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 § 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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 87-113 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dimitrova et al (WO 2019/028340, 02/07/2019, of record) as evidenced by Creadon (IG Living, 2009, of record), Freedom60 Syringe Infusion System manual (Koru Medical Systems, 2020) and Freedom60 Syringe Infusion System manual (RMS Medical Products, 2018).
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Dimitrova et al teach administration of high concentration (e.g. 80mg/ml) defibrotide and a viscosity reducer, such as Gly-Gly at 34mM, subcutaneously via a device such as the Freedom60 pump. Viscosity and osmolality values measured were within the ranges recited in instant claims 93 and 94 . See the abstract, ¶’s [0095]-[0098], [00103]-[00104], [00121]-[0125], Tables 1-3, claim 30. The Freedom60 syringe device inherently comprises a housing containing a syringe (reservoir) and a dispenser in fluid communication with the reservoir (tubing connected to an injection needle). See Creadon et al (p. 45, second column), Freedom60 manual 2020 (page 4, page 6, Figs. 3-4) and Freedom60 manual 2018 (page 2, administration instructions). A major portion of the housing is configured to be “off-body”, the device comprises an adhesive (step 5, page 5 of the 2018 manual; Fig 12, page 7 of the 2020 manual), and the device comprises controller knobs.
Claims 90-92, 99, 100, 105 recite inherent characteristics of the defibrotide formulation, apparently when administered. According to MPEP § 2112.01, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Further, such characteristics are taught by Dimitrova et al in claims 33-35, 37, 38
Claims 108-110 modify the patch only and do not remove the device as an alternative.
Claims 111-113 are taught by Dimitrova et al in claims 44, 41 (¶ [002]), and 113, respectively.
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.
Claims 90-92, 105 are 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 90 recites the limitation "the high concentration defibrotide formulation delivered subcutaneously" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 92 recites the limitation "the high concentration defibrotide formulation delivered subcutaneously" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 105 recites the limitation "the shear" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638