FINAL REJECTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed on 03/24/2026 does not comply with the requirements of 37 CFR 1.121(c)(2) because new claim 21 is not underlined in its entirety. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.” (emphasis added)
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 1, 4-9, 11-14, 17, 19-21 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. Independent claims 1 and 14 have been amended to include the new claim language of “remain still and stable.” The claims and the specification do not provide the metes and bounds of the terms “remain still and stable.” These words are not used in the specification and the specification does not provide any description of how or to what degree “remain still and stable” is achieved. Rather, the specification describes “securement to the patient’s skin.”
Claim 21 recites the limitation "the septum access cannula” and “the integrated catheter septum.” There is insufficient antecedent basis for these limitations in this claim. Changing the dependency of claim 21 from claim 1 to claim 6 would correct the insufficient antecedent basis since claim 4 introduces “a septum access cannula” and claim 6 introduces “an integrated catheter septum.” It is noted that for prior art evaluation below it is assumed that claim 21 depends from claim 6 since claim 6 and claim 4 from which it depends support the limitations of "the septum access cannula” and “the integrated catheter septum.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 8, 11-12, 14, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2019/0321599 to Burkholz et al. (“Burkholz ‘599”) in view of CA 2413941 to Bierman et al. (“Bierman”).
Regarding claim 1, Burkholz ‘599 teaches a vascular access system (see Figs. 1D and 2C) for use with a blood draw or probe delivery device (see Fig. 2D), the system comprising: a catheter adapter (12) having a proximal end portion (16) and a distal end portion (14), wherein a catheter (20) extends from the distal end portion of the catheter adapter (see Figs. 1A and 1B and para. [0039]); and an extension set (see Figs. 1A and 1B), the extension set comprising: a stabilization platform (see below), a catheter adapter interface (34), wherein the catheter adapter interface is configured to secure the proximal end portion of the catheter adapter (see Fig. 1B and para. [0041]), and a probe access portion (30), wherein the probe access portion comprises a needle free connector (30/38) configured to receive a distal connector portion of the blood draw or probe delivery device (see Figs. 1C and 2D), and wherein the probe access portion is positioned in-line with the catheter adapter to provide a direct fluid path for a tube or probe of the blood draw or probe delivery device to be advanced through the probe access portion, the catheter adapter, and the catheter (see Fig. 1C and 2D).
Regarding the newly added claim limitations to claim 1 in the amendment filed 03/24/2026, Burkholz ‘599 either explicitly teaches these limitations or provides a teaching, suggestion or motivation for incorporating these claim limitations.
Burkholz ‘599 teaches that the stabilization platform is securable to the skin of a patient (see stabilization platform (55 and 72) and para. [0057] stating, “In some embodiments, the platforms 55 may each include an adhesive layer 56, which may be configured to contact the skin of the patient. In some embodiments, the adhesive layer 56 may be covered by a removable backing layer, which may be removed prior to securing the stabilization feature 54 to the patient.” (emphasis added)).
Burkholz ‘599 further teaches an intermediate tubing (24) disposed between the proximal end portion of the catheter adapter (12) and the probe access portion (30/38). Additionally, the probe access portion (30/38) is disclosed as a luer adapter (see para. [0040] stating, “In some embodiments, the connector 30 may include a luer adapter, such as a male or female luer adapter, or any other suitable connector. In some embodiments, the connector 30 may be a luer-activated needleless connector or a non-luer activated needleless connector. In some embodiments, the connector 30 may include a SMARTSITE™ Needle-Free Connector available from Becton, Dickinson and Company, a Q-SYTE™ Luer Activated Split Septum available from Becton, Dickinson and Company, an INTERLINK™ Needlefree System available from Baxter, or another similar connector.”)
Regarding the claim limitation of “wherein the probe access portion is directly coupled to a top surface of the stabilization platform,” Burkholz ‘599 does not show this configuration. However, Burkholz ‘599 contemplates multiple stabilization platforms and a stabilization platform being connected to the probe access portion (30) (see para. [0055] stating, “In some embodiments, the stabilization feature 54 may be disposed on the connector 30 or the connector 34. … In some embodiments, the stabilization feature 54 may snap onto the connector 30 and/or the connector 34.” and para. [0052] stating, “In some embodiments, the stabilization feature 54 may include one or more platforms 55, which may be configured to contact the skin of the patient.” (emphasis added)).
