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 .
Response to Amendment
The amendment filed 11/17/25 has been entered. Claims 10-11 have been amended. Claims 1, 4-6, 8, 12-13, and 16 are in the original/ previously presented form. Claims 2-3, 7, 9, 14-15, and 17-24 are cancelled. Thus, claims 1, 4-6, 8, 10-13, and 16 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 08/15/25.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a coupling for coupling” in line 6 of claim 1. A coupling is considered a generic placeholder for “means” and the claim does not recite further structure for this “coupling for coupling” to the delivery device. Applicant’s disclosure [0070] reads: An inlet end of cartridge 76 includes a coupling 80 for connecting to the fluid coupling 82 of the dispensing device or pump mechanism for supplying insulin formulation to the infusion set.”, this inlet end coupling mechanism 80 appears to be a threaded connection as in FIG.10. Thus, a “coupling for coupling” as in claim 1 is interpreted as a threaded connection
An inlet end with “a coupling for connecting to said pump mechanism” in lines 11-12 of claim 13. Similar to the claim interpretation applied in claim 1 above, the coupling mechanism 80 of the inlet end appears to be a threaded connection in FIG. 10 and thus a “coupling for connecting” is interpreted as a threaded connection
An outlet end with a recess having “a coupling member for connecting” to said base in lines 12-13 of claim 13. According to Applicant’s [0071]: The open bottom end has a recess 89 for coupling with the coupling 94 of the infusion set... Thus, it appears that the “coupling member” for coupling is the recess itself because the recess 89 is the member that interacts with the coupler of the base 94. Thus, it is interpreted that the “coupling member” for connecting to the base is a recess of the outlet end of the device.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan et al. (U.S. PGPUB No. 2006/0102555), hereinafter Jordan, in view of Davies et al. (U.S. PGPUB No. 2012/0130346), hereinafter Davies, and Ward et al. (U.S. PGPUB No. 2016/0354542), hereinafter Ward.
Regarding claim 1, Jordan discloses a delivery device for delivering a substance to a patient (see Fig. 1 and [0004]: device for connecting to syringes for purposes such as injecting fluids and [0015]: specifically to a patient), comprising:
a storage container containing the substance (see [0004], [0011], [0016], [0035], [0038]: device is connectable to a syringe for injecting a fluid and therefore the device comprises a storage container==syringe when the syringe is connected at portion 1 as detailed in [0035]);
a pen needle (see [0035]: luer lok threads 9 for securing a luer lok (e.g., hub portion of a needle) and therefore the device comprises a needle when a needle hub is affixed at 9) connected to said storage container (see [0035]: s syringe affixed at portion 1) by a fluid pathway (via lumens 3 & 10, see [0035]: input lumen 3 and output lumen 10), said pen needle (needle of needle hub assembly affixed at 9, see [0035]) having a proximal end (proximal end of lumen 10 abutting filter 6) for receiving the substance (fluid moves from input lumen 3 to output lumen 10, see [0035] and thus the proximal end of lumen 10 receives the substance first) and a distal end with a cannula for injecting the substance into the patient (see [0035]: a needle hub is affixed via threads 9 and therefore the substance moves from lumen 10 and out needle of needle hub to be injected into patient); and
a filter cartridge (5) having an inlet end (1) with a coupling for coupling (2, see [0035]: a luer lok flange 2 connects syringe to device. Thus, Jordan discloses a ‘threaded’ coupling for coupling as interpreted under 112f above) with the storage container (syringe as in at least [0035]), an outlet end (7) connected to said pen needle (needle hub as in at least [0035]), and an internal cavity (see cavity containing filter 6), a filter (6) positioned in said internal cavity (as seen in FIG. 1) and in a fluid pathway between (see [0035]: filter located between inlet and outlet lumens) said storage container (syringe connected via inlet lumen 3 as in at least [0035]) and said pen needle (needle hub including needle connected at outlet lumen 7 as in at least [0035]) for removing selected compounds from said substance before delivering to the patient (see [0005]: filters used to remove unwanted particulate in fluids and [0016], [0037-0038]: filter can be different porosities and materials and thus designed for different filtration purposes),
wherein said inlet end (1) of said filter cartridge (5) is an open end (see open end leading into inlet lumen 3)
Jordan is silent to the filter being “an activated charcoal adsorbent” and the filter cartridge open end “with a filter cartridge cannula for piercing a septum in an outlet end of said storage container, a distal end of said filter cartridge cannula being disposed immediately adjacent said activated charcoal adsorbent.”
