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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require a drug product comprising a primary packaging component, a nominal volume, the primary packaging component includes a body and a flange, a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume, and the volume of formulated drug substance is within an interior of the body of the primary packaging component, a plunger rod, a stopper sized and configured to fit snugly within a wall of the interior of the body, and the stopper is positioned within the primary packaging component at a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal formed by the stopper.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the flange surrounds an opening in the body.
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises a protein, a nucleic acid, a blood component, a vaccine, an anti-allergenic, a gene therapy medicament, an antibiotic, a pain management medication, an anesthetic, and/or a hormone.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody and an excipient.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody and an excipient.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody at a concentration of at least 100 mg/mL and an excipient.
Claim 31 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the formulated drug substance comprises an antibody having a viscosity of at least 5 cPoise.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the stopper position is distal from a proximal end of the primary packaging component.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the stopper position is distal from a proximal end of the primary packaging component and the stopper position is at a position in which the plunger rod is limited by the wall of the interior of the body to a maximum tilting angle of the plunger rod, with respect to a longitudinal axis of the body.
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the distance is at least 2.5 mm distal to the flange.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the distance is between about 2.5 mm and about 5.0 mm distal to the flange.
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the nominal volume is about 1 mL.
Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the volume of the formulated drug substance is at least 0.05 mL greater than the nominal volume of the primary packaging component.
Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims the volume of formulated drug substance is at least 1.05 mL.
Claim 40 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12440622 B2 in view of Okihara (US 20150190578 A1).
U.S. Patent No. 12440622 B2 discloses a drug product, comprising: a primary packaging component having a nominal volume, wherein the primary packaging component comprises a body and a flange; a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume, and wherein the volume of formulated drug substance is within an interior of the body of the primary packaging component; a plunger rod; and a stopper sized and configured to fit snugly within a wall of the interior of the body, and the stopper is positioned within the primary packaging component at a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal formed by the stopper..
The device of U.S. Patent No. 12440622 B2 does not disclose a prefilled syringe comprising a syringe.
Okihara discloses in Figures 1-2 and 5 a prefilled syringe (100, the pre-filled syringe is the prefilled syringe), comprising: a syringe (107 and Paragraph [0094], the syringe assembly is the pre-filled that is prefilled before the gasket is inserted), wherein the syringe (107) comprises a body (106) and a flange (117).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of U.S. Patent No. 12440622 B2 to include a prefilled syringe comprising a syringe and the syringe comprises a body and a flange as taught by Okihara with the motivation to produce multiple syringes for patients while reducing the time for production.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require a prefilled syringe comprising a syringe having a nominal volume, the syringe comprises a body and a flange, the volume of formulated drug substance is greater than the nominal volume, the volume of formulated drug substance is within an interior of the body of the syringe; a plunger rod, a stopper sized and configured to fit snugly within a wall of the interior of the body, and the stopper is positioned within the syringe at a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal formed by the stopper.
Claim 41 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody and an excipient.
Claim 42 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody and an excipient.
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises an antibody at a concentration of at least 100 mg/mL and an excipient.
Claim 44 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the volume of the formulated drug substance is at least 0.05 mL greater than the nominal volume of the primary packaging component.
Claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12440622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require the formulated drug substance comprises a protein, a nucleic acid, a blood component, a vaccine, an anti-allergenic, a gene therapy medicament, an antibiotic, a pain management medication, an anesthetic, and/or a hormone.
The Office notes that claims 39 and 46 are not being rejected under Double Patenting.
Allowable Subject Matter
Claims 25-38 and 40-45 are allowed pending resolution of the Double Patenting Rejections mentioned above.
Claim 39 and 46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest pieces of prior art are Okihara (US 20150190578 A1) in view of Py (US 20050029307 A1) in further view of Takeshima (JP 2005118222 A).
Regarding Claim 25:
Okihara discloses in Figures 1-2 and 5 a drug product (100, the pre-filled syringe is the drug product), comprising: a primary packaging component (107 and Paragraph [0094], the syringe assembly is the primary packaging component that is prefilled before the gasket is inserted), wherein the primary packaging component includes a body (106) and a flange (117); wherein the volume of formulated drug substance (110) is within an interior (118) of the body of the primary packaging component (106); and a stopper (112, the gasket is the stopper) sized and configured to fit snugly within a wall of the interior of the body (Paragraph [0047], the stopper is liquid-tight within the body).
