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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on January 9, 2026. As directed by the amendment: claims 1-27 have been cancelled and claims 28-54 have been added. Thus, claims 28-54 are presently pending in this application.
Response to Arguments
Applicant's arguments filed January 9, 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the Remarks that the previously applied prior art does not teach or disclose the limitations of new claims 28-54. The examiner disagrees and maintains that the previously applied prior art teaches all of the limitations set forth in the new claims, discussed in more detail below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 53 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 53, the claim recites “applying a first/second/third/fourth force” when the dose is either 40 or 80 USP. It is unclear if the method is requiring all four forces be applied in the same method or if these are alternative method steps so that the method is only requiring one of the claimed forces be applied. For examination purposes, the second interpretation was used since it does not appear that the original disclosure provides support for the first interpretation.
Further regarding claim 53, there is a lack of antecedent basis in the limitation “the manual apparatus” in line 12. It is unclear if this limitation should be amended to recite “the manual injector device” or if the limitation is drawn to a different apparatus. For examination purposes, the first interpretation was used. The examiner notes that this limitation is present in lines 15 and 18 additionally.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 28-30, 34, 42-50, 52, and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Guide to Taking Acthar” (PDF guide retrieved from the Wayback Machine - https://web.archive.org/web/20200605082215/http://actharmsattack.com/downloads/acthar-msrelapse-injection-guide.pdf), hereinafter referred to as “the Guide”, in view of Tiberg (US 20220202898).
Regarding claim 28, the Guide discloses a method of treating a patient having a motor impairment with a repository corticotropin pharmaceutical composition comprising:
providing a single use manual injector device (pg. 3 under “Preparing the Injection”, step 6 discloses providing a syringe with a cap and a needle) containing a repository corticotropin pharmaceutical composition (pg. 2 discloses ACTHAR Gel which is used to treat MS in adults; paragraph 32 of Applicant’s specification discloses that ACTHAR gel is a repository corticotropin pharmaceutical composition),
administering the repository corticotropin pharmaceutical composition to the patient using the manual injector device (pg. 6 under “How to Inject”, step 5).
Regarding the last limitation “wherein the manual injector device is configured….”, MPEP 2112.01 recites that “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed inherent”. In the instant case, the claimed manual injector device is devoid of any further structure so that the claimed product is “a manual injector device”. The Guide discloses a manual injector device in the form of a manual syringe and, thus, comprises all of the structure of the claimed product. Thus, it is the examiner’s opinion that the syringe of the Guide is fully capable of performing the claimed function since the syringe comprises all of the structure of the claimed manual injector device.
While the Guide does not explicitly teach or disclose the device contains a unitary 40 USP dose or a unitary 80 USP dose, the Guide teaches that a unitary 80 USP dose is a well-tolerated single dose (pg. 12 of Prescribing Information under “Overdosage”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device to contain a unitary 80 USP dose since the Guide teaches that this is a well-tolerated single dose.
However, the Guide does not teach or disclose the repository corticotropin pharmaceutical composition has a viscosity of 5 cPs to 30 cPs.
Tiberg is directed towards a manual apparatus (“syringe” in paragraph 28) which can comprise a corticotropin composition (paragraph 108). Tiberg further teaches that the viscosity of the composition can be between 5 cPs to 30 cPs at 25°C (paragraph 60 discloses 10 cPs to 1000 cPs). Therefore, it would have been obvious to have selected the viscosity of the composition to be between 10 cPs-30 cPs, as taught by Tiberg, since Tiberg teaches that this viscosity can be effectively delivered by a syringe within a tolerable period of time (paragraph 60), and it appears that the modified method of the Guide would operate equally well with a composition delivered at this viscosity and temperature, and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 29, in the modified method of the Guide, the Guide discloses the administering step comprises pushing a handle of the manual apparatus with a maximum injection force that is directly proportional to the viscosity of the repository corticotropin pharmaceutical composition (pg. 8, step 5 discloses pushing down the plunger; PHOSITA would recognize that the maximum injection force used to push the plunger would be dictated in part by the viscosity of the composition so that the force is proportional to the viscosity, absent any other limitations).
