DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
2. Claim 17 is objected to because of the following informalities: "wherein the diamond shaped openings having a length of about 20 to about 25 mm, and a width" should read --wherein the diamond shaped openings have a length of about 20 to about 25 mm and a width--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 recites the limitation "along its length" in the second line. There is insufficient antecedent basis for this limitation in the claim, as it is unclear whether the limitation is intended to refer to a length dimension of the main body or of the net, and also unclear as to which length dimension the limitation is purported to refer, as no frame of reference has been established.
Claim 1 further recites the limitation "the wrapped sterilization container" in the fourth line. There is insufficient antecedent basis for this limitation in the claim, as it is unclear whether the limitation is intended to refer to the sterilization container referenced in the claim preamble or to a different, unrecited wrapped version.
6. Claims 2-17 are indefinite by virtue of their dependence on indefinite claim 1.
7. Claim 13 recites the limitation “the transverse direction” in the second line. There is insufficient antecedent basis for this limitation in the claim, as it is unclear what direction is being referenced which leads to uncertainty as to how the claimed knot count would be defined. For the purpose of examination, due to the challenge of defining a total transverse length based on the embodiment of FIG. 1, a knot count along any direction of a prior art sheath would be considered to read upon the knot count claimed.
8. Claim 15 recites the limitations "the transverse direction" and “the machine direction”. There is insufficient antecedent basis for this limitation in the claim, as no frame of reference has been established to sufficiently identify either direction on the sheath of claim 1.
9. Claim 16 recites the limitation "the diamond shaped openings" in the first line. There is insufficient antecedent basis for this limitation in the claim, as the parent claim 1 does not recite diamond shaped openings. For the purpose of examination, the claim is analyzed as dependent from claim 2 to provide sufficient antecedent basis for the diamond shaped openings for claim 16 and its dependent claim 17.
Claim Rejections - 35 USC § 102
10. 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.
11. Claims 1, 3, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takken et al (US 20180221104 A1).
12. Regarding claim 1, Takken discloses an external sheath for a sterilization container (protectors 80 to protect sterilization wrap 20 along the sides of a package wrapped with wrap 20 and/or to protect the sides of sterilization tray 10, par 0075, FIGS. 9-12), comprising:
a main body (protector 80 comprising piece of material M having a first surface and a second surface, par 0071, FIG. 9) comprising a net having a plurality of shaped openings along its length (material M may be a nonwoven material such as a highly perforated film, par 0071), a first open end and a second open end (FIGS. 10-11), the main body having a geometry configured for a slip fit over the wrapped sterilization container (one or more expandable protectors 80 may be positioned against outer surface 24 of sterilization wrap 20 when wrap 20 is wrapped about sterilization tray 10, par 0075; portions 88 of each expandable protector 80 may expand to position protector 80 [i.e. slide protector 80 over] wrap 20, par 0073) and being formed of a sterilization-grade material (Material M may be the same or substantially similar to the material used to make the sterilization wrap, par 0071; sterilization packaging systems used must be of the size and shape to accommodate the items to be sterilized and must be compatible with and withstand the physical conditions of the sterilization process, par 0003).
13. Regarding claim 3, Takken discloses the external sheath of claim 1, wherein the main body comprises a rectangular shaped tube (FIGS. 10-12).
14. Regarding claim 7, Takken discloses the external sheath of claim 1, further being configured for multiple cycles of sterilization (material M may be selected such that expandable protector 80 is reusable, par 0071).
15. Regarding claim 8, Takken discloses the external sheath of claim 1, further being configured for single use (Material M may be selected such that expandable protector 80 is disposable, par 0071).
16. Regarding claim 9, Takken discloses the external sheath of claim 1, further being configured for steam sterilization or chemical sterilization (sterilization conditions can include, e.g., steam, ethylene oxide, or hydrogen peroxide plasma sterilization conditions, par 0034).
