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 .
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 12, 37 and 46 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.
Regarding claims 12, 37 and 46, the limitation “the method further comprises assembling the infusion set by driving a cannula assembly of the infusion set, which is carried by the at least one insertion sharp, into another portion of the infusion set” is unclear because claims 10, 35 and 44, upon which claims 12, 37 and 46 respectively depend, already recite a medical device set presumed to be in its assembled state. Therefore, it is not clear how claims 12, 37 and 46 could recite a method of assembling an infusion set, which is part of a medical device, as part of the method of placing an assembled medical device onto the skin/surface.
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 10, 11, 13-18, 35, 36, 38-45 and 47-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rose et al (U.S. Pub. 2017/0165420 A1, hereinafter “Rose”).
Regarding claim 10, Rose discloses a method of placing a medical device (such as a needle 417 and tubing 408 associated with an infusion bag 402; see Fig. 23 and para [0103]) of an inserter assembly 410 (see Fig. 24A) on a patient comprising:
coupling the inserter assembly 410 to skin (see para [0112] and step S310 in Fig. 32);
lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (squeezing wings 430 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see Fig. 25A-25B and paras [0103]-[0106]; and see para [0112], disclosing step S312 in which wings are pinched together, causing a tent of skin to be pulled up);
triggering an actuation assembly 450 (see Figs. 25B, 26) of the inserter assembly automatically as the skin is lifted (the wings are squeezed inward to a sufficient amount to depress the actuators 454, triggering the firing mechanism 450 to unblocking a needle slot 452 so that the needle 417 can automatically be deployed through the slot 452 under the bias of a spring; see paras [0103], [0104], [0106]; and see para [0112], disclosing step S312 includes automatically deploying a needle).
Fig. 34 also shows an alternative embodiment but uses the same method:
placing a medical device (such as needle hub 619 and needle 617) of an inserter assembly 610 on a patient, comprising:
coupling the inserter assembly 610 to skin (see para [0114]);
lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (squeezing wings 640 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see para [0115]); and
triggering an actuation assembly 650 of the inserter assembly automatically as the skin is lifted (see para [0131], disclosing that the wings are squeezed inward, causing the skin to be “pinched up” between the wings, a sufficient amount to rotate actuators 654 to rotate out of latching engagement with a retaining mechanism 620/622, permitting spring to automatically extend and push a needle 617 and slider 620 along slider tracks 662 to be deployed through a needle aperture 633 in the base and be inserted into the skin of the patient).
Regarding claim 11, Rose discloses the method of claim 10, wherein the method further comprises releasing a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp through the skin (see para [0103], disclosing that when in the deployed mode, a needle in a spring-loaded barrel 416 passes through the needle slot 452 and through an aperture in the base 430 to puncture the skin; the bias member is understood to be the single large spring shown in Figs. 24C, 26, 27 and 31; a similar bias member is disclosed in the embodiment shown in Fig. 34 and described in paras [0114] and [0131]).
Regarding claim 13, Rose discloses the method of claim 11, wherein the method further comprises releasing a retraction prevention latch 454 (sufficiently depressing the actuators 454 causes the needle slot 452 to be unblocked in order to drive the needle both forwards and backwards) and driving the at least one insertion sharp in a direction away from the skin (see step S316 in Fig. 32, disclosing that insertion sharp can be withdrawn from the skin).
Rose discloses a similar method in the embodiment shown in Fig. 34, whereby a retraction prevention latch (slider 620) is released, permitting the needle to be both inserted into and withdrawn from the skin (see para [0134]).
Regarding claim 14, Rose discloses removing a lock member (blocking engagement structure between the actuators 454 and the needle slot 452), which prevents triggering of the actuation assembly (in the blocked position shown in Fig. 26, the actuation assembly 450 cannot be triggered).
Rose discloses a similar mechanism in the embodiment shown in Fig. 34, whereby a lock member 628 locks the needle 617 in place until the actuators 654 are rotated out of engagement with the stop wall 622 of the lock member 628).
Regarding claim 15, Rose discloses the method of claim 10, wherein coupling the inserter assembly to the surface comprises adhering a portion of the medical device to the surface via adhesive (the coupling of the inserter assembly also causes the medical device, which is coupled to the inserter, to be adhered to the surface via the adhesive of the inserter assembly).
