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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/18/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/21/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant's arguments filed 3/18/2026 regarding the limitations of wherein the neural delivery device be “configured to be inserted through a sealed port of an insertion tube” have been fully considered but they are not persuasive.
Applicant contends that, while no insertion tube is expressly recited or claimed as a component of the claimed invention, the device of Cigaina would not be reasonably capable of performing the recited function, as a matter of functional language, on the grounds that the device of Cigaina has a sharp front end 7 tipped with a needle 12 which is expressly for the purpose of penetrating tissue with the leading edge of the tool (see Cigaina Figs. 1-3 and Para. [0041], [0066], [0068], [0071], and [0074]-[0077]). In light of this feature and description, Applicant contends that any sealed port which Cigaina’s device is passed through would be cut or damaged by the sharp front end and thus be compromised in its sealing function.
While the Examiner acknowledges the sharp front end of Cigaina, the Examiner notes that Cigaina provides a description in Para. [0071] pertaining to a condition in which the device is navigated to an intended target site. In this paragraph, Cigaina discloses wherein the implantable device 1 is positioned within the containment body such that the rounded distal end of the implantable device is extending distally beyond the sharp front end so as not to cause lacerations in tissue. Cigaina thus appear to disclose an operating state in which the sharp front end 7 may be used to insert the device into a target tissue, or in this case an insertion tube, without causing lacerations or substantial damage to the impacted structures/tissue by allowing the contacted structures to be pushed aside by the rounded distal end of the implantable device. The Examiner respectfully contends that, should the device of Cigaina be inserted and guided to a target site through a sealed insertion tube, the device of Cigaina would initially enter the sealed tube but would not cause damage thereto, allowing the seal to reform around the device of Cigaina once inserted therein.
Applicant's arguments filed 3/18/2026 regarding the limitations of wherein the opening provides the holder” have been fully considered but they are not persuasive.
Applicant contends that the piston of Cigaina, previously cited to correspond to the claimed “holder” does not meet the amended limitations of being “an inside wall of the opening” as described in the specification Para. [0090].
The Examiner respectfully contends that having the holder be an inside wall of the opening is currently not recited in the claims. The presently-claimed limitations describing the holder recite, “wherein the neural delivery device includes a holder near the opening at the distal end for holding the neural interface device in a position at the opening of the neural delivery device” and “wherein the opening provides the holder by…” which does not expressly recite that the holder is one of the walls of the neural delivery device. Rather, the claims appears to require the holder is positioned near the opening at the distal end of the neural delivery device while being “provided” by the opening. The Examiner respectfully contends that the piston of Cigaina is positioned near the opening at the distal end of the containment body (see Figs. 1-3) and is provided by the opening such that the opening provides a space within which the holder is disposed.
Applicant’s arguments with respect to claim(s) 1 regarding the limitations of “wherein the opening provides the holder by being configured to hold a neural interface device by at least one of (i) friction between the inner surface of the opening of the neural delivery device and the neural interface device and (ii) an interference fit of the neural interface device with the opening” 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. Specifically, while Cigaina remains relied upon to disclose the claimed “holder”, Cigaina is not relied upon to disclose the amended limitations pertaining to the friction or interference fit provided between the holder and neural interface device.
Applicant's arguments filed 3/18/2026 with regards to the proposed combination of Cigaina and Castro, pertaining to claims 37, 40, 47-48 and 50, have been fully considered but they are not persuasive.
Applicant contends that one of ordinary skill in the art would not have found it obvious to combine the delivery sheath (i.e., main tube 12) of Castro into the system of Cigaina for the purpose of providing a sealed delivery sheath to provide access and guidance to a body cavity for a surgical instrument inserted therethrough on the grounds that the device of Cigaina is intended to be used without needing a surgical operation (see Cigaina Para. [0027]) whereas Castro is designed to facilitate complex surgical procedures with multiple sealed instrument access points. Applicant contends that the two intended-use cases for Castro and Cigaina contradict one-another and one of ordinary skill in the art would not have looked to Castro’s complex surgical system to provide a guide sheath for the device of Cigaina.