17. Regarding claim 10, Takken discloses the external sheath of claim 9, wherein the chemical sterilization includes ethylene oxide gas, vaporized hydrogen peroxide (ethylene oxide, or hydrogen peroxide plasma sterilization conditions, par 0034).
18. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ULINE (ULINE Catalog Spring/Summer 2021, accessed via Wayback Machine dated 22 June 2021, archive.org/details/uline-catalog-spring-summer-us-2021/page/292/mode/2up).
19. Regarding claim 1, ULINE discloses an external sheath (netting that serves as external sheath for various objects, pictures on page 292). The limitation for a sterilization container describes an intended use of the sheath that does not result in a structural difference thus does not carry patentable weight per MPEP 2111.02(II). ULINE discloses the sheath comprising:
a main body comprising a net (protective netting, page 292) having a plurality of shaped openings along its length (protective netting pictures, page 292), a first open end and a second open end (e.g., bottom picture in protective netting section, page 292), the main body having a geometry configured for a slip fit (netting slides easily over odd size objects, page 292). The intended use of sliding over the wrapped sterilization container is given limited patentable weight per MPEP 2114(II), as the netting pictured at the bottom of the protective netting section is capable of being slid over a sterilization container; further, because the netting is sold as a roll, a person having ordinary skill in the art would understand to fit the netting to the size of the container as desired. As for the limitation being formed of a sterilization-grade material, there is no formal definition of “sterilization grade” as applied generally to all conceivable types of sterilization, and no such standard is presented in the present Specification except that “the sterilization-grade material can comprise a polypropylene, polylactic acid, polyethylene, a polybutylene adipate terephthalate, or a blend thereof”. As the netting of ULINE is composed of polyethylene (page 292), the disclosure of ULINE reads upon the claim.
20. Regarding claim 2, ULINE discloses the external sheath of claim 1, wherein the shaped openings comprise diamond shaped openings (protective netting shows diamond shaped openings, page 292).
21. Regarding claim 3, ULINE discloses the external sheath of claim 1, wherein the main body comprises a rectangular shaped tube (bottom picture of protective netting comprises rectangular cross section, page 292).
22. Regarding claim 4, ULINE discloses the external sheath of claim 1, wherein the sterilization-grade material comprises a polypropylene, polylactic acid, polyethylene, a polybutylene adipate terephthalate, or a blend thereof (polyethylene, page 292).
23. Regarding claim 8, ULINE discloses the external sheath of claim 1, further being configured for single use (page 292 depicts custom wrapping of individual parts which envisions a single use plastic).
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.
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.
24. Claims 2, 5-6, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Takken et al (US 20180221104 A1) as applied to claim 1 above, and further in view of Cederblad et al (US 20050183329 A1).
25. Regarding claim 2, Takken discloses the external sheath of claim 1 but is silent regarding the shape of the openings thus does not teach diamond shaped openings.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein netting may be extruded by conventional methods from polypropylene, polyethylene, or blends thereof (par 0005) in a variety of configurations such as diamond, square, twill, etc. (pars 0005 and 0072, FIG.1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to employ for the highly perforated film of Takken a netting having diamond shaped openings as taught by Cederblad, because diamond-shaped openings can be readily made by conventional netting extrusion processes and would predictably provide suitable porous breathability as required by Takken (par 0043), the modification involving substitution of one known element for another by known methods to yield predictable results. See MPEP 2143(I)(B).
