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
The amendment filed December 29, 2025 has been entered. Claims 1 and 3-27 are currently pending.
Drawings
The drawings were received on December 29, 2025. These drawings are acceptable.
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.
[AltContent: connector]Claims 1 and 3-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,263,066. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including an apparatus for penetrating a membrane comprising: a tubular member with a plurality of apices extending from a distal end of said tubular member and a plurality of valleys defining a plurality of serrated blades/cutting edges, the tubular member configured to translate between first and second positions and extract a portion of the membrane. The difference between claims 1-23 of the application and claims 1-19 of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of claims 1-19 of the patent is in effect a “species” of the “generic” invention of claims 1-23. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-23 are anticipated by claims 1-19 of the patent, they are not patentably distinct from claims 1-19.
Instant Claim
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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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 6, 8, 15, 21, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umar et al. (US 2015/0250493, hereinafter “Umar”).
Regarding claim 1, Umar discloses an apparatus (Figs 1-9) for penetrating a membrane of the inner ear (fully capable of penetrating inner ear) comprising:
a tubular member (12) including a proximal portion (14), a distal portion (16), and inner and outer surfaces defining a circumference around the tubular member,
a plurality of apices (defining prong like members 13) extending from a distal end of said tubular member and arranged around the circumference, the distal end including an inside bevel (24, 26) (Figs 8-9; para [0027]),
a plurality of valleys (defining prong like members 13), wherein each valley is disposed between neighboring apices, wherein the plurality of apices and the plurality of valleys define a circumferential crown shape (defined by Merriam-webster as topmost part; top form or outline of an object) and define a plurality of serrated blades (13); and the tubular member being configured to:
translate between a first position and a different second position upon entering a membrane (fully capable of being positioned between first and second positions), and
extract a portion of the membrane by engaging at least one apex of the plurality of apices with the membrane (fully capable of extracting a portion of a membrane when pushed through the membrane since serrated blades cut tissue – para [0026]).
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Regarding claim 3, wherein at least two serrated blades (13) are defined by the plurality of apices and valleys (Figs 5, 8; para [0026]).
Regarding claim 4, wherein a respective one of the at least two serrated blades includes a wedge configuration (bevels form wedge – Figs 5, 8; para [0027]).
Regarding claim 6, wherein each of the plurality of apices includes a tip at a most distal end, and a proximal portion, and further wherein a cutting edge extends proximally from the tip of the respective apex to an edge of an adjacent valley (Figs 5, 8).
Regarding claim 8, wherein the inside bevel (24 or 26) forms a cutting edge (25) (Figs 8-9; para [0027]).
Regarding claim 15, wherein the proximal end of the tubular member is configured to engage a handle (proximal end 14 fully capable of engaging a handle. It is noted the handle is not positively recited).
Regarding claim 21, Umar discloses an apparatus (Figs 1-9) for penetrating a membrane of the inner ear (fully capable of penetrating inner ear) comprising:
a member (12) including a distal portion (16), and an outer surface defining a circumference around the member, the member defining a plurality of apices extending from a distal end of said member and defining a circumferential crown shape (defined by Merriam-webster as topmost part; top form or outline of an object), a plurality of valleys, wherein each valley is disposed between neighboring apices, a plurality of cutting edges (13) defined by the plurality of apices and the plurality of valleys disposed on the outer circumference of the member; a tip at a most distal end of each of the apices, the distal end comprising an inside bevel ((24, 26) around the circumference of the distal end portion (Figs 8-9; para [0027]), and a trailing edge extending from the tip to the center of the member (Figs 5, 8; para [0026]).
Regarding claim 24, wherein the trailing edge comprises a planar portion nearest the tip and cutting edge (25) nearest the center of the member (Figs 5, 8).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watanabe et al. (WO2015200923, hereinafter “Watanabe”).
Regarding claim 16, Watanabe discloses a system for penetrating a membrane of the inner ear (para [0039]) comprising:
a tubular member (100) having a proximal portion (110), a distal portion (120) and a lumen there between, wherein the distal portion includes a plurality of alternating apices (130) and valleys (150) to define a plurality of serrated blades that define a circumferential crown shape (defined by Merriam-webster as topmost part; top form or outline of an object), the distal portion comprises an inside bevel around the circumference of the distal end of the distal portion (arcute bottom edge can be beveled sharply against the inner cylinder of the needle – Fig 5; para [0041]; alternatively, bevel interpreted as cutting edge 140 formed at a beveled angle along width of tip and thus interpreted as being an inside bevel, i.e. inside the thickness of the tubular member); and an aspirator operatively engaged to the tubular member (para [0050]).
Regarding claim 17, wherein the tubular member includes a stopper coaxially disposed about the tubular member (Fig 1B; para [0055, 0071]).
Regarding claim 18, wherein the plurality of alternating apices (130) and valleys (150) define at least two spaced apart serrated blades (160; para [0040-0041]).
Regarding claim 19, wherein the serrated blades have a wedge shaped configuration (wedge formed by beveled edge para [0041-0042]).
