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 .
Status of Claims
Claims 1-8 are pending and examined on the merits.
Claim Objections
Claims 1-3 are objected to because of the following informalities:
Re Claim 1, it should be a colon, instead of a comma, immediately following “the outer inserter comprises.”
Re Claim 2, “the hollow” should be changed to “a hollow”.
Re Claim 3, “the head pat” should be “the head part.” Additionally, it should be a colon, instead of a comma, immediately following “the inner inserter comprises.”
Appropriate correction is required.
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.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically for Claim 3, it is not understood how the through-part of the inner inserter can be inserted into itself. The Specification at [0052] (see pre-grant Publication, namely US 2025/0367360) also discloses the same. But in Fig. 2, it is shown that through-part (220) is inserted into a lumen/hollow of the outer inserter (100). Examiner believes that the drawing is showing the correct disposition of the through-part of the inner inserter.
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 1-8 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.
Re Claim 1, the claim recites “an inner inserter inserted … while peeling tissues in front of the outer inserter.” It is not readily understood what “peeling tissues” may mean. Typically peeling refers to the action of removing an outer layer but in this case the outer inserter is believed to be pushed deep into a human body, therefore it is difficult to imagine the inner inserter, being positioned within the outer inserter, would be used for “peeling tissue.” Looking at the original disclosure, Examiner thinks that “peeling tissue” may simply mean “penetrating tissue” as the inner inserter is shown to have a pointed end that may make penetration into biological tissues more effortless.
Additionally, Claim 2 recites the limitation "the inner inserter or drainage tube". There is insufficient antecedent basis for the drainage tube in the claim. Additionally, this limitation appears to equate the inner inserter to a drainage tube but it is not readily clear if Applicant has ever intended the inner inserter to be a drainage tube. Looking to the original disclosure, it appears that the inner inserter is a penetrating/cutting tool and will be removed from the outer inserter and then replaced by a drainage tube in its place.
Re Claim 3, it is recited “the inner inserter comprises … a through-part inserted into the hollow of the inner inserter.” It is unclear how the inner inserter has a part that inserts into itself. Based on the drawings, it appears that the through-part is inserted into the hollow, i.e., central lumen, of the outer inserter and therefore Examiner is using this interpretation when looking for prior art.
Claims 4-8 are rejected for being dependent on at least one of Claims 1-3.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schreck et al. (US 2012/0226341).
Re Claim 1, Schreck discloses a guide device (Figs. 1A & 1B) comprising:
an outer inserter (introducer 12); and
an inner inserter (catheter 20) inserted in a hollow of the outer inserter while peeling tissues in front of the outer inserter (the sharp pointed end of the catheter 20 is configured to extend beyond the outer inserter and therefore, wherein the outer inserter comprises:
a head part (where female docking mechanism 18 is located) extending along one direction; and
a guide tube (introducer sheath 14) extending downward from the head part.
The claim term “drainage tube” that immediately precedes “guide device” and the limitation “inserted along the abdominal wall” are directed to the intended use of the guide device, i.e., the guide device is intended for guiding a drainage tube and the outer inserter is intended for insertion along the abdominal wall. While features of an apparatus may be recited either structurally or functionally, claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does. Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. One skilled in the art is able to insert a drainage tube insider the outer inserter after removing the inner inserter and is also able to insert the entire system along an abdominal wall because that is dependent on manipulation by the medical professional.
Re Claim 2, Schreck discloses claim 1 and further discloses wherein the head part comprises an inlet hole formed on an upper surface (evident from Figs. 1A-1B), in communication with a hollow of the guide tube, so that the inner inserter can be inserted into the guide tube (Fig. 1B).
Re Claim 3, Schreck discloses claim 2 and further disclosing wherein the inner inserter comprises:
a coupling part (male docking mechanism 22) coupled to the head part; and
a through-part (shaft 24) inserted into the hollow of the outer inserter.
Re Claim 4, Schreck discloses claim 3 and further disclosing wherein a protrusion (the sharp pointed tip of shaft 24, see Fig. 1A) protruding forward through the guide tube is formed in the through-part.
Re Claim 5, Schreck discloses claim 2 and further disclosing wherein the protrusion is inclined downward toward an end (see the pointed tip shown in Fig. 1A).
Re Claim 6, Schreck discloses claim 3 and further disclosing wherein the head part comprises a coupling groove (female docking mechanism 18 forms a groove structure, clearly shown in Fig. 1A) formed in each of both sides of the inlet hole formed in the head part, and
the coupling part comprises a hook portion (male docking mechanism 22) clearly shown in Fig. 1A) protruding along both directions and fitted to the coupling groove.
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.
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schreck in view of Annis (US 10,434,272).
Re Claim 7, Schreck discloses claim 1, but does not disclose wherein the length of the guide tube is 21 cm to 31 cm but in a different embodiment, the outer guide tube is disclosed to be “any desired length” (e.g., [0084], [0097]). Schreck does not limit the location in which the catheter system may be deployed ([0120]) and may be useful for the trachea. Annis discloses an insertion guide device for use in the trachea wherein a common size suitable for use with adult patient is 22-28 cm in length (col. 5 lines 52-56). It would have been obvious to one skilled in the art at the time of filing to glean from Annis such that the catheter system is properly sized for use in the anatomical location it is designed for.
Re Claim 8, Schreck discloses claim 1 but does not disclose wherein the guide tube has a curved shape. Schreck does not limit the location in which the catheter system may be deployed ([0120]) and may be useful for the trachea. Annis discloses an insertion guide device for use in the trachea wherein both the outer and inner inserters are curved (see Fig. 2). It would have been obvious to one skilled in the art at the time of filing to modify Schreck with the shape taught in Annis because doing so would make the insertion guide device safer to use for that particular location on the human body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 31 July 2026
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