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/Restrictions
Applicant’s election without traverse of Group I and Species a and c (claims 1-7, 9, 10, 12, 13, 16, and 19-22) in the reply filed on 1/16/26, as clarified via interview on 2/9/26 (see attached interview summary), is acknowledged. Claims 17, 23, 24, and 28 are withdrawn from consideration.
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) 1, 3, 10, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehrlich et al. (US 5250026).
Regarding claim 1, Ehrlich et al. discloses an injector device (overall device illustrated in fig. 1-3) for injecting an injectable cardiac monitor (device, as disclosed for delivering an “implant”, is fully capable of injecting an injectable cardiac monitor; see at least fig. 1, abstract, and col. 1, ln. 8-15), the device comprising: a push-rod 26 (see fig. 2A-B) configured to be inserted into a case (comprising at least 10 and 12) at a first end of the case (proximal end of 10/12); the case configured to hold the injectable cardiac monitor (via mutual engagement of elements, see at least fig. 1), the case comprising: a first handle protruding from a first side of the case (one of the two flanges protruding to the side of 10 near where 12 is positioned, see fig. 1 and 3); a second handle protruding from a second side of the case (the other of the two flanges protruding to the side of 10 near where 12 is positioned, see fig. 1 and 3); and a beveled needle 14 (see bevel in fig. 1 and 3) configured to be attached to a second end of the case (see fig. 1-3), and configured to be inserted into a mammal to inject the injectable cardiac monitor into the mammal (fully capable of performing this function; see at least fig. 1, abstract, and col. 1, ln. 8-15).
Regarding claim 3, Ehrlich et al. discloses a locking device (comprising at least 16, 94, and 96) including a switch 16, the locking device configured such that: when the switch is in a first position, the locking device prevents release of the injectable cardiac monitor; and when the switch is in a second position, the locking device allows release of the injectable cardiac monitor (see fig. 6 and col. 5, ln. 9-26).
Regarding claim 10, Ehrlich et al. discloses the structure as claimed which is fully capable of injecting an injectable cardiac monitor, as noted for claim 1 above, where the injectable cardiac monitor comprises: a sensor configured to detect a cardiac signal from the mammal; a transmitter configured to transmit the processed signal to a computing device; and a capsule for injecting into the mammal, the capsule comprising: a body configured to enclose all of the sensor, and the transmitter; and a wing configured to, upon deployment into the mammal, deploy outwardly from the body of the capsule (see the structure of fig. 1-3 as cited above which is fully capable of performing this claimed function).
Regarding claim 16, Ehrlich et al. discloses the beveled needle is further configured to extend from an interior of the second end of the case in response to a twisting force exerted on the case (twisting force on 12; see fig. 1-3 and col. 5, ln. 27-38).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich in view of Bardy (US 8251946) and Kellerman et al. (US 20130123827).
Regarding claim 2, Ehrlich et al. discloses the device as claimed, except for the beveled needle has: (i) a primary bevel angle of between 9 and 13 degrees, and (ii) a secondary bevel angle of between 15 and 19 degrees. However, Bardy teaches an injector designed for implantables where the beveled needle has: (i) a primary bevel angle, and (ii) a secondary bevel angle (see embodiments of fig. 10A-C; col. 17, ln. 50 – col. 18, ln. 3). 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 beveled needle of Ehrlich et al. to have two bevel angles, as taught by Bardy, for the purpose of providing sufficient structure to enable progressive cutting of the injection site during implantation.
Bardy fails to explicitly teach the specific angles claimed, the first angle being between 9 and 13 degrees and the second angle being between 15 and 19 degrees. However, Kellerman et al. teaches utilizing a first angle between 12-20 degrees and a second angle between 5-20 degrees for a primary and secondar bevel respectively (see fig. 7; par. 0016 and 0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to choose, for the two bevels, angles within the claimed ranges, as taught by Kellerman et al., for the purpose of providing sufficient structure for prevent coring/plugging and thus minimize bleeding (par. 0044).
Claim(s) 4-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich et al. in view of Sacherman et al. (WO 2019103906).
Regarding claims 4 and 9, Ehrlich et al. discloses the device as claimed, except for specifically disclosing the first and second handles comprise a polypropylene (PP) homopolymer and/or the push-rod comprises a polypropylene (PP) homopolymer. However, Sacherman et al. teaches that polypropylene homopolymers are suitable non-erodible, biocompatible polymers for construction of medical devices (par. 0155). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize PP homopolymer for the first handle, second handle, and/or push-rod, as taught by Sachmeran et al., since Sacherman et al. establishes the suitability of this material for construction of medical device components.
