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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-14) in the reply filed on August 3, 2026 is acknowledged. Claims 15-20 are noted as canceled and new claims 21-26 are entered.
Claim Objections
Claims 1, 8, 14, and 22 are objected to because of the following informalities:
In claim 1, line 2, “of a patient simulator” should read “of the patient simulator” as the limitation has antecedence in line 1.
In claim 8, line 6, “a simulated torso” should read “the simulated torso”.
In claim 14, line 11, “the first simulated arm and second” should read “the first simulated arm and the second”.
In claim 22, line 2, “by a user” should read “by the user” as the limitation has antecedence in claim 9.
Appropriate correction is required.
Applicant is advised that should claim 12 be found allowable, claim 25 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-14, and 25 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Blaine (US 4439162).
Regarding claim 1, Blaine teaches a shoulder assembly for a patient simulator (Abstract; Col 3, lines 6-12; Col 4, lines 35-44 teach a training model or manikin including a shoulder portion (assembly)), the shoulder assembly configured to control positioning and orientation of a simulated arm of a patient simulator (Col 4, lines 35-44 teach the arm and shoulder portion are attached (configured) for universal movement which thereby would allow for a user to manipulate the position and orientation of the arm), comprising: a first portion connected to a simulated torso of the patient simulator (Col 4, lines 35-44 teach the shoulder portion (first portion) is attached to the upper torso); and a second portion (Col 4, lines 45-51 teach an upper arm section (second portion) attached to the shoulder portion), wherein the first portion includes a mechanical joint (Col 4, lines 35-44 teach the shoulder portion (first portion) is attached to the upper torso by a connection (mechanical joint)), wherein the mechanical joint is configured to rotate around a first axis and a second axis (Col 4, lines 35-44 teach the connection comprises a pin and a nut such that the shoulder portion is rotatably mounted to the upper torso permitting rotation on the pin about the nut’s axis (first axis) and the pin is formed with a loop whereby the should portion can rotate about the pin (second axis)).
Regarding claim 2, Blaine further teaches wherein the shoulder assembly is actuatable at the mechanical joint to allow the simulated arm of the patient simulator to be configured for examination by a user (Col 4, lines 35-44; Col 5, lines 3-5; Col 5, lines 10-40 teach the shoulder portion (first portion) is attached to the upper torso by a connection (mechanical joint) allowing universal and lifelike movements (actuatable) permitting palpitation (examination) exercises and instruction).
Regarding claim 3, Blaine further teaches wherein the examination is a breast or axilla examination (Col 5, lines 10-40 teach the manikin can be used to simulate breast and/or axilla palpation (examination)).
Regarding claim 4, Blaine further teaches further comprising: an outer sleeve surrounding at least the first portion and connected to the simulated torso (Col 5, lines 10-40 teach the manikin can include an elastic cover which can cover the upper torn, breast inserts, and shoulders as shown in Fig 1a).
Regarding claim 5, Blaine further teaches wherein the first axis and the second axis are perpendicular to each other (Fig. 7; Col 4, lines 35-44 teaches and shows the connection comprises a pin threadably engaged in a nut wherein the two rotation axes are about the loop of the nut and the pin axis wherein since the pin is threadably engaged in the nut it is perpendicular thereby making the rotation axes perpendicular).
Regarding claim 6, Blaine further teaches wherein the shoulder assembly is sized for an adult patient simulator (Col 3, lines 6-12 teach the model or manikin simulates a life size adult human).
Regarding claim 8, Blaine teaches a patient simulator (Abstract; Col 1, lines 6-10; Col 3, lines 6-12; teach a training model or manikin for simulating a life size adult human for providing training exercise for human patients), a simulated torso (Col 3, lines 13-21; Col 3, lines 30-54 teach the manikin includes a simulated torso); a first simulated arm (Col 4, lines 35-63 teach the manikin includes a left arm), wherein the first simulated arm includes a shoulder assembly configured to control positioning and orientation of the first simulated arm (Col 4, lines 35-44 teach the arm and shoulder portion are attached (configured) for universal movement which thereby would allow for a user to manipulate the position and orientation of the arm), wherein the shoulder assembly includes: a first portion connected to a simulated torso of the patient simulator (Col 4, lines 35-44 teach the shoulder portion (first portion) is attached to the upper torso); and a second portion connected to the first portion (Col 4, lines 45-51 teach an upper arm section (second portion) attached to the shoulder portion), wherein the first portion includes a mechanical joint (Col 4, lines 35-44 teach the shoulder portion (first portion) is attached to the upper torso by a connection (mechanical joint)), wherein the mechanical joint is configured to rotate around a first axis and a second axis (Col 4, lines 35-44 teach the connection comprises a pin and a nut such that the shoulder portion is rotatably mounted to the upper torso permitting rotation on the pin about the nut’s axis (first axis) and the pin is formed with a loop whereby the should portion can rotate about the pin (second axis)).
