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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/08/2026 has been entered.
Status of the Claims
Claim 13 is newly added. Claims 4 and 12 are currently amended. Claims 4-13 are currently pending. Claims 4-13 are currently rejected.
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not fully persuasive.
The amendment of the term “media stability” to “media resistance” in claim 4 is acknowledged by the Examiner as obviating the prior 112(b) rejection, which is thus withdrawn.
Applicant’s arguments with respect to claim(s) 4 and 12 have been fully considered but are moot because the new ground of rejection does not rely on the same interpretation of the prior art used in the previous rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that [0133-0134] provides support for claim 9, previously rejected under 112(a), which claims “wherein the front part and the rear part comprises completely different materials”, are not found to be persuasive. The pertinent parts of the instant specification are [0133-0134] which does 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. Therefore, the 112(a) rejection of claim 9 is maintained, and is repeated below.
Applicant argues that Examiner incorrectly characterized Davies since Davies does not have a second plateau and transition flank. However, Davies is used only to teach a curved transition region between sections of a cam surface, regardless of what those specific cam surfaces are. Castellano teaches a first plateau, region of inclination, second plateau, and transition plank as described in the prior rejection of at least claim 11. Davies is relied on only to teach a curved transition region, and 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 the cam surfaces disclosed by Castellano, as would have been obvious to one of ordinary skill in the art.
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation “the driver is connected to the piston rod via a pair of guide rods”. Claim 13 depends from claim 4 which recites the limitation in lines 29-30 “the driver being connected to the piston rod via a guide rod”. It is unclear whether the pair of guide rods introduced in claim 13 is supposed to introduce two new guide rods which together form a pair, separate from the already claimed guide rod in claim 4, or whether claim 13 is meant to introduce a second guide rod which, together with the already claimed guide rod in claim 4, forms a pair of guide rods. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
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) 4-7 and 9-10 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). Reference is made to the pdfs of Simmons and Metal Supermarkets included the previous Office Action.
Regarding claim 4, Castellano discloses a device for administering a fluid ([0059] needle-less injector shown in fig. 21), comprising
a cylinder (cylinder 3026, fig. 21, [0059]), including an open dispensing end (discharge nozzle 3020, fig. 21, [0059]);
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a piston (tip section of piston 3007, similar to tip section shown in fig. 24a, note [0023] “FIGS. 21-26 depict aspects of a needle-less injector in accordance with an embodiment of the present invention.”), 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 (body of piston 3007 noted as the piston rod in fig. 24a above, note similar numbering between fig. 21 and 24a/b, and [0023] which notes figs. 21-26 show details of a needle-less injector) which, along a first direction, protrudes from a rear end of the cylinder (3026) opposite the open dispensing end (3020) (fig. 21 shows piston rod 3007 extends past rear end of cylinder 3026);
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 (body of 3007) along the first direction in a tensioning procedure until the piston (tip of 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 (body of 3007) toward the open dispensing end (3020) ([0062] motor 3004 rotates cam 3011 which retracts piston rod/connecting rod 3006 against a spring 3005, piston rod 3007 follows part of longitudinal travel and draws fluid into the cylinder),
wherein the tensioning device, when the piston (tip of 3007) is in its rear end position, can release the piston rod (body of 3007) in a dispensing procedure such that, owing to the pretension which is present, the piston (tip of 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),
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wherein the ramp track (cam profile in fig. 26) ascends from a first plateau (see 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), the roller (3010) being connected to the piston rod (body of 3007) via a guide rod (connecting rod 3006, fig. 21, [0061] a follower 3010 attached to the connecting rod 3006; [0060] piston 3007 is loosely located within a hole 3027 in the end of a connecting rod 3006), 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 a guide 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).
wherein a material of the front part (steel, noted above) has a greater strength and/or has a greater media resistance than a material of the rear part (aluminum, as noted above) (Examiner notes that material properties are inherent to the materials. Furthermore, Metal Supermarkets notes on page 5 that stainless steel is stronger than aluminum, thus Castellano as modified satisfies the claim limitation).
