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 in response to the Applicant’s amendment filed 1 December 2025 wherein Claims 35, 47, 54, 71, and 72 are amended, Claims 84 – 85 are newly added, and Claims 1 – 34, 36, 37, 39 – 46, 48 – 53, 55 – 63, 65 – 69, and 74 – 83 are or previously were cancelled. Therefore, Claims 35, 38, 47, 54, 64, 70 – 73, 84, and 85 are currently pending within the Application.
The Applicant’s replacement drawing sheets filed 1 December 2025 has been fully considered. The replacement drawing sheets have overcome each Drawing Objection set forth in the Non-Final Rejection dated 29 July 2025 (hereinafter referred to as “Non-Final Rejection”). Each Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Specification filed 1 December 2025 have been fully considered. The amendments to the Specification has overcome each Specification Objection set forth in the Non-Final Rejection. Each Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 1 December 2025 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 11 – 13, filed 1 December 2025, with respect to the 35 U.S.C. 102 rejection in view of Horvath et al. (US 2015/0051583 A1) have been fully considered and are persuasive. The 35 U.S.C. §§ 102 and 103 rejections of the claims have been withdrawn.
Applicant's arguments filed 1 December 2025 pertaining to the Double Patenting Rejection have been fully considered. The Examiner maintains the Double Patenting Rejection set forth in the Non-Final Rejection in view of USPAT No. 11,357,912 in view of Horvath et al. (US 2015/0051583).
Claim Objections
Claims 35, 38, 47, and 72 are objected to because of the following informalities:
Claim 35 recites “the wall,” “the weakened portions,” the internal bore,” “the weakened portions,” and “the tubular body.” The Examiner suggests amending Claim 1 to recite the following to provide proper antecedent basis for each claim limitation and improve the language consistency when referring to these structures within the claims:
An infusion device for subcutaneous delivery of a therapeutic agent to a patient comprising:
a cannula comprising a tubular body member comprising a tubular wall at least partly enclosing a longitudinally-extending internal bore, a distal portion of the tubular body member having a distal tip end comprising at least one tip opening, wherein the tubular wall comprises at least two weakened portions in the tubular wall oriented in a longitudinal direction parallel with the longitudinally-extending internal bore, the at least two weakened portions being capable of allowing the cannula to flex outwards away from the longitudinally-extending internal bore in an area comprising the at least two weakened portions when the cannula is exposed to a compression force or an increased internal pressure; and
a hub part configured to be fastened onto the patient's skin via a mounting pad,
wherein each of the at least two weakened portions is formed as a slit located at a same circumferential location of the tubular body member, wherein the width of a particular slit is greater than the width of a corresponding slit located about 180 degrees opposite from the particular slit.
Claim 38 recites “the weakened portions.” The Examiner suggests amending this to recite “the at least two weakened portions” to provide proper antecedent basis for this claim limitation and to improve the language consistency when referring to this structure within the claims.
Claim 47 recites “at the tip opening at least one of the weakened portions.” The Examiner suggests amending this to recite “at the at least one tip opening, at least one of the two weakened portions” to provide proper antecedent basis for these claim limitations and to improve the language consistency when referring to these structures within the claims.
Claim 72 recites “to the tip opening, wherein the upper boundaries are at the same distance from the tip opening of the cannula.” The Examiner suggests amending this to recite “to the at least one tip opening, wherein the upper boundaries are at the same distance from the at least one tip opening of the cannula” to provide proper antecedent basis for these claim limitations and to improve the language consistency when referring to these structures within the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 64 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 35 recites “wherein each of the at least two weakened portions is formed as a slit located at a same circumferential location of the tubular body.”
Claim 64 recites the following:
The infusion device of claim 35, wherein the at least two weakened portions comprises a first weakened portion and a second weakened portion, wherein the second weakened portion comprises a side opening having a circular or oval cross-sectional area permitting communication from the inside of the tubular body member to the outside of the tubular body member, said first and second weakened portion are formed at the same circumferential location of the tubular body member and substantially opposite each other.
Claim 64 is rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement because the subject matter recited in Claim 64 in addition to the subject matter in Claim 35 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or joint inventor had possession of the claimed invention. The Specification does not describe an embodiment where the at least two weakened portions comprise a slit and a side opening. The specification only includes support for embodiments where the weakened portions comprise a slit, hole, or a groove. There is no embodiment where the weakened portions are interchangeable in their structure where some are slits while others are holes or grooves. Therefore, Claim 64 fails to comply with the written description requirement because this subject matter was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or joint inventor had possession of the claimed invention.
