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 .
Application Status
Present office action is in response to application filed 02/16//2024. Claims 1-22 are currently pending in the application.
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 1 and dependents thereof 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. The claims are filled with recitations of reference terms, each followed by a reference number in parentheses expressed as e.g., reference number). In particular, using claim 1 as representative, claim 1 recites a case (e.g., 102); a model (e.g., 122); (e.g., 130); a thyroid analogue (e.g., 132); a cricoid analogue (e.g., 136); a tracheal analogue (e.g., 144); a skin analogue (e.g., 150). Each of the recitations of reference number in parentheses is interpreted to signify: “for example, said reference number”, and as such renders each resulting claim indefinite because each resulting claim does not clearly set forth the metes and bounds of the patent protection desired. (see Ex Parte Hasche, 86 USPQ 481).
In claims 21-22, the term “relatively” in each of the recitations of “relatively hard durometer material” and “relatively soft durometer material” is found to be indefinite in terms of the knowledge in the art.
When a subjective term is used in the claim, the examiner should determine whether the specification supplies some standard for measuring the scope of the term, similar to the analysis for a term of degree. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005).
In the instant application, the originally filed disclosure as reproduced in the published Specification (see ¶¶ 35, 92) does not provide examples, standards, requirements, or guidance for a skilled artisan to understand when “durometer material” is “relatively hard” or “relatively soft”. A particular person may consider a material to be “relatively hard” or “relatively soft” while another person may not consider the material to be “relatively hard” or “relatively soft”. The claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Some objective standard must be provided in order to allow the public to determine the scope of the 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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-3, 5, 8 and 19-21 are rejected under 35 U.S.C. 103 as obvious over PROPST et al. (US 20200410898 A1) (PROPST) and Parry et al. (US 20220058983 A1) (Parry).
Re claims 1-3, 5, 8 and 19-21:
[Claims 1-2] PROPST teaches or at least suggests a trainer (e.g., 100) for cricothyrotomy, the trainer comprising: a model (e.g., 122) of a patient, the model comprising: a hyoid analogue (e.g., 130); a thyroid analogue (e.g., 132) adjacent to the hyoid analogue; a cricoid analogue (e.g., 136) adjacent to the thyroid analogue; a tracheal analogue (e.g., 144) adjacent to the cricoid analogue; and a skin analogue (e.g., 150) adapted to cover the hyoid, thyroid, cricoid, and tracheal analogues (at least ¶ 3: Surgery and procedures involving the neck and airway include … cricothyroidotomy; ¶¶ 6, 8-10, 13, 17: a simulator for practicing surgery or procedures involving the neck and airway, comprising: b) an anatomical structure/tissue layer to mimic the neck and airway of a person mounted on the top surface of the rigid base; c) the anatomical structure/tissue layer comprised of: skin … muscles synthesized to mimic sternocleidomastoid muscles, sternohyoid muscles, sternothyroid muscles, omohyoid muscles, thyrohyoid muscles, and cricothyroid muscles … tracheal cartilage synthesized to mimic hyoid bone, thyroid cartilage, cricoid cartilage, tracheal rings …; ¶¶ 30, 42, 54: … polymer material mimicking the hyoid bone, thyroid cartilage, cricoid cartilage, tracheal rings …; ¶ 91).
PROPST appears to be silent on but Parry teaches or at least suggests a case (e.g., 102) and a model (e.g., 122) of a patient mounted within the case, ([Claim 2]) wherein the case comprises: a base (e.g., 104); and a cover (e.g., 112) (at least ¶ 3: a simulant with an optional case adapted to receive the simulant whereby the simulant approximates portion of a body, human or animal, with or without a wound structure and whereby the simulant permits a user to practice a task-specific medical procedure; ¶ 75: Regardless of the means employed to open and close the case 2, the base 3 and the lid 4 should permit access to and use of the simulant 6 in an open configuration – wherein the base and the cover are slidably interconnected to enable the cover to slide relative to the base to expose the model would have been an obvious matter of choice; ¶ 102: FIGS. 9-15, the wound box trainer 1 may be configured with a simulant 6 which approximates a neck with or without a chin portion to facilitate practice of a task-specific procedure for establishing an emergency airway. In one non-limiting example, the emergency airway may be formed by way of a cricothyrotomy procedure wherein an opening is cut through the neck and into a trachea and a tube or a needle is inserted into the trachea via the opening. This form of the wound box trainer 1 permits a user to create a wound required for treatment of another wound either simulated or not simulated by the simulant; ¶ 103: The simulant 6 may reside within an optional case 2 including an optional base 3 with or without an optional lid 4. The lid 4 may be secured to the base 3 via an optional hinge 5. The case 2 may surround the simulant 6 in part or whole when the wound box trainer 1 is not in use). It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized Parry’s case feature to modify PROPST as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 3] PROPST in view of Parry teaches or at least suggests wherein a proximal end (e.g., 108) of the base rises above the hyoid, thyroid, cricoid, and trachea analogues to represent the patient's chin (at least PROPST: FIG. 8A-10B).