Regarding claim 9, Blaine further teaches wherein the shoulder assembly is actuatable at the mechanical joint to allow the simulated arm of the patient simulator to be configured for examination by a user (Col 4, lines 35-44; Col 5, lines 3-5; Col 5, lines 10-40 teach the shoulder portion (first portion) is attached to the upper torso by a connection (mechanical joint) allowing universal and lifelike movements (actuatable) permitting palpitation (examination) exercises and instruction).
Regarding claim 10, Blaine further teaches wherein the examination is a breast or axilla examination (Col 5, lines 10-40 teach the manikin can be used to simulate breast and/or axilla palpation (examination)).
Regarding claim 11, Blaine further teaches further comprising: an outer sleeve surrounding at least the first portion and connected to the simulated torso (Col 5, lines 10-40 teach the manikin can include an elastic cover which can cover the upper torn, breast inserts, and shoulders as shown in Fig 1a).
Regarding claims 12 and 25, Blaine further teaches wherein the first axis and the second axis are perpendicular to each other (Fig. 7; Col 4, lines 35-44 teaches and shows the connection comprises a pin threadably engaged in a nut wherein the two rotation axes are about the loop of the nut and the pin axis wherein since the pin is threadably engaged in the nut it is perpendicular thereby making the rotation axes perpendicular).
Regarding claim 13, Blaine further teaches wherein the shoulder assembly is sized for an adult patient simulator (Col 3, lines 6-12 teach the model or manikin simulates a life size adult human).
Regarding claim 14, Blaine further teaches further comprising: a second simulated arm (Col 5, lines 6-9 teach the model includes a right arm identical to the left arm), wherein the second simulated arm includes a second shoulder assembly configured to control positioning and orientation of the second simulated arm (Col 4, lines 35-44; Col 5, lines 6-9 teach the arm and shoulder portion are attached (configured) for universal movement which thereby would allow for a user to manipulate the position and orientation of the arm), wherein the second shoulder assembly includes: a third portion connected to the simulated torso of the patient simulator on a side opposite the first portion (Col 4, lines 35-44; Col 5, lines 6-9 teach the shoulder portion (third portion) is attached to the upper torso); and a fourth portion (Col 4, lines 45-51; Col 5, lines 6-9 teach a lower arm section (fourth portion) integrated with the shoulder portion), wherein the third portion includes a second mechanical joint (Col 4, lines 35-44; Col 5, lines 6-9 teach the shoulder portion (first portion) is attached to the upper torso by a connection (mechanical joint)), wherein the mechanical joint is configured to rotate around a third axis and a fourth axis (Col 4, lines 35-44; Col 5, lines 6-9 teach the connection comprises a pin and a nut such that the shoulder portion is rotatably mounted to the upper torso permitting rotation on the pin about the nut’s axis (first axis) and the pin is formed with a loop whereby the should portion can rotate about the pin (second axis)), and wherein the first simulated arm and second simulated arm are configured for bilateral articulation (Col 4, lines 35-44; Col 5, lines 6-9 teach the arms are both rotatable and attached for universal movement such that a user could manipulate both arms for bilateral articulation without further modification of Blaine).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A 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.
Claim(s) 7 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaine in view of Agro (US PGPub 20100099067).
Regarding claims 7 and 26, Blaine may not explicitly teach wherein the shoulder assembly is sized for a child patient simulator. However, Agro teaches a mannequin for medical training representing a human body wherein the mannequin may be sized to simulate an adolescent or child human (Abstract; Paragraph 0012).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blaine to incorporate the teachings of Agro by applying the teaching of the model/mannequin being adult or child sized of Agro to the manikin/model of Blaine, as both references and the claimed invention are directed to medical training manikins/models. One of ordinary skill in the art would modify Blaine by modifying the manikin to be sized for a child or adolescent patient by scaling/sizing the manikin proportionally. Upon such modification, the method and system of Blaine would include wherein the shoulder assembly is sized for a child patient simulator. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Agro with Blaine’s system and method in order to provide further training by providing realistic models for a variety of patients and as a change in size/proportion would be obvious to one of ordinary skill in the art as it would not change how the manikin of Blaine functions (see MPEP 2144.04).
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaine in view of Trotta et al. (US PGPub 20110207104), hereinafter referred to as Trotta.
