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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9) in the reply filed on 12/22/2025 is acknowledged.
Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/2025.
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:
Injection control module in claim 7
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.
There is no corresponding structure in the specification.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 sets forth the 112(f)-invoking term "injection control module". A claim with a term that invokes 112(f) is interpreted as requiring the structure disclosed in the specification as corresponding to that term. In the present application, there is no disclosure of any corresponding structure. The "injection control module" is not shown in any drawing. It is described in the specification only in terms of the function it performs. It appears, though it is not clear, that this is a computer-implemented function. It is not clear from the disclosure if the "module" that performs the claimed function is only software (in which case it cannot invoke 112f), is hardware only, or if it is a combination of hardware and software. No algorithm is provided for performing all of the claimed functions, which is required when invoking 112(f) for computer-implemented means-plus-function limitations. Consequently, not only is it unclear if 112(f) can be/is being invoked, but it is also impossible to determine scope of the claim because of the lack of disclosure of corresponding structure, both of which warrant a rejection under 35 USC 112(b) (see rejection below). Further, the lack of corresponding structure (an algorithm, if the limitations are computer- implemented) results in a lack of evidence that Applicant was is possession of the invention as claimed at the time of filing. This warrants a rejection under 35 USC 112(a) for failure to comply with the written description requirement. Claim 8 is rejected by virtue of the dependency on claim 7.
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 7-8 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.
Claim 7 sets forth the 112(f)-invoking term "injection control module". In the present application, there is no disclosure of any corresponding structure. The "injection control module" is not shown in any drawing. It is described in the specification only in terms of the function it performs. It appears, though it is not clear, that this is a computer-implemented function. It is not clear from the disclosure if the "module" that performs the claimed function is only software (in which case it cannot invoke 112f), is hardware only, or if it is a combination of hardware and software. No algorithm is provided for performing all of the claimed functions, which is required when invoking 112(f) for computer-implemented means-plus-function limitations. Consequently, not only is it unclear if 112(f) can be/is being invoked, but it is also impossible to determine scope of the claim because of the lack of disclosure of corresponding structure. Claim 8 is rejected by virtue of the dependency on claim 7.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosengart et al. (US 6,508,802; hereafter Rosengart) in view of Fung et al. (US 2012/0095434; hereafter Fung).
In regard to claim 1, Rosengart discloses a method for delivering therapeutic injectates to a heart comprising: introducing at least one intrusion needle (56) through a chest wall; positioning the at least one intrusion needle (56) adjacent a heart of a treatment subject via use of at least one cardiac mapping technique; inserting at least one probing device (64) through the at least one intrusion needle to locate at least one injection site on the heart of the treatment subject (see col. 7, line 59- col. 8, line 23); introducing at least one secondary needle (20) for intrusion into the myocardium; and injecting a therapeutic injectate via the at least one secondary needle when movement of a heart of the treatment subject causes the heart to engage the at least one secondary needle (see col. 7, lines 34-38; the heart is beating so the beat of the heart is involved in the injection); and wherein delivery of the therapeutic agent occurs without performing thoracotomy while the heart is on-beat (see col. 7, lines 12-24).
Rosengart fails to explicitly disclose inserting the intrusion needle via use of at least one cardiac mapping technique as is recited in claim 1.
In a similar art, Fung discloses a sheath (902) that is inserted into a subject (930) at a location beneath the sternum (922). Once the sheath (902) has been inserted, the curved region (906) may be adjusted in order to bring the distal portion (908) close to the surface of the heart (920). For example, the distal portion (908) may be navigated underneath the ribs (928) towards the heart (920). Once the distal portion (908) of the sheath (902) is in a desired location, e.g., an anterior and/or slightly lateral side of the heart, the curved region (906) may be locked to retain the curvature of the curved region. The location of the distal portion (908) may be monitored using any suitable imaging modality, for example, ultrasound, fluoroscopy, and the like (see par. [0043]).
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 method/device of Rosengart with the cardiac mapping technique of Fung in order to provide the predictable result of providing a means for locating and guiding a distal tip of a needle/cannula.
In regard to claim 4, Rosengart discloses wherein the secondary needle (20) engages the myocardium orthogonally (see Fig. 6; the needle 20 is inserted orthogonally into the heart tissue 72).
In regard to claim 5, Rosengart discloses wherein positioning of the secondary needle (20) is adjusted via a control system (15; the barrel is effectively a handle that is used to guide the needle 20 into the body) that can position the secondary needle prior to, and after an injection into the myocardium (15 is engageable at any time during the injection).
In regard to claim 6, Rosengart discloses wherein the injection occurs when the heart of the treatment subject is enlarged during the cardiac cycle (the injection occurs during the beating of the heart including the diastole and systole).
In regard to claim 7, Rosengart discloses wherein an injection control module (“computer-controlled device”; see col. 6, lines 6-8) determines time points for injection, volume to deliver, initiation, and stoppage of the injection (furthermore, the physician controlling the syringe 15 can be considered the injection control module; see 112b).
In regard to claim 8, Rosengart discloses wherein a hydrodynamic system employing a precision pump controls injectate delivery (15 is a syringe).
In regard to claim 9, Rosengart discloses wherein the at least one injection occurs at an infarct area of the heart (see col. 3, lines 27-47).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rosengart and Fung and further in view of Pflueger et al. (US 5,304,115; hereafter Pflueger).
The combination fails to teach wherein the at least one probing device is a fiber angioscope producing real time images as is recited in claim 2.
In a similar art, Pflueger discloses (see FIGS. 16 and 16a) an angioscope 70 comprising a flexible catheter body 72 having a first lumen 74, a second lumen 76 and a third lumen 78 extending longitudinally therethrough. The second lumen 76 contains a plurality of optical fibers extending longitudinally therethrough and providing optical image transmission to the angioscopic device 82 mounted on the proximal end thereof. An attendant TV monitor 84 is provided for optimal viewing of the procedure. The optical fibers 77 within second lumen 76 may comprise light transmitting fibers which function to transmit light from a proximal light source to the distal tip of the catheter 72 and image return fibers which serve to transmit the optical image from the distal tip of the catheter 72 to the angioscopy device 82.
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 combination with the fiber angioscope device of Pflueger in order to provide real-time images inside the treating area of the patient.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rosengart and Fung and further in view of Ozaki (US 2015/0209079).
The combination fails to teach wherein the at least one probing device is a conductive probe that measures bio-impedance of the myocardium.
In a similar art, Ozaki discloses (see FIG. 12) an electrode for measuring the bioelectrical impedance, serving as biological information, may be provided as the sensor 13. Because the bioelectrical impedance differs between when the body tissue or the pericardium A is in contact with the electrode and when the electrode is disposed in a space inside the pericardial cavity E, the relative movement mode can be automatically switched to the protection mode upon detection of a change in bioelectrical impedance, similarly to the case of the pressure.
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 combination with the bio-impedance electrode of Ozaki in order to provide a device which can use impedance of the heart to trigger actuation of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783