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 .
Status of Claims
This office action is in response to the patent application 18/123,262 originally filed on March 18, 2023. Claims 1-16 are presented for examination. Claim 1 is independent.
Priority
This application claims priority of US Provisional Application 63/342,116, filed March 18, 2023.
Specification
The abstract of the disclosure is objected to because of the length. The abstract has 413 words and exceeds the 150 word limit of 37 C.F.R. § 1.72 (b). Correction is required. See MPEP § 608.01(b).
Drawings
Regarding FIGS. 7-12, 37 CFR 1.84(b)(1), stated in part, indicates that black and white photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. Therefore, the use of a black and white photographs lacking sufficient reproducible quality prevents FIGS. 7-12 from complying with 37 CFR 1.84(b)(1).
Claim Objections
Claims 1-16 are objected to because of the following informalities: claims containing more than one period.
Claim 1, and substantially similar limitations in claim 13, is objected to because steps [(1), (2), (3), etc.] each have a period after their respective limitations. These periods should be removed, or preferably substituted with a semicolon (“;”) or comma (“,”), as each claim can only have one period. Per MPEP 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Appropriate correction is required. Claims 2-16 are also objected to based on their respective dependencies to claim 1.
Claim 2, and substantially similar limitations in claims 3 and 4, is objected to because respective identifiers “(1.1), (1.5), (1.10), (1.11), (1.12), (1.13), (1.14), (1.15) or (1.16),” “(1.3),” and “(1.15)” each have a period in them. These identifiers should be amended such that they do not contain periods, as each claim can only have one period. Per MPEP 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).
Claims 5-7 and 16 are objected to because of the following informalities: typographical errors.
Claim 5, and substantially similar limitations in claims 6 and 7, recites the limitation “where in.” The Examiner reasonably believes this is a typographical error and should be corrected to “ wherein.” Appropriate correction is required. Dependent claim 16 is also objected to based on its dependency to claim 6.
Claim 16 recites the limitation “the body can made into fabric.” The Examiner reasonably believes this is a typographical error and should be corrected to “the body can be made into fabric.” Appropriate correction is required.
Claim 15 is objected to because of the following informalities: claims not properly terminated by a period.
Claim 15 is objected to because it is not properly terminated by a period. Per MPEP 608.01(m), each claim begins with a capital letter and ends with a period.
Claim Rejections - 35 USC § 112
Claims rejected under § 112(b)
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.
Claims 1-16 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitations “the CLP malformation,” “the nose, lips and palate,” “the height,” “the distribution,” “the mass and weight,” “the weight, height, facial and intraoral CLP features,” “The face, lips, nose, oral and nasal cavities,” “the actual anatomical dimensions and proportions,” “The facial, nasal and intraoral features,” “The arms, legs and neck,” “the distribution of densities and weights,” “the body parts, limbs, neck and head,” “the lips and cheeks,” “The mouth opening,” “The maxillary segments, premaxilla and palatal shelves,” “the mannequin’s mouth,” “the action,” “The nostrils and alar cartilage,” “the mannequin’s nose,” “The lips, nose, oral and nasal cavities,” “the mucosa,” “the color,” “these structures,” “The texture,” “the tissues,” “the real human layers,” “The characterization,” “the tongue,” “the pinky color and rough texture,” “the anatomy,” “the taste buds,” “the tongue tissue,” “the shape,” “the maxillary segments,” “the characteristic,” “the palatal rugae,” “the alveolar ridges,” “the premaxilla,” “the two hemi uvulae,” “the vestibule fundus,” “the front and lateral frenulum,” “the external surface texture,” “the whole body,” “the surface,” “the scalp area,” and “The eyes”. These limitations are not previously introduced in claim 1. As such, the limitations lack antecedent basis. Therefore, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 1 recites the limitations “a complete newborn baby,” “a human newborn,” “a newborn,” “a newborn human,” and “a human infant.” It is uncertain whether these limitations are intended to refer to the same entity, or if they are intended to be different entities. These limitations appear to be used interchangeably in the claims. Therefore, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 1 recites the limitation “a human newborn.” The limitation is originally introduced earlier in claim 1. