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 .
Status of Submission
This Office action is responsive to the amendment filed on June 28, 2021 which has been entered.
Claims Subject to Examination
Patent claims 1-5 and new claims 6-20 are subject to examination. Claims 1 and 3 have been amended.
Related Proceedings
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,105,536 (hereinafter ‘the ‘536 patent’) is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Objections to Amendments - Formalities
The claim amendments filed on June 28, 2021 are objected to as failing to comply with 37 CFR 1.173(b)(2), (d) and (g). Amended claims must show all changes made relative to the patent claims, with omitted text enclosed in single brackets, and added text underlined. New claims must be underlined in their entirety.
The claim amendments are improper because:
Amended claims 1 and 3 have not omitted text using enclosed single brackets, but rather used strikethrough and/or double brackets to indicate omitted text.
Applicant is required to place the amendments into compliance with 37 CFR 1.173(a)-(g) in response to this Office action.
Consent of Assignee
This application is objected to under 37 CFR § 1.172(a) as lacking a proper written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR § 1.172. See MPEP § 1410.01. Specifically, the person who signed the submission establishing ownership interest is not recognized as an officer of the assignee, and the person who signed it has not been established as being authorized to act on behalf of the assignee. See MPEP § 325. In the instant application, the Consent of Assignee filed 6/28/21, is signed by Jon C. Trachtenberg, Division Counsel, IP Cardiac Arrhythmias & Heart Failure. This title is not a recognized authoritative position.
The consent of assignee must be signed by a party authorized to act on behalf of the assignee. For applications filed on or after September 16, 2012, the consent may be signed by the assignee or a patent practitioner of record. For applications filed before September 16, 2012, the consent must be signed by the assignee. Where the assignee is a juristic entity, the consent may be signed by a person in the organization having apparent authority to sign on behalf of the organization, or a person who makes a statement of authorization to act on behalf of the assignee. Parties authorized to act on behalf of the assignee include, an officer (chief executive officer, president, vice-president, secretary, or treasurer), chairman of the board of directors but not the signature of an individual director, and modifications of these basic titles are acceptable, such as vice-president for sales, executive vice-president, assistant treasurer, vice-chairman of the board of directors. Additionally, in foreign countries, a person who holds the title "Manager" or "Director" is normally an officer and is presumed to have the authority to sign on behalf of the organization. A person having a title (administrator, general counsel) that does not clearly set forth that person as an officer of the assignee is not presumed to have authority to sign the submission on behalf of the assignee.
A proper assent of the assignee in compliance with 37 CFR §§ 1.172 and 3.73 is required in reply to this Office action. Alternatively, it would be acceptable for a person, other than a recognized office to sign a submission establishing ownership interest, provided the record for the application includes a duly signed statement that the person is empowered to sign a submission establishing ownership interest and/or act on behalf of the assignee. Accordingly, a new submission establishing ownership interest which includes such a statement above, will be considered to be signed by an appropriate official of the assignee. A separately filed paper referencing the previously filed submission establishing ownership interest and containing a proper empowerment statement would also be acceptable.
Correction of the Consent of Assignee is required. Use of Form PTO/AIA /53 is
encouraged.
Reissue Oath/Declaration
The Reissue Application Declaration By The Inventor (Form PTO/AIA /05) filed on February 5, 2024 is defective because it fails to properly and specifically identify at least one error which can be relied upon to support the reissue application. See 37 CFR 1.175(e) and MPEP 1414-1414.01. The current error statement recites:
Claim 1 did not provide the narrow structure of at least the following quoted limitations of new independent claim 60: "wherein the compressible fixation sleeve includes a plurality of tines configured to fold back and splay radially outward."
(emphasis added)
As required by 37 CFR 1.175(a), While the error statement does identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid.
As required by 37 CFR 1.175(a), the reissue oath/declaration must specifically identify at least one error pursuant to 35 U.S.C. 251 being relied upon as the basis for reissue. In identifying the error, it is sufficient that the reissue oath/declaration identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. Thus, while the error statement does identify a single error, the statement refers to “new independent claim 60” which is not present in the claims filed 6/28/21. It appears to be a typographical error and should read “new independent claim 6”.
A replacement reissue oath/declaration must be submitted to comply with 37 CFR 1.175.
Claim Rejections - 35 USC § 251
The following is a quotation of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
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(b) MULTIPLE REISSUED PATENTS.—The Director may issue several reissued patents for distinct and separate parts of the thing patented, upon demand of the applicant, and upon payment of the required fee for a reissue for each of such reissued patents.
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(c) APPLICABILITY OF THIS TITLE.—The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest.
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(d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS. No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.