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.
Claim(s) 35, 38, 47, 54, 64, 70 – 73, and 84 – 85 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 35 recites the following:
wherein each of the at least two weakened portions is formed as a slit located at a same circumferential location of the tubular body, wherein the width of a particular slit is greater than the width of a corresponding slit located about 180 degrees opposite from the particular slit.
Claim 35 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the “particular slit” and “corresponding slit” are referring to the slits of the at least two weakened portions or two separate slits. This then creates confusion as to how many slits Claim 35 requires. Is there two slits (one of the at least two weakened portion is the particular slit while the other is the corresponding slit) or are four slits required (e.g., the two weakened portions comprising slits, the particular slit, and the corresponding slit)? In order to clarify the claim language, the Examiner suggests amending this limitation to recite:
wherein each of the at least two weakened portions is formed as a slit located at a same circumferential location of the tubular body, wherein the slits comprise a particular slit and a corresponding slit, wherein the width of [[a]] the particular slit is greater than the width of [[a]] the corresponding slit located about 180 degrees opposite from the particular slit.
Claims 38, 47, 54, 64, 70 – 73, and 84 – 85 are dependent upon Claim 35 and therefore are also rejected under 35 U.S.C. § 112(b) for the same rationale as Claim 35.
Claim 64 recites the following:
The infusion device of claim 35, wherein the at least two weakened portions comprises a first weakened portion and a second weakened portion, wherein the second weakened portion comprises a side opening having a circular or oval cross-sectional area permitting communication from the inside of the tubular body member to the outside of the tubular body member, said first and second weakened portion are formed at the same circumferential location of the tubular body member and substantially opposite each other.
Claim 64 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the “side opening” is referring to the “slit” recited within Claim 35 or a separate structure of the weakened portions. Additionally, if the side opening is referring to the slit then how can the slit have a circular or oval cross-sectional area?
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) 35, 38, 47, 54, 64, 70 – 73, 84, and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 7, and 9 – 12 of U.S. Patent No.11,357,912 B2 in view of Horvath et al. (US 2015/0051583 A1; hereinafter referred to as “Horvath”).
USPAT 11,357,912 and Horvath are each cited in the Notice of References Cited dated 29 July 2025.
With regards to claim 35, Claims 1, 11, and 12 of USPAT 11,357,912 recites an infusion device for subcutaneous delivery of a therapeutic agent to a patient comprising (see Col. 17, lines 46 – 47 of USPAT 11,357,912):
a cannula comprising a tubular body member comprising a tubular wall at least partly enclosing a longitudinally-extending internal bore, a distal portion of the tubular body member having a distal tip end comprising at least one tip opening, wherein the tubular wall comprises at least two weakened portions in the wall, the weakened portions being capable of allowing the cannula to flex outwards away from the internal bore in an area comprising the weakened portions when the cannula is exposed to a compression force or an increased internal pressure (see Col. 17, lines 49 – 59 of USPAT 11,357,912); and
wherein each of the at least two weakened portions is formed as a slit located at a same circumferential location of the tubular body, wherein the width of a particular slit is greater than the width of a corresponding slit located about 180 degrees opposite from the particular slit (see Col. 18, lines 37 – 48 of USPAT 11,357,912).
However, Claims 1, 11, and 12 of USPAT 11,357,912 are silent with regards to:
the at least two weakened portions in the wall being oriented at a longitudinal direction parallel with the longitudinally-extending internal bore; and
a hub part configured to be fastened onto the patient's skin via a mounting pad.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 2 – 4) the infusion device (10) (see [0004]) further comprising:
the at least two weakened portions (31) (see [0068]) in the wall (see at 30 in Fig. 9) being oriented at a longitudinal direction parallel with the longitudinally-extending internal bore; (see the bore at the bottom reference numeral 30 in Fig. 9) and
a hub part (12) (see [0004]) configured to be fastened onto the patient's skin via a mounting pad (15) (see [0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion device of USPAT 11,357,912 in view of a teaching of Horvath such that the at least two weakened portions in the wall being oriented at a longitudinal direction parallel with the longitudinally-extending internal bore; and a hub part configured to be fastened onto the patient's skin via a mounting pad. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches that it is preferable for the splits to be oriented along the length of the catheter (see [0071] of Horvath) and the adhesive pad secures the infusion device to the user’s skin (see [0004] of Horvath).