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[a]] the human newborn”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 1. Therefore, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 1, and substantially similar limitations in claims 10 and 11, recites the limitation “a newborn.” The limitation is originally introduced earlier in claim 1. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[a]] the newborn”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 1. Therefore, claims 1, 10, and 11 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 1 recites the limitation “(11) The texture of the tissues in smooth and touch simulates as in the real human layers of skin, scalp, nails, and mucous membranes; soft to the touch, slightly yielding with gentle pressure or tension.” These limitations contain grammatical errors that make them difficult to interpret. For example, “The texture of the tissues in smooth” will be interpreted as “The texture of the tissues is smooth.” “[T]he tissues” is not previously introduced, and will be interpreted as the simulated material which makes up the mannequin simulator. “[T]ouch simulates as in the real human layers of skin, scalp, nails, and mucous membranes” will be interpreted as meaning that the skin, scalp, nails, and mucous membranes of the mannequin simulator feels similar to the touch as real human skin, nails, and mucous membranes. “[S]oft to the touch, slightly yielding with gentle pressure or tension” contains subjective and relative terminology that will be interpreted under the broadest reasonable interpretation in light of the disclosure. Here, it is unclear how the “nails” can be “soft to the touch, slightly yielding with gentle pressure or tension,” because the specification does not elaborate and human nails are generally considered rigid. It is also unclear if the limitation “soft to the touch, slightly yielding with gentle pressure or tension” is intended to refer to “the real human layers of skin, scalp, nails, and mucous membranes” at all, since it is provided as a distinct limitation separated in the claim by a semicolon. For these reasons, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 1 recites the limitations “(14) The external surface texture of the whole body is completely smooth and uniform. (15) Natural human hair is grafted onto eyebrows, eyelashes and the surface of the scalp area.” It is unclear how the “the whole body” can be “completely smooth and uniform,” yet hair is grafted onto the surface of the scalp, since grafting hair onto a surface of the body mannequin would change the texture of that surface. That is, the whole body would be completely smooth and uniform, except where the hair is grafted. For these reasons, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-16 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 3 recites the limitation “the characteristics intraoral, nasal and facial described.” The limitation is not previously introduced in claim 1 or 3, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 3 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites the limitation “the appearance.” The limitation is not previously introduced in claim 1 or 3, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 3 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 recites the limitation “the natural human hair.” The limitation is not previously introduced in claim 1 or 4, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 4 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 recites the limitation “the body sex variants.” The limitation is not previously introduced in claim 1 or 5, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 5 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites the limitation “the component.” The limitation is not previously introduced in claim 1 or 6, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 6 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 16 is also rejected under 35 U.S.C. § 112(b), based on its dependency to claim 6.
Claim 6 recites the limitation “the skin.” The limitation is not previously introduced in claim 1 or 6, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 6 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 16 is also rejected under 35 U.S.C. § 112(b), based on its dependency to claim 6.
Claim 6 recites the limitation “the whole body, head and cavities.” The limitation is not previously introduced in claim 1 or 6, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 6 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 16 is also rejected under 35 U.S.C. § 112(b), based on its dependency to claim 6.
