DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 5/13/2026 As directed by the amendment: claims 1-2, 14-15, 17, and 21-24 have been amended; claims 3 and 16 have been cancelled; and no claims have been added. Thus, claims 1-2, 4-15, and 17-29 are presently pending in this application.
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 1-2 and 4-13 are rejected under 35 U.S.C. 103 as being unpatentable over Patient Support (“Your Step-by-Step Injection Guide”, NPL retrieved from <https://www.actharhcp.com/Static/pdf/PSR%20Injection%20Guide%20Step-By-Step%20Instructions%20(Digital).pdf>) in view of Blake, III (US 5273542 A) further in view of Bachynsky (US 5865804 A) further in view of Hjertman et al. (US 5873856 A).
Regarding claim 1, Patient Support discloses a method comprising:
removing a pre-filled apparatus from a refrigerator (Page 11), the apparatus comprising a repository corticotropin pharmaceutical composition for a pediatric patient ≥ 2 years old in need thereof (Pages 2 and 30, Page 30 discusses side effects for patients over 2 years old, which indicates that the composition is administered to pediatric patients > 2 years old);
waiting between 30 minutes and up to 24 hours after removal of the pre-filled apparatus from the refrigerator (Page 11); and
administering the repository corticotropin pharmaceutical composition from the a manual component of the apparatus to the pediatric patient ≥ 2 years old (Pages 19, 22-23, and 30) by applying a force to the manual component of the apparatus (Page 23);
wherein the repository corticotropin pharmaceutical composition is a naturally sourced complex mixture comprising porcine ACTH (1-39) (Page 2, Acthar Gel is a naturally sourced complex mixture comprising N-25 deamidated porcine ACTH (1-39), as evidenced by applicant’s disclosure, see Paragraph [0026]);
wherein the repository corticotropin pharmaceutical composition has a viscosity of 5 cPs to 30 cPs and a temperature of 22 °C to 25 °C at the time of the administering (Page 11 discloses injecting the medicine at room temperature (which is within 22 °C to 25 °C) and Acthar gel has a viscosity of 5 cPs to 30 cPs, as evidenced by applicant’s disclosure, see Paragraph [0165] and Fig. 8);
wherein the force required to administer a dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C (Page 12 discloses delivering 40 units/0.5mL of Acthar gel and the language “wherein the force required to administer a dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0066]);
wherein the force required to administer a dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C (Page 12 discloses delivering 80 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer a dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0066]); and
wherein the repository corticotropic pharmaceutical composition is administered subcutaneously (Page 23).
Patient Support is silent regarding
the apparatus being a pre-filled manual apparatus;
wherein the method results in a breakage rate of less than 30% during administration (Examiner notes that the claimed steps would result in a breakage rate of less than 30% during administration, therefore if the prior art teaches the method steps above, then it would also result in a breakage rate of less than 30% during administration); and
wherein the repository corticotropic pharmaceutical composition is consistently administered at a depth between 4 to 8 mm below the surface of the skin of the pediatric patient.
In analogous art, Blake, III teaches a pre-filled manual apparatus (Col 1, lines 31-54).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus (a pre-filled vial used to fill a syringe) of Patient Support to incorporate the teachings of Blake, III to incorporate being a pre-filled manual apparatus (a pre-filled syringe) in order to provide persons with the convenience of not having to fill a syringe each time an injection is required (Col 1, lines 31-54).
In analogous art, Bachynsky teaches that subcutaneous injections are administered at a minimum of ¼ inch below the body skin surface (Col 2, lines 46-50).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the composition of Patient Support to incorporate the teachings of Bachynsky to incorporate administered between ¼ inch (~6 mm) below the surface of the skin of the patient since it is a known depth when administering injections subcutaneously (Col 2, lines 46-50).
In analogous art, Hjertman et al. teaches consistently administering an injection subcutaneously (Col 1, lines 4-9).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the composition of Patient Support in view of Bachynsky to incorporate the teachings of Hjertman to incorporate being consistently administered subcutaneously in order to facilitate injection and achieve a correct therapeutical effect from the injected drug even if the injection site is altered by the patient (Col 1, lines 4-9).
