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 .
Response to Amendment
The Amendment filed on 7/18/2025 has been entered. Claims 1, 5-14, and 27-28 remain pending in the application. Claims 27-28 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 2/20/2025.
Applicant has failed to overcome the objections to the specification previously set forth in the Non-final Office Action mailed 2/20/2025. No amendments were made to the specification and no arguments regarding the specification objections were included in the response filed 7/18/2025. Accordingly, the objections to the specification remain as detailed below.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 2/20/2025.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 2/20/2025.
Specification
The abstract of the disclosure is objected to because:
Line 2 recites “from tissue (T), the surgical delivery device”. Examiner suggests replacing “from tissue (T), the surgical delivery device” in line 2 with “from tissue (T). The surgical delivery device” to put the abstract in clearer form.
Line 3 recites “thereof”. Examiner suggests replacing “thereof” with “of the main body” to put the abstract in clearer form as to what structure “thereof” refers to.
Line 3 recites “the body”. Examiner suggests replacing “the body” in line 3 with “the main body” to put the abstract in clearer form that the body is the main body and not the body of a patient.
Line 4 recites “the body”. Examiner suggests replacing “the body” in line 4 with “the main body” to put the abstract in clearer form that the body is the main body and not the body of a patient.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Page 6, line 39-41 of Applicant’s disclosure states “The guideway 24 thus comprises a proximal portion 24a which is located upstream of the chamber 18 and a distal portion 24b which is located downstream of the chamber 18”. Page 7, line 25-27 of Applicant’s disclosure then states “During this initial evacuation phase the needle 26 is in the retracted position in which the tip 30 is located downstream of the chamber 18 within the proximal portion 24a” and page 8, line 6 states “continue upstream of the chamber 18, to enter into the distal portion 24b of the guideway 24”. Page 4, line 24-30 also provides a definition for upstream and downstream. Page 7, line 25-27 and page 8, line 6 appears to contradict page 6, line 39-41. It appears a typo has been made on page 6, line 39-41 since when the tip is in proximal portion 24a, it would be downstream of the chamber as defined by Applicant and therefore the proximal portion of the guideway would be located downstream of chamber 18, not upstream as stated on page 6, and the distal portion of the guideway would be located upstream of the chamber 18, not downstream as stated on page 6. Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
Line 2 recites “the distal tip”. Claim 14 depends on claim 13 and 1. Claim 13 introduces an atraumatic distal tip of the main body and claim 1 introduces a tip of the needle. Examiner suggests replacing “the distal tip” in line 2 of claim 14 with “the distal tip of the main body” to make abundantly clear which tip “the distal tip” refers to.
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 1 and 5-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 1,
Line 5-7 recites “a retracted position in which a tip of the needle is located downstream of the chamber and an extended position in which the tip of the needle is located within or upstream of the chamber”. As noted in the specification objection above, Page 6, line 39-41 of Applicant’s disclosure states “The guideway 24 thus comprises a proximal portion 24a which is located upstream of the chamber 18 and a distal portion 24b which is located downstream of the chamber 18”. Page 7, line 25-27 of Applicant’s disclosure then states “During this initial evacuation phase the needle 26 is in the retracted position in which the tip 30 is located downstream of the chamber 18 within the proximal portion 24a”. Page 8, line 6 states “continue upstream of the chamber 18, to enter into the distal portion 24b of the guideway 24”. Examiner believes a typo has been made in page 6, line 39-41 of the specification. However, as the specification currently contradicts itself, it is unclear if the downstream and upstream locations are claimed properly in claim 1. For examination purposes, Examiner construes the downstream location to be proximal of the chamber and the upstream location to be distal of the chamber. Examiner suggests addressing the specification objection and then modifying claim 1 accordingly.
Examiner notes claims 5-14 are similarly rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richard (U.S. PG publication 20070198042).