Claim 7 recites the limitation “the standard dimensions, appearance or colors.” The limitation is not previously introduced in claim 1 or 7, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 7 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8 recites the limitation “the external surface.” The limitation is not previously introduced in claim 1 or 8, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 8 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 8 recites the limitation “the entire body.” The limitation is not previously introduced in claim 1 or 8, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 8 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites the limitations “the characterization,” “the skin,” “the route,” “the veins,” and “the relief,” and “the clavicles, ribs, nipples, elbows and knees.” These limitations are not previously introduced in claim 1 or claim 9. As such, the limitations lack antecedent basis. Therefore, claim 9 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites new characteristics labeled (1), (2), and (3). However, characteristics (1), (2), and (3) were previously defined in parent claim 1. The labels for these characteristics should be either removed or renamed as (17), (18), and (19), respectively. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “Head, oral and maxillofacial region design.” The limitation is originally introduced earlier in claim 13. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “the h[[H]]ead, oral and maxillofacial region design.”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 13. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “the CLP neonate.” The limitation is not previously introduced in claim 1 or 13, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “a computer tomography (CT).” The limitation is originally introduced earlier in claim 13. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[a]] the computer tomography (CT).”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 13. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “a three-dimensional (3-D) image.” The limitation is originally introduced earlier in claim 13. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[a]] the three-dimensional (3-D) image.”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 13. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “the CLP newborn.” The limitation is not previously introduced in claim 1 or 13, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13 recites the limitation “photogrammetry.” The limitation is originally introduced earlier in claim 13. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “the photogrammetry.”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 13. Therefore, claim 13 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15 recites new characteristics labeled (1) and (2). However, characteristics (1) and (2) were previously defined in parent claim 1. The labels for these characteristics should be either removed or renamed as (17) and (18), respectively. Therefore, claim 15 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 recites the limitation “the body.” The limitation is not previously introduced in claim 1, 6, or 16, respectively. As such, the limitation lacks antecedent basis. Therefore, claim 16 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 recites the limitation “polymer-based material.” The limitation is originally introduced earlier in claim 16. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “the polymer-based material.”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 16. Therefore, claim 16 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 recites the limitation “where a part of the body can [be] made into fabric.” It is unclear from the disclosure how a part of the body can be made into fabric. Therefore, claim 16 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims rejected under § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4, 12, 13, and 15 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites the following: “The mannequin simulator of claim 1, where at least one of the characteristics (1.1), (1.5), 1.10), (1.11), (1.12), (1.13), (1.14), (1.15) or (1.16) is absent.” Specifically, removing limitations from the parent claim broadens the dependent claim (i.e., fails to further limit the subject matter of the claim upon which it depends). As such, claim 2 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Therefore, claim 2 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 4 recites the following: “The mannequin simulator of claim 1, where the natural human hair (1.15) can be painted rather than grafted.” As worded, the dependent claim states that the grafted hair of claim 1 is not required, but is instead optional. This broadens claim 4 such that it fails to further limit the subject matter of the claim upon which it depends. As such, claim 4 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Therefore, claim 4 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 12 recites the following: “The mannequin simulator of claim 1, where at least one of the characteristics (10) or (11) is absent.” Specifically, removing limitations from the parent claim broadens the dependent claim (i.e., fails to further limit the subject matter of the claim upon which it depends). As such, claim 12 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Therefore, claim 12 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 13 recites the following: “A process of design of the mannequin simulator of claim 1…”. However, claim 13 recites a process of design (a process), while parent claim 1 recites a mannequin simulator (a machine). The limitations of claim 13 do not require or further limit any of the limitations of claim 1 (i.e., fails to further limit the subject matter of the claim upon which it depends). As such, claim 13 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Therefore, claim 13 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 15 recites the following: “A process of manufacture of any part of the mannequin of claim 1…”. However, claim 15 recites a process of manufacture (a process), while parent claim 1 recites a mannequin simulator (a machine). The limitations of claim 15 do not require or further limit any of the limitations of claim 1 (i.e., fails to further limit the subject matter of the claim upon which it depends). As such, claim 15 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Therefore, claim 15 is rejected under 35 U.S.C. 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lauer et al. (hereinafter “Lauer,” US 5,224,863) in view of Seitz et al. (hereinafter “Seitz,” US 2020/0316850) and Podolsky et al. (hereinafter “Podolsky,” US 2025/0209942), and in further view of George et al. (hereinafter “George,” US 6,071,171).
Regarding claim 1, and substantially similar limitations in claims 2 and 12, Lauer discloses a mannequin simulator of a complete newborn baby (Lauer col. 2 lines 14-16, “a newborn infant doll is provided which is realistic in feel, compressibility, flexibility and structure.”)… comprising:
(1) A complete body, trunk and limbs, having as reference the height and the distribution of the mass and weight of a human newborn (Lauer col. 2 lines 16-17, “The infant doll has a head, neck, arms, torso, and legs.” ; also Lauer col. 1 lines 22-26, “In the training of those who will be feeding, handling, or clothing newborn infants, as for example, nurses, medical attendants, family members, and particularly children, it is important that they appreciate the newborn infant's weight, size”).
