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 the Claims
Claim 14 is newly added. Claims 4 and 13 are currently amended. Claims 4-14 are currently pending. Claims 4-8, 10, and 13 are currently allowed. Claims 9, 11-12, and 14 are rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/12/2026, with respect to the rejection(s) of claim(s) 4-14 under 35 U.S.C. 103 have been fully considered and are somewhat persuasive. The art rejections of claims 4-10 and 13 are withdrawn; see Allowable Subject Matter section below. The 112(a) rejection of claim 9 is maintained. The art rejections of claims 11-12 are maintained, and claim 14 is also rejected.
Applicant argues that the 112(a) rejection is improper because a PHOSITA would understand “completely” different materials to mean two different materials (titanium vs plastic, which are not the same material). This argument is not found to be persuasive. As previously noted, the pertinent parts of the instant specification are [0133-0134] which do mention a list of materials for the front part and the rear part, and [0132] which notes that “The front part 11 and the rear part 12 are preferably formed from different materials”. However, the claims recite “a front part, which comprises the cylinder and the open dispensing end; and a rear part, which comprises the tensioning device”, and nowhere in the specification provides specific support directed to the cylinder and the open dispensing end comprising “completely” different materials than the tensioning device. Examiner notes that the term “completely” does not appear anywhere in the instant specification. Although the Applicant argues that this lack of presence of the term “completely” does not preclude a PHOSITA from understanding the term in the claims, the Examiner disagrees. A PHOSITA may interpret “completely different” to mean that if one material is a metal (titanium), then the other material cannot be any type of metal (including aluminum), or that “completely different” refers to a difference in color, permeability, weight, chemical composition, method of formation, or that “completely different” may require differences in all of the listed characteristics, and perhaps more. There is no clear characterization of what is meant by materials being “completely different” in the specification. Therefore, the 112(a) rejection of claim 9 is maintained, and is repeated below.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Davies “does not disclose a curved transfer region connection the second plateau and the transition flank”. Examiner reiterates that Davies is not relied on for teaching the second plateau and the transition flank, only for teaching a curved transfer region between two portions of a cam surface. Applicant argues that this teaching is insufficient specifically because “it is unlikely that the follower would produce much wear on the transition flank given its vertical orientation or the second plateau since it precedes the transition region, so the state reasons for the modification would not motivate persons of ordinary skill in the art to make such a modification”. Examiner disagrees, and notes that the cam follower would still impact all parts of the cam, and would be pulled down the flank as soon as a small portion of the cam follower crosses the point between the flank and the second plateau, thus over time exerting wear on the second plateau and the flank due to the abrupt transition. Additionally, the cam follower itself may be damaged by interaction with the sharp corner, and the cam follower acquiring an incorrect shape may further contribute to wear on the cam itself. Furthermore, the curved transition region of Davies [0430], as previously noted, provides support by noting that the curved transition reduces wear on cam surfaces. This motivation is not limited to the specific configuration of surfaces in Davies, but also would apply to transitions between any two cam surfaces, including those disclosed by Castellano, as would have been obvious to one of ordinary skill in the art.
Applicant argues that Bruggemann does not disclose a ramp. Bruggemann is not relied on to teach a ramp, but rather to teach a rotating element which is driven by a motor being arranged rearwardly of said motor. Furthermore, the Applicant’s argument that the arrangement of the ramp being reward to the motor would cause the device to be less compact in the vertical direction is not persuasive, as the motor rearrangement need not necessarily increase the vertical displacement of the handle (see fig. 21, [0061] handle part 3003 which houses an electrical battery 3022) and/or the reservoir 3016 (see fig. 21, [0059]) which currently mark the vertical extremes of the device. Additionally, the Applicant’s assertion that the modification may cause the device to be less compact in the vertical direction does not prevent the longitudinal shortening of the device from motivating a PHOSITA to pursue the arrangement.
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.
Claim 9 is 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.
Claim 9 recites the limitation “the front part and the rear part comprise completely different materials”. Applicant points to [0133]-[0134] of the published application for support:
“[0133] The material of the front part 11 can thus comprise titanium, steel or plastic (e.g. PEEK).
[0134] For the material of the rear part 12, in particular a material is selected which has as little weight as possible. Aluminum, magnesium, titanium or plastic are preferred here.”
