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 .
This office action is in response to applicant’s communication of 7/16/2026. Currently claims 1-20 are pending.
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Better et al. (US 2010/0081112 A1) in view of Funakoshi et al. (US 2015/0165458 A1).
Better discloses a medical device (as in figures 1-13b) comprising: a catheter (52/50/42) defining a lumen extending along a longitudinal axis of the catheter; a compressed gas source (see [0094], [0394] and 54 source may be gas); a valve member (see para [0128-0131] and valve disclosure) having: (i) a closed position in which the valve member blocks the compressed gas source from being in fluid communication with the lumen and (ii) an open position that allows fluid communication between the compressed gas source and the lumen; and a rotary actuator (110) that, when driven, rotates the catheter about its longitudinal axis.
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Better discloses the claimed invention except for the compressed gas source being an expandible bellows. Funakoshi teaches that it is known to use the compressed gas source being an expandible bellows as set forth in paragraphs [0009]-[0011] and devices shown in figures 4-8 and 19-21 to provide a means to supply a gas or fluid to a supply line fluid source. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Better with the compressed gas source being an expandible bellows as taught by Funakoshi, since such a modification would provide the system with the compressed gas source being an expandible bellows for providing a means to supply a gas or fluid to a supply line fluid source via compression.
Note example of an expandable bellows 26 and valve 24a below. Examiner is considering the 23 and internal space. Further note the valve 24 would block the bellow from being in fluid communication with the lumen near 21
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Concerning claim 2 and the catheter comprises a helical protrusion on an outer surface of the catheter (see 42 and 36).
Concerning claim 3 and the rotary actuator comprises a hand crank by which the catheter is manually rotatable about its longitudinal axis (see 110 and 150/160 tool).
Concerning claim 4 and the valve member is manually movable between the closed and open positions (see para [00190-192] and separation manually).
Concerning claim 5 and the compressed gas source comprises a spring (see para [0159] and piston bellow and spring).
Concerning claim 6 and the expandible bellows and the spring are arranged such that the spring resists an expansion of the expandable bellows to draw air into the expandible bellows (again see Better para [0159] and piston bellow and spring, and Funakoshi para [0085] and [0103] discussing the resilient and restoring forces on the bellows, which examiner is of the position is a type of spring).
Concerning claim 7 and the expandible bellows is manually expandable (see Better para [0432] and this is carried out by manual manipulation of the device; further see teaches as discussed above concerning the bellows of Funakoshi).
Concerning claim 8 and the expandible bellows is expanded, (ii) the valve member is in the open position, and (iii) a distal end of the lumen is occluded, the spring compresses the bellows to create a gauge pressure of 16mmHg to 20mmHg within the lumen (examiner is of the position that when the springs would compress the bellows piston that the gauge pressure would be in that range in order to manipulate the valve further see teaches as discussed above concerning the bellows of Funakoshi).
Concerning claim 9, Better discloses a method of accessing an internal region of a mammalian body (figure 11d for example), the method comprising: making a skin incision (access to mouth and region 100 on gum of patient); placing a distal tip portion of a trocar (32) through the skin incision and advancing the trocar a first distance into tissue (near 120); after advancing the trocar the first distance, increasing a gas pressure in a lumen of the trocar (para[0394]); after increasing the gas pressure in the lumen (para[0398]), advancing the trocar farther into the tissue until a decrease of the gas pressure in the lumen is noticeable, wherein the decrease of the gas pressure in the lumen indicates that the lumen has become in fluid communication with the internal region (para[0394]); and advancing a surgical instrument through the lumen and into the internal region via the lumen of the trocar (see figure 11d for example).
Concerning claim 10 and the advancing the trocar into the tissue is performed by rotating the trocar about its longitudinal axis such that helical protrusions on an outer surface of the trocar drill into the tissue (see para [0244]- [0245] and threads 36).
Concerning claim 11 and the increasing the gas pressure in the lumen comprises opening a valve member to put an internal space of an expandible bellows and the lumen of the trocar in fluid communication with each other (see para [0398] further see teaches as discussed above concerning the bellows of Funakoshi).
Concerning claim 12 and comprising, prior to opening the valve member, expanding the bellows to: (i) cause gas to flow into the bellows and (ii) add loading to a spring (see para [0159]).
Concerning claim 13 and further comprising, after expanding the bellows, closing the valve member prior to advancing the trocar farther into the tissue (see para [00432] examiner is of the position that the valve would be closed in order to not expel fluid unnecessarily).
Concerning claim 14 and the decrease of the gas pressure in the lumen causes the trocar to no longer be rotatable (see para [0041] and decrease and pressure drop).
Concerning claim 15 and the gas pressure is increased to a gauge pressure of 16mmHg to 20mmHg within the lumen of the trocar (examiner is of the position that gas would be in the gauge pressure range in order to manipulate the trocar through the tissue as appropriate).
Concerning claim 16 Better discloses a trocar installation device comprising: a trocar (30) defining a lumen (40) extending along a longitudinal axis of the trocar; and a compressed gas source (54 and para [0394] 54 may be gas) that is manually actuatable to selectively pressurize the lumen.
Concerning claim 17 and the trocar (30) comprises a helical protrusion (36) on an outer surface of the trocar, and wherein the trocar installation device further comprises a manual hand crank (110) mechanism that is operable to rotate the trocar about its longitudinal axis.
Concerning claim 18 and the compressed gas source comprises an expandible bellows (480) and a spring (see figure 15B and 482 spring) and an internal space of the expandable bellows is fluidly coupled to the lumen (see teaches as discussed above concerning the bellows of Funakoshi).
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Concerning claim 19 and a latch mechanism that is operable to releasably detain the bellows in an expanded configuration and the spring in a loaded configuration (see element 484 (which acts as a control to the bellows spring movement).
Concerning claim 20 and the compressed gas source comprises a pressurized bottle containing the gas (see [0394] and 54 which examiner is of the position is a type of pressurized bottle as this is a known source of gas).
Response to Arguments
Applicant's arguments filed 7/16/2026 have been fully considered but they are not persuasive. Applicant’s argue the that prior art fails to disclose the newly amended claim language of the expandible bellows and/or a “trocar”.
Concerning the expandible bellows examiner is of the position that the prior art of Funakoshi in combination with the teachings of Better teach the expandible bellows arrangement and valve arangment as claimed. See discussion above concerning the teachings of Funakoshi and the compressed gas source being an expandible bellows to supply fluid to a supply line.
Concerning the claim limitations regarding the term “trocar”; in response to applicant's argument that the prior art structures is not a trocar, 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.
It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitation of the claim. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon.
The elements disclosed in Better, Funakoshi, and any obvious modifications thereof are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, 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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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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