DETAILED ACTION
This Office Action is in response to the restriction response filed 4 June 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.
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-39 and 66 and Species A) in the reply filed on 4 June 2026 is acknowledged.
Claims 40-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4 June 2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2-4, 6-12, 25 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7 recites “the needle array of the first handle engages the tissue on a first side of the incision and the needle array of the second handle engages the tissue on a second side of the incision,” Which recites the needle array in combination with human tissue.
Any claim not specifically addressed is rejected based on its dependency from a rejected claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 18, 19 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 10 recites the limitation “in closed position” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner expects this was intended to refer to the “the everted position”, but clarification is needed.
Claims 18, 19 refers to “the needle array” while claim 1 introduces a needle array at the end of each handle (i.e. two needle arrays), therefore it is unclear if claims 18 and 19 is intending to refer to both needle arrays or one of the needle arrays introduced in claim 1.
Claim 31 recites “some each one of the cartridges” in line 2. It is unclear what is meant by this term. Claim 31 recite “the apparatus comprises a plurality of needle cartridges” which implies at least two needle cartridges. However, the claim goes onto recite that “some of the cartridges comprise a needle configuration differing from the other cartridges” implying more than two cartridges. Therefore, it is unclear if Applicant intends to at least four cartridges (i.e. “some cartridges” implies at least two cartridges; “other cartridges” implies at least two additional cartridges)? Further, each handle comprises a cartridge, according to claim 3. Does Applicant intend to recite that each handle has a plurality of cartridges? Or does the entire device have a plurality of cartridges (i.e. a single cartridge on each of the two handles)? Clarification is needed.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5-19, 29, 32-39 are rejected under 35 U.S.C. 103 as being unpatentable over Blake (US Patent 4,506,669) in view of Atkinson et al. (US Patent Publication 2014/0309687).
Claim 1: Blake’’669 teaches an apparatus (Figure 5-7) for closing an incision (14a, 14b) formed in a patient comprising:
(a) a frame (2, 3) having a first side (2) and a second side (3);
(b) a handle assembly (50, 51) pivotably coupled to the frame, the assembly comprising a pair of handles (50, 51) at least partially disposed between the first side and the second side (Figures 5-7), the pair of handles comprising a first handle (50) movable about a first pivot axis (9) and a second handle (51) movable about a second pivot axis (10) spaced apart from the first pivot axis, wherein a viewing space is defined between the first handle and the second handle for viewing the incision (space between and under the handles allows for viewing the incision);
(c) a needle array (12 and 13) positionable at a first end of each of the first handle and the second handle for penetrating tissue of the patient adjacent to the incision (Figures 5-7).
Blake’669 does not disclose a tube holder adjacent the first or second side for securing a tube.
Like Blake’669, Atkinson’687 teaches a device for closing an incision (Figure 13-15) including a frame (50; Figure 13), a pair of handles (4, 6) each having a needle array (12, 12) for engaging tissue. Atkinson’687 further teaches a tube holder (paragraph [0085]-[0087]; Figures 24-30) on a side of the wound closure device. Atkinson’687 teaches this advantageous because it allows the wound closure device to be capable of use in other contexts than just wound closure – including to allow for wound access to inject therapeutic material into the wound while approximating wounded skin with pressure to actively clot blood and staunch blood flow (paragraph [0091], [0092]).
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 Blake’669 by providing the device with a tube holder, as taught by Atkinson’687, to provide the advantages discussed above.
Claim 2: Blake’669 teaches each of the first handle (50) and the second handle (51) is movable relative to the frame between a disengaged position wherein the needle array does not penetrate the tissue of the patient and an engaged position wherein the needle array penetrates the tissue of the patient (Figures 5-7, show the handles are movable about pivot points 9, 10; handles 9, 10 can be moved downward, relative to the page/skin, in Figure 5 to be in a disengaged position and upward, relative to the page/skin, to be in an engage position).
Claim 5: Blake’669’s device discloses the apparatus (1) is positionable on the patient with the incision (14a, 14b) extending between the handles within the viewing space (Figures 5, 7).
Claim 6: Blake’669 teaches the handle assembly (50, 51) is movable between an inserted position wherein the needle array of each of the handles penetrates the tissue of the patient (Figure 5) and an everted position wherein the tissue of the patient engaged by the handles is everted (Figure 7).
Claim 7: Blake’669 teaches needle array (12) of the first handle (50) engages the tissue on a first side of the incision (14a) and the needle array (13) of the second handle (51) engages the tissue on a second side of the incision (14b),
wherein the handle assembly is configured for bringing everted tissue on the first side and the second side together to close the incision (Figures 5-7).