GROUND 1: Claims 1-20 are rejected under 35 U.S.C. 251 as being based upon a defective reissue oath/declaration. See 37 CFR 1.175. The nature of the defect(s) in the reissue oath/declaration is explained above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
GROUND 2: Claim(s) 1-17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2012/0172690 to Anderson et al.
In regard to claim 1, Anderson et al. disclose a method of manufacturing a leadless pulse generator 16A, the method comprising: positioning a distal electrode 122 of the leadless pulse generator within a hollow interior of a compressible fixation sleeve 118 including at least a radiopaque portion (see para 0154); and coupling the compressible fixation sleeve to a housing 150 of the leadless pulse generator by coupling an anchor mount 120 to the housing such that a portion of the compressible fixation sleeve is sandwiched between the anchor mount and a portion of the housing (See Fig. 3A-B and para 0059-0060).
In regard to claims 2 and 7, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the portion of the compressible fixation sleeve comprises an inner annular ring (i.e. inner surface of base 111) (See Fig. 4A).
In regard to claims 3 and 8, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the housing comprises a distal protrusion 155
that borders the distal electrode and is also positioned in the hollow interior (See Fig. 3B and paras 0050, 0058).
In regard to claims 4 and 9-10, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the distal protrusion mechanically couples with the anchor mount when the anchor mount is coupled to the housing (See Fig. 3B and paras 0059-061).
In regard to claims 5, 11, 16 and 19, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the distal protrusion and the anchor mount threadably engage with each other in the course of being mechanically coupled with each other (See Fig. 3B and paras 0059-061).
In regard to claims 6, 14, Anderson et al. disclose a method of manufacturing a leadless pulse generator 16A, the method comprising: positioning a distal electrode 122 of the leadless pulse generator within a hollow interior of a compressible fixation sleeve 118 including at least a radiopaque portion (See para 0154), wherein the compressible fixation sleeve includes a plurality of tines 102 configured to fold back and splay radially outward (see Figs. 4A-B); and coupling the compressible fixation sleeve to a housing 150 of the leadless pulse generator by coupling an anchor mount 120 to the housing such that a portion of the compressible fixation sleeve is sandwiched between the anchor mount and a portion of the housing (See Fig. 3A-B and para 0059-0060). With further regard to claim 14, Anderson et al. disclose coupling an anchor mount to the housing such that a proximal surface of an annular ring proximal to the plurality of tines matingly abuts a distal face of the house (See Figs. 3B and 4A-B).
In regard to claim 12, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the plurality of tines are separated by gaps, and
wherein a gap width of the gaps is greater than a tine width of the plurality of tines (See Fig. 4A).
In regard to claim 13, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the plurality of tines are rectangular-shaped (See Fig. 4A).
In regard to claim 15, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the plurality of tines are arranged uniformly about a circumference of a distal section of the compressible fixation sleeve (See Fig. 4A).
In regard to claim 17, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the leadless pulse generator includes a radiopaque indicator on or within the housing (see para 0154).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
GROUND 3: Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0172690 to Anderson et al. in view of U.S. Patent Application Publication No. 2010/0198327 to Helland.
In regard to claim 18, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the leadless pulse generator includes a radiopaque indicator on or within the housing (see para 0154) but are silent with respect to wherein the radiopaque indicator indicates a rotational direction. Helland teaches of an analogous pulse generator which may include radiopaque markers thereon to allow for determining whether or not the helical anchor of the pulse generator is fully embedded in the cardiac tissue of the desired implantation site (See paras 0007-0011). It would have been obvious to a POSITA to include radiopaque markings on the pulse generator and/or tines of the compressible sleeve of Anderson et al. in the manner disclosed by Helland to enable clear identification of placement within cardiac tissue (i.e. “indicate a rotational direction”).
GROUND 4: Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0172690 to Anderson et al.
In regard to claim 20, Anderson et al. disclose a method of manufacturing a leadless pulse generator, wherein the leadless pulse generator include an anti-inflammatory drug (see para0061) but are silent with respect to specifically including a steroid-eluting matrix. However, it is well known to a POSITA in conventional pacing electrode-leads to include a steroid-eluting matrix to minimize fibrotic reactions. In view of the disclosure of Anderson et al. to include an anti-inflammatory drug within the leadless pulse generator, a POSITA would have been motivated to include a steroid-eluting matrix to minimize fibrotic reactions as is extremely well known in the art. Further evidence that the inclusion of a steroid-eluting matrix within pulse generators can be found within US 7801624 (see Col. 6, Lines 34-40) and US 6463334 (see Figs. 2-3, steroid collar 151) wherein a steroid is provided to reduce inflammation.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “wherein the distal protrusion and the anchor mount threadably engage with each other” as described in the specification and recited in claims 5, 11, 16 and 19. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Pertinent Art
It is noted, Helland (U.S. 2010/0198327) discloses and teaches of nearly the same inventive concept as the instant invention (i.e. a compressible fixation sleeve) and is merely silent with respect to how the compressible sleeve is coupled to the housing of the implantable lead.
