DETAILED ACTION
Claims 1-5, 7, 10-14 are currently pending. Claims 5, 7 and 10-11 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn Rejection
The rejection of claims 5, 7 and 10-11 under 112(b) is withdrawn in view of the instant claim specifying the formula, antecedent basis for octreotide and Applicant pointing to the instant specification defining a connection between the “n” and “x” values and %EWC.
Examiner’s Note
Applicant's amendments and arguments filed 08/13/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 08/13/2025, it is noted that claims 5 and 11 have been amended and no new matter or claims have been added.
New Objection:
The following objection is based on Applicant’s claim amendments.
Claim Objections
Claim 5 is objected to because of the following informalities: Instant claim 5 contains the limitation “polvol” which is a typographical error to the previously recited “polyol”. Appropriate correction is required.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendment.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5, 7 and 10-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0204540 (Applicant provided) in view of US 2005/0037078 (Applicant provided).
Regarding claim 5, the limitation of a drug delivery device for the controlled release of octreotide over an extended period of time to produce local or systemic pharmacological effects, comprising: a) a polyurethane based polymer formed to define a cylindrically-shaped reservoir and b) a solid drug formulation comprising octreotide and optionally one or more pharmaceutically acceptable carriers, wherein the reservoir surrounds the solid drug formulations, wherein the device provides a desired release rate of octreotide from the device after implantation, wherein the device releases the octreotide or pharmaceutically acceptable salt thereof at a substantially zero order rate of in vitro by diffusion through the polyurethane-based polymer at a rate of about 25ug/day to about 4000 ug/day is met by the ‘540 publication teaching octreotide or pharmaceutically acceptable salts thereof which provide controlled release of a therapeutically effective amount of octreotide for a period of at least about 2 months (abstract). The octreotide is contained within polyurethane-based polymers [0018]. Octreotide is contained in a polymer reservoir [0019] which is an implant [0018]. Polyurethane polymers are preferably made into cylindrical hollow tubes with one or two open ends through extrusion [0075]. The two ends are taught to be sealed [0090]. The controlled release formulation may contain hydrophilic copolymers [0023], thus teaching optional carrier. The ‘540 publication teaches the controlled release formulation to be an implant (title). The ‘540 publication teaches the desired daily dosage is for example about 10 to about 1000ug of octreotide per day, more preferably about 30 to about 300 ug of octreotide per day [0086]. The release is taught to be zero-order or near zero order release of the active [0049].
Regarding claim 7, the limitation of wherein the pharmaceutically acceptable carrier is stearic acid is met by the ‘540 publication teaching formulations including octreotide acetate and stearic acid [0151].
The ‘540 publication does not specifically teach wherein the drug delivery device is conditioned and primed under conditions chosen to match the water solubility characteristics of octreotide (claim 5).
The ‘540 publication does not specifically teach wherein the polyurethane-based polymer comprises a reaction product of 4,4’-diisocyanato dicyclohexylmethane, a polyol of the general formula –[O-(CH2)n]x-O, and 1,4-butanediol and has an equilibrium water content of about 5% to about 25wt% (claim 5) and has a flex modulus of about 4,000 to about 4300 (claim 10).
The ‘540 publication does not specifically teach wherein the appropriate conditioning and priming parameters can be selected to establish the desired delivery rates of the at least one active agent, wherein the priming parameters are time, temperature, conditioning medium and priming medium (claim 11).
The ‘078 publication teaches the use of polyurethane-based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane-based polymer completely surrounds the reservoir (abstract). The release of the drug is taught to be affected by the water content and is measured at 24% (Figure 6). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. The flex modulus is taught to be 4,300 or 4,000 [0111]. The ‘078 publication teaches the cartridges are sealed on both ends with filled reservoir, they are conditioned and primed for an appropriate period of time to ensure a constant delivery rate [0087]. The conditions used for conditioning and priming step depend on the active, the temperature and the medium in which they are carried out. The conditions for conditioning and priming may be the same in some instances [0088]. A hydrophilic drug would be preferably conditioned and primed in an aqueous solution and more preferably in saline solution [0090]. The temperature used to condition and prime may vary. The time period may vary. A person skilled in the art would understand the steps of conditioning and priming the implants is to optimize the rate of release of the drug contained within the implant ([0090]-[0093]). The instant specification evidences the structure of Tecophilic polyurethane polymer reads on the claim structure ([0016], [0019]).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the specific Tecophilic polyurethane polymer as taught by the '078 publication [0110] for the polyurethane polymer taught by the '540 publication [0075] because the '078 publication teaches Tecophilic polyurethane polymer is commercially available [0110] and is known to be used to achieve zero order release to maximize therapeutic effects and can be used to form devices that are easy to retrieve if necessary to end treatment [0081] as taught by the ‘078 publication. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success as the ‘540 publication teaches polyurethane polymers to be formed into cylindrical hollow tubes for drug release through extrusion [0075] and the ‘078 publication teaches Tecophilic polyurethane polymer are processed through the extrusion process to form tubes [0110].
