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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/26 has been entered.
Response to Amendment
The amendment filed 04/23/26 has been entered. Claims 1, 4-6, 8, 10-13, and 16 are in the original/ previously presented form. Claims 2-3, 7, 9, 14-15, and 17-24 are cancelled. Claims 25-31 are newly presented. Thus, claims 1, 4-6, 8, 10-13, 16, and 25-31 remain pending in the application. There were no objections or 112 rejections previously set forth in the Final Office Action mailed 01/23/26. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 line 8 reads “and outlet end” and should likely read “and an outlet end” to provide antecedent basis for outlet end in the claim
Claim 29 in the last line of the claim reads “the internal cavity of the filter cartridge.” And should likely read “[[the]] an internal cavity of the filter cartridge.” to provide proper antecedent basis for internal cavity which has yet to be introduced in claim 29.
Appropriate correction is required.
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:
Claim 1 line 6: “a coupling for coupling” with the storage container. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a coupling” is considered a generic placeholder for “means” because “a coupling” has no specific structural meaning
Prong 2: functional language—for coupling
Prong 3: not modified by other structural language in the claims—no structure is recited for how the coupling functions in order to achieve “coupling” with the storage container. Only the desired outcome of coupling is recited.
According to Applicant’s disclosure under 112(f), the coupling for coupling is interpreted as a threaded connection or equivalent (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.).
Claim 13 lines 11-12: “a coupling for connecting to said pump mechanism” with the storage container. Therefore, claim 13 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a coupling” is considered a generic placeholder for “means” because “a coupling” has no specific structural meaning
Prong 2: functional language—for connecting
Prong 3: not modified by other structural language in the claims—no structure is recited for how the coupling functions in order to achieve “connecting” to the pump mechanism. Only the desired outcome of connecting is recited.
According to Applicant’s disclosure under 112(f), the coupling for connecting is interpreted as a threaded connection or equivalent (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.).
Claim 13 lines 12-13: An outlet end with a recess having “a coupling member for connecting” to said base. Therefore, claim 13 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means or generic placeholder is recited— “a coupling member” is considered a generic placeholder for “means” because “a coupling member” has no specific structural meaning
Prong 2: functional language—for connecting
Prong 3: not modified by other structural language in the claims—no structure is recited for how the coupling member functions in order to achieve “connecting” to the base. Only the desired outcome of connecting is recited.
According to Applicant’s disclosure under 112(f), the coupling member for connecting is interpreted as a recess at the outlet of the device or equivalent (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.).
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. See ‘Modified FIG. 1’ below)
PNG
media_image1.png
628
537
media_image1.png
Greyscale
connected to said storage container (see [0035]: 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 further discloses that the inlet end for connecting to a syringe can be modified to accommodate a syringe tip OR could secure to a luer lock of the syringe (see [0038]).
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. 3 and [0059]: a module==cartridge 4 for attaching to drug delivery device 7) for connecting to (connected as shown in FIG. 3) a storage container (11, see [0066] & [0070]: prefilled sealed cartridge), wherein an inlet end (see upward end of 4 disposed over threads 8 of device 7 and ‘Modified FIG. 3’ below)
PNG
media_image2.png
761
546
media_image2.png
Greyscale
of said cartridge (4) is an open end (see open end with threads disposed over threads of drug delivery device 7—‘syringe threads’ as shown in ‘Modified FIG. 3’ above) immediately adjacent an internal cavity (see ‘Modified FIG. 3’ above and [0065]: axial package space as described is the internal cavity). Further, the open end (upward end) comprises a cartridge cannula (22) for piercing a septum (10, septum 10 labeled in FIG. 2 but also shown in FIG. 3 without label—see ‘Modified FIG. 3’ above. See [0061],[0063],[0066],[0070]: primary needles of embodiments, such as primary needle 22 in FIG. 3, are to penetrate septum 10) in an outlet end (downward end of device 7 housing cartridge 11 as shown in FIG. 3) 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 (such as by mounting a proximally extending needle to a retention cap immediately adjacent the cavity, see ‘Jordan in view of Davies’ figure below)
PNG
media_image3.png
628
994
media_image3.png
Greyscale
for the purpose of piercing a septum of a container to provide a fluid connection in a case where the connected storage container has a sealed cartridge containing the medicament (see [0059]), such as a prefilled syringe, which is advantageous to the device of Jordan to increase the versatility of Jordan’s filter cartridge by allowing the cartridge to be connected to prefilled syringes which are commonly used in the art for providing medicament in a sterile and sealed container, 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. 3) 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 [0066]) 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 Wu et al. (U.S. PGPUB No. 2011/0208160), hereinafter Wu, in view of Demaria (U.S. PGPUB No. 2019/0054233), DiLeo et al. (U.S. Patent No. 7,824,548), hereinafter DiLeo, and Ward (U.S. PGPUB No. 2016/0354542).
