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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim(s) 21, 23-37 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 14-20 and 3 of U.S. Patent No. 10,857,289 in view of U.S. Publication No. 2014/0207104 (“Vouillamoz”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 21, ‘289 claims (see Clm. 14) a fluid dispensing device adapted for dispensing a measured amount of fluid into a living organism, wherein the device comprises a main housing enclosing a number of operative components of the device, a fluid reservoir, wherein the fluid reservoir comprises a first slideable septum therein, an injection assembly including a needle, wherein the needle has a first end adapted to establish fluid communication with the fluid contained in the fluid reservoir and a second end adapted for injecting the fluid into a living organism, and a trigger mechanism adapted to activate the dispensing of the measured amount of fluid into the living organism establishing the fluid communication between the injection assembly and the fluid reservoir.
‘289 substantially claims the instant invention except for explicitly requiring that the device is adapted such that when the first septum moves within the reservoir for expelling the fluid through the needle, the needle is adapted to advance into the living organism. ‘289 does explicitly claim movement of the needle/septum into the reservoir as well as guided insertion of the needle into the patient tissue to affect fluid delivery, but falls just short of particularly indicating that translation of the needle into the living organism necessarily occurs simultaneously with septum movement within the reservoir. Specifically, while ‘289 requires both ends of the needle to perform a piercing function “while translating together” dislodging of the septum within the reservoir to affect fluid expression is recited without necessarily requiring further advancement of the needle within the tissue. However, there are certainly questions as to whether or not the device, as claimed, could function WITHOUT such common movement since the needle ends aren’t claimed (or disclosed) as being moveable with respect to one another.
However, such simultaneously insertion of a needle paired with an expelling function a reservoir in a fluid delivery device is notoriously well-known in the art. For example, Vouillamoz discloses that while the fluid is expelled through the needle the needle is adapted to advance into the living organism (see Figs. 16A-16C; Fig. 20B; Par. 97 – re: “ in normal subcutaneous injection protocol, the needle is first inserted a certain depth under the skin (3 to 5 mm), and only after insertion, does one inject the drug under the epidermis. Finally, the needle is withdrawn. Unless such embodiment or its equivalent is used, the fluid will be distributed linearly throughout the penetration of the needle into the skin, from the surface until the final depth” and Par. 104 “In the infusion state, the fluidic channel is then opened and the reservoir begins to empty as the needle continues to travel to the 4mm to 5mm subcutaneous target depth”) [emphasis added]. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the claimed invention of the ‘289 reference patent to provide for simultaneous advancement of the needle into the tissue and movement of the septum/needle within the reservoir to affect simultaneous fluid delivery with needle insertion, as disclosed by Vouillamoz, in order to ensure linear distribution of the injectate throughout penetration of the needle into the skin from the surface thereby assisting in injectate diffusion.
Regarding Claim 23, in the instant case the ‘289 patent and the instant invention both claim the same “trigger mechanism” as predicated by means-plus-function language under 35 USC 112(f). As such, while ‘289 does not explicitly address “abutting” of the trigger mechanism against the living organism, such abutting is certainly covered by the claimed “mechanism”.
Clm. 24-28 corresponds to Clm. 16-20, respectively, of the reference ‘289 patent.
Clm. 29 recites subject matter not explicitly claimed, but understood to be obvious in view of at least Vouillamoz (see 106).
Clm. 30 recites subject matter found in Claim 14.
Clm. 31 recites subject matter found in Claim 14.
Clm. 32 recites subject matter found in Claim 14.
Clm. 33 recites subject matter understood to be derivative from the second end of the needle being “lodged” in the second septum during retraction of the needle/reservoir recited in Claim 14.
Clm. 34 recites limitations not found with respect to the claim chain of Claims 1, 14, and dependents of Claim 14. However, these limitations are recited in Claim 3, whereby while only being explicitly directed toward the reservoir functionally recites the fluid delivery device having the claimed characteristics, such that it would have been obvious to positively require the functionally recited fluid delivery device in association with the reservoir of Claim 3 in satisfaction of a complete, useful device.
Clm. 35 recites subject matter found in Claim 14.
Regarding Claim 36, the ‘289 reference patent fails to explicitly disclose an anti-resuse mechanism to deform the needle to prevent reuse of the system after injection. However, such mechanisms are known and obvious (see Vouillamoz – Par. 60) in order to prevent reuse to avoid cross-contamination from dirty equipment.