Regarding claim 30, in the modified method of the Guide, the Guide discloses the administering step pushing a handle of the manual apparatus with a 25-gauge needle or a 23-gauge needle (pg. 3 under “Organizing Injection Materials” discloses the needle gauges and pg. 8, step 5 discloses pushing the plunger).
Regarding claim 34, in the modified method of the Guide, the Guide discloses warming the manual apparatus the temperature (pg. 5 under “2.4 Preparation” discloses warming to room temperature).
Regarding claim 42, in the modified method of the Guide, the Guide discloses the administering is to an upper thigh, abdomen, or back of arm of the patient (pg. 7 discloses injecting in the upper outer thigh).
Regarding claim 43, in the modified method of the Guide, the Guide discloses gathering an alcohol swab, bandage, sharps container, and combinations thereof prior to administering (pg. 3 discloses the step of “gather all your supplies” under “Preparing the Injection” and “Organizing Injection Materials” discloses an alcohol swab, adhesive bandage, and puncture-resistant container”).
Regarding claim 44, in the modified method of the Guide, the Guide discloses the administering does not occur through clothing (pg. 8 discloses injecting to bare skin).
Regarding claim 45, in the modified method of the Guide, the Guide discloses the administering is to an injection site without irritated skin, tattoos, warts, scars, or birthmarks (pg. 7 under “Before Injecting Acthar”).
Regarding claim 46, in the modified method of the Guide, the Guide discloses the administering is not a navel, knee, or groin area of the patient (pg. 7 discloses injecting in the upper-outer thigh muscle).
Regarding claim 47, the modified Guide teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the administering is over a period of 2.5 seconds to 30 seconds.
Tiberg teaches that it is beneficial to administer the composition over a period of time less than 30 seconds (paragraph 60). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of administering over a period of 2.5 seconds to 30 seconds, as taught by the Tiberg, since Tiberg teaches that this amount of time is tolerable for the patient (paragraph 60) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 48, in the modified Guide, the Guide discloses the manual injector device is pre-filled with the repository corticotropin pharmaceutical composition (pg. 3 under “Preparing the Injection” step 9 discloses filling the syringe so that the syringe would be pre-filled prior to injection).
Regarding claim 49, in the modified Guide, the Guide discloses the force is less than 100 N (as noted above, the syringe of the Guide is capable of using force less than 100 N since the syringe has all of the claimed structure).
Regarding claim 50, in the modified Guide, the Guide discloses the patient has one or more of motor impairment, reduced strength, pain, limited range of motion, and tremors (pg. 3 of Prescribing Information discloses using the composition on MS patients, infantile spasms, and rheumatic disorders).
Regarding claim 52, in the modified Guide, the Guide discloses the repository corticotropin pharmaceutical composition is a naturally sourced complex mixture comprising N-25 deamidated porcine ACTH (1-39) (paragraph 60 of Applicant’s specification discloses ACTHAR Gel as being an example composition having the claimed properties).
Regarding claim 54, the Guide discloses a method of treating a patient having a motor impairment with a repository corticotropin pharmaceutical composition comprising:
providing a single use manual injector device (pg. 3 under “Preparing the Injection”, step 6 discloses providing a syringe with a cap and a needle) containing the repository corticotropin pharmaceutical composition (pg. 2 discloses ACTHAR Gel which is used to treat MS in adults; paragraph 32 of Applicant’s specification discloses that ACTHAR gel is a repository corticotropin pharmaceutical composition), and
administering the repository corticotropin pharmaceutical composition to the patient using the manual injector device (pg. 6 under “How to Inject”, step 5),
Regarding the limitation “the manual injector device is configured to deliver the entire unitary dose with a success rate of about 90% or more with an applied force that does not exceed about 155.5 N”, MPEP 2112.01 recites that “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed inherent”. In the instant case, the claimed manual injector device is devoid of any further structure so that the claimed product is “a manual injector device”. The Guide discloses a manual injector device in the form of a manual syringe and, thus, comprises all of the structure of the claimed product. Thus, it is the examiner’s opinion that the syringe of the Guide is fully capable of performing the claimed function since the syringe comprises all of the structure of the claimed manual injector device.