26. Regarding claim 5, Takken discloses the external sheath of claim 1, wherein the net comprises a nonwoven material (Material M may be a nonwoven material, par 0071). Takken does not specifically teach that this material would also be monofilament and extruded.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein netting may be extruded by conventional methods from polypropylene, polyethylene, or blends thereof (par 0005), wherein the netting includes individual strands that are extruded i.e. monofilaments that are crossed during extrusion i.e. not woven or knitted for form the net-like structure (pars 0028-0030, FIG. 1), a structure that demonstrates strength at high temperature (pars 0082-0089).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to produce the nonwoven netting material of Takken by crossing monofilaments during extrusion as taught by Cederblad, because this monofilament and extruded material would predictably exhibit the same strength and heat resistance properties and involves simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
27. Regarding claim 6, Takken discloses the external sheath of claim 1, but Takken does not teach wherein the sterilization-grade material is partially or fully biodegradable.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) and may similarly comprise polypropylene or polyethylene and copolymers (par 0005), but that this material may advantageously be made biodegradable to reduce waste and avoid release of dangerous decomposition products (par 0009) by including a biodegradable additive or manufacturing the netting from entirely from degradable materials (pars 0030-0031).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to employ for the nonwoven material of Takken a partially or fully biodegradable material as taught by Cederblad, because such a polymeric composition would predictably provide suitable strength and resistance (Cederblad pars 0072-0075) while providing the same waste reduction advantages, and involves a simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
28. Regarding claim 11, Takken discloses the external sheath of claim 1, but Takken is silent regarding the thickness so does not specify wherein the net has a thickness in the range of about 0.050 to about 0.100 inches.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has strands that have an average thickness/diameter of 1 to 300 mils [0.001-0.300 inches], in other embodiments 10 to 50 mils [0.010-0.050 inches] (par 0078). When crossed with a second layer to form the highly perforated netting (pars 0076-0077), the thickness of the net would be accordingly greater than the single strand thickness but not more than double this strand thickness, overlapping with the claimed thickness range of about 0.050 to about 0.100 inches, and with a narrower range of about 0.065 to about 0.085 inches. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as netting thickness is considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to fabricate the net of Takken with a thickness of about 0.050-0.100 inches as taught by Cederblad, because this thickness would predicably provide the netting with suitable tensile strength in a similar manner as taught by Cederblad (pars 0074-0075) with a reasonable expectation of success. See MPEP 2143(I)(G).
29. Regarding claim 12, Takken as modified by Cederblad teaches the external sheath of claim 11, and for the same reasons detailed above for the overlapping thickness range, renders obvious wherein the net has a thickness in the range of about 0.065 to about 0.085 inches.
30. Regarding claim 13, Takken discloses the external sheath of claim 1 but does not teach wherein the net has a knot count in the range of about 40 to about 120 in the transverse direction.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 10 strands/inch (par 0076) and wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 6 strands per inch (par 0077). A total knot count in the transverse direction can be estimated by multiplying the strands/inch by the length in inches, which to cover a wrapped sterilization container would necessarily depend on the length of the container (an intended use of the sheath) but as a design parameter for the sheath would be expected to be on the order of inches. As an example, a transverse length of 12 inches with a strand count of 5 strands per inch would yield a knot count of 60, and an overlapping range for knot count may be constructed accordingly. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as the claimed knot counts in either direction closely overlap with the prior art and are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of Takken to have a knot count in the range of about 40 to about 120 in the transverse direction as taught by Cederblad, because this strand count in both directions would predictably provide a suitable net having openings and involve simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
31. Regarding claim 14, Takken as modified by Cederblad teaches the external sheath of claim 13, and for the same reasons detailed above for the overlapping ranges provided by Cederblad for a knot count in the transverse direction based upon the strand counts in both directions, renders obvious wherein the net has a knot count in the range of about 54 to about 100 in the transverse direction.
32. Regarding claim 15, Takken discloses the external sheath of claim 1, further contemplating fiber structures (par 0040) but not sufficiently teaching wherein the net comprises strands, and the strands per inch of the net is in the range of about 3 to about 10 in the transverse direction (TD), and about 1 to about 9 in the machine direction (MD).
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 10 strands/inch (par 0076) and wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 6 strands per inch (par 0077). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as the claimed strands counts in either direction closely overlap with the prior art and are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of Takken using strands with 3-10 strands per inch in the machine direction and 1-9 strands per inch in the machine direction as taught by Cederblad, because these strand counts would predictably provide a suitable net having openings and involve simple substitution of one known element for another to yield predictable results . See MPEP 2143(I)(B).
