DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Rejections - 35 USC § 112
3. 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 1-20 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 pre-AIA the applicant regards as the invention.
(a) Claim 1 recites, “an external portion comprising an external simulated skin, wherein the external simulated skin” (emphasis added).
However, it is unclear whether the phrase, “wherein the external simulated skin”, is attempting to incorporate further limitation(s) to the external simulated skin.
(b) Claim 1 further recites, “a body configured to contact a torso of a wearer when worn by the wearer and is further configured to support an internal portion; an internal portion comprising a tube of simulation fluid and simulated vertebrae” (emphasis added).
However, it is unclear whether the claim is referring to two different internal portions or one internal portion.
(c) Claim 4 recites, “the fastening member is a strap that encircles a torso of the
wearer” (emphasis added).
However, it is unclear whether the term “a torso” is referring to the same torso recited per claim 1 or a different torso.
(d) Claim 8 recites, “the external simulated skin comprises or consists of a silicone rubber embedded fabric” (emphasis added).
However, conflating the two terms, namely the term “comprises” and the term “consists of”, as recited above, renders the claim indefinite since the scope of the claim is unclear.
Nevertheless, for examination purpose, the claim is interpreted based on the term “comprises” (see below the analysis presented under section §102).
(e) Claim 17 recites the limitation, “the connector of the tube”; however, given the lack of sufficient antecedent basis regarding the above limitation, it is unclear what is feature is encompassed per the above limitation.
Note that claim 18 is also subjected to the same deficiency since it is directly dependent on claim 17.
Applicant is further required to evaluate the limitations recited per each of the claims and make appropriate correction if additional discrepancies exist.
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of pre-AIA 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.
Note that the one or more citations (paragraphs or columns) presented in this office action regarding the teaching of a cited reference(s) are exemplary only. Accordingly, such citation(s) are not intended to limit/restrict the teaching of the reference(s) to the cited portion(s) only. Applicant is required to evaluate the entire disclosure of each reference; such as additional portions that teach or suggest the claimed limitations.
● Claim 1-3, 5, 6, 8 and 9 are rejected under 35 U.S.C.102(a)(1) as being anticipated by Segall 2018/0308394.
Regarding claim 1, Segall teaches the following claimed limitations: a training device configured to be wearable during use ([0002]; also see FIG 1, label “10”; FIG 2A, label “11”; also FIG 7, label “100” : e.g., a training device for practicing one or more medical procedures—such as, providing a first aid to a patient; wherein the training devices comprises a plurality of parts; such as: an external part or a raiment—label “10”, and an internal part in the form of (a) a vest—label “11” and/or (b) an internal organ module—label “100”; and wherein the training device is already configured to be worn by a person or a model), comprising: an external portion comprising an external simulated skin, wherein the external simulated skin (see FIG 1, label “24”: [0034]: e.g., the external part—namely the raiment—already comprises an outer surface—label “24”; such as, a layer made of silicon material; and wherein this outer surface simulates a human skin); and a body configured to contact a torso of a wearer when worn by the wearer ([0033] lines 1-13: e.g., the training device, which includes the vest, already covers the torso of a person who is wearing the training device; and thus, the training device already comprises a body configured to contact a torso of the wearer when the wearer is wearing the training device) and is further configured to support an internal portion; an internal portion comprising a tube of simulation fluid and simulated vertebrate ([0052] to [0054]: e.g., the internal organ module, which can be used in conjunction with the vest and/or the raiment, already comprises a center frame, which is a tube structure—label “112” of FIG 8—that simulates the spinal column of a human; and wherein the tube structure already comprises at least one internal tube that contains a fluid); and one or more fastening members coupled to the body, wherein the one or more fastening members are configured to secure the device to the torso of a wearer when worn during use ([0040]; [0055]: e.g., the training device, which includes the vest, already incorporates one or more fastening members—such as, one or more straps that implement buckles or Velcro, etc. Accordingly, as the wearer is wearing the device, the device is secured on the body of the wearer using one or more of the straps).