(2) A complete head, skull, face and neck, having as reference the weight, height, facial… features of a human newborn (see Lauer Fig. 1).
…
(5) The arms, legs and neck have a similar mobility to that of a newborn human: while holding creates a realistic feeling the distribution of densities and weights in the body parts, limbs, neck and head (see Lauer col. 2 lines 14-27, “a newborn infant doll is provided which is realistic in feel, compressibility, flexibility and structure. The infant doll has a head, neck, arms, torso, and legs. The infant doll has a detachable head which is formed with a substantially stiff but flexible vinyl rubber material which simulates the hard surface of an infant baby's head. The remainder of the infant doll's body, which includes the neck, the torso, the arms, and the legs, is constructed of a less rigid vinyl material which simulates the feel and compressibility of a newborn infant. The housing for the doll is shaped to outline the exterior of an infant, and is proportionate to the shape of an infant”).
…
(11) The texture of the tissues in smooth and touch simulates as in the real human layers of skin, scalp, nails, and mucous membranes; soft to the touch, slightly yielding with gentle pressure or tension (Lauer col. 4 lines 59-68, “Referring now to the separate lower doll section 8, continuous housing wall 9 forms the neck 10, the torso 11, arms 12 and legs 13. The continuous wall 9 is comprised of a flexible material, such as the vinyl rubber compound described above. The continuous wall preferably has an average thickness of 0.08 inches (0.2 cm.) with a variance of 0.04 inches 0.1 cm.). The composition and thickness of the vinyl rubber compound simulate the soft, compressible skin texture and body structure of an infant baby.”).
…
(14) The external surface texture of the whole body is completely smooth and uniform (Lauer col. 4 lines 59-68, “Referring now to the separate lower doll section 8, continuous housing wall 9 forms the neck 10, the torso 11, arms 12 and legs 13. The continuous wall 9 is comprised of a flexible material, such as the vinyl rubber compound described above. The continuous wall preferably has an average thickness of 0.08 inches (0.2 cm.) with a variance of 0.04 inches 0.1 cm.). The composition and thickness of the vinyl rubber compound simulate the soft, compressible skin texture and body structure of an infant baby.”).
Lauer does not teach that the mannequin simulator of the complete newborn baby has facial and intraoral features of the CLP malformation for training or intervention procedures involving the nose, lips and palate… intraoral CLP features of a human newborn… The face, lips, nose, oral and nasal cavities have the actual anatomical dimensions and proportions of a newborn with CLP deformity… The facial, nasal and intraoral features showing one of the following various options: A) Complete and incomplete right CLP; B) Complete and incomplete left CLP; C) Complete and incomplete bilateral CLP; D) Complete and incomplete medial CLP; and F) Cleft palate… The lips and cheeks are flexible and expandable similar to that of the human newborn… The lips, nose, oral and nasal cavities are painted with pink tones showing different shades of the mucosa, to simulate the color of these structures of a human infant… The shape of the maxillary segments resembles the characteristic anatomical of a newborn with CLP deformity with details of the palatal rugae, the alveolar ridges, the premaxilla, the two hemi uvulae, the vestibule fundus, the front and lateral frenulum.