Regarding claim 16, Rose discloses the method of claim 10, wherein the method further comprises inhibiting relative movement between a casing 660 (see Fig. 33) of the inserter assembly 610 and a second portion of the inserter assembly at least when the skin begins to be lifted (the aforementioned wing/actuator latching holds slider 620 in place until a sufficient squeezing of the wings takes place; it is understood that some amount of skin would begin to be lifted before the wings are squeezed sufficiently to unlatch the actuators from the slider 620).
Regarding claim 17, Rose discloses the method of claim 10, wherein the method further comprises releasing the medical device from a portion of the inserter assembly (i.e., the aforementioned release of the actuators, which form “a portion of the inserter assembly”, from the needle of the medical device).
Regarding claim 18, Rose discloses the method of claim 10, wherein the method further comprises assembling the inserter assembly by coupling a disposable cartridge containing the medical device to a reusable portion of the inserter assembly (i.e., the disposable cartridge can be the infusion bag 402, tubing 408 and valve 406 connected to the insertable assembly for use; although Rose does not explicitly disclose that these components are disposable, the disposability is inherent because they can be disposed of).
Regarding claim 35, Rose discloses a method of placing a medical device (such as a needle 417 and tubing 408 associated with an infusion bag 402; see Fig. 23 and para [0103]) of an inserter assembly 410 (see Fig. 24A) on a surface (the skin) comprising:
coupling the inserter assembly 410 to the surface (i.e., skin; see para [0112] and step S310 in Fig. 32);
lifting the surface from a resting position by displacing the inserter assembly in a direction away from the surface (squeezing wings 430 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see Fig. 25A-25B and paras [0103]-[0106]; and see para [0112], disclosing step S312 in which wings are pinched together, causing a tent of skin to be pulled up);
triggering an actuation assembly 450 (see Figs. 25B, 26) of the inserter assembly automatically as the surface is lifted (the wings are squeezed inward to a sufficient amount to depress the actuators 454, triggering the firing mechanism 450 to unblocking a needle slot 452 so that the needle 417 can automatically be deployed through the slot 452 under the bias of a spring; see paras [0103], [0104], [0106]; and see para [0112], disclosing step S312 includes automatically deploying a needle).
Fig. 34 also shows an alternative embodiment but uses the same method:
placing a medical device (such as needle hub 619 and needle 617) of an inserter assembly 610 on a surface (skin), comprising:
coupling the inserter assembly 610 to the surface (see para [0114]);
lifting the surface from a resting position by displacing the inserter assembly in a direction away from the surface (squeezing wings 640 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see para [0115]); and
triggering an actuation assembly 650 of the inserter assembly automatically as the surface is lifted (see para [0131], disclosing that the wings are squeezed inward, causing the skin to be “pinched up” between the wings, a sufficient amount to rotate actuators 654 to rotate out of latching engagement with a retaining mechanism 620/622, permitting spring to automatically extend and push a needle 617 and slider 620 along slider tracks 662 to be deployed through a needle aperture 633 in the base and be inserted into the skin of the patient).
Regarding claim 36, Rose discloses the method of claim 35, wherein the method further comprises releasing a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp through the surface (see para [0103], disclosing that when in the deployed mode, a needle in a spring-loaded barrel 416 passes through the needle slot 452 and through an aperture in the base 430 to puncture the skin; the bias member is understood to be the single large spring shown in Figs. 24C, 26, 27 and 31; a similar bias member is disclosed in the embodiment shown in Fig. 34 and described in paras [0114] and [0131]).
Regarding claim 38, Rose discloses the method of claim 36, wherein the method further comprises releasing a retraction prevention latch 454 (sufficiently depressing the actuators 454 causes the needle slot 452 to be unblocked in order to drive the needle both forwards and backwards) and driving the at least one insertion sharp in a direction away from the surface (see step S316 in Fig. 32, disclosing that insertion sharp can be withdrawn from the skin).
Rose discloses a similar method in the embodiment shown in Fig. 34, whereby a retraction prevention latch (slider 620) is released, permitting the needle to be both inserted into and withdrawn from the skin (see para [0134]).