However, Davies teaches a drug delivery device with a cartridge (4, see FIG. 2 and [0063]: a module==cartridge 4 for attaching to drug delivery device 7) for connecting to (connected as shown in FIG. 2) a storage container (11), wherein an inlet end (see rightward end of 4 disposed over threads 8 of device 7) of said cartridge (4) is an open end (see open end disposed over threads of drug delivery device 7) immediately adjacent an internal cavity (17). Further, the open end (rightward end) comprises a cartridge cannula (15) for piercing a septum (10, septum 10 labeled in FIG. 2 but also shown in FIG. 1 without label. See [0064]: attachment of cartridge 4 causes needle 15 to penetrate septum 10) in an outlet end (leftward end of device 7 housing cartridge 11 as shown in FIG. 2) of said storage container (11).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter cartridge inlet end comprising an open end for connecting to a storage container disclosed in Jordan to include a proximally extending needle immediately adjacent the internal cavity as taught by Davies for the purpose of piercing a septum of a container to provide a fluid connection (see [0063]) in a case where the connected storage container has a sealed cartridge containing the medicament, such as a prefilled syringe, thus achieving the filter cartridge open end “with a filter cartridge cannula for piercing a septum in an outlet end of said storage container, a distal end of said filter cartridge cannula being disposed immediately adjacent said” cavity containing the filter
Jordan in view of Davies is silent to the filter being specifically “an activated charcoal adsorbent”.
However, Ward teaches a drug delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8) with a filter (12) made of an activated charcoal adsorbent (i.e., charcoal and activated carbon, see [0053]: charcoal can be used to filter harmful compounds like phenol) for filtering selected compounds from the substance prior to delivering the substance to a patient (see [0052]: filtering phenolics from an insulin formulation).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving the filter being specifically “an activated charcoal adsorbent”.
Regarding claim 4, the modified system of Jordan teaches the delivery device of claim 1, but Jordan is silent to “wherein said substance comprises an insulin formulation containing a phenolic stabilizing agent, and wherein said activated charcoal adsorbent is adapted for removing said phenolic stabilizing agent from said insulin formulation before delivering to the patient.”
However, Ward teaches a delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8), wherein said substance comprises an insulin formulation (see Ward [0028]: insulin formulation delivered to the filter) containing a phenolic stabilizing agent (see [0031]: insulin formulation includes phenolic stabilizing agent such as phenol/ m-cresol), and wherein an activated charcoal adsorbent (see [0053]: filter material may be charcoal) is adapted for removing said phenolic stabilizing agent from said insulin formulation before delivery to a patient (see [0052]: the filter is designed to filter out m-cresol/phenol).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the storage container containing a substance disclosed in Jordan to contain an insulin formulation containing a phenolic stabilizing agent as taught by Ward for the purpose of using a readily available formulation (see [0031]) for treating a specific medical condition, like diabetes (see [0002]), thus achieving “wherein said substance comprises an insulin formulation containing a phenolic stabilizing agent”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving “and wherein said activated charcoal adsorbent is adapted for removing said phenolic stabilizing agent from said insulin formulation before delivering to the patient.”
Regarding claim 8, the modified system of Jordan teaches the delivery device of claim 1, and Jordan further discloses wherein said delivery device comprises a pen needle assembly (see [0035]: luer lok threads 9 for securing a luer lok (e.g., hub portion of a needle) and therefore the device comprises a needle assembly when a needle hub is affixed at 9) and said pen needle (needle hub connected at outlet lumen 7 as in at least [0035]) having said cannula (needle hub including a needle ==cannula, see [0035]); and wherein said filter cartridge (5, see Fig. 1) is oriented in said flow path (via lumens 3 & 10, see [0035]: input lumen 3 and output lumen 10 with filter located between).
Jordan remains silent to “including a delivery pen, an insulin cartridge containing insulin and defining said storage container,” and the filter cartridge “containing said activated charcoal adsorbent”.