Regarding Claim 37, the ‘289 reference patent fails to explicitly disclose an window used to expos a colored moving component to signify an injection has taken place, but the use of such systems is well known and obvious (see Vouillamoz – Par. 105) in order to signify to a user that the device has been used and should therefore be discarded and replaced.
Claim Rejections - 35 USC § 112
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.
Claim(s) 23, 29, 31 and dependents is/are 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.
Regarding Claim 23, Applicant recites the limitation “to release the needle to inject the fluid into the living organism when abutted thereagainst.” However, the subject of this claim as to what is “abutted thereagainst” the living organism is unclear. It is unclear if the claim requires the “fluid dispensing device”, the “trigger mechanism”, or the “needle” to be the subject controlled by the “abutted thereagainst” limitation.
Regarding Claim 29, Applicant recites “the base on the main housing”. However, neither Claim 29 nor parent Claim 21 introduces the main housing to have “a base”. It is therefore unclear to what component Applicant refers.
Further regarding Claim 29, Applicant recites “the skin of a living organism”. However, the use of the definite article “the” is unclear here inasmuch as the living organism has not been previously indicated as having “skin” and it is not understood to be inherent that the device would be adapted to attach to ALL possible skin surfaces of a living organism (e.g. it is unclear if the device would be capable of attaching to skin covered by thick amounts of hair that would interfere with adherence of the base to the skin surface underlying the hair).
Regarding Claim 31, Applicant recites “The fluid dispensing device of Claim 30… wherein, when the needle lodges into the second septum…”. However, neither Claim 30, nor parent Claim 21, introduce “a second septum”. It is unclear if Claim 31 was intended to be dependent on Claim 32, which first introduces “a second septum” and therefore inherit the additional limitations thereof, or if the septum was intended to be separately introduced in Claim 31 requiring ONLY the explicitly limitations thereto recited in Claim 31.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 21, 23-30, 32-33, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0207104 (“Vouillamoz”) in view of FR 1320820 (“Steiner”) and U.S. Patent No. 4,227,528 (“Wardlaw”).
Regarding Claim 21, Vouillamoz discloses a fluid dispensing device (see generally 10 – more particularly Fig. 16) for dispensing a measured amount of fluid into a living organism, wherein the device has:
a main housing (see generally Fig. 332 – note labeled in Fig. 16) enclosing a number of operative components of the device (inter alia 900, 314…etc.)
a fluid reservoir (900), wherein the fluid reservoir comprises a first slidable septum (360) therewith;
an injection assembly including a needle (312) wherein the needle has a first end (314) adapted to establish a fluid communication with the fluid contained in the fluid reservoir (see Fig. 16A) and a second end (316) adapted for injecting the fluid into a living organism (1006); and
a trigger mechanism (see generally 24) adapted to activate the dispensing of the measured amount of fluid into the living organism establishing the fluid communication between the injection assembly and the fluid reservoir (Par. 9);
wherein the device is adapted such that when the first septum moves for expelling the fluid through the needle (see Figs. 16A-16C; Par. 97), wherein while the fluid is expelled through the needle the needle is adapted to advance into the living organism (see Figs. 16A-16C; Fig. 20B; Par. 97 – re: “ in normal subcutaneous injection protocol, the needle is first inserted a certain depth under the skin (3 to 5 mm), and only after insertion, does one inject the drug under the epidermis. Finally, the needle is withdrawn. Unless such embodiment [Figs. 16] or its equivalent is used, the fluid will be distributed linearly throughout the penetration of the needle into the skin, from the surface until the final depth” and Par. 104 “In the infusion state, the fluidic channel is then opened and the reservoir begins to empty as the needle continues to travel to the 4mm to 5mm subcutaneous target depth”) [emphasis added].
Vouillamoz discloses the invention substantially as claimed except that that the septum moves “within” the reservoir. However, the prior art, see Steiner, demonstrates that such collapsible bellows-type reservoirs (see Fig. 6) are suitable, alternative and equivalent reservoirs to those comprising a slidable septum (29) within a reservoir configured to be pierced by a needle first end (5 – see at 30) in order to push the septum within the reservoir such that a proximal end of the fluid reservoir is moved toward the septum (see Pg. 2, Col. 2). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to replace the collapsible, bellows type reservoir of the invention of Vouillamoz with a slideable, septum/piston type reservoir, as disclosed by Steiner, whereby Steiner establishes the two constructions to be suitably, known alternatives to one another and it has been held that simple substitution of know equivalents to obtain a predictable and expected outcome is obvious and requires only ordinary levels of knowledge, skill, and understanding, see KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Wardlaw demonstrates that such reservoirs with displaceable septum (see Fig. 2 and 6-8) can be paired with insertable needles with predictable results and a clear expectation of success.