Regarding claim 39, Rose discloses the method of claim 35, wherein the method further comprises removing a lock member (blocking engagement structure between the actuators 454 and the needle slot 452), which prevents triggering of the actuation assembly (in the blocked position shown in Fig. 26, the actuation assembly 450 cannot be triggered).
Rose discloses a similar mechanism in the embodiment shown in Fig. 34, whereby a lock member 628 locks the needle 617 in place until the actuators 654 are rotated out of engagement with the stop wall 622 of the lock member 628).
Regarding claim 40, Rose discloses the method of claim 35, wherein coupling the inserter assembly to the surface comprises adhering a portion of the medical device to the surface via adhesive (the coupling of the inserter assembly also causes the medical device, which is coupled to the inserter, to be adhered to the surface via the adhesive of the inserter assembly).
Regarding claim 41, Rose discloses the method of claim 35, wherein the method further comprises inhibiting relative movement between a casing 660 (see Fig. 33) of the inserter assembly 610 and a second portion of the inserter assembly at least when the skin begins to be lifted (the aforementioned wing/actuator latching holds slider 620 in place until a sufficient squeezing of the wings takes place; it is understood that some amount of skin would begin to be lifted before the wings are squeezed sufficiently to unlatch the actuators from the slider 620).
Regarding claim 42, Rose discloses the method of claim 35, wherein the method further comprises releasing the medical device from a portion of the inserter assembly (i.e., the aforementioned release of the actuators, which form “a portion of the inserter assembly”, from the needle of the medical device).
Regarding claim 43, Rose discloses the method of claim 35, wherein the method further comprises assembling the inserter assembly by coupling a disposable cartridge containing the medical device to a reusable portion of the inserter assembly (i.e., the disposable cartridge can be the infusion bag 402, tubing 408 and valve 406 connected to the insertable assembly for use; although Rose does not explicitly disclose that these components are disposable, the disposability is inherent because they can be disposed of).
Regarding claim 44, Rose discloses a method of placing a medical device (such as a needle 417 and tubing 408 associated with an infusion bag 402; see Fig. 23 and para [0103]) of an inserter assembly 410 (see Fig. 24A) on a patient comprising:
coupling the inserter assembly 410 to skin (i.e., skin; see para [0112] and step S310 in Fig. 32);
stretching the skin away from underlying anatomy by displacing the inserter assembly in a direction away from the surface (squeezing wings 430 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see Fig. 25A-25B and paras [0103]-[0106]; and see para [0112], disclosing step S312 in which wings are pinched together, causing a tent of skin to be pulled up);
triggering an actuation assembly 450 (see Figs. 25B, 26) of the inserter assembly automatically as the skin is stretched with a force exerted by skin (the wings are squeezed inward to a sufficient amount to depress the actuators 454, triggering the firing mechanism 450 to unblocking a needle slot 452 so that the needle 417 can automatically be deployed through the slot 452 under the bias of a spring; see paras [0103], [0104], [0106]; and see para [0112], disclosing step S312 includes automatically deploying a needle). The claim does not appear to clearly establish that the force exerted by the skin actually triggers the actuation assembly, but nonetheless the skin exerts a minimal force against the movement of the wings that permits the wings to depress the actuators.
Fig. 34 also shows an alternative embodiment but uses the same method:
placing a medical device (such as needle hub 619 and needle 617) of an inserter assembly 610 on the patient comprising:
coupling the inserter assembly 610 to skin (see para [0114]);
stretching the skin away from underlying anatomy by displacing the inserter assembly in a direction away from the surface (squeezing wings 640 causes the inserter to be moved upward as a tent of skin is “pinched up” between the wings; see para [0115]); and
triggering an actuation assembly 650 of the inserter assembly automatically as the skin is stretched with a force exerted by the skin (see para [0131], disclosing that the wings are squeezed inward, causing the skin to be “pinched up” between the wings, a sufficient amount to rotate actuators 654 to rotate out of latching engagement with a retaining mechanism 620/622, permitting spring to automatically extend and push a needle 617 and slider 620 along slider tracks 662 to be deployed through a needle aperture 633 in the base and be inserted into the skin of the patient). The claim does not appear to clearly establish that the force exerted by the skin actually triggers the actuation assembly, but nonetheless the skin exerts a minimal force against the movement of the wings that permits the wings to depress the actuators.
