DETAILED ACTION
Remarks
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 species I (claims 1-15) in the reply filed on 6/29/26 is acknowledged. Claims 1-20 are pending, claims 16-20 are withdrawn from examination, and claims 1-15 are under examination.
Drawings Objections
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 10, 11, and 13-15 is/are rejected under 35 U.S.C. 103 as being obvious over US 2007/0166665 A1 to COPE.
Regarding claim 1, COPE teaches A phantom for use in biopsy training (par. 0004: teaching, demonstration, and simulation models; par. 0023: model is designed to simulate and replicate actual anatomical features and material properties of actual tissue including hardness and thickness), the phantom comprising:
a first section (FIG. 1C and 2, ref. 35; par. 0022-23: medullary bone portion);
a second section at least partially surrounding the first section (FIG. 1C and 2, ref. 25; par. 0022-23: cortical bone portion); and
a third section at least partially surrounding the second section (FIG. 1C and 2, ref. 20, 21, 22, 36, 40, 41; par. 0022: mucosa, tissue, muscle).
Regarding claim 10, COPE teaches the elements above, but does not expressly disclose wherein the minimum thickness of the second section is greater than 11 mm.
Regarding claim 11, COPE teaches the elements above, but does not expressly disclose wherein the third section has a thickness of 35 mm.
To the extent COPE does not expressly disclose the exact ranges claimed regarding the first, second, and third section thickness and hardness, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of “less than 6 pounds per cubic feet” and the prior art range of “between 6 lbs./ft3 and 25 lbs./ft3” were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
In this case, COPE discloses ranges that overlap with the claimed ranges (e.g., a first section including a minimum thickness of greater than or equal to 15 mm, a maximum thickness of less than or equal to 30 mm (par. 0025: thickness ranging between 0.5 mm and 15 mm), and a hardness of less than or equal to 16 Hv (par. 0025: hardness ranging between 50 MPa and 2,500 MPa); the second section including…a hardness of less than or equal to 65 Hv (par. 0026: hardness ranging between 0.5 GPa and 20 GPa)) or are close to the claimed range (e.g., the second section including a minimum thickness of greater than or equal to 10 mm, a maximum thickness of less than or equal to 30 mm and wherein the minimum thickness of the second section is greater than 11 mm (par. 0026: thickness ranging between 0.5 mm and 5 mm)). Further, the application as originally filed does not disclose any criticality with regards to the claimed ranges. Therefore, because the range of COPE overlaps or are close to overlapping with the claimed range, and there is no showing of criticality for the claimed range, modifying COPE to have the claimed range would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Although COPE does not expressly disclose the third section including a minimum thickness of greater than or equal to 25 mm, a maximum thickness of less than or equal to 45 mm, and a hardness less than that of each of the first section and the second section and wherein the third section has a thickness of 35 mm, COPE does disclose that the material utilized to construct the facial gum tissue 20 and the lingual gum tissue 26 of the dental model 1 is made of a soft, but resilient, polymethylmethacrolate (acrylic) self-curing denture reline material, and that a person of ordinary skill in the art will understand, that other materials can also be used to construct the facial gum tissue 20 and the lingual gum tissue 26 to achieve a life-like look and feel as actual gum tissue that can also be cut or incised, reflected, and sutured without departing from the scope and spirit of the present invention (par. 0020). Further, COPE discloses the model is designed to simulate and replicate actual anatomical features and material properties of actual tissue including hardness and thickness (par. 0023). COPE discloses a desire to provide a model with hardness, thickness, and life-like appearance of each tissue designed and configured in the present invention (par. 0030). One of ordinary skill in the art before the effective filing date of the claimed invention would understand that actual gum tissue has a hardness that is less than that of the underlying bone, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date, in providing gum tissue that simulates and replicates actual gum tissue as disclosed in COPE, to make the gum tissue hardness less than the disclosed bone (both medullary and cortical), thereby simulating and replicating the physical properties of actual human anatomy. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as a matter of design choice, to make the thickness of the tissue, including mucosa, tissue, muscle surrounding the underlying cortical bone, a minimum thickness of greater than or equal to 25 mm, a maximum thickness of less than or equal to 45 mm in order to simulate and replicate the physical properties of actual human anatomy. Applicant has not disclosed that this range of thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected COPE’s model, and applicant’s invention, to perform equally well with the thickness of COPE or the claimed thickness because both would perform the same function of simulating the soft tissue at least partially surrounding a bone. Therefore, it would have been prima facie obvious to modify COPE to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of COPE. See also MPEP 2144.04, subsection IV. A. – change in size or proportion.
Regarding claim 13, COPE further teaches wherein each of the second section and the third section includes a planar surface for engaging a support surface (FIG. 2, showing bottom surface of 25 and 40 including flat bottom surface capable of engaging a support surface).
Regarding claim 14, COPE further teaches wherein the first section further includes the minimum thickness disposed at one end, and the maximum thickness disposed at an opposite end, and the first section tapers continuously from the end having the maximum thickness to the end having the minimum thickness (FIG. 2, showing first portion 35 having two ends, wherein the maximum thickness is at the bottom, which tapers to the minimum thickness at the top).
Regarding claim 15, COPE further teaches wherein the second section further includes the minimum thickness disposed at one end, and the maximum thickness disposed at an opposite end, and the second section tapers continuously from the end having the maximum thickness to the end having the minimum thickness (FIG. 2, showing second portion 25 having two ends, wherein the maximum thickness is at the bottom, which tapers to the minimum thickness at the top).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being obvious over COPE, as applied to claim 1, in view of US 2015/0170548 A1 to MCCLINTOCK.