Regarding claim 13, Wu discloses a delivery device (see FIG. 20) for delivering a substance to a patient (see [0051]: i.e., the drug delivery device may be an infusion pump or syringe as shown in FIGs. 19-20), said delivery device comprising:
a storage container (see ‘Modified FIG. 20’ below) containing the substance (see [0051]: filter engaged to drug delivery device with fluid source or container, such as infusion pump),
PNG
media_image4.png
404
801
media_image4.png
Greyscale
a delivery member (catheter 1000, see FIG. 20 and [0079]) in fluid communication with said storage container by a fluid pathway for delivering the substance into the patient (see [0079-0081]: drug delivered from storage container and to drug delivery site via catheter),
a pump mechanism for delivering the substance from the storage container to the patient at a controlled basal flow rate (see [0051]: i.e., the drug delivery device may be an infusion pump and therefore has a pump mechanism ‘for’ delivering a substance such as “at a controlled basal flow rate”); and
a filter cartridge (500, see [0078-0079]: system of FIG. 20 uses filter 500 from FIG. 14. Therefore, paragraphs related to the embodiment shown in FIG. 14 will be referenced for structures that are only described once.) having an internal cavity (512, see [0065]), an inlet end (200) with a coupling for connecting (see [0044]: connection may be luer slip or luer threaded connection) to said pump mechanism (see [0051]), and an outlet end (610) with a recess (see ‘Modified FIG. 20’ and [0074]: 610 formed of hollow body with a space 616, or recess, seen best in FIG. 12) having a coupling member (624, see [0074-0078]: 610 has threads 624 for engaging non-luer fitting 900 as in Fig. 20. Numeral 624 shown in FIG. 12) for connecting directly to a coupling member of a base (624 is a threaded connector that connects to a coupling member, such as non luer fitting 900. Therefore the threaded coupling member 624 is ‘for’ connecting directly to any coupling member, such as a coupling member of a base), an inlet end (514) of said internal cavity (512), and a filter material (see [0008]) positioned in the internal cavity (512) of said filter cartridge (500) and said fluid pathway between said storage container and said delivery member (filter material provided in cavity 512 and is therefore in the fluid path between the storage container and delivery member as shown in FIG. 10);
wherein said substance passes through said inlet (514) and outlet ends (512) of the internal cavity (512, see description of fluid flow through device in [0079-0081]).
Wu further teaches the drug delivery system may include a conduit for attachment to a catheter (such as in the embodiment of FIG. 20) or another delivery site (see [0035], [0040], [0067-0068]: i.e.: a delivery site may be disposed at a non-parallel angle, such as up to 90degrees from the first axis).
Wu is silent to “where said substance includes a phenolic stabilizing agent in an amount to stabilize said substance;”, “the delivery member comprising an infusion set having a base with a top face with a coupling member;” the outlet end with a the recess having a coupling member for connecting directly to “said” coupling member of “said” base, the inlet end of said internal cavity “having a porous membrane and said outlet end having a porous membrane”, the filter material being specifically “an activated charcoal adsorbent” and “for removing at least a portion of the phenolic stabilizing agent from the substance before delivering to the patient;”, wherein said substance passes through “said porous membranes”.
However, Demaria teaches 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).
