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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 25, 2026 has been entered. By this amendment, claims 1, 11, and 18 are amended and claims 1-20 are now pending in the application.
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.
Claims 1-7, 9-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang (U.S. 2019/0140220, previously cited) in view of Ota et al. (U.S. 2004/0101746). Regarding claim 1, Jiang discloses a feedthrough assembly for an implantable medical device, the feedthrough assembly comprising: a ferrule having a lumen 25 (see Figure 1B); an inner conductor 24 extending through the lumen of the ferrule (see Figure 1B), the inner conductor having a first material composition (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]); and an insulating core 26 disposed within the lumen of the ferrule and separating the inner conductor from the ferrule (see Figure 1B), the insulating core having a second material composition that is different from the first material composition of the inner conductor (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]), wherein a coefficient of thermal expansion (CTE) of the inner conductor is no less than the CTE of the insulating core (inherent properties of the materials listed in Jiang), and wherein the inner conductor is bonded to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core (“The feedthrough pins 24 can be immobilized within the openings by an electrically insulating sealing medium 26 such as is used in a Glass-To-Metal Seal (GTMS).”, paragraph [0053]). However, Jiang fails to disclose that the inner conductor is molecularly bonded with heat to the insulating core to form the glass-to-metal seal. Ota teaches that “[e]lectronic device seals that bond glass and other ceramics to metal are generally known in the art” and “[m]olecular bonding is accomplished by oxidizing the surface of the metal component to facilitate bonding to the glass component. Heating the components causes the glass to soften and flow into the oxidized area of the metal component thereby creating a hermetic seal when the components are cooled” (see paragraph [0003]). 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 invention of Jiang to molecularly bond the inner conductor with heat to the insulating core to form the glass-to-metal seal, as taught by Ota, as it is well known in the art to do so, as evidenced by the teachings of Ota.
Regarding claim 2, Jiang discloses a case 14 having a feedthrough port 10 and containing a battery 12 within the case, wherein the ferrule is disposed in the feedthrough port of the case and the inner conductor is electrically connected to the battery within the case (see Figures 1A and 1D).
Regarding claim 3, Jiang discloses that the second material composition of the insulating core comprises a glass (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]).
Regarding claim 4, Jiang discloses that the first material composition of the inner conductor comprises one or both of titanium or niobium (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]).
Regarding claim 5, Jiang discloses that the CTE of the inner conductor is greater than the CTE of the insulating core (inherent properties of the materials listed in Jiang).
Regarding claim 6, Jiang discloses that the glass-to-metal seal between the inner conductor and the insulating core is a hermetic seal (glass-to-metal seals are inherently hermetic).
Regarding claim 7, Jiang discloses that the ferrule has a third material composition (“Suitable materials for the cover member include, but are not limited to, titanium, stainless steel, and aluminum.”, paragraph [0052]), and the CTE of the ferrule is greater than the CTE of the insulating core (inherent properties of the materials listed in Jiang).
Regarding claim 9, Jiang discloses that the lumen of the ferrule is a first lumen, the inner conductor is a first inner conductor, and the insulating core is a first insulating core, wherein the ferrule defines a second lumen spaced apart from the first lumen, and the feedthrough assembly further comprises a second inner conductor and a second insulating core, the second inner conductor extending through the second lumen, the second insulating core disposed within the second lumen and separating the second inner conductor from the ferrule (see Figures 1A-1D that shows two lumens, insulating cores, and inner conductors).
Regarding claim 10, Jiang discloses that the first inner conductor is electrically connected to a cathode assembly of a battery cell stack and the second inner conductor is electrically connected to an anode assembly of the battery cell stack (see paragraphs [0055] and [0056]).
