DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 September 2025 has been entered.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 25 September 2025, Applicant amended independent claim 1 to recite the limitations of cancelled claims 3 and 6. Specifically, the claims now define the cranial-caudal axis as the axis that extends between the cranial and caudal contact face and base body curves around this axis. This feature is best seen in Figure 3 of Applicant’s specification, for example. Applicant argues none of the cited references - namely Pell’766, Sanghera’505 or Haig’193 – teach this curvature. This argument is persuasive. However, upon further consideration, a new secondary reference, Clark’355, is relied upon to show this feature is an obvious modification. See the updated rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 5, 7, 12-15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Pell et al. (US Patent Publication 2013/0237766) in view of Clark et al. (US Patent 2012/0041335).
Claim 1: Pell’766 teaches an intracorporeal guide component (Figure 156a-d), comprising: a base body (N1201, N1202 connected as shown in Figure 156b) with a line channel (N1295) for receiving and guiding one or more lines (Figure 156d); and
one or more contact faces (N1271, N1270) positioned on a circumference of the base body which are designed for direct form-fit and/or direct force-fit engagement on a bone structure (H46, H47, as shown in Figure 156c, step 5) of a living being.,
the intracorporeal guide component (Figures 156a-d) is formed from several parts from a plurality of guide component elements (Figure 156a shows two parts N1201,N1202), and
wherein the one or more contact faces (N1271, N1270) comprises two mutually opposite contact faces (Figure 156b) designed for form-fit and/or force-fit engagement on a bone structure of the living being (Figure 156c);
wherein the guide component is designed as an intercostal guide component (Figure 156a-d) of which the base body comprises a cranial contact face (N1271) which is configured for form-fit and/or force-fit engagement on a cranial rib of the living being (H46 or H47, as shown in Figure 156c, step 5),
wherein the base body comprises a caudal contact face (N1270) which is configured for form-fit and/or force-fit engagement on a caudal rib of the living being H46 or H47, as shown in Figure 156c, step 5),
Pell’766 does not teach the base body has a basic shape curved around the cranial-caudal central axis of the base body (i.e. the top to bottom, relative to the device, when it when it is implanted between two ribs, as identified in the two figures below).
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Like Pell’766, Clark’335 teaches a guide component (10 or 120) for placement between two ribs (Figure 10). The guide component has a basic shape curved around a cranial-caudal axis of the base body (Figures 1-8 show the device has a curvature along the cranial caudal axis, for example, as identified in Figure 8 below)
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It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Pell’766, such that the guide component has a curvature around the cranial-caudal axis, in order to follow the contour/arcuate shape of a human rib.
The preamble, which states the guide component is “for long term use for guiding transcutaneous lines of medical devices within a living being”, is considered a statement of intended use. MPEP 2111 Section II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.“ In this case, the body of the claim recites the structure of the guide component and the intention to use it for long term use to guide transcutaneous lines is a statement of intended use.
MPEP 2112.01 Section I, which states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In this case, Pell’766 in view of Clark’335 is considered to render the claim obvious because it teaches the claimed structure and therefore, is considered capable of being used to guide transcutaneous lines for long term use.
Claim 4: Pell’766 teaches the guide component is formed in two parts from two guide component elements (Figure 156a shows two parts N1201, N1202).
Claim 5: Pell’766 teaches the guide component elements (N1201, N1202) comprises one or more connectors (N1234) for connecting to each other.
Claim 7: Pell’766 teaches the line channel (N1295) runs between a ventral surface (N1214, N1224) of the base body and a dorsal surface (N1215, N1225) (paragraph [0642]).
Claim 12: Pell’766 teaches the contact faces are designed as a groove running at least in parts of the circumference of the base body (N1270, N1271 are a groove, see arrow in annotated figure below).
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Claim 13: Pell’766 teaches a holding structure (N1321, N1331; Figure 157a, 157b) on a groove base of the groove.
Claim 14: Pell’766 teaches a line channel (N1295) having a diameter. The line is a not a positively recited element of the invention and a line passing through the line channel could correspond to the diameter of the discloses line channel (N1295).
Claim 15: Pell’766 teaches making the guide component from a biocompatible metal or polymer (paragraph [0507]).
Claim 17: Pell’766 teaches the holding structure (N1321, N1331; Figure 157a, 157b) is formed in one piece with the base body (Figure 157a, 157b).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pell’766 in view of Clark’335, as applied to claim 1, further in view of Rogers et al. (US Patent Publication 2011/0071473).
