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, 3, 6, of 8/25/2025 acknowledged and entered.
Cancellation of claims 2, 5 of 8/25/2025 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive. Regarding the argument of p. 17, para. 1, applicant argues that the recitation of “a blunt, transparent and non-cutting edge glass tip…” as recited in the amended claims distinguishes the claim from the standing rejection to Smith under USC 103. Examiner is, however, not in accordance. Examiner cannot find support for this amendment within the specification as provided by applicant. Remarks document cites a p.4, para. [0052] multiple times, but no such paragraph labeled [0052] exists in the entire document, much less on page 4. While examiner acknowledges that the paragraph numbering resets after [0033], even para. [0019] after the renumbering does not contain relevant information. Further, the citation lists fig. 1, element 104, but it remains unclear to examiner what is meant to be shown by this citation. Elsewhere in remarks, applicant cites fig. 9b, which examiner would concur does appear to at least be a tip, but element 906, which appears in fig. 9b, does not appear to be cited in the body of the specification. Further, examiner is of the opinion the tip as shown looks quite sharp, not blunt as claimed. Finally, a search for the term “blunt” in the specification yields no results, and “tip” and “glass” are used in conjunction, but never in a context that suggests a particularly blunt or explicitly non-cutting quality.
From this, examiner is to conclude that the amendment as provided is unsupported and new matter.
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, 3, 6-8, 10 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.
Regarding claim 1, ln. 12, the “blunt, transparent and non-cutting edge glass tip” is not supported by the specification nor drawings. Regarding claim 1, ln. 25, the term “only” may be interpreted to mean that the one-way valve has the express and exclusive purpose of expanding the peritoneal cavity. A negative limitation such as this must appear verbatim in the specification if it were to be claimed. Hence, the amended claim limitations constitute new matter because they are not described in the application as originally filed.
Claims 3, 6-8, 10 are rejected for dependency upon claim 1.
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.
Claims 1, 3, 6-8, 10 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 1, ln. 25, it is unclear how the term “only” is being used. The claim may be interpreted to mean that a single port manual insufflator bulb with one way valve is the only valve present in the invention, or it may be interpreted to mean that the manual insufflator bulb may be used for only the express purpose to expand the space within the peritoneal cavity. Because it is unclear what is meant by the claim language, it is considered to be indefinite and rejected under USC 112b.
The term “minimal patient discomfort” in claim 1 is a relative term which renders the claim indefinite. The term “minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what could be meant by “minimal patient discomfort”, as the measure is subjective between patients. Further, the limitation borders upon intended use, as it describes that a user takes particular care in the operation of the device rather than describing any particular qualities of the device.
Claims 3, 6-8, 10 are rejected for their dependency upon claim 1.
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), 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 visual guidance with minimal patient discomfort.
Cardenas does not explicitly teach a scope 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, 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 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 3, Cardenas in view of Smith and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Further, Nakajima teaches the device wherein the distal portion of the optical scope is flexible forming a flexible distal portion configured to bend within a deflection angle ranging from 5 degrees to 20 degrees (fig. 20, [0286], turn from the duodenum to the bile duct, of which the scope is capable of, appears to be at least 90 degrees, which would mean that a 20 degree turn is similarly possible),
wherein the distal portion of the optical scope is controlled by manipulators for visualization the peritoneal cavity from multiple angles ([0214], endoscope 10 is steerable).
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 steering mechanism in order to improve visualization angles within the body cavity (Nakajima [0214]).
Regarding claim 6, Cardenas in view of Smith 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 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 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 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).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardenas in view of Smith and Nakajima as applied to claim 1 above, and further in view of Labiche (FR 3085830 A1).
Regarding claim 2, Cardenas in view of Smith and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Cardenas in view of Smith and Nakajima do not explicitly teach the device wherein the optical scope is of a length that ranges from 10 cm to 45 cm and a breadth that ranges from 1 mm to 10 mm.
However, Labiche teaches the device wherein the optical scope (fig. 33, element 222) is of a length that ranges from 10 cm to 45 cm and a breadth that ranges from 1 mm to 10 mm (p. 9, para. 7, length of 40 cm within range of length, and diameter of 5mm in range of breadth).
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 size of the scope of Cardenas to be in the range as taught in Labiche in order to accommodate tools while maintaining a small profile (Labiche p. 9, para. 6-7).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cardenas in view of Smith and Nakajima as applied to claim 1 above, and further in view of Teh Eu-Lee (WO 2020201946 A1).
Regarding claim 5, Cardenas in view of Smith and Nakajima teach The portable and disposable MicroPeritoneoscope as claimed in claim 1,
Cardenas in view of Smith and Nakajima do not explicitly teach the device wherein the distal portion of the optical scope comprises a pressure sensor to gauge pressure inside the abdomen during and after insufflation.
However, Teh Eu-Lee teaches the device wherein the distal portion of the optical scope comprises a pressure sensor to gauge pressure inside the abdomen during and after insufflation (fig. 3, element 312, [0178]).
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 pressure sensor as taught in Teh Eu-Lee in order to maintain constant insufflation (The Eu-Luu [0009]).
Conclusion
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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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795