DETAILED ACTION
This Office Action is in response to the amendment filed 1 July 2026.
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 (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.
Response to Arguments
In the 1 July 2026 response, Applicant argues Clark, which is relied upon to teach the base body is curved with respect to the cranial-caudal of the device, is not analogous art because it is directed towards a temporary thoracic access port. Applicant argues the constant high pressure from Clark’s device would cause tissue necrosis and pain if left in the body long term.
This argument is not persuasive. MPEP 2141.01(a) states:
“A reference is analogous art to the claimed invention if:
(1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or
(2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).”
In this case, Clark is considered analogous art for both reasons: (1) The field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field. Like Applicant’s device, Clark is directed towards a device providing access to the thoracic cavity.
(2) Clark is reasonably pertinent to the problem faced by the inventor because both Clark and Applicant’s invention are placed between the ribs to provide access to the thoracic cavity.
Applicant argues the preamble limitation “for long-term use guiding transcutaneous lines” is more than intended use. Applicant argues a reference does not anticipate or render obvious a claim if the prior art structure is physically and functionally incapable of performing the claimed function. This argument is not persuasive. MPEP 2112.01 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. “Applicant has not provided any evidence to show the combined device is incapable of performing the claimed function. Further, Clark is a secondary reference; other references are relied on to show the claim is obvious under 35 USC 103.
Applicant argues combining Pell in view of Clark would render Pell inoperable for its intended purpose because Pell discloses a passive sleeve and Clark discloses an active expandable frame. Applicant argues combining the references would render Pell’s protective sleeve inoperable for its purpose of establishing a stable, sealed passage. This argument is not persuasive. The rejection only suggests curving the Pell’s base body with respect to the cranial-caudal axis, as taught by Clark, to follow the contour of the human rib. Providing Pell’s device with such a curve would not render it incapable of establishing a stable, sealed passage.
Applicant argues “under KSR the design incentives or market forces must prompt the combination” which is not the case because design incentives in the field of temporary surgical retractors are different than design incentives in the field of permanent transcutaneous implants. This argument is not persuasive. MPEP 2141.01(a) states “The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." (emphasis added). In this case, both the cited prior art surgical retractors and the claimed permanent implants are both placed between ribs to provide access to the thoracic cavity. One of ordinary skill in the art would consider the field of surgical retractors placed between the ribs because such devices provide access to the thoracic cavity.
Applicant makes similar arguments with respect to Sanghera and Clark. Applicant argues Sanghera is designed for long term pacing function while Clark is a frame to provide access to a cavity and not for use with a pacemaker. As discussed above, the rejection only suggests curving the Sanghera’s base body with respect to the cranial-caudal axis, as taught by Clark, to follow the contour of the human rib. Providing Sanghera’s device with such a curve would not change the function of the device.
Applicant argues Haig and Clark are both drawn to thoracic ports, but the combination does not teach an intracorporeal guide component for long term use within a living being, as claimed. As discussed above with respect to Pell in view of Clark, MPEP 2112.01 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. “Applicant has not provided any evidence to show the combined device is incapable of performing the claimed function.
Applicant further argues that modifying Haig in view of Clark to have an inclined bore, as required by amended claim 1, would defeat the purpose of the thoracic access port. This argument is not persuasive. Providing an inclined bore, as taught by Rogers, will merely guide the device passing through the port at a desired angle. It will not prevent a device from passing through the port.
For these reasons, the rejection is updated to address the claim amendments but is otherwise maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The limitations of dependent claim 8 were added to independent claim 1 via amendment in the 7-1-2026 response. Therefore, claim 8 is redundant and fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 8, 10-15, 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) in view of Rogers et al. (US Patent Publication 2011/0071473).
Claims 1, 8: 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 is 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 is 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, to follow the contour/arcuate shape of a human rib.
Pell’766 does not teach 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) 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, to provide the stated advantage.
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 10: Pell766 teaches the base body can be provided with a fastening structure (1600, 1620; Figure 160a) formed in one piece (1600, 1620 is attached to the base body) to aid in attaching the device to the body.
Claim 11: Pell’766 teaches the base body (N1270, N1271) has at least one fastening opening (N1232, N1233).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pell’766 in view of Clark’335 in view of Rogers’473, as applied to claim 1, further in view of Sanghera et al. (US Patent 9,636,505)
Claim 9: Pell’766 teaches the limitations of claim 9 except that the line channel has a constriction or a fixing structure protrudes into the line channel.
Like Pell’766, Sanghera’505 teaches a device (1400; Figures 14, 15) for placement between ribs to provide access to the thoracic cavity (Figure 13). Sanghera’505 teaches providing a line channels (1334) with 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) to prevent the egress of gas, fluid or other materials (column 23, lines 62 to column 24, lines 3).
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 with a constriction, as taught by Sanghera’505, to prevent the egress of gas, fluid or other materials.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pell’766 in view of Clark’335 in view of Rogers’473, as applied to claim 5, further in view of Richter (US Patent 810,675).
Claim 16: Pell’766, as modified, teaches the limitations of claim 16 but does not specifically teach the connector 1234 forms a releasable connection.
However, like Pell’766, Richter’675 teaches an access device with two arms which are pivotably connected via a hinge pin. Richter’675 teaches the hinge pin is connected via a releasable connection to disassemble the device for sterilization (page 20, lines 15-22).
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 Pell’766 so the hinge pin is removable via a releasable connection, as taught by Richter’675, to allow the device to be disassembled for sterilization.
Claims 1, 7-12, 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanghera’505 in view of Clark’335 in view of Rogers’473.
Claim 1, 8: 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
contact faces (outer surface of cylindrical element 1328) positioned on a circumference of the base body (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 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 intracorporeal 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 is 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, to follow the contour/arcuate shape of a human rib.
Sanghera’505 does not teach 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) 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 Sanghera’505 so the line channel is an inclined bore, as taught by Rogers’473, to provide the stated advantage.
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 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, 8, 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’335 in view of Rogers’473.
Claim 1, 8: 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
contact faces (outer surface of 16) positioned on a circumference of the base body (Figure 1a);
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 is 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, to follow the contour/arcuate shape of a human rib.
Haig’193 does not teach the line channel is designed as an inclined bore through the base body.
Like Haig’193, 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) 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 Haig’193 so the line channel is an inclined bore, as taught by Rogers’473, to provide the stated advantage.
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 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771
14 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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