Regarding claim 45, Rose discloses the method of claim 44, wherein the method further comprises releasing a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp through the skin (see para [0103], disclosing that when in the deployed mode, a needle in a spring-loaded barrel 416 passes through the needle slot 452 and through an aperture in the base 430 to puncture the skin; the bias member is understood to be the single large spring shown in Figs. 24C, 26, 27 and 31; a similar bias member is disclosed in the embodiment shown in Fig. 34 and described in paras [0114] and [0131]).
Regarding claim 47, Rose discloses the method of claim 35, wherein the method further comprises releasing a retraction prevention latch 454 (sufficiently depressing the actuators 454 causes the needle slot 452 to be unblocked in order to drive the needle both forwards and backwards) and driving the at least one insertion sharp in a direction away from the skin (see step S316 in Fig. 32, disclosing that insertion sharp can be withdrawn from the skin).
Regarding claim 48, Rose discloses the method of claim 44, wherein the method further comprises inhibiting relative movement between a casing 660 (see Fig. 33) of the inserter assembly 610 and a second portion of the inserter assembly at least when the skin begins to be lifted (the aforementioned wing/actuator latching holds slider 620 in place until a sufficient squeezing of the wings takes place; it is understood that some amount of skin would begin to be lifted before the wings are squeezed sufficiently to unlatch the actuators from the slider 620).
Regarding claim 49, Rose discloses the method of claim 44, wherein the method further comprises assembling the inserter assembly by coupling a disposable cartridge containing the medical device to a reusable portion of the inserter assembly (i.e., the disposable cartridge can be the infusion bag 402, tubing 408 and valve 406 connected to the insertable assembly for use; although Rose does not explicitly disclose that these components are disposable, the disposability is inherent because they can be disposed of).
Claims 10, 14, 15, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hadvary et al (U.S. Pat. 10,080,582 B2, hereinafter “Hadvary”).
Regarding claim 10, Hadvary discloses a method of placing a medical device (such as a syringe 38 and a needle 11; see Fig. 5A) of an inserter assembly (combination of coupling element 4 and needle holder 3) on a patient comprising:
coupling the inserter assembly to skin (see Fig. 5A and col. 7, lines 8-10, showing the inserter assembly coupled to the skin with adhesive layer 1 and then pressed downward by manual pressure);
lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (after manual pressure is applied to the skin, the skin is then lifted upward, relative to its position shown in Fig. 5A, by displacement of the inserter assembly away from the skin; even assuming typographical errors in the specification of Hadvary, this movement is clearly shown in Fig. 5B); and
triggering an actuation assembly of the inserter assembly automatically as the skin is lifted (as the skin is lifted, hook 41 automatically engages mechanism 8 and decouples the mechanism 8 from its engagement with a shoulder in part 38; upon such decoupling, part 38 is allowed to move downward in the direction indicated by downward arrow “5” in Fig. 5B).
Regarding claim 14, Hadvary discloses the method of claim 10, wherein the method further comprises removing a lock member 12 which prevents triggering of the actuation assembly (i.e., the ridge portion of ridge-and-groove member 12 normally prevents movement of the coupling element 4 in the direction of upward arrows “3” until it is able to be removed from the groove portion).
Regarding claim 15, Hadvary discloses the method of claim 10, wherein the method further comprises coupling the inserter assembly to the skin comprises adhering a portion of the medical device to the skin via adhesive 1 (see Fig. 5A).
Regarding claim 16, Hadvary discloses the method of claim 10, wherein the method further comprises inhibiting relative movement between a casing of the inserter assembly and a second portion of the inserter assembly (such as an adhesive 10) at least when the skin begins to be lifted (i.e., the adhesive is adhered to the skin and the casing is adhered to the adhesive such that the adhesive prevents movement between the casing and the adhesive).
Regarding claim 18, Hadvary discloses the method of claim 10, wherein the method further comprises assembling the inserter assembly by coupling a disposable cartridge 6 (although Hadvary does not explicitly disclose that the cartridge 6 is disposable, a skilled artisan would know that it could be disposed of) containing the medical device to a reusable portion of the inserter assembly (e.g., the coupling element 4); see Fig. 5A, showing that the disposable cartridge 6 and coupling element 4 are already assembled, which implicitly requires them to have undergone assembly before use).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 12, 37 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Rose in view of Carter et al (U.S. Pub. 2007/0282269 A1, hereinafter “Carter”).