Pell’766, as modified, teaches the limitations of claim 8 except that the line channel is designed as an inclined bore through the base body.
Like Pell’766, Rogers’473 is directed towards inserting an instrument into the body (Pell’766 at Figure 156d; Rogers’473 at Figure 20d) through a port (Pell’766 at Figure 156d; Rogers’473 at Figure 16b).
Rogers’473 teaches providing the port with a line channel (1636b) that is an inclined bore (Figure 16b) in order to hold the instruments passing through the line channel at a desired angle (paragraph [0011], [0145]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the line channel taught by Pell’766 so the line channel is an inclined bore, as taught by Rogers’473, in order to provide the stated advantage.
Claims 1, 7, 9-12, 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanghera et al. (US Patent 9,636,505) in view of Clark et al. (US Patent 2012/0041335).
Claim 1: Sanghera’505 teaches an intracorporeal guide component (1400; Figures 14, 15), comprising:
a base body (1328) with a line channel (1334) for receiving and guiding one or more lines (column 22, lines 65 to column 23, line 2); and
one or more contact faces (outer surface of cylindrical element 1328) positioned on a circumference of the base body which are designed for form-fit and/or force-fit engagement on a bone structure (Figure 13; column 24, lines 36-45) of a living being;
the intracorporeal guide component (Figure 14) is formed from several parts (1336, 1328, 1338) from a plurality of guide component elements (Figure 14), and
wherein the one or more contact faces (outer surface of cylindrical element) comprise at least two mutually opposite contact faces (opposite sides of circumference of cylinder) designed for direct form-fit and/or direct force-fit engagement on a bone structure of the living being (Figure 13; column 24, lines 36-45),
wherein the guide component is designed as an intercostal guide component (Figure 13) of which the base body comprises a cranial contact face (outer surface of 1328) which is configured for form-fit and/or force-fit engagement on a cranial rib of the living being (Figure 13; also, the device is configured for form-fit/force-fit engagement with the ribs because it could be placed into a patient having a different sized body than what is shown in Figure 13),
wherein the base body comprises a caudal contact face (outer surface of 1328) which is configured for form-fit and/or force-fit engagement on a caudal rib of the living being (Figure 13).
Sanghera’505 does not teach the base body has a basic shape curved around the cranial-caudal central axis of the base body (the cranial caudal axis of the device is identified in the figure below).
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Like Sanghera’505, Clark’335 teaches a guide component (10 or 120) for placement between two ribs (Figure 10). The guide component has a basic shape curved around a cranial-caudal axis of the base body (Figures 1-8 show the device has a curvature along the cranial caudal axis, for example, as identified in Figure 8 below)
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It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Sanghera’505, such that the guide component has a curvature around the cranial-caudal axis, in order to follow the contour/arcuate shape of a human rib.
The preamble, which states the guide component is “for long term use for guiding transcutaneous lines of medical devices within a living being”, is considered a statement of intended use. MPEP 2111 Section II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. “ In this case, the body of the claim recites the structure of the guide component and the intention to use it for long term use to guide transcutaneous lines is a statement of intended use.
MPEP 2112.01 Section I, which states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In this case, Sanghera’505 in view of Clark’335 is considered to render the claim obvious because it teaches the claimed structure and therefore, is considered capable of being used to guide transcutaneous lines for long term use.
Claim 7: Sanghera’505 teaches the line channel (1334) runs between a ventral surface (flange 1336) of the base body and a dorsal surface (flange 1338) (Figure 13).
Claim 9: Sanghera’505 teaches the one or more line channels (1334) has a cross- sectional constriction in parts, and/or wherein a fixing structure of the base body (2) protrudes into one of the one or more line channels (1340 is a constriction/fixing structure which protrudes into the line channel (Figure 15; column 23, lines 62 to column 24, line 5).
Claim 10: Sanghera’505 teaches the base body has at least one fastening structure (1332) formed in one piece with the base body.
Claim 11: Sanghera’505 teaches the base body has at least one fastening opening (1332).
Claim 12: Sanghera’505 teaches the contact faces are designed as a groove running at least in parts on the circumference of the base body (groove is formed as space along the circumference of the base body between flanges 1336, 1338).
