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 .
Specification
The disclosure is objected to because of the following informalities: [0047] “plunder” should be “plunger.”
Appropriate correction is required.
Claim Objections
Claims 7, 8, and 19 are objected to because of the following informalities: there should be a comma in the preamble after the claim number. Appropriate correction is required.
Claim 18 is objected to because it includes reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim 3 is objected to because of the following informalities: “are positioned symmetrical with respect…” requires grammar correction. “second remaining arm” should be “second retaining arm.” Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “wherein the main seal body having an annular ridge to abut against the flange of the syringe…” requires grammar correction. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “an annular ridge a the second surface…” requires grammar correction. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 5 and 16 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. Claims 5 and 16 recite “the second flange sealing interface” which lacks antecedent basis. It is not clear if this is the same as the same as the plunger sealing interface or a different interface, for purposes of examination it is taken as the same interface.
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.
Claim(s) 1, 11, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1) in view of Armstrong (WO 2014/0153572 A1).
With regard to claim 1, Gray teaches a syringe cover device comprising: a first frame (Fig. 12 half of 606) and a first seal (Fig. 12 half of 609) coupled to the first frame; a second frame (Fig. 12 second half of 606) and a second seal (Fig. 12 second half of 609) coupled to the second frame; the first frame and the second frame to surround the first seal and the second seal therebetween (Fig. 12); the first seal and the second seal form a main seal body and disposed between the first frame and the second frame, the main seal body having a first surface abutting against the first frame and the second frame (Fig. 12 first surface facing proximally), a second surface (Fig. 12 second surface facing distally) opposite to the first surface and an aperture formed between the first seal and the second seal and through the first surface and the second surface (Fig. 12 aperture 610CSO). The embodiment of Fig. 12 does not show a flange, however, a flange 503 is shown in Fig. 11. Gray does not disclose the first and second frames and seals as couplable. However, Armstrong teaches an insert around a plunger which can be placed inside the barrel or externally attached which can be one piece or split into two portions coupled at a midpoint allowing the device to be attach from the side (Figs. 3-5 and 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use coupled first and second frames and seals as opposed to a single piece in Gray as Armstrong teaches such to be an art effective equivalent configuration and further to connect it externally about a barrel with a flange as Armstrong teaches this to be equivalent to an internally connected insert which would still yield the same predictable result of providing the seal around the plunger and use with various barrels and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Further, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin V. Erlicnman, 168 USPQ 177, 179.
With regard to claim 11, Gray teaches a syringe comprising: a barrel having a front opening, a back opening (Fig. 12 600), a plunger having a plunger strut movably disposed through the back opening (Fig. 12 604PS and 604PSR); a first seal and a second seal form an aperture through which the plunger strut passes (Fig. 12 first and second half of 609, aperture 610CSO); a first frame and a second frame to surround the first seal and the second seal therebetween and to clamp the first seal and the second seal to the flange (Fig. 12 first and second half of 606). The embodiment of Fig. 12 does not show a flange, however, a flange 503 is shown in Fig. 11. Further, Gray does not disclose the first and second frames and seals as couplable. However, Armstrong teaches an insert around a plunger which can be placed inside the barrel or externally attached which can be one piece or split into two portions coupled at a midpoint allowing the device to be attach from the side (Figs. 3-5 and 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use coupled first and second frames and seals as opposed to a single piece in Gray as Armstrong teaches such to be an art effective equivalent configuration and further to connect it externally about a barrel with a flange as Armstrong teaches this to be equivalent to an internally connected insert which would still yield the same predictable result of providing the seal around the plunger and use with various barrels. Further, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin V. Erlicnman, 168 USPQ 177, 179.
With regard to claim 16, Gray discloses flexible lips, the interior of the seal is capable to flex against the plunger to orient the tip in an orthogonal orientation to form a plunger sealing interface to the outer periphery which forms the flange sealing surface.
With regard to claim 17, Gray teaches the material of 609 is molded to 606 ([0072]). Gray also teaches during a molding process dovetail grooves may be molded with secondary material to anchor it ([0068], [0069]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to mold the two components such that a projection of one is received in a recess of the other as Gray teaches this is an art effective molding technique. Further, as there are a limitation number of options, either the seal receives the frame or the frame receives the seal, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to mold the components such that the seals have recesses which received projections of the frame. Such a construction would yield the same predictable result of molding the two materials together.
Claim(s) 2-6, 10, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1) and Armstrong (WO 2014/0153572 A1) as applied to claims 1 and 11 above, and further in view of Takeshima (JP 2002360692A).