However, Davies teaches a drug delivery device (see FIG. 2) including a delivery pen (7, see [0019]: drug delivery device comprises pen-type injectors) and an insulin cartridge (storage container 11 described as ‘cartridge’, see [0064]) containing insulin (see [0013]: preferred embodiment contains insulin) and defining said storage container (11).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe storage container attached via luer lock at the inlet of the filter cartridge disclosed in Jordan with an injection pen device with a delivery pen and an insulin cartridge containing insulin as taught by Davies for the purpose of dispensing the drug from a sterile container (see [0059]), or allowing the user to set the dose delivered through the filter cartridge (see [0019]), thus achieving the device “including a delivery pen, an insulin cartridge containing insulin and defining said storage container”.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies and Ward as applied to claim 4 above, and further in view of Kriesel (U.S. Patent No. 6,030,363).
Regarding claim 5, the modified system of Jordan teaches the delivery device of claim 4, and Jordan further discloses wherein said filter (6, see FIG. 1) is positioned relative to said pen needle (see [0035]: needle hub and needle affixed via threads 9) wherein said substance passing through (see [0014-0015]: substance moves into filter when injected such as via attached syringe, see [0016]) said filter (6) has a residence time (substance passes through the filter and thus has a “residence time” within said filter) in said filter cartridge (5). Lastly, again, Jordan discloses that the filter may be formed of different porosities and materials ([0037-0038]: filter can be different porosities and materials and thus designed for different filtration purposes).
Jordan is silent to the filter being specifically an “activated charcoal adsorbent”, the residence time being “to minimize denaturing or loss of potency before injecting into the patient”, and the substance being specifically an “insulin formulation”.
However, Ward teaches Ward teaches a delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8), wherein said substance comprises an insulin formulation (see [0028]: insulin formulation delivered to the filter), and a filter (see [0052]: the filter is designed to filter out m-cresol/phenol) being an activated charcoal adsorbent (see [0053]: filter material may be charcoal).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving the filter being specifically an “activated charcoal adsorbent”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the storage container containing a substance disclosed in Jordan to contain an insulin formulation as taught by Ward for the purpose of using a readily available formulation (see [0031]) for treating a specific medical condition, like diabetes (see [0002]), thus achieving the substance being specifically an “insulin formulation”.
Jordan in view of Ward remain silent to the residence time being “to minimize denaturing or loss of potency before injecting into the patient”.
However, Kriesel teaches a drug delivery device for delivering a substance to a patient (see FIG. 20 and see col. 10 line 59-61: 112 contains prefilled medicament vial 120), with a filter (145, see col. 11 lines 43-61: filter 145 for filtering particulates). Kriesel further teaches that modifying the filter porosity will modify the residence time of the device (see col. 11 lines 43-61: rate of fluid flowing out of device controlled by designed wafers 142a, 142b –one of which contains the filtering means. Flow control pores varying in diameter, patterns, etc. of wafers will modify fluid rate.). Therefore, a person of ordinary skill in the art would consider the residence time to be a result effect variable that is optimized through routine experimentation of changing/modifying the filter porosity to obtain a residence time “to minimize denaturing or loss of potency before injecting into the patient”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the residence time of the filter taught by Modified Jordan by modifying the filter porosity as taught in Kriesel to obtain a residence time “to minimize denaturing or loss of potency before injecting into the patient” as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies and Ward as applied to claim 4 above, and further in view of Satterfield (U.S. PGPUB No. 2014/0208945).
Regarding claim 6, the modified system of Jordan teaches the delivery device of claim 4, but Modified Jordan is silent to “wherein said activated charcoal adsorbent comprises a phosphoric acid treated activated charcoal adsorbent.”
However, Satterfield teaches an activated carbon material for removing impurities from a substance (see [0012]), wherein the activated carbon material comprises a phosphoric acid treated activated charcoal adsorbent (see [0005] and [0008]—activated charcoal adsorbent formed by treating raw material with phosphoric acid).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the activated charcoal adsorbent filter taught by Modified Jordan to include an activated charcoal adsorbent comprising phosphoric acid treated activated charcoal adsorbent as taught by Satterfield for the purpose of modifying the microporosity or mesoporosity of the material to obtain specific filtering capabilities (see [0051]-[0053]), thus achieving “wherein said activated charcoal adsorbent comprises a phosphoric acid treated activated charcoal adsorbent”.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies and Ward as applied to claim 4 above, and further in view of Demaria et al. (U.S. PGPUB No. 2019/0054233), hereinafter Demaria.
