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)(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.
Claim(s) 1-3, 5, 7, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0267507 (Kao).
1. Kao teaches a needle assembly (embodiment of FIG. 2 or 5) comprising:
a needle (needle 220/320);
a handle (needle holder 224/324 including second fastening structure 260/360) at a proximal end portion of the needle (FIG. 2 and 5; P0022-P0024), the handle having a proximal end and a distal end (FIG. 2 and 5);
a guide tube (needle case 240/340) sized to house the needle and handle (FIG. 4-5; P0022 and P0024), the guide tube comprising an inwardly-extending projection (first fastening structure 242/342) adjacent a proximal end of the guide tube (FIG. 4-5; P0021 and P0024),
the needle assembly is repositionable between a released configuration (FIG. 2; P0027) and an engaged configuration (FIG. 4; P0027)(e.g., Kao teaches its assembly being repositioned from the engaged configuration of FIG. 4 to the released configuration of FIG. 2 by distally pushing the handle and removing the guide where it is inherent that the assembly can be repositioned from the released configuration (as shown in FIG. 2) to the engaged position of FIG. 4 as shown in FIG. 2 in order to assemble the assembly of two distinct pieces with the needle and handle being inserted into the tube to position the device in the engaged configuration; note the insertion of the handle/needle into the guide tube in FIG. 2);
in the engaged configuration (FIG. 4), the inwardly-extending projection engages an engagement portion (second fastening structure 260/360 having flute 262/362) of the handle to retain the needle within the guide tube such that a distal tip of the needle is positioned within the guide tube and a proximal end portion of the handle extends from the proximal end of the guide tube (FIG. 4-5; P0022, P0024, and P0027);
the needle assembly is releasable from the engaged configuration to the released configuration upon a force applied to the proximal end of the handle that disengages the engagement portion from the inwardly-extending projection and allows the needle to move distally along the guide tube without further disruption (e.g., without further disruption after the second fastening structure 260 is moved distally past the first fastening structure) to extend the distal tip of the needle out of the guide tube (e.g., “Based on the design of this present invention, the needle case could be steadily handled in one of the acupuncturist's hands. At the same time, the acupuncture needle is punched by one finger (e.g. index finger) of the same hand. The resistant friction from these two fastening structures is overcome by the pressure of the finger and therefore the acupuncture needle is released.” at P0029)(FIG. 4-5; P0022, P0024 and P0027). Examiner notes that this release from the inwardly-extending projection appears to be the same as disclosed in this application).
2. The handle is secured to the proximal end portion of the needle (FIG. 2; P0022).
3. The engagement portion of the handle comprises a textured anti-slip surface (see concave flute 262/362 forming a textured anti-slip surface).
5. The engagement portion of the handle is located intermediate distal and proximal end portions of the handle (see second fastening structure 360 being located intermediate end portions of handle 324 in FIG. 5 and P0023-P0024).
7. The needle and handle are metallic (P0022).
11. A distal end of the handle (distal end of second fastening structure 260 or distal end of needle holder 324) has at least one indent (see opening in FIG. 3; also see needle holder 324 in FIG. 5 being wrapped about the needle body 322 to form an indent) for securing the needle to the handle (FIG. 2-3 and 5).
12. The inwardly-extending projection extends inwardly to such extent that when engaged with the handle, an opposite face of the handle abuts an internal wall of the guide tube (FIG. 4; P0022 and P0027).
13. The engagement portion of the handle has a textured anti-slip surface (see concave flute 362) and is located intermediate the distal end of the handle and the proximal end of the handle (FIG. 5; P0023-P0024).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao), as applied to claim 3 above, and further in view of US 3,861,392 (Moen).
Kao discloses the invention substantially as claimed as discussed above and further discloses the engagement portion of the handle define the textured anti-slip surface (FIG. 3; P0022) but does not disclose the surface being etched. Moen teaches a handle (12) having an engagement portion (14) in the same field of endeavor which is etched (see “threaded or knurled” at col. 2, lns. 21-22) for the purpose of providing a roughened surface (col. 2, ln. 22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement portion of Kao to be etched as taught by Moen in order to provide a roughened surface.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao), as applied to claim 1 above, and further in view of US 4,907,590 (Wang).
