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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Release mechanism of claim 1 and 11 is interpreted according to para. [0062] as being any mechanism coupled to the housing and capable of releasing the needle.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8-11, 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gelfand et al. (US 2017/0319120 A1).
Regarding claim 1, Gelfand discloses (Figs. 11A-13) a safety lancet transseptal access system 10C comprising: a housing 12 having a proximal end and a distal end (Fig. 12), the proximal end having an opening (Figs 11C-11D) with a plunger 70 and the distal end terminating in a housing wall (Fig. 11C-11D, distal wall), a housing lumen (i.e., through which 130 extends; see para. [0090]) extending through the housing (Figs. 11C-11D) and a release mechanism (release mechanism is described in para. [0099] and includes 92, 96, 94) coupled to the housing (Fig. 33); a puncture device spring 102 connected to the plunger (Fig. 7A-7C) and a disk (i.e., body 76 to which 82 extends from); and a puncture device 72 connected to the disk (i.e., as shown in Fig. 13); and a pair of opposing ramps 94 positioned on opposing sides of the housing lumen and connected to the release mechanism (Figs. 12-13); wherein when the plunger is pushed distally towards the distal end of the housing (para. [0075], para. [0088], [0099]), the puncture device spring compresses and a distal portion 82 (i.e., see Fig. 10; 82 is more distal than the proximal end) of the plunger advances distally over the opposing ramps (Figs. 14-15) until the release mechanism is triggered, (para. [0099]; i.e., see Figs. 14 and 15 such that 18 advances distally over 82) which then causes the puncture device to be deployed past the housing wall (para. [0099]-[0100]), and wherein once deployed, tension from the puncture device spring pulls the disk and the puncture device back into the housing to a neutral position (para. [0102]).
Regarding claim 2, Gelfand discloses the safety lancet of claim 1. Gelfand also discloses wherein the housing further comprises a plunger return spring 110 and wherein the plunger return spring is configured to push the plunger back to an undeployed state once deployed (para. [0088]).
Regarding claim 3, Gelfand discloses the safety lancet of claims 2. Gelfand also discloses wherein the puncture device is configured to be redeployed.
The device of Gelfand is fully capable of being redeployed, if one desired to do so - note that the limitations of claim 3 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 4, Gelfand discloses the safety lancet of claim 1. Gelfand also discloses wherein the safety lancet further comprises a tubular dilator 50 having an elongated body (Fig. 12) with a proximal end portion connected to the housing wall (Fig. 12) and a distal end portion terminating in a distal tip (Fig. 12), a dilator lumen extending through the body (Fig. 12), the body being dimensioned to slidingly receive a hypotube 76 and the puncture device (Fig. 17).
Regarding claim 5, Gelfand discloses the safety lancet of claims 4. Gelfand also discloses wherein the hypotube is configured to be extended out of the distal tip of the dilator by the puncture device spring (i.e., 76 is not required to be extended out of the distal tip, but does function to be movable back and forth via the puncture device spring such that it is configured to be extended out of the distal tip of the dilator).
Regarding claim 8, Gelfand discloses the safety lancet of claim 4. Gelfand also discloses wherein the puncture device is an automatic spring-loaded puncture device (paras. [0088], [0099]-[0102]).
Regarding claim 9, Gelfand discloses the safety lancet of claim 1. Gelfand also discloses wherein the puncture device is mechanically triggered by a user applying an outside force (para. [0116]).
Regarding claim 10, Gelfand discloses the safety lancet of claim 1. Gelfand also discloses wherein the puncture device is configured to pierce the atrial septum and withdraw (i.e., such as lancet 72 which is capable of piercing the atrial septum).
Regarding claim 11, Gelfand discloses (Figs. 11A-13) a safety lancet transseptal access system 10C comprising: a housing 12 having a proximal end and a distal end (Fig. 12), the proximal end having an opening (Figs 11C-11D) with a plunger 14 and the distal end terminating in a housing wall (Fig. 11C-11D, distal wall), a housing lumen (i.e., through which 130 extends; see para. [0090]) extending through the housing (Figs. 11C-11D) and a release mechanism (release mechanism is described in para. [0099] and includes 92, 96, 94) coupled to the housing (Fig. 33); a single puncture device spring 102 connected to the plunger (Fig. 13 for example) and a disk 82; and a tubular dilator 50 having an elongated body (Fig. 12) having a proximal end portion connected to the housing wall (Fig. 12) and a distal end portion terminating in a distal tip (Fig. 12), a dilator lumen extending through the body (Fig. 12), the body being dimensioned to slidingly receive a hypotube 76 and a puncture device 72, the puncture device being connected to the disk(i.e., as shown in Fig. 13); wherein when the plunger is pushed distally towards the distal end of the housing (para. [0075], para. [0088], [0099]), the single puncture device spring compresses triggering the release mechanism (para. [0099]) which then causes the puncture device to be deployed past the housing wall (para. [0099]-[0100]), and wherein once deployed, tension from the single puncture device spring pulls the disk and the puncture device back into the housing to a neutral position (para. [0102]).