The modification of Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman would teach wherein the method results in a breakage rate of less than 30% during administration (Examiner notes that the claimed steps would result in a breakage rate of less than 30% during administration, therefore if the prior art teaches the method steps above, then it would also result in a breakage rate of less than 30% during administration).
Regarding claim 2, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 1, wherein the composition is administered to the pediatric patient > 2 years of age by an adult of at least 18 years of age (The language “wherein the composition is administered to a pediatric patient > 2 years of age by an adult of at least 18 years of age” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the composition is capable of being administered to a pediatric patient > 2 years of age by an adult of at least 18 years of age).
Regarding claim 4, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 1, wherein the force required to administer the dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N (Page 12 discloses delivering 40 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer the dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force less than or equal to 35 N, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0241], Patient Support).
Further, the instant disclosure describes the parameter of the force required as being merely preferable, and does not describe the force as contributing any unexpected results to the system. As such, parameters such as force are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the force would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 5, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 4, but are silent regarding wherein the composition is administered at a rate of 150 +/- 5 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 6, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 4, but are silent regarding wherein the composition is administered at a rate of 150 +/- 4 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 7, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 4, but are silent regarding wherein the composition is administered at a rate of 150 +/- 3 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 8, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 4, but are silent regarding wherein the composition is administered at a rate of 150 +/- 2 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 9, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 1, wherein the force required to administer the dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N (Page 12 discloses delivering 80 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer the dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force less than or equal to 35 N, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0247], Patient Support).
Further, the instant disclosure describes the parameter of the force required as being merely preferable, and does not describe the force as contributing any unexpected results to the system. As such, parameters such as force are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the force would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 10, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 9, but are silent wherein the composition is administered at a rate of 150 +/- 5 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 11, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 9, but are silent wherein the composition is administered at a rate of 150 +/- 4 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 12, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 9, but are silent wherein the composition is administered at a rate of 150 +/- 3 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 13, Patient Support in view of Blake, III further in view of Bachynsky further in view of Hjertman disclose the method of claim 9, but are silent wherein the composition is administered at a rate of 150 +/- 2 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claims 14-15 and 17-29 are rejected under 35 U.S.C. 103 as being unpatentable over Patient Support (“Your Step-by-Step Injection Guide”, NPL retrieved from <https://www.actharhcp.com/Static/pdf/PSR%20Injection%20Guide%20Step-By-Step%20Instructions%20(Digital).pdf>) in view of Blake, III (US 5273542 A) further in view of Tiberg et al. (US 20220202898 A1) further in view of Bachynsky (US 5865804 A) further in view of Hjertman et al. (US 5873856 A).
Regarding claim 14, Patient Support discloses method of consistent administration of a repository corticotropin pharmaceutical composition comprising:
removing a pre-filled apparatus from a refrigerator (Page 11), the apparatus comprising a repository corticotropin pharmaceutical composition for a pediatric patient ≥ 2 years old in need thereof (Pages 2 and 30, Page 30 discusses side effects for patients over 2 years old, which indicates that the composition is administered to pediatric patients > 2 years old);
waiting after apparatus removal from the refrigerator (Page 11); and
administering the repository corticotropin pharmaceutical composition from a manual component of the apparatus to the pediatric patient ≥ 2 years old (Pages 19, 22-23, and 30) by applying a force to the manual component of the apparatus (Page 23);
wherein the repository corticotropin pharmaceutical composition has a viscosity of 5 cPs to 30 cPs and a temperature of 22 °C to 25° C at the time of the administering (Page 11 discloses injecting the medicine at room temperature (which is within 22 °C to 25 °C) and Acthar gel has a viscosity of 5 cPs to 30 cPs, as evidenced by applicant’s disclosure, see Paragraph [0165] and Fig. 8);
wherein the force required to administer a dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C (Page 12 discloses delivering 40 units/0.5mL of Acthar gel and the language “wherein the force required to administer a dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force between 19.2 N and 77 N at 24 °C to 25 °C and between 31.8 N and 90.5 N at 22 °C to 23 °C, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0066]);
wherein the force required to administer a dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C (Page 12 discloses delivering 80 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer a dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force between 15.2 N and 67.2 N at 24 °C to 25 °C and between 19.6 N and 155.5 N at 22 °C to 23 °C, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0066]); and
wherein the repository corticotropin pharmaceutical composition is administered subcutaneously (Page 23).