Regarding Claim 23, Vouillamoz discloses the trigger mechanism is adapted to trigger the injection assembly to release the needle to inject the fluid into the living organism when abutted thereagainst (Par. 9; Fig. 16, 20).
Regarding Claim 24, Vouillamoz discloses the fluid dispensing device is adapted to be retained against the skin of the living organism by a retainer (e.g. Par. 91) and may be manually, automatically or remotely adapted to actuate injection of a fluid into the living organism (Par. 10).
Regarding Claims 25-27, Vouillamoz suggests the fluid may comprise those species and genera among those particularly enumerated in the claims (see e.g. Par. 72).
Regarding Claim 28, Vouillamoz discloses that the device is configured to administer the injection at least subcutaneously (Abstract).
Regarding Claim 29, Vouillamoz discloses a base of the main housing adapted to be attached on a skin of a living organism (Par. 10).
Regarding Claim 30, Vouillamoz, as modified in view of Steiner, discloses the fluid reservoir is movable within the main housing (see particularly Fig. 20B – i.e. the reservoir withdraws in the proximal direction) and that the septum and the fluid reservoir move in opposite directions with respect to one another (see generally Fig. 20B – see also Steiner Fig. 4 in consideration as to modification of Fig. 20B of Vouillamoz to replace the collapsible bellows with a telescoping arrangement whereby the septum – generally 360 and modified by Steiner – will move in the distal direction which is opposite to the proximal withdrawal of the reservoir after delivery).
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Regarding Claim 32, Vouillamoz discloses the reservoir further comprises a second septum (902) disposed therein configured to close the first/extraction end of the needle in order to prevent accidental aspiration of the drug upon withdrawal of the needle (Par. 97).
Regarding Claim 33, Vouillamoz discloses the second septum is slidable (see Fig. 20B, i.e. the second septum slides rearward with the reservoir during retraction) and configured to engage with the first/extraction end of the needle after the measured amount of fluid is injected into the living organism, in order to avoid sucking back or aspiration of the injected fluid during the needle's extraction (see Fig. 16C, Par. 97).
Regarding Claim 35, Vouillamoz discloses a mechanism configured to move the needle back out together with the second septum (see 1012 – see Fig. 20B).
Regarding Claim 36, Vouillamoz discloses an anti-reuse structure so that the second end of the needle returns to a position different from the start position deforming the needle and making it impossible to reuse (see Fig. 20B, Par. 60).
Regarding Claim 37, Vouillamoz discloses a window in the main housing exposes a portion of the needle which is flagged with a color, the color moving into view of the window after the injection has taken place to indicated that the injection as occurred (see Par. 105).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0207104 (“Vouillamoz”) in view of FR 1320820 (“Steiner”) and U.S. Patent No. 4,227,528 (“Wardlaw”) as applied above, and further in view of CN 100493638 (“Hu”).
Regarding Claim 31, Vouillamoz discloses the needle and the fluid reservoir move together within the main housing, during the extraction of the needle (see Fig. 20) with the needle lodged into a second septum. Vouillamoz discloses the invention substantially as claimed except that the needle has a “barb” to ensure that upon retraction the needle remains lodged in the second septum. However, Hu discloses a related injection device wherein the needle second end has a bar (272) provided thereon configured to ensure that the needle remains lodged within a septum (13). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the second end of the needle of Vouillamoz with a barb, as disclosed by Hu, in order to ensure that the needle remains effectively embedded within the second septum after injection thereby ensuring that the device cannot be refilled or accidentally aspirate fluids from the patient tissue.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claim(s) 34 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims as well as satisfaction of the outstanding Double Patenting rejection with filing of a Terminal Disclaimer with the offending reference patent. No particular conclusion has been made with respect to any claim which might be amended to depend from Claim 34 if written in independent form and additional time for consideration is necessary to ensure such claims comply with non-prior art statutes under 35 USC 101 and 112.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
10/02/2025