DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 23, 25-27, 30, 36 and 37 are objected to because of the following informalities:
Regarding claim 23, line 14, the recitation “injecting pressure” appears to be amended to recite “the injecting pressure” in order to refer to “injecting pressure” recited in line 12.
Claim 25 recites the limitation “the surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation “the surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 27, line 1, the recitation “injecting pressure” appears to be amended to recite “the injecting pressure” in order to refer to “injecting pressure” recited in claim 23, line 12.
Claim 30 recites the limitation “the distal portion” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 36, line 1, the recitation “needle” appears to be amended to recite “the needle” in order to refer to “needle” recited in claim 23.
Regarding claim 37, line 1, the recitation “needle” appears to be amended to recite “the needle” in order to refer to “needle” recited in claim 23.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 23, 25, 26, 28, 30, 33 and 34 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Karlsson (US 2005/0261634 A1).
Regarding claim 23, Karlsson teaches a method (paragraph 0034) for delivering a medicament to a subject in need thereof, the method comprising injecting the medicament in the subject using an injector comprising:
a prefilled syringe (integrated structure formed by elements 30, 28 and 32 in figures 1A and 3A) comprising:
a container portion 30 defining a chamber (hollow portion inside element 30) containing a medicament (paragraph 0024, lines 15-17);
a needle 28 disposed at a distal end (end of element 30 where element 28 is present) of the chamber (hollow portion inside element 30), the needle 28 having an injection tip (tip of element 28 that gets inserted into the patient’s skin) configured for piercing an insertion location, and defining a fluid pathway (hollow portion inside element 28) in fluid communication with the chamber; and
a plunger 32 movable within the chamber 30;
a housing 12 (figure 1A) that houses the prefilled syringe;
a syringe support 14 supportively mounting the prefilled syringe to the housing 12; and
an energy source 78 configured for biasing the plunger 32 with a force selected to produce an injecting pressure in the medicament in the chamber during the injection of the medicament to inject the medicament from the chamber through the needle to an injection site (paragraph 0032, lines 12-17, paragraph 0034, lines 1-12),
wherein a penetration depth and injecting pressure are sufficient to substantially prevent backflow of the injected medicament (no backflow is occurring due to pressure and penetration depth), and
wherein the prefilled syringe is associated with the housing 12 in a fixed position (paragraph 0024, lines 3-6) before and during activation of the energy source for firing of the injector.
Regarding claim 25, Karlsson teaches wherein the housing 12 is configured for allowing insertion of the needle 28 to the penetration depth, which is between 1 mm and 4 mm below the surface at an insertion location (by selecting needle of appropriate length, the housing can be used to insert the needle into the patient’s skin at a penetration between 1 mm and 4 mm below the surface at an insertion location).
Regarding claim 26, Karlsson teaches wherein the housing is configured for allowing insertion of the needle to the penetration depth which is about 3 mm below the surface at an insertion location (by selecting needle of appropriate length, the housing can be used to insert the needle into the patient’s skin at a penetration depth of about 3 mm below the surface at an insertion location).
Regarding claim 28, Karlsson teaches wherein the energy source 78 comprises a spring 78.
Regarding claim 30, Karlsson teaches wherein the syringe support 14 axially supports an end (see “E” in figure 1A below) of the chamber during the injection of the medicament, such that the distal portion (portion of element 30 near 26) of the prefilled syringe is substantially unsupported (element 14 doesn’t have structure touching element 30 near element 26 that provides axial direction support beyond element “E” in figure 1A below) in an axial direction.
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Regarding claim 33, Karlsson teaches wherein the housing 12 comprises a retractable guard 34 that is movable between: a protecting position (position shown in figure 4A) in which the needle 28 is disposed within the guard 34; and
an injecting position (position shown in figure 6A) in which the tip of the needle 28 is exposed for insertion to an insertion point.
Regarding claim 34, Karlsson teaches wherein the injector further comprises a trigger mechanism 48 operably associated with the energy source 78 for activating the energy source to inject the medicament, wherein the trigger mechanism 48 is configured for activating the energy source after the retractable guard 34 is retracted from the protecting position (paragraph 0032).
Claim Rejections - 35 USC § 103
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Baum (US 4,929,238).
Regarding claim 24, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson is silent regarding wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament.
However, Baum teaches a design of an injector device wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament (column 10, lines 52-61) for the purpose of introducing the medium requiring higher pressure due to the nature of medical procedure (column 1, lines 22-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the injecting pressure of Karlsson to incorporate wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament as taught by Baum for the purpose of introducing the medium requiring higher pressure due to the nature of medical procedure (column 1, lines 22-25).
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Galli (US 5,681,291).
Regarding claim 27, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson does not explicitly recite wherein the penetration depth and injecting pressure are sufficient such that the injection site is subcutaneous.
However, Galli teaches a design of an injector wherein the penetration depth and injecting pressure are sufficient such that the injection site is subcutaneous (column 1, lines 21-24, column 1, line 63-column 2, line 4) for the purpose of injecting the medicine subcutaneously as needed medically (column 1, lines 21-24).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the penetration depth and injecting pressure to incorporate wherein the penetration depth and injecting pressure are sufficient such that the injection site is subcutaneous as taught by Galli for the purpose of injecting the medicine subcutaneously as needed medically (column 1, lines 21-24).
Claim 31, 32, 36 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Sadowski et al. (US 2002/0045866 A1).
Regarding claims 31 and 32, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson is silent regarding wherein about 0.2 mL to about 4 mL of the medicament is delivered or wherein about 0.5 mL of the medicament is delivered.
However, Sadowski teaches a design of a needle assisted jet injector to deliver entire content inside the chamber wherein about 0.2 mL to about 4 mL of the medicament is delivered or wherein about 0.5 mL of the medicament is delivered (paragraph 0013, lines 1-4) for the purpose of delivering the amount of the medicament as needed by the medical procedure (paragraph 0013, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the volume of the medicament delivered of Karlsson to incorporate wherein about 0.2 mL to about 4 mL of the medicament is delivered or wherein about 0.5 mL of the medicament is delivered as taught by Sadowski for the purpose of delivering the amount of the medicament as needed by the medical procedure (paragraph 0013, lines 1-4).
Regarding claims 36 and 37, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson is silent regarding wherein the energy source and needle are configured for injecting the medicament at a rate of between about 0.2 mL/sec and about 0.75 mL/sec and wherein the energy source and needle are configured for injecting the medicament at a rate of about 0.75 mL/sec.
However, Sadowski teaches wherein the energy source and needle are configured for injecting the medicament at a rate of between about 0.2 mL/sec and about 0.75 mL/sec (paragraph 0014, lines 1-5, 1/2.5 = 0.4 and 2/2.5 = 0.8 which is about 0.75) and wherein the energy source and needle are configured for injecting the medicament at a rate of about 0.75 mL/sec for the purpose of delivering the medicament quickly at a lower pressure (paragraph 0010, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the energy source and needle of Karlsson to incorporate wherein the energy source and needle are configured for injecting the medicament at a rate of between about 0.2 mL/sec and about 0.75 mL/sec and wherein the energy source and needle are configured for injecting the medicament at a rate of about 0.75 mL/sec as taught by Sadowski for the purpose of delivering the medicament quickly at a lower pressure (paragraph 0010, lines 1-5).
Claim 35 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Reinicke (US 4,834,704).
Regarding claim 35, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson is silent regarding wherein the energy source is configured for biasing the plunger with a force of about 10 pounds to about 15 pounds.
However, Reinicke teaches wherein the energy source is configured for biasing the plunger with a force of about 17 pounds (column 4, lines 59-65) but does not expressly disclose the force of about 10 pounds to about 15 pounds as required by the claim. Since the claim recites about 15 pounds, Reinicke’s about 17 pounds could be construed as being falling within the claimed range. Furthermore, it would have been obvious to one having ordinary skill in the at the time the invention was made to modify the force of Reinicke to be between 10 pounds to about 15 pounds as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would be motivated to modify the force of Karlsson to be about 10 pounds to about 15 pounds as taught by Reinicke for the purpose of being able to apply manual force (column 4, lines 59-65).
Claim 38 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Larsen et al. (US 2002/0004648 A1).
Regarding claim 38, Karlsson discloses the claimed invention substantially as claimed, as set forth above in claim 23. Karlsson is silent regarding wherein the needle length of between about 4 mm to about 8 mm.
However, Larsen teaches a design of injection needles wherein the needle length of between about 4 mm to about 8 mm (paragraph 0013, lines 1-4) for the purpose of designing the needle that allows self-injection of the medicine (paragraph 0013, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the needle length to incorporate wherein the needle length of between about 4 mm to about 8 mm as taught by Larsen for the purpose of designing the needle that allows self-injection of the medicine (paragraph 0013, lines 1-4).
Claim 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karlsson (US 2005/0261634 A1) in view of Baum (US 4,929,238) in view of Reinicke (US 4,834,704) in view of Sadowski et al. (US 2002/0045866 A1) and further in view of Larsen et al. (US 2002/0004648 A1).
Regarding claim 39, Karlsson discloses a method (paragraph 0034) for delivering a medicament to a subject in need thereof, the method comprising injecting the medicament in the subject using an injector comprising:
a prefilled syringe (integrated structure formed by elements 30, 28 and 32 in figures 1A and 3A) comprising:
a container portion 30 defining a chamber (hollow portion inside element 30) containing a medicament (paragraph 0024, lines 15-17);
a needle 28 disposed at a distal end (end of element 30 where element 28 is present) of the chamber (hollow portion inside element 30), the needle 28 having an injection tip (tip of element 28 that gets inserted into the patient’s skin) configured for piercing an insertion location, and defining a fluid pathway (hollow portion inside element 28) in fluid communication with the chamber; and
a plunger 32 movable within the chamber 30;
a housing 12 (figure 1A) that houses the prefilled syringe;
a syringe support 14 supportively mounting the prefilled syringe to the housing 12; and
an energy source 78 configured for biasing the plunger 32 with a force selected to produce an injecting pressure in the medicament in the chamber during the injection of the medicament to inject the medicament from the chamber through the needle to an injection site (paragraph 0032, lines 12-17, paragraph 0034, lines 1-12),
wherein a penetration depth and injecting pressure are sufficient to substantially prevent backflow of the injected medicament (no backflow is occurring due to pressure and penetration depth), and
wherein the prefilled syringe is associated with the housing 12 in a fixed position (paragraph 0024, lines 3-6) before and during activation of the energy source for firing of the injector, wherein the housing 12 is configured for allowing insertion of the needle 28 to the penetration depth, which is between 1 mm and 4 mm below the surface at an insertion location (by selecting needle of appropriate length, the housing can be used to insert the needle into the patient’s skin at a penetration between 1 mm and 4 mm below the surface at an insertion location)
Karlsson is silent regarding wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament.
However, Baum teaches a design of an injector device wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament (column 10, lines 52-61) for the purpose of introducing the medium requiring higher pressure due to the nature of medical procedure (column 1, lines 22-25).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to modify the injecting pressure of Karlsson to incorporate wherein the energy source is configured such that the injecting pressure remains between 80 psi and 1000 psi during injection of the medicament as taught by Baum for the purpose of introducing the medium requiring higher pressure due to the nature of medical procedure (column 1, lines 22-25).
Karlsson is silent regarding wherein the energy source is configured for biasing the plunger with a force of about 10 pounds to about 15 pounds.
However, Reinicke teaches wherein the energy source is configured for biasing the plunger with a force of about 17 pounds (column 4, lines 59-65) but does not expressly disclose the force of about 10 pounds to about 15 pounds as required by the claim. Since the claim recites about 15 pounds, Reinicke’s about 17 pounds could be construed as being falling within the claimed range. Furthermore, it would have been obvious to one having ordinary skill in the at the time the invention was made to modify the force of Reinicke to be between 10 pounds to about 15 pounds as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would be motivated to modify the force of Karlsson to be about 10 pounds to about 15 pounds as taught by Reinicke for the purpose of being able to apply manual force (column 4, lines 59-65).
Karlsson is silent regarding wherein the energy source is configured for biasing the plunger with a force of about 10 pounds to about 15 pounds.
However, Reinicke teaches wherein the energy source is configured for biasing the plunger with a force of about 17 pounds (column 4, lines 59-65) but does not expressly disclose the force of about 10 pounds to about 15 pounds as required by the claim. Since the claim recites about 15 pounds, Reinicke’s about 17 pounds could be construed as being falling within the claimed range. Furthermore, it would have been obvious to one having ordinary skill in the at the time the invention was made to modify the force of Reinicke to be between 10 pounds to about 15 pounds as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would be motivated to modify the force of Karlsson to be about 10 pounds to about 15 pounds as taught by Reinicke for the purpose of being able to apply manual force (column 4, lines 59-65).
Karlsson is silent regarding wherein the needle length of between about 4 mm to about 8 mm.
However, Larsen teaches a design of injection needles wherein the needle length of between about 4 mm to about 8 mm (paragraph 0013, lines 1-4) for the purpose of designing the needle that allows self-injection of the medicine (paragraph 0013, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the needle length to incorporate wherein the needle length of between about 4 mm to about 8 mm as taught by Larsen for the purpose of designing the needle that allows self-injection of the medicine (paragraph 0013, lines 1-4).
Allowable Subject Matter
Claim 29 is 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 prior art of record, Karlsson (US 2005/0261634 A1), is silent regarding wherein the ram comprises a bell portion on which the spring is seated, and the bell portion defines a hollow interior configured for receiving the prefilled syringe when the device is fired in combination with other claimed limitations of claim 29. Furthermore, one will not have any motivation to modify the ram of Karlsson to arrive at a claimed limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Peter (US 5,244,465): discloses a design of an injector with a biasing spring and a chamber fixed to the housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