While the Guide does not explicitly teach or disclose the device contains a unitary 40 USP dose or a unitary 80 USP dose, the Guide teaches that a unitary 80 USP dose is a well-tolerated single dose (pg. 12 of Prescribing Information under “Overdosage”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device to contain a unitary 80 USP dose since the Guide teaches that this is a well-tolerated single dose.
However, the Guide does not explicitly teach or disclose administering the composition at room temperature and wherein the repository corticotropin pharmaceutical composition has a viscosity of 5 cPs to 30 cPs.
Tiberg is directed towards a manual apparatus (“syringe” in paragraph 28) which can comprise a corticotropin composition (paragraph 108). Tiberg further teaches that the viscosity of the composition can be between 5 cPs to 30 cPs at 25°C (paragraph 60 discloses 10 cPs to 1000 cPs) and the composition is administered at room temperature (paragraph 28). Therefore, it would have been obvious to have selected the viscosity of the composition to be between 10 cPs-30 cPs, as taught by Tiberg, since Tiberg teaches that this viscosity can be effectively delivered by a syringe within a tolerable period of time (paragraph 60), and it appears that the modified method of the Guide would operate equally well with a composition delivered at this viscosity and temperature, and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally, it would have been obvious to have administered the composition at room temperature, as taught by Tiberg, in order to ensure patient safety.
Claim(s) 31, 32, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Lampkin (US 3885562) in further view of Knaack (US 20030143258).
Regarding claims 31 and 32, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above.
However, the modified Guide does not teach or disclose sitting the manual injector device on a clean, dry, flat surface at room temperature for 30/60 minutes before administering.
Tiberg teaches sitting the manual apparatus for 60 minutes before administering (paragraph 28). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide so that the manual injector device sits for 60 minutes before administering, as taught by Tiberg, to allow the device to equilibrate to room temperature before administration (paragraph 28).
The Guide teaches that the needle must remain sterile and to not put the device on an unclean surface (pg. 3 under “Before Injecting”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of placing the apparatus on a clean surface to ensure that the needle remains sterile (pg. 3 of the Guide).
Lampkin teaches placing a manual apparatus on a flat surface (4:8-13). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the modified Guide to include the step of placing the apparatus on a flat surface to ensure that the apparatus remains on the surface and does not roll off.
Knaack teaches using a dry syringe plunger (paragraph 207). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of placing the apparatus on a dry surface to ensure that the syringe plunger remains dry to ensure that the users fingers do not slip while using the device.
Regarding claim 51, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above. The Guide further discloses prior to the administering, removing a vial from a refrigerator (pg. 3 under “Preparing the Injection”, step 2).
However, the modified Guide does not teach or disclose removing the manual injector device from a refrigerator and sitting the manual injector device on a clean, dry, flat surface for at least 30 minutes.
Tiberg teaches removing a manual injector device from a refrigerator and sitting the device for at least 30 minutes (paragraph 28). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the modified Guide so that the manual injector device is removed from a refrigerator and sat for 30 minutes prior to administration, as taught by Tiberg. This modification would provide a pre-filled syringe for the patient to use to ensure proper dosing and would allow the syringe to equilibrate to room temperature to ensure patient safety (paragraph 28).
The Guide teaches that the needle must remain sterile and to not put the device on an unclean surface (pg. 3 under “Before Injecting”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of placing the apparatus on a clean surface to ensure that the needle remains sterile (pg. 3 of the Guide).
Lampkin teaches placing a manual apparatus on a flat surface (4:8-13). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the modified Guide to include the step of placing the apparatus on a flat surface to ensure that the apparatus remains on the surface and does not roll off.
Knaack teaches using a dry syringe plunger (paragraph 207). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of placing the apparatus on a dry surface to ensure that the syringe plunger remains dry to ensure that the users fingers do not slip while using the device.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Carter (US 6010486).
Regarding claim 33, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above, but does not teach or disclose the force applied to the manual apparatus increases over a period of time that the force is applied.
Carter is directed towards a manual apparatus (fig. 1) where the force applied to the manual apparatus increases over a period of time that the force is applied (4:32-35 discloses applying an increase in force at the end of the travel of the plunger to cause retraction of the needle). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the manual apparatus of the modified Guide to the manual apparatus of Carter and to have the force applied to the manual apparatus increases over a period of time that the force is applied, as taught by Carter, for the purpose of allowing a safe, one-handed injection which sheaths the needle post use (4:39-45).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Romanello (US 20200054833).