Kao discloses the invention substantially as claimed as discussed above but does not disclose the guide tube being manufactured of a translucent polymer. Wang teaches a guide tube (4) in the same field of endeavor which is manufactured of a translucent polymer (col. 2, ln. 46-47) for the purpose of allowing light to pass through the guide tube (see general definition of “translucent”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide tube of Kao to be manufactured of a translucent polymer as taught by Wang in order to allow light to pass through the guide tube.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao), as applied to claim 1 above.
Kao discloses the invention substantially as claimed as discussed above and further discloses, in an engaged configuration, a distance exists between the inwardly-extending projection and a proximal end of the handle (FIG. 4) but is silent regarding the distance such that it does not disclose it being between about 5 mm and 8 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the distance between about 5 mm and 8 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kao would not operate differently with the claimed distance since length would not alter the functionality of the needle 220 with it functioning appropriately having the claimed value. Further, applicant places no criticality on the range claimed, indicating the value “may be” the claimed range (see P0019).
Claims 8, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao), as applied to claims 7, 1, and 9 above, and further in view of US 4,950,279 (Chang).
Kao discloses the invention substantially as claimed as discussed above and further discloses the needle and handle being metal (P0022) but is silent regarding the specific metals such that it does not disclose the needle being stainless steel and the handle being aluminum. Chang teaches a needle in the same field of endeavor where the needle is stainless steel and the handle is aluminum (col. 2, lns. 41-44) such that it was well known in the art before the effective filing date to form the needle and handle of these specific metals. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Kao to be manufactured of a stainless steel with the handle being manufactured of aluminum as taught by Chang since it was well known in the art. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the needle of Kao to be manufactured of a stainless steel with the handle being manufactured of aluminum, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice and it appears that the prior art of Kao would perform equally as well as the claimed invention. In re Leshin, 125 USPQ 416.
Kao discloses the invention substantially as claimed as discussed above but is silent regarding the diameter of the handle such that it does not disclose the diameter being between about 2 mm and 2.5 mm. Chang teaches a handle diameter in the same field of endeavor being 1.5 mm (col. 2, ln. 37). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the handle diameter of Kao to be between about 2 mm and 2.5 mm as applicant appears to have placed no criticality on the claimed range (see P0020 indicating diameter “may be” in the claimed range) and since it has been held that “[i]n 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).
Kao discloses the invention substantially as claimed as discussed above and further discloses the distal end of the handle (distal end of second fastening structure 260) has at least one indent (see opening in FIG. 3; also see needle holder 324 in FIG. 5 being wrapped about the needle body 322 to form an indent) for securing the needle to the handle (FIG. 2-3 and 5) but is silent regarding the diameter of the handle such that it does not disclose the diameter being between about 2 mm and 2.5 mm. Chang teaches a handle diameter in the same field of endeavor being 1.5 mm (col. 2, ln. 37). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the handle diameter of Kao to be between about 2 mm and 2.5 mm as applicant appears to have placed no criticality on the claimed range (see P0020 indicating diameter “may be” in the claimed range) and since it has been held that “[i]n 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).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao), as applied to claim 13 above, in view of US 4,907,590 (Wang) and further in view of US 4,950,279 (Chang).
Kao discloses the invention substantially as claimed as discussed above but does not disclose the guide tube being manufactured of a translucent polymer. Wang teaches a guide tube (4) in the same field of endeavor which is manufactured of a translucent polymer (col. 2, ln. 46-47) for the purpose of allowing light to pass through the guide tube (see general definition of “translucent”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide tube of Kao to be manufactured of a translucent polymer as taught by Wang in order to allow light to pass through the guide tube.
Kao discloses the invention substantially as claimed as discussed above and further discloses the needle and handle being metal (P0022) but is silent regarding the specific metals such that it does not disclose the needle being stainless steel and the handle being aluminum. Chang teaches a needle in the same field of endeavor where the needle is stainless steel and the handle is aluminum (col. 2, lns. 41-44) such that it was well known in the art before the effective filing date to form the needle and handle of these specific metals. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Kao to be manufactured of a stainless steel with the handle being manufactured of aluminum as taught by Chang since it was well known in the art. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the needle of Kao to be manufactured of a stainless steel with the handle being manufactured of aluminum, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice and it appears that the prior art of Kao would perform equally as well as the claimed invention. In re Leshin, 125 USPQ 416.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0267507 (Kao) in view of US 4,907,590 (Wang) and further in view of US 3,861,392 (Moen).