Neither paragraph provided above describes the front part and rear part explicitly comprising “completely” different materials. In fact, the lists of materials overlap, both containing titanium and plastic. [0131] of the published application states “As has already been explained, the front part 11 and the rear part 12 are two separate parts which are connected to each other, as can also be clearly seen in the illustrations in FIGS. 24 and 25.”. Although it may be possible to select steel for the front part and aluminum for the rear part, as is clearly shown in fig. 9, the piston rod 25 extends into both the front part and the rear part, and therefore the front part and rear part (in this case interpreted as areas), which both comprise various other structures as noted in claim 4. Thus, the front part and the rear part cannot comprise completely different materials because they both comprise the piston rod 25.
Additionally, as noted in the Response to Arguments above, the claims recite “a front part, which comprises the cylinder and the open dispensing end; and a rear part, which comprises the tensioning device”. Even if the “front part” and “rear part” are interpreted strictly as structures and not areas comprising the noted structures, nowhere in the specification provides specific support directed to the cylinder and the open dispensing end comprising “completely” different materials than the tensioning device. Examiner notes that the term “completely” does not appear anywhere in the instant specification.
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.
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.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castellano (US 20040035491 A1; hereafter Castellano) in view of Simmons (Colin H Simmons, Dennis E Maguire, Neil Phelps, Chapter 28 - Cams and gears, Editor(s): Colin H Simmons, Dennis E Maguire, Neil Phelps, Manual of Engineering Drawing (Third Edition), Butterworth-Heinemann, 2009, Pages 213-224, ISBN 9780750689854, https://doi.org/10.1016/B978-0-7506-8985-4.00028-0. (https://www.sciencedirect.com/science/article/pii/B9780750689854000280); hereafter Simmons), Daly et al (US 20050103339 A1; hereafter Daly), Goumeniouk (US 20180344950 A1; hereafter Goumeniouk), and Metal Supermarkets (Metal Supermarkets, “10 Differences Between Aluminum and Stainless Steel”, 15 December 2014, https://www.metalsupermarkets.com/10-differences-aluminum-stainless-steel/; hereafter Metal Supermarkets), and Davies et al (US 20070131717 A1; hereafter Davies).
Regarding claim 11, Castellano discloses a device for administering a fluid ([0059] needle-less injector shown in fig. 21), comprising
a cylinder (cylinder 3026), including an open dispensing end (discharge nozzle 3020);
a piston (piston 3007), which is displaceable in the cylinder (3026) between a front end position and a rear end position ([0060] piston moves freely in a longitudinal direction) and is connected to a piston rod (connecting rod 3006) which, along a first direction, protrudes from a rear end of the cylinder opposite the open dispensing end (fig. 21 shows connecting rod 3006 extend past rear end of cylinder);
a nonreturn valve (non-return valve 3019 closes discharge nozzle 3020) closing the open dispensing end (discharge nozzle 3020);
a tensioning device (cam 3011 and motor 3004) connected to the piston rod (connecting rod 3006), including a ramp (cam 3011) which is rotatable via a motor (motor 3004), and a ramp track extending along a helical line (cam profile in fig. 26, and top edge of cam 3011 as shown in fig. 21 and best shown in fig. 22);
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a front part (see annotated fig. 21 above, note that the front part comprises the structures within designated area of the “front part” excluding the front section 3001, noted in [0059]), which comprises the cylinder (cylinder 3026) and the open dispensing end (discharge nozzle 3020) (See annotated fig. 21 above, both the cylinder 3026 and the discharge nozzle 3020 fall within the designated area of the front part.); and
a rear part (see annotated fig. 21 above, note that the rear part comprises the structures within designated area of the “rear part” excluding the rear section 3002, noted in [0059]), which comprises the tensioning device (cam 3011 and motor 3004, [0061]) see fig. 21) (See annotated fig. 21 above, both the cam 3011 and motor 3004 fall within the designated area of the rear part.),
wherein the tensioning device (motor 3004 is part of tensioning device, noted above) moves the piston rod (3006) along the first direction in a tensioning procedure until the piston (3007) is in its rear end position, in order to fill the cylinder (3026) with the fluid to be administered and to pretension the piston rod (3006) toward the open dispensing end (3020) ([0062] motor 3004 rotates cam 3011 which retracts piston rod/connecting rod 3006 against a spring 3005, piston 3007 follows part of longitudinal travel and draws fluid into the cylinder),
wherein the tensioning device, when the piston (3007) is in its rear end position, can release the piston rod (3006) in a dispensing procedure such that, owing to the pretension which is present, the piston (3007) is moved counter to the first direction toward the open dispensing end (3020) and, in the process, fluid in the cylinder (3026) is dispensed via the nonreturn valve (3019) for administration ([0063] cam follower 3010 is suddenly released by cam profile at reference letter C in fig. 26, piston rod and piston move toward dispensing end and fluid is dispensed),