[Claim 5] PROPST in view of Parry teaches or at least suggests wherein the hyoid, thyroid, and cricoid analogues have lateral mobility within the base representing side-to-side mobility of the patient's larynx (at least PROPST: FIG. 8A-10B).
[Claim 8] As shown above, PROPST in view of Parry discloses hyoid and thyroid analogues (at least PROPST: ¶¶ 30, 42, 54). However, PROPST in view of Parry appears to be silent on wherein the hyoid and thyroid analogues are part of a unitary hyoid/thyroid analogue structure (e.g., 124). It would have been obvious to one having ordinary skill in the art, at the time before the effective filing date of the invention to integrally form the unitary hyoid/thyroid analogue structure claimed, since it has been held to be within the general skill of a worker in the art to make plural parts unitary as a matter of obvious engineering choice. In re Larson, 144 USPQ 347 (CCPA 1965); In re Lockart, 90 USPQ 214 (CCPA 1951).
[Claims 19-20] PROPST in view of Parry may not explicitly disclose wherein the thyroid analogue's lamina (e.g., 134) forms an angle of approximately 90 degrees to represent a male patient, wherein the thyroid analogue's lamina (e.g., 134) forms an angle of approximately 120 degrees to represent a female patient. The Examiner takes official notice that it is common knowledge that thyroid angle is the angle formed by the fusion of the two laminae of the thyroid cartilage, approximately 90 degrees in males and 120 degrees in females. Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified PROPST in view of Parry as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 21] PROPST in view of Parry may not explicitly disclose wherein: the cricoid analogue is made of a relatively hard durometer material; and the tracheal analogue is made of a relatively soft durometer material that forms a removable, friction fit between the tracheal analogue and the cricoid analogue that enables the tracheal analogue to be replaceable. However, PROPST (¶ 17) discloses “laryngeal and tracheal cartilage synthesized to mimic hyoid bone, thyroid cartilage, cricoid cartilage, tracheal rings, epiglottis, arytenoid cartilages, mimicked by a polymer material having a tensile strength in a range from about 100 to about 1000 psi, a modulus M100 in a range from about 10 to about 450 psi, and a Die B tear strength in a range from about 50 to about 250 pli (about 8.8 to about 43.8 kN/m)”. It would have been obvious to one having ordinary skill in the art at the time before the effective filing date of the invention to modify PROPST in view of Parry and Rios by constructing the cricoid analogue and tracheal analogue as claimed since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering choice. In re Leshin, 125 USPQ 416 (CCPA 1960).
Claim 4 is rejected under 35 U.S.C. 103 as obvious over PROPST and Parry, as applied to claim 1, further in view of Segall (US 20140154656 A1).
Re claim 4:
[Claim 4] PROPST in view of Parry appears to be silent on wherein, after the cover has been slid relative to the base to expose the model, the cover represents the patient's sternum (at least PROPST: FIG. 8A-10B). However, having a portion of the model representing the patient's sternum is old and well-known, as evident in Segall (¶ 8: … head and upper torso mannequin that allows for practicing at least the following six skill sets: (1) insertion of a Nasopharyngeal Airway ("NPA") for airway management; (2) performing head tilt, chin lift, visual inspection of mouth and physical sweep to remove foreign bodies from the mouth in support of airway management; (3) performing a surgical airway ("cricothyrotomy") for airway management; (4) performing needle chest decompression ("NCD") for tension pneumothorax; (5) insertion of an Intraosseous Infusion ("IO") System into the sternum; and (6) insertion of an IO System into the proximal humerus; ¶ 36: TCCC 100 enables training in a number of particular tactical combat casualty care skill sets designed to target … training procedures … including but not limited to: needle chest decompression for tension pneumothorax, nasal and oral airway management, cricothyrotomy, and humeral and sternum intraosseous infusion and fluid delivery; ¶ 54: the TCCC 100 allows insertion of a breathing tube (described below) as would be accomplished during an intubation procedure through the nasal passage, mouth, or via cricothyrotomy; ¶ 79: … IO infusion is one method by which medical professionals are capable of delivering fluids and required medications to individuals with such conditions. As is known in the art, the sternum, humerus, and tibia are three locations within the human body that are both accessible and well-suited for such a procedure). It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the head and upper torso mannequin of Segall and modify PROPST in view of Parry as claimed to predictably allow practicing, in addition to cricothyrotomy, skill sets such as performing needle chest decompression ("NCD") for tension pneumothorax and insertion of an Intraosseous Infusion ("IO") System into the sternum (Segall: ¶ 8).