33. Regarding claim 16, Takken as modified by Cederblad teaches the external sheath of claim 2, but the combination does not specifically teach wherein the diamond shaped openings have a length in the range of about 10 to 25 mm and a width in the range of about 5 to 15 mm.
However, Cederblad further teaches a strand thickness and a strand count to provide information that enables estimation of the openings pictured in FIG. 1, specifically wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch [a strand every 0.5 to 250 millimeters], or more narrowly 1 to 10 strands/inch [a strand every 2.5 to 25 millimeters] (par 0076), wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch [a strand every 0.5 to 250 millimeters], or more narrowly 1 to 6 strands per inch [a strand every 4.25 to 25 millimeters] (par 0077), and wherein the extruded netting has strands that have an average thickness/diameter of 1 to 300 mils [0.025-7.62 mm], in other embodiments 10 to 50 mils [0.254-1.27 mm](par 0078). By providing ranges particularly including a strand every 2.5 mm to 25 mm at any of the strand widths disclosed, Cederblad provides a sufficient overlapping range to render obvious the claimed hole dimensions. See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), as the diamond-shaped hole dimensions are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of modified Takken to have diamond-shaped openings having a length of about 10-25 mm and a width of about 5-15 mm as taught by Cederblad, because these openings would predictably suitable porous breathability as required by Takken (par 0043) and involve routine optimization of non-critical variables, i.e., the strand counts and strand diameter taught by Cederblad. See MPEP 2144.05(I).
34. Regarding claim 17, Takken as modified by Cederblad teaches the external sheath of claim 16, and for the same reasons detailed above for the overlapping ranges provided by Cederblad for strand counts and strand thicknesses, renders obvious wherein the diamond shaped openings having a length of about 20 to about 25 mm, and a width of about 10 to about 15 mm.
35. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Takken et al (US 20180221104 A1).
Regarding claim 4, Takken discloses the external sheath of claim 1, wherein the material M used for the protector 80 may be the same or substantially similar to the material used to make the sterilization wrap 20 (par 0071). Takken provides a list of nonwoven materials that may be used for the sterilization-grade wrap material including polyolefin-based fibers (pars 0038-0039) but does not specifically teach that the protector material of the FIGS. 9-12 embodiments comprises a polypropylene, polylactic acid, polyethylene, a polybutylene adipate terephthalate, or a blend thereof.
However, Takken further teaches that the wrap may comprise polypropylene (par 0039), which advantageously imparts strength characteristics to the sterilization wrap (par 0039). Because protector material M may be the same material used to make the sterilization wrap, a person having ordinary skill in the art would be motivated to employ polypropylene within the protector material for the same advantageous strength characteristics to protect the sterilization container or tray (pars 0074-0075).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate polypropylene into the sterilization grade material for the main body as taught by Takken, because the inclusion of polypropylene in the protective sheath would impart the same strength characteristics that Takken extols in the use of polypropylene for the wrap, with a reasonable expectation of success since Takken teaches that the wrap and the protector may be made of the same material. See MPEP 2143(I)(G).
--
36. Claims 5-6 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over ULINE as applied to claim 1 above, and further in view of Cederblad et al (US 20050183329 A1).
