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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Applicant’s submission of a Response
Applicant’s submission of a response was received on 01/27/2026. Presently, claims 1-19 are now pending.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive. Claims have overcome each and every objection and 112(b) rejection previously set forth in the Final Office Action mailed 10/29/2025. Applicant’s representative asserts that the amended claims limitations are not met. However, in light of the amendments to the claims, new rejections under 35 U.S.C. 103 have been presented, as discussed in detail below.
Applicant’s representative alleges the following:
In regards to Rejection of Claims Under 35 U.S.C. § 112(b), “the FOA is incorrect - hypotonia is defined as decreased resistance to passive movement of the limbs and joints, resulting in floppiness and poor postural control. In premature or term neonates specifically, this occurs when the infant has reduced spontaneous movements, poor head control, and limbs that feel unusually soft and extend easily when handled. Thus, the recited simulation of a hypotonic condition of the premature neonatal infant provides decreased resistance of movement of the limbs and joints compared to that of a non-premature neonatal infant.” (Page 7 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “The figures in Moffat depict general baby poses, but the disclosure is directed to generic baby articulation across newborn to less than one year (paragraph [0048]) and does not disclose tailoring joint directions, angles, and ranges of motion to premature neonates, alignment with neonatal intensive care developmental positioning practice, or simulation of a hypotonic condition” (Page 10 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “No disclosure identifies decreased passive resistance, reduced head control, or other features characteristic of hypotonia, and no disclosure ties any alleged lack of resistance to a predetermined range of motion configured to permit developmental positioning in supine, prone, and sidelying in the premature context” (Page 10 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “Background text in Sweeney mentions an objective to provide simulation devices in a mannequin the size, shape, and weight of a newborn or premature baby, but no disclosure provides explicit premature neonatal dimensions matching those recited in claim 1, and no disclosure addresses articulated joint configurations for developmental positioning or joints providing a predetermined range of motion in all extremities based on simulation of a hypotonic condition.” (Page 10 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “Moffat does not disclose, teach, or suggest configuring the joints based on a hypotonic condition or designing the joints to simulate lack of muscle resistance. Moffat's joints are designed to mimic natural movement of a real baby, which inherently includes normal muscle tone and resistance. The mere capability of a ball and socket joint to move in all axes does not teach or suggest configuring that joint with a predetermined range of motion based on the specific characteristics of hypotonia.” (Page 11 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “Moffat addresses general baby articulation and does not suggest adaptation to preterm anthropometrics or neonatal intensive care developmental positioning practice. Assertions that ball-and-socket joints inherently simulate hypotonia or automatically permit extreme ranges do not address the recited structural configuration requiring directions and angles natural to premature neonates with predetermined ranges enabling developmental positioning.” (Page 12 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “The limited background mention of newborn or premature baby sizing in Sweeney does not provide explicit premature neonatal dimensions nor any teaching to scale to extreme 26-week gestation anthropometrics while maintaining the joint mechanics and developmental positioning behavior recited in claim 1.” (Page 13 of Remarks).
In regards to Rejection of Claims Under 35 U.S.C. § 103, “Assertions in the FOA that ball-and- socket joints would permit lack of muscle resistance and extreme ranges do not address the structure-specific requirement for directions and angles natural to premature neonates and predetermined ranges correlated with developmental positioning practice, and are not supported by Moffat's disclosure, which focuses on openings limiting axes and deliberately limited single-axis motion at elbows and knees.” (Page 14 of Remarks).
Regarding point (1), the examiner respectfully disagrees.
Applicant’s representative argues that “the FOA is incorrect - hypotonia is defined as decreased resistance to passive movement of the limbs and joints, resulting in floppiness and poor postural control. In premature or term neonates specifically, this occurs when the infant has reduced spontaneous movements, poor head control, and limbs that feel unusually soft and extend easily when handled. Thus, the recited simulation of a hypotonic condition of the premature neonatal infant provides decreased resistance of movement of the limbs and joints compared to that of a non-premature neonatal infant. However, the claims have been amended to advance prosecution expeditiously. Specifically, the claims have been amended to recite that the joints provide a predetermined range of motion in all extremities based on a hypotonic condition and are configured to permit developmental positioning in supine, prone, and sidelying positions as practiced in neonatal intensive care.” (Page 7 of Remarks).
