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 § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites the limitation “at least one completed electrical connection between the tissue target and the secondary connector.” This appears to be claiming a connection between the system and the human subject.
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 2 and 4-5 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 2 recites the limitation, “a return for each said completed connection.” This phrase is unclear, as it is not known what physical structure is required for the “return” and it is unclear how the return relates to the completed electrical connection between the tissue target and the secondary connector.
Claim 4 recites the limitation, “said proximal end being configured to pick up energy from a trial lead.” This phrase is unclear, as it is not known how the proximal end can “pick up” energy and it is unclear how the “trial lead” is related to the rest of the system.
Claim 5 recites “at least one secondary lead.” This phrase is unclear, as there is no antecedent basis for a primary lead.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown (US 2006/0015163).
Regarding claim 1, Brown discloses system for transferring energy to at least one tissue target, said system comprising (e.g. Figure 1):
at least one primary lead having a distal end and a proximal end (e.g. lead 14 as shown in Figure 1);
a primary connector attached to said proximal end of each of said primary leads (e.g. female or male connector 24);
at least one secondary lead having a first end and a second end (e.g. lead extension 16);
a complementary connector attached to each said first end of each of said secondary leads, said complementary connector being joinable to one of said primary connectors (e.g. connector 32);
a secondary connector attached to said second end of each of said secondary leads such that, when said distal end of said at least one primary lead is positioned near said at least one tissue target and said primary and complementary connectors are joined, the provides at least one completed electrical connection between the tissue target and the secondary connector, which is accessible to a device providing electrical energy (e.g. connector 30).
Regarding claim 4, Brown discloses a device comprising:
a primary lead having a distal end and a proximal end (e.g. lead 14 as shown in Figure 1);
having a primary connector attached to said proximal end (e.g. female or male connector 24);
said device configured for injecting fully into a body through a delivery device (e.g. device is sized and shaped such that it can be “injected fully into a body through a delivery device), and
said device further configured such that the distal end may be placed near a tissue target (e.g. distal end 20),
said proximal end being configured to pick up energy from a trial lead (as best the claim can be understood, the device has a proximal connector end that can receive energy from an IPG), and
said primary connector is available to be connected being configured to join to a complementary connector that in turn is connectable to a device providing electrical energy (e.g. as shown in Figure 1).
Regarding claim 5, Brown discloses a device comprising:
at least one secondary lead having a first end and a second end (e.g. lead extension 16);
with a complementary connector attached to said first end of each of said secondary leads (e.g. connector 32), and
a secondary connector attached to said second end of each of said secondary leads and configured for connection to a device providing electrical energy, the complementary connector being configured to be connected to a primary connector on a proximal end of a primary lead previously placed in a body to provide an electrical connection between the primary lead and the secondary connector (e.g. connector 30).
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nageri et al. (US 2020/0346021).
Regarding claim 1, Nageri discloses a system for transferring energy to at least one tissue target, said system comprising (e.g. Figure 1):
at least one primary lead having a distal end and a proximal end (e.g. leads 12 and 212);
a primary connector attached to said proximal end of each of said primary leads (retention sleeve 208);
at least one secondary lead having a first end and a second end (e.g. lead extensions 24 and 312);
a complementary connector attached to each said first end of each of said secondary leads, said complementary connector being joinable to one of said primary connectors (e.g. lead-extension connector 390);
a secondary connector attached to said second end of each of said secondary leads such that, when said distal end of said at least one primary leads is positioned near said at least one tissue target and said primary and complementary connectors are joined, the provides at least one completed electrical connection between the tissue target and the secondary connector, which is accessible to a device providing electrical energy (e.g. retention sleeve 308).
Regarding claim 2, as best the claim can be understood, Nageri additionally discloses a return for each said completed connection (e.g. lead-extension terminals 327).
Regarding claim 3, Nageri additionally discloses a plurality of said primary leads and said secondary leads (e.g. as shown in Figure 1), wherein at least a portion of each of said secondary leads is insulated and said insulated portions of said secondary leads are joined together (e.g. lead body 206) and said secondary connectors are located on a connecting structure selected from the group of a socket and an insertion pin (e.g. insertion pin as located on lead terminal 327).
Regarding claim 4, Nageri discloses a device comprising:
a primary lead having a distal end and a proximal end (e.g. leads 12 and 212);
having a primary connector attached to said proximal end (retention sleeve 208);,
said device configured for injecting fully into a body through a delivery device (e.g. device is sized and shaped such that it can be “injected fully into a body through a delivery device), and, and
said device further configured such that the distal end may be placed near a tissue target, said proximal end being configured to pick up energy from a as a trial lead (as best the claim can be understood, the device has a proximal connector end that can receive energy from an IPG), and
said primary connector is available to be connected being configured to join to a complementary connector that in turn is connectable to a device providing electrical energy (e.g. as shown in Figure 1).
Regarding claim 5, Nageri discloses a device comprising:
at least one secondary lead having a first end and a second end (e.g. lead extensions 24 and 312);
with a complementary connector attached to said first end of each of said secondary leads (e.g. lead-extension connector 390); and
a secondary connector attached to said second end of each of said secondary leads and configured for connection to a device providing electrical energy (e.g. retention sleeve 308), the complementary connector being configured to be connected to a primary connector on a proximal end of a primary lead previously placed in a body to provide an electrical connection between the primary lead and the secondary connector (e.g. as shown in Figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art documents also disclose lead extension devices:
Brase et al. (USPN 8,600,507); Osypka (US 2003/0077943); Goetz et al. (US 2008/0103522); Leven (USPN 10/201,713).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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