Regarding claim 35, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above. The Guide further discloses inspecting the repository corticotropin pharmaceutical composition (pg. 2 under “Once You Receive Acthar, Be Sure to”). However, the modified Guide does not teach or disclose inspecting in an injector window.
Romanello teaches an injector having an injector window (window 34 in fig. 15; paragraph 69). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus to include an injector window, as taught by Romanello, to enable inspection of the composition prior to injection.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Campbell (US 20040006314).
Regarding claim 36, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above. The Guide further discloses placing the manual apparatus flat on cleaned skin at a 90-degree angle, wherein the skin is not pinched (pg. 8, steps 1-4 discloses cleaning the skin and placing the syringe at 90 degree angle). However, the modified Guide does not explicitly teach or disclose the skin is not pinched.
Campbell is directed towards intramuscular injections in which the skin is spread to insert the needle (paragraph 97). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of spreading the skin rather than pinching the skin, since Campbell teaches that this step is preferred in the medical field (paragraph 97).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of “Intramuscular” (https://www.youtube.com/watch?v=9S0T8Mn7_gU).
Regarding claim 37, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above. The Guide further discloses pushing a handle of the manual apparatus down to inject the repository corticotropin pharmaceutical composition (pg. 8, step 5).
While the Guide further appears to disclose pushing without lifting the manual apparatus from the patient’s skin until administration is complete (pg. 8, step 5 does not disclose lifting the syringe), the modified Guide does not explicitly teach or disclose this step.
Intramuscular is a video depicting how to perform intramuscular injections (first screenshot below) which teaches pushing a handle of a manual apparatus without lifting the manual apparatus from the patient’s skin until administration is complete (the video shows the injection from time 2:00 to 2:03 and shows that the manual apparatus is not lifted from the skin). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide to include the step of pushing without lifting the manual apparatus from the patient’s skin until administration is complete, as taught by Intramuscular, since Intramuscular teaches that this is proper administration of an intramuscular injection.
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Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Ogawa (US 20160001017).
Regarding claim 38, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above, but does not teach or disclose automatically setting off a click sound generated from the manual apparatus upon completion of administration.
Ogawa is directed towards a pre-filled manual apparatus (syringe 1 in fig. 7) which comprises the step of automatically setting off a click sound generated from the manual apparatus upon completion of administration (paragraph 92). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus so that the apparatus automatically sets off a click sound upon completion of the administration, as taught by Ogawa, for the purpose of enabling a user to recognize that the drug has been fully administered (paragraph 92).
Claim(s) 39 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Diaz (US 20180361080).
Regarding claim 39, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above, but does not teach or disclose inspecting a color indicator on a housing of the manual apparatus upon completion of administration.
Diaz is directed towards a manual apparatus (injection system 400 in fig. 74) and further teaches inspecting a color indicator on a housing of the manual apparatus upon completion of administration (paragraph 153 discloses inspecting for the lack of colored gap portion 458 which is touching the adapter 460 so that it is positioned on a housing). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the manual apparatus to have the color indicator and the associated method to include the step of inspecting a color indicator on a housing of the manual apparatus upon completion of administration, as taught by Diaz, for the purpose of allowing a user to inspect to see if dosing is complete (paragraph 153).
Regarding claim 40, in the modified method of the Guide, Diaz discloses disappearance of the color indicator indicates a complete dosing (paragraph 153).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg, as applied to claim 28 above, and further in view of Dunne (US 20170049970).
Regarding claim 41, the modified Guide teaches all of the claimed limitations set forth in claim 28, as discussed above. The Guide further teaches the step of removing the manual apparatus off the patient. However, the modified Guide does not teach or disclose the removal from the skin of the patient automatically locks a needle guard into place (pg. 8, step 8).
Dunne is directed towards a manual apparatus (paragraph 27) which incorporates a needle guard which locks into place upon removal from the skin of the patient (paragraphs 70 and 71). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the manual apparatus to have a needle guard so that the removal from the skin of the patient automatically locks the needle guard into place, as taught by Dunne, for the purpose of protecting the user from needle stick injuries (paragraph 71).
