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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the claims have an effective filing date of October 6, 2022, having priority going back to KR10-2022-0127767.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “tube insertion unit” in claim 2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “tube insertion unit” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 2 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 2 recites “so that the tube is inserted into the body” and “the other end of the insertion case faces the inside of the trachea” which positively recites the human body. It is suggested to use functional language such as “able to be inserted” and “other end is able to face” or other similar language.
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 limitation “tube insertion unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification repeats the claim language and the specification and drawings do not disclose what the tube insertion unit is. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-6 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.
Regarding claim 1, the phrase "may be" (which is synonymous with “for example”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner will treat with art as best understood.
Claim 3 recites the limitation "the other end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the one end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the other end" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “further comprising a video laryngoscope” which makes it sound like the video laryngoscope is a separate component but looking at the specification, figures and the other claim limitations in claim 5 (where the camera is located at the other end of the insertion case and the display on one end of the insertion case), it seems that the endotracheal intubation guide device itself is the laryngoscope. It seems that the first two lines of claim 5 is not necessary. Clarification is requested and examiner will treat with art as best understood.
Claim 6 recites the limitation "a video laryngoscope" in line 9. There is insufficient antecedent basis for this limitation in the claim. It is not clear if applicant is referring to the same laryngoscope in claim 5 or a different laryngoscope.
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, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woo KR 20120039212 (reference is made to English Translation provided by applicant).
Regarding Claim 1, Woo discloses an endotracheal intubation guide device (Fig 1), comprising:
an insertion case (see Fig below) which is bent (in area near #103, Fig 1) along a lengthwise direction to be inserted into the mouth (Fig 1, 11) and has an opening formed through an upper part thereof (see Fig below, opening for tube #115);
a balloon (see Fig below) provided at the insertion case to widen the mouth (Fig 4, paragraph 24, 38, page 8, 9th paragraph “may be expanded after the intubation body 100 is inserted ..”, see Fig 15 where examiner notes that the balloon is able to be placed in the mouth such that when inflated, is able to widen the mouth); and
a tube (#115a, see Fig below) which is connected to the balloon to inject air into the balloon and thus expand the balloon and is connected to a front part of the balloon (see Fig below, page 11 7th paragraph)
wherein the balloon may be disposed at the opening of the insertion case to enable the balloon to come into contact with a ceiling of the mouth when air is injected through the tube (Fig below, page 8, 9th paragraph “may be expanded after the intubation body 100 is inserted ..”, see Fig 15 where examiner notes that the balloon is able to be placed in the mouth such that when inflated, it will come into contact with the ceiling of the mouth).
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Regarding Claim 5, Woo discloses a video laryngoscope (see 112 rejection above) configured to observe the trachea, the video laryngoscope comprising:
a camera (#120) disposed on the other end of the insertion case and configured to photograph the trachea (page 8 second paragraph “photographing is performed through a camera…”, Fig 4 where the camera is at the other end and is able to photograph the trachea); and
a display (#420) disposed on one end of the insertion case (see Fig 1) and connected to the camera to display information obtained from the camera (page 9 paragraph 6 “displaying image information captured by the camera”).
Claims 1, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang US 2014/0166020.
Regarding Claim 1, Chang discloses an endotracheal intubation guide device (Fig 2a), comprising:
an insertion case (see Fig below) which is bent (in area near #504, Fig 5a) along a lengthwise direction to be inserted into the mouth (Fig 4) and has an opening formed through an upper part thereof (see Fig below);
a balloon (#406, see Fig below) provided at the insertion case to widen the mouth (Fig 4, paragraph 24, 38); and
a tube (#514, see Fig below) which is connected to the balloon to inject air into the balloon and thus expand the balloon and is connected to a front part of the balloon (see Fig below, paragraph 43),
wherein the balloon may be disposed at the opening of the insertion case to enable the balloon to come into contact with a ceiling of the mouth when air is injected through the tube (Fig 54, paragraph 24, 38).
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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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Parker US 5,174,283 in view of Chang US 2014/0166020.
Chang discloses an endotracheal intubation guide device (Fig 2a), comprising:
an insertion case (see Fig below) which is bent (in area near #504, Fig 5a) along a lengthwise direction to be inserted into the mouth (Fig 4) and has an opening formed through an upper part thereof (see Fig below);
a balloon (#406, see Fig below) provided at the insertion case to widen the mouth (Fig 4, paragraph 24, 38, 42, the balloon is compliant/elastic able to be inflated and thus widen the mouth); and
a tube (#514, see Fig below) which is connected to the balloon to inject air into the balloon and thus expand the balloon and is connected to a front part of the balloon (see Fig below, paragraph 43),
wherein the balloon may be disposed at the opening of the insertion case to enable the balloon to come into contact with a ceiling of the mouth when air is injected through the tube (Fig 54, paragraph 24, 38), the balloon sealing the oral cavity and preventing air leak via the mouth (paragraph 42)
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Parker to include a balloon, tube and an opening in view of Chang above because this seals the oral cavity and prevents air leak via the mouth as well as expanding the oral cavity when inflated.
Regarding Claim 2, Parker as modified discloses one end of the insertion case is provided with a tube insertion unit (handle #14 in Parker) opened (as seen in Fig 5 in Parker, the handle #14 is open and in communication with lumen #16) so that the tube is inserted into the body (Fig 5, 8 in Parker where one is able to grip the tube insertion unit/ handle #14 to place the tube, as modified by Chang, into the body via the mouth), wherein the other end (near ref #48, Fig 8) of the insertion case faces the inside of the trachea (end facing trachea #116 in Fig 8 in Parker).
Regarding Claim 3, Parker as modified discloses an epiglottis hanging portion (see annotated Fig 1 of Parker below) provided on a lower side of the other end of the insertion case when the insertion case is inserted into the trachea (see Fig below, Fig 8 in Parker); and
an esophagus insertion prevention tube (see annotated Fig 1-2 of Parker below) provided on an upper side of the other end of the insertion case when the insertion case is inserted into the trachea and protruding farther in a lengthwise direction of the insertion case than the epiglottis hanging portion.
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Regarding Claim 4, Parker as modified discloses the balloon is disposed between one end (where the epiglottis hanging portion is in annotated Fig 1 of Parker above in claim 3) and the other end (where handle #14 is located in Parker, Fig 5) of the insertion case (with the modification in view of Chang the balloon is located between the opposing ends, one end and the other end, of the insertion case).
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Allowable Subject Matter
Claim 6 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art (see rejections above) does not disclose an air injection device with a processor that performs the steps as claimed in claim 6. The prior art teaches the use of pressure not image analysis to control the inflation of the balloon. For example Supiez US 20100191054 discloses the use of a pressure regular 101 to control expansion of the balloon 8.
Conclusion
See PTO-892 for other guide devices/laryngoscopes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773
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