DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/2025 has been entered.
Response to Amendment
This office action is in response to the amendments filed on 12/31/2025. Claim 1 is amended. Claim 2 has been canceled. Claims 1 and 3-15 are pending and addressed below.
Response to Arguments
Applicant’s arguments, filed on 12/31/2025, with respect to claim 1 have been considered but are moot because the arguments do not apply to the new reference being used in the current rejection. Applicant’s arguments are only directed to the amended claims, therefore the arguments are addressed in the body of the rejection below.
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 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 of this title, 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, 3-10 and 15 rejected under 35 U.S.C. 103 as being unpatentable over Manicka (US Patent No. 10,471,251) in view of Suwito (US Pub No. 2016/0166277).
Regarding claim 1, Manicka discloses (Figures 15 and 22A-23C) a method of subcutaneously injecting and anchoring a device (600) (Figures 22A-23C) to a bone, a muscle, and/or a first tissue in a patient (Col. 20-23), the device having a clip (604) (Figure 22A) configured to anchor the device to the bone, the muscle, or the first tissue (Col. 26-27), the method comprising: making an incision in the patient (step 302) (Figure 15) (Col. 20, lines 58-62), wherein making the incision in the patient comprises making the incision below a xiphoid process and/or a sternum of the patient (step 302) (Figure 15) (Col. 20, lines 58-62); inserting an insertion device (200) loaded with the device through the incision (step 304) (Figure 15) (Col. 20, lines 63-67 and Col. 21, lines 1-18 ); advancing the insertion device through the tunnel to the bone, the muscle, and/or the first tissue upon which the device is to be anchored (step 306) (Figure 15) (Col. 21, lines 19-27); and anchoring the device to the bone, the muscle, and/or the tissue using the clip on the device (step 314) (Figure 15) (Col. 22, lines 18-51).
Manicka fails to disclose the method of inserting, directly through the incision, and advancing, through a second tissue of the patient, a first surgical instrument that spreads the second tissue from the incision toward the bone, the muscle, and/or the first tissue to form a tunnel in the second tissue that extends from the incision toward the bone, the muscle, and/or the first tissue, wherein the first surgical instrument comprises a portion having a flat cross-section that extends to a distal end of a tip of a distal end of the first surgical instrument; and removing the first surgical instrument from the patient directly through the incision.
Suwito, in the analogous art of devices used to assist in surgical procedures for inserting implants, teaches (Figure 1) a method of inserting, directly through the incision, and advancing, through a tissue of the patient (Paragraphs 0016-0021), a first surgical instrument (200) (Figure 1) that spreads the tissue from the incision toward a bone, a muscle, and/or another tissue to form a tunnel in the tissue that extends from the incision toward the bone, the muscle, and/or the another tissue (Paragraphs 0016-0021 and 0068-0089), wherein the first surgical instrument comprises a portion (see annotated figure below) having a flat cross-section that extends to a distal end of a tip (207) of a distal end of the first surgical instrument (clearly shown in Figure 1), and removing the first surgical instrument from the patient directly through the incision (Paragraphs 0016-0021 and 0068-0089). Since both Manicka and Suwito are directed to inserting implants in the body by making an incision in the patient, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Manicka to have included the step of inserting, directly through the incision, and advancing, through a second tissue of the patient, a first surgical instrument that spreads the second tissue from the incision toward the bone, the muscle, and/or the first tissue to form a tunnel in the second tissue that extends from the incision toward the bone, the muscle, and/or the first tissue, wherein the first surgical instrument comprises a portion having a flat cross-section that extends to a distal end of a tip of a distal end of the first surgical instrument; and removing the first surgical instrument from the patient directly through the incision as taught by Suwito, in order to facilitate the surgical procedure by creating an appropriate sized subcutaneous implant pocket for the implantable medical device while preventing inadvertent abrasion and other injury to the incision site and underlying muscle (Suwito, Paragraphs 0013, 0043 and 0065).
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Regarding claim 3, Manicka modified by Suwito further discloses wherein advancing the insertion device to the bone, the muscle, and/or the first tissue upon which the device is to be anchored comprises advancing the instrument to the xiphoid process and/or the sternum of the patient (Manicka, step 306) (Figure 15) (Col. 21, lines 19-27).
Regarding claim 4, Manicka modified by Suwito further discloses wherein advancing the first surgical instrument comprises advancing the first surgical instrument at an angle to a sternum of the patient toward an intercostal space between the fifth and sixth ribs (Paragraph 0041 of Suwito discloses that the distal portion 202 can be angled which would result in Manicka modified by Suwito as a whole to disclose this method step since Manicka already discloses the method of being used on a sternum (Col. 20, lines 46-57)).
Regarding claim 5, Manicka modified by Suwito further discloses a prong (Manicka, 606A) (Figure 22A) configured to contact an organ, a nerve, the first tissue, and/or a third tissue (Col. 26-27).
Regarding claim 6, Manicka modified by Suwito discloses all of the elements of claim 5 above except for wherein the prong of the device is between about 70 millimeters and 100 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 20 degrees and about 30 degrees to the sternum of the patient.
Since Manicka discloses a prong that is configured to contact an organ, a nerve, the first tissue, and/or a third tissue similar to the applicant’ device and also, Suwito discloses the step of advancing the first surgical instrument at an angle but does not explicitly discloses the exact angle, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prong of the device to be between about 70 millimeters and 100 millimeters and also, have the first surgical instrument to be advanced at an angle between about 20 degrees and about 30 degrees to the sternum of the patient since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 7, Manicka modified by Suwito discloses all of the elements of claim 5 above except for wherein the prong of the device is between about 70 millimeters and 80 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 45 degrees and about 60 degrees to the sternum of the patient.