Regarding claim 10, the modified system of Jordan teaches the delivery device of claim 4, but Jordan is silent to “wherein said activated charcoal adsorbent is included in an amount to remove at least about 60% by weight of the phenolic stabilizing agent from said insulin formulation over a period of time of at least four days while maintaining an insulin potency of at least about 73% relative to untreated insulin”.
However, Ward teaches a drug delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8) with a filter (12) made of an activated charcoal adsorbent (i.e., charcoal and activated carbon, see [0053]: charcoal can be used to filter harmful compounds like phenol), wherein said activated charcoal adsorbent is included in an amount to remove a phenolic stabilizing agent from an insulin formulation prior to delivering the substance to a patient (see [0052]: filtering phenolics from an insulin formulation).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving “wherein said activated charcoal adsorbent is included in an amount to remove the phenolic stabilizing agent from said insulin formulation”.
Modified Jordan remains silent to wherein said activated charcoal adsorbent is included in an amount to remove “at least about 60% by weight” of the phenolic stabilizing agent from said insulin formulation “over a period of time of at least four days while maintaining an insulin potency of at least about 73% relative to untreated insulin”.
However, Demaria teaches an insulin delivery device with a sorbent filter (240)(see FIG. 2) included in an amount to remove at least about 60% of a phenolic stabilizing agent (see [0036]: at least 60% and [0063]: 91% overall decrease of m-cresol and shown in FIG. 18) from an insulin formulation (see [0032]) over a period of time of at least four days (see [0033]: infusion site may last 3, 5, 7, or more days and in [0062]: sorbent material tests for 2, 4, 6, 8, 10 days).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter of Modified Jordan to remove 60% of the phenolic stabilizing agent over a four day time period as taught by Demaria for the purpose of ensuring that the filter material has a high affinity for collecting phenolic excipient (see [0036]), making the medication safe for patient delivery, thus achieving wherein said activated charcoal adsorbent is included in an amount to remove “at least about 60%” of the phenolic stabilizing agent from said insulin formulation “over a period of time of at least four days”.
Next, Demaria teaches two specific examples where the adsorbent material for removing a phenolic stabilizing agent was tested within time intervals (examples detailed in [0062-0067]) including reported percentages of the phenolic agent plotted over time (see FIG. 18-19).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have used the examples as taught in Demaria to determine a time where the adsorbent material taught by Modified Jordan in view of Demaria had removed at least 60% of the phenolic agent by weight.
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the two identified (example setups detailed in [0062-0067]), predictable (see FIG. 18-19 for result outputs) solutions with a reasonable expectation of success for determining the time where at least 60% by weight of the phenolic agent had been removed, thus achieving removing at least about 60% “by weight” of the phenolic stabilizing agent.
Lastly, Demaria teaches that modifying the fluid pathways (see [0044]: increase the surface area contact, volume contact, and/or the exposure time between the insulin formulation and sorbent material) transporting the insulin formulation will change a patient dosing schedule/ amount of time that the insulin is retained in the device (i.e.: can optimize the pathways for 0.75 units/ hr, see [0044]). Therefore, a person of ordinary skill in the art would consider the amount of time the insulin is retained in the device over a patient dosing schedule to be a result effect variable that is optimized through routine experimentation of changing/modifying the fluid pathways to obtain a desired dosing schedule wherein the insulin remains effective.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the time the insulin is retained in the device of Modified Jordan in view of Demaria by modifying the fluid pathways to obtain a patient dosing schedule that includes a time the insulin remains in the device and maintains a 73% potency as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving “while maintaining an insulin potency of at least about 73% relative to untreated insulin”.
Regarding claim 11, the modified system of Jordan teaches the delivery device of claim 4, but Jordan is silent to “wherein said delivery device provides a continuous and controlled delivery of said insulin formulation for a predetermined period of time, and wherein said activated charcoal absorbent is included in an amount to remove at least about 60% by weight of the phenolic stabilizing agent from said insulin formulation, and said insulin formulation exhibiting an insulin potency of at least about 73% after about 7 days.”