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 substance in the storage container disclosed in Wu with the substance including a phenolic stabilizing agent in an amount to stabilize said substance as taught by Demaria for the purpose of choosing the device substance to treat a specific condition (such as delivering an insulin formulation in an artificial pancreas system, see Demaria [0033], wherein said insulin formulation is stabilized with phenolic stabilizing agents, see [0005-0010]), thus achieving “where said substance includes a phenolic stabilizing agent in an amount to stabilize said substance”.
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 delivery member of the delivery site disclosed in Wu to include an infusion set having a base with a top face with a coupling member as taught by Demaria (see Modified Wu in view of Demaria below)
PNG
media_image5.png
434
1056
media_image5.png
Greyscale
for the purpose of delivering the substance to a subcutaneous site by known methods in the art, such as infusion sets (see [0003-0007] & [0032]), thus achieving “the delivery member comprising an infusion set having a base with a top face with a coupling member;” and the outlet end with a the recess having a coupling member for connecting directly to “said” coupling member of “said” base.
Further, a person of ordinary skill in the art could have combined the elements (a filter connected to an infusion pump with a luer connector at the outlet as disclosed in Wu combined with an infusion set connected at the outlet via a connector 220 such as taught in Demaria [0032]) as claimed by known methods (coupling mechanisms such as luer connectors as described in these applications are well known in the art and infusion sets are well known in the art to be used for drug deliver to subcutaneous sites) with no change to the respective functions (both devices deliver a drug from a pump to a drug delivery site via connectors/couplings such as Luers). Further, the combination would yield nothing more than predictable results (delivering the filtered infusion pump substance to a subcutaneous drug deliver site) to one of ordinary skill in the art.
Wu in view of Demaria remain silent to the inlet end of said internal cavity “having a porous membrane and said outlet end having a porous membrane”, the filter material being specifically “an activated charcoal adsorbent” and “for removing at least a portion of the phenolic stabilizing agent from the substance before delivering to the patient;”, wherein said substance passes through “said porous membranes”.
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)
PNG
media_image6.png
425
532
media_image6.png
Greyscale
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 disclosed in Wu to each include a porous membrane as taught by DiLeo for the purpose of sealing at least the circumference of the filter cavity to impede fluid from flowing against the inner wall of the cavity (see col. 17 line 64- col 18 line 29), which better directs fluid flow through the filter material within the internal cavity and subsequently increasing filtering efficiency, thus achieving the inlet end of said internal cavity “having a porous membrane and said outlet end having a porous membrane” and wherein said substance passes through “said porous membranes”.
Wu in view of Demaria and DiLeo remain silent to the filter material being specifically “an activated charcoal adsorbent” and “for removing at least a portion of the phenolic stabilizing agent from the substance 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), 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 a filter material formed of an activated charcoal adsorbent (see [0053]: carbon/ activated charcoal can be used to filter harmful compounds like phenol) and positioned in the internal cavity of said filter cartridge (12), the activated charcoal adsorbent for removing at least a portion of the phenolic stabilizing agent from the substance before delivering to the patient (see [0053]: carbon/ activated charcoal can be used to filter harmful compounds like 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 filter material contained in the filter cartridge taught by Wu in view of Demaria 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 delivered substance, such as the insulin formulation delivered by the device of Wu in view of Demaria), thus achieving the filter material being specifically “an activated charcoal adsorbent” and “for removing at least a portion of the phenolic stabilizing agent from the substance before delivering to the patient;”.
Claim 16 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Demaria, 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 Wu teaches the delivery device of claim 13, but Modified Wu 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 Wu 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”.
Regarding claim 27, the modified system of Wu teaches the delivery device of claim 13, but Modified Wu is silent to “wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid at pH 6.7.”
However, Satterfield teaches an activated carbon material for removing impurities from a substance (see [0012]), wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid (see [0005] and [0008]—activated charcoal adsorbent formed by treating raw material with phosphoric acid) at pH 6.7 (see FIG. 3A and [0093]: pH decreases with increasing phosphoric acid content. A pH of 6.7 would be associated with a phosphoric acid dose or 5-7.5%, see sample columns 3-4 and 3-5).