With regard to claims 2, 10, 12-15, as combined the frame is secured to a flange of the syringe and the seals clamp a plunger strut to cover the back of the syringe. As combined the portions of the frame which face each other along the slot are taken as stoppers but Gray and Armstrong do not teach first and second stoppers of the frames to abut. However, Takeshima teaches a member which attaches about a syringe plunger which can either have an open slit or a latch arm locked with a catch (exemplary Figs. 1, 7, 10, 14, arm and catch 16 and 15). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to latch the frame about the syringe and plunger in Gray as Takeshima teaches this to be equivalent to a slot and would yield the same predictable result with enhanced securement. Further, regarding claims 14 and 15, as combined with Takeshima the arms are shown as in Reference Figure 1 below and are capable of being arranged as claimed.
With regard to claims 3 and 4, see slits 610CSO (Fig. 12). As combined with Takeshima the arms are shown as in Reference Figure 1 below and are capable of being arranged as claimed.
With regard to claim 5, Gray discloses flexible lips, the interior of the seal is capable to flex against the plunger to orient the tip in an orthogonal orientation to form a plunger sealing interface to the outer periphery which forms the flange sealing surface.
With regard to claim 6, Gray teaches the material of 609 is molded to 606 ([0072]). Gray also teaches during a molding process dovetail grooves may be molded with secondary material to anchor it ([0068], [0069]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to mold the two components such that a projection of one is received in a recess of the other as Gray teaches this is an art effective molding technique. Further, as there are a limitation number of options, either the seal receives the frame or the frame receives the seal, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to mold the components such that the seals have recesses which received projections of the frame. Such a construction would yield the same predictable result of molding the two materials together.
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Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1), Armstrong (WO 2014/0153572 A1), and Takeshima (JP 2002360692A) as applied to claim 2 above, and further in view of Chen (CN 108904926 A).
With regard to claim 7, Gray teaches a device substantially as claimed but does not disclose an orifice with an air filter. However, Chen teaches a piston seal with an air film valve 12 to prevent leakage but allow airflow (Fig. 4, abstract, Pg. 3 paragraphs 5 and 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an air filter in Gray as Chen teaches this is beneficial to prevent leakage and allow air flow.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1), Armstrong (WO 2014/0153572 A1), and Takeshima (JP 2002360692A) as applied to claim 2 above, and further in view of Rogers et al. (US 5,555,881).
With regard to claim 8, Gray as combined teaches a device substantially as claimed but does not disclose a hinge pin. However, Rogers et al. teach equivalently using a living hinge or a hinge pin (Col. 3 lines 23-26). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a hinge pin with Gray as combined with Takeshima as Rogers et al. teach this to be equivalent to a living hinge and would yield the same predictable result. As combined the bearing is the hole the pin is inserted into and the arms are the rings of each portion of the frame through which the pin is inserted.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1), Armstrong (WO 2014/0153572 A1), Takeshima (JP 2002360692A), Rogers et al. (US 5,555,881) as applied to claim 8 above, and further in view of Pearson et al. (US 2008/0105253 A1).
With regard to claim 9, Gray as combined teaches a device substantially as claimed but does not disclose a groove so that the hinge pin is slidable. However, Pearson et al. teach a hinge pin which may also slide along a groove for additional range of motion (Fig. 1 groove 12, [0036], [0072]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a groove to allow the hinge to slide as combined in Gray as Pearson et al. teach this is beneficial for range of motion, this would allow the device to accommodate a greater range of plunger sizes.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1) and Armstrong (WO 2014/0153572 A1) as applied to claim 11 above, and further in view of Chen (CN 108904926 A).
With regard to claim 18, Gray teaches a device substantially as claimed but does not disclose an orifice with an air filter. However, Chen teaches a piston seal with an air film valve 12 to prevent leakage but allow airflow (Fig. 4, abstract, Pg. 3 paragraphs 5 and 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an air filter in Gray as Chen teaches this is beneficial to prevent leakage and allow air flow.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1) and Armstrong (WO 2014/0153572 A1) as applied to claim 11 above, and further in view of Rogers et al. (US 5,555,881).
With regard to claim 19, Gray as combined teaches a device substantially as claimed but does not disclose a hinge pin. However, Rogers et al. teach equivalently using a living hinge or a hinge pin (Col. 3 lines 23-26). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a hinge pin with Gray as combined with Takeshima as Rogers et al. teach this to be equivalent to a living hinge and would yield the same predictable result. As combined the bearing is the hole the pin is inserted into and the arms are the rings of each portion of the frame through which the pin is inserted.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US 2003/0139706 A1), Armstrong (WO 2014/0153572 A1), and Rogers et al. (US 5,555,881) as applied to claim 19 above, and further in view of Pearson et al. (US 2008/0105253 A1).
With regard to claim 20, Gray as combined teaches a device substantially as claimed but does not disclose a groove so that the hinge pin is slidable. However, Pearson et al. teach a hinge pin which may also slide along a groove for additional range of motion (Fig. 1 groove 12, [0036], [0072]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a groove to allow the hinge to slide as combined in Gray as Pearson et al. teach this is beneficial for range of motion, this would allow the device to accommodate a greater range of plunger sizes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783