Bierman depicts and discloses such a stabilization platform (pad 28 and retainer 30). As shown in Figs. 1 and 11A-F a luer lock connector is directly coupled to the top surface of the stabilization platform. See also Fig. 1 which shows the pad and retainer secured to the skin of a patient. Additionally, Bierman is titled as Anchoring System for Luer Lock Connector and states, “[a] further aspect of the present invention involves an anchoring system for securely anchoring to a patient a luer lock connector.”
At the time of filing, it would have been obvious to one skilled in the art to incorporate Bierman’s stabilization platform into the invention of Burkholz ‘599 to stabilize the probe access portion (30/38) directly to the top of a stabilization platform and secured to the skin of a patient as shown in Bierman Fig. 1. First, both references are analogous in the art of catheter stabilization systems; therefore, a combination is proper. Additionally, Burkholz ‘599 already contemplates the use of a stabilization platform with retainer for the probe access portion (30/38) but does not show that configuration (see disclosure in Burkholz ‘599 above). Bierman’s stabilization platform (28 and 30) is a structure that is designed for luer locks such as the Burkholz ‘599 probe access portion (see above). The motivation to make the incorporation is found in the references themselves and would have been carried out into order to achieve a function already contemplated (see disclosure of Burkholz ‘599 above).
Regarding the claim limitation of “with the catheter adapter interface being moveable relative to the probe access portion while the stabilization platform and probe access portion remain still and stable on the skin of the patient,” Burkholz ‘599 discloses that catheter adapter interface (34) includes a free rotating collar (see para. [0041] stating, “In some embodiments, the connector 34 may include a luer adapter, such as a male or female luer adapter, or any other suitable connector. In some embodiments, the luer adapter may include a rotating collar luer lock. For example, the luer adapter may include a free rotating collar with threads, and locking may be achieved by rotating the collar.” (emphasis added)). This rotation capability makes the catheter adapter interface movable relative to the probe access portion while the stabilization platform of the probe access portion remains still and stable on the skin of the patient.
Regarding claim 8, Burkholz ‘599 teaches the system of claim 1 and also wherein the catheter adapter interface (34) is configured to non-removably secure the proximal end portion of the catheter adapter (see para. [0041] stating, the connector may … fixedly couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12.” The disclosure of “fixedly couple” is non-removably secure).
Regarding claim 11, Burkholz ‘599 teaches the system of claim 1 and also wherein the extension set further comprises a proximal extension tubing (44) extending from a side surface of the probe access portion (30) distal to the needle free connector (38).
Regarding claim 12, Burkholz ‘599 teaches the system of claim 11 and also wherein the proximal extension tubing (44) extends from the side surface of the probe access portion at an angle between 30°-150° relative to a longitudinal axis of the probe access portion (see Fig. 1B which shows an angle of between 30°-150° relative to a longitudinal axis of the probe access portion).
Regarding claim 14, Burkholz ‘599 teaches an extension set for use with a vascular access device (see Figs. 1D and 2C), the extension set comprising: a stabilization platform (see below); a catheter adapter interface (34), wherein the catheter adapter interface is configured to secure a proximal end portion of a catheter adapter of the vascular access device (see Fig. 1B); a septum access cannula (see annotated Fig. 1B below) extending distally from the catheter adapter interface; and a probe access portion (30/38), wherein the probe access portion comprises a needle free connector (38) configured to receive a distal connector portion of a blood draw or probe delivery device, and wherein the probe access portion is positioned in-line with the septum access cannula (see Fig. 1C and 2D).
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Regarding the newly added claim limitations to claim 1 in the amendment filed 03/24/2026, Burkholz ‘599 either explicitly teaches these limitations or provides a teaching, suggestion or motivation for incorporating these claim limitations.
Burkholz ‘599 teaches that the stabilization platform is securable to the skin of a patient (see stabilization platform (55 and 72) and para. [0057] stating, “In some embodiments, the platforms 55 may each include an adhesive layer 56, which may be configured to contact the skin of the patient. In some embodiments, the adhesive layer 56 may be covered by a removable backing layer, which may be removed prior to securing the stabilization feature 54 to the patient.” (emphasis added)).