Regarding claim 20, wherein, the plurality of apices (130) includes a first apex and a different second apex, the first apex and the second apex are spaced apart from each other with a respective valley (150) of the plurality of valley in between the first apex and the second apex (Figs 1-2 – eight spaced apart apices shown with valleys therebetween).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-15, and 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Watanabe (WO2015200923) or, in the alternative, under 35 U.S.C. 103 as obvious over Watanabe (WO2015200923), as applied to claim 1 above, further in view of Umar (US 2015/0250493).
Regarding claim 1, Watanabe discloses an apparatus for penetrating a membrane of the inner ear (para [0039]) comprising:
a tubular member (100) including a proximal portion (110), a distal portion (120), and inner and outer surfaces defining a circumference around the tubular member,
a plurality of apices (130) extending from a distal end of said tubular member and arranged around the circumference, the distal end defining an inside bevel (arcute bottom edge can be beveled sharply against the inner cylinder of the needle – Fig 5; para [0041]; alternatively, bevel interpreted as cutting edge 140 formed at a beveled angle along width of serrated blade within valley and thus interpreted as being an inside bevel, i.e. inside the thickness of the tubular member and extending to the inner wall),
a plurality of valleys (150), wherein each valley is disposed between neighboring apices, wherein the plurality of apices and the plurality of valleys define a circumferential crown shape (defined by Merriam-webster as topmost part; top form or outline of an object) and define a plurality of serrated blades (104) (Figs 1-2; para [0040]), the tubular member is configured to:
translate between a first position and a different second position upon entering a membrane (fully capable of being positioned between first and second positions), and
extract a portion of the membrane by engaging at least one apex of the plurality of apices with the membrane (fully capable of extracting a portion of a membrane when pushed through the membrane since serrated blades cut tissue – para [0043]).
However, in the alternative, Umar discloses a similar apparatus capable of penetrating an anatomic membrane comprising a tubular portion (12) with a plurality of apices and valleys forming a plurality of serrated blades (13), wherein the valleys are configured to include a bevel (24 and 26) on the inner surface of the tubular member (Figs 1-9; para [0027]), although Umar acknowledges the bevel can be placed on the outer surface in alternative embodiments (para [0027]). Therefore, in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the valleys are configured to include a bevel disposed on the inner surface of the tubular member, as taught by Umar, for the purpose of cutting tissue within the needle.
Regarding claim 3, wherein at least two serrated blades (160) are defined by the plurality of apices and valleys (para [0040-0041]).
Regarding claim 4, wherein a respective one of the at least two serrated blades includes a wedge configuration (wedge formed by beveled edge para [0041-0042]).
Regarding claim 5, wherein the apparatus includes at least eight serrated blades (160) disposed around the circumference of the tubular member (para [0041]; Fig 2).
Regarding claim 6, wherein each of the plurality of apices includes a tip at a most distal end (136), and a proximal portion, and further wherein a cutting edge (140) extends proximally from the tip of the respective apex to an edge of an adjacent valley (150) (para [0041]; Fig 2).
Regarding claim 7, wherein the tubular member is a metallic needle (para [0045]).
Regarding claim 8, wherein the inside bevel forms a cutting edge (para [0041-0042]).
However, in the alternative, Umar discloses a similar apparatus capable of penetrating an anatomic membrane comprising a tubular portion (12) with a plurality of apices and valleys forming a plurality of serrated blades (13), wherein the valleys are configured to include a bevel (24 and 26) on the inner surface of the tubular member (Figs 1-9; para [0027]), although Umar acknowledges the bevel can be placed on the outer surface in alternative embodiments (para [0027]). Therefore, in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the valleys are configured to include a bevel disposed on the inner surface of the tubular member, as taught by Umar, for the purpose of cutting tissue within the needle.
Regarding claim 9, Watanabe discloses wherein the inside bevel includes an inner surface, the inner surface forms an angle of about 15 degrees with a longitudinal axis of the tubular member (para [0042]). Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify Watanabe such that the inner surface of the bevel forms an angle of about 15 degrees with a longitudinal axis of the tubular member since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233
Regarding claim 10, wherein the tubular member has an outer diameter and inner diameter of about 1 mm (millimeter) (see Watanabe’s claim 11).
Regarding claim 11, wherein the tubular member has an inner diameter of about 0.6 mm (millimeter) to about 0.8 mm (see Watanabe’s claim 12).
Regarding claim 12, wherein the tubular member has an outer diameter of about 0.8 to about 1.1 mm (millimeter) (see Watanabe’s claim 13).
Regarding claim 13, wherein the distal portion of the tubular member has a length of about 2 mm (millimeter) (Fig 7B; see also Watanabe’s claim 14).
Regarding claim 14, wherein the tubular member further includes a stopper disposed proximal to the distal portion of the tubular member (Fig 1B; para [0055, 0071]).
Regarding claim 15, wherein the proximal end of the tubular member is configured to engage a handle (200) (para [0040]).
