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
This office action is responsive to the amendment filed on 10/13/2025. As directed by the amendment: claims 1, 6, 9, 16 have been amended; claims 7-8, 10, 17 have been canceled; and no new claims have been added. Thus, claims 1-6, 9, 11-16 are presently pending in this application.
Response to Arguments
Applicant’s argument page 9 of the remarks filed 10/13/2025 that Tutera does not disclose a cannula-obturator structure with posterior handles. Applicant’s argument has been fully considered and are not persuasive. Tutera discloses in fig. 1 the handle 22/26 of the cannula 14 and the handle 86 of the obturator 18. Therefore, Tutera discloses a cannula-obturator structure with posterior handles.
Applicant’s argument page 9 of the remarks filed 10/13/2025 that Tutera does not disclose a cannula-obturator structure with a tab-and-notch coupling mechanism. Applicant’s argument has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection has been made, as seen below.
Applicant’s argument page 9 of the remarks filed 10/13/2025 that Tutera’s system relies on a spring-load shield and sharp tip, not a blunt cannula and rounded obturator designed for tissue-safe probing. Tutera does not address subcutaneous targeting and does not teach the single-unit operational behavior of the present invention. Applicant’s argument has been fully considered and are not persuasive. Tutera discloses in par. 0028 that in operation, a small tunnel or stab wound is made into the subcutaneous tissue. Then, element 14 is advanced into the wound under pressure from only the fingers using a rotating motion. No significant pressure is applied from the user’s forearm during placed. Element 14 is advanced only by force from the thumb and forefinger. The result is a more blunt dissection, rather than the sharp cuts of typical devices that can lead to more damage to the subcutaneous tissue. Therefore, Tutera’s system is not a sharp cutting system; and Tutera discloses the device being used for subcutaneous area. In addition, see figs. 1-4 for the obturator 18 being positioned within the cannula 14 and being operated as a single unit.
Applicant’s argument pages 10-11 of the remarks filed 10/13/2025 that Tutera and McKay does not disclose the amended limitation in the independent claims. Applicant’s argument has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection has been made, as seen 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 (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 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.
Claim(s) 1, 3-6, 9, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tutera (US 2017/0065805) in view of Kafiluddi et al. (US 2014/0324090).
Regarding claim 1, Tutera discloses
A minimally traumatic trocar apparatus (10, figs. 1-4 and pars. 0019-0029) for delivering one or more medication pellets (42, fig. 1 and par. 0024) to a subcutaneous insertion site (see pars. 0008 and 0028), the minimally traumatic trocar apparatus (10, figs. 1-4) comprising:
a blunt cannula (14, fig. 2 and pars. 0024-0029) with a tubular cannula body (body of 14), wherein a surface of an anterior end of the tubular cannula body (anterior end surface of 14) includes a smooth edge (see figs. 1-4. See also par. 0028 for the blunt dissection when 14 is advanced into the wound under pressure from only the fingers), wherein the blunt cannula (14) is formed with a medication slot (38) disposed along the tubular cannula body (see fig. 1 and par. 0024); and
a cannula handle (22/26, fig. 1) fixedly coupled to the tubular cannula body (body of 14);
an obturator (18, fig. 2 and par. 0027) that includes an anterior rounded tip (78, figs. 2-4) and an obturator body (body of 18) that is inserted within the tubular cannula body (see figs. 3-4);
an obturator handle (86) fixedly coupled to the obturator body (body of 18);
the anterior rounded tip of the obturator extends past the anterior end of the cannula (see figs. 3-4);
wherein the cannula (14) and the obturator (18) operate as a single unit during insertion into the subcutaneous insertion site (Examiner notes: see figs. 3-4 and par. 0024 for 14 comprising a lumen sized to receive 18. Therefore, 14 and 18 are capable of being operated as a single unit during insertion).
Tutera is silent about the coupling between the cannula and the obturator being a notch-tab coupling such that a first coupling element proximate to the cannula handle that includes a notch, and a second coupling element proximate to the obturator handle that includes a tab; wherein the notch interfaces with the tab such that the anterior rounded tip of the obturator extends past the anterior end of the cannula.