However, Ward teaches a delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8), wherein said delivery device provides a continuous and controlled delivery (see [0002]: insulin pump is a controllable device) of an insulin formulation for a predetermined period of time (see [0028]: insulin delivered and [0054]: one experiment allows delivery for 3 days==predetermined period of time at the specified dosage every 5 minutes), and wherein said activated charcoal absorbent is included in an amount to remove a phenolic stabilizing agent from said insulin formulation (see [0052]: filtering phenolics from an insulin formulation).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe storage container attached via luer lock at the inlet of the filter cartridge disclosed in Jordan with an insulin pump as taught by Ward for the purpose of filtering a substance provided by an automated, controllable dosing mechanism such as a pump (see [0054]), instead of a manual syringe, thus achieving “wherein said delivery device provides a continuous and controlled delivery of said insulin formulation for a predetermined period of time”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving “wherein said activated charcoal absorbent is included in an amount to remove the phenolic stabilizing agent from said insulin formulation”.
Modified Jordan remains silent to wherein said activated charcoal absorbent is included in an amount to remove “at least about 60% by weight” of the phenolic stabilizing agent from said insulin formulation, “and said insulin formulation exhibiting an insulin potency of at least about 73% after about 7 days.”
However, Demaria teaches an insulin delivery device with a sorbent filter (240)(see FIG. 2) included in an amount to remove at least about 60% of a phenolic stabilizing agent (see [0036]: at least 60% and [0063]: 91% overall decrease of m-cresol and shown in FIG. 18) from an insulin formulation (see [0032]) over a period of time of about 7 days (see [0033]: infusion site may last 3, 5, 7, or more days and in [0062]: sorbent material tests for 2, 4, 6, 8, 10 days).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter of Modified Jordan to remove 60% of the phenolic stabilizing agent over a 7 day time period as taught by Demaria for the purpose of ensuring that the filter material has a high affinity for collecting phenolic excipient (see [0036]), making the medication safe for patient delivery, thus achieving wherein said activated charcoal absorbent is included in an amount to remove “at least about 60%” of the phenolic stabilizing agent from said insulin formulation… after about 7 days.”
Next, Demaria teaches two specific examples where the adsorbent material for removing a phenolic stabilizing agent was tested within time intervals (examples detailed in [0062-0067]) including reported percentages of the phenolic agent plotted over time (see FIG. 18-19).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have used the examples as taught in Demaria to determine a time where the adsorbent material taught by Modified Jordan in view of Demaria had removed at least 60% of the phenolic agent by weight.
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the two identified (example setups detailed in [0062-0067]), predictable (see FIG. 18-19 for result outputs) solutions with a reasonable expectation of success for determining the time where at least 60% by weight of the phenolic agent had been removed, thus achieving removing at least about 60% “by weight” of the phenolic stabilizing agent.
Lastly, Demaria teaches that modifying the fluid pathways (see [0044]: increase the surface area contact, volume contact, and/or the exposure time between the insulin formulation and sorbent material) transporting the insulin formulation will change a patient dosing schedule/ amount of time that the insulin is retained in the device (i.e.: can optimize the pathways for 0.75 units/ hr, see [0044]). Therefore, a person of ordinary skill in the art would consider the amount of time the insulin is retained in the device over a patient dosing schedule to be a result effect variable that is optimized through routine experimentation of changing/modifying the fluid pathways to obtain a desired dosing schedule wherein the insulin remains effective.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the time the insulin is retained in the device of Modified Jordan in view of Demaria by modifying the fluid pathways to obtain a patient dosing schedule that includes a time the insulin remains in the device and maintains a 73% potency as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving “and said insulin formulation exhibiting an insulin potency of at least about 73% after about 7 days.”
Regarding claim 12, the modified system of Jordan teaches the delivery device of claim 11, but Jordan is silent to “wherein said phenolic stabilizing agent is selected from the group consisting of phenol, m-cresol, and mixtures thereof.”