Regarding claim 5, Castellano as modified and applied to claim 4 above, discloses the device of claim 4, including wherein the material of the front part comprises titanium, steel (Castellano annotated fig. 21 shows cylinder 3026 and discharge nozzle 3020 in front part, the cylinder and nozzle modified by Goumeniouk [0053] to be made of stainless steel) or plastic, and the material of the rear part comprises aluminum (Castellano annotated fig. 21 shows cam 3011 and motor 3004 in rear part, the motor modified by Daly [0079] to be made of aluminum), magnesium, titanium or plastic.
Regarding claim 6, Castellano as modified and applied to claim 5 above, discloses the device of claim 5. Castellano further discloses comprising a housing (front section 3001 and rear section 3002; [0059] the needle-less injector shown in fig. 21 comprises an outer casing having a front section 3001 and a rear section 3002) surrounding the front part (see annotated fig. 21) and the rear part (see annotated fig. 21), wherein a portion of the front part (cylinder 3026 and discharge nozzle 3020 noted as the front part as seen in annotated fig. 21) protrudes from the housing (3001/3002) (see fig. 21 which shows that the end of discharge nozzle 3020 extends past the end of the front section 3001 of housing 3001/3002).
Regarding claim 7, Castellano as modified and applied to claim 4 above, discloses the device of claim 4. Castellano further discloses comprising a housing (front section 3001 and rear section 3002; [0059] the needle-less injector shown in fig. 21, comprises an outer casing having a front section 3001 and a rear section 3002) surrounding the front part (see annotated fig. 21) and the rear part (see annotated fig. 21), wherein a portion of the front part (cylinder 3026 and discharge nozzle 3020) protrudes from the housing (3001/3002) (see fig. 21 which shows that the end of discharge nozzle 3020 extends past the end of the front section 3001 of housing 3001/3002).
Regarding claim 9, Castellano as modified and applied to claim 4 above, discloses the device of claim 4, including wherein the front part (see annotated fig. 21) and the rear part (see annotated fig. 21), comprise completely different materials (note 112a rejection) (see 103 rejection of claim 4 above, cylinder 3026 and discharge nozzle 3020 are modified by Goumeniouk [0053] to be made of stainless steel, motor 3004 modified by Daly [0079] to be made of aluminum; Examiner notes that these are not the same material, and so are ‘completely’ different materials.).
Regarding claim 10, Castellano as modified and applied to claim 4 above, discloses the device of claim 4, including wherein the tensioning device (3004/3011, fig. 21) is formed of a different material (see 103 rejection of claim 4 above, 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) (see 103 rejection of claim 4 above, 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.).
Regarding claim 13, Castellano as modified and applied to claim 4 above, discloses the device of claim 4, including the driver (Simmons: portion of roller follower which attaches wheel to rod, see annotated fig. 28.12) being connected to the guide rod (Simmons: rod in annotated fig. 28.12) and the guide rod (Castellano: connecting rod 3006, fig. 21, [0061]) being connected to the piston rod (Castellano: body of 3007, see annotated fig. 24a).
Castellano further discloses wherein the guide rod is connected to the piston via a pair of guide rods (see 112b interpretation above) (pair of pins 3024, fig. 21 and fig. 24A, [0060] and [0062] he piston 3007 initially remains stationary, until the lefthand ends of the slots 3025 in connecting rod 3006 are contacted by the pins 3024 in piston 3007).
Thus, Castellano as modified further discloses wherein the driver (Simmons: portion of roller follower which attaches wheel to rod, see annotated fig. 28.12) is connected to the piston (Castellano: body of 3007, see annotated fig. 24a) via a pair of guide rods (see 112b interpretation above) (Castellano: pair of pins 3024, fig. 21)
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castellano as modified and applied to claim 4 above, and further in view of Davies et al (US 20070131717 A1; hereafter Davies).
Regarding claim 8, Castellano as modified and applied to claim 4 above, discloses the device of claim 4.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Simmons, Daly, Goumeniouk, 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);
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, see 103 rejection of claim 4 above 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).
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, and Metal Supermarkets, and alternatively further in view of 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 4 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 discloses all claim limitations except for wherein the ramp is arranged rearwardly of the motor. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the motor to be located closer to the front of the device than the cam, thereby yielding predictable results without change to inventive function. Furthermore, placing the motor farther forward in the device than the cam would be obvious to try by beneficially locating the motor of Castellano closer to the battery of Castellano, decreasing the required wiring length which thus could decrease cost and complexity of the device. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device could still function appropriately with the motor located in a different location.
Alternatively, 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.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/10/2026