21. Kao discloses a needle assembly (embodiment of FIG. 2 or 5) comprising:
a needle (needle 220/320);
a handle (needle holder 224/324 including second fastening structure 260/360) secured at a proximal end portion of the needle (FIG. 2 and 5; P0022-P0024), the handle having a proximal end and a distal end (FIG. 2 and 5);
a guide tube (needle case 240/340) sized to house the needle and handle (FIG. 4-5; P0022 and P0024), the guide tube comprising an inwardly-extending projection (first fastening structure 242/342) adjacent a proximal end thereof (FIG. 4-5; P0021 and P0024), the inwardly-extending projection is configured to engage an engagement portion (second fastening structure 260/360 having flute 262/362) of the handle for retaining the needle within the guide tube such that a distal tip of the needle is positioned within the guide tube and the proximal end of the handle extends from the proximal end of the guide tube (FIG. 4-5; P0022, P0024, and P0027);
the needle assembly is repositionable between a released configuration (FIG. 2; P0027) and an engaged configuration (FIG. 4; P0027)(e.g., Kao teaches its assembly being repositioned from the engaged configuration of FIG. 4 to the released configuration of FIG. 2 by distally pushing the handle and removing the guide where it is inherent that the assembly can be repositioned from the released configuration (as shown in FIG. 2) to the engaged position of FIG. 4 as shown in FIG. 2 with the needle and handle being inserted into the tube to position the device in the engaged configuration);
the needle assembly is releasable from the engaged configuration to the released configuration upon a force applied to the proximal end portion of the handle that disengages the engagement portion from the inwardly-extending projection and allows the needle to move distally along the guide tube without further disruption (e.g., without further disruption after the second fastening structure 260 is moved distally past the first fastening structure) to extend the distal tip of the needle out of the guide tube (e.g., “Based on the design of this present invention, the needle case could be steadily handled in one of the acupuncturist's hands. At the same time, the acupuncture needle is punched by one finger (e.g. index finger) of the same hand. The resistant friction from these two fastening structures is overcome by the pressure of the finger and therefore the acupuncture needle is released.” at P0029)(FIG. 4-5; P0022, P0024 and P0027). Examiner notes that this release from the inwardly-extending projection appears to be the same as disclosed in this application).
the engagement portion of the handle comprises a textured anti-slip surface (see concave flute 262/362 forming a textured anti-slip surface);
the engagement portion of the handle is located intermediate the distal end of the handle and the proximal end of the handle (see second fastening structure 360 being located intermediate end portions of handle 324 in FIG. 5 and P0023-P0024).
Kao discloses the invention substantially as claimed as discussed above but does not disclose the guide tube being manufactured of a translucent polymer. Wang teaches a guide tube (4) in the same field of endeavor which is manufactured of a translucent polymer (col. 2, ln. 46-47) for the purpose of allowing light to pass through the guide tube (see general definition of “translucent”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guide tube of Kao to be manufactured of a translucent polymer as taught by Wang in order to allow light pass through the guide tube.
Kao discloses the invention substantially as claimed as discussed above and further discloses the engagement portion of the handle define the textured anti-slip surface (FIG. 3; P0022) but does not disclose the surface being etched. Moen teaches a handle (12) having an engagement portion (14) in the same field of endeavor which is etched (see “threaded or knurled” at col. 2, lns. 21-22) for the purpose of providing a roughened surface (col. 2, ln. 22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement portion of Kao to be etched as taught by Moen in order to provide a roughened surface.
Response to Arguments
Applicant further argues that Kao fails to teach the needle assembly is repositionable between a released configuration and an engaged configuration. Examiner respectfully disagrees. Kao teaches its assembly having a release configuration (FIG. 2; P0027) and an engaged configuration (FIG. 4; P0027). Specifically, Kao teaches its assembly being repositioned from the engaged configuration of FIG. 4 to the released configuration of FIG. 2 by distally pushing the handle and removing the guide from the needle (P0029). In the released configuration of FIG. 2, the needle and guide inherently have to be capable of being assembled to the engaged configuration of FIG. 4. Furthermore, the released configuration of FIG. 2 specifically shows the handle/needle being inserted into the proximal end of the guide tube to position the device in the engaged configuration of FIG. 4.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771