Burkholz ‘599 further teaches an intermediate tubing (24) disposed between the proximal end portion of the catheter adapter (12) and the probe access portion (30/38). Additionally, the probe access portion (30/38) is disclosed as a luer adapter (see para. [0040] stating, “In some embodiments, the connector 30 may include a luer adapter, such as a male or female luer adapter, or any other suitable connector. In some embodiments, the connector 30 may be a luer-activated needleless connector or a non-luer activated needleless connector. In some embodiments, the connector 30 may include a SMARTSITE™ Needle-Free Connector available from Becton, Dickinson and Company, a Q-SYTE™ Luer Activated Split Septum available from Becton, Dickinson and Company, an INTERLINK™ Needlefree System available from Baxter, or another similar connector.”)
Regarding the claim limitation of “wherein the probe access portion is directly coupled to a top surface of the stabilization platform,” Burkholz ‘599 does not show this configuration. However, Burkholz ‘599 contemplates multiple stabilization platforms and a stabilization platform being connected to the probe access portion (30) (see para. [0055] stating, “In some embodiments, the stabilization feature 54 may be disposed on the connector 30 or the connector 34. … In some embodiments, the stabilization feature 54 may snap onto the connector 30 and/or the connector 34.” and para. [0052] stating, “In some embodiments, the stabilization feature 54 may include one or more platforms 55, which may be configured to contact the skin of the patient.” (emphasis added)).
Bierman depicts and discloses such a stabilization platform (pad 28 and retainer 30). As shown in Figs. 1 and 11A-F a luer lock connector is directly coupled to the top surface of the stabilization platform. See also Fig. 1 which shows the pad and retainer secured to the skin of a patient. Additionally, Bierman is titled as Anchoring System for Luer Lock Connector and states, “[a] further aspect of the present invention involves an anchoring system for securely anchoring to a patient a luer lock connector.”
At the time of filing, it would have been obvious to one skilled in the art to incorporate Bierman’s stabilization platform into the invention of Burkholz ‘599 to stabilize the probe access portion (30/38) directly to the top of a stabilization platform and secured to the skin of a patient as shown in Bierman Fig. 1. First, both references are analogous in the art of catheter stabilization systems; therefore, a combination is proper. Additionally, Burkholz ‘599 already contemplates the use of a stabilization platform with retainer for the probe access portion (30/38) but does not show that configuration (see disclosure in Burkholz ‘599 above). Bierman’s stabilization platform (28 and 30) is a structure that is designed for luer locks such as the Burkholz ‘599 probe access portion (see above). The motivation to make the incorporation is found in the references themselves and would have been carried out into order to achieve a function already contemplated (see disclosure of Burkholz ‘599 above).
Regarding the claim limitation of “with the catheter adapter interface being moveable relative to the probe access portion while the stabilization platform and probe access portion remain still and stable on the skin of the patient,” Burkholz ‘599 discloses that catheter adapter interface (34) includes a free rotating collar (see para. [0041] stating, “In some embodiments, the connector 34 may include a luer adapter, such as a male or female luer adapter, or any other suitable connector. In some embodiments, the luer adapter may include a rotating collar luer lock. For example, the luer adapter may include a free rotating collar with threads, and locking may be achieved by rotating the collar.” (emphasis added)). This rotation capability makes the catheter adapter interface movable relative to the probe access portion while the stabilization platform of the probe access portion remains still and stable on the skin of the patient.
Regarding claim 17, Burkholz ‘599 teaches the system of claim 14 and also wherein the stabilization platform is angled such that the septum access cannula is angled toward a patient's skin surface (see Fig. 2D).
Regarding claim 19, Burkholz ‘599 teaches the system of claim 14 and also wherein the extension set further comprises a proximal extension tubing (44) extending from a side surface of the probe access portion (30) distal to the needle free connector (38).
Claim(s) 4-7, 9, 14, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘599 in view of Bierman and in further view of US Pub. No. 2020/0078565 to Scherich et al. (“Scherich”).
If Burkholz ‘599 in view of Bierman is found to not teach a septum access cannula extending distally from the catheter adapter interface than a septum access cannula would have been obvious in view of Scherich.