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 choose the activated charcoal adsorbent filter taught by Modified Wu to be a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid 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 is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through 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 choose the phosphoric acid treated activated charcoal adsorbent taught by Modified Wu in view of Satterfield to be through phosphoric acid at pH 6.7 as taught by Satterfield for the purpose of maintaining a certain amount of basic mineral constituents of the activated carbon that is non-neutralized by the acid or to obtain a low amount of phosphate levels in the filtered product (see [0053]), thus achieving wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid “at pH 6.7.”
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies and Ward as applied to claim 1 above, and further in view of Satterfield (U.S. PGPUB No. 2014/0208945).
Regarding claim 25, the modified system of Jordan teaches the delivery device of claim 1, but Modified Jordan is silent to “wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid at pH 6.7.”
However, Satterfield teaches an activated carbon material for removing impurities from a substance (see [0012]), wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid (see [0005] and [0008]—activated charcoal adsorbent formed by treating raw material with phosphoric acid) at pH 6.7 (see FIG. 3A and [0093]: pH decreases with increasing phosphoric acid content. A pH of 6.7 would be associated with a phosphoric acid dose or 5-7.5%, see sample columns 3-4 and 3-5).
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 choose the activated charcoal adsorbent filter taught by Modified Jordan to be a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid 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 is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through 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 choose the phosphoric acid treated activated charcoal adsorbent taught by Modified Jordan in view of Satterfield to be through phosphoric acid at pH 6.7 as taught by Satterfield for the purpose of maintaining a certain amount of basic mineral constituents of the activated carbon that is non-neutralized by the acid or to obtain a low amount of phosphate levels in the filtered product (see [0053]), thus achieving wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid “at pH 6.7.”
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies and Ward as applied to claim 1 above, and further in view of Rosenberg (U.S. Patent No. 3,650,093).
Regarding claim 26, the modified system of Jordan teaches the delivery device of claim 1, but Modified Jordan is silent to “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
However, Rosenberg teaches a filter cartridge (30, filter cartridge 30 comprises filter material such as disc 64. see FIG. 6&7 and col 12 lines 1-24), wherein the filter cartridge (30) is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge (see col 16 lines 15-33: filter cartridge housing is transparent to permit visual observation and therefore is ‘configured to permit visual observation’ specifically of the insulin fibrillation/denaturing in the cartridge).
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 housing disclosed in Jordan to be formed of a clear transparent plastic as taught by Rosenberg for the purpose of forming a transparent filter housing so that the functioning of the device and the condition of the filter materials can be observed (see col. 16 lines 15-33), thus achieving “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Demaria, DiLeo, and Ward as applied to claim 13 above, and further in view of Rosenberg (U.S. Patent No. 3,650,093).
Regarding claim 28, the modified system of Wu teaches the delivery device of claim 1, but Modified Wu is silent to “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
However, Rosenberg teaches a filter cartridge (30, filter cartridge 30 comprises filter material such as disc 64. see FIG. 6&7 and col 12 lines 1-24), wherein the filter cartridge (30) is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge (see col 16 lines 15-33: filter cartridge housing is transparent to permit visual observation and therefore is ‘configured to permit visual observation’ specifically of the insulin fibrillation/denaturing in the cartridge).
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 housing disclosed in Wu to be formed of a clear transparent plastic as taught by Rosenberg for the purpose of forming a transparent filter housing so that the functioning of the device and the condition of the filter materials can be observed (see col. 16 lines 15-33), thus achieving “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan (U.S. PGPUB No. 2006/0102555) in view of Davies (U.S. PGPUB No. 2012/0130346), Bengtsson et al. (U.S. PGPUB No. 2021/0030966. The foreign priority document has been provided with this action to confirm that all relied upon elements from the USPUB were taught in the foreign document prior to the effective filing date of the current Application), hereinafter Bengtsson, and Flaherty et al. (U.S. Patent No. 7,018,360), hereinafter Flaherty.