The Examiner respectfully disagrees with Applicant’s interpretation of Cigaina. The cited Para. [0027] of Cigaina merely cites that the device of Cigaina is intended to implant a device for electric stimulation of tissues without needing a surgical operation. Cigaina does provide disclosure within the cited paragraph that precludes incorporating additional tools or instruments to make the implantation procedure more efficient. The Examiner respectfully contends that the introducer sheath of Castro would be reasonable to incorporate into the device of Cigaina to provide a sealed entry port device to allow insertion of instruments therethrough while preventing contamination of the surgical device during insertion into a bodily space (see Castro Para. [0054]-[0055]). The device of Castro does not inherently require a complex surgical operation be performed but rather is merely providing a sealed introducer means by which to introduce other surgical device to a target site. The operation of the device of Castro is understood to be in-line with the device of Cigaina as the device of Cigaina is intended to be inserted into a bodily space before being navigated to a target site to implant an electrical stimulation device. Castro provides a device with a cited benefit in making the procedure of Cigaina more efficient by reducing chance of contamination of the surgical instrument.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 3/18/2026, with respect to the objection to claim 39 for reciting “to hold a neural interface device one of by at least one of…” which contained a grammatical/typographical error have been fully considered and are persuasive in light of Applicant’s amendment to cancel claim 39 from the pending claim set. The objection of claim 39 has been rendered moot.
Claim Interpretation
Applicant’s arguments, see “Remarks”, filed 3/18/2026, with respect to the 112(f) invocation of the phrase “a neural delivery device retention feature” in claims 27 have been fully considered but are not persuasive.
Applicant contends that the phrase “a neural delivery device retention feature” recites and invokes sufficient structure used to perform the recited function in light of the description of claimed “retention feature” found within the specification. Applicant cites to Para. [0091], [0101]-[0102], [0114]-[0115], [0117] and [0119] which describes various structures that may be considered the “retention feature” that are used interchangeably based on selected design needs. While the term “feature” may constitute, on its own, a generic placeholder, Applicant contends the context and written support found within the specification impart sufficient structure such that one of ordinary skill in the art would understand “retention feature” to mean a structural component selected from the disclosed alternatives, each of which having a definite structure.
While the Examiner acknowledges the specification provides various definite structures for the “retention feature” that may be used interchangeably with one-another, the Examiner respectfully notes that it is improper to import claim limitations from the specification (see MPEP 2111). Without providing an recitation of one of the retention structures found within the specification, the term “retention feature” is understood to constitute a generic placeholder that may be swapped/substituted with any of the alternative retention structures found within the specification. As the phrase does not refer to any singular specific structure, the term is understood to be generic. Should Applicant wish to recite a specific structure for the retention feature, the limitations describing the intended structure from the specification should be recited within the claims. Until further clarifying structure is included within the claims to define and describe an intended structure for the “retention feature”, the 112(f) invocation for this phrase is upheld and maintained.
Applicant’s arguments, see “Remarks”, filed 3/18/2026, with respect to the 112(f) invocation regarding the phrase “retention feature” recited in claim 28 have been fully considered and are persuasive in light of Applicant’s arguments point out that claim 28 provides ample structure used to perform the recited function. Specifically, claim 28 recites wherein the “retention feature” is a transverse hole for receiving a thread therethrough. The 112(f) invocation of “retention feature” recited within claim 28 has been withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a neural delivery device retention feature” in claim 27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2, 4-5, 25, 27-28, 40, 43-48 and 50 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, “wherein the opening provides the holder by being configured to hold a neural interface device” and it is unclear whether the recited “a neural interface device” is referring to the previously-introduced neural interface device recited in claim 1, or whether this limitation seeks to define a new, second neural interface device separate and distinct from the previously-introduced neural interface device.
Claims 2, 4-5, 25, 27-28, 40, 43-48 and 50 are additionally rendered indefinite due to their dependency and further modification of claim 1.
Claim 5 recites, “the first end including a holder for holding the neural interface device in the position” and it is unclear whether the recited “a holder” is referring to the previously-introduced holder recited in claim 1, or whether this limitation seeks to define a new, second holder that is separate and distinct from the previously-introduced holder of claim 1. For the purposes of examination, the “holder” recited in claim 5 is interpreted to refer back to and further modify the “holder” recited in claim 1.