Regarding claim 11, Jiang discloses a method for forming an implantable medical device, the method comprising: forming a feedthrough assembly by: inserting an inner conductor 24 to extend through a lumen 25 of a ferrule (see Figure 1B), the inner conductor having a first material composition (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]); positioning an insulating core 26 within the lumen of the ferrule such that the insulating core separates the inner conductor from the ferrule (see Figure 1B), the insulating core having a second material composition that is different from the first material composition of the inner conductor (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]), wherein a coefficient of thermal expansion (CTE) of the insulating core is no greater than the CTE of the inner conductor (inherent properties of the materials listed in Jiang); and bonding the inner conductor to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core (“The feedthrough pins 24 can be immobilized within the openings by an electrically insulating sealing medium 26 such as is used in a Glass-To-Metal Seal (GTMS).”, paragraph [0053]); and inserting the feedthrough assembly into a feedthrough port of a case 14 (see Figures 1A-1D). However, Jiang fails to disclose molecularly bonding with heat the inner conductor to the insulating core to form the glass-to-metal seal. Ota teaches that “[e]lectronic device seals that bond glass and other ceramics to metal are generally known in the art” and “[m]olecular bonding is accomplished by oxidizing the surface of the metal component to facilitate bonding to the glass component. Heating the components causes the glass to soften and flow into the oxidized area of the metal component thereby creating a hermetic seal when the components are cooled” (see paragraph [0003]). 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 invention of Jiang to molecularly bond the inner conductor with heat to the insulating core to form the glass-to-metal seal, as taught by Ota, as it is well known in the art to do so, as evidenced by the teachings of Ota.
Regarding claim 12, it is respectfully submitted that the steps of “heating the ferrule, the insulating core, and the inner conductor to a temperature sufficient to cause the insulating core to melt and flow into contact with an outer surface of the inner conductor and an inner surface of the ferrule along the lumen; and thereafter cooling the ferrule, the insulating core, and the inner conductor to re-solidify the insulating core” are inherent steps in the formation of a Glass-To-Metal Seal, as formed in Jiang. As such, it is respectfully submitted that Jiang satisfies the limitations of claim 12.
Regarding claim 13, Jiang discloses loading a battery into the case; and electrically connecting the inner conductor to the battery within the case (see paragraphs [0055] and [0056]).
Regarding claim 14, Jiang discloses that the first material composition of the inner conductor comprises one or both of titanium or niobium (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]), and the second material composition of the insulating core comprises a glass (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]).
Regarding claim 15, Jiang discloses that the CTE of the inner conductor is greater than the CTE of the insulating core (inherent properties of the materials listed in Jiang).
Regarding claim 17, Jiang discloses that the lumen of the ferrule is a first lumen, the inner conductor is a first inner conductor, and the insulating core is a first insulating core, wherein the ferrule defines a second lumen spaced apart from the first lumen, and forming the feedthrough assembly further comprises: inserting a second inner conductor to extend through the second lumen of the ferrule, the inner conductor having the first material composition; positioning a second insulating core within the second lumen of the ferrule such that the second insulating core separates the second inner conductor from the ferrule, the second insulating core having the second material composition; and bonding the second inner conductor to the second insulating core to form a glass-to-metal seal between the second inner conductor and the second insulating core (see Figures 1A-1D that shows two lumens, insulating cores, and inner conductors).
Regarding claim 18, Jiang discloses an implantable medical device comprising: a case 14 including a feedthrough port; a battery 12 disposed within the case; and a feedthrough assembly 10 disposed in the feedthrough port of the case, the feedthrough assembly comprising: a ferrule having a lumen 25 (see Figure 1B); an inner conductor 24 extending through the lumen of the ferrule (see Figure 1B), the inner conductor having a first material composition (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]), the inner conductor electrically connected to the battery (see paragraphs [0055] and [0056]); and an insulating core 26 disposed within the lumen of the ferrule and separating the inner conductor from the ferrule (see Figure 1B), the insulating core having a second material composition that is different from the first material composition of the inner conductor (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]), wherein a coefficient of thermal expansion (CTE) of the inner conductor is no less than the CTE of the insulating core (inherent properties of the materials listed in Jiang), and wherein the inner conductor is bonded to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core (“The feedthrough pins 24 can be immobilized within the openings by an electrically insulating sealing medium 26 such as is used in a Glass-To-Metal Seal (GTMS).”, paragraph [0053]). However, Jiang fails to disclose that the inner conductor is molecularly bonded with heat to the insulating core to form the glass-to-metal seal. Ota teaches that “[e]lectronic device seals that bond glass and other ceramics to metal are generally known in the art” and “[m]olecular bonding is accomplished by oxidizing the surface of the metal component to facilitate bonding to the glass component. Heating the components causes the glass to soften and flow into the oxidized area of the metal component thereby creating a hermetic seal when the components are cooled” (see paragraph [0003]). 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 invention of Jiang to molecularly bond the inner conductor with heat to the insulating core to form the glass-to-metal seal, as taught by Ota, as it is well known in the art to do so, as evidenced by the teachings of Ota.
