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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19, 2025 has been entered.
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 132 is 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 21 recites the fluid flow path is defined between the inner wall and the shaft of the medical instrument. Claim 132 recites the fluid flow path is directed distally beyond the distal end of the medical instrument when the medical instrument extends distally of the open distal end of the body. As the path is initially defined as between the two components it is not clear how it could be present in a location where the accessory is absent. For purposes of examination, it is considered as the accessory is configured to direct fluid in a direction distally beyond the distal end of the medical instrument.
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) 21-36 and 126-132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht et al. (US 2007/0213675 A1) in view of Buyda et al. (US 2019/0059937 A1).
With regard to claims 21-23, 25, 26-34, and 36, Albrecht et al. teach a medical instrument accessory for localizing fluid flow around a distal end of a medical instrument, the medical instrument accessory comprising: a body (Fig. 15 member 312) configured to be removably mounted over at least a portion of a shaft of the medical instrument (capable of removal), the body comprising: a lumen with an inner wall (Fig. 29), a proximal end (Fig. 29), an open distal end (Fig. 29), and at least one structure extending inwardly from the inner wall, the at least one structure configured to, in use, position the shaft of the medical instrument in the lumen such that a fluid flow path is defined between the inner wall and the shaft of the medical instrument shaft and that fluid can be directed into the open distal end or out from the open distal end and around the distal end of the medical instrument (Fig. 29, ribs/protrusions/fins forming channels 334, Fig. 16 shows the instrument in the accessory); and a sealable attachment mechanism configured, in use to sealably attach the medical instrument accessory to a proximal end of the medical instrument (exemplary Fig. 18 member 350, [0059], [0060], Figs. 14 and 15 show additional attachments at 364 and 362 and 372 and 374). In paragraph [0064] Albrecht et al. discuss that there is a gap at either end between the instrument and the accessory which appears to imply in the area of the ribs there would not be a gap and the inner and outer walls would be in contact, however, this is not explicitly disclosed. However, Buyda et al. teach raised members, which direct gas flow between the outer body an inner instrument, are in direct contact with the outer body to seal between the channels (Fig. 3, [0050]). Buyda et al. discloses additional embodiments where gas flow is directed between the inner and outer surfaces of the members (see the embodiments in Figs. 10-19, particularly in Fig. 11 flow is between structures between the inner and outer surfaces). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the structures contact the instrument in Albrecht et al. as Buyda et al. teach this is effective for sealing the components and would yield the same predictable result of providing flow.
With regard to claim 24, gas is provided ([0097]) and as such the proximal end is necessarily in fluid communication with the source.
With regard to claim 35, Albrecht et al. teach a device substantially as claimed. Albrecht et al. do not disclose non-uniform spacing. However, Buyda et al. teach raised members which direct gas flow between the outer body an inner instrument may be uniformly placed or randomly placed ([0074]). It would have been obvious to a person having ordinary skill in the art a before the effective filing date of the claimed invention to have placed the ribs of Albrecht et al. randomly as Buyda et al. teach this to be an art effective equivalent to uniform placement which would yield the same predictable result. Alternatively, one of ordinary skill in the art would also have found it obvious before the effective filing date of the claimed invention to substitute randomly spaced raised portions, considered as ribs, structured as in Buyda et al. in Albrecht et al. as this would yield the same predictable result and Buyda et al. teach using such raised portions or longitudinal grooves (Fig. 3, Fig. 11).
With regard to claims 126-128, gas is provided ([0097]) and as such an inlet port (Fig. 29 shown but not numbered) is necessarily connected to a gas delivery tube.
With regard to claim 129, Albrecht et al. teach a system comprising: the medical instrument accessory of Claim 21 (see the rejection above); and the medical instrument (Fig. 16 member 250).
With regard to claim 130, see Fig. 17 member 410 receives the accessory.
With regard to claim 131, the port is distal to 350 and associated connections attaching the components (Fig. 18).
With regard to claim 132, see Fig. 19, 250 is distal of 312 ([0058]), the fluid flow path ends where 250 continues past 312. The fluid is directed in a distal direction, the direction may extend distally of the instrument. The distal end of the instrument is considered as the distal half of the instrument.
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive. The Examiner maintains her position regarding the combination of Albrecht et al. and Buyda et al. Applicant argues Buyda et al. do not disclose ribs extending inwardly from an inner wall. Buyda et al. is not relied upon to teach this feature. The ribs of Albrecht et al. result in a configuration with a path as in Buyda et al. Applicant argues Buyda et al. do not disclose ribs which contact a medical instrument, Buyda et al. is not relied upon to teach this feature. Applicant argues Buyda et al. do not disclose a fluid flow bath as it directs a tube-like structure which conveys fluid. Fluid is still provided along the path. The Examiner has pointed to additional embodiment of Buyda et al. which show flow directly within the channels between the inner and outer components. Buyda et al. is relied upon to show inner and outer members with flow directing structures between the member in which the flow direction structures are in contact with both surfaces. Both references teach similar flow paths and the combination yields the same result. Regarding new claim 132, in addition to the rejection made under 35 U.S.C. 112, the Examiner would also note the claims do not recite what the fluid is for or where it is directed relative to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783