Claims 5-7 are rejected under 35 U.S.C. 103 as obvious over PROPST and Parry, as applied to claim 1, further in view of NAKANO et al. (US 20190333414 A1) (NAKANO).
Re claims 5-7:
[Claims 5-6] In addition to the above, and/or in the event the earlier interpretation of wherein the hyoid, thyroid, and cricoid analogues have lateral mobility within the base representing side-to-side mobility of the patient's larynx is viewed as not being reasonable, NAKANO teaches or at least suggests wherein the hyoid, thyroid, and cricoid analogues have lateral mobility within the base representing side-to-side mobility of the patient's larynx, wherein the hyoid, thyroid, and cricoid analogues have the lateral mobility within the base with the skin analogue applied to the hyoid, thyroid, and cricoid analogues (at least ¶ 158: … enables the simulated thyroid cartilage portion 85 to move in the anteroposterior direction, in the left-right direction, and in the craniocaudal direction with respect to the neck upon application of external force, which makes it possible to faithfully reproduce the structure of the thyroid cartilage and its surroundings of a human body). It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the simulated thyroid cartilage portion features of NAKANO and modify PROPST in view of Parry as claimed to predictably reproduce the structure of the thyroid cartilage and its surroundings of a human body (NAKANO: ¶ 158).
[Claim 7] PROPST in view of Parry and NAKANO appears to be silent on wherein the base has at least one transverse slot (e.g., 110) that engages with at least one structure (e.g., 160) of the model to enable the lateral mobility. This feature would have been and obvious matter of design choice to enable lateral mobility.
Claims 9-10 are rejected under 35 U.S.C. 103 as obvious over PROPST and Parry, as applied to claim 1, further in view of Doelling et al. (US 20090025734 A1) (Doelling).
Re claims 9-10:
[Claims 9-10] PROPST in view of Parry appears to be silent on but Doelling teaches or at least suggests wherein the unitary hyoid/thyroid analogue structure further comprises two lateral struts (e.g., 126) that support the hyoid and thyroid analogues, ([Claim 10]) wherein each lateral strut has a notch (e.g., 128) that engages a different articulating connection (e.g., 140) of the cricoid analogue to connect the cricoid analogue to the unitary hyoid/thyroid analogue structure (at least ¶ 69: One or more magnets or ferrous structures 14 may be affixed to the body of the hyoid bone 12, as FIG. 5 shows. Alternatively, or in combination (as FIG. 6 shows), one or more magnets or ferrous structures 14 can be affixed by attachment means 16 to one or more of the greater horn(s) 13 of the hyoid bone 12; ¶ 69: … One or more magnets or ferrous structures 14 may be affixed to the body of the hyoid bone 12, as FIG. 5 shows. Alternatively, or in combination (as FIG. 6 shows), one or more magnets or ferrous structures 14 can be affixed by attachment means 16 to one or more of the greater horn(s) 13 of the hyoid bone 12. … ; ¶ 78: any combination of anterior, lateral, caudal, or anterior cranial displacement of the hyoid bone as a whole and/or the greater horns of the hyoid bone may be selected for treatment, depending upon each individual patient's needs; ¶ 83: one or more magnets or ferrous structures 14 can be affixed by attachment means 16 to the thyroid cartilage, the crichoid cartilage, or both the thyroid and crichoid cartilages, as shown in FIGS. 13, 14, and 15). It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the structures affixed by attachment means of Doelling and modify PROPST in view of Parry as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Claims 14-18 are rejected under 35 U.S.C. 103 as obvious over PROPST and Parry, as applied to claim 1, further in view of Rios et al. (US 20140212864 A1) (Rios).