In regard to claim 1,
[AltContent: textbox (Enlarged view of Figure 1)][AltContent: rect][AltContent: textbox (Lateral window)][AltContent: textbox (Guideway )][AltContent: arrow][AltContent: rect][AltContent: textbox (Evacuatable chamber)][AltContent: connector][AltContent: connector]
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Richard discloses a surgical delivery device (figure 1, item 1; paragraph [0033] and [0038]) comprising; an elongate main body (figure 1, item 20) defining an evacuatable chamber (see enlarged view of figure 1 above; Examiner notes the chamber is evacuatable as bone marrow can be removed via the needle as supported by paragraph [0033] or the needle could be removed/evacuated from the chamber) internally of the main body (see figure 1); a lateral window (see enlarged view of figure 1 above wherein the opening into the evacuatable chamber forms the lateral window) in the main body in communication with the chamber (see figure 1; paragraph [0036]); and a guideway (portion of the lumen of item 20 which item 10 is within and moveable through; see enlarged view of figure 1 above; Examiner notes the guideway does not include the portion of the evacuatable chamber formed by the opening 25) extending through the main body and into the chamber (see figure 1 above); and a needle (figure 1, item 10) captured for axial displacement within the guideway (paragraph [0038]; Examiner notes the needle can be axially displaced within the guideway by moving the main body axially) between a retracted position (the position of the needle when tip 11 is proximal of item 25 is construed as the retracted position) in which a tip (figure 1, item 11) of the needle is located downstream of the chamber (see 112 rejection above; when the needle tip 11 is proximal of item 25, the needle is located downstream of the chamber) and an extended position (see figure 1) in which the tip of the needle is located within or upstream of the chamber (see 112 rejection above; see figure 1; Examiner notes “captured for axial displacement within the guideway between a retracted position in which a tip of the needle is located downstream of the chamber and an extended position in which the tip of the needle is located within or upstream of the chamber” is a functional limitation. The needle is fully capable of the intended function as supported by paragraph [0038]); wherein the needle comprises a lumen (see figure 1) and an outlet (figure 1, item 15) providing fluid communication between the lumen and an exterior of the needle (paragraph [0036]), the tip of the needle is sealed from the lumen (see figure 1) and the outlet is located in a sidewall of the needle (see figure 1).
In regard to claim 6,
[AltContent: ][AltContent: textbox (Distal portion of guideway)][AltContent: textbox (Proximal portion of guideway)][AltContent: ][AltContent: connector][AltContent: textbox (Evacuatable chamber)][AltContent: textbox (Enlarged view of Figure 1)][AltContent: rect][AltContent: textbox (Guideway )][AltContent: rect][AltContent: connector]
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Richard discloses the surgical delivery device according to claim 1, in which the guideway comprises a proximal portion (see enlarged view of figure 1 above) on one side of the chamber (see enlarged view of figure 1 above) and terminating at the chamber (see enlarged view of figure 1 above), and a distal portion (see enlarged view of figure 1 above) on an opposed side of the chamber and extending from the chamber (see enlarged view of figure 1 above).
In regard to claim 7,
Richard discloses the surgical delivery device according to claim 6, in which the proximal portion and the distal portion are coaxially aligned (see enlarged view of figure 1 above).
In regard to claim 8,
Richard discloses the surgical delivery device according to claim 1, in which the guideway comprises a cylindrical bore (see figure 1 and 2).
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 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.
Claims 5 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Richard (U.S. PG publication 20070198042) further in view of Ryan (U.S. PG publication 20110288437).
In regard to claim 5,
Richard discloses the surgical delivery device according to claim 1, in which the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber (see figure 1; Examiner notes “in which the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber” is a functional limitation. As supported by paragraph [0036]-[0037], the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber via item 25 and 15).
Richard is silent as to in which the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber via negative pressure applied to the chamber from within the main body.
Ryan teaches the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber (chamber of tube described in paragraph [0034]; see figure 9 for example which shows an outer tube mounted over a needle) via negative pressure applied to the chamber from within the main body (paragraph [0034]; Examiner notes a vacuum source/vacuum pressure is not positively required by the claim).