In response to the arguments above, this newly amended language still only mentions the functional aspect but does not explain how the structural elements, specifically the joints and their predetermined range of motion in all extremities is being used. The MPEP states “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting. Other factors may be more relevant for particular arts. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.” (MPEP 2173.05(g) Functional Limitations). For (1) the subject matter is directed towards the hypotonic condition, (2) here it only states a result obtained, (3) there is no clear indication of what structure or steps are used for this hypotonic condition. For example, “reduced resistance to extension to replicate lack of muscle tone in hypotonic premature neonatal infants” is not fully explained in the written description and does not explain how the structural limitations are achieving this result. Therefore, the claim language leaves room for ambiguity because there are no clear or precise boundaries. (See 112(b) rejection below)
Regarding point (2), the examiner respectfully disagrees.
Applicant’s representative argues that “Moffat describes a baby mannequin with articulated joints and openings that limit travel in certain axes (paragraphs [0097] and [0100]) and expressly limits elbow and knee movement to single-axis motion of approximately 90° by deliberate geometry (paragraph [0140]). The figures in Moffat depict general baby poses, but the disclosure is directed to generic baby articulation across newborn to less than one year (paragraph [0048]) and does not disclose tailoring joint directions, angles, and ranges of motion to premature neonates, alignment with neonatal intensive care developmental positioning practice, or simulation of a hypotonic condition” (Page 10 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how Moffat’s limitations would stop Moffat from simulating a hypotonic condition. Furthermore, the structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). Applicant must disclose how the structure of Moffat stops it from simulating a hypotonic condition, since all the structural limitation are being met by Moffat. (See 103 rejection below)
Regarding point (3), the examiner respectfully disagrees.
Applicant’s representative argues that “The Office Action states that ball-and-socket joints provide the mechanical capability to simulate a hypotonic condition because such joints can allow movement in all axes and a lack of muscle resistance. That assertion is not supported by Moffat's text, which focuses on geometric constraints that limit travel to design-selected ranges and on deliberately restricted single-axis motion for elbows and knees. No disclosure identifies decreased passive resistance, reduced head control, or other features characteristic of hypotonia, and no disclosure ties any alleged lack of resistance to a predetermined range of motion configured to permit developmental positioning in supine, prone, and sidelying in the premature context.” (Page 10 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how they achieve a “decreased passive resistance, reduced head control, or other features characteristic of hypotonia, and no disclosure ties any alleged lack of resistance to a predetermined range of motion configured to permit developmental positioning in supine, prone, and sidelying in the premature context.”. The structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). Applicant must disclose how the structure of Moffat stops it from simulating a developmental positioning in supine, prone, and sidelying in the premature context, since all the structural limitation are being met by Moffat and these developmental positions are being disclosed in Figures 2, and 18-19. (See 103 rejection below)
Regarding point (4), the examiner respectfully disagrees.
Applicant’s representative argues that “Background text in Sweeney mentions an objective to provide simulation devices in a mannequin the size, shape, and weight of a newborn or premature baby, but no disclosure provides explicit premature neonatal dimensions matching those recited in claim 1, and no disclosure addresses articulated joint configurations for developmental positioning or joints providing a predetermined range of motion in all extremities based on simulation of a hypotonic condition.” (Page 10 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how Moffat’s limitations would stop Moffat from simulating a hypotonic condition. The structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). Applicant must disclose how the structure of Moffat stops it from simulating a hypotonic condition, since all the structural limitation are being met by Moffat. In regards to “explicit premature neonatal dimensions matching those recited in claim 1” (Page 10 of Remarks), the office action relies on Routine Optimization (MPEP 2144.05 II). (See 103 rejection below)
Regarding point (5), the examiner respectfully disagrees.
Applicant’s representative argues that “Moffat does not disclose, teach, or suggest configuring the joints based on a hypotonic condition or designing the joints to simulate lack of muscle resistance. Moffat's joints are designed to mimic natural movement of a real baby, which inherently includes normal muscle tone and resistance. The mere capability of a ball and socket joint to move in all axes does not teach or suggest configuring that joint with a predetermined range of motion based on the specific characteristics of hypotonia.” (Page 11 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how Moffat’s limitations would stop Moffat from simulating a hypotonic condition. The structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). Applicant must disclose how the structure of Moffat stops it from simulating a hypotonic condition, since all the structural limitation are being met by Moffat. Furthermore, the present invention also relies on natural realistic movement in their model (¶58 of the specification of the present invention). (See 103 rejection below)
Regarding point (6), the examiner respectfully disagrees.
