputer or signal processing electronics, can be physically and electrically coupled to the sensor of the medical device).
Alternatively/Additionally, Al-Ali discloses any well-known structure(s) allowing for a wired connection to external electronics may be utilized (¶ [0063]). Valley discloses a body (hub 308) configured for physical and electrical coupling with an electronic device (hub 308 includes an electrical connector 324 enabling communication of a pressure signal to an electronic pressure monitor 353; col. 17, lines 23-51; etc.).
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 medical device of Al-Ali with the body being configured for physical and electrical coupling with an electronic device (e.g., the body having an electrical connector to which a wire/cable can be physically/electrically coupled) as a simple substitution of one suitable configuration/arrangement allowing for a wired connection to external electronics for another to yield no more than predictable results. See MPEP 2143(I)(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791