Claim 14: Sanghera’505 teaches a line channel (1304) having a diameter. The line is a not a positively recited element of the invention and a line passing through the line channel could correspond to the diameter of the discloses line channel (1304).
Additionally, Sanghera’505 teaches a constriction in the line channel for sealing around the line (column 23, lines 62 to column 24, line 5).
Claim 15: Sanghera’505 teaches making the guide component from a biocompatible metal or polymer (column 23, lines 43-61).
Claims 1, 4, 7, 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Haig et al. (US Patent Publication 2012/0130193) in view of Clark et al. (US Patent 2012/0041335).
Claim 1: Haig’193 teaches an intracorporeal guide component (10), comprising:
a base body (12, 14; Figure 1a) with a line channel (24) for receiving and guiding one or more lines (paragraph [0021]; and
one or more contact faces (outer surface of 16) positioned on a circumference of the base body which are designed for direct form-fit and/or direct force-fit engagement on a bone structure (Figure 1a; R1, R2) of a living being;
wherein the intracorporeal guide component is formed from several parts from a plurality of guide component elements (Figure 1 shows the device is formed from two pieces 12, 14), and
wherein the one or more contact faces comprises at least two mutually opposite contact faces (opposite sides of circumference of cylinder) designed for form-fit and/or force-fit engagement on a bone structure of the living being (Figure 1A; paragraph [0026]);
wherein the guide component is designed as an intercostal guide component (Figure 1a) of which the base body comprises a cranial contact face (outer surface of 16) which is configured for form-fit and/or force-fit engagement on a cranial rib of the living being (Figure 1a),
wherein the base body comprises a caudal contact face (outer surface of 16) which is configured for form-fit and/or force-fit engagement on a caudal rib of the living being (Figure 1a).
Haig’193 does not teach the base body has a basic shape curved around the cranial-caudal central axis of the base body (i.e. the top to bottom, relative to the device, when it when it is implanted between two ribs, as identified in the two figures below. The arrows in the two figures are intended to show the same axis in different orientations).
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Like Haig’193, Clark’335 teaches a guide component (10 or 120) for placement between two ribs (Figure 10). The guide component has a basic shape curved around a cranial-caudal axis of the base body (Figures 1-8 show the device has a curvature along the cranial caudal axis, for example, as identified in Figure 8 below)
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It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Haig’193, such that the guide component has a curvature around the cranial-caudal axis, in order to follow the contour/arcuate shape of a human rib.
The preamble, which states the guide component is “for long term use for guiding transcutaneous lines of medical devices within a living being”, is considered a statement of intended use. MPEP 2111 Section II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. “ In this case, the body of the claim recites the structure of the guide component and the intention to use it for long term use to guide transcutaneous lines is a statement of intended use.
MPEP 2112.01 Section I, which states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In this case, Haig’193 in view of Clark’335 is considered to render the claim obvious because it discloses the claimed structure and therefore, is considered capable of being used to guide transcutaneous lines for long term use.
Claim 4: Haig’193 teaches the guide component (10) is formed in two parts from two guide component elements (12, 14; Figure 1, 1a).
Claim 7: Haig’193 teaches the line channel (1334) runs between a ventral surface (flange 18) of the base body and a dorsal surface (flange 22) (Figure 1a).
Claim 14: Haig’193 teaches a line channel (24) having a diameter. The line is a not a positively recited element of the invention and a line passing through the line channel could correspond to the diameter of the discloses line channel (24).
Claim 15: Haig’193 teaches making the guide component from a biocompatible metal or polymer (column 23, lines 43-61).
Claims 5, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Haig’193 in view of Clark’335, as applied to claim 4, further in view of Eltoft et al. (US Patent Publication 2014/0357958).
Claim 5, 16: Haig’193 teaches the guide component elements 12, 14 may be snap fit but does not specifically disclose the guide component elements have connectors for connecting to each other. Haig’193 discloses the guide component elements 12, 14 are releasably connected (paragraph [0031]).
It is old and well known that releasable snap fit connections include mating connectors. For example, Eltoft’958 teaches a releasable snap fit connection between elements 4 and 2 (paragraph [0034]). Element 4 includes a connector 32 which engages with connector 16 on element 2 (paragraph [0075]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the guide component elements of Haig’193 with a snap fit connection, as taught by Eltoft’958, in order to ensure the two components remain connected until the procedure is completed and the user wishes to detach the two elements from each other.
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 2 January 2026
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771