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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 18, 2026 has been entered.
Response to Arguments
The amendment to claim 2 filed in the March 18, 2026 response is sufficient to overcome the 35 USC 112(d) rejection of claim 5 found in the previous Office action mailed October 21, 2025. This rejection is hereby withdrawn.
The amendment to claim 2 filed in the March 18, 2026 response is also sufficient to overcome the 35 USC 102 rejection of at least claim 2 found in the previous Office action. While the claims are allowable over prior art, additional issues under 35 USC 112 exist for claims 2 and 19. These rejections can be found below.
Claim Interpretation
The following limitations remain interpreted under 35 USC 112(f) for the reasons given in the Office action mailed December 19, 2024:
"A rotation assembly constructed and arranged to optically and mechanically connect to the imaging probe, and to rotate the optical assembly" as found in claims 2-21.
"A retraction assembly constructed and arranged to mechanically connect to the imaging probe and to retract the optical assembly and the elongate shaft in unison" as found in claims 2- 21.
"A linear force transfer mechanism" as found in claim 10.
The following newly added limitation is interpreted under 35 USC 112(f) for the reasons given in the Office action mailed December 19, 2024:
“A sealing element configured to plug a distal end of the window . . .” as found in claim 19.
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.
Claim 2-21 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.
Regarding claim 2, beginning in line 11, the claim recites “an axial separation distance (D1) between the distal end of the spring tip and the optical assembly configured to support a pullback imaging procedure distance (P) of at least 40mm”. However, this language is unclear, as this limitation, in a reasonable interpretation, appears to indicate that the optical assembly is configured to support a pullback imaging procedure distance of at least 40mm when the optical assembly is earlier set forth to be configured to direct light to tissue and collect reflected light from the tissue. How is the optical assembly configured to support a pullback imaging procedure distance?
To overcome this rejection, the examiner suggests amending the limitation to read “an axial separation distance (D1) between the distal end of the spring tip and the optical assembly supports a pullback imaging procedure distance (P) of at least 40mm”.
As for claim 19, which depends from claim 18, recites “wherein the distal tip portion comprises a sealing element configured to plug a distal end of the window to inhibit egress of gel surrounding at least a portion of the optical assembly.” As the limitation “sealing element” is interpreted under 35 USC 112(f), the examiner turns to the specification to determine what structural element is the claimed sealing element configured to plug a distal end of the window. Paragraph 126 states that this sealing element is element 1192 in Fig. 2C, which is “configured to “plug” (e.g. prevent egress from) the distal end of window 130, such as to prevent gel 118 from exiting the distal end of window 130.” Paragraph 112 also states, “Alternatively or additionally, tip 119 can comprise a cap or plug, configured to seal the distal opening of window 130.” Therefore, the examiner interprets the structure of the sealing element to be a cap or plug that seals the distal opening of a window.
However, parent claim 18 recites “the imaging probe comprises a distal tip portion that includes a cap or plug configured to seal a distal opening of a window surrounding at least a portion of the optical assembly.” As a result, while claim 18 recites that the distal tip portion includes a cap or plug for sealing a distal opening of a window, claim 19 also recites a cap or plug configured to seal a distal end of the window. While claim 19 further limits claim 18 because of the fact that the plug is further claimed to inhibit egress of gel surrounding at least a portion of the optical assembly, claim 19 is considered indefinite because, being dependent on claim 18, it is unclear how many caps or plugs are actually set forth by the imaging system of claim 19. Is the claimed sealing element in claim 19 the same element as the cap or plug of claim 18? Or are they different elements as denoted by claiming “a cap or plug” in claim 18 and “a sealing element” in claim 19? If so, how can the distal tip portion have two caps or plugs when the specification only appears to provide support for one? Clarification is required.
Additionally, it is not clear whether “a distal opening of a window” in claim 18 and “a distal end of a window” in claim 19 are the same element or different elements for similar reasons.
As a suggestion to overcome the rejection, the examiner suggests amending the body of claim 19 to read “wherein the cap or plug is configured to plug the distal opening of the window to inhibit egress of gel surrounding at least a portion of the optical assembly.”
Claims 3-18 and 20-21 are rejected by virtue of their dependency on at least claim 2, thereby containing all the limitations of the claim on which it depends.
Allowable Subject Matter
Claims 2-21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 2, the prior art of record, taken either alone or in combination, fails to disclose or render obvious an imaging system for a patient, the system comprising, among other essential features, an axial separation distance (D1) between the distal end of the spring tip and the optical assembly supports a pullback imaging procedure distance (P) of at least 40mm, wherein D1 is at least P, and wherein, prior to the pullback imaging procedure, the optical assembly is positioned at or distal to the first location at the end of the pullback imaging procedure; wherein the imaging probe is constructed and arranged to collect image data from a patient site during the pullback imaging procedure, in combination with the rest of the limitations of the above claim.
With further regard to the above claim, please see pages 6-7 of applicant’s remarks filed March 18, 2026 in response to the previous Office action of record. While the examiner notes that WO 2016/168605 to Petroff et al. discloses a length for the sidecar 105 (see paragraph 0161), the spring tip 104 (see paragraph 0174), and the pullback imaging procedure (see paragraph 0186), the examiner agrees with applicant’s argument that there is no direct correlation between the length between the distal end of the spring tip and the optical assembly and the length of the pullback distance as set forth by the claim. As a result, Petroff does not disclose such a distance, and it given the benefits to such a distance provided by applicant in the instant specification, there is no reason for one having ordinary skill in the art would to find it obvious to have the axial separation distance between the length of the distal end of the spring tip and the optical assembly be at least the same length as the pullback procedure distance, even if there may be some overlap between the distances disclosed by Petroff.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at 571-270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael A Lyons/Primary Examiner, Art Unit 2877 March 25, 2026
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