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 .
Status of Claims
This office action is responsive to the amendment filed 30 March 2026.
Claims 1-9 are withdrawn.
Claims 10-18 are presently pending in this application.
Election/Restrictions
Applicant's election with traverse of claims 10-18 in the reply filed on 30 March 2026 is acknowledged. The traversal is on the grounds that the inventions are exemplary aspects of the decompression needle assembly and are in a common class (A61M). This is not found persuasive because of the following reasons:
Inventions I and II are separately classified. The inventions belonging to overarching class (A61M) does not constitute common classification.
Invention I is classified in A61M25/065.
Invention II is classified in A61M2210/101.
The inventions, as cited in the Requirement for Restriction/Election filed 29 January 2026, require different features that must be found separately and, thus, would not appear naturally upon examination of one or the other. Applicant has not provided explanation as to how these features can be found naturally when searching for either invention separately.
The requirement is still deemed proper and is therefore made FINAL.
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 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.
Claim 10 recites the limitation “a rib”. It is unclear if the “rib” refers to a structural element of the invention or a rib bone of a patient. For the purposes of examination, examiner interprets “a rib” to mean –a rib of the patient--.
Claim 10 also recites the limitation “the distal marking being a set number rearward from the proximal marking”. It is unclear what “set number” refers to, as a set number can refer to distance or markings in the instant case. For the purposes of examination, examiner interprets “a set number” to mean –a set number of markings of the plurality of markings--. All claims that recite “the set number” are interpreted the same way.
Claim 10 also recites the limitation “a set range from the axial direction”. It is unclear what “a set range” refers to, as a set range can refer to a measurement of distance or angle. For the purposes of examination, examiner interprets “a set range” to mean –a set angle range--.
Claim 10 also recites the limitation “the selected marking”. It is unclear if “the selected marking” refers to the distal marking or an alternative selected marking. For the purposes of examination, examiner interprets “the selected marking” to mean –the distal marking--.
All other claims are rejected as they depend on independent claim 10.
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 202, 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 10-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over DeBusk (US Patent Publication No. 20250288323 A1), in view of Sastry et al. (US Patent Publication No. 20180271407 A1), hereinafter Sastry.
Regarding claim 10, DeBusk discloses a method of using a decompression needle assembly (DeBusk: Fig. 14A, tube device 200) comprising catheter (Fig. 14A, chest tube 202) extending between a proximal catheter end (PCE) (Fig. 14B, proximal end of tube 202) and a tapered distal catheter end (TDCE) (Fig. 14B, tube 202 towards tip 208), a hub body (Fig. 14B, flared opening 210) disposed on the catheter (202), and a needle (Fig. 14C, stylet portion 204) extending between a distal needle end (DNE) (Fig. 14C, distal tip 222) and a proximal needle end (PNE) (Fig. 14C, proximal end of stylet portion 204 towards handle 220) and having a scalpel tip (Fig. 14C, tip 222 is beveled knife-like; para. 0071) defined at the DNE (222), the method comprising: driving the decompression needle assembly (200) along an axial direction within a patient toward a pleural space such that the DNE (222) contacts a middle portion of a rib (assembly 200 is inserted into pleural space; para. 0054); noting a proximal marking (Fig. 19, proximal most marking on stylet 232, measuring implicitly requires noting of a specific marker; para. 0102) of a plurality of markings (Fig. 19, markings; para. 0102) defined on the catheter (200), the proximal marking (Fig. 19, distal most marking on 232 towards tip 222) being most proximal to an epidermis surface of the patient and outside thereof (para. 0083), pivoting a needle (204) within a set angle range from the axial direction within the patient (stylet 204 can be partially inserted, then articulated to change the orientation; para. 0113), and further driving a decompression needle assembly (Fig. 14A, tube 202) at the set range (para. 0113) within the pleural space to a selected location (tube 202 can be partially inserted, the insertion angle can be changed, then be further inserted; para. 0113).
DeBusk does not expressly disclose selecting a distal marking of the plurality of markings, the distal marking being a set number of markings of the plurality of markings rearward from the proximal marking.
Sastry teaches an injection method involving selecting a distal marking of a plurality of markings (Sastry: Fig. 2 and 9, step 912, measuring arrangement 250 allows the user to determine the length of an affecting portion during injection, which includes selecting a distal marking a set distance from the proximal marking to determine a length; para. 0023-0024 and 0050), the distal marking (para. 0023-0024) being a set number rearward from the proximal marking (para. 0023-0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of DeBusk such that it comprised selecting a distal marking of the plurality of markings, the distal marking being a set number of markings of the plurality of markings rearward from the proximal marking as taught by Sastry in order to measure the length of insertion (para. 0023-0024 and 0050).