Claim Rejections - 35 USC § 103
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 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) 1-2, 4-5, 27-28, 43-46 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cigaina (US 2016/0375256 A1)(previously of record) in view of Hagemeier (US 2003/0135153 A1).
Regarding claim 1, Cigaina discloses:
A neural delivery device (see Fig. 1 showing tubular connection 11 and containment body 6 forming an overall delivery device) for delivery of a neural interface device (implantable device 1, see Fig. 1) into an abdominal cavity for implantation within a patient (see Para. [0050]);
wherein the neural delivery device is configured to be inserted through a sealed port of an insertion tube (the delivery device of Cigaina, comprising all of the structural limitations of the invention of Claim 1, is fully and reasonably capable of being inserted through a sealed port of an outer insertion tube; the examiner notes that no “insertion tube” is positively recited in the currently-presented limitations of Claim 1 and the delivery device of Cigaina therefore merely needs to be capable of being inserted through an outer insertion tube, see MPEP 2114); and
wherein the neural delivery device comprises an opening at a distal end of the delivery device for the neural interface device (see Fig. 1 showing wherein the containment body comprises a distal opening receiving the implantable device);
wherein the neural delivery device includes a holder near the opening at the distal end (piston 16, see Fig. 4 and Examiner’s Diagram of Fig. 1 below; see also Para. [0066]-[0071] and [0076] reciting wherein the piston 16 is configured to rest against the device 1 (i.e., in a direct contacting abutment) during navigation to a target site while also being responsible for ejecting the implantable device 1 from the containment body by pushing the implantable device distally outward therefrom) for holding the neural interface device in a position at the opening of neural delivery device (see Figs. 1, 4 and 8 and Para. [0071] mentioning wherein the device 1 is configured to rest against the piston 16 during navigation to a target site).
However, while Cigaina discloses wherein the implantable device 1 is configured to remain within the containment body 6 until ejected therefrom via a user input, Cigaina does not expressly disclose a mechanism or means by which the implantable device is secured within the containment body so as not to become loose and dislodged prior to deployment. Thus, Cigaina does not expressly disclose wherein the opening provides the holder by being configured to hold a neural interface device by at least one of (i) friction fit between an inner surface of the opening of the neural delivery device and the neural interface device, and (ii) an interference fit of the neural interface device with the opening.
In a relevant field of endeavor, namely implantable devices configured to be stored within a holding portion at the distal end of a delivery device, Hagemeier teaches a delivery device (needle 10, see Fig. 1) for delivery of an implantable device (implant 12, see Figs. 1-3); wherein the delivery device comprises an opening at a distal end thereof for receiving the implantable device (opening 14, see Figs. 1-3); wherein the implantable device is secured within said opening by a friction fit between the three abutting, radially inward walls of the opening (see Para. [0036] and Figs. 2 and 6) to provide a securement means by which to secure the implantable device within the opening of the delivery device until such time as a user wishes to eject and deploy said implantable device (see Para. [0036]).
Since Cigaina discloses wherein the implantable device is configured to be held within the containment body until a user actuates an ejection mechanism, but is silent in regards to how the implantable device is secured within said containment body prior to ejection, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have secured the implantable device of Cigaina within the opening of the containment body by at least a loose friction/interference fit between the radially-inward walls in contact therewith in addition to the piston in contact with the proximal end thereof, as disclosed to be a known securement means for securing implants within a receiving opening of a delivery device by Hagemeier, to provide a known securement means within the art for securing the implant within the containment body via contact on three sides of the device so as to prevent accidental dislodging of the implant prior to intended delivery (see Hagemeier Para. [0036]).
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Examiner’s Diagram of Fig. 1
Regarding claim 2, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the neural delivery device is a delivery tube (see Fig. 1 showing wherein the containment body is a hollow tube to house the implantable device therein for delivery to a desired treatment site as recited in Para. [0050]).
