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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a locator system, classified in A61B1/01.
II. Claims 17-20, drawn to a method of locating a target site, classified in A61F2/958.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the locator system can be used in a materially different process such as locating a tumor site for removal.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their classification;
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Karen Horowitz on 8/28/25 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claims 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. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘621 anticipates 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).
With regard to claim 2, claim 1 of ‘621 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 recites wherein said tissue engagement member is an inflatable balloon.
With regard to claim 5, claim 1 of ‘621 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 § 102
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 1-3, 5, 7-9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dayton (US2021/0196106).
Regarding claim 1, Dayton 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).
Regarding claim 2 Dayton discloses 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 an inflatable balloon (balloon 704, [0079]).
Regarding claim 5, Dayton discloses the locator system of claim 2, wherein said tissue engagement member is mounted on said flexible elongate member (see Fig. 7, [0079]).
Regarding claim 7, Dayton discloses 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 discloses 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 discloses 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]).
Regarding claim 13, Dayton discloses 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 discloses 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 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 4, 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 4, Dayton discloses the locator system of claim 2; yet, is silent regarding wherein said tissue engagement member is an expandable stent. 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 10, Dayton discloses 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 discloses 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 discloses 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 discloses 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 discloses 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774