Regarding claims 12, 37 and 46, Rose discloses the method of claims 11, 35 and 44 respectively, and the medical device may be an infusion set (such as the needle and/or the needle with hub), but does not appear to disclose that the method further comprises assembling the infusion set by driving a cannula assembly of the infusion set, which is carried by the at least one insertion sharp, into another portion of the infusion set.
Carter discloses a method of placing a medical device of an inserter assembly on a patient comprising coupling an inserter assembly with a medical device to the skin, and discloses that an insertion sharp carries a cannula (see para [0013]). The cannula has been inserted into another portion of an infusion set, such as a fluid coupler (see Fig. 13).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Rose, so that the method comprises assembling the infusion set by driving a cannula assembly of the infusion set, which is carried by the at least one insertion sharp, into another portion of the infusion set, in order to provide a well-known connection between the skin and an external source (such as the bag already disclosed in Rose), with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed in an Appeal Brief (hereinafter “Brief”) filed on 07/23/2026 have been considered.
It is noted that a new ground of rejection has been applied, citing Rose and Carter, to all of the pending claims. The new ground of rejection does not hinge on any argument presented in the Appeal Brief; for this reason, those arguments are moot as they relate to the new ground of rejection.
However, the arguments in the Brief are considered to be relevant to the outstanding rejection of claims 10, 14, 15, 16 and 18 over Hadvary, maintained in the present Office action.
Applicant argued that Hadvary does not teach or suggest claim 10, alleging that Hadvary discloses that “manual pressure toward the skin …. manually accelerates Hadvary’s item 3 (‘needle holder’) to the skin.” (See Brief, pg. 11). Applicant argued that FIG. 5A of Hadvary shows that the skin is depressed against underlying anatomy “in contrast to what is recited in claim 10” and that “[i]t is unclear how the Hadvary device could be triggered and effectuate an insertion with lifting.”
Examiner does not dispute that Hadvary discloses an initial step of manual application of the needle holder downward against the skin, as shown in Fig. 5A.1 But claim 10 is open-ended (by virtue of the transitional phrase “comprising” in the preamble) and therefore does not exclude applying manual downward pressure on the inserter assembly. Applicant’s claim only that the skin is “lifted from underlying anatomy”. If the underlying anatomy (Applicant has not specified what the underlying anatomy is) remains stationary relative to skin movement, then the upward movement is “lifting from underlying anatomy.”
Therefore, Applicant’s allegation that Hadvary’s disclosure is sufficient to overcome the rejection (see Brief, pg. 13, alleging that an admission that Hadvary’s method applies pressure toward the skin “is sufficient to overturn the rejection in light of the recitations present in claim 10”) is not persuasive.
Hadvary shows, by way of Figs. 5A and 5B, that after manual pressure is applied to the skin, the skin is then lifted upward (shown in Fig. 5B relative to its position shown in Fig. 5A) by displacement of the inserter assembly away from the skin (this movement is clearly shown in Fig. 5B and disclosed at col. 7, lines 59-62), anticipating the claimed limitation of “lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin”). Even assuming that Hadvary contains typographical errors in its specification related to the discussion of the embodiment in Figs. 5A-5C (see Brief, pg. 14), Figs. 5A and 5B nonetheless unambiguously show that the skin is lifted in Fig. 5B relative to its position in Fig. 5A.
Then, as the skin is lifted, hook 41 automatically engages mechanism 8 and decouples mechanism 8 from its engagement with a shoulder in part 38. This movement permits part 38 to move downward in the direction indicated by downward arrow “5” in Fig. 5B, anticipating the claimed limitation of “triggering an actuation assembly of the inserter assembly automatically as the skin is lifted.”
Examiner also notes that claim 10 does not recite “insertion [of the needle] with lifting” or any insertion of a needle whatsoever. Claim 10 recites broadly “triggering an actuation assembly of the inserter assembly automatically as the skin is lifted”; this step contains no mention whatsoever of needle insertion.
Conclusion
THIS ACTION IS MADE NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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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.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/14/2026
1 Applicant incorrectly alleged that “the Examiner and Applicant appear to be in agreement that Hadvary is
not an anticipatory reference.” (See Brief, pg. 13).