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the percent equilibrium water content in the polyurethane polymer as the ‘540 publication teaches the cylindrical device formed of polyurethane [0075] and the ‘078 publication drug releasing polyurethane based cylindrical device which have a water content of 24% ([0114], Figure 6). One of ordinary skill in the art at the time the invention was made would be motivated to optimize the %EWC in the polyurethane polymer in the device of the '540 publication because the '540 publication teaches the EWC value of non-polyurethane polymers used in the implant wherein the EWC value is taught to be desired to be in the range of about 20% to about 75% and have an effect on the drug release rate [0070]. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success as the ‘078 publication teaches a polyurethane polymer which has a water content of 24% being used to form a cylindrical implant for drug delivery (abstract, figure 6, [0114]). Additionally, the ‘078 publication teaches the claimed Tecophilic polyurethane polymer [0110] and thus would be expected to have the claimed EWC value, absent factual evidence to the contrary.
It would have been prima facie obvious to one of ordinary skill in the art before the claimed invention was made to condition and prime the implant taught by the ‘540 publication because the ‘078 publication teaches conditioning and priming is known to optimize the drug release rate. One of ordinary skill in the art before the claimed invention was made would have a reasonable expectation of success as the ‘540 publication teaches polyurethane polymers to be formed into cylindrical hollow tubes for drug release through extrusion [0075] and the ‘078 publication teaches Tecophilic polyurethane polymer are processed through the extrusion process to form tubes [0110], thus both the ‘540 publication and the ‘078 publication are directed to polyurethane drug delivery devices.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
US patent 8,383,577
Claims 5, 7 and 10-11 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US patent 8,383,577 in view of US 2006/0204540 (Applicant provided) and US 2005/0037078 (Applicant provided). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant application and the ‘577 patent are directed to a device for implantation of an octreotide, wherein a therapeutically effective amount of octreotide is released at overlapping amounts, wherein the device is formed of hydrophilic polyurethane polymer and the active agent is contained in the device with the carrier stearic acid. The ‘577 patent and the instant claims differ in that the instant claims require the drug delivery device is conditioned and primed under conditions chosen to match the water solubility characteristics of the at least one active agent and have a specific polyurethane based polymer structure. The ‘540 publication teaches octreotide formulation released over a period of at least two months (abstract) wherein the octreotide is preferably contained within a polyurethane based polymer [0018]. The process of forming the polyurethane formation includes prefabricating a polyurethane formulation and in the final process conditioning and priming the implant to achieve the delivery rates required for the actives ([0092]-[0093]).
The ‘078 publication teaches the use of polyurethane based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane based polymer completely surrounds the reservoir (abstract). The release of the drug is taught to be affected by the water content and is measured at 24% (Figure 6). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. The flex modulus is taught to be 4,300 or 4,000 [0111]. The ‘078 publication teaches the cartridges are sealed on both ends with filled reservoir, they are conditioned and primed for an appropriate period of time to ensure a constant delivery rate [0087]. The conditions used for conditioning and priming step depend on the active, the temperature and the medium in which they are carried out. The conditions for conditioning and priming may be the same in some instances [0088]. A hydrophilic drug would be preferably conditioned and primed in an aqueous solution and more preferably in saline solution [0090]. The temperature used to condition and prime may vary. The time period may vary. A person skilled in the art would understand the steps of conditioning and priming the implants is to optimize the rate of release of the drug contained within the implant ([0090]-[0093]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to subject the implant of the ‘577 patent to conditioning and priming as the ‘540 publication teaches that it is known to conditioning and prime polyurethane implants in order to obtain the delivery rates desired.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the specific Tecophilic polyurethane polymer as taught by the '078 publication [0110] for the polyurethane polymer taught by the ‘577 patent because the '078 publication teaches Tecophilic polyurethane polymer is commercially available [0110] and is known to be used to achieve zero order release to maximize therapeutic effects and can be used to form devices that are easy to retrieve if necessary to end treatment [0081]. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success as the ‘540 publication teaches polyurethane polymers to be formed into cylindrical hollow tubes for drug release through extrusion [0075] and the ‘078 publication teaches Tecophilic polyurethane polymer are processed through the extrusion process to form tubes [0110] and the ‘577 patent teaches the use of polyurethane polymers.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
The ‘540 publication (Kuzma) in view of the ‘078 publication (Kuo):
Applicant argues neither the ‘540 publication or the ‘078 publication disclose or make obvious the drug delivery device of claim 5. The ‘540 publication dose not teach the claimed polyurethane reservoir. The ‘078 publication describes Tecophilic polyurethane polymer reservoirs but not for delivery octreotide. None of these reference describe drug delivery device capable of releasing octreotide at a substantially zero order rate in vitro by diffusion through the polyurethane that comprises the claimed polymer structure, equilibrium water content of 5 to 24% and a rate of about 25 ug to about 4,000 ug a day.