Applicant’s representative argues that “Moffat addresses general baby articulation and does not suggest adaptation to preterm anthropometrics or neonatal intensive care developmental positioning practice. Assertions that ball-and-socket joints inherently simulate hypotonia or automatically permit extreme ranges do not address the recited structural configuration requiring directions and angles natural to premature neonates with predetermined ranges enabling developmental positioning.” (Page 12 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how Moffat’s limitations would stop Moffat from simulating a hypotonic condition. The structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). There is no mention of how these “extreme ranges” are achieved, applicant must disclose how the structure of Moffat stops it from simulating a hypotonic condition or “extreme ranges”, since all the structural limitation are being met by Moffat. (See 103 rejection below)
Regarding point (7), the examiner respectfully disagrees.
Applicant’s representative argues that “ The limited background mention of newborn or premature baby sizing in Sweeney does not provide explicit premature neonatal dimensions nor any teaching to scale to extreme 26-week gestation anthropometrics while maintaining the joint mechanics and developmental positioning behavior recited in claim 1.” (Page 13 of Remarks).
In response to the arguments above, the structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). In regards to the “explicit premature neonatal dimensions matching”, the office action relies on Routine Optimization (MPEP 2144.05 II). (See 103 rejection below)
Regarding point (8), the examiner respectfully disagrees.
Applicant’s representative argues that “Assertions in the FOA that ball-and- socket joints would permit lack of muscle resistance and extreme ranges do not address the structure-specific requirement for directions and angles natural to premature neonates and predetermined ranges correlated with developmental positioning practice, and are not supported by Moffat's disclosure, which focuses on openings limiting axes and deliberately limited single-axis motion at elbows and knees.” (Page 14 of Remarks).
In response to the arguments above, there is no mention in the claims or specification of the present invention on how Moffat’s limitations would stop Moffat from simulating a hypotonic condition. The structure of Moffat discloses the use of ball and socket joints to closely mimic natural movement of a baby (abstract of Moffat) and the specification of the present invention shows examples of the structure of a premature infant mannequin that mention first, second, third, and fourth joints comprise ball and socket joints (¶54 of the present invention). Applicant must disclose how the structure of Moffat stops it from simulating a hypotonic condition and fully disclose the “structure-specific requirement” quoted above, since all the structural limitation are being met by Moffat. (See 103 rejection below)
Regarding claims 5 and 12, since they recite similar features to claim 1, they will be rejected with the newly found prior art as stated above. Therefore, the rejection is maintained as present below.
Applicant’s representative argues that since the references do not disclose the suggested features of claim 1, 5, and 12 and so, dependent claims 2-4, 6-11, and 13-17 are patentable. However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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.
Claims 1-11 and 19 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.
Claims 1 and 5 recite the indefinite claim language of “the joints provide a predetermined range of motion in all extremities based on a hypotonic condition with reduced resistance to extension to replicate lack of muscle tone in hypotonic premature neonatal infants and are configured to permit developmental positioning in supine, prone, and sidelying positions”. This limitation is unclear because this limitation merely states a function (based on a hypotonic condition) without providing any indication about how the function is performed. The recited function does not follow from the structure recited in the claim, i.e., the torso, the head, the joints, or the four limbs, so it is unclear whether the function requires some other structure or is simply a result of operating the mannequin in a certain manner.
Claims 2-4, 6-11, and 19 objected to as being dependent upon a rejected base claim.
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.
Claims 1-3, 5-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over MOFFAT et al. (US 20190285112 A1 see-IDS; hereinafter Moffat) in view of Kevin M. Sweeney (US 4331426 A; hereinafter Sweeney) and Prem2Pram (Premature Baby Growth Chart; hereinafter Prem).