Regarding claim 2, COPE teaches the elements above, but does not disclose wherein the first section includes a polyurethane foam. However, MCCLINTOCK teaches an anatomical model (Abstract) which uses polyurethane foam for simulated bones because it has characteristics similar to human bone (par. 0036). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate polyurethane foam, as taught by MCCLINTOCK, for the bones of COPE, thereby using a known material having characteristics similar to human bone to achieve predictable results.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being obvious over COPE, as applied to claim 1, in view of US 2018/0005548 A1 to BLAIR-PATTISON.
Regarding claim 3, COPE teaches the elements above, but does not disclose wherein the second section includes epoxy. However, BLAIR-PATTISON teaches a simulated human bone that provides tactile feedback that feels similar to real bone which uses epoxy as a hardening agent for simulated bones (par. 0025; 0037; 0050). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of epoxy to form a simulated bone, as taught by BLAIR-PATTISON, into the invention of COPE, in order to provide tactile feedback that feels similar to real bone, thus applying a known technique to a similar device to yield predictable results.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being obvious over COPE, as applied to claim 1, in view of CN 114014976 to LI.
Regarding claim 4, COPE teaches the elements above, but does not disclose wherein the third section includes a psyllium fiber blend. However, LI teaches the use of psyllium husk powder in a human tissue model (Novelty; Preferred Components). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate psyllium husk powder, as taught by LI, into the tissue model of COPE, thereby applying a known technique of manufacturing a tissue model to a similar tissue model to yield predictable results.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being obvious over COPE, as applied to claim 1, in view of US 2015/0352250 A1 to DALMAN.
Regarding claim 5, COPE teaches the elements above, but does not disclose wherein the third section includes ballistic gel. However, DALMAN teaches an artificial bone construct (Abstract) including a fleshy outer layer comprising a ballistics gel to mimic the properties of human tissue (par. 0064). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of ballistics gel, as taught by DALMAN, as the soft tissue of COPE, in order to mimic the properties of human tissue using a known material, thereby achieving predictable results.
Claim(s) 6-9 and 12 is/are rejected under 35 U.S.C. 103 as being obvious over COPE, as applied to claim 1, and alternatively in view of US 2020/0360090 A1 to BOHL.
Regarding claim 6, COPE teaches the elements above, but does not disclose wherein the first section extends along a longitudinal axis of the phantom such that both ends of the first section are intersected by the longitudinal axis, and a location of the minimum thickness of the first section is located between the ends of the first section.
Regarding claim 7, COPE teaches the elements above, but does not disclose wherein the first section tapers continuously from each of the ends of the first section to the location of the minimum thickness.
Regarding claim 9, COPE teaches the elements above, but does not disclose wherein each of the minimum thickness and the maximum thickness of the first section is a diameter of the first section measured in a plane orthogonal to a longitudinal axis of the first section.
Regarding claim 12, COPE teaches the elements above, but does not disclose wherein the first section is circular in cross-section in a plane orthogonal to a longitudinal axis of the phantom, the thickness of the second section is measured in a radial direction relative to the longitudinal axis, and the thickness of the third section is measured in a radial direction relative to the longitudinal axis.
Although COPE does not disclose the particular shape/proportions of sections described in claims 6, 7, 9, and 12, COPE discloses the purpose of the model is to provide a model to practice surgical procedures (par. 0029), and that the disclosed process of designing and making a teaching model can be applied for the design and construction of other anatomical models for other human and/or veterinary tissues and organs (par. 0032). Further, Applicant has not disclosed that these particulars shapes/proportions of sections provide an advantage, is used for a particular purpose, or solves a stated problem. Thus, it would have been prima facie obvious to modify the model of COPE to have the shape/proportions as specified in claims 6, 7, 9, and 12 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of COPE. See also MPEP 2144.04, subsection IV. A. – change in size or proportion. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the sections disclosed by COPE to have the shape and proportions recited in claims 6, 7, 9, and 12, in order to simulate other known anatomical human tissues and organs, thereby applying a known manner of constructing an anatomical model that can be used to practice other surgical procedures.
Alternatively, BOHL teaches a related anatomical model (Abstract) for training a surgeon (par. 0051) which includes human tissue, cortical bone, and medullary bone (par. 0108). BOHL further teaches that in one embodiment, the simulated body part is a leg, as shown comprising wherein the first section extends along a longitudinal axis of the phantom such that both ends of the first section are intersected by the longitudinal axis, and a location of the minimum thickness of the first section is located between the ends of the first section, wherein the first section tapers continuously from each of the ends of the first section to the location of the minimum thickness, wherein each of the minimum thickness and the maximum thickness of the first section is a diameter of the first section measured in a plane orthogonal to a longitudinal axis of the first section, and wherein the first section is circular in cross-section in a plane orthogonal to a longitudinal axis of the phantom, the thickness of the second section is measured in a radial direction relative to the longitudinal axis, and the thickness of the third section is measured in a radial direction relative to the longitudinal axis (as shown in Figures 28A and 28B; par. 0107). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching model disclosed by COPE to other anatomical models including the model of a leg comprising a medullary bone, cortical bone, and tissue, as taught by BOHL, thereby applying a known manner of design and construction to other anatomical models for other human and/or veterinary tissues and organs to yield predictable results.
Regarding claim 8, COPE teaches the elements above, but does not disclose wherein the minimum thickness of the first section is greater than 17 mm. However, COPE does the thickness of the medullary bone ranging between 0.5 mm and 15 mm (par. 0025). Applicant has not disclosed that this range of thickness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected COPE’s model, and applicant’s invention, to perform equally well with the thickness of COPE or the claimed thickness because both would perform the same function of simulating the soft tissue at least partially surrounding a bone. Therefore, it would have been prima facie obvious to modify COPE to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of COPE. See also MPEP 2144.04, subsection IV. A. – change in size or proportion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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