Claim 8: Blake’669 teaches the handle assembly is pivotably movable (about pivots 9 and 10) between the inserted position and the everted position (Figures 5-7).
Claim 9: Blake’669 teaches the distance between the first handle and the second handle is adjustable in the everted position to alter the distance between the tissue on the first side and the second side of the incision (the distance between the handles can be adjusted by rotating the handles 50, 51 or by pivoting the frame about pivot 4).
Claims 10, 11: Blake’669 does not teach the handle assembly is releasably lockable in a closed position where in the everted tissue is in contact and the incision is closed.
Atkinson’687 teaches providing the handle assembly with a releasable lock to hold the device in the closed position to allow for one-handed operation (paragraphs [0071], [0072], [0074]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Blake’669 so that the handle is releasably lockable in the closed position to hold the tissue, as taught by Atkinson’687, in order to maintain the position of the tissue closure device without requiring the user to hold it in that position so the user can perform other tasks.
Claim 12: Blake’669’s device, the distance between the first handle (50) and the second handle (51) is adjustable in the everted position to adjust the compressive force applied to the tissue on either side of the incision in contact when the incision is closed (the distance between the handles can be adjusted by rotating the handles 50, 51 or by pivoting the frame about pivot 4).
Claim 13: Atkinson’687’s tube holder is positionable overlying the first or second end of the incision (paragraph [0085]).
Claim 14: Atkinson’687’s tube holder is configured to securely receive a chest tube extending through an end portion of the incision (paragraph [0085]-[0087]).
Claim 15: Blake’669’s viewing space (space between and under the handles allows for viewing the incision) is aligned with a transverse centerline of the frame extending between the first and second side (Figures 5-7).
Claim 16: Atkinson’687’s tube holder is generally u-shaped having a central portion aligned with the transverse centerline (Figure 24 shows the holder has two u-shaped halves; paragraph [0085] teaches the holder is secured to the longitudinal axis of the device but can be pivoted to any side of the device).
Claim 17: Blake’669’s apparatus is positionable relative to the incision such that the length of the incision is generally aligned with the transverse centerline of the frame (Figures 5-7)
Claim 18: Blake’669 teaches the needle array comprises a plurality of spaced part needles (Figure 6).
Claim 19: Blake’669 teaches at least some of the needles are oriented at a non-vertical angle differing from the other needles (the needle array on handle 50 can be oriented at a non-vertical and different angle from the needle array on handle 51 by pivoting the needle array around pivot point 9).
Claim 29: Blake’669 does not teach the height of the apparatus is less than 3cm in a deployed configuration.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Blake’669, as modified, et al. to have a maximum height of 3 cm since it has been held that “where the only difference between the prior art and the claims was 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 was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Blake’669, as modified, would not operate differently with the claimed height. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification, as filed, at paragraph [0093]).
Claim 32: Blake’669 teaches method of closing an incision (14a, 14b) formed in a patient (16), the incision having a length extending between a first end and a second end thereof, the method comprising:
(a) providing an apparatus (Figures 5-7);
(b) positioning the apparatus overlying the incision such that the incision is aligned between the handles (Figure 5-7);
(c) penetrating the needle array (12, 13) of each of the handles into the tissue of the patient adjacent to the incision (Figure 5);
(d) moving the handles relative to the frame to evert the tissue adjacent to the incision (Figures 5-7); and
(e) bringing everted tissue on either side of the incision into contact to close the incision (Figure 7).
Blake’669 teaches the device of claim 1 except for a tube holder, as discussed in the rejection to claim 1 above. Atkinson’687 shows it would be obvious to provide Blake’669’s wound closure device with a tube holder, as discussed in the rejection to claim 1 above.
Claim 33: Atkinson’687 teaches positioning a tube at one end of the incision (Figure 29, for example) and securing the tube within the tube holder before moving the handle to close the incision (paragraph [0101] and Figure 27).
Claim 34: Blake’669 does not teach the handle assembly is lockable in a closed position where in the everted tissue is in contact and the incision is closed.
Atkinson’687 teaches providing the handle assembly with a releasable lock to hold the device in the closed position to allow for one-handed operation (paragraphs [0071], [0072], [0074]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Blake’669 so that the handle is releasably lockable in the closed position to hold the tissue, as taught by Atkinson’687, in order to maintain the position of the tissue closure device without requiring the user to hold it in that position so the user can perform other tasks.