Regarding claim 21, Watanabe discloses an apparatus for penetrating a membrane of the inner ear (para [0039]) comprising:
a member (100) including a distal portion (120), and an outer surface defining a circumference around the member, the member defining a plurality of apices (130) extending from a distal end of said member and defining a circumferential crown shape (defined by Merriam-webster as topmost part; top form or outline of an object), a plurality of valleys (150), wherein each valley is disposed between neighboring apices, a plurality of cutting edges defined by the plurality of apices and the plurality of valleys disposed on the outer circumference of the member; a tip at a most distal end (136) of each of the apices, the distal end comprising an inside bevel around the circumference of the distal end of the distal portion (arcute bottom edge can be beveled sharply against the inner cylinder of the needle – Fig 5; para [0041]; alternatively, bevel interpreted as cutting edge 140 formed at a beveled angle along width of serrated blade within valley and thus interpreted as being an inside bevel, i.e. inside the thickness of the tubular member and extending to the inner wall), and a trailing edge (140) extending from the tip to the center of the member (Figs 1-2; para [0040-0041]).
However, in the alternative, Umar discloses a similar apparatus capable of penetrating an anatomic membrane comprising a tubular portion (12) with a plurality of apices and valleys forming a plurality of serrated blades (13), wherein the valleys are configured to include a bevel (24 and 26) on the inner surface of the tubular member (Figs 1-9; para [0027]), although Umar acknowledges the bevel can be placed on the outer surface in alternative embodiments (para [0027]). Therefore, in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the valleys are configured to include a bevel disposed on the inner surface of the tubular member, as taught by Umar, for the purpose of cutting tissue within the needle.
Regarding claim 22, wherein the apparatus includes at least eight serrated blades (160) disposed around the circumference of the tubular member (para [0041]; Fig 2).
Regarding claim 23, wherein the tubular member is a metallic cylinder (para [0045]).
Regarding claim 24, wherein the trailing edge (140) comprises a planar portion nearest the tip and cutting edge nearest the center of the member (para [0041]).
Regarding claim 25, wherein the distal portion of the member has an outer diameter of about 400 microns to about 800 microns (para [0047] discloses an example with a 21-gauge needle that has an 0.8 mm outer diameter, which is within the claimed range; see also Watanabe claim 13).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Watanabe (WO2015200923) and Umar (US 2015/0250493), as applied to claim 21 above.
Regarding claim 26, Watanabe discloses the invention substantially as claimed as shown above, but fails to disclose the distal portion of the member has a length of about 500 microns to about 650 microns. However, Watanabe does recognize the length of the curvature is a result effective variable to ensure precise penetration of the target membrane without contacting other inner ear structures (para [0055]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the distal portion of the member has a length of about 500 microns to about 650 microns to optimize the length of the needle for a particular use since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, Watanabe discloses the invention substantially as claimed as shown above, but fails to disclose the tip radius of curvature is about 1.0 to 1.5 microns. However, Watanabe does recognize the tip radius of curvature as a result effective variable to quantify the sharpness of the needle (para [0073]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the tip radius of curvature was about 1.0 to 1.5 microns to optimize the sharpness of the needle since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
Regarding the rejection of claims 1-4, 6, 8, and 15 under 35 USC 120(a)(1) as being anticipated by Umar, Applicant argues Umar fails to teach the amended language of the apices and valleys defining a circumferential crown shape. The specification does not provide a special definition for the term “crown shape” and thus the plain meaning of the term is used. Crown is defined by Merriam-webster as the topmost part and thus the distal end or top form or outline of the object is interpreted as forming the crown shape. It is known crowns come in many different shapes and is not limited by the number of prongs. Although Umar includes two prongs, the prongs are still arranged around the circumference and the two prongs meet the claim limitations of a plurality of apices and valleys.
Regarding the rejection of claims 1, 5-7, and 10-15 under 35 USC 120(a)(1) as being anticipated by Watanabe, Applicant argues Watanabe fails to disclose the distal end defines an inside bevel. The Examiner respectfully disagrees and reiterates with regard to previously presented claim 2, Watanabe discloses the arcute bottom edge can be beveled sharply against the inner cylinder of the needle – Fig 5; para [0041]. Alternatively, the bevel may be interpreted as cutting edge 140 formed at a beveled angle along width of serrated blade within valley and thus interpreted as being an inside bevel, i.e. inside the thickness of the tubular member and extending to the inner wall. Applicant argues Watanabe may disclose an outside bevel, but the beveled surface cannot be interpreted as an inside bevel. The Examiner respectfully disagrees with Applicant's interpretation and notes the "inside bevel" may be interpreted as a bevel between apices and thus "inside" the cut out of the distal end. Alternatively, the bevel may be interpreted as being "inside" the tubular member since it is formed along the thickness of the tubular member. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the face of the inside bevel is directed toward a central axis of the tubular member) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references of Watanabe and Umar, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Umar discloses a similar apparatus and teaches the bevel may be on the outside surface or the inside surface (para [0027]). Therefore, in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe such that the valleys are configured to include a bevel disposed on the inner surface of the tubular member, as taught by Umar, for the purpose of cutting tissue within the needle.
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771