Segall teaches the claimed limitations as discussed above per claim 1. Segall further teaches:
Regarding claim 2, the external simulated skin simulates human epidermal, dermal, subcutaneous, muscle layers, or combinations thereof ([0034] lines 1-11: e.g., the outer surface of the raiment is already colored and textured to simulate a human skin; and thus, the outer surface above simulates at last human epidermis);
Regarding claim 3, the tube is configured to simulate a spinal cord ([0053]: e.g., the center frame, which is a tube structure, is already simulating the spinal column that comprises an internal tube that holds a fluid; and this simulates the spinal cord of a human);
Regarding claim 5, the wearer is a person or a manikin ([0033]: e.g., a person or a model wears the training device);
Regarding claim 6, the body is constructed of a rigid material that is resistant to punctures or piercings ([0035]: e.g., the vest comprises a covering portion, which is made of a rigid material—such as, polyurethane resin. Thus, the body is already constructed of a rigid material);
Regarding claim 8, the external simulated skin comprises or consists of a silicone rubber embedded fabric ([0034]: e.g., the raiment’s outer surface, FIG 1 label “24”, which simulates the human skin, is made of a silicon material that contains nylon fibers; and thus, the simulated skin already comprises a silicone rubber embedded fabric. Note that silicon is a synthetic rubber);
Regarding claim 9, the one or more fastening members are fastened to the wearer with one or more of a clip, buckle, or hook and loop portion ([0040]: e.g., one or more of the straps already incorporate buckles and or Velcro; and therefore, the one or more fastening members are fastened to the wearer with one or more of a buckle, or a hook and loop fasteners).
Claim Rejections - 35 USC § 103
5. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) are applied for establishing obviousness under 35 U.S.C.103.
Note that the one or more citations (paragraphs or columns) presented in this office action regarding the teaching of a cited reference(s) are exemplary only. Accordingly, such
citation(s) are not intended to limit/restrict the teaching of the reference(s) to the cited portion(s) only. Applicant is required to evaluate the entire disclosure of each reference; such as additional portions that teach or suggest the claimed limitations.
● Claims 4, 7 and 13-15 are rejected under 35 U.S.C.103 as being unpatentable over Segall 2018/0308394.
Regarding claim 4, Segall teaches the claimed limitations as discussed above per claim 1.
Although Segall teaches a strap as the fastening member ([0040]), Segall does not expressly describe that the strap encircles the torso of the wearer.
Nevertheless, given the teaching of Segall regarding the implementation a strap (see FIG 4, label “38b”), which incorporates buckles, ties or Velcro ([0040]), it would
have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Segall’s system; for example, by incorporating at least one additional strap—such as, a strap with sufficient length to surround the abdomen the person wearing the device, particularly when the person wearing the device has a large body form than the norm (e.g., one with overweight, etc.); so that the additional strap provides additional support to properly secure the training device on the torso of the person during training.
Regarding claim 7, Segall teaches the claimed limitations as discussed above per claim 1.
Although Segall already teaches a tube of simulation fluid and simulated vertebrate ([0053]; [0054]), Segall does not expressly describe that the tube is constructed of a flexible plastic.
However, Segall already teaches the implementation of flexible tubes for simulating various internal organ models ([0044]; [0045]); and furthermore, the tube simulating the spinal cord is also configured to simulate internal bleeding ([0054]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Segall’s system; for example, by utilizing a flexible tube or hose for modeling the spinal cord; so that the process of simulating one or more injuries, including an internal bleeding, would be more realistic.
Regarding claim 13, Segall teaches the claimed limitations as discussed above per claim 1.
Although Segall does not expressly teach that the one or more fastening members connect to the body of the device via one or more slots or openings in the body, Segall already teaches that the vest, which corresponds to the body of the device, is secured on the torso of the wearer using one or more straps; such as, straps that implement buckles, ties, Velcro, etc. (see [0040]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Segall’s system; for example, by forming one or more reinforced apertures on the vest,
which allows the user to easily insert one or more straps when securing the vest on the wearer; so that, the arrangement above provides additional flexibility to easily secure the training device on different individuals (or models) with different body sizes, etc.