Claim 35: Blake’669 teaches adjusting the distance between the handles when the tissue is everted to adjust the compressive force applied to the tissue when the incision is closed (Figures 5-7 show that the distance between the handles is adjusted as the tissue everted as shown in how the device moves between Figures 5 and 7).
Claim 36: Blake’669 teaches a method of closing an incision with a wound closure device (Figures 5-7) including by moving the needle array (12, 13) relative to the frame (2, 3) from a disengaged position to an engaged position to cause the needles to penetrate the tissue adjacent the incision (14a, 14b) and moving the handles (50, 51) relative to the frame (2, 3) in the engaged position to evert the tissue adjacent to the incision to bring the everted tissue in contact to close the incision.
However, Blake’669 but does not teach securing a chest tube within the incision.
Atkinson’687 teaches a method of using a wound closure device to hold a chest tube within an incision and maintain the incision in the closed configuration (paragraph [0101]) comprising:
(a) making an incision in a chest wall of a patient (paragraph [0101]) in a chest wall of the patient;
(b) inserting the chest tube through the incision (paragraph [0101]) and placing the chest tube at one end of the incision (paragraph [0085])};
(d) positioning the apparatus such that the incision is aligned between the handles (Figure 8) and the chest tube is received within the tube holder (paragraph [0101]);
(e) releasably securing the chest tube in the tube holder (Figure 28; paragraph [0101];
(g) moving the handles relative to the frame in the engaged position to evert the tissue adjacent to the incision and bring the everted tissue in contact to close the incision (Figure 8; paragraph [0088]).
Blake’669 and Atkinson’687 teach a step of providing the device of claim 1, as discussed in the rejection to claim 1 above.
It would be obvious to modify the method taught by Blake’669 by placing a chest tube in the incision, as taught by Atkinson’687, because it allows the wound closure device to be capable of use in other contexts than just wound closure – including to allow for wound access to inject therapeutic material into the wound while approximating wounded skin with pressure to actively clot blood and staunch blood flow (Atkinson’687 at paragraph [0091], [0092]).
Claim 37: Blake’669 teaches the handles are moved towards one another in the engaged position to close the incision (Figures 5, 7).
Claim 38: Blake’669 does not teach the handle assembly is releasably lockable in a closed position maintaining the everted tissue is in contact.
Atkinson’687 teaches providing the handle assembly with a releasable lock to hold the device in the closed position to allow for one-handed operation (paragraphs [0071], [0072], [0074]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Blake’669 so that the handle is releasably lockable in the closed position to hold the tissue, as taught by Atkinson’687, in order to maintain the position of the tissue closure device without requiring the user to hold it in that position so the user can perform other tasks.
Claim 39: Blake’669 teaches adjusting the distance between the handles when the tissue is everted to adjust the compressive force applied to the tissue when the incision is closed (Figures 5-7 show that the distance between the handles is adjusted as the tissue everted as shown in how the device moves between Figures 5 and 7).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Blake’669 in view Atkinson’687, as applied to claim 1, further in view of Bond et al. (US Patent Publication 2012/0168571).
Claim 26: Atkinson’687 does not teach the tube holder has a locking arm for releasably locking a tube within the tube holder.
It is old and well known to provide tube holders with a locking arm. For example, Bond’571 teaches a tube holder (Figure 10; 870, 875, 878) with a locking arm (877 or 878) for releasably locking a tube within the tube holder (paragraph [0044]) in order to prevent the tube from slipping through the receiving area.
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 Blake’669 and Atkinson’687 such that the tube holder has a locking arm, as taught by Bond’571, in order to prevent the tube from slipping from the holder while in use.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Blake’669 in view Atkinson’687, as applied to claim 1, further in view of Fleischmann (US Patent Publication 2013/0282056).
Claim 30: Blake’669, as modified, does not teach the needle array is removably connectable to a respective one of the handles.
Like Blake’669, Fleischmann’056 teaches a device for closing a wound (paragraph [0002]) having a frame (10), a handle assembly (20) having individual handles each with a needle array (26) positioned at the end for pulling tissue together.
Fleischmann’056 further teaches the needle array (26) is removably connectable to the handle (20) (needle array 26 fits within receptacle 24 on handle 20).
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 Blake’669, such that the needle array is removably connectable to the handle, as taught by Fleischman’056 in order to provide the surgeon with more flexibility in choosing the type of needles needed to engage tissue. For example, closing a wound on a tough area of the body, like the knee, will require stronger/thicker needles than the needle array used to close a wound on the delicate tissues of the face.
Allowable Subject Matter
Claim 66 is allowed.
Claims 3, 4, 20-24, 27, 28 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 31 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 23 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