Regarding claim 11, DeBusk in view of Sastry discloses the method above, further comprising: cutting (DeBusk: making an incision prior to insertion; para. 0054), prior to driving the decompression needle assembly (200) along the axial direction, a non-puncture incision (para. 0054) on the epidermis surface of the patient (para. 0054).
Regarding claim 12, DeBusk does not expressly disclose that the set number of markings of the plurality of markings is 3.
Sastry teaches selecting a distal marking a set distance from the proximal marking to determine a length; para. 0023-0024 and 0050), the distal marking (para. 0023-0024) being a set number rearward from the proximal marking (para. 0023-0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of DeBusk such that the set number of markings of the plurality of markings is any predetermined number as taught by Sastry in order to measure the length of insertion (para. 0023-0024 and 0050). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select any particular predetermined number of markings, as it is a result effective variable determined based on the necessary insertion length (Sastry: para. 0023-0024 and 0050). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other set number of markings of the plurality of markings. Absent a teaching as to criticality that the set number of markings of the plurality of markings is 3, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 14, DeBusk in view of Sastry discloses the method above, further comprising removing the needle (204) from the pleural space while holding the catheter (202) within the pleural space (Fig. 17A, portion 204 is withdrawn, sliding out of portion 202 while the portion 202 is left within the pleural space; para. 0099).
Regarding claim 15, DeBusk in view of Sastry discloses the method above, further comprising: driving, following removing the needle (204), the catheter (202) assuming within the pleural space past the selected distal marking (after pivoting, the portion 202 is further inserted into the pleural space. Examiner interprets that if the portion 202 was further inserted, it would have to be further past the bend location; para. 0113).
Regarding claim 16, DeBusk does not expressly disclose the catheter defines a plurality of distance markings longitudinally spaced apart between the PCE and the TDCE, and wherein the distance markings are equally spaced apart from each other.
Sastry teaches a catheter (Sastry: Fig. 2, tubular member 210) defines a plurality of distance markings (Fig. 2, plurality of markers 216a) longitudinally spaced apart between the PCE and the TDCE (Fig. 2, markers 216a are shown to be spaced from the proximal end 212 and the distal end 214; para. 0023), and wherein the distance markings (216a) are equally spaced apart from each other (uniformly spaced; para. 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of DeBusk such that the catheter defines a plurality of distance markings longitudinally spaced apart between the PCE and the TDCE, and wherein the distance markings are equally spaced apart from each other as taught by Sastry in order to enable measuring a length of insertion of the catheter (para. 0023).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over DeBusk in view of Sastry, in further view of Worley et al. (US Patent Publication No. 20070066878 A1), hereinafter Worley.
Regarding claim 13, DeBusk in view of Sastry does not expressly disclose withdrawing, prior to pivoting the needle, the DNE within the patient along the axial direction.
Worley teaches withdrawing (Worley: the catheter is withdrawn prior to pivoting; para. 0043), prior to pivoting a needle (Fig. 1, catheter 10), a DNE (Fig. 1, tip assembly 17) within a patient along an axial direction (para. 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Debusk in view of Sastry such that it included withdrawing, prior to pivoting the needle, the DNE within the patient along the axial direction as taught by Worley in order to maneuver the DNE around the treatment site (Worley: para. 0043).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over DeBusk in view of Sastry, in further view of Navratil et al. (US Patent No. 12661458 B2), hereinafter Navratil.
Regarding claim 17, DeBusk in view of Sastry does not expressly disclose the scalpel tip defines a needle slope at a set slope angle between 10 degrees and 20 degrees.
Navratil teaches a scalpel tip (Navratil: Fig. 1A-D, needle architecture 100) defines a needle slope at a set slope angle between 10 degrees and 20 degrees (Fig. 1C, secondary bevel angle 108B is 20 degrees; col 1, ln 63-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the scalpel tip of Debusk in view of Sastry such that the scalpel tip defines a needle slope at a set slope angle between 10 degrees and 20 degrees to achieve a desired level of sharpness depending on the desired site of insertion (Navratil: col 4, ln 15-30). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 18, DeBusk in view of Sastry does not expressly disclose the scalpel tip comprises a pair of sharpening bevel notches at the DNE.
Navratil teaches a scalpel tip (Navratil: 100) comprises a pair of sharpening bevel notches (Fig. 1A, secondary bevel 108 is reflected on both sides of the architecture 100) at a DNE (Fig. 1C, tip 114).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the scalpel tip of Debusk in view of Sastry such that the scalpel tip comprises a pair of sharpening bevel notches at the DNE as taught by Navratil in order to achieve a desired level of sharpness depending on the desired site of insertion (Navratil: col 4, ln 15-30). Furthermore, it would have been an obvious matter of design choice, as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the scalpel tip comprises a pair of sharpening bevel notches at the DNE, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-2000.
/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
Prosecution Insights