Regarding claims 1 and 12, Moffat discloses a neonatal mannequin (mannequin in Fig 1) comprising: a neonatal body comprising a torso, a head, joints, and four limbs, arranged and connected to model an infant (mannequin with connected parts Fig 1), wherein each of the head and the four limbs are movably attached to the torso by a respective joint of the joints, the joints being configured to move in directions and at angles natural to a neonatal infant (¶40-41 and Fig 1), the joints allowing simulation of realistic neonatal movement of the head and the four limbs relative the torso (¶8), the joints provide a predetermined range of motion in all extremities (there is a predetermined range of motion because it needs to have a specific range and predetermined range in order to closely mimic a range of poses or postures in ¶21 and the mannequin is designed in the desired amount of joint travel, therefore the motion can be predetermined; ¶34) based on a hypotonic condition with reduced resistance to extension to replicate lack of muscle tone in hypotonic premature neonatal infants (this is intended use, the structure of Moffat discloses the limitations claimed) and are configured to permit developmental positioning in supine, prone, and sidelying positions wherein as practiced in neonatal intensive care (shows multiple positions like supine, prone, or sidelying; See Fig 18-19), wherein the joints and body parts are configured to provide measurable positioning parameters evaluable by Infant Positioning Assessment Tool (IPAT), the positioning parameters including shoulder placement, hand placement, hip placement, knee placement, ankle placement, foot placement, head placement, and neck positioning (this is intended use because Moffat still discloses all the structural limitations, this does not change the end result of the product), and wherein the premature neonatal mannequin is configured to train neonatal intensive care unit nurses (used train healthcare workers in ¶74 and also intended use because Moffat discloses all the structural limitations) in developmental positioning of premature neonatal infants (shows multiple positions like supine or prone; See Fig 18-19).
Moffet discloses the full structure of claim 1 for a neonatal mannequin but does not explicitly disclose this neonatal mannequin to be a premature neonatal mannequin, wherein the torso, the head, and the four limbs are proportioned to simulate an average neonatal infant body having a weight of up to 1 pound 11 ounces and a length of up to 13 inches.
However, Sweeney focuses on a premature mannequin for CPR, which relates to Moffet because they both are focus on creating a realistic model for a newborn mannequin. Sweeney teaches in their background of invention this neonatal mannequin to be a premature neonatal mannequin (col 1 lines 41-43), wherein the torso, the head, and the four limbs are proportioned to simulate an average neonatal infant body having a weight of up to 1 pound 11 ounces and a length of up to 13 inches (here the premature baby has the size, shape and weight of premature baby; col 1 lines 41-43). Although Sweeney does not explicitly mention a range of length and weight for a premature mannequin, Prem shows a chart with multiple dimensions for premature newborn babies with multiple ranges of a weight of up to 1 pound 11 ounces and a length of up to 13 inches. Configuring Moffat to change the size and dimensions of their mannequin model in order to have the torso, the head, and the four limbs proportioned to simulate an average neonatal infant body having a weight of up to 1 pound 11 ounces and a length of up to 13 inches is a Routine Optimization because Moffat only differs from the present invention over these claimed ranges for the weight and length of the mannequin.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney and Prem because in order to simulate a realistic mannequin of a premature newborn baby, you would need the right dimensions and weight. The dimension and weight of the mannequin up to 1 pound 11 ounces and a length of up to 13 inches is a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, scaling the dimensions and weight of a mannequin is a Routine Optimization (MPEP 2144.05 II. Routine Optimization).
Regarding claim 2, Moffat discloses wherein each of the joints is configured to move in a direction natural to an infant (mimic natural movement; ¶14). Moffat does not explicitly disclose the infant to be a premature infant.
However, Sweeney teaches in their background of invention that the mannequin of a newborn can also be made of a premature baby (col 1 lines 41-43).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney because the structure of a mannequin for a newborn baby can also simulate the structure for a premature newborn baby. This is beneficial to provide a training mannequin for multiple types of newborn babies (such as premature/preterm, term, post-term, etc.) to make training more realistic.
Regarding claim 3, Moffat discloses wherein each of the joints is configured to move at an angle natural to an infant (mimic natural movement would include the natural angles made through movement; ¶14). Moffat does not explicitly disclose the infant to be a premature infant, but examiner notes that a premature neonatal infant falls within the category of a neonatal infant.
However, Sweeney teaches in their background of invention that the mannequin of a newborn can also be made of a premature baby (col 1 lines 41-43).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney because the structure of a mannequin for a newborn baby can also simulate the structure for a premature newborn baby. This is beneficial to provide a training mannequin for multiple types of newborn babies (such as premature/preterm, term, post-term, etc.) to make training more realistic.