However, Seitz discloses that the mannequin simulator of the complete newborn baby has facial and intraoral features of the CLP malformation for training or intervention procedures involving the nose, lips and palate… intraoral CLP features of a human newborn… The face, lips, nose, oral and nasal cavities have the actual anatomical dimensions and proportions of a newborn with CLP deformity… The facial, nasal and intraoral features showing one of the following various options: A) Complete and incomplete right CLP; B) Complete and incomplete left CLP; C) Complete and incomplete bilateral CLP; D) Complete and incomplete medial CLP; and F) Cleft palate… The lips and cheeks are flexible and expandable similar to that of the human newborn… The lips, nose, oral and nasal cavities are painted with pink tones showing different shades of the mucosa, to simulate the color of these structures of a human infant… The shape of the maxillary segments resembles the characteristic anatomical of a newborn with CLP deformity with details of the palatal rugae, the alveolar ridges, the premaxilla, the two hemi uvulae, the vestibule fundus, the front and lateral frenulum (Seitz Abstract, “Anatomical models are produced by the drop on demand method using at least two structure forming materials which are different from each other, and as a result can accurately mimic either generic or patient specific structures, including, when desired, various colors and hardnesses representing different types of tissue.”; also Seitz Fig. 4, showing a model with complete cleft lip and palate on one side; also Seitz [0110-0112], “Generation of the Digital Model: …The bone contours are adjusted to those of an infant. For the soft-tissue model, the nose, nasal septum, lip contour, labial frenulum and, if necessary, further structures are shaped. For easier processing and smoothing of the inner side of the lips and cheeks, the palate is separated in the region of the hard palate. A new palate is created via an offset from the upper jaw of the bone model and is added to the soft-tissue model,” realistically modeled mouth structures; also Seitz [0043], “the printing compounds can preferably be colored such that they match the optical appearance of the biological tissue as well as possible. For example, silicone printing compounds can be colored with a variable proportion of color paste,” realistic colors; also Seitz [0099], “A further preferred property of the anatomical models is that different tissue types are depicted as realistically as possible with regard to their hardness. A particularly preferred property of the anatomical models is a realistic representation of soft tissue by silicones of different Shore hardnesses,” realistic hardnesses).
Seitz is analogous to Lauer, as both are drawn to the art of anatomical mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer, to include that the mannequin simulator of the complete newborn baby has facial and intraoral features of the CLP malformation for training or intervention procedures involving the nose, lips and palate… intraoral CLP features of a human newborn… The face, lips, nose, oral and nasal cavities have the actual anatomical dimensions and proportions of a newborn with CLP deformity… The facial, nasal and intraoral features showing one of the following various options: A) Complete and incomplete right CLP; B) Complete and incomplete left CLP; C) Complete and incomplete bilateral CLP; D) Complete and incomplete medial CLP; and F) Cleft palate… The lips and cheeks are flexible and expandable similar to that of the human newborn… The lips, nose, oral and nasal cavities are painted with pink tones showing different shades of the mucosa, to simulate the color of these structures of a human infant… The shape of the maxillary segments resembles the characteristic anatomical of a newborn with CLP deformity with details of the palatal rugae, the alveolar ridges, the premaxilla, the two hemi uvulae, the vestibule fundus, the front and lateral frenulum, as taught by Seitz, so that medical personnel can practice surgical techniques on specific anatomical structures such as cleft lip (Seitz [0003]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Lauer in view of Seitz does not teach the mouth opening is also comparable to that of a newborn… The maxillary segments, premaxila and palatal shelves of the mannequin’s mouth can be approximated and separated manually or by the action of any device (plate or prosthesis)… The nostrils and alar cartilage of the mannequin’s nose are flexible and allow for the insertion of intranasal devices… The characterization of the tongue includes the pinky color and rough texture that resembles the anatomy of the taste buds present on a human epithelium of the tongue tissue.
However, Podolsky discloses the mouth opening is also comparable to that of a newborn… The maxillary segments, premaxila and palatal shelves of the mannequin’s mouth can be approximated and separated manually or by the action of any device (plate or prosthesis)… The nostrils and alar cartilage of the mannequin’s nose are flexible and allow for the insertion of intranasal devices… The characterization of the tongue includes the pinky color and rough texture that resembles the anatomy of the taste buds present on a human epithelium of the tongue tissue (see Podolsky Fig. 21, showing a mouth opening; also Podolsky [0190], “other elements may further be internal to the cartridge, including lateral cartilage which may include lower lateral cartilage 1040B and upper lateral cartilage 1040A, a hard palate 1044 (which may be bony in texture), soft palate musculature section 1042, a superior constrictor muscle 1054, a tensor veli palatini muscle 1064, a hard bony palate 1044, nasal cartilage 1040, a premaxilla, a palatopharyngeus muscle, a musculus uvula, a palatoglossus muscle, a fatty tissue layer 1066.”; also see Podolsky Fig. 14, showing lip and nostril areas of skin, which is flexible; also Podolsky [0186], “The cartridge comprises multiple elements, including several that are visible to a user upon the exterior surface of the cartridge, including a lateral lip element 1004, a cutaneous roll 1006, a vermillion, which further comprises a vermillion cutaneous junction 1008 and a vermillion mucosal junction 1012, a prolabium 1016, and an alar base… includes the tongue 1028 which is visible from an exterior view of the cartridge but is internal to the cartridge,” intranasal portion of the simulator allows insertion of intranasal devices; see also Podolsky Fig. 10, showing tongue portion of a mold).
