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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/16/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 6/16/26. The claims 1-20 are pending. The claims 1, 3, 4, 12, 17 are amended. Claims 17-20 are withdrawn.
Response to Arguments
Applicants amendment has traversed the previous double patenting rejection. However, a new double patenting rejection has been made in view of U.S. Patent No. 12150621 in view of Dayton (US2021/0196106).
Applicants arguments, filed 6/16/26 with respect to the interpretation of the claims under 35 U.S.C. 112(f) have been fully considered but are not persuasive. Applicant argues the claim recitation “tissue engagement member” is absent of the term “means” and should not be treated in accordance with 35 U.S.C. 112(f). Applicant notes the presumption against 112(f) when the word “means” is absent. However, Applicant ignores the presumption is rebuttable and is overcome when the claim “recites function without reciting sufficient structure, material or acts to entirely perform the recited function” MPEP 7.20.05. Applicant further argues, that “member” is not a nonce word and carries structural meaning. The Examiner respectfully disagrees, “member” is a generic structural placeholder and is treated as a nonce word, since it has no specific structural meaning for performing the claimed function, see MPEP 7.20.05. Applicant argues, that “tissue engagement” is not a function but instead imparts structural meaning to the member. Examiner disagrees, where “engagement” is a functional term. “Engagement” describes what a component does, not what it is. The act of engaging is a function, similar to “engaging” or “coupling” that are functional limitations. Where a “tissue engagement member” is a member that performs the function of engaging tissue. Applicant further argues, “a member is known by those of ordinary skill in the art as being a member of a known class of structures with the capability (not a function) of engagement with tissue”. Examiner disagrees, Applicant fails to define what class of structures the member belongs to. Any physical object that makes contact with tissue is potentially a “tissue engagement member”. Further Applicant states that the “tissue engagement member” is “a structural component of the claimed locator system which is in contact with tissue”. Being “in contact with tissue” is a functional description, it describes what a component does (contacts tissue) and not what the component structurally is. The 112(f) interpretation of “tissue engagement member” is hereby maintained.
Applicant’s arguments, filed 6/16/26 with respect to the rejections of claims 1-3, 5, 7-9, and 12-14 under 35 U.S.C. 102(a)(1) as being anticipated by Dayton (US2021/0196106) have been fully considered and the amendment overcomes the anticipation rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection has been made in view of Dayton.
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 1-3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12150621 in view of Dayton (US2021/0196106).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘621 in view of Dayton is obvious over the claims 1-3 and 5 of the instant application.
Claim 1 of ‘621 recites a locator system comprising:
a flexible elongate member (elongated member); a beacon (location device including at least one light emitting diode (LED)) mounted on said flexible elongate member; and
a tissue engagement member (balloon);
wherein said tissue engagement member is configured to engage tissue at a target site to anchor said locator system with respect to target site (balloon is recited to be configured to be inflated, and is therefore capable of performing anchoring the locator system).
Patent ‘621 is silent regarding said beacon is in a different axial location than the tissue engagement member. Dayton teaches the LEDs 710 may be any number and may be arranged on the sheath 702 in any manner described in any of the other embodiments ([0079]). Dayton according to the embodiment of Fig. 12 teaches LEDs 1204 (interpreted as the claim beacon) disposed along the length of the elongate member 1200 with the location device 1202 (interpreted as the claimed tissue engagement member) disposed at the distal end of the elongate member 1200 ([0090]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Patent ‘621 with the embodiment of Fig. 12 of Dayton to have the position of the beacon be in a separate axial position than the tissue engagement member since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04 VI. (C).
With regard to claim 2, claim 1 of ‘621 in view of Dayton recites wherein said tissue engagement member is expandable to engage tissue at the target site to anchor said locator system with respect to the target site (balloon is recited to be configured to be inflated, and is therefore capable of performing anchoring the locator system).
With regard to claim 3, claim 1 of ‘621 in view of Dayton recites wherein said tissue engagement member is an inflatable balloon.
With regard to claim 5, claim 1 of ‘621 in view of Dayton recites wherein said tissue engagement member is mounted on said elongate flexible member (a balloon at the distal end of the elongated member).
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:
“tissue engagement member” in claims 1 and 12. Where the “tissue engagement member” is interpreted as a “inflatable balloon” or a “expandable stent” or a “pair of grasper arms” as stated in paragraphs [0007], [0008] of the instant specification and equivalents thereof.
