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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on February 8, 2024 has/have been acknowledged and is/are being considered by the Examiner.
The information disclosure statement filed May 9, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein, which has been lined-through has not been considered. It is noted that there were five Foreign Reference documents filed on 5/9/2024, however each of these entries includes a blank page followed by a page indicating an error. As such, these documents were lined-through. Additionally, the non-patent literature entry for Vida includes only the cover page and does not include all 8 pages of the document and it has therefore been lined-through.
Drawings
The drawings are objected to because the boxes 109, 102, 103, 60, 112-115, 10, and 111 in Figure 2 should be labeled to indicate what is contained or indicated by such boxes. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed February 8, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/GB2022/052071 and US provisional application US63/231,611 is ineffective as it was added after the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 08/09/2022, see MPEP 1893.03(b). Therefore the specification amendment of 02/08/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is advised to remove the phrase “, the disclosures of which are hereby incorporated herein by reference in their entireties” from the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 81-83, 97, 98, and 100-104 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 81 recites the limitation "the reduction in CRP levels in plasma" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claims fail to previously recite plasma.
Claim 82 recites the limitation "the reduction in CRP levels in plasma" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claims fail to previously recite plasma.
Claim 83 recites the limitation "the transducer" in line 1. It is unknown which of the previously recited “at least one transducer” is being referenced with “the transducer”. It is suggested that claim 83 be amended to recite “the at least one transducer”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 97 recites the broad recitation “a contact time period no longer than 24 hours”, and the claim also recites “a contact time period no longer than…18 hours, 15 hours, 12 hours, 10 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hour, 2 hours, 1 hour, 30 minutes, or 20 minutes” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 98 recites the broad recitation “the reduction in the inflammatory parameter is detectable within…5 days”, and the claim also recites “the reduction in the inflammatory parameter is detectable within 1 day, 2 days, 3 days, 4 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 100 recites the limitations "providing a system of claim 80" in line 4, “positioning at least one transducer” in line 5, “at least one controller coupled to the at least one transducer” in lines 7-8. Claim 80 already includes at least one transducer and a controller and, therefore, it is unclear if the additional recitations of at least one transducer and controller recited in claim 100 are intended to be additional transducers and controllers, or are intended to instead refer to the previously-recited at least one transducer and controller.
Claim 101 recites the limitation "the reduction in CRP levels in plasma" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claims fail to previously recite plasma.
Claim 102 recites the limitation "the reduction in CRP levels in plasma" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claims fail to previously recite plasma.
Claim 103 recites the limitation "the transducer" in line 1. It is unknown which of the previously recited “at least one transducer” is being referenced with “the transducer”. It is suggested that claim 83 be amended to recite “the at least one transducer”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 80-104 are rejected under 35 U.S.C. 101 because 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 80-104 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). The recitations “at least one transducer in signaling contact with the one or more nerves innervating the spleen” (claim 80), “the neural interface is placed at least partially inside the splenic artery” (claim 90), “the neural interface is placed in signaling contact with the spleen or nerve” (claim 92), “at least one transducer in signaling contact with a target selected from at least one nerve supplying a spleen and the spleen” (claim 94), and “the transducer is in signaling contact with the target” (claim 97) amount to recitations of portions of the human body per se without referring to any functionality of the system. Then Assistant Secretary and Commissioner of Patents and Trademarks, Donald J. Quigg, issued a notice in the Official Gazette stating, "A claim directed to or including within its scope a human being will not be considered to be patentable subject matter under 35 U.S.C. § 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution." 1077 OG 24 (1987), reprinted in 1146 TMOG 24 (1993). It is recommended that Applicant utilize “configured to” language to indicate that the components of the system are merely configured to be in signaling contact, rather than requiring them to be in contact, thereby impermissibly being directed to or encompassing a human organism.
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.
Claims 80-92 and 94-99 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chew et al. (U.S. 2018/0117319), herein Chew. Regarding claim 80, Chew discloses a system 100, the system comprising: at least one transducer 102 in signaling contact with the one or more nerves innervating the spleen (“A first such element is a first transducer, preferably an electrode, 102 which is shown in proximity to a splenic nerve or SMP 90 of the patient.”, paragraph [0139]); and at least one controller 104 electrically coupled to the at least one transducer (“The transducer 102 may be operated by a controller element 104.”, paragraph [0139]), the at least one controller configured to control operation of the at least one transducer to apply an electrical signal to the one or more nerves (“Each neuromodulation device 100 may carry out the required neuromodulation independently, or in response to one or more control signals. Such a control signal may be provided by the controller 104 according to an algorithm”, paragraph [0140]). It is respectfully submitted that the language “for stimulating neural activity of one or more nerves supplying a spleen for reducing post-operative surgical complications, wherein the one or more nerves innervates the spleen” is directed to the intended use of the claimed system and fails to further define the claimed system over that of the prior art. Applicant is suggested to utilize “configured to” language to further limit the functional and intended use recitations found within the claim. Furthermore, in any response, Applicant is suggested to clearly point out how the reference would be incapable of performing the intended use or function of the claimed system. It is additionally pointed out that the language “wherein the signal produces a reduction in C-reactive protein (CRP) levels resulting in reducing post-operative surgical complications” is directed to the intended result of the use of the claimed system and not to any further limitation of the system. In order to give patentable weight to this recitation, it is recommended that the claim recite that the control unit is configured determine an initial plasma level of C-reactive protein in the patient, control the electrical signal based the determined initial plasma level of C-reactive protein, determine a post-stimulation plasma level of C-reactive protein in the patient, and repeat the steps until a threshold reduction in CRP levels is detected. It is further pointed out that Chew discloses that use of the device results in reduction in CRP levels (“the controller controlling the signal to be applied by the transducer or transducers, such that the signal modulates the neural activity of the nerve to which it is applied (i.e., the splenic nerve and/or the SMP, as appropriate) to produce a physiological response in the patient”, paragraph [0081] and ”the physiological response produced in the patient is one or more of…a decrease in one or more inflammatory markers (for example…C-reactive protein”, paragraph [0104]).
Regarding claim 81, it is respectfully submitted that the recitation “the reduction in CRP levels in plasma is to less than 245 mg/L” further limits something, the CRP levels, that have not been previously positively recited.
Regarding claim 82, it is respectfully submitted that the recitation “the reduction in CRP levels in plasma is to less than 215 mg/L” further limits something, the CRP levels, that have not been previously positively recited.
Regarding claim 83, Chew discloses that the transducer comprises a neural interface with at least one electrode (“a first transducer, preferably an electrode, 102”, paragraph [0139]).
Regarding claim 84, Chew discloses that the neural interface is configured to be placed around at least one splenic nerve (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve)”, paragraph [0139]).
Regarding claim 85, Chew discloses that the neural interface is configured to be placed around at least one splenic arterial nerve (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve) and the associated blood vessel (e.g., the SMP and associated mesenteric artery)”, paragraph [0139]).
Regarding claim 86, Chew discloses that the neural interface is configured to be placed around a neurovascular bundle (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve) and the associated blood vessel (e.g., the SMP and associated mesenteric artery)”, paragraph [0139]).
Regarding claim 87, Chew discloses that the neural interface is configured to be placed on at least one splenic nerve (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve)”, paragraph [0139]).
Regarding claim 88, Chew discloses that the neural interface is configured to be placed on at least one splenic arterial nerve (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve) and the associated blood vessel (e.g., the SMP and associated mesenteric artery)”, paragraph [0139]).
Regarding claim 89, Chew discloses that the neural interface is configured to be placed on the splenic artery (“transducer 102 may be in the form of a cuff electrode configured such that, when implanted, it encompasses the nerve (SMP or splenic nerve) and the associated blood vessel (e.g., the SMP and associated mesenteric artery)”, paragraph [0139]).
Regarding claim 90, it is respectfully submitted that the recitation “the neural interface is placed at least partially inside the splenic artery” is directed to an intended use of the system rather than further limiting a structural aspect of the device itself. It is recommended that Applicant utilize “configured to” language in the claim to encompass this subject matter.
Regarding claim 91, Chew discloses that the neural interface comprises: two electrically active electrode arms 100; an inert arm located in between each of the two electrically active electrode arms; and a spine 132 that provides mechanical and electrical connection between the two electrically active electrode arms and the inert arm (see annotated Figure 2B below).
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Regarding claim 92, it is respectfully submitted that the recitation “the neural interface is placed in signaling contact with the spleen or nerve for less than one of the following of: 24 hours,<18 hours,<15 hours, or ≤12 hours” is directed to an intended use of the system rather than further limiting any patentable aspect of the system. Furthermore, Chew discloses that the neural interface is placed in signaling contact with the spleen or nerve for less than one of the following of: 24 hours,<18 hours,<15 hours, or ≤12 hours (“the controller causes the signal to be applied intermittently. In certain such embodiments, the controller causes the signal to applied for a period of time (e.g., a first time period)”, paragraph [0121] and “ the duration of each of the first, second, third and fourth time periods is any time from 5 seconds (5 s) to 24 hours (24 h), 30 s to 12 h, 1 min to 12 h, 5 min to 8 h, 5 min to 6 h, 10 min to 6 h, 10 min to 4 h, 30 min to 4 h, 1 h to 4 h (or any combination of such lower and upper limits)”, paragraph [0122]).
Regarding claim 94, Chew discloses a system, the system comprising: at least one transducer 102 in signaling contact with a target selected from at least one nerve supplying a spleen and the spleen, wherein the transducer is configured to be in temporary signaling contact with the target (“A first such element is a first transducer, preferably an electrode, 102 which is shown in proximity to a splenic nerve or SMP 90 of the patient.”, paragraph [0139]); and at least one controller 104 coupled to the at least one transducer (“The transducer 102 may be operated by a controller element 104.”, paragraph [0139]), the at least one controller configured to control operation of the at least one transducer to apply a signal to the target (“Each neuromodulation device 100 may carry out the required neuromodulation independently, or in response to one or more control signals. Such a control signal may be provided by the controller 104 according to an algorithm”, paragraph [0140]). It is respectfully submitted that the language “for reducing post-operative surgical complications by eliciting a reduction in an inflammatory parameter” is directed to the intended use of the claimed system and fails to further define the claimed system over that of the prior art. Applicant is suggested to utilize “configured to” language to further limit the functional and intended use recitations found within the claim. Furthermore, in any response, Applicant is suggested to clearly point out how the reference would be incapable of performing the intended use or function of the claimed system. It is additionally pointed out that the language “wherein temporary application of the signal to the target results in a reduction of post-operative surgical complications and elicits a reduction in an inflammatory parameter selected from at least one of C-reactive protein (CRP) levels and Interleukin-6 (IL-6) levels” is directed to the intended result of the use of the claimed system and not to any further limitation of the system. In order to give patentable weight to this recitation, it is recommended that the claim recite that the control unit is configured determine an initial plasma level of an inflammatory parameter selected from at least one of C-reactive protein (CRP) levels and Interleukin-6 (IL-6) levels, control the electrical signal based the determined initial plasma level of the inflammatory parameter, determine a post-stimulation plasma level of the inflammatory parameter in the patient, and repeat the steps until a threshold reduction in the inflammatory parameter is detected. It is further pointed out that Chew discloses that use of the device results in reduction in CRP and IL-6 levels (“the controller controlling the signal to be applied by the transducer or transducers, such that the signal modulates the neural activity of the nerve to which it is applied (i.e., the splenic nerve and/or the SMP, as appropriate) to produce a physiological response in the patient”, paragraph [0081] and ”the physiological response produced in the patient is one or more of…a decrease in one or more inflammatory markers (for example…IL-6…C-reactive protein”, paragraph [0104]).