Regarding each of claims 14 and 15, Segall teaches the claimed limitations as discussed above per claim 1.
Segall does not expressly describe that the simulation fluid is distilled water (per claim 14); and the simulation fluid simulates spinal fluid (per claim 15).
However, Segall already teaches that the medical device simulates injuries that may occur to one or more organs to the body; and wherein the device implements tubes and/or reservoirs filled with at least one fluid simulating a fluid that is naturally found in the body ([0042]; [0050] to [0054]).
Moreover, the use of distilled water as a simulation fluid (per claim 14) is merely a design choice the specification describes that distilled water is one of the different alternative fluids that can be used (e.g., see [0010]; also see [0059], “[t]he simulation fluid may be distilled water, glycol, or any other suitable fluid”, emphasis added).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Segall’s system; for example, by incorporating one or more types of fluids, including fluids (e.g. distilled water, etc.) that are easily available in common households; so that, depending on the type of medical procedure being simulated, one or more tubes and/or reservoirs of the training device are filled with the relevant fluid (e.g., filling at least one tube simulating the spinal cord with a distilled water, etc.); so that, the trainee would have additional opportunity to simulate different types of injury scenarios; and such simulation scenarios enhance the trainee’s awareness regarding different types of injuries.
● Claims 10, 16, 19 and 20 are rejected under 35 U.S.C.103 as being unpatentable over Segall 2018/0308394 in view of Trotta 2011/0207102.
Regarding claim 10, Segall teaches the claimed limitations as discussed above per claim 1.
Segall does not teach that the external simulated skin self-repairs after piercing the external simulated skin.
However, Trotta teaches a training device—namely a patient simulator—for practicing one or more medical procedures ([0053]); wherein the patient simulator includes an outer skin layer and/or underlying tissues layer(s) formed from a material that the natural human skin ([0054]; [0057]), including self-sealing characteristics that allows it to automatically seal after a needle punctured it ([0058]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify
the invention of Segall in view of Trotta; for example, by utilizing a simulated skin with self-sealing characteristics; so that when practicing a medical procedure that requires injecting the simulated skin with a needle, the simulated skin automatically seals itself (e.g., momentarily after the needle is removed) in a similar fashion that a natural human skin seals itself; so that the trainee would have a more realistic training experience.
Regarding claim 16, Segall teaches the claimed limitations as discussed above per claim 1.
Segall further teaches, filling the tube with the simulation fluid; securing the device to a torso of the wearer with the one or more fastening members (see [0033] lines 1-9; [0035]; [0054]: e.g., the tube is filled with fluid in order to simulate an internal bleeding related to an injury; and accordingly, prior to starting the medical scenario, it is just basic common sense that a person first wears the training device, which comprises the raiment and the vest; and wherein one or more the straps are utilized to secure the training device on the torso of the person).
Although Segall further teaches performing a simulated medical procedure on the device ([0049]; [0050]), Segall does not teach inserting a needle through the external simulated skin and into the tube, wherein the needle is coupled to a syringe; extracting the simulation fluid from the tube and/or injecting a fluid into the tube via the syringe; and retracting the needle from the device.
However, Trotta teaches a training device—i.e., a patient simulator (see FIG 9, label “222”), which is utilized for practicing a medical procedure; such as, proper procedures for administering epidural injection, which relates to administering medication into the epidural space of the spine ([0051]); and accordingly, once identifying the appropriate location (e.g., the lumbar and/or thoracic vertebrates, etc.) for inserting the epidural needle, the trainee inserts the needle into the epidural space after passing it through the different tissue layers of the simulated skin—such as, advancing the needle while applying a light pressure on the syringe plunger; and subsequently injects a fluid into the epidural space; wherein the epidural space is in fluid communication with a drain or a large reservoir in order to allow fluid injected into the epidural space to be removed; thereby proving the trainee with further option to inject
additional fluid into the epidural space; and furthermore, the simulated skin above has self-sealing characteristics, which allows it to seal itself after the needle is removed or retracted ([0052] to [0055]; [0057] to [0059]).