In response, the ‘540 publication is not only as good as exemplified compositions. The ‘540 publication octreotide is contained in a polymer reservoir [0019] which is an implant [0018]. Polyurethane polymers are preferably made into cylindrical hollow tubes with one or two open ends through extrusion [0075]. The two ends are taught to be sealed [0090]. The ‘540 publication teaches the desired daily dosage is for example about 10 to about 1000ug of octreotide per day, more preferably about 30 to about 300 ug of octreotide per day [0086]. The release is taught to be zero-order or near zero order release of the active [0049]. The ‘078 publication teaches the use of polyurethane-based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane based polymer completely surrounds the reservoir (abstract). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. The instant specification evidences the structure of Tecophilic polyurethane polymer reads on the claim structure ([0016], [0019]). Thus the ‘540 publication teaches the use of polyurethane polymers to be formed into a tube for drug release and the ‘078 publication teaches a specific polyurethane polymer known to be formed into a tube for drug release, thus making it obvious to use a specific known polyurethane polymer which may be optimized for drug release for the polyurethane polymer taught by the ‘540 publication.
Applicant argues the design and performance of reservoir type implantable dosage forms remains highly unpredictable even to those of extraordinary skill in the art, see Siepmann.
In response, as discussed above the ‘540 publication teaches the use of polyurethane polymers for the implant material. The ‘078 publication is directed to a specific polyurethane material which is commercially available for use in tubes for drug delivery at a constant rate (abstract, [0110], [0081]). The ‘078 publication additionally teaches a method of optimizing the release rate of the drug through equilibrium water content of the polyurethane polymer [0070]. Thus the ‘540 publication teaches the use of polyurethane polymers for controlled release of an implant formed as a cylindrical tube and the ‘078 publication teaches a specific polyurethane polymer for drug release from a cylindrical implant, wherein method of optimizing the drug release rate are known.
Applicant argues the unpredictability inherent in this art is underscored by the examples of the present application. Table 2A and 2C seen that octreotide acetate eluted in therapeutically relevant amounts from Tecophilic polyurethanes, in Table 2B did not elute at therapeutic level if at all from Tecoflex. Even a small different in chemical structure had a significant and unpredictable effects on drug elution behavior. There is a much greater different between the acrylate of the ‘540 publication and Tecophilic than of those in the presented examples.
In response, as addressed above the ‘540 publication teaches the use of a polyurethane polymer for the implantable material, thus acrylate polymers do not need to be substituted for polyurethane polymers, as the polyurethane polymer is already taught. Further the tables in the instant specification demonstrate different variables in polyurethane polymers that are known to affect the release rate of the active agent. It is noted that one of the tested variables having a large effect on release rate is EWC% which is not specified in the claim and is a known factor in affecting release rates as discussed above and in the ‘078 publication. Further Applicant has not provided Tecoflex polymer structure tested, thus it is not possible to compare the Tecophilic and Tecoflex polymer structures. Additionally providing differences in the release rate of the polymers does not mean the polymer wouldn’t work, a difference in release rate is expected as the polymer are structurally different. Thus Applicant has not demonstrated unexpected results.
Applicant argues the ‘540 publication describes a hydrogel which provides consistent predetermined and controlled release of octreotide upon subcutaneous implantation under the skin. Preferable hydrogels include methacrylate and polyurethane based polymer. Despite the knowledge of how to prepare polyurethane formulations for making reservoir devices, for any new combination of active ingredient and polymer, those of skill must still measure the diffusivity of the active agent through rate limiting polymer membrane [0082]-[0085]. The diffusivity of the active agent through a given polymer must be determine on an empirical basis because there was at the time of the invention and remains to this day no reliable manner of predicting the elution behavior of any untried combination of rate liming polymer. Despite the disclosure of potential polyurethane materials for use in the manufacture, the ‘540 publication discloses no actual examples.
In response, the ‘540 publication is not only as good as exemplified compositions. The ‘540 publication octreotide is contained in a polymer reservoir [0019] which is an implant [0018]. Polyurethane polymers are preferably made into cylindrical hollow tubes with one or two open ends through extrusion [0075]. The two ends are taught to be sealed [0090]. The ‘078 publication teaches the use of polyurethane based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane based polymer completely surrounds the reservoir (abstract). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. Thus the ‘540 publication teaches the use of polyurethane polymers to be formed into a tube for drug release and the ‘078 publication teaches a specific polyurethane polymer known to be formed into a tube for drug release, thus making it obvious to use a specific known polyurethane polymer which may be optimized for drug release for the polyurethane polymer taught by the ‘540 publication.
