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 § 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) 59-74, 76-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan et al. (US 2016/0081745 A1) in view of Wilson (US 2005/0048043 A1).
With regard to claim 59, Rajagopalan discloses A method of treating a medical condition of a patient, comprising:
selecting a patient for treatment ([0009], [0010], [0013], Fig. 1, Step 10);
selecting a depositing device (Fig. 1, step 30, specifically Fig. 3, element 100/111a, 111b), wherein the depositing device comprises a depositing element (130 with element 132/135/138, [0298]);
selecting an access device (Fig. 3, element 350, Fig. 1 step 30), wherein the access device comprises an ultrasonically guided endoscope ([0270], [0302], ultrasound visualization can be used and the access device is an endoscope) comprising a working channel ([0270]) sized to slidingly receive the depositing device (see Fig. 3, element 111 slides within 350);
advancing the access device through the patient's mouth ([0282], inserted orally into the patient); and performing at least one injection ([0282], [0298], [0303]) comprising:
advancing the depositing element through the ultrasonically guided endoscope to a location proximate an at least one deposit site in the patient (Fig.1 step 40, [0220], [0282]);
and delivering a treatment agent into the at least one deposit site via the depositing element ([0282]), wherein the at least one deposit site comprises the intraparenchymal space of the pancreas of the patient ([0028], duodenum is considered part of the intraparenchymal space as it is located and connected with the head of the pancreas),
and wherein the method treats a medical condition of the patient selected from the group consisting of: type one diabetes; type two diabetes; obesity; and combinations thereof ([0008], [0013]).
However, Rajagopalan does not explicitly disclose wherein the treatment agent comprises gene therapy.
Wilson teaches the delivery of an agent to the pancreas for treatment of diabetes and further teaches the agent may comprises gene therapy ([0025], [0028]).
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 treatment agent of Rajagopalan with the gene therapy as taught by Wilson because the substitution of one known agent for another for treatment of the same disease state is well-known in the art and does not alter the overall function of the device ([0025], [0028]).
With regard to claim 60, Rajagopalan discloses wherein the at least one deposit site comprises the body and tail of the pancreas ([0028], duodenum is considered part of the intraparenchymal space of the pancreas as it is located and connected with the head of the pancreas and would deliver out to the body and tail of the pancreas).
With regard to claim 61, Rajagopalan discloses the claimed invention except for a gene therapy material.
Wilson teaches wherein the gene therapy material comprises adeno-associated virus-based gene therapy material ([0025], [0028]).
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 treatment agent of Rajagopalan with the gene therapy as taught by Wilson because the substitution of one known agent for another for treatment of the same disease state is well-known in the art and does not alter the overall function of the device ([0025], [0028]).
With regard to claim 62 and 63, Rajagopalan/Wilson teach the claimed invention except for the specific flow rate.
However, it would be prima facie obvious to optimize the flow rate to be no more than 5 mL/min and more specifically not more than 3mL/min or 1mL/min as doing so does not alter the overall function of the device.
With regard to claim 64, Rajagopalan discloses wherein a total volume of treatment agent delivered comprises a volume of at least 1mL, a volume of no more than 25mL, or both ([0303]).
With regard to claim 65, Rajagopalan discloses wherein performing the at least one injection comprises performing two or more injections in which the depositing element is advanced two or more times ([0303]).
With regard to claim 66, Rajagopalan discloses wherein the depositing element comprises one or more needles (138, [0303]) and/or at least one needle with multiple fenestrations.
With regard to claim 67 and 68, Rajagopalan discloses wherein the depositing element comprises one or more needles (138, [0303]), wherein each needle comprises a distal segment (inherent).
While Rajagopalan does not explicitly disclose a specific gauge it would be prima facie obvious to optimize the size of the needle to be a maximum of 25 gauge or 27 gauge as doing so is a mere design choice and does not change the overall function of the device.
With regard to claim 69, Rajagopalan discloses the claimed invention except for the exact length of the needle.
However, it would be prima facie obvious for one of ordinary skill in the art to optimize the length of the needle to be at least 2cm as doing so would not alter the overall function of the device.
With regard to claim 70, Rajagopalan discloses wherein the performing of the at least one injection comprises performing a single injection only ([0303], can be one injection or several injections).
With regard to claim 71, Rajagopalan discloses wherein the performing of the at least one injection comprises performing no more than seven injections ([0303]).
With regard to claim 72, Rajagopalan discloses wherein the at least one deposit site comprises a first deposit site and a second deposit site different than the first deposit site ([0303]), and wherein the performing of the at least one injection comprises performing a first injection at the first deposit site and a second injection at the second deposit site ([0303]).
With regard to claim 73, Rajagopalan discloses wherein the method is configured to minimize distribution of the treatment agent to non-target tissue ([0086]).
With regard to claim 74, Rajagopalan discloses wherein the non-target tissue comprises non-target organs of the patient ([0209]).
With regard to claim 76, Rajagopalan discloses wherein the performing of the at least one injection comprises delivering the treatment agent to: at least 20% of the volume of tissue of the pancreas ([0237]); at least 10% or at least 20% of the islet cells of the pancreas; at least 10% or at least 20% of the alpha cells of the pancreas; and/or at least 10% or at least 20% of the beta cells of the pancreas. It would also be prima facie obvious to optimize the delivery percentage as doing so would be within the skill of one of ordinary skill in the art and not alter the overall function of the device.
With regard to claim 77, Rajagopalan discloses wherein the method further comprises performing a flush procedure during which a flush material is delivered into the depositing element ([0303] because the device is configured to deliver multiple injections of fluid, one of the injections can be considered a flush procedure during which a flush material is delivered).
With regard to claim 78, Rajagopalan discloses wherein the depositing element comprises a lumen defining a lumen volume ([0298], fluid delivery elements 132 and 135 can be comprised of lumens), and wherein the volume of the flush material delivered into the depositing element comprises a volume at or below the lumen volume (the delivery amount would necessarily be at or below the lumen volume as the lumen cannot carry more than the lumen volume).
With regard to claim 79, Rajagopalan discloses wherein the method further comprises delivering a tissue-disseminating agent to the at least one deposit site prior to and/or during the performing of the at least one injection of the treatment agent to the at least one deposit site ([0303], multiple injections can be performed and therefore one of the multiple injections can be considered as delivering an agent prior to the performing of the at least one injection of the treatment agent to the deposit site. The agent delivered is considered tissue-disseminating as it is delivered and spread to the tissue).
With regard to claim 80, Rajagopalan discloses wherein the tissue-disseminating agent is co-formulated with the treatment agent ([0303]).
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan et al. (US 2016/0081745 A1) in view of Wilson (US 2005/0048043 A1) and in further view of Rajagopalan et al. (US 2017/0007310 A1)(hereinafter referred to as Rajagopalan II).
With regard to claim 75, Rajagopalan/Wilson teach the claimed invention except for delivery to a blood vessel.
Rajagopalan II teaches delivery to the pancreas and further teaches delivery to a blood vessel in communication with the pancreas ([0251] delivery to the duodenum which is the same as that of Rajagopalan).
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 treatment agent of Rajagopalan/Wilson with the delivery to a blood vessel as taught by Rajagopalan II for the purpose of treatment into the target organ ([0251]).
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783