Py teaches in Figure 16 an ophthalmic dispenser, comprising: a primary packaging component (10, the dispenser is the primary packaging component) having a nominal volume (Paragraph [0156], the nominal volume is the amount of medicament the chamber can hold); and a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume (Paragraph [0156], the medicament supplied to the chamber is greater than what the chamber can hold).
Takeshima teaches in Figure 1 a syringe, comprising: a plunger rod (5) connected to the stopper (4); and wherein the stopper (4) is positioned within the primary packaging component (1) at a stopper position (Figure 1, the stopper position is at the end of the body) that is at a distance distal to the flange (2).
The prior art fails, does not disclose, or make obvious:
a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal by the formed by the stopper.
Okihara is the closest reference teaching a stopper position in which the stopper is below the flange (Paragraphs [0122-0123], the stopper position is the insertion position). Takeshima teaches the tilting of the plunger rod (5, Figure 1) causes the stopper to deform (Paragraph [0018]).
However, the prior art fails to disclose or make obvious the distance below the flange restricts the plunger rod from tilting to compromise the seal formed by the stopper. The limitation in view of all other limitations of claim 25 is considered to be allowable.
Claims 26-39 depend from claim 25 and are considered allowable as being dependent on claim 25.
Regarding Claim 40:
Okihara discloses in Figures 1-2 and 5 a prefilled syringe (100, the pre-filled syringe is the prefilled syringe), comprising: a syringe (107 and Paragraph [0094], the syringe assembly is the pre-filled that is prefilled before the gasket is inserted), wherein the syringe (107) comprises a body (106) and a flange (117); wherein the volume of formulated drug substance (110) is within an interior (118) of the body of the syringe (107); and a stopper (112, the gasket is the stopper) sized and configured to fit snugly within a wall of the interior of the body (Paragraph [0047], the stopper is liquid-tight within the body).
Py teaches in Figure 16 an ophthalmic dispenser, comprising: a primary packaging component (10, the dispenser is the primary packaging component) having a nominal volume (Paragraph [0156], the nominal volume is the amount of medicament the chamber can hold); and a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume (Paragraph [0156], the medicament supplied to the chamber is greater than what the chamber can hold).
Takeshima teaches in Figure 1 a syringe (1), comprising: a plunger rod (5); and wherein the stopper (4) is positioned within the syringe (1) at a stopper position (Figure 1, the stopper position is at the end of the body) that is at a distance distal to the flange (2).
The prior art fails, does not disclose, or make obvious:
a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal by the formed by the stopper.
Okihara is the closest reference teaching a stopper position in which the stopper is below the flange (Paragraphs [0122-0123], the stopper position is the insertion position). Takeshima teaches the tilting of the plunger rod (5, Figure 1) causes the stopper to deform (Paragraph [0018]).
However, the prior art fails to disclose or make obvious the distance below the flange restricts the plunger rod from tilting to compromise the seal formed by the stopper. The limitation in view of all other limitations of claim 25 is considered to be allowable.
Claims 41-16 depend from claim 40 and are considered allowable as being dependent on claim 40.
However, a full determination of allowability for the application will be made once all objections and rejections are overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Morris (US 2832340 A) teaches a syringe push rod comprising a syringe, a stopper, a plunger rod, and the prevention of the seal breaking between the syringe body and the stopper.
Gross (US 6171286 B1) teaches a self-aligning syringe plunger comprising a syringe, a plunger rod, a stopper, and preventing misalignment between the plunger and the syringe body.
Koska (US 6368306 B1) teaches syringes comprising a plunger rod, a stopper, and the prevention of leaks due to deformation of the stopper.
Prasad (US 11471605 B2) teaches a leak-free stopper comprising a syringe, a plunger rod, a stopper, and preventing leaks from the stopper during movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A SHRIEVES whose telephone number is (571)272-5373. The examiner can normally be reached Monday to Friday: 9:30AM to 5:30PM.
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/STEPHANIE A SHRIEVES/Examiner, Art Unit 3753
/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753
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