However, Kafiluddi teaches an outer cannula (14) and an inner cannula (12) wherein a first coupling element (36) proximate to the outer cannula handle (handle of 14) that includes a notch (36, see fig. 1B and par. 0030), and a second coupling element (26) proximate to the inner cannula handle (handle of 12) that includes a tab (26); wherein the notch (36) interfaces with the tab (26) such that the tip of the inner cannula extends past the tip of the outer cannula (see figs. 2A and 2C).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tutera by adding Kafiluddi first coupling element to Tutera cannula and adding Kafiluddi second coupling element to Tutera obturator, for the purpose of providing a locking engagement between the cannula and the obturator when needed.
Regarding claim 3, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 1 as set forth above, except for wherein the cannula has a length that ranges from 13 cm to 17 cm and the obturator has a length that ranges from 18 cm to 22 cm.
Tutera only discloses the cannula (14, fig. 2) and the obturator (18) wherein the obturator is longer than the cannula (see figs. 1-4 and par. 0027). However, Tutera is silent about the length of the cannula and the length of the obturator.
It appears Tutera apparatus would operate equally well with the claimed lengths since the obturator is configured to be inserted into the cannula and the obturator is longer than the cannula to push the medication pellets out of the cannula. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to cause Tutera apparatus to have the claimed lengths for the cannula and the obturator because it appears to be an arbitrary design consideration which fails to patentably distinguish over Tutera.
Regarding claim 4, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 1
Tutera further discloses the apparatus configured to align at least two medication pellets of the one or more medication pellets along a non-linear path (Examiner notes: the limitation “configured to align … along a non-linear path is interpreted as functional limitation. Tutera apparatus is used to deliver medication pellets 42 to the treatment site. Therefore, it is capable of aligning the medication pellets 42 along a non-linear path).
Regarding claim 5, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 1 as set forth above, except for wherein the tubular cannula body includes an outer diameter of at least 3.5 mm, and the obturator includes an outer diameter of at least 3 mm.
There is no evidence of record that establishes that changing the outer diameter of the tubular cannula and the outer diameter of the obturator would result in a difference in function of the Tutera device. Further, a person having ordinary skill in the art, being faced with modifying the tubular cannula and the obturator of Tutera, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameters. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the outer diameter of Tutera tubular cannula being at least 3.5mm and the outer diameter of Tutera obturator being at least 3mm as an obvious matter of design choice within the skill of the art.
Regarding claim 6, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 1,
Tutera discloses a posterior end of the tubular cannula body (posterior end of 14, fig. 2) and a posterior end of the obturator (posterior end of 18, fig. 2).
Kafiluddi teaches a notch (36, fig. 1B) adjacent to the posterior end of the outer cannula (see fig. 1B) and a tab (26, fig. 1A) adjacent to the posterior end of the inner cannula (see fig. 1A), wherein the notch interfaces with the tab (see fig. 2C).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to further modify the notch and the tab to be adjacent to the posterior end of the cannula and the obturator, as taught by Kafiluddi, for the purpose of providing a locking engagement between the cannula and the obturator when the obturator is completely inserted into the cannula.
Regarding claim 9, Tutera discloses
A minimally traumatic trocar system (10, figs. 1-4 and pars. 0019-0029) for delivering one or more medication pellets (42, fig. 1 and par. 0024) to a subcutaneous insertion site (see pars. 0008 and 0028), the minimally traumatic trocar system (10, figs. 1-4) comprising:
a blunt cannula (14, fig. 2 and pars. 0024-0029) with a tubular cannula body (body of 14), wherein a surface of an anterior end of the tubular cannula body (anterior end surface of 14) includes a smooth edge (see figs. 1-4. See also par. 0028 for the blunt dissection when 14 is advanced into the wound under pressure from only the fingers), wherein the blunt cannula (14) is formed with a medication slot (38) disposed along the tubular cannula body (see fig. 1 and par. 0024);
a cannula handle (22/26, fig. 1) fixedly coupled to the tubular cannula body (body of 14);
an obturator (18, fig. 2 and par. 0027) that includes an anterior rounded tip (78, figs. 2-4) and an obturator body; wherein the obturator extends through the tubular cannula body so that the anterior rounded tip of the obturator extends past the anterior end of the tubular cannula body (body of 18);
an obturator handle (86) fixedly coupled to the obturator body (body of 18);
the anterior rounded tip of the obturator extends past the anterior end of the cannula (see figs. 3-4);
wherein the cannula (14) and the obturator (18) operate as a single unit during insertion into the subcutaneous insertion site (Examiner notes: see figs. 3-4 and par. 0024 for 14 comprising a lumen sized to receive 18. Therefore, 14 and 18 are capable of being operated as a single unit during insertion);
the obturator (18) configured to be removed from the tubular cannula body (see fig. 2); and
the anterior rounded tip (78) of the obturator (18) is configured to contact and push the one or more medication pellets (42) through the tubular cannula body (body of 14) to the subcutaneous insertion site (see figs. 1-4).