Regarding claims 5-7, Sacherman et al. does not explicitly teach the claimed material properties of the PP homopolymer, including an elastic modulus of approximately 1790 MPa, a mass density of approximately 0.034 lb/in3, and/or a tensile strength of approximately 33 MPa. Sacherman et al. is interpreted to read on these limitations where they are reciting inherent material properties of PP homopolymer. Furthermore, there is no evidence of record that establishes that choosing a PP homopolymer with the specific claimed material properties would result in a difference in function of the Ehrlich et al. in view of Sacherman et al. device. A person having ordinary skill in the art, being faced with modifying the material or material properties of Ehrlich et al. in view of Sacherman et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed material property values. Lastly, applicant has not disclosed that the claimed values solve any stated problem, simply indicating that the PP homopolymer possesses these properties (par. 0103 and table 1) and therefore there appears to be no criticality placed on the material property values as claimed such that it produces an unexpected result beyond the choice of PP homopolymer as the material, which is taught by Sacherman et al. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ehrlich et al. in view of Sacherman et al. to utilize PP homopolymer with these specific material properties as an obvious matter of design choice within the skill of the art.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich et al. in view of Gast et al. (US 5984890).
Regarding claims 12 and 13, Ehrlich et al. discloses the device as claimed, except for specifically disclosing the first and second handles comprise a thermoplastic polymer, and the thermoplastic polymer comprises ABS or nylon. However, Gast teaches forming utilizing nylon for construction of elements of a medical device (col. 8, ln. 44-47; see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ehrlich et al. to utilize handles comprising nylon, as taught by Gast et al., since Gast et al. teaches that nylon is a medically acceptable molded polymer.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Erhlich et al. in view of Bardy.
Regarding claim 19, Ehrlich et al. discloses the device as claimed, except for specifically disclosing the beveled needle is square. However, Bardy teaches adapting needle bores to reflect cross sections of various implantables (see col. 1, ln. 60-67 and col. 5, ln. 21-28), and envisions utilizing a square shape where needed (fig. 5A-D; col. 16, ln. 39-51). 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 beveled needle to be square, as taught by Bardy, for the purpose of adapting the bore for delivery of implantables which require a square bore.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich et al. in view of Shirley (US 2086580).
Regarding claim 20, Ehrlich et al. discloses the device as claimed, except for specifically disclosing the push-rod is configured to deploy the injector cardiac monitor into the mammal in response to a rotational motion exerted on the push-rod. However, Shirley teaches utilizing a push-rod mechanism where rotational movement is exerted on the push-rod (see ln. 1-15 in the first column of pg. 2; see fig. 1, in particular threaded plunger 6 and its interface with nut 5). 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 push-rod deployment mechanism of Ehrlich et al. to utilize a rotation motion for deployment, as taught by Shirley, for the purpose of providing sufficient structure to achieve controlled, progressive delivery.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich et al. in view of Allen (US 4581013).
Regarding claim 21, Ehrlich et al. discloses the device as claimed, except for specifically disclosing the case is further configured to: (i) connect to a fluid container, and (ii) deploy fluid from the fluid container when the injectable cardiac monitor is inserted into the mammal. However, Allen teaches, in an apparatus for delivery of a solid (abstract, see fig. 1-3), providing a connection 5 for a fluid container (syringe in fig. 1) to deploy fluid therefrom. 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 device of Erhlich et al. to include accommodate connection to a fluid container for delivery of fluid as claimed, as taught by Allen, for the purpose of providing sufficient structure for delivery of fluid when needed.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrlich et al. in view of Cappiello et al. (US 20140326249) and Kercso (US 4105030).
Regarding claim 22, Ehrlich et al. discloses the device as claimed, except for the push-rod comprises a first material with a first stiffness; the case comprises a second material with a second stiffness; and the first stiffness is greater than the second stiffness. However, Cappiello et al. teaches adjusting the stiffness of a push rod based on variable requirements of the device (par. 0178), and Kercso further teaches utilizing metal for a push rod of an implant delivery device, as opposed to molded plastics for the remainder of the device, to improve strength and durability of the push-rod (col. 6, ln. 67 – col. 7, ln. 29). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ehrlich et al. to utilize a more stiff material for the push-rod, such as metal, as taught by Cappiello et al. and Kercso, for the purpose of adapting the material properties of the push-rod for strength and durability sufficient for a desired delivery application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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