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
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim1 and all dependents thereof rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the Glide Force Variation test method” in the last line however a Glide Force Variation test is not previously recited in the claims. Further a reading of the specification appears to indicate that the Glide Force Variation is determined by a specific equation but is not a well-known or standardized test. It is suggested for clarity the equation or determination of the Glide Force Variation be add as a limitation in the claims.
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) 1-4, 9, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1).
With regard to claim 1, Nagata discloses a medical delivery device (Fig. 1) comprising: a barrel (11) having at least one therapeutic (P) and an inner surface (see Fig. 1); and a stopper (13) contacting at least a portion of the inner surface of the barrel, wherein the inner surface of the barrel is free or substantially free of lubricants (barrel is treated with a corona discharge treatment which is not considered a coating or lubricant. Further the claims recite “substantially free” therefore some lubricant may exist and still read on the claim) and has a water contact angle of about 1 degree to 58 degree ([0031], discloses a water contact angle of 50-80 degrees which overlaps with the claimed range).
However, Nagata does not disclose a specific glide force variation.
Felts teaches a syringe having a glide force variation of less than about 1.3N when calculated according to the Glide Force Variation test method (a review of the specification appears to indicate the Applicant is using a specific equation to determine glide force variation. The term “glide force variation test” does not appear to be a standard test or measurement having one known calculation. However, using Applicant’s definition of a Glide Force Variation Test as defined by the specification, it appears that Felts teaches the claimed limitation because Table shows an uncoated syringe (top line of Table 1 on p. 53 indicating the initiation force and the maintenance force are the same thus no variation would exist.) Further the claims do not present recitations indicating the significance of this particular glide force variation and therefore, it could also be considered prima facie obvious to optimize the glide force variation to be less than about 1.3N as doing so would not alter the overall function of the device.
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 Nagata with the glide force variation as taught by Felts for the purpose of optimizing the friction of the stopper in the syringe barrel ([0088]).
With regard to claim 2, Nagata discloses wherein said barrel is a silicone free syringe barrel (barrel is not coated and is only treated using corona discharge treatment which is not considered a coating).
With regard to claim 3 and 4, Nagata discloses wherein said therapeutic comprises a vaccine ([0035]).
With regard to claim 9, Nagata discloses wherein the device is used for treatment of ocular disease (this is a functional limitation and therefore device would be capable of being used in ocular disease).
With regard to claim 18, Nagata/Felts teaches the claimed invention including a glide force. However, Nagata/Felts does not explicitly teach the average glide force being less than 4N. However, it would be prima facie obvious for one of ordinary skill in the art to optimize the average glide force to be less than 4N as doing so would not alter the overall function of the device and the claims have not provided a significance to this particular range.
With regard to claim 19, Nagata/Felts teaches the claimed invention including a water contact angle. However, Nagata/Felts does not explicitly teach the water contact angle to be between 10 and about 35 degrees. However, it would be prima facie obvious for one of ordinary skill in the art to optimize the water contact angle to be between 10 and 35 degrees as doing so would not alter the overall function of the device and the claims have not provided a significance to this particular range.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1) and in view of Jones et al. (US 2016/0015898 A1).
With regard to claim 5, Nagata/Felts discloses the claimed invention except for a specific therapeutic.
Jones teaches a syringe for delivery of proteases ([0157]).
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 Nagata/Felts to deliver proteases as taught by Jones because the substitution of one drug for another is well known in the art and would not alter the overall function of the device ([0157]).
With regard to claim 6, Nagata/Felts discloses the claimed invention except for a specific therapeutic.
Jones teaches a syringe for delivery of antibodies ([0156]).
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 Nagata/Felts to deliver cytokines as taught by Jones because the substitution of one drug for another is well known in the art and would not alter the overall function of the device ([0156]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1) and in view of Ingram et al. (US 2009/0092674 A1).
With regard to claim 7, Nagata/Felts discloses the claimed invention except for a specific therapeutic.
Ingram teaches a delivery device including delivery of stem cells ([0014], [0041]).
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 Nagata/Felts to deliver stem cells as taught by Ingram because the substitution of one drug for another is well known in the art and would not alter the overall function of the device ([0041]).