37. Regarding claim 5, ULINE discloses the external sheath of claim 1 of a flexible polyethylene netting (page 292) but does not sufficiently teach that the net comprises a monofilament and extruded, nonwoven material.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein netting may be extruded by conventional methods from polypropylene, polyethylene, or blends thereof (par 0005), wherein the netting includes individual strands that are extruded i.e. monofilaments that are crossed during extrusion i.e. not woven or knitted for form the net-like structure (pars 0028-0030, FIG. 1), a structure that demonstrates strength at high temperature (pars 0082-0089).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to produce the netting material of ULINE by crossing monofilaments during extrusion as taught by Cederblad, because this monofilament and extruded nonwoven material would predictably exhibit the same strength and heat resistance properties and involves simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
38. Regarding claim 6, ULINE discloses the external sheath of claim 1, but ULINE does not teach wherein the sterilization-grade material is partially or fully biodegradable.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) and may similarly comprise polypropylene or polyethylene and copolymers (par 0005), but that this material may advantageously be made biodegradable to reduce waste and avoid release of dangerous decomposition products (par 0009) by including a biodegradable additive or manufacturing the netting from entirely from degradable materials (pars 0030-0031).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to employ for the netting material of ULINE a partially or fully biodegradable material as taught by Cederblad, because such a polymeric composition would predictably provide suitable strength and resistance (Cederblad pars 0072-0075) while providing the same waste reduction advantages, and involves a simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
39. Regarding claim 11, ULINE discloses the external sheath of claim 1 but is silent regarding the thickness so does not specify wherein the net has a thickness in the range of about 0.050 to about 0.100 inches.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has strands that have an average thickness/diameter of 1 to 300 mils [0.001-0.300 inches], in other embodiments 10 to 50 mils [0.010-0.050 inches] (par 0078). When crossed with a second layer to form the highly perforated netting (pars 0076-0077), the thickness of the net would be accordingly greater than the single strand thickness but not more than double this strand thickness, overlapping with the claimed thickness range of about 0.050 to about 0.100 inches, and with a narrower range of about 0.065 to about 0.085 inches. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as netting thickness is considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to fabricate the net of ULINE with a thickness of about 0.050-0.100 inches as taught by Cederblad, because this thickness would predicably provide the netting with suitable tensile strength in a similar manner as taught by Cederblad (pars 0074-0075) with a reasonable expectation of success. See MPEP 2143(I)(G).
40. Regarding claim 12, ULINE as modified by Cederblad teaches the external sheath of claim 11, and for the same reasons detailed above for the overlapping thickness range, renders obvious wherein the net has a thickness in the range of about 0.065 to about 0.085 inches.
41. Regarding claim 13, ULINE discloses the external sheath of claim 1 but does not teach wherein the net has a knot count in the range of about 40 to about 120 in the transverse direction.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 10 strands/inch (par 0076) and wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 6 strands per inch (par 0077). A total knot count in the transverse direction can be estimated by multiplying the strands/inch by the length in inches, which to cover a wrapped sterilization container would necessarily depend on the length of the container (an intended use of the sheath) but as a design parameter for the sheath would be expected to be on the order of inches. As an example, a transverse length of 12 inches with a strand count of 5 strands per inch would yield a knot count of 60, and an overlapping range for knot count may be constructed accordingly. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as the claimed knot counts in either direction closely overlap with the prior art and are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of ULINE to have a knot count in the range of about 40 to about 120 in the transverse direction as taught by Cederblad, because this strand count in both directions would predictably provide a suitable net having openings and involve simple substitution of one known element for another to yield predictable results. See MPEP 2143(I)(B).
42. Regarding claim 14, ULINE as modified by Cederblad teaches the external sheath of claim 13, and for the same reasons detailed above for the overlapping ranges provided by Cederblad for a knot count in the transverse direction based upon the strand counts in both directions, renders obvious wherein the net has a knot count in the range of about 54 to about 100 in the transverse direction.
43. Regarding claim 15, ULINE discloses the external sheath of claim 1, further contemplating fiber structures (par 0040) but not sufficiently teaching wherein the net comprises strands, and the strands per inch of the net is in the range of about 3 to about 10 in the transverse direction (TD), and about 1 to about 9 in the machine direction (MD).
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 10 strands/inch (par 0076) and wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch, or more narrowly 1 to 6 strands per inch (par 0077). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)), as the claimed strands counts in either direction closely overlap with the prior art and are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of ULINE using strands with 3-10 strands per inch in the machine direction and 1-9 strands per inch in the machine direction as taught by Cederblad, because these strand counts would predictably provide a suitable net having openings and involve simple substitution of one known element for another to yield predictable results . See MPEP 2143(I)(B).