wherein the ramp track (cam profile in fig. 26) ascends from a first plateau (see 103 rejection of claim 4 for annotated fig. 26) along a region of inclination (sloping portion of the cam profile, [0062] position shown by reference point A in fig. 26) to a second plateau (a substantially zero lift or parallel part of the cam, [0062] position shown by reference point B in fig. 26) and descends from the second plateau to the first plateau via a transition flank ([0063] the cam follower 3010 is suddenly released by the cam profile, shown by reference point C in fig. 26),
wherein the ramp track (cam profile in fig. 26) includes a transfer region (circled portion of cam profile in annotated fig. 26) connecting the second plateau and the transition flank (transfer region is between second plateau and transition flank in annotated fig. 26),
wherein the tensioning device includes a roller (cam follower 3010) which is in contact with the ramp track ([0062-0063] cam follower 3010 runs along cam surface during loading and dispensing of dose), and therefore, upon rotation of the ramp along a first rotation direction ([0062] roller/cam follower 3010 runs along ramp when cam 3011 is rotated), the ramp track runs below the thus rotating roller (fig. 26 shows cam follower 3010 position along ramp track),
wherein, in the tensioning procedure, the ramp track (cam profile in fig. 26) rotates along the first rotation direction ([0062] cam 3011 is rotated) such that the roller (3010) runs on the region of inclination ([0062] cam follower 3010 to travel on region of inclination/sloping portion of cam profile shown in fig. 26) as far as the second plateau and the piston is thereby moved to its rear end position ([0062] cam follower reaches maximum stroke position on a zero lift or parallel portion of the cam, piston rod/connecting rod 3006’s movement linked to that of cam follower 3010), and
wherein, in the dispensing procedure, starting from a contact of the roller (3010) with the second plateau ([0063] cam follower 3010 retained in “latched” position as shown by reference point B in fig. 26), the ramp track rotates along the first rotation direction until the roller runs over the transfer region and, on account of the pretensioning, accelerates toward the first plateau ([0063] motor 3004 rotates cam 3011 a few more degrees which causes a rapid movement of cam follower 3010 shown by reference point C in fig. 26) and, as a result, the piston is moves toward the open dispensing end, ([0061] since follower 3010 is attached to connecting rod 3006, piston and piston rod are moved toward the open dispensing end).
Castellano is silent to the roller being mounted in a driver connected to the piston rod.
Simmons teaches a roller (wheel in annotated fig. 28.12 of a roller cam) which is mounted rotatably in a driver (portion of roller follower which attaches wheel to rod), the driver being connected to the piston rod (rod in annotated fig. 28.12).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the roller follower style taught by Simmons with the cam follower of Castellano because the mounted wheel system of Simmons reduces the friction between the cam follower and the cam, therefore generating less heat and reducing wear and tear on the device over time.
The embodiment of Castellano shown in fig. 21 and Simmons are silent to the materials making up the front part and rear part of the device.
Daly, in the art of medical ventilation pumps and motors therefor, teaches wherein a motor is made of aluminum ([0089] the motor is investment cast from aluminum).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the motor of Castellano, located in the rear part as shown in annotated fig. 21, to be made of aluminum as taught by Daly because both Castellano and Daly deal with motors used in medical devices for fluid (air/drug) delivery to a patient. One would have been motivated to make the modification because, as noted by Daly [0079], aluminum is a good conductor of heat and facilitates the dissipation of heat generated by the accelerating and decelerating motor, and as Daly [0109] further asserts, dissipating the heat extends motor life/reliability.
Castellano as modified is silent to the material making up the front part.
Goumeniouk, in the art of drug delivery devices, teaches wherein a cylinder and nozzle are made from plastic or stainless steel ([0053] medication storage cylinder, connecting tube and the discharge nozzle can be made from either plastic or stainless steel).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the front part of Castellano, which comprises the cylinder and the open dispensing end/nozzle, to be made of steel as taught by Goumeniouk because Goumeniouk also deals with fluid delivery in a medical context. One would have been motivated to make the modification because, as noted by Goumeniouk [0053], steel is a resilient and corrosion resistant material. Since the cylinder and nozzle are meant to engage with a fluid drug, it would make sense to use a corrosion resistant material.