Regarding claim 4, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the neural delivery device includes a wall positioned near the distal end of the neural delivery device (see Figs. 1 and 6 showing wherein the containment body comprises a base 8 at the proximal end thereof), wherein the wall extends in a plane transverse to the longitudinal axis of the neural delivery device (see Figs. 1 and 6).
Regarding claim 5, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the neural delivery device tool is configured to receive a pusher rod (thrust cable 17, see Fig. 1), the pusher rod having a first end for insertion into a sealable end of the delivery device (see Fig. 1 showing wherein a distal end of thrust cable inserts into the proximal end of the containment body – the examiner notes that the term “sealable” in interpreted to mean that the insertion opening is “capable” of being sealed and the proximal end of the containment body of Cigaina is understood to be capable of being sealed due to being a confined opening) and a second end for extending out of the sealable end of the neural delivery device (proximal end of thrust cable as shown in Fig. 1), the first end including a holder for holding the neural interface device in the position (piston 16 is secured to the distal end of thrust cable 17 as shown in Fig. 1; see also Para. [0071]).
Regarding claim 25, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the neural delivery device is a solid delivery tube, and wherein the opening at the distal end of the neural delivery device is a hole formed in the distal end of the solid delivery tube (the connection member and containment unit are understood to be “solid tubes” having an opening at the distal end thereof which extends through a substantial portion of the device; the examiner notes that the term “solid” is interpreted to mean “formed from a solid tube” in this context as Applicant provides an express definition of this term in Para. [0001] of Pg. 15 of the Specification, reciting “’solid’ refers to a structure where the interior is completely filled up or free from cavities. However, this definition is contrasted by the formation of a hole or opening therein, which detracts from the provided definition of “completely filled”. Therefore, in light of the allowed interpretation from the specification, the examiner notes that the delivery device of Cigaina is “solid” with an axial hole running substantially therethrough), wherein an axis of the hole corresponds to an axis of the solid deliver tube (see Fig. 1 showing wherein the opening defined within the containment body is axially aligned with the body thereof).
Regarding claim 27, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the neural delivery device comprises a delivery device retention feature configured to prevent the neural delivery device from passing through the insertion tube by more than a predetermined amount (thrust cable 17 attached to piston 16, see Para. [0069]; this is equivalent under 112f to the structure disclosed in the specification as corresponding to the claimed means plus function limitation, which may be a cap, a string or a suture configured and positioned to prevent accidental release of the delivery tube– see Spec. Pg. 19, Para. [0001]-[0002]; the examiner notes that as the piston comprises a large surface area that is radially larger than the lumen of tubular connection 11, should the thrust cable be pulled proximally, the containment body and the tubular connection member would be prevented from moving further distally within an insertion tube than desired by a user).
Regarding claim 28, the combination of Cigaina and Hagemeier discloses the invention of claim 27, Cigaina further discloses wherein the neural delivery device retention feature comprises a transverse hole in a proximal end of the neural delivery device (see Figs. 1-2 showing wherein a hole is present in the base 8 of the containment unit to receive the thrust cable and connect to the piston 16) for receiving a thread (thrust cable 17, see Figs. 1-2), wherein the transverse hole passes through the neural delivery device in a direction perpendicular to a length of the neural delivery device (the hole in the base of the containment member comprises a width that extends in a direction transverse to the longitudinal axis).
Regarding claim 43, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina, as modified by Hagemeier, further discloses wherein the opening is a hole in the distal end of the neural delivery device (see Cigaina Figs. 1-4), and wherein the sidewall of the hole is configured to hold the neural interface device by friction or interference fit (see Hagemeier Para. [0036] mentioning wherein the implantable device is secured within the opening of the corresponding delivery device by a friction fit against the radially-inward walls of the opening in contact therewith, as incorporated into the device of Cigaina in the above rejection of claim 1).
Regarding claim 44, the combination of Cigaina and Hagemeier discloses the invention of claim 43, Cigaina further discloses wherein the hole has an end wall (rear base 8, see Fig. 1) and the sidewall of the hole is configured to hold the neural interface device by friction or interference fit while the neural interface device is spaced from the end wall (see Hagemeier Para. [0036] mentioning wherein the implantable device is secured within the opening of the corresponding delivery device by a friction fit against the radially-inward walls of the opening in contact therewith, as incorporated into the device of Cigaina in the above rejection of claim 1).
