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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Status of Claims
Applicant’s amendment filed 05/19/2026 has been entered. Claims 1-5, 7-10, 12-20, and 23-24 are pending and currently under consideration for patentability under 37 CFR 1.104. Response to arguments below.
Priority
It is noted that the instant application is a Continuation-In-Part of U.S. Application No. 16/707,693
. MPEP 211.05 I. B. first paragraph states, “A continuation-in-part application may include matter not disclosed in the prior-filed application. See MPEP § 201.08. Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application.”
Claim 1 of the instant application recites, “wherein the imaging sensor comprises an infrared transmitter and an infrared receiver.” There is no support for an infrared transmitter and an infrared receiver in U.S. 16/707,693. Therefore, claim 1 and all dependent claims thereof will be treated with a priority date of 01/10/2023.
Claim 13 of the instant application recites, “an imaging sensor at the distal end, wherein the imaging sensor comprises an infrared transmitter and an infrared receiver.” There is no support for an infrared transmitter and an infrared receiver in U.S. 16/707,693. Therefore, claim 13 and all dependent claims thereof will be treated with a priority date of 01/10/2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the processor located in the handle (claim 24) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
a processor configured to control the imaging sensor to capture infrared images and to control the distance sensor to determine a distance between the distal end and an object in claims 1 and 13.
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 § 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 1, 13, and all dependent claims thereof is 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.
Claims 1 and 13 have been amended to recite inter alia “a processor configured to control the first imaging sensor to capture infrared images, to control the second imaging sensor to capture visible light images, and to control the distance sensor to determine a distance between the distal end and an object.” MPEP 2161.01 I. 6th para states, “claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” There is no support in the specification for the specific structure of the controller or what functions it performs to control the image sensor and distance sensor. Therefore claim 1 and all dependent claims thereof are rejected for failing the written description requirement.
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.
Claim limitation “a processor configured to control the imaging sensor to capture infrared images and to control the distance sensor to determine a distance between the distal end and an object” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim(s) 1-5, 7-10, 12-20, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta et al. (U.S. 2022/0248944) in view of Hsia (U.S. 2021/0169310) and Ushijima et al. (U.S. 2021/0099645).
With respect to claim 1, Dacosta et al. teaches an imaging catheter comprising:
a shaft (140) extending along a longitudinal axis between a proximal end and a distal end;
a plug (150) at the proximal end, the plug comprising electrical terminals (para [0065]); and
a first imaging sensor at the distal end, wherein the first imaging sensor comprises an infrared imaging sensor transmitter (170) and an infrared imaging sensor receiver (190, para [0073]);
a second imaging sensor that is configured to sense visible light (para [0118]);
a distance sensor (175);
a processor configured to control the first imaging sensor to capture infrared images, to control the second imaging sensor to capture visible light images, and to control the distance sensor to determine a distance between the distal end and an object (para [0109], [0112], [0118]-[0125] for example)
However, Dacosta does not show the orientation of the electrical terminals of the plug. Further, Dacosta et al. does not expressly teach the distance sensor is an infrared transmitter and receiver.
With respect to claim 1, Hsia teaches a plug comprising electrical terminals oriented perpendicular to the longitudinal axis (FIG. 2).
With respect to claim 1, Ushijima et al. teaches a distance sensor comprises an infrared transmitter and another infrared receiver (para [0038]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the plug of Dacosta et al. to utilize the configuration of Hsia in order to maximizes the amount of data from the distal sensor that can be communicated through its connection to the handle (para [0018] of Hsia).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the distance sensor of Dacosta et al. to utilize the infrared transmitter and receiver in the manner taught by Ushijima et al. teaches it is one of a known set of options that can be substituted for one another such that the results of such a substitution would have been predictable (para [0038] of Ushijima et al.).
With respect to claim 2, Dacosta et al. teaches the infrared imaging sensor transmitter is configured to transmit near infrared light and the infrared imaging sensor receiver is configured to receive the near infrared light (para [0082] for example).
With respect to claim 3, Hsia teaches at least some electrical terminals of the electrical terminals are longitudinally or circumferentially offset from at least some other electrical terminals of the electrical terminals (FIG. 4B for example).
With respect to claim 4, Hsia teaches the plug comprises a curved outer wall and apertures extending through the curved outer wall, and the apertures respectively accommodate the electrical terminals (FIG. 4B for example).
With respect to claim 5, Dacosta et al. teaches a the distance sensor is configured to detect a signal; and the controller is configured to determine a distance between the distal end and the object based on the signal (para [0124] for example)).
With respect to claims 7-10, these limitations are considered intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With respect to claim 12, Hsia teaches markers located along the longitudinal axis the distal end (para [0053]).