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 § 103
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 of this title, 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 1-5, 7-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US2021/0196106).
Regarding claim 1, Dayton according to the embodiment of Fig. 7, discloses a locator system comprising:
a flexible elongate member (flexible sheath 702 as seen in Fig. 7, [0079]);
a beacon (LEDs 710) mounted on said flexible elongate member (see Fig. 7); and
a tissue engagement member (balloon 704, where the balloon is an equivalent structure to the “tissue engagement member” interpreted under 112(f) by being a balloon);
wherein said tissue engagement member is configured to engage tissue at a target site to anchor said locator system with respect to the target site ([0080] and illustrated for similar device in Fig. 9).
Dayton according to the embodiment of Fig. 7 is silent regarding said beacon is in a different axial location than the tissue engagement member. Dayton according to the embodiment of Fig. 7 has the tissue engagement 704 over the beacon 710 and therefore share an axial location. Dayton teaches the LEDs 710 may be any number and may be arranged on the sheath 702 in any manner described in any of the other embodiments ([0079]). Dayton according to the embodiment of Fig. 12 teaches LEDs 1204 (interpreted as the claim beacon) disposed along the length of the elongate member 1200 with the location device 1202 (interpreted as the claimed tissue engagement member) disposed at the distal end of the elongate member 1200 ([0090]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Fig. 7 of Dayton with the embodiment of Fig. 12 to have the position of the beacon be in a separate axial position than the tissue engagement member since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04 VI. (C).
Regarding claim 2 Dayton makes obvious the locator system of claim 1, wherein said tissue engagement member is expandable to engage tissue at the target site to anchor said locator system with respect to the target site ([0079-0080]).
Regarding claim 3, Dayton discloses the locator system of claim 2, wherein said tissue engagement member is selected from the group consisting of: an inflatable balloon (balloon 704, [0079]).
Regarding claim 4, Dayton makes obvious the locator system of claim 1, wherein said beacon is mounted on said flexible elongate member proximal to a proximal end of said tissue engagement member (the modified invention teaches the beacon at a located proximal to the tissue engagement member as taught by the embodiment of Fig. 12 of Dayton).
Regarding claim 5, Dayton makes obvious the locator system of claim 1, wherein said tissue engagement member is mounted on said flexible elongate member (see Fig. 7, [0079]).
Regarding claim 7, Dayton makes obvious the locator system of claim 1, further comprising a controller (inflation at outlet controlled by fluid lumen 708, [0079]) extending along said flexible elongate member and actuatable to shift said tissue engagement member between a delivery configuration and a tissue-engaging configuration ([0079]-[0080]).
Regarding claim 8, Dayton makes obvious the locator system of claim 7, wherein said tissue engagement member is inflatable ([0079]), and said controller is an inflation lumen through said flexible elongate member ([0079]).
Regarding claim 9, Dayton makes obvious the locator system of claim 7, wherein said tissue engagement member is inflatable ([0079]), and said controller is an inflation lumen within an inflation line extending along said flexible elongate member (inflation line is interpreted as structure with the inflation lumen, [0079]).
Regarding claim 12, Dayton discloses a locator system and delivery system therefor, comprising:
a beacon (LEDs 710);
a tissue engagement member (balloon 704, where the balloon is an equivalent structure to the “tissue engagement member” interpreted under 112(f) by being a balloon); and
a controller (inflation at outlet controlled by fluid lumen 708, [0079]) actuatable to shift said tissue engagement member between a delivery configuration in which said tissue engagement member is compact and deliverable transluminally to a target site ([0080]), and a tissue-engaging configuration in which said tissue engagement member engages tissue at the target site to anchor said beacon with respect to the target site ([0080]).
Dayton according to the embodiment of Fig. 7 is silent regarding said beacon is in a different axial location than the tissue engagement member, and the tissue engagement member engages tissue at a target site axially spaced apart from said beacon. Dayton according to the embodiment of Fig. 7 has the tissue engagement 704 over the beacon 710 and therefore share an axial location. Dayton teaches the LEDs 710 may be any number and may be arranged on the sheath 702 in any manner described in any of the other embodiments ([0079]). Dayton according to the embodiment of Fig. 12 teaches LEDs 1204 (interpreted as the claim beacon) disposed along the length of the elongate member 1200 with the location device 1202 disposed at the end of the elongate member 1200 ([0090]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Fig. 7 of Dayton with the embodiment of Fig. 12 to have the position of the beacon be in a separate axial position than the tissue engagement member since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04 VI. (C).