Regarding claim 5, Moffat discloses a neonatal mannequin (Fig. 1) comprising: a torso, the torso being anatomically correct for a neonatal infant (torso shown in Fig. 1), the torso having a first side, a second side, an upper portion and a lower portion (all sides shown in figure 1); a first arm attached to the torso at the first side in the upper portion (arm shown in Fig 1), the first arm attached to the torso by a first joint configured to simulate infant movement of the first arm (mimics movement of an infant; ¶43-44); a second arm attached the torso at the second side in the upper portion (second arm attached in Fig 1), the second arm attached to the torso by a second joint configured to simulate premature infant movement of the second arm (mimics movement of an infant; ¶43-44); a first leg attached to the torso at the first side in the lower portion (first leg attached in Fig 1), the first leg attached to the torso by a third joint configured to simulate premature infant movement of the first leg (mimics movement of an infant; ¶43-44); a second leg attached to the torso at the second side in the lower portion (second leg attached in Fig 1), the second leg attached to the torso by a fourth joint configured to simulate premature infant movement of the second leg (mimics movement of an infant; ¶43-44); and a head connected to the torso by a neck at an end of the upper portion (head connected in Fig 1), the neck comprising a neck joint (¶42), wherein the neck joint is configured to simulate infant movement of the head (mimics movement of an infant; ¶43-44), wherein each of the first arm, the second arm, the first leg, the second leg, and the head are moveable relative the torso in a realistic manner for the neonatal infant (moving in a realistic manner; ¶44) due to the first, second, third, fourth, and neck joints being configured to move in directions and at angles natural to the neonatal infant (mimicking range of poses or postures requires movement in directions and angles natural to an infant); wherein the joints provide a predetermined range of motion in all extremities (there is a predetermined range of motion because it needs to have a specific range and predetermined range in order to closely mimic a range of poses or postures; ¶21) based on a hypotonic condition with reduced resistance to extension to replicate lack of muscle tone in hypotonic premature neonatal infants (this is intended use, the structure of Moffat discloses the limitations claimed) and are configured to permit developmental positioning in supine, prone, and sidelying positions as practiced in neonatal intensive care (shows multiple positions like supine, prone, or sidelying; See Fig 18-19), wherein the first, second, third, fourth, and neck joints and body parts are configured to provide measurable positioning parameters evaluable by Infant Positioning Assessment Tool (IPAT), the positioning parameters including shoulder placement, hand placement, hip placement, knee placement, ankle placement, foot placement, head placement, and neck positioning (this is intended use because Moffat still discloses all the structural limitations, this does not change the end result of the product), and wherein the premature neonatal mannequin is configured to train neonatal intensive care unit nurses (can be used to train healthcare workers; ¶74) in developmental positioning of premature neonatal infants (shows multiple positions like supine or prone; See Fig 18-19). Moffat does not explicitly disclose each of the first arm, the second arm, the first leg, the second leg, and the head are proportioned relative the torso to simulate a premature neonatal infant body having a weight of up to 1 pound 11 ounces and a length of up to 13 inches.
However, Sweeney focuses on a premature mannequin for CPR, which relates to Moffet because they both are focus on creating a realistic model for a newborn mannequin. Sweeney teaches in their background of invention this neonatal mannequin to be a premature neonatal mannequin (col 1 lines 41-43), each of the first arm, the second arm, the first leg, the second leg, and the head are proportioned relative the torso to simulate a premature neonatal infant body (here the premature baby has the size, shape and weight of premature baby; col 1 lines 41-43). Although Sweeney does not explicitly mention a range of length and weight for a premature mannequin, Prem shows a chart with multiple dimensions for premature newborn babies with multiple ranges of a weight of up to 1 pound 11 ounces and a length of up to 13 inches. Configuring Moffat to change the size and dimensions of their mannequin model in order to have the torso, the head, and the four limbs proportioned to simulate an average neonatal infant body having a weight of up to 1 pound 11 ounces and a length of up to 13 inches is a Routine Optimization because Moffat only differs from the present invention over these claimed ranges for the weight and length of the mannequin.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney and Prem because in order to simulate a realistic mannequin of a premature newborn baby, you would need the right dimensions and weight. The dimension and weight of the mannequin up to 1 pound 11 ounces and a length of up to 13 inches is a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, scaling the dimensions and weight of a mannequin is a Routine Optimization (MPEP 2144.05 II. Routine Optimization).
Regarding claim 6, Moffat discloses wherein the first, second, third, and fourth joints comprise ball and socket joints (abstract).
Regarding claim 7, Moffat discloses wherein the first and second joints comprise compound joints (¶41) configured to simulate a neonatal infant shoulder (Fig 1).
Regarding claim 8, Moffat discloses wherein the third and fourth joints comprise compound joints (¶41) configured to simulate a neonatal infant hip (Fig 1 and ¶42).
Regarding claim 9, Moffat discloses wherein the neck joint comprises a plurality of facet joints (to achieve realistic movement, the neck joint must have facet joints or facet joint-like structure; ¶44 and ¶52).