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 modify Richard to include a vacuum source in communication with the chamber, as taught by Ryan, therefore resulting in the lateral window is shaped and dimensioned to permit a quantity of tissue to be drawn into the chamber via negative pressure applied to the chamber from within the main body, for the purpose of aiding in drawing tissue into an opening (paragraph [0034] of Ryan).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Richard (U.S. PG publication 20070198042) further in view of Beckman (U.S. PG publication 20070213630) as evidenced by Ryan (U.S. PG publication 20110288437).
In regard to claim 9,
Richard discloses the surgical delivery device according to claim 1.
Richard fails to disclose in which the main body defines an evacuation circuit in communication with the chamber and operable to apply a negative pressure to the chamber when the lateral window is occluded.
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Beckman teaches in which the main body (figure 4, item 26) defines an evacuation circuit (figure 4, item 29) in communication with the chamber (see figure 4 above) and operable to apply a negative pressure to the chamber when the lateral window (opening of item 27 in figure 4) is occluded (paragraph [0038], [0057] and [0040]; Examiner notes a vacuum source in communication with vacuum lumen 29, which is in communication with the chamber via vacuum ports 30, enables negative pressure to be applied to the chamber when the lateral window is occluded with tissue as supported by paragraph [0040] and [0057]. Examiner further notes “operable to apply a negative pressure to the chamber when the lateral window is occluded” is a functional limitation. The evacuation circuit is fully capable of the intended function due to its structure).
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 modify Richard to include a vacuum source, vacuum lumen, and vacuum ports in communication with the chamber, as taught by Beckman, therefore resulting in in which the main body defines an evacuation circuit in communication with the chamber and operable to apply a negative pressure to the chamber when the lateral window is occluded, for the purpose of aiding in drawing tissue into a lateral opening as evidenced by Ryan who supports it is beneficial to use vacuum pressure to aid in drawing tissue into a lateral window (see paragraph [0033]-[0034] of Ryan). Paragraph [0037] of Richard also supports that the surgical delivery device can be used to remove tissue.
In regard to claim 10,
Richard in view of Beckman as evidenced by Ryan teaches the surgical delivery device according to claim 9, in which at least a portion of the evacuation circuit extends substantially parallel to the guideway (see figure 4 of Beckman and analysis of claim 9 above).
In regard to claim 11,
Richard in view of Beckman as evidenced by Ryan teaches the surgical delivery device according to claim 9, in which the chamber comprises a stop positioned to limit a depth to which tissue may be drawn into the chamber (Examiner notes the wall which defines the chamber forms a stop as the wall functions to limit a depth to which tissue may be drawn into the chamber; see analysis of claim 9 above and figure 4 of Beckman and figure 1 of Richard).
In regard to claim 12,
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Richard in view of Beckman as evidenced by Ryan teaches the surgical delivery device according to claim 11, in which the evacuation circuit extends around the stop to establish two or more regions within the chamber at which the negative pressure may be applied (see figure 4 of Beckman where the evacuation circuit extends partially around the stop to establish two or more regions within the chamber at which the negative pressure may be applied).
Claims 13-14 rejected under 35 U.S.C. 103 as being unpatentable over Richard (U.S. PG publication 20070198042) further in view of Gnanapragasam (U.S. PG publication 20170196543).
In regard to claim 13,
[AltContent: textbox (Distal tip)][AltContent: ][AltContent: textbox (Enlarged view of Figure 1)]
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Richard discloses the surgical delivery device of claim 1, in which the main body comprises a distal tip (see enlarged view of figure 1 above; Examiner notes the distal tip of the main body appears blunt).
Richard is silent as to in which the main body comprises an atraumatic distal tip.
Gnanapragasam teaches the main body (figure 1A and 1B, item 3) comprises an atraumatic distal tip (paragraph [0021]).
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 modify the distal tip of the main body of Richard to be an atraumatic distal tip, as taught by Gnanapragasam, for the purpose of enabling movement along a surface without puncturing, cutting, or tearing the tissue (paragraph [0021] of Gnanapragasam).
In regard to claim 14,
Richard in view of Gnanapragasam teaches the surgical delivery device according to claim 13, in which the chamber is located adjacent the distal tip (see figure 1 of Richard and analysis of claim 13 above).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 5-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783