With respect to claim 13, Dacosta et al. teaches a medical device comprising:
a shaft (140) extending along a longitudinal axis between a proximal end and a distal end;
a plug (150) at the proximal end, the plug comprising first electrical terminals (para [0065]);
a first imaging sensor at the distal end, wherein the first imaging sensor comprises an infrared imaging sensor transmitter (170) and an infrared imaging sensor receiver (190, para [0073]);
a second imaging sensor that is configured to sense visible light (para [0118]);
a distance sensor (175);
a processor configured to control the first imaging sensor to capture infrared images, to control the second imaging sensor to capture visible light images, and to control the distance sensor to determine a distance between the distal end and an object (para [0109], [0112], [0118]-[0125] for example); and
a handle (110) extending along the longitudinal axis and configured to detachably connect to the proximal end (para [0065]), the handle comprising second electrical terminals, wherein the second electrical terminals, when the plug is inserted in the handle establish electrical connections with the first electrical terminals (para [0065]).
However, Dacosta does not show the orientation of the electrical terminals of the plug. Further, Dacosta et al. does not expressly teach the distance sensor is an infrared transmitter and receiver.
With respect to claim 13, Hsia teaches a medical device comprising:
a shaft extending along a longitudinal axis between a proximal end and a distal end (FIG. 2);
a plug at the proximal end (80), the plug comprising first electrical terminals oriented perpendicular to the longitudinal axis (FIG. 2, 4A);
a handle extending along a longitudinal axis (40 FIG. 2, see also FIG. 1A) and configured to detachably connect to the proximal end, the handle comprising second electrical terminals oriented perpendicular to the longitudinal axis (FIG. 4D for example), wherein, when the plug is inserted in the handle, the second electrical terminals establish electrical connections with the first electrical terminals (FIG. 4E for example).
With respect to claim 13, Ushijima et al. teaches a distance sensor comprises an infrared transmitter and another infrared receiver (para [0038]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the plug of Dacosta et al. to utilize the configuration of Hsia in order to maximizes the amount of data from the distal sensor that can be communicated through its connection to the handle (para [0018] of Hsia).
Further, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the distance sensor of Dacosta et al. to utilize the infrared transmitter and receiver in the manner taught by Ushijima et al. teaches it is one of a known set of options that can be substituted for one another such that the results of such a substitution would have been predictable (para [0038] of Ushijima et al.).
With respect to claim 14, Dacosta et al. teaches the infrared imaging sensor transmitter is configured to transmit near infrared light and the infrared imaging sensor receiver is configured to receive the near infrared light (para [0082] for example).
With respect to claim 15, Hsia teaches at least some electrical terminals of the electrical terminals are longitudinally or circumferentially offset from at least some other electrical terminals of the electrical terminals (FIG. 4B for example), and at least some second electrical terminals of the second electrical terminals are longitudinally or circumferentially offset from at least some other second electrical terminals of the second electrical terminals (FIG. 4D for example).
With respect to claim 16, Hsia teaches the plug comprises a curved outer wall and apertures extending through the curved outer wall, and the apertures respectively accommodate the electrical terminals (FIG. 4B for example).
With respect to claim 17, Hsia teaches the handle comprises an inner wall that defines a cavity configured to receive the plug (FIG. 2, 4E for example).
With respect to claim 18, Hsia teaches the cavity further comprises second apertures (100) that extend through the inner wall, wherein the second apertures respectively accommodate the second electrical terminals (FIG. 4D).
With respect to claim 19, Hsia teaches the second electrical terminals, when the plug is inserted in the cavity, are received the first apertures to establish the electrical connections (FIG. 4E for example).
With respect to claim 20, Hsia teaches electrical conductors extending through the shaft from the proximal end to the distal end, wherein respective electrical conductors are electrically connected to respective first electrical terminals and to the first imaging sensor and the second imaging sensor (para [0056]).
With respect to claim 23, Dacosta et al. in view of Ushijima et al. teaches the infrared imaging sensor transmitter is different from the infrared distance sensor transmitter, and infrared imaging sensor receiver is different from the infrared distance sensor receiver (para [0038] of Ushijima et al., para [0118] of Dacosta).
With respect to claim 24, Dacosta et al. teaches the processor is within the handle (para [0119] for example).
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive.
Applicant's arguments with respect to the rejection under 35 U.S.C. 112(a) and (b) fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to applicant's argument that Ushijima does not teach a distance sensing unit together with an infrared based imaging sensor, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The primary reference of Dacosta teaches an infrared based imaging sensor and a range finder. The secondary reference of Ushijima is to modify the range finder of Dacosta to utilize the IR based distance sensor disclosed by Ushijima.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799
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