Regarding claim 45, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the opening is configured to receive all or substantially all of the neural interface device within the opening (see Fig. 1 and Para. [0071]).
Regarding claim 46, the combination of Cigaina and Hagemeier discloses the invention of claim 1, Cigaina further discloses wherein the opening is configured to hold the neural interface device by friction or interference fit (see Hagemeier Para. [0036] mentioning wherein the implantable device is secured within the opening of the corresponding delivery device by a friction fit against the radially-inward walls of the opening in contact therewith, as incorporated into the device of Cigaina in the above rejection of claim 1) with all or substantially all of the neural interface device received within the opening (see Cigaina Fig. 1 showing wherein the implantable device is disposed within the entirety of the internal space of the containment body).
Regarding claim 51, Cigaina discloses:
A system (see Fig. 1) for laparoscopic delivery and deployment of a neural interface device (implantable device 1, see Fig. 1) into an abdominal cavity for implantation within a patient (see Para. [0050]), the system comprising:
a neural delivery device (see Fig. 1 showing tubular connection 11 and containment body 6 forming an overall delivery device) configured to be inserted through a sealed port of an insertion tube (the delivery device of Cigaina, comprising all of the structural limitations of the invention of Claim 1, is fully and reasonably capable of being inserted through a sealed port of an outer insertion tube; the examiner notes that no “insertion tube” is positively recited in the currently-presented limitations of Claim 1 and the delivery device of Cigaina therefore merely needs to be capable of being inserted through an outer insertion tube, see MPEP 2114), the neural delivery device comprising an opening at a distal end of the neural delivery device (see Fig. 1 showing wherein the containment body comprises a distal opening for receiving the implantable device therein);
wherein the opening has an inner surface (see Fig. 1 showing inner surfaces of the opening at the distal end of the containment body); and
a neural interface device (implantable device 1, see Fig. 1);
wherein the opening and the neural interface device are configured and arranged such that the neural interface device is able to be inserted into the opening (see Fig. 1).
However, while Cigaina discloses wherein the implantable device 1 is configured to remain within the containment body 6 until ejected therefrom via a user input, Cigaina does not expressly disclose a mechanism or means by which the implantable device is secured within the containment body so as not to become loose and dislodged prior to deployment. Thus, Cigaina does not expressly disclose:
Wherein the neural interface device is held within the opening of the neural delivery device by at least one of (i) a friction fit between the inner surface of the opening and the neural interface device, and (ii) an interference fit between the inner surface of the opening and the neural interface device.
In a relevant field of endeavor, namely implantable devices configured to be stored within a holding portion at the distal end of a delivery device, Hagemeier teaches a delivery device (needle 10, see Fig. 1) for delivery of an implantable device (implant 12, see Figs. 1-3); wherein the delivery device comprises an opening at a distal end thereof for receiving the implantable device (opening 14, see Figs. 1-3); wherein the implantable device is secured within said opening by a friction fit between the three abutting, radially inward walls of the opening (see Para. [0036] and Figs. 2 and 6) to provide a securement means by which to secure the implantable device within the opening of the delivery device until such time as a user wishes to eject and deploy said implantable device (see Para. [0036]).
Since Cigaina discloses wherein the implantable device is configured to be held within the containment body until a user actuates an ejection mechanism, but is silent in regards to how the implantable device is secured within said containment body prior to ejection, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have secured the implantable device of Cigaina within the opening of the containment body by at least a loose friction/interference fit between the radially-inward walls in contact therewith in addition to the piston in contact with the proximal end thereof, as disclosed to be a known securement means for securing implants within a receiving opening of a delivery device by Hagemeier, to provide a known securement means within the art for securing the implant within the containment body via contact on three sides of the device so as to prevent accidental dislodging of the implant prior to intended delivery (see Hagemeier Para. [0036]).