Regarding claim 29, Jordan discloses a delivery device (see Fig. 1 and [0004]: device for connecting to syringes for purposes such as injecting fluids and [0015]: specifically to a patient) for delivering insulin (see [0016]: device injects fluid and thus can be “for” delivering insulin) comprising:
a delivery device having a storage container (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). See ‘Modified FIG. 1’ below) having a proximal end (see [0035]: proximal end/ hub portion of pen needle affixed at threads 9),
PNG
media_image7.png
702
536
media_image7.png
Greyscale
a cannula (see [0035]: pen needle has needle) extending from a distal end (downward in FIG.1) of said pen needle (see [0035]) and in fluid communication with said storage container (see [0035]: syringe affixed at portion 1) by a fluid pathway for injecting the insulin into the patient (via lumens 3 & 10, see [0035]: input lumen 3 and output lumen 10); and
a filter cartridge (5) having an inlet end (1) with a recess (see ‘Modified FIG. 3’ above) having a threaded coupling (2) for connecting to a threaded end of the delivery device (see [0035]: a luer lok flange 2 connects syringe to device), and outlet end (8) with a threaded coupling (9) for connecting to said proximal end of said pen needle (see [0035]), said outlet end (8) to provide fluid communication between the pen needle and the internal cavity (cavity in which filter 6 is disposed) of the filter cartridge (5, see [0016] & [0035]).
Jordan is silent to the delivery device being specifically a delivery “pen”, the storage container “containing the insulin”, “a cannula in said recess of said filter cartridge for piercing a septum of said delivery pen”, said outlet end with an “external” threaded coupling (outlet end of Jordan has a Luer with internal threads), and said outlet end “having a septum configured to be pierced by a proximal end of said cannula of the pen needle” to provide fluid communication.
However, Davies teaches a delivery pen (drug delivery device can be delivery pen, see [0019]) for delivering insulin (see [0002-0003] & [0013-0015]) comprising a storage container (11, see FIG. 3 and [0066]), a cartridge comprising a recess (see ‘Modified FIG. 3’ below),
PNG
media_image8.png
468
546
media_image8.png
Greyscale
the storage container (11) containing insulin (see [0013]: preferred embodiment contains insulin), a cannula (22) in said recess (see ‘Modified FIG. 3’ above) of said cartridge for piercing a septum (10, septum 10 labeled in FIG. 2 but also shown in FIG. 3 without label) of said delivery pen (7, See [0061],[0063],[0066],[0070]: primary needles of embodiments, such as primary needle 22 in FIG. 3, are to penetrate septum 10).
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 comprising a delivery pen and a storage container 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 delivery device being specifically a delivery “pen” and the storage container “containing the insulin”.
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 having an inlet end with a recess for connecting to a storage container disclosed in Jordan to include a cannula in said recess of said filter for piercing a septum as taught by Davies (such as by mounting a proximally extending needle to a retention cap immediately adjacent the cavity, see ‘Jordan in view of Davies’ figure below)
PNG
media_image3.png
628
994
media_image3.png
Greyscale
for the purpose of piercing a septum of a container to provide a fluid connection in a case where the connected storage container has a sealed cartridge containing the medicament (see [0059]), such as a prefilled syringe, which is advantageous to the device of Jordan to increase the versatility of Jordan’s filter cartridge by allowing the cartridge to be connected to prefilled syringes which are commonly used in the art for providing medicament in a sterile and sealed container, thus achieving ““a cannula in said recess of said filter cartridge for piercing a septum of said delivery pen”.
Jordan in view of Davies remain silent to said filter cartridge outlet end with an “external” threaded coupling and said outlet end “having a septum configured to be pierced by a proximal end of said cannula of the pen needle” to provide fluid communication.
However, Bengtsson teaches a drug delivery device (700, see FIG. 7B and [0020]) comprising a pen needle (230, [0330]: flow conducting device 230 and see [0324]: flow conducting device can be pen needle) attached to a cartridge (290), wherein the cartridge (290) has an outlet end (leftward end in FIG. 7B), wherein the outlet end (leftward end in FIG. 7B) has an external threaded coupling (see ‘Modified FIG. 7B’ below and external threads more visible in FIG.7A. see [0304]: connectors 236 simplistically shown in earlier embodiments such as fig. 3A are threads)
PNG
media_image9.png
422
770
media_image9.png
Greyscale
for connecting to said proximal end of said pen needle (as shown in FIG. 7A).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the internal threaded coupling of the outlet end of the filter cartridge for connecting to said proximal end of said pen needle disclosed in Jordan with the external threaded coupling of the outlet end of a cartridge for connecting to said proximal end of said pen needle as taught in Bengtsson. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (internal threaded coupling of the outlet end of the filter cartridge for connecting to said proximal end of said pen needle disclosed in Jordan) for another known element (external threaded coupling of the outlet end of a cartridge for connecting to a proximal end of a pen needle taught in Bengtsson) in the art to obtain the predictable result of coupling modules/cartridges of a pen needle device together (see MPEP § 2143.I.B), thus achieving said filter cartridge outlet end with an “external” threaded coupling.