Re claims 14-18:
[Claims 14-16] PROPST in view of Parry appears to be silent on but Rios teaches wherein the skin analogue comprises a middle layer (e.g., 154) between a base layer (e.g., 152) and a top layer (e.g., 156), ([Claim 15]) wherein the base layer enables the skin analogue to be removably applied to the hyoid, thyroid, and cricoid analogues, ([Claim 16]) wherein: the base and top layers are made of elastomer; and the middle layer comprises a wet, absorbent material to represent bleeding by the patient (at least ¶ 14: … layers of elastomer membranes simulating human or animal muscle or skin … one or more of these layers can be removable and/or replaceable … the top layer of injectable skin consists of separate layers simulating mammalian skin: the epidermis, dermis, and hypodermis. The layers of injectable muscle and skin may be of uniform density … the layers of skin may be thicker or thinner to simulate the skin of humans or animals with uneven skin layers or damaged skin. The separate layers of injectable skin may consist of elastomers simulating the look and feel of human or animal skin and muscle; ¶ 97: … More or fewer layers of simulated skin and muscle can also be used depending on the desired injection and the level of detail required). The base layer having an adhesive surface would have been an obvious matter of choice. Similarly, the base and top layers being made of plastic would have been an obvious matter of choice. Hence, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the simulated skin features of Rios and modify PROPST in view of Parry as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
The additional limitation ([Claim 17]) wherein: the base layer represents the patient's cricothyroid membrane; the middle layer represents the patient's subcutaneous tissue; and the top layer represents the patient's skin would have been an obvious matter of choice, at least in view of Rios teaching that “more or fewer layers of simulated skin and muscle can also be used depending on the desired injection and the level of detail required”.
[Claim 18] PROPST in view of Parry and Rios appears to be silent on the base and top layers are made of plastic; and the middle layer comprises a wet, absorbent material to represent bleeding by the patient. As noted above, Rios discloses “The plastic shell can be covered with layers of elastomer membranes simulating human or animal muscle or skin. In an embodiment, one or more of these layers can be removable and/or replaceable. In some embodiments, the top layer of injectable skin consists of separate layers simulating mammalian skin: the epidermis, dermis, and hypodermis. The layers of injectable muscle and skin may be of uniform density. In other embodiments, the layers of skin may be thicker or thinner to simulate the skin of humans or animals with uneven skin layers or damaged skin. The separate layers of injectable skin may consist of elastomers simulating the look and feel of human or animal skin and muscle” (¶ 14). Additionally, as per Wikipedia1, “the dermis or corium is a layer of skin between the epidermis (with which it makes up the cutis) and subcutaneous tissues, that primarily consists of dense irregular connective tissue and cushions the body from stress and strain. It is divided into two layers, the superficial area adjacent to the epidermis called the papillary region and a deep thicker area known as the reticular dermis. The dermis is tightly connected to the epidermis through a basement membrane. Structural components of the dermis are collagen, elastic fibers, and extrafibrillar matrix. It also contains mechanoreceptors that provide the sense of touch and thermoreceptors that provide the sense of heat. In addition, hair follicles, sweat glands, sebaceous glands (oil glands), apocrine glands, lymphatic vessels, nerves and blood vessels are present in the dermis”. It would have been obvious to one having ordinary skill in the art at the time before the effective filing date of the invention to modify PROPST in view of Parry and Rios since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious engineering choice. In re Leshin, 125 USPQ 416 (CCPA 1960).
Allowable Subject Matter
Claims 11-13 and 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to disclose or suggest a trainer/simulator having each of the
recited limitations. While various anatomical training devices are known, including
devices for cricothyrotomy, the specific configuration of structural elements as recited in claim 11 and dependents 12-13 and claim 22 are not disclosed in the prior art, nor is there any motivation or suggestion to modify the teachings of the prior art to create the claimed invention without using impermissible hindsight. In particular, PROPST in view of Parry, taken either alone or in combination with the prior art of record fails to disclose or fairly suggest wherein: the cricoid analogue comprises an extension (e.g., 142) having lateral ridges (e.g., 138); and the tracheal analogue comprises lateral rails (e.g., 147) that engage the lateral ridges to connect the tracheal analogue to the cricoid analogue, in combination with the remaining elements and features of the instant invention. Subsequently, claim 11 and dependents 12-13 and claim 22 contain allowable subject matter.
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO Form 892 and is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDDY SAINT-VIL whose telephone number is (571)272-9845. The examiner can normally be reached Mon-Fri 6:30 AM -6:00 PM.
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/EDDY SAINT-VIL/Primary Examiner, Art Unit 3715
1 https://en.wikipedia.org/wiki/Dermis
Prosecution Insights