DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 1-8, 10 and 14 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.
Claim 1 recites the limitation "the drainage bag" in the last line. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 2-8 inherit the deficiencies of claim 1 through their dependencies, and are thus rejected for the same reasons.
Claim 10 recites the term “a bold”. It appears this should recite “a bolt”.
Regarding claim 14, it appears the word “the” is missing between “cavity of” and “simulated skull”.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1, 2, 4-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le Roy (US Patent No. 4,003,141).
Regarding claims 1, 2, 4-9 and 11-14, Le Roy discloses a medical training device comprising:
a simulated skull (skull model 10) that defines an inner cavity (inner layers for example disposed within membranes 20, 22 and 24 – column 3, lines 32-66) and defines an access port (e.g. tubing 56) between an outer side of the skull and the cavity (see Fig. 1);
a pressure vessel (inflatable member 38) contained within the cavity of the skull, wherein the pressure vessel expands and contracts based on changes to pressure within the pressure vessel (column 3, line 67 – column 4, line 24);
a pressure regulator (pump 62) that allows adjustment of pressure in the pressure vessel (column 4, line 52 – column 5, line 16);
a liquid vessel (e.g. ventricles 48, 50, 52, 54) that contains liquid, disposed within the cavity of the skull and positioned adjacent to the pressure vessel (column 4, lines 35-51);
a display that shows information about pressure in the liquid vessel (recorder 74, which may be a display in the form of a Tektronix Model 412 – column 5, lines 38-57);
a collection container (reservoir 66); and
a drain tube (liquid source functions as a simulated drain to the spinal column – column 5, lines 17-22) having first and second ends, wherein the drain tube passes through the access port of the skull, wherein said first end is connected to the liquid vessel and said second end is connected to the collection container located outside of the skull, and said drain tube conducts the liquid between the liquid vessel and the drainage bag (see Fig. 1) (as per claim 1),
a transducer (pressure sensor, for example recorder 84 – column 2, lines 49-56) that measures pressure in the liquid vessel and communicates data about the pressure to the display (as per claim 2),
the pressure vessel is expandable (inflatable), contains air, and expands and contracts in response to air pressure within the pressure vessel (column 6, lines 3-21) (as per claim 4),
the pressure regulator is a manually operated air pump connected to the pressure vessel by an air tube that passes through an opening in the skull (column 4, line 52 – column 5, line 16) (as per claim 5),
the pressure monitor is disposed within the cavity of the skull (column 2, line 49-56) (as per claim 6),
the pressure monitor is disposed within the liquid vessel (column 2, line 49-56) (as per claim 7),
a method of simulating intracranial pressure in a human skull comprising:
increasing pressure in a pressure vessel contained within a cavity of a simulated human skull (column 3, line 67 – column 4, line 24);
measuring pressure of a liquid contained in a liquid vessel disposed within the cavity, wherein pressure of the liquid in the liquid vessel changes based upon pressure in the pressure vessel (column 4, lines 35-51); and
draining liquid from the liquid vessel into a collection container using a drain tube that passes through an access port in the skull (column 5, lines 17-22; see Fig. 1) (as per claim 8),
the measuring comprises using a transducer (84) to measure pressure in the liquid vessel, and further comprising communicating data about the pressure to a display (recorder 74) (as per claim 9),
the pressure vessel is expandable, contains air, and expands and contracts in response to air pressure within the pressure vessel (column 6, lines 3-21) (as per claim 11),
manually operating an air pump to regulate pressure in the pressure vessel, wherein the air pump is connected to the pressure vessel by an air tube that passes through an opening in the skull (column 4, line 52 – column 5, line 16) (as per claim 12),
the measuring of the pressure comprises measuring pressure using a pressure monitor that is disposed within the cavity of simulated skull (column 2, line 49-56) (as per claim 13), and
the measuring of the pressure comprises measuring pressure using a pressure monitor is disposed within the liquid vessel (column 2, line 49-56) (as per claim 14).
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Le Roy (US Patent No. 4,003,141) in view of Alexander et al. (US 2023/0116175 A1).
Regarding claims 3 and 10, Le Roy does not appear to disclose a bolt fixedly attached to the skull at the port and holds the outlet tube in place (as per claim 3), and the drain tube is held in place at the skull with a bolt that fixedly attaches to the skull at the port and holds the outlet tube in place (as per claim 10). However, Alexander discloses the use of a bolt (110) to attach a cranial drain and pressure monitor to a skull of an actual patient (see Par. 42). Accordingly, it would have been obvious to one skilled in the art before the filing date of the invention to modify the teachings of Le Roy by using a bolt to hold the outlet tube in place, as taught by Alexander, to obtain predictable results of providing a more realistic simulated drain.
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rodriguez et al. (US 2020/0152092 A1) discloses a simulated skull with a drainage line (see Par. 68). Hoyle (US 2024/0249645 A1) discloses a simulated skull for surgical training.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571) 270-3548. The examiner can normally be reached 9:00 AM – 5:00 PM, Monday through Friday Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter R Egloff/
Primary Examiner, Art Unit 3715
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