Applicant argues the only actual examples of devices made and tested in the ‘540 publication was made of acrylic hydrogels, and there is no reasonable basis to predict the permeability of octreotide through polyurethanes, if only because the significant structural different between acrylic hydrogels and polyurethanes. But even with the context of the work with acrylic hydrogels difficulties arose in identifying suitable polymers that would release octreotide without complications. Examples 1 and 3 caused bursting due to osmotic pressure.
In response, the ‘540 publication is not only as good as exemplified compositions. The ‘540 publication octreotide is contained in a polymer reservoir [0019] which is an implant [0018]. Polyurethane polymers are preferably made into cylindrical hollow tubes with one or two open ends through extrusion [0075]. The two ends are taught to be sealed [0090]. The ‘078 publication teaches the use of polyurethane based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane based polymer completely surrounds the reservoir (abstract). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. Thus the ‘540 publication teaches the use of polyurethane polymers to be formed into a tube for drug release and the ‘078 publication teaches a specific polyurethane polymer known to be formed into a tube for drug release, thus making it obvious to use a specific known polyurethane polymer which may be optimized for drug release for the polyurethane polymer taught by the ‘540 publication and providing for a reasonable expectation of success.
Applicant argues the ‘078 publication does describe the actual preparation and testing of polyurethane based reservoir. Both the ‘540 and the ‘078 teach that when a polyurethane devise is used for delivery of water soluble drug, the release rate can be controlled by incorporating hydrophilic pendant groups to include hydrophilic of the polymer. Examples of the ‘078 publication describe the effective elution of highly water soluble drugs from hydrophilic Tecophilic polyurethanes. Octreotide however is far less water soluble than any of these drugs. Both the ‘540 publication and the ‘078 publication teach that sparingly water soluble drugs should be paired with hydrophilic, not hydrophilic polyurethanes. It follows that effective elution of octreotide form hydrophilic polyurethane such as Tecophilic would not be expected and would indeed be unexpected.
In response, the ‘540 publication teaches the use of pendent groups depending on the solubility of the drug, however additionally teaches that the release rates of the actives can be controlled by the hydrophilicity/hydrophobicity of the polyurethane polymers [0080], thus teaching the addition of pendant group is not required. The ‘078 publication teaches the use of polyurethane polymers can be used for hydrophobic drugs with the use of different conditioning or priming steps [0096], thus polymers of the ‘078 publication can be used for hydrophilic or hydrophobic drugs.
Applicant argues Siepmann only three weeks before the priority date of the present application, would not have allowed the skilled person to conclude reasonably the claimed implant would delivery octreotide in therapeutically effective manner. Sipeman observes that in practice often deviations from the ideal systems are observed and that any conclusion should be vied with great caution. Thus, at the time the invention those skilled in the art would not have reasonably predicted the outcome of a previously untested combination of drug and membrane material as presently claimed, which combination accordingly would not have been prima facie obvious over the ‘540 publication in view of the ‘078 publication.
In response, the ‘540 publication is not only as good as exemplified compositions. The ‘540 publication octreotide is contained in a polymer reservoir [0019] which is an implant [0018]. Polyurethane polymers are preferably made into cylindrical hollow tubes with one or two open ends through extrusion [0075]. The two ends are taught to be sealed [0090]. The ‘078 publication teaches the use of polyurethane based polymer as a drug delivery device which delivers the drug at a constant rate for an extended period of time comprising a reservoir wherein the reservoir contains at least one active ingredient and one carrier and wherein the polyurethane based polymer completely surrounds the reservoir (abstract). Tubes are taught to be formed by Tecophilic polyurethane polymer and processed through the extrusion process [0110]. The drug delivery device is taught to achieve controlled release to maximize therapeutic effects and minimize unwanted side effects and can be easy to retrieve the device if necessary to end treatment [0081]. Thus the ‘540 publication teaches the use of polyurethane polymers to be formed into a tube for drug release and the ‘078 publication teaches a specific polyurethane polymer known to be formed into a tube for drug release, thus making it obvious to use a specific known polyurethane polymer which may be optimized for drug release for the polyurethane polymer taught by the ‘540 publication. The ‘078 publication teaches the use of polyurethane polymers can be used for hydrophobic drugs with the use of different conditioning or priming steps [0096], thus polymers of the ‘078 publication can be used for hydrophilic or hydrophobic drugs.
Double Patenting:
Applicant asks the double patenting rejection be held in abeyance until the claims are otherwise found allowable.
In response, Applicant submitted no substantive arguments and thus the rejection is maintained for reasons of record.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613