Patient Support is silent regarding
the apparatus being a pre-filled manual apparatus;
waiting between 45 minutes and up to 24 hours after apparatus removal from the refrigerator;
wherein the repository corticotropin pharmaceutical composition is consistently administered at a skin depth of 4 to 8 mm with every performed administration.
In analogous art, Blake, III teaches a pre-filled manual apparatus (Col 1, lines 31-54).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus (a pre-filled vial used to fill a syringe) of Patient Support to incorporate the teachings of Blake, III to incorporate being a pre-filled manual apparatus (a pre-filled syringe) in order to provide persons with the convenience of not having to fill a syringe each time an injection is required (Col 1, lines 31-54).
In analogous art, Tiberg et al. teaches waiting between 45 minutes and up to 24 hours after apparatus removal from the refrigerator (Paragraph [0028]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Patient Support to incorporate the teachings of Tiberg to incorporate waiting between 45 minutes and up to 24 hours after apparatus removal from the refrigerator in order to ensure that enough time has passed to allow the composition to equilibrate at room temperature (Paragraph [0028]) and be safe for injection.
In analogous art, Bachynsky teaches that subcutaneous injections are administered at a minimum of ¼ inch below the body skin surface (Col 2, lines 46-50).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the composition of Patient Support to incorporate the teachings of Bachynsky to incorporate administered between ¼ in (~6 mm) below the surface of the skin of the patient since it is a known depth when administering injections subcutaneously (Col 2, lines 46-50).
In analogous art, Hjertman et al. teaches consistently administering an injection subcutaneously with every performed administration (Col 1, lines 4-9).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the composition of Patient Support in view of Bachynsky to incorporate the teachings of Hjertman to incorporate being consistently administered subcutaneously with every performed administration in order to facilitate injection and achieve a correct therapeutical effect from the injected drug even if the injection site is altered by the patient (Col 1, lines 4-9).
Regarding claim 15, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 14, wherein the composition is administered to the pediatric patient > 2 years of age by an adult of at least 18 years of age (The language “wherein the composition is administered to a pediatric patient > 2 years of age by an adult of at least 18 years of age” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the composition is capable of being administered to a pediatric patient > 2 years of age by an adult of at least 18 years of age).
Regarding claim 17, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 14, wherein the repository corticotropin pharmaceutical composition is a naturally sourced complex mixture comprising porcine ACTH (1-39) (Page 2, Acthar Gel is a naturally sourced complex mixture comprising N-25 deamidated porcine ACTH (1-39), as evidenced by applicant’s disclosure, see Paragraph [0026], Patient Support).
Regarding claim 18, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 17, wherein the administering step comprises pushing a handle of the manual apparatus (Page 23, Patient Support) with a maximum injection force that is directly proportional to the viscosity of the repository corticotropin pharmaceutical composition (One of ordinary skill in the art would recognize that the viscosity of the repository corticotropin pharmaceutical composition would affect the maximum injection force that can be applied to the handle of the manual apparatus, therefore the maximum injection force would be directly proportional of the viscosity of the repository corticotropin pharmaceutical composition).
Regarding claim 19, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 17, wherein the method results in a breakage rate of less than 30% during administration (Examiner notes that the claimed steps would result in a breakage rate of less than 30% during administration, therefore if the prior art teaches the method steps above, then it would also result in a breakage rate of less than 30% during administration).