Claim(s) 37, 40 and 47-48 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cigaina (US 2016/0375256 A1)(previously of record) in view of Hagemeier (US 2003/0135153 A1), further in view of Castro (US 2011/0060183 A1)(previously of record).
Regarding claim 37, Cigaina discloses:
A tool (see Fig. 1) for delivering a neural interface device (implantable device 1, see Fig. 1) into an abdominal cavity for implantation within a patient (see Para. [0050]), comprising:
the neural delivery device of claim 1 (see Fig. 1).
However, while Cigaina discloses wherein the neural delivery device is inserted into the abdomen of a patient (see Para. [0050]) Cigaina does not expressly disclose wherein the tool apparatus includes:
an insertion tube for insertion through the abdominal cavity, the insertion tube having a sealed port and an open end for being positioned within the abdominal cavity when inserted; and
wherein the neural delivery device is for insertion through the sealed port of the insertion tube.
However, in the same field of endeavor, namely tubular catheter devices for insertion and treatment of medical conditions within the abdomen (see Para. [0003], [0108]-[0111]), Castro teaches wherein an outer delivery sheath (main tube 12, see Fig. 1) is provided within a surgical instrument delivery system which is configured to allow for insertion and guidance of internal surgical instrument tubes therethrough (see Para. [0054]) to provide access and guidance to a body cavity (see Para. [0054]); the delivery sheath comprises O-ring seals at the proximal port ends of access tubes disposed within the main tube (see Para. [0055], see also Fig. 2B) that seal against the shafts of instruments positioned within the access tubes (see Para. [0055]) which can prevent contamination of the surgical device during insertion into a bodily space.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a sealed outer delivery sheath disposed around the containment body and connection member of Cigaina as taught and suggested by Castro to, in this case, provide an outer guiding sheath member configured to receive the device of Cigaina therethrough to guide the device through the body to a desired surgical location while preventing contamination of the containment body and connection member when being inserted into a bodily space (see Castro Para. [0054]).
Regarding claim 40, Cigaina discloses:
A method of delivering a neural interface device into an abdominal cavity of a patient for implantation (see Para. [0050]), the method comprising:
providing the neural interface device (implantable device 1, see Fig. 1) at an opening of a delivery device (see Fig. 1, see also Para. [0062]);
wherein the delivery device is the neural delivery device of claim 1 (see Fig. 1).
However, while Cigaina discloses wherein the implantable device 1 is configured to remain within the containment body 6 until ejected therefrom via a user input, Cigaina does not expressly disclose a mechanism or means by which the implantable device is secured within the containment body so as not to become loose and dislodged prior to deployment. Thus, Cigaina does not expressly disclose:
wherein the neural interface device is held in the opening of the neural delivery device by friction or an interference fit; and
wherein the neural delivery device is inserted through a sealed port of an insertion tube; and
In the same field of endeavor, namely tubular catheter devices for insertion and treatment of medical conditions within the abdomen (see Para. [0003], [0108]-[0111]), Castro teaches wherein an outer delivery sheath (main tube 12, see Fig. 1) is provided within a surgical instrument delivery system which is configured to allow for insertion and guidance of internal surgical instrument tubes therethrough (see Para. [0054]) to provide access and guidance to a body cavity (see Para. [0054]); the delivery sheath comprises O-ring seals at the proximal port ends of access tubes disposed within the main tube (see Para. [0055], see also Fig. 2B) that seal against the shafts of instruments positioned within the access tubes (see Para. [0055]) which can prevent contamination of the surgical device during insertion into a bodily space.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a sealed outer delivery sheath disposed around the containment body and connection member of Cigaina as taught and suggested by Castro to, in this case, provide an outer guiding sheath member configured to receive the device of Cigaina therethrough to guide the device through the body to a desired surgical location while preventing contamination of the containment body and connection member when being inserted into a bodily space (see Castro Para. [0054]).