Jordan in view of Davies and Bengtsson remain silent to said outlet end “having a septum configured to be pierced by a proximal end of said cannula of the pen needle” to provide fluid communication.
However, Flaherty teaches a drug delivery device (610, see FIG. 23 provided for immediate reference below)
PNG
media_image10.png
286
469
media_image10.png
Greyscale
comprising a filter cartridge (600, see col 18 lines 18-21: system 600 has a filter) with an outlet end (602), said outlet end (602) having a septum (692) configured to be pierced by a proximal end of a cannula to provide fluid communication (see col. 3 lines 44-45: outlet plug has needle septum material, col. 13 lines 45-58: needle septum 92 is resealable, and see col 18 lines 43-59: septum 692 is the needle septum as previously described by similar numeral. Therefore, the septum is “configured to be pierced” by a cannula to provide fluid communication).
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 outlet end disclosed in Jordan to include a septum configured to be pierced by the proximal end of the cannula to provide fluid communication as taught by Flaherty for the purpose of allowing a needle to puncture into the cartridge while maintaining a seal after such a needle is withdrawn (see col. 13 lines 45-58), which would aid in disposal of the cartridge after use, thus achieving said outlet end “having a septum configured to be pierced by a proximal end of said cannula of the pen needle” to provide fluid communication.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies, Bengtsson, and Flaherty as applied to claim 29 above, and further in view of Satterfield (U.S. PGPUB No. 2014/0208945).
Regarding claim 30, the modified system of Jordan teaches the delivery device of claim 29, but Modified Jordan is silent to “wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid at pH 6.7.”
However, Satterfield teaches an activated carbon material for removing impurities from a substance (see [0012]), wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid (see [0005] and [0008]—activated charcoal adsorbent formed by treating raw material with phosphoric acid) at pH 6.7 (see FIG. 3A and [0093]: pH decreases with increasing phosphoric acid content. A pH of 6.7 would be associated with a phosphoric acid dose or 5-7.5%, see sample columns 3-4 and 3-5).
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 choose the activated charcoal adsorbent filter taught by Modified Demaria to be a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid 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 is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through 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 choose the phosphoric acid treated activated charcoal adsorbent taught by Modified Jordan in view of Satterfield to be through phosphoric acid at pH 6.7 as taught by Satterfield for the purpose of maintaining a certain amount of basic mineral constituents of the activated carbon that is non-neutralized by the acid or to obtain a low amount of phosphate levels in the filtered product (see [0053]), thus achieving wherein said activated charcoal adsorbent is a phosphoric acid treated activated charcoal adsorbent which is attained by acid treating an activated charcoal through phosphoric acid “at pH 6.7.”
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Davies, Bengtsson, and Flaherty as applied to claim 29 above, and further in view of Rosenberg (U.S. Patent No. 3,650,093).
Regarding claim 31, the modified system of Jordan teaches the delivery device of claim 29, but Modified Jordan is silent to “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
However, Rosenberg teaches a filter cartridge (30, filter cartridge 30 comprises filter material such as disc 64. see FIG. 6&7 and col 12 lines 1-24), wherein the filter cartridge (30) is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge (see col 16 lines 15-33: filter cartridge housing is transparent to permit visual observation and therefore is ‘configured to permit visual observation’ specifically of the insulin fibrillation/denaturing in the cartridge).
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 housing disclosed in Jordan to be formed of a clear transparent plastic as taught by Rosenberg for the purpose of forming a transparent filter housing so that the functioning of the device and the condition of the filter materials can be observed (see col. 16 lines 15-33), thus achieving “wherein the filter cartridge is transparent or has a viewing portion or window configured to permit visual observation of insulin fibrillation/denaturing in the cartridge.”