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over The Guide in view of Tiberg in view of De La Serna (US 20030233070).
Regarding claim 53, the Guide discloses a method of treating a patient having a motor impairment with a repository corticotropin pharmaceutical composition comprising:
removing a pre-filled apparatus from a refrigerator (pg. 3 under “Preparing the Injection” discloses taking the vial out of the refrigerator), the manual apparatus comprising a repository corticotropin pharmaceutical composition for an adult patient ≥ 18 years old in need thereof (pg. 2 discloses ACTHAR Gel which is used to treat MS in adults; paragraph 32 of Applicant’s specification discloses that ACTHAR gel is a repository corticotropin pharmaceutical composition); and
administering the repository corticotropin pharmaceutical composition to the patient (pg. 7 under “Injecting the Upper-Arm Muscle” discloses injecting the area), wherein the repository corticotropin pharmaceutical composition is administered by applying a force to a plunger of a syringe (pg. 8, step 5 discloses pushing a plunger),
wherein the repository corticotropin pharmaceutical composition is a naturally sourced complex mixture comprising N-25 deamidated porcine ACTH (1-39) (paragraph 60 of Applicant’s specification discloses ACTHAR Gel as being an example composition having the claimed properties).
While the Guide does not explicitly teach or disclose the dose of the composition is 80 USP units/1.0mL, the Guide teaches that a unitary 80 USP/1.0mL is a well-tolerated single dose (pg. 12 of Prescribing Information under “Overdosage”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the dose of the composition to be 80 USP/1.0mL since the Guide teaches that this is a well-tolerated single dose.
However, the Guide does not teach or disclose removing a pre-filled injector device from a refrigerator, administering the composition between 30 minutes and up to 24 hours after removal from the refrigerator, and applying a third force to the manual injector device of 15.2N to 67.5 N at a temperature between 24 °C to 25 °C. Additionally, the Guide does not teach or disclose the repository corticotropin pharmaceutical composition has a viscosity of 5 cPs to 30 cPs at a time of the administering, and wherein the method results in a breakage rate of less than 30% during administration.
Tiberg is directed towards a pre-filled manual injection device (“syringe” in paragraph 28) which can comprise a corticotropin composition (paragraph 108). Tiberg further teaches removing the manual injection device from the refrigerator (paragraph 28) and allowing the temperature of the composition to equilibrate to 25°C prior to administration for a time period between 30 minutes and 24 hours (paragraph 28 discloses 1 hour and equilibrating to 25°C). Tiberg further discloses the viscosity of the composition can be between 5 cPs to 30 cPs at 25°C (paragraph 60 discloses 10 cPs to 1000 cPs).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of the modified Guide so that the method includes removing a pre-filled manual injection device from a refrigerator and administering the composition 60 minutes after removal at a temperature of 25°C, as taught by Tiberg. This modification would ensure proper dosing by obviating the need to aspirate the composition from a vial and would ensure patient safety by administering the composition at a safe temperature. Additionally, it would have been obvious to have selected the viscosity of the composition to be between 10 cPs-30 cPs, as taught by Tiberg, since Tiberg teaches that this viscosity can be effectively delivered by a syringe within a tolerable period of time (paragraph 60), it appears that the modified method of the Guide would operate equally well with a composition delivered at this viscosity and temperature, and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
De La Serna teaches that the injection force is chosen based on the desired dose of medicament and the desired time to deliver the medicament (paragraph 49). Additionally, De La Serna teaches that using Hagen-Poiseuille Law, changing the amount of composition delivered and the desired time would affect the required force to deliver that particular amount of composition in that particular amount of time (paragraph 7) so that the force required to administer a dose relative to a specific volume of the dose is disclosed to be a result effective variable as changing the force given a specific volume of composition would result in a different amount of time needed to inject the composition. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified Guide to have the force required to administer the dose of the composition to be between 15.2 N and 67.2 N, as such force ranges for the specific amount of composition would be optimized based on the desired time to inject the composition to minimize patient discomfort and to ensure adequate delivery of the composition.
The limitation “the method results in a breakage rate of less than 30% during administration” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although the modified Guide does not discuss that the method results in the claimed breakage rate, this result is inherently met since the claimed method steps are disclosed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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