Accordingly, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the invention of Segall in view of Trotta; for example, by implementing a simulated skin with self-sealing characteristics; and wherein a medical syringe with a needle is also provided, so that the trainee would have further option to practice additional medical procedures—such as, the proper technic to administer epidural injection; wherein the trainee first identifies the appropriate location for inserting the epidural needle (e.g., the lumbar and/or thoracic vertebrates, etc.); and subsequently inserts the needle into the epidural space by passing it through the different layers of the simulated skin (e.g., advancing the needle while applying a light pressure on the syringe plunger); and the trainee injects a fluid into the epidural space; and the epidural space is in fluid communication with a drain or a large reservoir in order to allow fluid injected into the epidural space to be removed; thereby providing the trainee with further option to inject additional fluid into the epidural space; and finally, as part of a common-sense procedure, the trainee retracts the needle from the simulated skin, thereby allowing the simulated skin to self-seal, etc.
Regarding each of claims 19 and 20, Segall in view of Trotta teaches the claimed limitations as discussed above per claim 16.
Each of the limitations, “positioning the syringe needle between at least two vertebrae to access the tube” (per claim 19), and “filling a reservoir in the tube with simulation fluid to provide additional simulation fluid for extraction” (per claim 20), is already addressed per the modification discussed with respect to claim 16. In particular, the process of identifying the appropriate location—such as the lumbar and/or thoracic vertebrates, etc., already involves positioning the syringe needle between at least two vertebrae in order to access the tube (as required per claim 19); and furthermore, the epidural space is already in fluid communication with a large reservoir in order to allow fluid injected into the epidural space to be removed; thereby proving the trainee with further option to inject additional fluid into the epidural space; and this indicates filling a reservoir in the tube with simulation fluid to provide additional simulation fluid for extraction (as required per claim 20).
Note also that the motivation discussed per claim 16 also applies to each of claims 19 and 20 since each of claims 19 and 20 is directly dependent on claim 16.
● Claims 11 and 12 are rejected under 35 U.S.C.103 as being unpatentable over Segall 2018/0308394 in view of Heruth 2005/0106545.
Regarding claim 11, Segall teaches the claimed limitations as discussed above per claim 1.
Although Segall teaches that the tube has a connector on at least one terminal end ([0054]: e.g., the tube comprises at least one inlet port that connects to a source of fluid), Segall does not teach that the tube connects to a syringe via that terminal end.
However, Heruth discloses a training device; namely, a human spinal model apparatus (see FIG 1, label “100”), which comprises a simulated spinal cord and its passage way (FIG 1, labels “300” and “202”; also FIG 2, label “302”; [0034]); and furthermore, a syringe is utilized as a means to infuse a substance (e.g., a fluid, etc.) into the passage way ([0053]).
Thus, given the above teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Segall in view of Heruth; for example, by incorporating a further option—namely a syringe—to infuse a fluid into the tube simulating the spinal cord; so that the trainee would have a further option to practice the process of injecting, using a syringe, a simulated drug into the spinal cord, etc.; and this further enhances the trainee’s medial skills.
Regarding claim 12, Segall in view of Heruth teaches the claimed limitations as discussed above per claim 11.
Although Segall—as modified per Heruth—does not expressly teach that the connector is a Luer lock, the use of Luer lock is a common practice, particularly in medical procedures that involve fluid delivery or transfer (e.g., syringes, catheters, IV tubing, etc.).
Accordingly, given that fact that Segall’s system is a medical procedure simulating system, which involves one or more tubes for delivering or transferring fluid from one component to another ([0054]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Segall’s system; for example, by incorporating one or more additional standard connectors—such as Luer lock—that are commonly used in the medical field for properly securing medical instruments; so that the trainee would have a further opportunity to learn the proper way to use such standard connectors.
Status of claims 17 and 18
● Considering claim 17 as a whole, which includes the indefinite feature identified under section §112(b), the prior art does not teach claims 17 and 18 as currently presented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUK A GEBREMICHAEL whose telephone number is (571) 270-3079. The examiner can normally be reached on 7:00AM-3:00PM.
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/BRUK A GEBREMICHAEL/Primary Examiner, Art Unit 3715