DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to the preliminary amendment filed on 2/21/2025, claim 1 has been canceled, and newly added claims 2-21 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 6 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly added claims 5 and 15 recite “the first stiffness is grater than the second stiffness” and newly added claim 6 recites “the outer fixation element has a higher spring constant than the inner fixation element.” However, the original disclosure does not provide support for these limitations. The original specification has only disclosed the first stiffness as being less than the second stiffness (see published application paragraphs [0062], [0063], [0129], [0150]) and the outer fixation element has a lower spring constant than the inner fixation element (see published application paragraphs [0009], [0060], [0130], [0151]). There, the original disclosure appears to only support the opposite of what is presently recited in claims 5, 6 and 15 and therefore the limitations of these claims are considered new matter.
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.
Claim(s) 2-4, 7 -10, 13, 14, 16-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haasl et al US 2015/0025612).
Haasl et al discloses the following limitations:
Claim 2. A biostimulator (Figs. 1-2), comprising:
a housing (110, 210) having a longitudinal axis (along the longitudinal shape; [0030]) and an electronics compartment (inside of housing) containing pacing circuitry ([0023], [0024]); and
a header assembly mounted on the housing, wherein the header assembly includes
an outer fixation element (130, 230) having an outer helix extending about the longitudinal axis in a helical direction and having a first stiffness in a longitudinal direction, and
an inner fixation element (120, 220) having an inner helix radially inward of the outer helix and extending about the longitudinal axis in the helical direction and having a second stiffness in the longitudinal direction, and wherein the first stiffness is different than the second stiffness ([0026], [0037], [0038]).
Claim 3. The biostimulator of claim 2, wherein the first stiffness is less than the second stiffness ([0026], [0037]).
Claim 4. The biostimulator of claim 3, wherein the outer fixation element has a lower spring constant than the inner fixation element ([0026], [0037]; the Examiner considers that since the spring constant is a measure of the stiffness of the spring (i.e. the stiffer the spring, the larker the spring constant), the less stiff outer coil 240 will have a lower spring constant).
Claim 7. The biostimulator of claim 2, wherein the outer fixation element and the inner fixation element are formed from materials having different elastic moduli ([0037]).
Claim 8. The biostimulator of claim 2, wherein the outer fixation element has a different helical pitch than the inner fixation element (Fig. 2).
Claim 9. The biostimulator of claim 2, wherein the outer fixation element has a different wire cross-sectional area than the inner fixation element (Fig. 2; [0038]).
Claim 10. The biostimulator of claim 2, wherein the outer fixation element extends to a first distal tip (232), wherein the inner fixation element extends to a second distal tip (222), and wherein the first distal tip is proximal to the second distal tip (Fig. 2B).
Claim 13. A biostimulator system, comprising:
a transport system including a catheter having a distal end ([0022]); and
a biostimulator (Figs. 1, 2) coupled to the distal end and including
a housing (110, 210) having a longitudinal axis (along the longitudinal shape; [0030]) and an electronics compartment (inside of housing) containing pacing circuitry ([0023], [0024]), and
a header assembly mounted on the housing, wherein the header assembly includes
an outer fixation element (130, 230) having an outer helix extending about the longitudinal axis in a helical direction and having a first stiffness in a longitudinal direction, and
an inner fixation element (120, 220) having an inner helix radially inward of the outer helix and extending about the longitudinal axis in the helical direction and having a second stiffness in the longitudinal direction, and wherein the first stiffness is different than the second stiffness ([0026], [0037], [0038]).
Claim 14. The biostimulator system of claim 13, wherein the first stiffness is less than the second stiffness ([0026], [0037]).
Claim 16. The biostimulator system of claim 13, wherein the outer fixation element and the inner fixation element are formed from materials having different elastic moduli ([0037]).
Claim 17. The biostimulator system of claim 13, wherein the outer fixation element has a different helical pitch than the inner fixation element (Fig. 2).
Claim 18. The biostimulator system of claim 13, wherein the outer fixation element has a different wire cross-sectional area than the inner fixation element (Fig. 2; [0038]).
Claim 19. The biostimulator system of claim 13, wherein the outer fixation element extends to a first distal tip (232), wherein the inner fixation element extends to a second distal tip (222), and wherein the first distal tip is proximal to the second distal tip (Fig. 2B).
Claim 21. A method, comprising:
advancing a biostimulator system to a target tissue, wherein the biostimulator system includes a transport system including a catheter having a distal end ([0022]), and a biostimulator (Figs. 1, 2) coupled to the distal end and including a housing (1 210) having a longitudinal axis (along the longitudinal shape; [0030]) and an electronics compartment (inside of housing) containing pacing circuitry ([0023], [0024]), and a header assembly mounted on the housing, wherein the header assembly includes an outer fixation (130, 230) element having an outer helix extending about the longitudinal axis in a helical direction and having a first stiffness in a longitudinal direction, and an inner fixation element (120, 220) having an inner helix radially inward of the outer helix and extending about the longitudinal axis in the helical direction and having a second stiffness in the longitudinal direction, and wherein the first stiffness is different than the second stiffness ([0026], [0037], [0038]);
contacting the inner fixation element and the outer fixation element against the target tissue ([0061]); and
rotating the biostimulator to screw the inner fixation element and the outer fixation element into the target tissue ([0061]).
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11, 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haasl et al in view of Clark et al (US 2012/0185023).
Claims 11, 12 and 20. Haasl et al discloses the invention substantially as claimed above, but fails to disclose one or more of the outer fixation element or the inner fixation element are formed from a biodegradable material (as per claims 11 and 20) and wherein the biodegradable material includes a biodegradable metal (as per claim 12).
However, in the same field of endeavor, Clark et al teaches a biostimulator (14) having a tissue piercing fixation element (24) (akin to the inner fixation element 220 of Haasel et al having a tissue penetrating end as discussed in [0031]) made of a biodegradable metal (29) ([0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal tissue penetration end of the inner fixation element of Haasl et al to be formed of a biodegradable material based upon the teachings of Clark et al to allow the tissue penetration end of the fixation elements to biodegrade over time, leaving behind a more blunt end portion to minimize trauma to the tissue ([0052]).
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11541243 in view of Haasl et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in some respects and merely add an obvious feature absent from the patent claim in other respects.
Claims 1, 13 and 21 recite the additional feature of the outer fixation element having a first stiffness in the longitudinal direction, and the inner fixation element having a second stiffness in the longitudinal direction, and wherein the first stiffness is different (less) than the second stiffness. However, in the same field of endeavor, Haasl et al teaches a biostimulator having an outer fixation element (230) having a first stiffness, and inner fixation element (220) having a second stiffness, wherein the first stiffness is less than the second stiffness ([0026], [0037], [0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patent claims to include this feature to allow the outer fixation element to more easily collapse and provide compression against tissue to improve anti-unscrewing capability when the inner fixation element is fixed to target tissue ([0037]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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