Castellano, as modified by Simmons, Daly, and Goumeniouk, thus discloses wherein the front part (Castellano fig. 21 shows cylinder 3026 and discharge nozzle 3020, the cylinder and nozzle modified by Goumeniouk [0053] to be made of stainless steel) and the rear part (Castellano fig. 21 shows cam 3011 and motor 3004 as seen in fig. 21, the motor modified by Daly [0079] to be made of aluminum) comprise different materials (Examiner notes that aluminum and steel are different materials, and thus this claim limitation is satisfied).
Castellano as modified is silent to wherein the transfer region is curved.
Davies, in the art of a fluid dispensing device, teaches wherein the transfer region (transition portion 723c, fig. 39, [0430]) is curved (see fig. 39).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the transfer region of Castellano as modified to be curved as taught by Davies because both deal with fluid dispensing devices. One would have been motivated to make the modification because, as noted by Davies [0430], the transition portion shown in fig. 39 provides a smooth transfer of the cam follower across the cam surfaces and reduces wear on the cam surfaces.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Simmons, Daly, Goumeniouk, Metal Supermarkets, and Bruggemann et al (US 20120172817 A1; hereafter Bruggemann).
Regarding claim 12, Castellano discloses a device for administering a fluid ([0059] needle-less injector shown in fig. 21), comprising
a cylinder (cylinder 3026), including an open dispensing end (discharge nozzle 3020);
a piston (piston 3007), which is displaceable in the cylinder (3026) between a front end position and a rear end position ([0060] piston moves freely in a longitudinal direction) and is connected to a piston rod (connecting rod 3006) which, along a first direction, protrudes from a rear end of the cylinder opposite the open dispensing end (fig. 21 shows connecting rod 3006 extend past rear end of cylinder);
a nonreturn valve (non-return valve 3019 closes discharge nozzle 3020) closing the open dispensing end (discharge nozzle 3020);
a tensioning device (cam 3011 and motor 3004) connected to the piston rod (connecting rod 3006), including a ramp (cam 3011) which is rotatable via a motor (motor 3004), and a ramp track extending along a helical line (cam profile in fig. 26, and top edge of cam 3011 as shown in fig. 21 and best shown in fig. 22);
a front part (see annotated fig. 21 above, note that the front part comprises the structures within designated area of the “front part” excluding the front section 3001, noted in [0059]), which comprises the cylinder (cylinder 3026) and the open dispensing end (discharge nozzle 3020) (See annotated fig. 21 above, both the cylinder 3026 and the discharge nozzle 3020 fall within the designated area of the front part.); and
a rear part (see annotated fig. 21 above, note that the rear part comprises the structures within designated area of the “rear part” excluding the rear section 3002, noted in [0059]), which comprises the tensioning device (cam 3011 and motor 3004, [0061]) see fig. 21) (See annotated fig. 21 above, both the cam 3011 and motor 3004 fall within the designated area of the rear part.),
wherein the tensioning device (motor 3004 is part of tensioning device, noted above) moves the piston rod (3006) along the first direction in a tensioning procedure until the piston (3007) is in its rear end position, in order to fill the cylinder (3026) with the fluid to be administered and to pretension the piston rod (3006) toward the open dispensing end (3020) ([0062] motor 3004 rotates cam 3011 which retracts piston rod/connecting rod 3006 against a spring 3005, piston 3007 follows part of longitudinal travel and draws fluid into the cylinder),
wherein the tensioning device, when the piston (3007) is in its rear end position, can release the piston rod (3006) in a dispensing procedure such that, owing to the pretension which is present, the piston (3007) is moved counter to the first direction toward the open dispensing end (3020) and, in the process, fluid in the cylinder (3026) is dispensed via the nonreturn valve (3019) for administration ([0063] cam follower 3010 is suddenly released by cam profile at reference letter C in fig. 26, piston rod and piston move toward dispensing end and fluid is dispensed),
wherein the ramp track (cam profile in fig. 26) ascends from a first plateau (see 103 rejection of claim 4 above for annotated fig. 26) along a region of inclination (sloping portion of the cam profile, [0062] position shown by reference point A in fig. 26) to a second plateau (a substantially zero lift or parallel part of the cam, [0062] position shown by reference point B in fig. 26) and descends from the second plateau to the first plateau via a transition flank ([0063] the cam follower 3010 is suddenly released by the cam profile, shown by reference point C in fig. 26),
wherein the ramp track (cam profile in fig. 26) includes a transfer region (circled portion of cam profile in annotated fig. 26) connecting the second plateau and the transition flank (transfer region is between second plateau and transition flank in annotated fig. 26),
wherein the tensioning device includes a roller (cam follower 3010) which is in contact with the ramp track ([0062-0063] cam follower 3010 runs along cam surface during loading and dispensing of dose), and therefore, upon rotation of the ramp along a first rotation direction ([0062] roller/cam follower 3010 runs along ramp when cam 3011 is rotated), the ramp track runs below the thus rotating roller (fig. 26 shows cam follower 3010 position along ramp track),
wherein, in the tensioning procedure, the ramp track (cam profile in fig. 26) rotates along the first rotation direction ([0062] cam 3011 is rotated) such that the roller (3010) runs on the region of inclination ([0062] cam follower 3010 to travel on region of inclination/sloping portion of cam profile shown in fig. 26) as far as the second plateau and the piston is thereby moved to its rear end position ([0062] cam follower reaches maximum stroke position on a zero lift or parallel portion of the cam, piston rod/connecting rod 3006’s movement linked to that of cam follower 3010), and
wherein, in the dispensing procedure, starting from a contact of the roller (3010) with the second plateau ([0063] cam follower 3010 retained in “latched” position as shown by reference point B in fig. 26), the ramp track rotates along the first rotation direction until the roller runs over the transfer region and, on account of the pretensioning, accelerates toward the first plateau ([0063] motor 3004 rotates cam 3011 a few more degrees which causes a rapid movement of cam follower 3010 shown by reference point C in fig. 26) and, as a result, the piston is moves toward the open dispensing end, ([0061] since follower 3010 is attached to connecting rod 3006, piston and piston rod are moved toward the open dispensing end).
Castellano is silent to the roller being mounted in a driver connected to the piston rod.
Simmons teaches a roller (wheel in annotated fig. 28.12 of a roller cam, see 103 rejection of claim 11 for annotated figure) which is mounted rotatably in a driver (portion of roller follower which attaches wheel to rod), the driver being connected to the piston rod (rod in annotated fig. 28.12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the roller follower style taught by Simmons with the cam follower of Castellano because the mounted wheel system of Simmons reduces the friction between the cam follower and the cam, therefore generating less heat and reducing wear and tear on the device over time.
The embodiment of Castellano shown in fig. 21 and Simmons are silent to the materials making up the front part and rear part of the device.
Daly, in the art of medical ventilation pumps and motors therefor, teaches wherein a motor is made of aluminum ([0089] the motor is investment cast from aluminum).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the motor of Castellano, located in the rear part as shown in annotated fig. 21, to be made of aluminum as taught by Daly because both Castellano and Daly deal with motors used in medical devices for fluid (air/drug) delivery to a patient. One would have been motivated to make the modification because, as noted by Daly [0079], aluminum is a good conductor of heat and facilitates the dissipation of heat generated by the accelerating and decelerating motor, and as Daly [0109] further asserts, dissipating the heat extends motor life/reliability.
Castellano as modified is silent to the material making up the front part.
Goumeniouk, in the art of drug delivery devices, teaches wherein a cylinder and nozzle are made from plastic or stainless steel ([0053] medication storage cylinder, connecting tube and the discharge nozzle can be made from either plastic or stainless steel).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the front part of Castellano, which comprises the cylinder and the open dispensing end/nozzle, to be made of steel as taught by Goumeniouk because Goumeniouk also deals with fluid delivery in a medical context. One would have been motivated to make the modification because, as noted by Goumeniouk [0053], steel is a resilient and corrosion resistant material. Since the cylinder and nozzle are meant to engage with a fluid drug, it would make sense to use a corrosion resistant material.
Castellano, as modified by Simmons, Daly, and Goumeniouk, thus discloses wherein the front part (Castellano fig. 21 shows cylinder 3026 and discharge nozzle 3020, the cylinder and nozzle modified by Goumeniouk [0053] to be made of stainless steel) and the rear part (Castellano fig. 21 shows cam 3011 and motor 3004 as seen in fig. 21, the motor modified by Daly [0079] to be made of aluminum) comprise different materials (Examiner notes that aluminum and steel are different materials, and thus this claim limitation is satisfied), and
wherein the tensioning device (3004/3011, fig. 21) is formed of a different material (motor 3004 of Castellano modified by Daly [0079] to be made of aluminum) than both of the cylinder (3026, fig. 21) and the open dispensing end (3020, fig. 21) (cylinder 3026 and discharge nozzle 3020 are modified by Goumeniouk [0053] to be made of stainless steel) (Examiner notes that the tensioning device is not made of steel, so the claim limitation is satisfied.).
Castellano as modified is silent to wherein the ramp is arranged rearwardly of the motor.
Bruggemann, in the art of a medicament delivery device, teaches wherein a gear system (drive train 15 and transfer drive 16, fig. 8, [0040] drive train 15 includes pinion 21, gear 22, gear 23, and gear 24) is located rearwardly of a motor (electric motor 13, fig. 9, [0029]) (see figs. 8 and 9 which show the noted elements located rearwardly of the motor).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the arrangement of Castellano as modified to have the driven cam located rearwardly of the motor, as taught by Bruggemann having the drive train located rearwardly of the motor, since Bruggemann also deals with a drug injection device. One would have been motivated to make the modification because, as noted by Bruggemann [0018], the arrangement taught by Bruggemann provides for more compact medicament delivery devices, both in terms of the axial length of the device as well as the diameter of medicament container.
Regarding claim 14, Castellano as modified discloses the device of claim 12, as described above, including wherein the driver (3010, fig. 21) is disposed rearwardly of the rear part (tensioning device and motor; note that driver 3010 rides on the surface of the cam 3011, and as modified by Bruggeman, the cam is located rearwardly of the motor, thus placing the driver 3010 reward of the rear part).
Allowable Subject Matter
Claims 4-8 and 10 are allowed.
The following is an examiner’s statement of reasons for allowance:
Claim 4 was previously rejected under 103 over Castellano (US 20040035491 A1; hereafter Castellano) in view of Simmons (Colin H Simmons, Dennis E Maguire, Neil Phelps, Chapter 28 - Cams and gears, Editor(s): Colin H Simmons, Dennis E Maguire, Neil Phelps, Manual of Engineering Drawing (Third Edition), Butterworth-Heinemann, 2009, Pages 213-224, ISBN 9780750689854, https://doi.org/10.1016/B978-0-7506-8985-4.00028-0. (https://www.sciencedirect.com/science/article/pii/B9780750689854000280); hereafter Simmons), Daly et al (US 20050103339 A1; hereafter Daly), Goumeniouk (US 20180344950 A1; hereafter Goumeniouk), and Metal Supermarkets (Metal Supermarkets, “10 Differences Between Aluminum and Stainless Steel”, 15 December 2014, https://www.metalsupermarkets.com/10-differences-aluminum-stainless-steel/; hereafter Metal Supermarkets).
The new claim amendments introduce the limitation “wherein the driver is connected to the piston rod via a pair of guide rods, and wherein the driver spans between each of the guide rods and is rotatably mounted to the roller”.
Previously, claim 4 called for one guide rod, and the Examiner relied upon guide rod 3006 in fig. 21 (aka 3106 in fig. 24a) to meet that limitation “wherein the driver is connected to the piston rod via a guide rod” (see Castellano figs. 21 and 24a below). Previously, claim 13 called for a pair of guide rods (two perpendicular rods 3024/3124 in Castellano fig. 24a below).
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Although the guide rods 3024/3124 pictured in Castellano fig. 24a could still meet the limitation of “wherein the driver is connected to the piston rod via a pair of guide rods”, and Simmons fig. 28.12 could be interpreted to disclose the driver “rotatably mounted to the roller” none of the prior art discloses “wherein the driver spans between each of the guide rods”.
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Neither Castellano nor any other prior art provides motivation for duplicating the guide rod 3006. Furthermore, although there is art, such as the reference Petersen pictured below, which include multiple guide rods, there is still no motivation or teaching in the prior art that would cause a PHOSITA to arrive at all the limitations of claim 4 including the multiple guide rods connected to a single piston rod as claimed and as shown in instant application figure 4.
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Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bokelman (US 20150174326 A1) – shows motor 106 arranged in various rear/forward relationships to a driven gear system, see for example figs. 10a-e, fig. 11a-b
Hirschel (US 20190117880 A1) – shows motor 83 disposed forward of a driven piston rod 80, see fig. 8, [0182], note that [0007] mentions compact mechanism design
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/02/2026
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