Amendments in Reissue Applications
Applicant is notified that any subsequent amendment to the specification, claims or drawings must comply with 37 CFR 1.173(b)-(g). In addition, for reissue applications filed before September 16, 2012, when any substantive amendment is filed in the reissue application, which amendment otherwise places the reissue application in condition for allowance, a supplemental oath/declaration will be required. See MPEP § 1414.01.
The provisions of 37 CFR 1.173(b)(1), (d), (f) and (g) govern amendments to the specification (other than the claims) in reissue applications. The following guidance is provided as to the procedure for amending the specification:
a) All amendments which include deletions or additions must be made by submission of the entire text of each added or rewritten paragraph containing the bracketing and/or underlining required by 37 CFR 1.173(d).
b) An entire paragraph of specification text may be deleted by a statement deleting the paragraph without presentation of the text of the paragraph.
c) Applicant must indicate the precise point where each amendment is made.
d) All bracketing and underlining is made in comparison to the original patent, not in comparison to any prior amendment in the reissue application. Thus, all paragraphs which are newly added to the specification of the original patent must be submitted as completely underlined each time they are re-submitted in the reissue application.
The provisions of 37 CFR 1.173(b)(2), (c)-(e) and (g) govern amendments to the claims in reissue applications. The following guidance is provided as to the procedure for amending the claims:
a) For each claim that is being amended, the entire text of the claim must be presented with the bracketing and/or underlining required by 37 CFR 1.173(d).
b) For each new claim added to the reissue, the entire text of the added claim must be presented completely underlined.
c) A patent claim should be canceled by a direction to cancel that claim. There is no need to present the patent claim surrounded by brackets.
d) A new claim (previously added in the reissue) should be canceled by a direction to cancel that claim.
e) Pursuant to 37 CFR 1.173(b)(2), each claim that is amended or added should include the appropriate status indicator following the claim number, e.g., “(amended)”, “(twice amended)”, “(new)”, and “(canceled)”.
f) Pursuant to 37 CFR 1.173(c), each amendment submitted must set forth the status of all patent claims and all added claims as of the date of the submission. The status to be set forth is whether the claim is pending or canceled.
g) Also pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the patent’s disclosure for all changes made in the claim(s), whether insertions or deletions.
h) Pursuant to 37 CFR 1.173(e), original patent claims are never to be renumbered. A patent claim retains its number even if it is canceled in the reissue proceeding, and the numbering of any added claims must begin after the last original patent claim.
i) Pursuant to 37 CFR 1.173(g), all bracketing and underlining is made in comparison to the original patent, not in comparison to any prior amendment in the reissue application.
The provisions of 37 CFR 1.173(b)(3) govern amendments to the drawings in reissue applications. The following guidance is provided as to the procedure for amending drawings:
a) Amending the original or printed patent drawing sheets by physically changing or altering them is not permitted.
b) Where a change to the drawings is desired, applicant must submit a replacement sheet for each sheet of drawings containing a figure to be revised. Any replacement sheet must comply with 37 CFR 1.84 and include all of the figures appearing on the original version of the sheet, even if only one figure is being amended. Each figure that is amended must be identified by placing the word “Amended” at the bottom of that figure. Any added figure must be identified as “New”. In the event that a figure is canceled, the figure must be identified as “Canceled” and also surrounded by brackets.
c) All changes to the figure(s) must be explained, in detail, beginning on a separate sheet which accompanies the papers including the amendment to the drawings.
d) If desired, applicant may include a marked-up copy of any amended drawing figure, including annotations indicating the changes made. Such a marked-up copy must be clearly labeled as “Annotated Marked-up Drawings”, and it must be presented in the amendment or remarks section that explains the change to the drawings.
Failure to fully comply with 37 CFR 1.173(b)-(g) will generally result in a notification to applicant that an amendment before final rejection is not completely responsive. Such an amendment after final rejection will not be entered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW J KASZTEJNA whose telephone number is (571)272-6086. The examiner can normally be reached M-F, 7AM--3PM.
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, Eileen Lillis can be reached on 571-272-6928. 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.
/MATTHEW J KASZTEJNA/ Reexamination Specialist, Art Unit 3993
Conferees:
/WILLIAM V GILBERT/Reexamination Specialist, Art Unit 3993 /EILEEN D LILLIS/ SPRS, Art Unit 3993
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