With regard to claim 8, Nagata/Felts discloses the claimed invention except for a specific therapeutic.
Ingram teaches a delivery device including delivery of factor VII ([0039]).
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 Nagata/Felts to deliver factor VII as taught by Ingram because the substitution of one drug for another is well known in the art and would not alter the overall function of the device ([0039]).
Claim(s) 10, 12, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1) and in view of D’Souza et al. (US 2011/0313363 A1).
With regard to claim 10 and 16, Nagata/Felts teaches the claimed invention except for the coated stopper.
D’Souza teaches wherein the stopper is at least partially covered with one or more non-fluoropolymer layers ([0054]).
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 Nagata/Felts to have a stopper coated with one or more non-fluoropolymer layers as taught by D’Souza for the purpose of reducing breakout force and slidability of the stopper ([0014], [0054]).
With regard to claim 12, Nagata discloses wherein the medical device is a pre-filled syringe (see Fig. 1).
Claim(s) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1) and in view of D’Souza and in further view of Ashmead et al. (US 2012/0251748 A1).
With regard to claim 11, Nagata/Felts/D’Souza discloses the claimed invention except for an autoinjector.
Ashmead teaches the use of syringes or other related devices including autoinjectors ([0003]).
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 Nagata/Felts/D’Souza to be in an autoinjector as taught by Ashmead because the substitution of one type of delivery for another is well known in the art and does not alter the overall function of the device ([0003]).
With regard to claim 15 and 17, Nagata/Felts/D’Souza discloses the claimed invention except for a composite material.
Ashemead teaches wherein the one or more fluoropolymer layers comprises a composite material having a barrier layer and a porous layer ([0029], [0030]), the barrier layer comprising at least one of densified ePTFE, PTFE ([0028]-[0030]).
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 Nagata/Felts/D’Souza to include a barrier layer and porous later coating as taught by Ashmead for the purpose of providing a scaffold that enable thin strong barrier layers to be made and improves the bond between the elastomer and the barrier, the barrier compliance is also important to maintain a seal between the stopper and the barrel ([0029]).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagata et al. (US 2010/0016714 A1) in view of Felts et al. (US 2015/0021339 A1) and in further view of Ashmead et al. (US 2012/0251748 A1).
With regard to claim 13 and 14, Nagata/Felts discloses the claimed invention except for a coating that is fluoropolymers.
Ashmead teaches a stopper that is coated with one or more fluoropolymer layers ([0031], [0035]) that comprises expanded polytetrafluoroethylene ([0035]).
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 Nagata/Felts to include a fluoropolymer coating as taught by Ashmead for the purpose of being able to provide thin barrier that remain intact during the forming and installation on the stopper of a syringe ([0028])
With regard to claim 15, Nagata/Felts discloses the claimed invention except for a composite material.
Ashemead teaches wherein the one or more fluoropolymer layers comprises a composite material having a barrier layer and a porous layer ([0029], [0030]), the barrier layer comprising at least one of densified ePTFE, PTFE ([0028]-[0030]).
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 Nagata/Felts to include a barrier layer and porous later coating as taught by Ashmead for the purpose of providing a scaffold that enable thin strong barrier layers to be made and improves the bond between the elastomer and the barrier, the barrier compliance is also important to maintain a seal between the stopper and the barrel ([0029]).
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,931,553 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present invention is a broader version of claim 4 (dependent and including all the limitations of claim 1) of U.S. Patent No. 11,931,553 B2 such that U.S. Patent No. 11,931,553 B2 teaches all the claimed elements of present claim 1 including a barrel ,a stopper a water contact angel between 1 and 28 degrees and a glide force variation less than about 1.3N wherein the barrel is free or substantially free of lubricant.
Further, dependent claims of the present invention are also taught by claims of U.S. Patent No. 11,931,553 B2 as outlined below.
Present Invention
U.S. Patent No. 11,931,553 B2
2 and 20
4
11
6
13
1
14
8
19
3
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,493,207 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of the present invention is a broader version of claim 9 of U.S. Patent No. 10,493,207 B2 such that U.S. Patent No. 10,493,207 B2 teaches all the claimed elements of present claim 1 including a barrel ,a stopper a water contact angel between 1 and 28 degrees and a glide force variation less than about 1.3N.
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