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 .
Response to Amendment
Amendments to claims 1, 6, 8, 10 of 3/25/2026 acknowledged and entered.
Cancellation of claims 3, 12 of 3/25/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. 7, para. 3, filed 3/25/2026, with respect to claim 1 have been fully considered and are persuasive. The USC 112 rejection of 3/25/2026 has been withdrawn.
Applicant’s arguments, see p. 8, para. 1, filed 3/25/2026, with respect to claim 1 have been fully considered and are persuasive. The USC 112 rejection of 3/25/2026 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3, 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardenas (US 20100249496 A1) in view of Nakajima (US 20230277046 A1), Smith (CA 2533359 A1), Mitelberg, and Taoda (US 5556411 A).
Regarding Claim 1, Cardenas teaches A portable and disposable MicroPeritoneoscope for direct visualization of peritoneal cavity by entering from abdominal wall of a patient with visual guidance under local anesthesia at point of care, wherein the portable and disposable MicroPeritoneoscope comprises:
an optical scope (fig. 1, element 3) comprising a proximal portion and a distal portion ([0013]),
wherein the proximal portion is attached to a handpiece (fig. 1, element 1) facilitating advancement and retraction of the optical scope ([0013]), wherein the proximal portion comprises a biopsy instrument entry port (fig. 1, element 2) to provide access into the peritoneal cavity ([0013]),
wherein the distal portion comprises a camera (fig. 1, element 8), a biopsy exit port (fig. 1, element 12), and at least one light source (fig. 1, element 7; [0013]);
a tubular optical trocar (fig. 1, element 1) comprising an optical port inner sheath and a peritoneoscopy port,
wherein the optical port inner sheath comprises a first portion with an opening configured to receive the optical scope (fig. 1, element 3),
wherein the peritoneoscopy port comprises a third portion with an opening to receive the optical port inner sheath (fig. 1, element 3), wherein the peritoneoscopy port comprises a port balloon (fig. 1, element 20) at a distal end and an inflation port at a proximal end, wherein, after insertion, the port balloon is inflated through the inflation port which enables the peritoneoscopy port to remain secured to an abdominal cavity of the patient for sequential monitoring during post-operative inspections of the peritoneal cavity (limitation describes intended use of the device),
wherein the optical port inner sheath is configured to pass through the peritoneoscopy port and fixed inside the peritoneoscopy port (fig. 1 shows the camera passes through the main sheath 3);
a digital display (fig. 1, element 11) that is connected to the camera of the optical scope for visualizing the peritoneal cavity, wherein the digital display is attached to the handpiece ([0013]);
and a biopsy instrument (fig. 1, element 4) that is introduced through the biopsy instrument entry port for obtaining a biopsy sample from intraperitoneal structures, wherein distal end of the biopsy instrument passes through the biopsy exit port of the optical scope to access organs or soft tissue within the peritoneal cavity for obtaining the biopsy sample ([0013]), wherein the biopsy sample is collected under the visual guidance.
Cardenas does not explicitly teach a scope wherein the distal portion of the optical scope is flexible forming a flexible distal portion with a deflection angle ranging from 0 degrees to 140 degrees, and wherein the distal portion of the optical scope is controlled by manipulators for visualization of the peritoneal cavity from multiple angles,
comprising a second portion with a glass tip to separate muscle layers under visual guidance in the abdominal wall, a single-port manual insufflator bulb with one-way valve to expand the space within the peritoneal cavity facilitating the optical scope to move within the peritoneal cavity for visualization, wherein the manual insufflator bulb is connected to the peritoneoscopy port;
and a fourth portion with a fixation element configured to secure the peritoneoscopy port to the patient’s skin
However, Mitelberg teaches wherein the distal portion of the optical scope is flexible forming a flexible distal portion with a deflection angle ranging from 0 degrees to 140 degrees (fig. 20, element 60, [0053], endoscope 60 performs a nearly 180 degree turn), and wherein the distal portion of the optical scope is controlled by manipulators for visualization of the peritoneal cavity from multiple angles ([0046], steerable endoscope 60),
However, Smith teaches a scope comprising a second portion with a glass tip (fig. 1, element 100) to separate muscle layers under visual guidance in the abdominal wall (p. 9, para. 1, cutting using an optical tip; p. 10, para. 1, glass composition).
However, Nakajima teaches a single-port manual insufflator bulb (fig. 11a, element 156) with one-way valve (fig. 11a, element 159) to expand the space within the peritoneal cavity facilitating the optical scope to move within the peritoneal cavity for visualization, wherein the manual insufflator bulb is connected to the peritoneoscopy port ([0238]).
However, Taoda teaches a trocar (fig. 1, element 1, col. 3, ln. 16-27, trocar assembly 1) with a fourth portion (fig. 1, element 5, col. 1, ln. 60-63, col. 3, ln. 16-27, cannula-retaining member 5 having an adhesive layer 52 provided at a bottom thereof, adhesive layer for fixing the cannula in place on the skin of a patient) with a fixation element configured to secure the peritoneoscopy port to the patient’s skin.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Cardenas to include a flexible and steerable tip as taught in Mitelberg in order to direct the assembly and view the lumen (Mitelberg [0046]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Cardenas to include a glass cutting tip as taught in Smith in order to visualize tissue while advancing into the peritoneal cavity (Smith p. 9, para. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Cardenas to include an inflation mechanism in order to inflate a distal balloon (Nakajima [0237-239]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Cardenas to include an adhesive layer as taught in Taoda in order to fix the cannula in place on the skin of a patient (Taoda col. 1, ln. 60-63).
Regarding claim 6, Cardenas in view of Smith, Taoda, Mitelberg, and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Further, Smith teaches the device wherein the optical port inner sheath and peritoneoscopy port is made up of polyurethanes, or Acrylonitrile Butadiene Styrene (ABS) (p. 7, para. 1, entire sleeve may be formed of polymer, of which polyurethanes and ABS are a part).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sleeve of Cardenas to be composed of steel as taught in Smith in order to provide structural support for piercing body tissue (Smith p. 9, para. 1).
Regarding claim 7, Cardenas in view of Smith, Taoda, Mitelberg, and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Further, Nakajima teaches the device wherein the manual insufflator bulb uses atmospheric air for insufflation ([0238-239]).
Regarding claim 8, Cardenas in view of Smith, Taoda, Mitelberg, and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Further, Smith teaches the device wherein the peritoneoscopy port is fixed in the abdominal cavity of the patient to conduct post-operative inspections of the peritoneal cavity (p. 7, para. 2, apertures for suture-anchoring the cannula assembly to the body).
Regarding claim 10, Cardenas in view of Smith, Taoda, Mitelberg, and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Further, Smith teaches the device wherein the MicroPeritoneoscope enables visualization of the peritoneal cavity with entry from the abdominal wall under visual guidance (Smith p. 9, para. 1).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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