Regarding claim 20, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 17, wherein the force required to administer the dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N (Page 12 discloses delivering 40 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer the dose of 40 USP units/0.5mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force less than or equal to 35 N, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0241], Patient Support).
Further, the instant disclosure describes the parameter of the force required as being merely preferable, and does not describe the force as contributing any unexpected results to the system. As such, parameters such as force are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the force would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 21, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 20, but are silent regarding wherein the composition is administered at a rate of 150 +/- 5 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 22, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 20, but are silent regarding wherein the composition is administered at a rate of 150 +/- 4 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 23, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 20, but are silent regarding wherein the composition is administered at a rate of 150 +/- 3 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 24, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 20, but are silent regarding wherein the composition is administered at a rate of 150 +/- 2 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 25, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 17, wherein the force required to administer the dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N (Page 12 discloses delivering 80 USP units/1.0 mL of Acthar gel and the language “wherein the force required to administer the dose of 80 USP units/1.0 mL of the repository corticotropin pharmaceutical composition is less than or equal to 35 N” constitutes intended use, indicating that the prior art need only be capable of being used in such a manner. Furthermore, the claim is a method claim, and is to be limited by method steps. The Office submits that the prior art meets the method steps of the claim, and the Acthar gel would be perfectly capable of being administered at a force less than or equal to 35 N, as evidenced by applicant’s disclosure, see Paragraphs [0026] and [0247], Patient Support).
Further, the instant disclosure describes the parameter of the force required as being merely preferable, and does not describe the force as contributing any unexpected results to the system. As such, parameters such as force are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the force would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 26, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 25, but are silent regarding wherein the composition is administered at a rate of 150 +/- 5 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 27, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 25, but are silent regarding wherein the composition is administered at a rate of 150 +/- 4 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 28, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 25, but are silent regarding wherein the composition is administered at a rate of 150 +/- 3 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding claim 29, Patient Support in view of Blake, III further in view of Tiberg further in view of Bachynsky further in view of Hjertman disclose the method of claim 25, but are silent regarding wherein the composition is administered at a rate of 150 +/- 2 mm/min.
However, the instant disclosure describes the parameter of the rate of administration as being merely preferable, and does not describe the rate as contributing any unexpected results to the system. As such, parameters such as rate are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the rate would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Response to Arguments
Applicant's arguments filed 5/13/2026 have been fully considered but they are not persuasive.
The argument on pages 7-8 that the amendments to the independent claim describing administering the composition to a pediatric patient >2 years of age are affirmative method steps and are not intended use is not persuasive. Claim 1 is directed to a method of administering a repository corticotropin pharmaceutical composition, the specific detail that the composition is administered to a pediatric patient >2 years old is an intended use of the method. Nonetheless, Patient Support teaches side effects for patients over 2 years old, which indicates that the composition in Patient Support is administered to pediatric patients >2 years old
The argument on page 8 that the cited art does not recognize a specific pediatric repository corticotropin problem is not persuasive because the cited art is not required to recognize the same problem, it is only required to teach each claimed limitation.
The arguments on pages 8-9 with respect to Patient Support, Blake III, Bachynsky, and Hjertman are not persuasive because they attack the references individually and do not consider the combination of references as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
The argument on page 9 that Bachynsky does not teach the lower end of the claimed range is not persuasive because any injection between 4 to 8mm (which would include Bachynsky's injection at ¼ in or ~6mm) would teach administering the composition "at a depth of between 4 to 8mm"
The argument that Bachynsky does not provide a reason to select the narrow 8 to 8 mm band is not persuasive because the claims do not require selecting a 4 to 8mm band, the claims only require administering the composition at a depth that is between 4 to 8 mm, which is taught by Bachynsky. Further, Bachynsky is not required to provide a reason for selecting its administration depth as ¼ in is a known injection depth as evidenced by Bachynsky.
The arguments on page 9 with respect to Hjertman and Tiberg not teaching the claimed 4 to 8mm depth is not persuasive because those references are not relied on to teach the claimed depth.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Thursday-Thursday 12-8 ET.
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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights