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 .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 2 recites a coated proximal region, a region of greater diameter and a transition region which appear to be part of the embodiment shown in Fig. 1a where in the inner diameter of the barrel is not constant throughout. However, Claim 1 from which claim 2 depends appears to be claiming the features of the embodiment of Fig. 3 which claims a barrel having a constant inner diameter and a coated proximal region that is formed via an insert. In this embodiment, as shown in Fig. 3, it does not appear that there is a transition zone to provide a gradual transition between the coated proximal region and the region of greater diameter. A review of the specification appears to only disclose the transition zone with reference to embodiment of Fig. 1a. Therefore, it appears there is an impermissible combination of embodiments and the specification does not support the combination of these two different embodiment. Applicant is asked to either point to support for the combination of embodiments to amend the claims in order to only claim a single embodiment.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 6, 18, 54-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2014/190225 A1) in view of Young et al. (US 2006/0173416 A1).
With regard to claim 1, Abrams discloses A medical delivery device comprising: a lubricant-free barrel ([0045], barrel 50 can be lubricant free) having a proximal end, a distal end, and an interior surface (64, fig. 2-4) defining a fluid chamber (56) for containment of at least one therapeutic (12); an elastomeric stopper (40) having an outer surface forming a fluid-tight seal with the interior surface of the barrel (shown in Fig. 2-4); a plunger rod (30) connected to the elastomeric stopper, and a covering material (first zone 70 has an additional thickness to the barrel considered a covering material, further teaching of this is described below in the 103 combination with Young) provided on a portion of the interior surface of the barrel at a proximal end thereof to form a coated proximal region, wherein the coated proximal region has a diameter that is less than a diameter of an uncoated distal region of the barrel (see Fig. 2, DI1 vs DI2) lacking the covering material to enhance an interference fit between the elastomeric stopper and the interior surface of the barrel ([0026]-[0027]), wherein the elastomeric stopper includes at least feature (ribs 38, 38a) that is more compressed when in abutting contact within the coated proximal region than when in abutting contact within the uncoated distal region (see fig. 2 where the ribs 38 are more compressed by the smaller diameter of DI1 and then when moved to Fig. 4, the ribs are less compressed as they move into the larger diameter area of DI2), and wherein the interior surface of the barrel has a uniform and constant diameter prior to the formation of the coated proximal region (between zone 70 and 72 which shows the uncoated diameter of the barrel, the barrel 50 has a constant diameter, see also the combination with Young as described below), the coating region being a gas barrier to inhibit oxygen infiltration into said barrel ([0027], the plunger and the zone 70 form a seal thus creating a gas barrier).
Young teaches a syringe barrel (Fig. 3, element 20) that includes a covering material (40) provided on a portion of the interior surface of the barrel (fig. 2 and 4), the interior surface of the syringe barrel has a constant diameter prior to the covering material being inserted (Fig. 4), wherein the covering material is at least one insert (40) in contact with the interior surface of the barrel to form the coated proximal region, said at least one insert being a gas barrier to inhibit oxygen infiltration into said barrel. Abrams teaches that the syringe system can be made in multiple parts ([0062], Abrams). Thus, the teaching of young having a separate insert (40) that is adhered to the inner surface of the syringe barrel could be applied to the syringe system of Abrams such that zone 70 having the smaller diameter can be formed by inserting the insert 40 of Young to crate this smaller diameter in the syringe barrel.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Abrams with the insert that is in contact with the interior surface of the barrel to form the coated region as taught by Young for the purpose of construction simplicity and minimization of manufacturing cost ([0002]).
With regard to claim 2, Abrams discloses wherein the barrel (50) contains the coated proximal region (70), a region of greater diameter (72) positioned at the distal end of the barrel, and a transition section (76, Fig. 5-7) positioned therebetween to provide a gradual transition between the coated proximal region and the region of greater diameter.