Response to Arguments
Applicant's arguments filed 04/23/26 have been fully considered but they are not persuasive.
On pages 8-10, Applicant submits that the 35 U.S.C. § 103 claim rejections under Jordan in view of Davies should be withdrawn because the examiner has provided no reasoning as to why one skilled in the art would go through additional expense and effort to “remove the proximal portion of the unit housing 5 of Jordan”. However, the examiner disagrees with this argument because it is a mischaracterization of the current modification. In view of the current rejection (see rejection of at least claim 1 above), the modification of Jordan in view of Davies does not require removal of any portion of Jordan’s device (the examiner has provided detailed modified figures and a rejection in view of Davies FIG. 3 in lieu of Davies FIG. 2 to best address Applicant’s concerns). Thus, the examiner maintains that a person of ordinary skill in the art would have found it obvious to modify Jordan in view of Davies as set forth in the rejection above (see MPEP § 2123.I: “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”). Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejections that include a combination of Jordan in view of Davies.
On page 10, Applicant argues that Davies is not a filter-cartridge cannula terminating at a filter. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Davies need not teach a filter or specifically a “filter cartridge” because Jordan has already disclosed such structural elements. Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejections that include a combination of Jordan in view of Davies.
On page 10, Applicant submits that the positioning of Davies fails to teach the “immediately adjacent” positioning of the needle, the combination of Jordan in view of Davies would require extensive reengineering of Jordan’s cartridge, and the combination of Jordan in view of Davies lacks motivation for the modification. Again, the examiner disagrees with this argument as it appears to be a mischaracterization of the current rejection. In hopes of expediting prosecution, the examiner has provided further explanation and visual elements to aid in the understanding of the current modification of Jordan in view of Davies. (see MPEP § 2143.01.II: although prior art teachings may have conflicts (i.e.: Jordan discloses a filter cartridge with a threaded inlet lumen immediately adjacent a filter retained in an internal cavity and Davies teaches a cartridge with an inlet having a needle lumen immediately adjacent an internal cavity), the disclosures may still be combined when the references would not have “deterred one of ordinary skill in the art from using” the teachings. Although Jordan and Davies are not identical, the teachings of Davies would have still motivated a person of ordinary skill in the art to modify Jordan without substantial reengineering of the cartridge. Further, the modification of Jordan in view of Davies would not require substantial reconstruction because Davies teaches the structure that would be necessary to perform the modification, see the rejection of at least claim 1 above and see MPEP § 2143.01.VI). Lastly, in response to Applicant' 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:
“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 (such as by mounting a proximally extending needle to a retention cap immediately adjacent the cavity, see ‘Jordan in view of Davies’ figure below)
PNG
media_image3.png
628
994
media_image3.png
Greyscale
for the purpose of piercing a septum of a container to provide a fluid connection in a case where the connected storage container has a sealed cartridge containing the medicament (see [0059]), such as a prefilled syringe, which is advantageous to the device of Jordan to increase the versatility of Jordan’s filter cartridge by allowing the cartridge to be connected to prefilled syringes which are commonly used in the art for providing medicament in a sterile and sealed container” (copied and pasted from the rejection of claim 1 above).
Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejections that include a combination of Jordan in view of Davies.
On pages 10-11, Applicant argues against the combination of Demaria in view of Wu. However, in order to expedite prosecution, a new rejection of claim 13 is presented using Wu in view of Demaria and the other references, rendering these arguments against the combination of Demaria in view of Wu moot.
On page 12 of Applicant arguments, Applicant argues that the motivation for combining DiLeo into the 35 U.S.C. § 103 claim rejections is inadequate because Applicant asserts that the device of Modified Wu or Demaria would already have the filter material retained in place. Although the examiner does not agree with this argument, in order to expedite prosecution, the examiner has provided new motivation from DiLeo for including porous membranes into the filter cartridge (sealing at the edges and better directing fluid flow, see rejection of claim 13 above). Therefore, the arguments presented against DiLeo on page 12 are moot because the argued motivation is no longer used.
No further arguments were presented for the depending claims and therefore the examiner has maintained the depending claim rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights