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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-15 in the reply filed on 4/24/26 is acknowledged. The traversal is on the ground(s) that Groups I and II have some limitations that overlap. This is not found persuasive because Applicant is misrepresenting the meaning of “overlapping in scope” under MPEP 806.05(j). It does not mean having some limitations in common. That would mean that the “related by distinct” restrictions only apply to non-related inventions, having no limitations in common. Unrelated inventions, which Applicant appears to allude to, is a separate type of restriction category (see MPEP 806.06). MPEP 806.05(j) specifies that overlapping in scope means “mutually exclusive inventions”. Overlapping limitations do not preclude mutually exclusive inventions. The examiner has shown the mutually exclusive limitations of Claims 1 and 16, including the furcated cable and patient contacting parts in Claim 1 which is not in Claim 16, and the coils corresponding to implanted medical devices in Claim 16 which are not in Claim 1 (inter alia). Applicant’s pointing to dependent claims (with alternative limitations, nevertheless), is further evidence that independent Claims 1 and 16 are drawn to different inventions, the invention of Claim 1 clearly lacking coils, at the very least under the principles of the doctrine of claim differentiation. We decline to read the limitations that are different between Claims 1 and 16, into both claims, absent special definitions, amendments or admissions on record. Applicant has also failed to show that Groups I and II would have been obvious over one another. As far as search burden is concerned, at the very least, the aforementioned differences in scope between Claims 1 and 16 are sufficient evidence of different fields of search as noted in the restriction requirement, as would be understood by a person having ordinary skill in the art (e.g. as it relates to coils, wired or wireless signal transmission, the location(s) and number thereof of application points and device parts relative to the body, implantable vs. external devices, the type of cables used etc.). Thus, Applicant’s arguments are not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
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: “patient-applied parts” in claim 1 (e.g. ¶ 49: electrical contacts, electrodes).
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 § 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.
Claims 1-4, 6, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0178030 by Lund in view of US 2021/0145357 by Siew.
Regarding Claim 1, Lund teaches a medical system (e.g. abstract: medical device), comprising:
an external medical device (e.g. ¶¶ 6, 23, Fig. 6: medical device 20);
two patient-applied parts configured to physically contact a patient during normal use (e.g. ¶ 36, Fig. 6: electrodes 100 for sensing and defibrillation/pacing);
a furcated cable having one proximal end configured to be connected to the external medical device and having two distal ends, including a first distal end and a second distal end, configured to be connected to the at least two patient-applied parts (e.g. ¶¶ 23, 36: cable 32 and the diverging two cables connected to the electrodes are a furcated cable with a proximal end connected to medical device 20 and two distal ends connected to electrodes 100; ¶ 23: the cable can be continuous and without connectors, even though the claim does not require this), the cable including:
first and second types of wire pairs, the second type of wire pairs including wires that have a lower gauge and higher current capacity than the first type of twisted wire pairs [e.g. ¶¶ 24, 26-27, Fig. 2: the therapeutic wires have a lower American Wire Gauge (AWG) rating, and higher current capacity than the sensing wires which have a higher AWG and lower current capacity. In addition, the ECG and oximetry sensing wires have a lower AWG and a higher current capacity than the CPR/accelerometry wires. Note here that the AWG scale standardizes both wire diameters and current ratings, and the lower the gauge number the larger the diameter and the current capacity rating. All four types of wires, e.g. 34a through 34d are in pairs or multiple pairs. The high voltage pacing/defibrillation wire 34a is rated at 22 AWG and corresponds to voltages over 65 mA. The ECG or oxygen saturation sensing wires 34b/34c are rated at 28 AWG and are for low current monitoring which is about 0.7 mA. The CPR assistance or accelerometer wires 34d are rated at 32 AWG, at even lower capacity; Note that between 22 AWG wire pairs 34a, 28 AWG wire pairs 34b/34c, and 32 AWG wire pairs 34d, there are five combinations thereof meeting the first and second types, 34a/34b, 34a/34c, 34a/34d, 34b/34d, 34c/34d];
one type of wire pairs is a twisted wire pair (e.g. ¶ 28: wire pairs 34c are twisted);
four sets of wire pairs (e.g. see Fig. 2: at least six sets of wire pairs 34a-34d),
including two sets of wire pairs of the first type and two sets of wire pairs of the second type (e.g. Fig. 2: the combination of 34c/34d has four sets, two 34c and two 34d), a first one of the two sets of wire pairs of the first type and a first one of the two sets of wire pairs of the second type extending from the proximal end to the first distal end; and a second one of the two sets of twisted wire pairs of the first type and a second one of the two sets of wire pairs of the second type extending from the proximal end to the second distal end (e.g. ¶¶ 23, 36 and Fig. 2: each of the two electrodes 100 includes CPR monitoring and pulse oximetry, a pair of each wires 34c/34d).
Lund does not explicitly teach that any of the other types of wire pairs are twisted.
However, Siew teaches an analogous medical device utilizing a twisted cable for power and data transmission between the medical device and physiological sensors, in order to reduce electromagnetic interference (e.g. ¶¶ 39, 41). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate twisted wires for any of the types of cables 34a, 34b, or 34d in a device according to the teachings of Lund, as taught by Siew, as: a) this would predictably provide electrical transmission between the medical device and the electrodes, and d) this would reduce electromagnetic interference, which is taught as being desirable by both (Siew, ¶ 41; Lund, ¶ 14).
The above combination relies on the 34c/34d pairs of the five possible combinations of pairs, and fully meets the claim. It is also noted, that the other four combinations of types of wire pairs would also meet the claim with a simple duplication of parts. In all of the other four cases, Lund not being explicit as to a second of 34a and 34b types of pairs being present in the cable, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate any of the pairs 34a and 34b throughout the cable, as is taught for pairs 34c and 34d, as it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (St. Regis Paper Co. v. Bemis Co., 193 USPQ 8; Also see MPEP 2144.04.B), and this would predictably transmit electrical signals between the medical device the electrodes. Thus, all five combinations of wires the first and second types, 34a/34b, 34a/34c, 34a/34d, 34b/34d, 34c/34d, meeting the claim.
Regarding Claim 2, Lund as modified in Claim 1 teaches the medical system of claim 1, wherein the external medical device includes an electrical port, and the one proximal end of the cable includes one connector plug for electrically connecting the four twisted wire pairs in the cable to the electrical port (e.g. ¶ 35, Fig. 5-6: connector 92).
Regarding Claim 3, Lund as modified in Claim 1 teaches the medical system of claim 1, wherein the first one of the two sets of twisted wire pairs of the first type and the first one of the two sets of twisted wire pairs of the second type are wired at the first distal end to a first one of the at least two patient-applied parts; and the second one of the at least two sets of twisted wire pairs of the first type and the second one of the at least two sets of twisted wire pairs of the second type are wired at the second distal end to a second one of the at least two patient-applied parts.
Lund does not explicitly disclose whether the wired connections are hardwired connection (ie. integral) at the patient-applied parts. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to integrate the cables to the electrodes, as it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1993). Also see MPEP 2144.04.V.B.
Regarding Claim 4, Lund as modified in Claim 1 teaches the medical system of claim 1, wherein each of the at least four sets of twisted pairs has a conductive shield (e.g. ¶ 7: all of the types of wires may be shielded; ¶¶ 26-27: Silver plated copper and/or tinned copper shields; It is also noted here more generally that “each X element has a shield” includes all of X elements being shielded by the same shield).
Regarding Claim 6, Lund as modified in Claim 1 teaches the medical system of claim 4, wherein the conductive shield includes a tinned copper spiral wound shield (e.g. ¶¶ 26-27: Silver plated copper and/or tinned copper shields).
Regarding Claim 13, Lund as modified in Claim 1 teaches the medical system of claim 1, wherein the patient-applied part includes: an electrode configured to contact the patient, wherein the electrode is used to deliver an electrical therapy to the patient (e.g. ¶ 36, Fig. 6: electrodes 100).
Regarding Claim 15, Lund as modified in Claim 1 teaches the medical system of claim 1, wherein the medical system is configured to treat a patient by the two patient-applied parts physically contacting the patient during normal use (e.g. ¶ 36, Fig. 6: electrodes 100).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0178030 by Lund/Siew, as applied to claim 1, and further in view of US 2005/0061536 by Proulx.
Regarding Claim 5, Lund as modified in Claim 1, teaches the medical system of claim 4, wherein the external medical device includes a ground node (¶25), yet does not explicitly teach the conductive shields are terminated together and electrically connected to the ground node in the external medical device.
However, Proulx teaches an analogous medical device with an electrical cable between the medical device and patient-applied parts, wherein the wires are twisted and shielded to the same ground in order reduce cross-talk and interference (e.g. abstract, ¶¶ 5, 20, 30, Fig. 3C, 3F: shield 30, 32 are grounded with the same ground). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, to ground the shields at the same ground in the cable of the combination, as taught by Proulx, in order to predictably ground the cable and prevent cross-talk and reduce interference.
Claims 7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0178030 by Lund/Siew, as applied to claims 1 and 6, and further in view of US 2008/0255435 by Al-Ali.
Regarding Claim 7, Lund as modified in claim 1 teaches the medical system of claim 6, wherein each wire within the four sets of twisted wire pairs is insulated with fluoropolymer tape and each of the conductive shields are insulated with fluoropolymer tape (e.g. ¶ 29).
Lund does not explicitly teach that the fluoropolymer is Perfluoroalkoxy (PFA) and polytetrafluoroethylene (PTFE) tape.
However, Al-Ali teaches using fluoropolymers, such as PFA or PTFE, to insulate twisted cables and their shields, the cables connecting multiple physiological sensors and a medical device (e.g. ¶¶ 22, 28, 30, 39-40: cable insulators 302 and 350 are made of PFA or PTFE). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select PFA and PTFE for the insulation of the twisted cables and their shields in the device of the combination, as taught by Al-Ali, as: a) this would only amount to a selection among known and limited options of fluoropolymers that would have been obvious to try, b) this would predictably provide insulation, and c) the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). [It is also noted here more generally that “each X element is insulated” includes all of X elements being insulated by the one insulation].
Regarding Claim 14, Lund as modified in claim 1 teaches the medical system of claim 6, wherein the first type and the second type of twisted wire pairs include 32 AWG and 28 AWG wires, respectively.
Lund does not explicitly teach that the second type includes 30 AWG wires.
However, Al-Ali teaches using twisted wires in the range of 32 AWG to 28 AWG, including 30 AWG wires, in cables connecting multiple physiological sensors, including oximetery/PPG and temperature sensors, and a medical device (e.g. ¶¶ 22, 28, 30, 42, 47: 30 AWG). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include 30 AWG wires in the cable of the combination, as taught by Al-Ali, in order to predictably transmit electrical signals between the electrode sensors and the medical device.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0178030 by Lund/Siew, as applied to claim 1, and further in view of US 6190385 by Tom.
Regarding Claim 8, Lund as modified in claim 1 teaches the medical system of claim 1, a first distal segment near the first distal end includes distal portions of the first one of the two sets of twisted wire pairs of the first type and the first one of the two sets of twisted wire pairs of the second type; and a second distal segment near the first distal end includes distal portions of the second one of the two sets of twisted wire pairs of the first type and the second one of the two sets of twisted wire pairs of the second type (e.g. ¶¶ 23, 36: cable 32 and the diverging two cables connected to the electrodes are a furcated cable with a proximal end connected to medical device 20 and two distal ends connected to electrodes 100; ¶ 23: the cable can be continuous and without connectors), yet does not explicitly teach wherein: the furcated cable is a zip cord style cable configured to be pulled apart into the first distal segment and the second distal segment.
However, Tom discloses an analogous electrical cable connecting electrodes to a medical device, wherein the cable is a zip cord style cable configured to be pulled apart into the first distal segment and the second distal segment (e.g. 1:58-59: zip style cables are well known in the art; 2:15-20, 39-40, 3:28-60, Fig. 1, Fig. 2: cable 5 is an improved zip cable which splits apart at the distal end(s) of electrodes 80/160, using yoke 50 that is pulled back to split the cable end). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the cable of the combination in a zip-cord style form, as taught by Tom, in order to predictably set the length of the divergent wires as needed to reach both of their intended attachment points on the body.
Regarding Claim 9, Lund as further modified in claim 8 teaches the medical system of claim 8, wherein the cable includes a yoke to keep the zip cord style cable from separating into the first and second distal segments past the yoke (e.g. Fig. 1, Fig. 2: yoke 50).
Regarding Claim 10, Lund as further modified in claim 8 teaches the medical system of claim 8, wherein the zip cord style cable includes: a first insulator jacket around the first one of the two sets of twisted wire pairs of the first type and the first one of the two sets of twisted wire pairs of the second type; and a second insulator jacket around the second one of the at least two sets of twisted wire pairs of the first type and the second one of the two sets of twisted wire pairs of the second type, the first insulator jacket being adjacent and fused to the second insulator jacket, wherein the first and second insulator jackets are configured to be separated along the fuse to provide the first distal segment using the first insulator jacket and provide the second distal segment using the second insulator jacket (e.g. 2:15-20, 39-40, 3:28-60, Fig. 1, Fig. 2: cable 5 is an improved zip cable which splits apart at the distal end(s) of electrodes 80/160, the zip cable formed with an insulator jacker which is fused in the middle and easy to split apart with yoke 50).
Regarding Claim 11, Lund as further modified in claim 8 teaches the medical system of claim 10, wherein the first and second insulator jackets include polyvinyl chloride (PVC) (Lund, ¶ 29: the wires are insulated with PVC casing 58).
Regarding Claim 12, Lund as further modified in claim 8 teaches the medical system of claim 10, further comprising: a first conductive jacket shield around the first one of the two sets of twisted wire pairs of the first type and the first one of the two sets of twisted wire pairs of the second type, the first insulator jacket coating the first conductive jacket shield; and a second conductive jacket shield around the second one of the two sets of twisted wire pairs of the first type and the second one of the two sets of twisted wire pairs of the second type, the second insulator jacket coating the second conductive jacket shield (e.g. ¶ 7: each of the types of wires may be shielded; ¶¶ 26-27: Silver plated copper and/or tinned copper shields; All of the shields and wires are within insulative casing 58, thus are all coated with the insulator jacked).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MANOLIS PAHAKIS/Examiner, Art Unit 3796
Prosecution Insights