Podolsky is analogous to Lauer in view of Seitz, as both are drawn to the art of anatomical models. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Seitz, to include the mouth opening is also comparable to that of a newborn… The maxillary segments, premaxila and palatal shelves of the mannequin’s mouth can be approximated and separated manually or by the action of any device (plate or prosthesis)… The nostrils and alar cartilage of the mannequin’s nose are flexible and allow for the insertion of intranasal devices… The characterization of the tongue includes the pinky color and rough texture that resembles the anatomy of the taste buds present on a human epithelium of the tongue tissue, as taught by Podolsky, because doing so would combine prior art elements of detailed mouth and head simulations and newborn mannequins according to known methods to yield predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Lauer in view of Seitz and Podolsky does not teach natural human hair is grafted onto eyebrows, eyelashes and the surface of the scalp area; The eyes can be open or closed and no eyelid mobility.
However, George discloses natural human hair is grafted onto eyebrows, eyelashes and the surface of the scalp area; The eyes can be open or closed and no eyelid mobility (George title, “realistic doll head system and method therefor”; also George col. 4 lines 14-23, “The selected eyes, eyelashes, eyebrows, hair, and birthmarks, moles, and/or freckles are attached to or painted on the doll head”; also George col 9 lines 23-30, “Eyes having the color selected are inserted into molded eye sockets, and eyelashes of the selected color are inserted into the eyelids above the eyes. Eyebrows corresponding to the color, thickness, and shape indicated on the facial characteristic chart are applied to the doll head above the eyes. In the preferred embodiment, the eyebrows are painted on the doll head. Hair of the color, cut, length, and style selected is then attached to the doll head.”).
George is analogous to Lauer in view of Seitz and Podolsky, as both are drawn to the art of mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Seitz and Podolsky, to include natural human hair is grafted onto eyebrows, eyelashes and the surface of the scalp area; The eyes can be open or closed and no eyelid mobility, as taught by George, in order to produce head that is realistic at a reasonable cost (George col. 4 lines 51-63). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 3, Lauer in view of Podolsky and George does not explicitly teach where the characteristics intraoral, nasal and facial described (1.3) have the appearance of a CLP syndromic newborn human, such as Down Syndrome in human.
However, Seitz discloses where the characteristics intraoral, nasal and facial described (1.3) have the appearance of a CLP syndromic newborn human, such as Down Syndrome in human (see Seitz Fig. 4, showing a model with complete cleft lip and palate on one side; also Seitz [0110-0112], “Generation of the Digital Model: …The bone contours are adjusted to those of an infant. For the soft-tissue model, the nose, nasal septum, lip contour, labial frenulum and, if necessary, further structures are shaped. For easier processing and smoothing of the inner side of the lips and cheeks, the palate is separated in the region of the hard palate. A new palate is created via an offset from the upper jaw of the bone model and is added to the soft-tissue model,” realistically modeled facial structures).
Seitz is analogous to Lauer in view of Podolsky and George, as both are drawn to the art of anatomical mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Podolsky and George, to include where the characteristics intraoral, nasal and facial described (1.3) have the appearance of a CLP syndromic newborn human, such as Down Syndrome in human, as taught by Seitz, so that medical personnel can practice surgical techniques on specific anatomical structures such as cleft lip (Seitz [0003]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 4, Lauer in view of Seitz and Podolsky does not teach where the natural human hair (1.15) can be painted rather than grafted.
However, George discloses where the natural human hair (1.15) can be painted rather than grafted (George col. 4 lines 14-23, “The selected eyes, eyelashes, eyebrows, hair, and birthmarks, moles, and/or freckles are attached to or painted on the doll head”).