Regarding claim 13, Gelfand discloses the safety lancet of claim 11. Gelfand doesn’t directly disclose wherein the puncture device is configured to be redeployed.
The device of Gelfand is fully capable of being redeployed, if one desired to do so - note that the limitations of claim 3 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 14, Gelfand discloses the safety lancet of claim 11. Gelfand also discloses wherein the hypotube is configured to be extended out of the distal tip of the dilator by the single puncture device spring (i.e., 76 is not required to be extended out of the distal tip, but does function to be movable back and forth via the puncture device spring such that it “may be” extended out of the distal tip of the dilator).
Regarding claim 15, Gelfand discloses the safety lancet of claim 11. Gelfand also discloses wherein the puncture device is an automatic spring-loaded puncture device (paras. [0088], [0099]-[0102]).
Regarding claim 16, Gelfand discloses the safety lancet of claim 11. Gelfand also discloses wherein the puncture device is mechanically triggered by a user by applying an outside force (para. [0116]).
Regarding claim 17, Gelfand discloses the safety lancet of claim 11. Gelfand also discloses wherein the puncture device is configured to pierce the atrial septum and withdraw (i.e., such as lancet 72 which is capable of piercing the atrial septum).
Regarding claim 18, Gelfand discloses a method of making a safety lancet transseptal access system (paras. [0072]-[0152]), the method comprising: providing a housing 12 having a proximal end and a distal end (Fig. 12), the proximal end having an opening (Figs 11C-11D) with a plunger 14 and the distal end terminating in a housing wall (Fig. 11C-11D, distal wall), a housing lumen (i.e., through which 130 extends; see para. [0090]) extending through the housing (Figs. 11C-11D) and a release mechanism (release mechanism is described in para. [0099] and includes 92, 96, 94) coupled to the housing (Fig. 33) securing a puncture device spring 102 connected to the plunger (Fig. 13 for example, para. [0087]) and a disk 82; connecting a puncture device 72 to the disk (i.e., as shown in Fig. 13 at least during assembly of the device); and positioning a pair of opposing ramps 94 on opposing sides of the housing lumen (Figs. 12-13) and connecting the ramps to the release mechanism (Figs. 12-13 i.e., at least during manufacturing); wherein when the plunger is pushed distally towards the distal end of the housing (para. [0075], para. [0088], [0099]), the puncture device spring compresses and a distal portion 82 of the plunger advances distally over the opposing ramps (Figs. 12-13; 14-15) until the release mechanism is triggered (para. [0099]), which then causes the puncture device to be deployed past the housing wall (para. [0099]-[0100]), and wherein once deployed, tension from the puncture device spring pulls the disk and the puncture device back into the housing to a neutral position (para. [0102]).
Regarding claim 19, Gelfand discloses the method of claim 18. Gelfand also discloses wherein the housing further comprises a plunger return spring 110.
Regarding claim 20 Gelfand discloses the method of claim 19. Gelfand also discloses wherein the puncture device may be redeployed (note: this is not required as it is being interpreted as an optional feature by way of the language “may be.” Further, the device of Gelfand may be redeployed).
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gelfand.
Regarding claim 6, Gelfand discloses the safety lancet of claim 4. Gelfand doesn’t directly discloses wherein the puncture device spring causes the puncture device to perforate an atrial septum and subsequently withdraw, allowing the hypotube and the dilator to advance through the atrial septum.
The device of Gelfand is fully capable of the puncture device spring causes the puncture device to perforate an atrial septum and subsequently withdraw, allowing the hypotube and the dilator to advance through the atrial septum, if one desired to do so - note that the limitations of claim 6 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 7, Gelfand discloses the safety lancet of claim 5. Gelfand doesn’t directly disclose wherein the hypotube operates to gradually enlarge a perforation initially created by the puncture device.
The device of Gelfand is fully capable of the hypotube operates to gradually enlarge a perforation initially created by the puncture device, if one desired to do so - note that the limitations of claim 7 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive.
Applicant disagrees with the claim interpretation but provides no arguments for the disagreement. Examiner points back to the interpretation which recites the language found in the specification and reiterated above.
Applicant argues that Gelfand does not disclose a pair of opposing ramps positioned on opposing sides of a housing lumen over which a plunger advances. Examiner disagrees and notes that the new interpretation of the plunger includes 82 which as shown in Figs. 14-15 advances over 94 to trigger the release mechanism. Further, anything that is more distal than a proximal end may be interpreted as being distal.
Applicant argues that spring 102 does not retract the device, however Examiner disagrees. Examiner notes that according to para. [0088], the retraction spring 110 is an option feature that “may be” provided at the forward end of the lancet device but is not required. Further, para. [0087] requires the movement through the device to be achieved through 102.
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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