However, Ward teaches a delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8), wherein the substance comprises an insulin formulation (see Ward [0028]: insulin formulation delivered to the filter) containing a phenolic stabilizing agent (see [0031]: insulin formulation includes phenolic stabilizing agent such as phenol/ m-cresol), wherein said phenolic stabilizing agent is selected from the group consisting of phenol, m-cresol, and mixtures thereof (see [0031]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the storage container containing a substance disclosed in Jordan to contain an insulin formulation containing a phenolic stabilizing agent as taught by Ward for the purpose of using a readily available formulation (see [0031]) for treating a specific medical condition, like diabetes (see [0002]), thus achieving wherein said substance comprises an insulin formulation containing a phenolic stabilizing agent.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter disclosed in Jordan to be made of an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving wherein said activated charcoal adsorbent is adapted for removing said phenolic stabilizing agent from said insulin formulation before delivering to the patient, “wherein said phenolic stabilizing agent is selected from the group consisting of phenol, m-cresol, and mixtures thereof”.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Demaria (U.S. PGPUB No. 2019/0054233), in view of Wu et al. (U.S. PGPUB No. 2011/0208160), hereinafter Wu, DiLeo et al. (U.S. Patent No. 7,824,548), hereinafter DiLeo, and Ward (U.S. PGPUB No. 2016/0354542).
Regarding claim 13, Demaria discloses a delivery device (200, see FIG. 2) for delivering a substance to a patient (see [0032]), said delivery device (200) comprising:
a storage container (insulin reservoir of pump not shown, see [0032]) containing the substance (see [0032]), where said substance includes a phenolic stabilizing agent (see [0035] phenolic excipients are filtered out of insulin formulation—thus, insulin formulation must include phenolic stabilizing agents wherein phenolic excipients originate) in an amount to stabilize said substance (see [0007]: phenolic agents are present in the insulin formulation prior to injection and see [0033]: the viability of the site may be longer than 7 days. Therefore, the amount of the phenolic agent MUST exist in the insulin formulation in an amount that provides stabilization of the insulin formulation over the disclosed time period. Otherwise, Demaria’s device would not be safe, appropriate, or viable for injecting the insulin formulation.);
a delivery member (234, see FIG. 11) in fluid communication with said storage container (insulin reservoir not shown) by a fluid pathway (222) for delivering the substance into the patient (see [0032]: insulin delivered from pump reservoir, through tubing 222, and into patient tissue via delivery member 234), the delivery member (234) comprising an infusion set (224,230) having a base (230) with a top face (224) with a coupling member (see [0032]: 224 is male buckle portion that is received into a female buckle portion of the base 230);
a pump mechanism (see [0032] pump not shown) for delivering the substance from the storage container (insulin reservoir not shown, see [0032]) to the patient (see [0032]: in use the insulin formulation is direction from the pump through 222 and through catheter 234 into patient tissue) at a controlled basal flow rate (i.e.: 0.75 units/ hour in [0044]); and
a filter cartridge (see [0042]: a filter material, 240, see FIG. 2, may be applied onto a filtration mechanism that is loaded into the device—like a cartridge) having, an inlet end (212, see [0043] and FIG. 2) with a coupling for connecting to said pump mechanism (see [0043]: filter material may be on line set tubing 222, which connects to pump not shown) and an outlet end (outlet via adhesive pad 232, see FIG. 11), and said outlet end (outlet via adhesive pad 232, see FIG. 11) having a porous membrane (282, see FIG. 12 and [0053]), and a sorbent material (240, see [0043]) positioned within said filter cartridge (see [0042-0043]) and said fluid pathway (sorbent material in fluid pathway so insulin contacts sorbent material before being delivered to patient in [0043]) between said storage container (insulin reservoir not shown) and said delivery member (234, see FIG. 11) for removing at least a portion of the phenolic stabilizing agent from the substance before delivering to the patient (sorbent material 240 adsorbs and removes phenolic excipients, see [0035-0036] and [0043]),
wherein said substance passes through (see [0053]: insulin substance travels through 282 to enhance sorption) said porous membrane (282, see FIG. 12) of said outlet end (outlet via adhesive pad 232).
Demaria is silent to the filter cartridge “having an internal cavity, and an outlet end with a recess having a coupling member for connecting directly to said coupling member of said base, an inlet end of said internal cavity having a porous membrane… and an activated charcoal adsorbent positioned in the internal cavity of said filter cartridge”, the inlet end with a coupling mechanism for coupling to said pump mechanism, as in lines 11-12, being specifically a threaded connection (as interpreted under 112(f) above), and wherein said substance passes through said porous membrane “s”.