Regarding claim 4, Burkholz ‘599 in view of Bierman teaches the system of claim 1 but does not teach a septum access cannula or the catheter adapter inface including a plurality of arms or clips protruding out distally past a distal end of the plurality of arms or clips. However, Scherich teaches an extension set (see Fig. 1A) further comprising a septum access cannula (38) extending distally from the catheter adapter interface (10). As shown in Fig. 1A, the septum access cannula protrudes out distally past a distal end of the plurality of arms or clips (30).
At the time of filing, it would have been obvious to incorporate the septum access cannula into the invention of Burkholz ‘599 in view of Bierman. Both devices are analogous in the art of over the needle peripheral intravenous catheters; therefore, a combination is proper. Additionally, Scherich provides the advantage that the septum access cannula provides a generally straight pathway for inserting an instrument (see Para. [0009]). Therefore, one skilled in the art would have made the combination in order to provide the device of Burkholz ‘599 in view of Bierman with an enhanced insertion configuration.
As noted above, Scherich teaches that the catheter adapter interface (10) comprises a plurality of arms (30) to secure the proximal end portion of the catheter adapter (see para. [0038]).
At the time of filing, it would have been obvious to incorporate the catheter adapter interface (10) with arm features (30) into the invention of Burkholz ‘599 in view of Bierman. Both devices are analogous in the art of over the needle peripheral intravenous catheters; therefore, a combination is proper. Additionally, this substitution would have been done in order to provide the device of Burkholz ‘599 in view of Bierman with an attachment mechanism that does not require rotation of the connector thereby resulting in an easier one-handed assembly configuration. It is noted that this combination would still meet the claim limitation of “with the catheter adapter interface being moveable relative to the probe access portion while the stabilization platform and probe access portion remain still and stable on the skin of the patient” since the arms will still be above to move in a radial outward direction when the catheter adapter is connected to the catheter adapter interface.
Regarding claim 5, Scherich teaches the system of claim 4 and also wherein the septum access cannula comprises a blunt cannula (see Fig. 1A).
Regarding claim 6, Scherich teaches the system of claim 4 and also wherein the catheter adapter (12) further comprises an integrated catheter septum (40) disposed within the proximal end portion (16) thereof (see Fig. 1C), and wherein the integrated catheter septum (40) is configured to receive the septum access cannula therein (see para. [0040]).
Regarding claim 7, Scherich teaches the system of claim 4 and also wherein the stabilization platform is angled such that the septum access cannula is angled toward a patient's skin surface (see Figs. 1A and 1B).
Regarding claim 9, Burkholz ‘599 in view of Bierman teaches the system of claim 8 but does not teach wherein the catheter adapter interface comprises a plurality of snap features to secure the proximal end portion of the catheter adapter. However, Scherich teaches that the catheter adapter interface (10) comprises a plurality of snap features (30) to secure the proximal end portion of the catheter adapter (see para. [0038]).
At the time of filing, it would have been obvious to incorporate the catheter adapter interface (10) with snap features (30) into the invention of Burkholz ‘599 in view of Bierman. Both devices are analogous in the art of over the needle peripheral intravenous catheters; therefore, a combination is proper. Additionally, this substitution would have been done in order to provide the device of Burkholz ‘599 in view of Bierman with an attachment mechanism that does not require rotation of the connector thereby resulting in an easier one-handed assembly configuration.
Regarding claim 14, Burkholz ‘599 in view of Bierman teaches an extension set for use with a vascular access device (see Figs. 1D and 2C), see rejection over Burkholz ‘599 in view of Bierman above.
Burkholz ‘599 in view of Bierman teaches the system of claim 14 but does not teach a septum access cannula extending distally from the catheter adapter interface. However, Scherich teaches an extension set (see Fig. 1A) further comprising a septum access cannula (38) extending distally from the catheter adapter interface (10).
At the time of filing, it would have been obvious to incorporate the septum access cannula into the invention of Burkholz ‘599 in view of Bierman. Both devices are analogous in the art of over the needle peripheral intravenous catheters; therefore, a combination is proper. Additionally, Scherich provides the advantage that the septum access cannula provides a generally straight pathway for inserting an instrument (see Para. [0009]). Therefore, one skilled in the art would have made the combination in order to provide the device of Burkholz ‘599 in view of Bierman with an enhanced insertion configuration.