Tutera is silent about the coupling between the cannula and the obturator being a notch-tab coupling such that a first coupling element proximate to the cannula handle that includes a notch, and a second coupling element proximate to the obturator handle that includes a tab; wherein the notch interfaces with the tab such that the anterior rounded tip of the obturator extends past the anterior end of the cannula.
However, Kafiluddi teaches an outer cannula (14) and an inner cannula (12) wherein a first coupling element (36) proximate to the outer cannula handle (handle of 14) that includes a notch (36, see fig. 1B and par. 0030), and a second coupling element (26) proximate to the inner cannula handle (handle of 12) that includes a tab (26); wherein the notch (36) interfaces with the tab (26) such that the tip of the inner cannula extends past the tip of the outer cannula (see figs. 2A and 2C).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tutera by adding Kafiluddi first coupling element to Tutera cannula and adding Kafiluddi second coupling element to Tutera obturator, for the purpose of providing a locking engagement between the cannula and the obturator when needed.
Regarding claim 12, see the rejection of claim 3.
Regarding claim 13, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 9 as set forth above, except for wherein the cannula has a length that ranges from 14 cm to 16 cm and the obturator has a length that ranges from 19 cm to 21 cm.
Tutera only discloses the cannula (14, fig. 2) and the obturator (18) wherein the obturator is longer than the cannula (see figs. 1-4 and par. 0027). However, Tutera is silent about the length of the cannula and the length of the obturator.
It appears Tutera apparatus would operate equally well with the claimed lengths since the obturator is configured to be inserted into the cannula and the obturator is longer than the cannula to push the medication pellets out of the cannula. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to cause Tutera apparatus to have the claimed lengths for the cannula and the obturator because it appears to be an arbitrary design consideration which fails to patentably distinguish over Tutera.
Regarding claim 14, see the rejection of claim 4.
Regarding claim 15, see the rejection of claim 5.
Regarding claim 16, see the rejection of claim 6.
Claim(s) 2, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tutera (US 2017/0065805) in view of Kafiluddi et al. (US 2014/0324090) in further view of McKay (US 2009/0131908).
Regarding claim 2, Tutera in view of Kafiluddi discloses the minimally traumatic trocar apparatus of claim 1, as set forth above, except for wherein the cannula includes at least one cannula marking corresponding to a medication length of the one or more medication pellets and wherein the obturator further includes at least one marking corresponding to the medication length.
However, McKay teaches an apparatus (figs. 1-6) comprising a cannula (24, fig. 1) with at least one cannula marking (19, fig. 1 and par. 0038) corresponding to a medication length of the one or more medication pellets (42/44/46, figs. 3C-3E) and wherein the obturator (58, fig. 2 and par. 0050. See also fig. 6) further includes at least one marking (19, fig. 2 and par. 0050. See also fig. 6) corresponding to the medication length (pars. 0050 and 0083).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Tutera apparatus to incorporate wherein the cannula includes at least one cannula marking corresponding to a medication length of the one or more medication pellets and wherein the obturator includes at least one marking corresponding to the medication length, as taught by McKay, for the purpose of keeping track of drug pellets delivered and accordingly “dial a dose” for the drug pellets to be delivered (par. 0038)
Regarding claim 11, see the rejection of claim 2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4, 6, 9, 11-14, 16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 3-4, 6, 9, 12-15 of U.S. Patent No. 11,406,806. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the application claims can be found in the patent claims.
Application 17/588,152
US 11,406,806
Claim 1
Claim 1
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 6
Claim 6
Claim 1
Claim 9
Claim 9
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 16
Claim 9
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 DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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, Bhisma Mehta can be reached at 571-272-3383. 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 571-272-1000.
/DUNG T ULSH/Examiner, Art Unit 3783