However, Wu teaches a filter cartridge (120, see FIG. 14) for filtering fluid from a drug delivery device (800, see FIG. 19 and [0051]: i.e., the drug delivery device may be an infusion pump and [0077]), wherein the filter cartridge (120) has an internal cavity (512, see FIG. 14 and [0065]), an inlet end (200) with a coupling (210, see FIG. 19) for connecting (see [0044]: connection may be luer slip or luer threaded connection) to a pump mechanism (see [0051]: filter may be attached to pump mechanism), and an outlet end (610) with a recess (see [0074]: 610 formed of hollow body with a space 616, or recess) having a coupling member (see [0073]: connection mechanism of 610 comprises a sleeve with threads, not shown) for connecting directly to a coupling member (916, see FIG.14 and [0075]: threads 916) of a device outlet (918, see [0075]: tubing connector 918, which could accommodate a tubular component/ cannula or see [0079]: a catheter 1000, see FIG. 20).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter cartridge with an inlet end coupled to the pump mechanism as disclosed in Demaria to include an internal cavity, a threaded inlet end coupling to the pump mechanism, and an outlet end with a coupling member coupled to the device outlet as taught by Wu for the purpose of eliminating unwanted components from the fluid prior to administration to a patient (see [0004]), thus achieving the filter cartridge “having an internal cavity, and an outlet end with a recess having a coupling member for connecting directly to said coupling member of said base” and the inlet end with a coupling mechanism for coupling to said pump mechanism, as in lines 11-12, being specifically a threaded connection (as interpreted under 112(f) above).
Demaria in view of Wu remains silent to the filter cartridge having “an inlet end of said internal cavity having a porous membrane”, “an activated charcoal adsorbent positioned in the internal cavity of said filter cartridge”, and wherein said substance passes through said porous membrane “s”.
However, DiLeo teaches a porous adsorptive filter cartridge (110, see Figure 8 and col. 4 lines 6-11: invention for porous adsorptive media) comprising an internal cavity (see ‘Modified Figure 8 below)
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and an inlet end (112) of said internal cavity having a porous membrane (118) and an outlet end (114) having a porous membrane (120).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inlet and outlet ends of said internal cavity taught by Demaria in view of Wu to include a porous membrane as taught by DiLeo for the purpose of maintaining the media contained within the cartridge in place (see col. 8 lines 13-21), thus achieving the filter cartridge having “an inlet end of said internal cavity having a porous membrane” and wherein said substance passes through said porous membrane “s”.
Demaria in view of Wu and DiLeo remain silent to “an activated charcoal adsorbent positioned in the internal cavity of said filter cartridge”.
However, Ward teaches a delivery device for delivering a substance to a patient (see [0028]: line 11 feeds from an insulin pump, FIG. 8), with a filter cartridge (12) having an internal cavity (see [0051]: filter cartridge 12 filled with filter material therefore must have a cavity for filling) with an activated charcoal adsorbent (see [0053]: carbon/ activated charcoal can be used to filter harmful compounds like phenol) positioned in the internal cavity of said filter cartridge (12).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter material contained in the filter cartridge taught by Demaria in view of Wu and DiLeo to contain an activated charcoal adsorbent as taught by Ward for the purpose of removing identified harmful substances, such as phenol, from a formulation before delivery (see [0059]: phenol has many adverse effects such as cancer and thus it would be desirable to have a filter that removes phenol from any substance), thus achieving “an activated charcoal adsorbent positioned in the internal cavity of said filter cartridge”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Demaria in view of Wu, DiLeo, and Ward as applied to claim 13 above, and further in view of Satterfield (U.S. PGPUB No. 2014/0208945).
Regarding claim 16, the modified system of Demaria teaches the delivery device of claim 13, but Modified Demaria is silent to “wherein said activated charcoal comprises a phosphoric acid activated charcoal”.
However, Satterfield teaches an activated carbon material for removing impurities from a substance (see [0012]), wherein the activated carbon material comprises a phosphoric acid treated activated charcoal adsorbent (see [0005] and [0008]—activated charcoal adsorbent formed by treating raw material with phosphoric acid).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the activated charcoal adsorbent filter taught by Modified Demaria to include an activated charcoal adsorbent comprising phosphoric acid treated activated charcoal adsorbent as taught by Satterfield for the purpose of modifying the microporosity or mesoporosity of the material to obtain specific filtering capabilities (see [0051]-[0053]), thus achieving “wherein said activated charcoal adsorbent comprises a phosphoric acid treated activated charcoal adsorbent”.