Regarding claim 17, Burkholz ‘599 in view of Bierman teaches the system of claim 14 and also wherein the stabilization platform is angled such that the septum access cannula is angled toward a patient's skin surface (see Fig. 2D).
Regarding claim 19, Burkholz ‘599 teaches the system of claim 14 and also wherein the extension set further comprises a proximal extension tubing (44) extending from a side surface of the probe access portion (30) distal to the needle free connector (38).
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘599 in view of Bierman alone or in view of Scherich in further view of WO2019/241369 to NP MEDICAL INC (“WO’369”).
Regarding claims 13 and 20, Burkholz ‘599 in view of Bierman alone or in view of Scherich teaches the system of claims 11 and 19 as described above and teaches wherein the probe access portion (30) includes at least one of an offset side port (see annotated Fig. 1B below) from which the proximal extension tubing (44) extends but Burkholz ‘599 does not teach a vortex feature. However, WO’369 teaches a vortex feature (frusto-conical portion 180) within a fluid path of the probe access portion (see Figs. 5A-5D). The limitation of “to direct fluid directed through the proximal extension tubing toward the needle free connector” is function in nature and the prior art only has to be capable of achieving this function. The frusto-conical portion 180 of WO’369 is capable of achieving this function since Fig. 5D shows (arrows) the flushing toward the needle free connector. At the time of filing, it would have been obvious to incorporate the flushing feature into the invention of Burkholz ‘599 in view of Bierman in order to provide an enhanced flushing capability that is not readily available with needle free connectors having extension tubes. As stated by WO’369 “when flushing through the extension set tubing, it is difficult to flush the needle free connector portion of the system, as it is not naturally within the direction of flow.” The flushing feature as taught by WO’369 solves this problem.
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Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz ‘599 in view of Bierman and Scherich and in further view of US Pub. No. 2020/0023176 to Hu et al. (“Hu”).
It is noted that for prior art evaluation it is assumed that claim 21 depends from claim 6 since claim 6 and claim 4 from which it depends support the limitations of "the septum access cannula” and “the integrated catheter septum.”
Burkholz ‘599 in view of Bierman and Scherich meets the claim limitations for claim 6 as described above but fails to teach a side hole in the septum access cannula and “wherein when the catheter adapter interface is secured to the proximal end portion of the catheter adapter, the side hole is positioned distal to a distal surface of the integrated catheter septum, to enable flushing of the catheter adapter.”
However, Hu discloses such a cannula and side hole. Hu shows two embodiments of a cannula (68/70) with side hole (72) at the distal end of the cannula. See Figs. 2C and 2D. See also paras. [0051-0052] which disclose that the side hole is used for flushing.
At the time of filing, one skilled in the art would have found it obvious to incorporate the distal side hole(s) into the invention of Burkholz ‘599 in view of Bierman and Scherich in order to provide the known capability of flushing the catheter chamber which would enhance the usability of the device to ensure all medicament is delivered and to leave a residual fluid in the catheter line so that blood does not back up into the catheter chamber. It is also noted that since Hu teaches that the flushing holes (72) are at the distal end of the catheter, once incorporated into the invention of Burkholz ‘599 in view of Bierman and Scherich the combined configuration will meet the claim limitation of “wherein when the catheter adapter interface is secured to the proximal end portion of the catheter adapter, the side hole is positioned distal to a distal surface of the integrated catheter septum, to enable flushing of the catheter adapter.” In particular see Fig. 1C of Scherich which shows that hole(s) at the distal end of the septum access cannula would be distal to the integrated catheter septum.
Response to Arguments
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive. Applicant argues that Burkholz ‘599 fails to meet the new claim limitations. Applicant does specifically argue with respect to Burkholz ‘599 that “it is not possible for the connector 34 to be movable relative to the connector 30 while the stabilization feature 54/72 and connector 30 remain still and stable on the skin of the patent…” However, the rejection above addresses this functional capability. Additionally, the rejection now includes new combinations of prior art in light of the amendments to the claims. See rejections of the claims above.
It is noted that applicant did not provide arguments against the merits of the combination of Burkholz ‘599 with Scherich or NP Medical but merely indicated that these references would not address the deficiencies of Burkholz ‘599.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
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