The infusion device of USPAT 11,357,912 modified in view of a teaching of Horvath will hereinafter be referred to as the infusion device of USPAT 11,357,912 and Horvath.
With regards to claim 38, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, however, Claims 1, 11, and 12 of USPAT 11,357,912 are silent with regards to wherein the weakened portions result from material properties of the tubular wall.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 1 – 10) wherein the weakened portions (31; see [0075] “split 31”) result from material properties ([0014], [0074], [0075], [0076], [0077], [0088] “During the development of various perforated catheter embodiments, multiple perforated catheter designs were evaluated that differed in…catheter materials,” [0110]) of the tubular wall (33; see [0068] “tubing 33”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion device of USPAT 11,357, 912 and Horvath in view of a further teaching of Horvath such that the weakened portions result from material properties of the tubular wall. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches that different catheter materials were evaluated to achieve various catheter structural integrity, infusion site leakage, and insertion reliability (see [0088] of Horvath).
With regards to claim 47, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, however, Claims 1, 11, and 12 of USPAT 11,357,912 is silent with regards to wherein when the canula is exposed to the compression force and/or the increased internal pressure and the internal pressure in the longitudinally-extending internal bore exceeds the internal pressure at the tip opening, at least one of the weakened portions provides a fluid communication between the longitudinally-extending internal bore and the outside of the cannula.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 1 – 10) wherein when the cannula is exposed to the compression force and/or the increased internal pressure and the internal pressure in the longitudinally-extending internal bore exceeds the internal pressure at the tip opening, at least one of the weakened portions provides a fluid communication between the longitudinally-extending internal bore and the outside of the cannula (see [0074], [0075], [0076], [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion device of USPAT 11,357,912 and Horvath in view of a further teaching of Horvath such that when the cannula is exposed to the compression force and/or the increased internal pressure and the internal pressure in the longitudinally-extending internal bore exceeds the internal pressure at the tip opening, at least one of the weakened portions provides a fluid communication between the longitudinally-extending internal bore and the outside of the cannula. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches that this difference in pressure creates the fluid communication between the longitudinally-extending internal bore and the outside of the cannula (see [0074] - [0077] of Horvath).
With regards to claim 54, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, and Claims 1, 11, and 12 of USPAT 11,357,912 further teaches the at least two weakened portions comprises 2-10 slits, and the slits are formed at the same circumferential location of the tubular body member (see Col. 17, lines 66 – 67 and Col. 18, lines 37 – 48 of USPAT 11,357,912).
With regards to claim 64, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, and Claims 1, 11, and 12 of USPAT 11,357,912 further teaches wherein the at least two weakened portions comprises a first weakened portion and a second weakened portion, said first and second weakened portion are formed at the same circumferential location of the tubular body member and substantially opposite each other (see Co. 17, lines 60 – 67 and Col. 18, lines 37 – 48 of USPAT 11,357,912).
However, USPAT 11,357,912 is silent with regards to wherein the second weakened portion comprises a side opening having a circular or oval cross-sectional area permitting communication from the inside of the tubular body member to the outside of the tubular body member.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Fig. 31) the second weakened portion (112) comprises a side opening having a circular or oval cross-sectional area (see at 112 in Fig. 31) permitting communication from the inside of the tubular body member to the outside of the tubular body member (see Fig. 31, [0068], [0075], [0077], and [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second weakened portion of the infusion device of USPAT 11,357,912 and Horvath in view of a further teaching of Horvath such that the second weakened portion comprises a side opening having a circular or oval cross-sectional area permitting communication from the inside of the tubular body member to the outside of the tubular body member. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches that this side opening shape is useful for forming a secondary infusion pathway (see [0075], [0081], and [0100] of Horvath).
With regards to claim 70, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, and Claims 1, 11, and 12 of USPAT 11,357,912 further teaches wherein each slit has a corresponding and respective width in a range of 10-100 µm (see Col. 18, lines 37 – 44).