Since Manicka discloses a prong that is configured to contact an organ, a nerve, the first tissue, and/or a third tissue similar to the applicant’ device and also, Suwito discloses the step of advancing the first surgical instrument at an angle but does not explicitly discloses the exact angle, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prong of the device to be between about 70 millimeters and 80 millimeters and also, have the first surgical instrument to be advanced at an angle between about 45 degrees and about 60 degrees to the sternum of the patient since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 8, Manicka modified by Suwito discloses all of the elements of claim 5 above except for wherein the prong of the device is between about 90 millimeters and 110 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 45 degrees and about 60 degrees to the sternum of the patient.
Since Manicka discloses a prong that is configured to contact an organ, a nerve, the first tissue, and/or a third tissue similar to the applicant’ device and also, Suwito discloses the step of advancing the first surgical instrument at an angle but does not explicitly discloses the exact angle, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prong of the device to be between about 90 millimeters and 110 millimeters and also, have the first surgical instrument to be advanced at an angle between about 45 degrees and about 60 degrees to the sternum of the patient since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 9, Manicka modified by Suwito discloses all of the elements of claim 5 above including first and second prongs (Manicka, 606A, 606B) (Figure 22A) but fails to disclose the first prong being between about 70 millimeters and 80 millimeters and the second prong being between about 90 millimeters and 110 millimeters, and advancing the first surgical instrument comprises advancing the first surgical instrument at an angle between about 45 degrees and about 60 degrees to the sternum of the patient.
Since Manicka discloses first and second prongs that is configured to contact an organ, a nerve, the first tissue, and/or a third tissue similar to the applicant’ device and also, Suwito discloses the step of advancing the first surgical instrument at an angle but does not explicitly discloses the exact angle, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first prong to be between about 70 millimeters and 80 millimeters and the second prong to be between about 90 millimeters and 110 millimeters and also, have the first surgical instrument to be advanced at an angle between about 45 degrees and about 60 degrees to the sternum of the patient since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 10, Manicka modified by Suwito further discloses wherein advancing the first surgical instrument includes directing pressure to a top of a handle (Suwito, 201) of the first surgical instrument, the handle configured to be grasped by a user (Suwito, Paragraphs 0040 and 0078).
Regarding claim 15, Manicka modified by Suwito further discloses removing the insertion device from the incision in the patient, wherein the device remains anchored to the bone, the muscle, and/or the tissue (Manicka, step 316) (Figure 15) (Col. 22, lines 52-67 and Col. 23, lines 1-23).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Manicka (US Patent No. 10,471,251) in view of Suwito (US Pub No. 2016/0166277) as applied to claim 1 above, and further in view of Gage (US Pub No. 2020/0197205).
Regarding claim 11, Manicka modified by Suwito discloses all of the elements of claim 1 above except for wherein anatomical marks are used to insert and advance the first surgical instrument.
Gage, in the analogous art of tunneling devices used in surgery, teaches (Figures 1 and 29) a tunneling instrument (100) and the method step of using anatomical marks (74) (Figure 29) to insert and advance the tunneling instrument (Paragraphs 0020 and 0083). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Manicka modified by Suwito to have included the step of using anatomical marks to insert and advance the first surgical instrument as taught by Gage, in order to identify proper placement of the first surgical instrument beginning from the incision into the body and thereby, increasing the accuracy of the procedure (Gage, Paragraph 0020 and 0083).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Manicka (US Patent No. 10,471,251) in view of Suwito (US Pub No. 2016/0166277) as applied to claim 1 above, and further in view of Zucherman (US Pub No. 2003/0018350).
Regarding claims 12-14, Manicka modified by Suwito discloses all of the elements of claim 1 above except for the method step of inserting and advancing a second surgical instrument, after removing the first surgical instrument, that further spreads the second tissue to expand the tunnel in the patient, inserting and advancing a third surgical instrument, after removing the second surgical instrument, that further spreads the second tissue to expand the tunnel in the patient and wherein the first surgical instrument, the second surgical instrument, and the third surgical instrument are broader in areas where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a xiphoid process and/or sternum of the patient and are narrower in areas where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a heart of the patient.
Zucherman, in the analogous art of tunneling devices used in surgery, teaches (Figures 1-4) a dilator system that includes a second surgical instrument (200) (Figure 2), after removing a first surgical instrument (100) (Figure 1), that further spreads the second tissue to expand the tunnel in the patient (Paragraphs 0011-0015); inserting and advancing a third surgical instrument (300) (Figure 3), after removing the second surgical instrument, that further spreads the second tissue to expand the tunnel in the patient (Paragraphs 0011-0015). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Manicka modified by Suwito to have included the method step of inserting and advancing a second surgical instrument, after removing the first surgical instrument, that further spreads the second tissue to expand the tunnel in the patient, inserting and advancing a third surgical instrument, after removing the second surgical instrument, that further spreads the second tissue to expand the tunnel in the patient as taught by Zucherman, in order to facilitate the surgical procedure by gradually dilating the opening in the body tissue to confirm the correct implant size prior to its insertion (Zucherman, Paragraph 0009 and 0011).
[Manicka modified by Suwito and Zucherman as a whole would result in wherein the first surgical instrument, the second surgical instrument, and the third surgical instrument to be broader in areas (proximal portion of the tip that widens as shown in Figure 1 of Suwito) where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a xiphoid process and/or sternum of the patient and are narrower in areas (tapering distal ends as shown in Figure 1 of Suwito) where the first surgical instrument, the second surgical instrument, and the third surgical instrument will be advanced closer to a heart of the patient]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/ Primary Examiner, Art Unit 3771