Regarding claim 10, Moffat discloses further comprising a first ankle joint connecting the first leg to a first foot and a second ankle joint connecting the second leg to a second foot (Fig 1 and ¶42).
Regarding claim 11, Moffat discloses further comprising a first wrist joint connecting the first arm to a first hand and a second wrist joint connecting the second arm to a second hand (Fig 1 and ¶42).
Regarding claim 13, Moffat discloses wherein the different positions comprise supine (Top left image; Fig 18), prone (Fig 2), and sidelying position (top right image; Fig 19).
Regarding claim 14, Moffat discloses further comprising moving one or more joints on the neonatal infant mannequin within a predetermined range of motion (design it in the desired amount of joint travel, therefore the motion can be predetermined; ¶34). Moffat does not explicitly disclose the infant to be a premature infant, but examiner notes that a premature neonatal mannequin falls within the category of a neonatal mannequin.
However, Sweeney teaches in their background of invention that the mannequin of a newborn can also be made of a premature baby (col 1 lines 41-43).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney because the structure of a mannequin for a newborn baby can also simulate the structure for a premature newborn baby. This is beneficial to provide a training mannequin for multiple types of newborn babies (such as premature/preterm, term, post-term, etc.) to make training more realistic.
Regarding claim 16, Moffat discloses wherein the one or more joints are configured to prevent motion outside the predetermined range of motion (limiting the travel in certain axes; ¶34).
Regarding claim 17, Moffat discloses further comprising positioning a head and a neck of the neonatal infant mannequin within a predetermined range of motion (design it in the desired amount of joint travel, therefore the motion can be predetermined; ¶34). Moffat does not explicitly disclose the infant to be a premature infant, but examiner notes that a premature neonatal mannequin falls within the category of a neonatal mannequin.
However, Sweeney teaches in their background of invention that the mannequin of a newborn can also be made of a premature baby (col 1 lines 41-43).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Sweeney because the structure of a mannequin for a newborn baby can also simulate the structure for a premature newborn baby. This is beneficial to provide a training mannequin for multiple types of newborn babies (such as premature/preterm, term, post-term, etc.) to make training more realistic.
Regarding claim 18, Moffat discloses wherein simulation of the hypotonic condition of the premature neonatal infant comprises encountering reduced resistance to extension in the joints to replicate lack of muscle tone (the structure of joints with ball and socket shown in the abstract of Moffat is the same structure disclosed in the specification of the present invention, and they are designed to closely mimic natural body part movement, which means the resistance that comes with the movement is also mimicked).
Regarding claim 19, Moffat discloses wherein the first and second joints comprise shoulder joints configured with compound articulation to permit arm movement in multiple planes (by tuning the geometry of the shaft and socket housing opening it is possible to design in the desired amount of joint travel in ALL axes; ¶34), and wherein the third and fourth joints comprise hip joints (compound joints configured to simulate a neonatal infant hip; Fig 1, ¶42 and ¶61) configured with compound articulation to permit leg movement in multiple planes (¶34).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Moffat in view of Sweeney and Prem in view of BIGNALL et al. (WO 2004077202 A2 see-IDS; hereinafter Bignall).
Regarding claim 4, Moffat discloses the realistic neonatal movement of each of the joints (mimic natural movement; ¶14). But does not explicitly disclose one or more sensors configured to monitor the realistic neonatal movement of each of the joints.
However, Bignall teaches further comprising one or more sensors configured to monitor the realistic neonatal movement of each of the joints (Page 6 lines 15-18).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Bignall because this is also used to train medical practitioners using a model of an infant mannequin. Here the sensors would help to know if the movement is natural or not.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Moffat in view of Sweeney and Prem in view of Christianson et al. (US 6050826 A; hereinafter Christianson).
Regarding claim 15, Moffat, as modified by sweeney above, does not explicitly disclose wherein, if moving the one or more joints extends outside of the predetermined range of motion, an alert is given.
However, Christianson teaches wherein, if moving the one or more joints extends outside of the predetermined range of motion (predetermined non acceptable position; col 3 lines 20-24), an alert is given (audio signal; col 3 lines 24-27).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moffat to implement the teachings of Christianson because realistic movement of the joints of an infant mannequin should also have realistic range of motion of the joints and realistic limits to that range of motion. An alert would help with training of a medical practitioner/nurse by signaling to the medical practitioner when the movement is not natural or out of an acceptable range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715
Prosecution Insights