George is analogous to Lauer in view of Seitz and Podolsky, as both are drawn to the art of mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Seitz and Podolsky, to include where the natural human hair (1.15) can be painted rather than grafted, as taught by George, in order to produce head that is realistic at a reasonable cost (George col. 4 lines 51-63). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 5, Lauer in view of Seitz, Podolsky, and George discloses where in the body sex variants are male, female or undefined (see Lauer Fig. 1, showing a newborn body of unspecified sex variant).
Regarding claim 6, Lauer in view of Podolsky and George discloses where in the component mimicking the skin and interior part of the whole body, head and cavities is made with polymer-based material.
However, Seitz discloses where in the component mimicking the skin and interior part of the whole body, head and cavities is made with polymer-based material (Seitz [0037], “The printing compounds can additionally comprise one or more of the following structure-forming printing materials: silicone gels, silicone resins, homopolymers or copolymers composed of monomers selected from the group consisting of acrylates, olefins, epoxides, isocyanates or nitriles, and also polymer blends comprising one or more of the aforementioned homopolymers and copolymers.”).
Seitz is analogous to Lauer in view of Podolsky and George, as both are drawn to the art of anatomical mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Podolsky and George, to include where in the component mimicking the skin and interior part of the whole body, head and cavities is made with polymer-based material, as taught by Seitz, so that medical personnel can practice surgical techniques on specific anatomical structures such as cleft lip (Seitz [0003]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 7, Lauer in view of Podolsky and George does not explicitly teach where in the standard dimensions, appearance or colors adjusted according to human race.
However, Seitz discloses where in the standard dimensions, appearance or colors adjusted according to human race (Seitz [0043], “the printing compounds can preferably be colored such that they match the optical appearance of the biological tissue as well as possible. For example, silicone printing compounds can be colored with a variable proportion of color paste. For example, it is possible to preferably color muscles in a red tone, bones in white and skin areas in a skin tone.”).
Seitz is analogous to Lauer in view of Podolsky and George, as both are drawn to the art of anatomical mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Podolsky and George, to include where in the standard dimensions, appearance or colors adjusted according to human race, as taught by Seitz, so that medical personnel can practice surgical techniques on specific anatomical structures such as cleft lip (Seitz [0003]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 8, Lauer in view of Podolsky and George does not explicitly teach where painting techniques are used to characterize the color of the external surface of the entire body.
However, Seitz discloses where painting techniques are used to characterize the color of the external surface of the entire body (Seitz [0043], “the printing compounds can preferably be colored such that they match the optical appearance of the biological tissue as well as possible. For example, silicone printing compounds can be colored with a variable proportion of color paste. For example, it is possible to preferably color muscles in a red tone, bones in white and skin areas in a skin tone.”).
Seitz is analogous to Lauer in view of Podolsky and George, as both are drawn to the art of anatomical mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Podolsky and George, to include where painting techniques are used to characterize the color of the external surface of the entire body, as taught by Seitz, so that medical personnel can practice surgical techniques on specific anatomical structures such as cleft lip (Seitz [0003]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 9, Lauer in view of Seitz and Podolsky does not explicitly teach where the characterization of the skin, the route of the veins, the relief of the clavicles, ribs, nipples, elbows and knees, are made with hyper-realistic painting techniques.
However, George discloses where the characterization of the skin, the route of the veins, the relief of the clavicles, ribs, nipples, elbows and knees, are made with hyper-realistic painting techniques (George col. 1 lines 15-25, “unique dolls that are so highly crafted, typically with ceramic heads, that they are truly sculpted and painted to be lifelike and corresponding to a particular human's image”).
George is analogous to Lauer in view of Seitz and Podolsky, as both are drawn to the art of mannequins. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Lauer in view of Seitz and Podolsky, to include where the characterization of the skin, the route of the veins, the relief of the clavicles, ribs, nipples, elbows and knees, are made with hyper-realistic painting techniques, as taught by George, in order to produce head that is realistic at a reasonable cost (George col. 4 lines 51-63). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 13, Lauer in view of Podolsky and George does not teach a process of design of the mannequin simulator of claim 1, comprising at least one of the following: (1) Head, oral and maxillofacial region design based on a computer tomography (CT) of a newborn head to obtain a three-dimensional (3-D) image of the CLP neonate.
However, Seitz discloses a process of design of the mannequin simulator of claim 1, comprising at lea