Response to Arguments
Applicant's arguments filed 11/17/25 have been fully considered but they are not persuasive.
On page 7 of Applicant remarks, Applicant submits that the combination of Jordan in view of Davies does not “result in the claimed device” of claim 1 and therefore the 35 U.S.C. § 103 claim rejections should be withdrawn. However, it is unclear what limitation is argued because Applicant fails to point out what exact claim limitation has not been met. On page 7, Applicant states that “if the end 1 of Jordan were replaced with the attachment means…” the remainder of the input lumen 3 would still intervene between the filter and the primary needle. Although it is unclear which limitation Applicant intends to address with this argument on page 7, this argument mischaracterizes the rejection, specifically the combination of Jordan in view of Davies. On pages 10-11 of the Non-Final Office Action (NFOA) mailed 08/15/25, the examiner sets forth that it would be obvious to “modify the filter cartridge inlet end comprising an open end for connecting to a storage container disclosed in Jordan to include a proximally extending needle immediately adjacent the internal cavity as taught by Davies for the purpose of piercing a septum of a container to provide a fluid connection (see [0063])…”. Thus, Applicant’s assertion that the combination of Jordan in view of Davies will “replace” Jordan’s inlet end such that the lumen intervenes between the filter and the needle does not argue the rejection as set forth by the examiner. The rejection modifies the inlet end of Jordan to include the needle that is immediately adjacent the cavity (and thus immediately adjacent the cavity housing the filter in Jordan) as taught in Davies. Thus, the examiner maintains that the 35 U.S.C. § 103 rejection of claim 1 including a combination of Jordan in view of Davies and Ward meet all claim limitations.
On page 8 of Applicant remarks, Applicant appears to argue that the combination fails to teach “a sealed cartridge.” However, a sealed cartridge is not recited in the claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sealed cartridge) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 1.
On page 8, Applicant submits that the examiner did not provide motivation to combine. In response to Appellant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, in the NFOA mailed 08/15/25, on pages 10-11, the examiner provides motivation for the combination of references “for the purpose of piercing a septum of a container to provide a fluid connection (see [0063])”. Therefore, the examiner was not persuaded that the combination of Jordan in view of Davies lacks motivation to combine and therefore the examiner has maintained the 35 U.S.C. § 103 claim rejection of claim 1.
On page 8 in regard to claim 13, Applicant submits that the motivation to combine Demaria in view of Wu already is accomplished by Demaria. However, there appears to be a typo in the examiner’s explanation on page 29 of the NFOA that reads “for the purpose of eliminating unwanted components from the fluid prior to administration to a patient (see [0004])”. [0004] of Wu reads “Accordingly, there is a need for a drug delivery system that can effectively (and physically) eliminate wrong-route medication error possibilities for use in all types of epidural anesthesia administration procedures that do not also require the use of additional and specialized components.” Thus, in view of Wu [0004], the examiner typo is evident that the motivation should read “for the purpose of eliminating unwanted components from the fluid device prior to administration to a patient” because Wu [0004] teaches the motivation of using the structure of Wu to form a filtering device that does not use additional/ unwanted structural components. Wu [0004] does not relate to a mere filtration of fluid as asserted by Applicant. Thus, the examiner disagrees with this argument and notes that in view of [0004], the motivation to eliminate unwanted structural components from the device is sufficient to combine Demaria in view of Wu. Therefore the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 13.
On page 9 of Applicant remarks, applicant submits that the motivation to combine Demaria in view of DiLeo is already achieved by Demaria and therefore the examiner lacks motivation to combine. Specifically, Applicant argues that Demaria already has a filter material that “stays in place.” However, the examiner disagrees and argues that even if Demaria’s sorbent material “stays in place”, a porous membrane such as taught in DiLeo enhances/ further ensures that the material stays in place even when fluid is flowed therethrough by ensuring that the inlet is sealed such that high pressure fluid flow will not force particulates or other material out the cartridge. A sealed cartridge as formed by Modified Demaria in view of DiLeo objectively retains the cartridge material in a superior way in comparison to an unsealed cartridge of Demaria alone. Therefore the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 13.
No further arguments are presented. Therefore, all depending 35 U.S.C. § 103 claim rejections are subsequently maintained.
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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783