Regarding claim 95, it is respectfully submitted that the recitation “the signal further produces a change in a physiological parameter indicative of target engagement” fails to further define the claimed invention over that of the prior art because it is directed to an intended result of the use of the system rather than further defining a patentable aspect of the system itself.
Regarding claim 96, it is respectfully submitted that the recitation “CRP and/or IL-6 is measured in a biological sample selected from the group consisting of blood, serum, and plasma” fails to further define the claimed invention over that of the prior art because it is directed to something, CRP and/or IL-6 levels, which are not positively recited previously. It is suggested that Applicant further limit the controller to be configured to measure CRP and/or IL-6 levels in a biological sample selected from the group consisting of blood, serum, and plasma.
Regarding claim 97, it is respectfully submitted that the recitation “the transducer is in signaling contact with the target for a contact time period no longer than 24 hours, 18 hours, 15 hours, 12 hours, 10 hours, 9 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hour, 2 hours, 1 hour, 30 minutes, or 20 minutes” is directed to an intended use of the system rather than further limiting any patentable aspect of the system. Furthermore, Chew discloses that the transducer is in signaling contact with the target for a contact time period no longer than 24 hours, 18 hours, 15 hours, 12 hours, 10 hours, 9 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hour, 2 hours, 1 hour, 30 minutes, or 20 minutes (“the controller causes the signal to be applied intermittently. In certain such embodiments, the controller causes the signal to applied for a period of time (e.g., a first time period)”, paragraph [0121] and “ the duration of each of the first, second, third and fourth time periods is any time from 5 seconds (5 s) to 24 hours (24 h), 30 s to 12 h, 1 min to 12 h, 5 min to 8 h, 5 min to 6 h, 10 min to 6 h, 10 min to 4 h, 30 min to 4 h, 1 h to 4 h (or any combination of such lower and upper limits)”, paragraph [0122]).
Regarding claim 98, it is respectfully submitted that the recitation “the reduction in the inflammatory parameter is detectable within 1 day, 2 days, 3 days, 4 days, or 5 days following a first application of the signal” is directed to an intended use of the system rather than further limiting any patentable aspect of the system.
Regarding claim 99, it is respectfully submitted that the recitation “the reduction in an inflammatory parameter is a decrease in Interleukin-6 (IL-6) levels” is directed to the intended result of the use of the claimed system and not to any further limitation of the system. It is further pointed out that Chew discloses that use of the device results in reduction in IL-6 levels (“the controller controlling the signal to be applied by the transducer or transducers, such that the signal modulates the neural activity of the nerve to which it is applied (i.e., the splenic nerve and/or the SMP, as appropriate) to produce a physiological response in the patient”, paragraph [0081] and ”the physiological response produced in the patient is one or more of…a decrease in one or more inflammatory markers (for example…IL-6”, paragraph [0104]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 93 is rejected under 35 U.S.C. 103 as being unpatentable over Chew (U.S. 2018/0117319, cited above) in view of Lai et al. (WO 2020/128790). Chew discloses the invention substantially as claimed, but fails to disclose that the electrical signal has a charge density of ≥ 40 µC per cm2 per phase to ≤ 260 µC per cm2. Lai teaches neurostimulation to be applied to a splenic arterial nerve, comprising an electrical signal that has a charge density of up to 4000 µC per cm2 (see page 35, lines 30-31), along with various upper and lower limits, to include lower limits of ≥ 50 µC per cm2 per phase (see page 36, line 7) and upper limits of ≤ 250 µC per cm2 (see page 36, line 2). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Chew to include that the electrical signal has a charge density of ≥ 50 µC per cm2 per phase to ≤ 250 µC per cm2, as taught by Lai, as it has been held that choosing from a finite number of identified, predictable solutions (the upper and lower limits of the charge density of Lai), with a reasonable expectation of success requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claims 100-103 are rejected under 35 U.S.C. 103 as being unpatentable over Chew (U.S. 2018/0117319, cited above) in view of Ortega-Deballon et al. (“C-Reactive Protein Is an Early Predictor of Septic Complications After Elective Colorectal Surgery”, World J Surg (2010) 34:808-814), herein Chew in view of Ortega. Regarding claims 100-102, Chew discloses a method for stimulating neural activity of one or more nerves supplying a spleen of a subject, wherein the one or more nerves directly innervates the spleen, the method comprising: providing a system 100 of claim 80; positioning at least one transducer 102 in signaling contact with one or more nerves supplying the spleen (“A first such element is a first transducer, preferably an electrode, 102 which is shown in proximity to a splenic nerve or SMP 90 of the patient.”, paragraph [0139]); and controlling operation of the at least one transducer with at least one controller 104 coupled to the at least one transducer (“The transducer 102 may be operated by a controller element 104.”, paragraph [0139]), the at least one controller configured to control the operation of the at least one transducer to apply an electrical signal to the spleen or the one or more nerves supplying the spleen (“Each neuromodulation device 100 may carry out the required neuromodulation independently, or in response to one or more control signals. Such a control signal may be provided by the controller 104 according to an algorithm”, paragraph [0140]), wherein the electrical signal produces a reduction in C-reactive protein (CRP) levels (“the controller controlling the signal to be applied by the transducer or transducers, such that the signal modulates the neural activity of the nerve to which it is applied (i.e., the splenic nerve and/or the SMP, as appropriate) to produce a physiological response in the patient”, paragraph [0081] and ”the physiological response produced in the patient is one or more of…a decrease in one or more inflammatory markers (for example…C-reactive protein”, paragraph [0104]). However, Chew fails to disclose that the method is for reducing post-operative surgical complications, the reduction in CRP levels is resulting in reduced post-operative surgical complications, or the reduction in CRP levels in plasma is to less than 245 or 215 mg/L. Ortega teaches that CRP levels have been used for the diagnosis of intra-abdominal surgical infection as a marker of an unfavorable postoperative course (see page 809, column 1, lines 2-4). Further, Ortega teaches that patients with CRP values less than 125 mg/L on the fourth postoperative day can be safely discharged from the hospital because the likelihood of septic complications is low (see page 813, column 1, lines 34-39). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the system of Chew for reducing post-operative surgical complications, as Ortega teaches the benefit of decreased CRP levels in reducing post-operative surgical complications. Furthermore, it would have been obvious to one having ordinary skill in the art to reduce the CRP levels in plasma to less than 125 mg/L, as Ortega teaches that such values result in low septic complications upon hospital discharge.
Regarding claim 103, Chew discloses that the transducer comprises a neural interface, the neural interface comprising: two electrically active electrode arms 100; an inert arm located in between each of the two electrically active electrode arms; and a spine 132 that provides mechanical and electrical connection between the two electrically active electrode arms and the inert arm (see annotated Figure 2B below).
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Claim 104 are rejected under 35 U.S.C. 103 as being unpatentable over Chew in view of Ortega as applied to claims 100-103 above, and further in view of Lai (WO 2020/128790, cited above). Chew in view of Ortega discloses the invention substantially as claimed, but fails to disclose that the electrical signal has a charge density of ≥ 40 µC per cm2 per phase to ≤ 260 µC per cm2. Lai teaches neurostimulation to be applied to a splenic arterial nerve, comprising an electrical signal that has a charge density of up to 4000 µC per cm2 (see page 35, lines 30-31), along with various upper and lower limits, to include lower limits of ≥ 50 µC per cm2 per phase (see page 36, line 7) and upper limits of ≤ 250 µC per cm2 (see page 36, line 2). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Chew in view of Ortega to include that the electrical signal has a charge density of ≥ 50 µC per cm2 per phase to ≤ 250 µC per cm2, as taught by Lai, as it has been held that choosing from a finite number of identified, predictable solutions (the upper and lower limits of the charge density of Lai), with a reasonable expectation of success requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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