44. Regarding claim 16, ULINE discloses the external sheath of claim 2, but does not specifically teach wherein the diamond shaped openings have a length in the range of about 10 to 25 mm and a width in the range of about 5 to 15 mm.
Cederblad teaches an analogous netting that may be used in medical gowns and medical drapes (Abstract, par 0008) and further teaches dimensional details that enable estimation of the openings pictured in FIG. 1, specifically wherein the extruded netting has a machine direction strands per inch of 0.1 to 50 strands/inch [a strand every 0.5 to 250 millimeters], or more narrowly 1 to 10 strands/inch [a strand every 2.5 to 25 millimeters] (par 0076), wherein the netting has a cross direction strands per inch of 0.1 to 50 strands/inch [a strand every 0.5 to 250 millimeters], or more narrowly 1 to 6 strands per inch [a strand every 4.25 to 25 millimeters] (par 0077), and wherein the extruded netting has strands that have an average thickness/diameter of 1 to 300 mils [0.025-7.62 mm], in other embodiments 10 to 50 mils [0.254-1.27 mm](par 0078). By providing ranges particularly including a strand every 2.5 mm to 25 mm at any of the strand widths disclosed, Cederblad provides a sufficient overlapping range to render obvious the claimed hole dimensions. See MPEP 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), as the diamond-shaped hole dimensions are considered a non-critical variable that can readily be optimized by a skilled artisan.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the net of ULINE to have diamond-shaped openings having a length of about 10-25 mm and a width of about 5-15 mm as taught by Cederblad, because these openings would predictably reproduce the structure depicted by ULINE (page 292) and involve routine optimization of non-critical variables, i.e., the strand counts and strand diameter taught by Cederblad. See MPEP 2144.05(I).
45. Regarding claim 17, ULINE as modified by Cederblad teaches the external sheath of claim 16, and for the same reasons detailed above for the overlapping ranges provided by Cederblad for strand counts and strand thicknesses, renders obvious wherein the diamond shaped openings having a length of about 20 to about 25 mm, and a width of about 10 to about 15 mm.
46. Claims 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over ULINE as applied to claim 1 above, and further in view of Maguire et al (US 20070253864 A1).
47. Regarding claim 7, ULINE discloses the external sheath of claim 1 wherein the netting material is polyethylene (page 292), though does not teach this material as being configured for multiple cycles of sterilization.
Maguire teaches a sterilization accessory for holding e.g. surgical instruments made of open cellular material (Abstract) conventionally made of polyethylene (pars 0015 and 0028) which is demonstrated as suitable for hydrogen peroxide gas sterilization (par 0050), these materials standing up to multiple sterilization cycles before requiring replacement (par 0061).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the polyethylene sheath of ULINE in multiple sterilization cycles as taught by Maguire, because the polyethylene material would predictably stand up to hydrogen peroxide gas sterilization in the same manner with a reasonable expectation of success. See MPEP 2143(I)(G).
48. Regarding claim 9, ULINE discloses the external sheath of claim 1 wherein the netting material is polyethylene (page 292), though does not teach this material as being configured for steam sterilization, dry heat sterilization, gamma radiation, x-rays, or chemical sterilization.
Maguire teaches a sterilization accessory for holding e.g. surgical instruments made of open cellular material (Abstract) conventionally made of polyethylene (pars 0015 and 0028) which is demonstrated as suitable for hydrogen peroxide gas sterilization (par 0050).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the polyethylene sheath of ULINE in vaporized hydrogen peroxide chemical sterilization cycles as taught by Maguire, because the polyethylene material would predictably stand up to hydrogen peroxide gas sterilization in the same manner with a reasonable expectation of success. See MPEP 2143(I)(G).
49. Regarding claim 10, ULINE as modified by Maguire teaches the external sheath of claim 9, wherein the chemical sterilization includes vaporized hydrogen peroxide (Maguire par 0050).
Conclusion
50. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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/ERIC TALBERT/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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