Regarding claim 19, Jiang discloses that the first material composition of the inner conductor comprises one or both of titanium or niobium (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]), and the second material composition of the insulating core comprises a glass (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]).
Claims 8, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang in view of Ota as applied to claims 1-7, 9-15, and 17-19 above, and further in view of Larson (U.S. 2003/0040781). Regarding claims 8 and 16, Jiang in view of Ota discloses the invention substantially as claimed, including that the first material composition of the inner conductor comprises titanium (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]), but fails to disclose that the second material composition of the insulating core comprises calcium-boro-aluminate-12 (CABAL-12) glass. Larson teaches an implantable medical device including a feedthrough assembly 30 including a ferrule including an insulating core 56 comprising CABAL-12 glass (see paragraphs [0069] and [0089]) and an inner conductor 34 comprising titanium (see paragraphs [0069] and [0089]). 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 invention of Jiang in view of Ota to include that the second material composition of the insulating core comprises calcium-boro-aluminate-12 (CABAL-12) glass, as taught by Larson, as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07
Regarding claim 20, Jiang in view of Ota discloses the invention substantially as claimed, but fails to disclose a memory disposed within the case, the memory configured to store program instructions; and one or more processors disposed within the case and configured to execute the program instructions in connection with at least one of monitoring a biological signal or administering a therapy. Larson teaches an implantable medical device that includes a memory 226/228 disposed within the case, the memory configured to store program instructions; and one or more processors 224 disposed within the case and configured to execute the program instructions in connection with at least one of monitoring a biological signal or administering a therapy (see Figures 23A and paragraphs [0126] and [0127]). 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 invention of Jiang in view of Ota such that the described battery and feedthrough are contained within a case including additionally a memory disposed within the case, the memory configured to store program instructions; and one or more processors disposed within the case and configured to execute the program instructions in connection with at least one of monitoring a biological signal or administering a therapy, as taught by Larson, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
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, 2, 4-6, 11, 13, 15, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1 and 10), 1, 6, 1, 1, 17, 18, 17, 1, and 1, respectively, of U.S. Patent No. 11,701,520 in view of Jiang (U.S. 2019/0140220) and Ota (U.S. 2004/0101746). Claims (1 and 10), 1, 6, 1, 1, 17, 18, 17, 1, and 1 of U.S. Patent 11,701,520 anticipate claims 1, 2, 4-6, 11, 13, 15, 18, and 20, respectively, of the present application except for wherein the inner conductor is molecularly bonded with heat to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core. Jiang teaches a feedthrough assembly for an implantable medical device, the feedthrough assembly comprising: a ferrule having a lumen 25 (see Figure 1B); an inner conductor 24 extending through the lumen of the ferrule (see Figure 1B), the inner conductor having a first material composition (“Suitable feedthrough pins 24 include, but are not limited to, molybdenum, titanium, and niobium.”, paragraph [0053]); and an insulating core 26 disposed within the lumen of the ferrule and separating the inner conductor from the ferrule (see Figure 1B), the insulating core having a second material composition that is different from the first material composition of the inner conductor (“Suitable sealing media include, but are not limited to, ceramics, glass, and quartz.”, paragraph [0053]), wherein a coefficient of thermal expansion (CTE) of the inner conductor is no less than the CTE of the insulating core (inherent properties of the materials listed in Jiang), and wherein the inner conductor is bonded to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core (“The feedthrough pins 24 can be immobilized within the openings by an electrically insulating sealing medium 26 such as is used in a Glass-To-Metal Seal (GTMS).”, paragraph [0053]). Further, Ota teaches that “[e]lectronic device seals that bond glass and other ceramics to metal are generally known in the art” and “[m]olecular bonding is accomplished by oxidizing the surface of the metal component to facilitate bonding to the glass component. Heating the components causes the glass to soften and flow into the oxidized area of the metal component thereby creating a hermetic seal when the components are cooled” (see paragraph [0003]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claims (1 and 10), 1, 6, 1, 1, 17, 18, 17, 1, and 1 of U.S. Patent 11,701,520 to include wherein the inner conductor is molecularly bonded with heat to the insulating core to form a glass-to-metal seal between the inner conductor and the insulating core, as taught by Jiang and Ota, in order to provide a stable hermetic seal.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
Prosecution Insights