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 .
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)(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, 8, 11, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Publication 2016/0155364 A1 to Piron et al. (hereinafter Piron).
Concerning claim 1,
Piron discloses a simulated skull for use as a surgical training device, said simulated skull comprising: a skull base defining a skull opening (0048, Figure 2, element 210);
a skull cap configured to be releasably coupled to said skull base at said skull opening such that said skull cap and said skull base collectively define an internal skull cavity (0048, Figure 2, element 220); and
a vessel for holding a fluid and configured to be secured to said skull cap within said skull cavity (0048, 0070, 0079, Figure 6);
wherein said skull cap and said vessel are configured to be penetrated by a drilling tool (0043, 0071-0072).
Concerning claim 8,
Piron discloses said vessel is selectively securable to said skull cap (0048, 0067, Figure 2).
Concerning claim 11,
Piron discloses said simulated skull further comprises an outer layer of simulated skin covering at least a portion of said skull cap (0106-0110).
Concerning claim 14,
Piron discloses a simulated skull for use as a surgical training device, said simulated skull comprising: a skull base defining a skull opening (0048, Figure 2, element 210);
a skull cap configured to be coupled to said skull base at said skull opening such that said skull cap and said skull base collectively define an internal skull cavity (0048, Figure 2, element 220);
a vessel coupled to an interior surface of said skull cap and configured to contain a fluid (0048, 0070, 0079, Figure 6); and
an outer layer of simulated skin covering at least a portion of said skull cap (0106-0110);
wherein said skull cap and said vessel are configured to be penetrated by a drilling tool (0043, 0071-0072); and
wherein said skull cap and said vessel are configured to discharge the fluid when said skull cap and said vessel are penetrated by the drilling tool (0043, 0071-0072, 0079).
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) 2-4, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2016/0155364 A1 to Piron et al. in view of US Publication 2003/0186203 A1 to Aboud (hereinafter Aboud).
Concerning claim 2,
Piron does not disclose said vessel further comprises an inlet port configured to receive the fluid into said vessel.
Aboud teaches said vessel further comprises an inlet port configured to receive the fluid into said vessel (0042, 0054, Figure 4b, Figure 6).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the head model of Piron with the fluid intake mechanism of Aboud as both deal with the simulation of the head for medical practice. The fluid intake mechanism of Aboud would allow for a greater physiological fidelity for head model of Piron, making it better for practice.
Concerning claim 3,
Aboud teaches said inlet port comprises a self-closing membrane (0042, 0054, Figure 4b, Figure 6, wherein the one-way valve described in Aboud is considered to be equivalent to a self-closing membrane).
Concerning claim 4,
Piron discloses said skull cap and said vessel are configured to discharge the fluid when said skull cap and said vessel are penetrated by the drilling tool (0043, 0071-0072, 0079).
Concerning claim 15,
Piron does not disclose said vessel comprises an inlet port having a self-closing membrane.
Aboud teaches said vessel comprises an inlet port having a self-closing membrane (0042, 0054, Figure 4b, Figure 6, wherein the one-way valve described in Aboud is considered to be equivalent to a self-closing membrane).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the head model of Piron with the fluid intake mechanism of Aboud as both deal with the simulation of the head for medical practice. The fluid intake mechanism of Aboud would allow for a greater physiological fidelity for head model of Piron, making it better for practice.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2016/0155364 A1 to Piron et al. in view of US Patent 6409516 B1 to Thill (hereinafter Thill).
Concerning claim 5,
Piron does not explicitly disclose said skull cap is coupled to said skull base via a press-fit connection (0067, Figure 2, wherein Figure 2 seems to show pegs in the skull cap paired with the hole in the skull base, but Piron does not describe this characteristic in its specifications).
Thill teaches said skull cap is coupled to said skull base via a press-fit connection (20).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the press fitting mechanism disclosed in Thill in the head model of Piron as both are models of the human anatomy with the skull incorporating the method of fastening claimed. The press fit fastening method described in Thill would improve the connection between the various parts of the skull described in Piron.
Concerning claim 6,
Thill teaches projections located at said skull base and/or said skull cap, and receiving holes located at said skull base and/or said skull cap, wherein said receiving holes are configured to receive said projections to couple said skull cap to said skull base (20).
Concerning claim 7,
Piron discloses said skull cap is at an upper portion of said simulated skull (0048, Figure 2).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2016/0155364 A1 to Piron et al.
Concerning claim 9,
Piron does not disclose said vessel is unitarily formed with said skull cap.
In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.) (MPEP 2144.04(v)(b)).
In the specifications applicant has provided, no apparent need is addressed by making the vessel integral to the skull cap. It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to integrate the manufacturing of the skull cap and vessel for the above reason.
Concerning claim 10,
Piron does not explicitly disclose three of said vessels at a lateral side of said skull cap, and three of said vessels at an opposing lateral side of said skull cap (0078, 0079, vessel layer could be interpreted to meet the claim).
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) (MPEP 2144.04(vi)(b)).
In the specification applicant has provided, no new and unexpected result is produced by duplicating the vessels. It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to duplicate the vessels in the model for the above reason.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2016/0155364 A1 to Piron et al. in view of US Publication 2020/0194128 A1 to Cheng (hereinafter Cheng).
Concerning claim 12,
Piron does not disclose said skull cap comprises a plurality of deposited plastic layers.
Cheng teaches said skull cap comprises a plurality of deposited plastic layers (0005, 0082-0083, Figure 9).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material of the skull described in in Cheng in the head model of Piron as both contain models of the skull anatomy. The composition of the skull taught in Cheng is more cost effective for producing a model described in the head model of Piron.
Concerning claim 13,
Piron does not disclose said skull base comprises a plurality of deposited plastic layers.
Cheng teaches said skull base comprises a plurality of deposited plastic layers (0005, 0082-0083, Figure 9).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material of the skull described in in Cheng in the head model of Piron as both contain models of the skull anatomy. The composition of the skull taught in Cheng is more cost effective for producing a model described in the head model of Piron.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication 2016/0155364 A1 to Piron et al. in view of US Publication 2003/0186203 A1 to Aboud and further in view of US Patent 6409516 B1 to Thill.
Concerning claim 16,
Piron does not explicitly disclose projections located at said skull base and/or said skull cap, and receiving holes located at said skull base and/or said skull cap, and wherein said receiving holes are configured to receive said projections to couple said skull cap to said skull base (0067, Figure 2, wherein Figure 2 seems to show pegs in the skull cap paired with the hole in the skull base, but Piron does not describe this characteristic in its specifications).
Thill teaches projections located at said skull base and/or said skull cap, and receiving holes located at said skull base and/or said skull cap, and wherein said receiving holes are configured to receive said projections to couple said skull cap to said skull base (20).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the press fitting mechanism disclosed in Thill in the head model of Piron as both are models of the human anatomy with the skull incorporating the method of fastening claimed. The press fit fastening method described in Thill would improve the connection between the various parts of the skull described in Piron.
Conclusion
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/I.S./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715