With regards to claim 71, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, however, Claims 1, 11, and 12 of USPAT 11,357,912 are silent with regards to the slits are offset in an axial direction with respect to one another, and wherein a longitudinal axis of each of the slits is parallel to a longitudinal axis of the cannula.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 1 – 10) the slits (31; see [0071] “one or more splits 31”) are offset in an axial direction with respect to one another (see [0072] “In addition, the splits 31 can be staggered, for instance at different distances from the distal tip 321 of the catheter 30, and at the same or different circumferential locations on the catheter 30.”), and wherein a longitudinal axis of each of the slits is parallel to a longitudinal axis of the cannula (see [0072] and Figs. 1 - 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the slits of the infusion device of USPAT 11,357,912 and Horvath in view of a further teaching of Horvath such that the slits are offset in an axial direction with respect to one another, and wherein a longitudinal axis of each of the slits is parallel to a longitudinal axis of the cannula. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches that the splits can be staggered, for instance at different distances from the distal tip of the catheter in order to position the splits on the catheter within the target tissue (see [0072] and [0073] of Horvath).
With regards to claim 72, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, however, Claims 1, 11, and 12 of USPAT 11,357,912 are silent with regards to wherein each slit comprises an upper or proximal boundary closest to a proximal portion of the cannula, and a lower or distal boundary closest to the tip opening, wherein the upper boundaries are at the same distance from the tip opening of the cannula, and longitudinal axes of each of the slits are each parallel to a longitudinal axis of the cannula.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 1 – 10) each slit (31; see [0071] “one or more splits 31”) comprises an upper or proximal boundary closest to a proximal portion of the cannula (see Fig. 7 and the portion of the slit that is closest to a proximal portion of the cannula), and a lower or distal boundary closest to the tip opening (see Fig. 7 and the portion of the slit that is closest to the tip opening 321), wherein the upper boundaries are at the same distance from the tip opening of the cannula (see [0071] “the lengths of the splits can be the same” and [0072] “A plurality of the splits 31 may also be spaced apart such that they are located 180.degree. around the catheter 30 from each other, for instance, at the same distance from the distal tip or tip hole 321 of the catheter 30.”), and longitudinal axes of each of the slits are each parallel to a longitudinal axis of the cannula (see [0071] “the split 31 (or splits) has a single axis, which is preferably oriented along the length of the catheter 30”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify each slit of the infusion device of USPAT 11,357,912 and Horvath in view of a further teaching of Horvath such that each slit comprises an upper or proximal boundary closest to a proximal portion of the cannula, and a lower or distal boundary closest to the tip opening, wherein the upper boundaries are at the same distance from the tip opening of the cannula, and longitudinal axes of each of the slits are each parallel to a longitudinal axis of the cannula. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches this configuration of each slit enables the physician to place the slit within the target tissue (see [0072] and [0073] of Horvath).
With regards to claim 73, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, however, Claims 1, 11, and 12 of USPAT 11,357,912 are silent with regards to wherein the device further comprises a pump in fluid connection with a reservoir configured to store medication/drug.
Nonetheless Horvath, which is within the analogous art of split and side-ported catheter devices (see abstract), teaches (see Figs. 1 – 10) the device (10; see [0004] “infusion set 10”) further comprises a pump (see [0004] “an insulin pump” and [0074]) in fluid connection with a reservoir configured to store medication/drug (see [0109] “the catheters were each connected to a reservoir filled with Iohexol in a generic ambulatory insulin infusion pump.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the infusion device of USPAT 11,357,912 and Horvath in view of a further teaching of Horvath such that the device further comprises a pump in fluid connection with a reservoir configured to store medication/drug. One of ordinary skill in the art would have been motivated to make this modification because Horvath teaches the inclusion of a pump allows for a physician to infuse medication through the catheter into the target location of the patient (see [0073] and [0109] of Horvath).
With regards to claim 84, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, and, Claims 1, 11, and 12 of USPAT 11,357,912 further teach wherein the width of the particular slit is about twice as large as the width of the corresponding slit located about 180 degrees opposite from the particular slit (see Col. 18, lines 45 – 48 of USPAT 11,357,912).
With regards to claim 85, the infusion device of USPAT 11,357,912 and Horvath teaches the claimed invention of claim 35, and Claims 1, 11, and 12 of USPAT 11,357,912 further teach wherein the at least two weakened portions comprises six slits, a width of at least three of the six slits being about twice as large as a width of a corresponding slit located about 180 degrees about a circumference of the tubular body member (see Col. 18, lines 45 – 48 of USPAT 11,357,912).
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 ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
03/03/2026