In a relevant field of endeavor, namely implantable devices configured to be stored within a holding portion at the distal end of a delivery device, Hagemeier teaches a delivery device (needle 10, see Fig. 1) for delivery of an implantable device (implant 12, see Figs. 1-3); wherein the delivery device comprises an opening at a distal end thereof for receiving the implantable device (opening 14, see Figs. 1-3); wherein the implantable device is secured within said opening by a friction fit between the three abutting, radially inward walls of the opening (see Para. [0036] and Figs. 2 and 6) to provide a securement means by which to secure the implantable device within the opening of the delivery device until such time as a user wishes to eject and deploy said implantable device (see Para. [0036]).
Since Cigaina discloses wherein the implantable device is configured to be held within the containment body until a user actuates an ejection mechanism, but is silent in regards to how the implantable device is secured within said containment body prior to ejection, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have secured the implantable device of Cigaina within the opening of the containment body by at least a loose friction/interference fit between the radially-inward walls in contact therewith in addition to the piston in contact with the proximal end thereof, as disclosed to be a known securement means for securing implants within a receiving opening of a delivery device by Hagemeier, to provide a known securement means within the art for securing the implant within the containment body via contact on three sides of the device so as to prevent accidental dislodging of the implant prior to intended delivery (see Hagemeier Para. [0036]).
Regarding claim 47, the combination of Cigaina and Castro disclose the invention of claim 37, Cigaina further discloses wherein the opening is a hole in the distal end of the neural delivery device (see Fig. 1).
However, while Cigaina discloses wherein the implantable device 1 is configured to remain within the containment body 6 until ejected therefrom via a user input, Cigaina does not expressly disclose a mechanism or means by which the implantable device is secured within the containment body so as not to become loose and dislodged prior to deployment. Thus, Cigaina does not expressly wherein the sidewall of the hole is configured to hold the neural interface device by friction or interference fit.
In a relevant field of endeavor, namely implantable devices configured to be stored within a holding portion at the distal end of a delivery device, Hagemeier teaches a delivery device (needle 10, see Fig. 1) for delivery of an implantable device (implant 12, see Figs. 1-3); wherein the delivery device comprises an opening at a distal end thereof for receiving the implantable device (opening 14, see Figs. 1-3); wherein the implantable device is secured within said opening by a friction fit between the abutting, radially inward walls of the opening (see Para. [0036] and Figs. 2 and 6) to provide a securement means by which to secure the implantable device within the opening of the delivery device until such time as a user wishes to eject and deploy said implantable device (see Para. [0036]).
Since Cigaina discloses wherein the implantable device is configured to be held within the containment body until a user actuates an ejection mechanism, but is silent in regards to how the implantable device is secured within said containment body prior to ejection, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have secured the implantable device of Cigaina within the opening of the containment body by at least a loose friction/interference fit between the radially-inward walls thereof, as disclosed to be a known securement means for securing implants within a receiving opening of a delivery device by Hagemeier, to provide a known securement means within the art for securing the implant within the containment body so as to prevent accidental dislodging of the implant prior to intended delivery (see Hagemeier Para. [0036]).
Regarding claim 48, the combination of Cigaina, Castro and Hagemeier disclose the invention of claim 47, Cigaina, as modified by Hagemeier, further discloses wherein the opening is configured to hold the neural interface device by friction or interference fit (see Hagemeier Para. [0036] mentioning wherein the implantable device is secured within the opening of the corresponding delivery device by a friction fit against the radially-inward walls of the opening in contact therewith, as incorporated into the device of Cigaina in the above rejection of claim 47) with all or substantially all of the neural interface device received within the opening (see Cigaina Fig. 1).
Regarding claim 50, the combination of Cigaina, Castro and Hagemeier disclose the method of claim 49, Cigaina, as modified by Castro, further discloses wherein all or substantially all of the neural interface device is received within the opening (see Cigaina Fig. 1) when the neural delivery device is inserted through the sealed port of the insertion tube (as the implantable device of Cigaina is held within the cavity of the containment body (see Cigaina Fig. 1), this configuration would remain unchanged when inserted through the outer guide tube of Castro, as incorporated into the device of Cigaina).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2016/0067513 A1 to Crutchfield, US 2015/0273207 A1 to Tran and US 7811245 B2 to Kennedy all elongate catheter devices configured to store an implantable device within an opening at the distal end thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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