Regarding claim 21, Blaine further teaches further comprising: a breast and axilla assembly (Fig 1, 1a; Col 5, lines 10-40 teach the model includes a breast insert and cover allowing for breast and axilla palpitation), comprising: an axilla portion (Col 5, lines 30-40; “the axilla”); a breast portion (Col 5, lines 10-29; “breast insert”), wherein the breast portion includes an outer breast portion and an inner breast portion (Abstract; Col 2, lines 11-15; Col 5, lines 10-29 teach the model includes breast inserts (inner breast portion) which can include a cover (outer breast portion) wherein the insert is designed to simulate the appearance and touch of normal and diseased breasts), but may not explicitly teach one or more simulated masses disposed within the inner breast portion or the axilla portion such that the one or more simulated masses are embedded in simulated breast tissue filling the inner breast portion or the axilla portion. However, Trotta teaches a system for medical training using materials to mimic natural human tissue including human breast tissue wherein the system includes simulated breasts and axillary regions wherein the simulated breast model includes a skin layer (outer portion) and a tissue layer (inner portion) wherein the inner portion can include one or more pathologies (simulated masses) in the breast or axilla regions (Abstract; Paragraphs 0075-0079, 0098).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blaine to incorporate the teachings of Trotta by substituting the breast tissue model of Trotta for the breast insert and cover of the manikin/model of Blaine, as both references and the claimed invention are directed to medical training manikins/models for breast examination. One of ordinary skill in the art would modify Blaine by having the breast insert include simulated pathologies in the breast and axilla region as Blaine already teaches the breast inserts are designed for simulating diseased breast tissue and palpation for tumor detection. Upon such modification, the method and system of Blaine would include one or more simulated masses disposed within the inner breast portion or the axilla portion such that the one or more simulated masses are embedded in simulated breast tissue filling the inner breast portion or the axilla portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Trotta with Blaine’s system and method in order to provide further training by providing realistic diseased models and pathologies for a user to be trained to detect and allowing the system to better mimic natural human tissue and pathologies (Trotta Abstract; Paragraphs 0003, 0081).
Regarding claim 22, Blaine, as modified, further teaches wherein the one or more simulated masses (see prior art rejection of claim 21 above) are palpable by a user during a simulated breast examination (Col 2, lines 11-15; Col 5, lines 10-40 teach the breast insert can be palpated for tumor detection (simulated breast examination) allowing life-like palpation instruction).
Regarding claim 23, Blaine may not explicitly teach wherein the one or more simulated masses are configured to be imaged using ultrasound. However, Trotta further teaches the breast tissue and pathologies mimicking the ultrasound properties of natural tissue (Paragraphs 0052, 0066-0067, 0090).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blaine to incorporate the teachings of Trotta by substituting the breast tissue model including the simulated pathologies wherein the model can be imaged/identified using ultrasound equipment of Trotta for the breast insert and cover of the manikin/model of Blaine, as both references and the claimed invention are directed to medical training manikins/models for breast examination. One of ordinary skill in the art would modify Blaine by having the breast insert include simulated pathologies in the breast and axilla region as Blaine already teaches the breast inserts are designed for simulating diseased breast tissue and palpation for tumor detection wherein the material of the breast tissue and pathologies allows for the use of ultrasound equipment to image and identify the corresponding tissue and pathologies. Upon such modification, the method and system of Blaine would include wherein the one or more simulated masses are configured to be imaged using ultrasound. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Trotta with Blaine’s system and method in order to provide further training by providing realistic diseased models and pathologies for a user to be trained to detect using ultrasound equipment, providing teaching for proper techniques for various pathologies, and allowing the system to better mimic natural human tissue and pathologies (Trotta Abstract; Paragraphs 0003, 0080, 0081).
Regarding claim 24, Blaine may not explicitly teach wherein the one or more simulated masses are indicative of one or more of: fibrocystic nodes, carcinoma in a milk duct, fibroadenomas, benign mass, giant sarcoma, giant mammary myxoma, or scirrhous carcinoma. However, Trotta further teaches the simulated pathologies of the breast tissue model can include fibrocystic nodes, carcinoma in a milk duct, fibroadenomas, benign mass, giant sarcoma, giant mammary myxoma, and/or scirrhous carcinoma (Abstract; Paragraphs 0075, 0080, 0097, 0112).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blaine to incorporate the teachings of Trotta by substituting the breast tissue model including the simulated pathologies of Trotta for the breast insert and cover of the manikin/model of Blaine, as both references and the claimed invention are directed to medical training manikins/models for breast examination. One of ordinary skill in the art would modify Blaine by having the breast insert include simulated pathologies in the breast and axilla region as Blaine already teaches the breast inserts are designed for simulating diseased breast tissue and palpation for tumor detection wherein the simulated pathologies would include fibrocystic nodes, carcinoma in a milk duct, fibroadenomas, benign mass, giant sarcoma, giant mammary myxoma, and/or scirrhous carcinoma. Upon such modification, the method and system of Blaine would include wherein the one or more simulated masses are indicative of one or more of: fibrocystic nodes, carcinoma in a milk duct, fibroadenomas, benign mass, giant sarcoma, giant mammary myxoma, or scirrhous carcinoma. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Trotta with Blaine’s system and method in order to provide further training by providing realistic diseased models and pathologies for a user to be trained to detect, providing teaching for proper techniques for various pathologies, and allowing the system to better mimic natural human tissue and pathologies (Trotta Abstract; Paragraphs 0003, 0080, 0081).
Conclusion
Accordingly, claims 1-14 and 21-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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, Kang Hu can be reached at (571)270-1344. 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.
/CORRELL T FRENCH/Examiner, Art Unit 3715
Prosecution Insights