Regarding claim 13, Dayton makes obvious the locator system and delivery system therefor of claim 12, further comprising a flexible elongate member (flexible sheath 702 as seen in Fig. 7, [0079]) on which said beacon and said tissue engagement member are mounted (see Fig. 7, [0079]).
Regarding claim 14, Dayton makes obvious the locator system and delivery system therefor of claim 12, wherein said tissue engagement member is an inflatable balloon (balloon 704, [0079]), and said controller is an inflation lumen in fluid communication with said balloon ([0079]).
Claim 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US2021/0196106) in view of Rajagopalan (US2017/0007310).
Regarding claim 10, Dayton makes obvious the locator system of claim 7; yet, is silent regarding wherein: said controller is a sheath extending about said flexible elongate member; and said tissue engagement member is an expandable stent positioned within said controller in the delivery configuration and expandable into the tissue-engaging configuration when outside said controller. Rajagopalan teaches an anchoring device for a catheter, where the anchoring device can include a radially expandable cage or stent to anchor within the vessel ([0423]). Where the controller of the anchoring device can be a conduit (sheath) having a lumen, where the conduit receives a control rod configured to expand the anchoring device by releasing from the conduit ([0423]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the anchoring expandable stent with the controller of Rajagopalan for the anchoring balloon with the controller of Dayton, since the substitution would have the same predictable result of anchoring the catheter within the vessel.
Regarding claim 15, Dayton makes obvious the locator system and delivery system of claim 12; yet, is silent regarding wherein: said controller is a sheath; and said tissue engagement member is an expandable stent shiftable between a delivery configuration when within said sheath and an expanded tissue-engaging configuration when outside said sheath. Rajagopalan teaches an anchoring device for a catheter, where the anchoring device can include a radially expandable cage or stent to anchor within the vessel ([0423]). Where the controller of the anchoring device can be a conduit (sheath) having a lumen, where the conduit receives a control rod configured to expand the anchoring device by releasing from the conduit ([0423]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the anchoring expandable stent with the controller of Rajagopalan for the anchoring balloon with the controller of Dayton, since the substitution would have the same predictable result of anchoring the catheter within the vessel.
Claims 6, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US2021/0196106) in view of Koehler (US2023/0042304).
Regarding claim 6, Dayton makes obvious the locator system of claim 1; yet, is silent regarding wherein said tissue engagement member has a pair of grasper arms configured to grasp tissue at the target site therebetween. Koehler teaches an anchoring device for a catheter 116, where the anchoring device can include grasping mechanism 192, that includes a pair of jaws (hook 192A and lever 192B) for grasping tissue ([0270]). The grasping mechanism having a controller (control wires at proximal end of catheter 116) ([0270]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the anchoring grasping mechanism with the controller of Koehler for the anchoring balloon with the controller of Dayton, since the substitution would have the same predictable result of anchoring the catheter within the vessel.
Regarding claim 11, Dayton makes obvious the locator system of claim 7; yet, is silent regarding wherein said tissue engagement member has a pair of grasper arms configured to grasp tissue at the target site therebetween. Koehler teaches an anchoring device for a catheter 116, where the anchoring device can include grasping mechanism 192, that includes a pair of jaws (hook 192A and lever 192B) for grasping tissue ([0270]). The grasping mechanism having a controller (control wires at proximal end of catheter 116) ([0270]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the anchoring grasping mechanism with the controller of Koehler for the anchoring balloon with the controller of Dayton, since the substitution would have the same predictable result of anchoring the catheter within the vessel.
Regarding claim 16, Dayton makes obvious the locator system and delivery system therefor of claim 12; yet, is silent regarding wherein said tissue engagement member comprises a pair of jaws movable by said controller between a closed configuration in which said jaws are in a delivery configuration or grasping tissue therebetween, and an open configuration in which said jaws may engage tissue therebetween. Koehler teaches an anchoring device for a catheter 116, where the anchoring device can include grasping mechanism 192, that includes a pair of jaws (hook 192A and lever 192B) for grasping tissue ([0270]). The grasping mechanism having a controller (control wires at proximal end of catheter 116) ([0270]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have substituted the anchoring grasping mechanism with the controller of Koehler for the anchoring balloon with the controller of Dayton, since the substitution would have the same predictable result of anchoring the catheter within the vessel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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