With regard to claim 3, Abrams discloses wherein the at least one feature includes two or more ribs (38, 38a) are in abutting contact with the coated proximal region while the elastomeric stopper is positioned at the proximal end of the barrel (Fig. 2).
With regard to claim 6, Abrams discloses wherein the at least one feature includes at least one rib (38, 38a) is in contact with the covering material when the syringe elastomeric stopper is positioned at the proximal end of the barrel (Fig. 2).
With regard to claim 18, Abrams discloses wherein the medical delivery device is a syringe (see Fig. 1), an auto-injector, or a pen.
With regard to claim 54, Abrams discloses the claimed invention except for the insert being affixed by adhesive.
Young teaches wherein said insert is affixed to the interior surface of the barrel via an adhesive ([0024]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Abrams with the insert that is in contact with the interior surface of the barrel to form the coated region as taught by Young for the purpose of construction simplicity and minimization of manufacturing cost ([0002]).
With regard to claim 55, Abrams discloses wherein said insert is integrally formed on the interior surface of the barrel (70 is formed integrally with the interior surface of the barrel 50).
With regard to claim 56, Abrams discloses the claimed invention except for the insert.
Young teaches wherein the at least one insert (40) comprises a solid polymer tube [0028] tube 40 can be made of any material meeting the desired functionality and therefore would be prima facie obvious to optimize the material and substitute one for another as is well-known in the prior art and does not alter the overall function of the device) that is bonded to the interior surface of the barrel ([0024]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2014/190225 A1) in view of Young et al. (US 2006/0173416 A1) and in further view of Futagawa et al. (US 5,827,233).
With regard to claim 5, Abrams/Young discloses the claimed invention except for a coating material.
Futagawa teaches a similar syringe type device (Fig. 1) and further teaches the barrel can have a material of acrylic (Col 4, lines 34-39). Thus, because the coating is designed to be a part of the barrel, the coating material could also be acrylic as it is a material designed to be part of a syringe barrel.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating in the barrel to be of acrylic as taught by Futagawa as a simple substation of one material for another is well-known in the art and would not affect the overall function of the device.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2014/190225 A1) in view of Young et al. (US 2006/0173416 A1) and in further view of Abrams (WO 2014/190225).
With regard to claim 7, Abrams/Young discloses the claimed invention except for the specific material of the covering material.
Abrams teaches wherein the coating material further comprises an oxygen absorbing material, an oxygen adsorbing material, or a combination thereof (because oxygen absorbing and oxygen adsorbing are opposites, the lubricant would be considered to fall in one of the two categories ([0037]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating in the barrel of Abrams/Young to be the oxygen absorbing material as taught by Abrams because the substitution of one known coating for material for another would be within the skill of one of ordinary skill in the art and would not change the overall function of the device.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2014/190225 A1) in view of Young et al. (US 2006/0173416 A1) and in further view of Ashmead et al. (US 2012/0251748 A1).
With regard to claim 8, Abrams/Young discloses several materials for the coating of the syringe stopper ([0035]).
However, Butts does not disclose ePTFE or densified ePTFE.
Ashmead teaches a syringe stopper being made of an elastomer ([0031]) and further covered with a layer of densified ePTFE ([0031], [0032]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Abrams/Young with the densified ePTFE layer as taught by Ashmead for the purpose of providing a stopper that has a low coefficient of friction, compliance, low extractables and leachables, and good barrier properties ([0031]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abrams et al. (WO 2014/190225 A1) in view of Young et al. (US 2006/0173416 A1) and in further view of Hansen et al. (US 2004/0037893 A1).
With regard to claim 16, Abrams/Young teach the claimed invention except for the specific therapeutic.
Hansen teaches delivery of Factor VII ([0071]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Abrams/Young to deliver Factor VII as taught by Hansen because the substation of one therapeutic for another is well-known in the art and does not affect the overall function of the device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-8, 16, 18, 54-56 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783