DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions/Response to Amendment
Applicant’s election without traverse of Group III (Claims 15-30) in the reply filed on 4/28/2026 is acknowledged.
Claims 1-6, 8-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/29/2023 and 1/31/2024 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities:
-Claim 17, line 2 recites “the opening.” but this should instead be recited as “the opening of the elongated drug reservoir lumen”.
- Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15-19, 22, 23, and 25-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Cima (US PGPUB 2009/0149833-cited in IDS), in view of Billeter (US Patent 4,731,054-cited in IDS) and in further view of Yagyu (US PGPUB 2009/0241482).
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
Regarding Claim 15, Cima discloses a method for assembling a drug delivery device (10; Figure 1), the method comprising:
pushing a drug rod (34; Figure 3B) into an opening of an elongated drug reservoir lumen (30, 12; loading the rod per Para. 0144, 0147);
inserting a retention frame (elastic wire 16; Figure 1) into an opening of an elongated retention frame lumen (sheath 18) of the body (18, 12/30) of the drug delivery device (10; Para. 0113 outlines 18 as a sheath which readily at least implies that the wire 16 is inserted therein); and then
sealing the openings of the elongated drug reservoir lumen (30 via 35; Para. 0068, 0078, 0144) and the elongated retention frame lumen (via the wire 20 and epoxy 22 which assist in retaining the wire 20 in place; Para. 0114; note in order to retain the wire 16 within the lumen 18 thereof, the wire must be sealed therein via the end wire 20/epoxy 22 or some other sealing manner).
However, Cima fails to explicitly disclose the drug rod being a plurality of drug tablets and does not disclose aligning a plurality of drug tablets, adjacent to an opening of an elongated drug reservoir lumen of a body of the drug delivery device.
First, attention is brought to Billeter which teaches a drug delivery device (Figure 3) which includes a plurality of medicine carriers (2; Figure 3) in the form of tablets (2; Figure 3 clearly shows the carriers in tablet form and note Col 1, lines 35-40 and Col 5, lines 10-13 outline such carriers having a strength “to prevent crumbling” thereby if such carriers are able to crumble at a certain force, such must be in tablet type form).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the drug rod of Cima to be embodied as tablets as taught by Billeter. By utilizing tablets instead of a drug rod, the drug delivery device will be further flexible and therefore leading to less mechanical irritation so that the device can be pushed with greater ease into the body as taught by Billeter (Col 1, lines 41-45, 65-68).
Second, attention is brought to the teachings of Yagyu which outlines a method for filling a drug delivery device (in the form of a capsule) wherein a plurality of drug tablets (t; Figures 18-19) are aligned (within holes 211 of disk 21) adjacent to an opening of a lumen (m) of a body of the drug delivery device (capsule) and loaded into the lumen (m; Para. 0089-0091 and 0096-0097).
Aligning tablets prior to loading into a corresponding receptacle is known in the art as outlined by Yagyu. It would have been obvious to one of ordinary skill in the art at the time was effectively filed to have loaded the tablets (of Billeter) incorporated into Cima in the aligned manner as taught by Yagyu. By loading the tablets in this manner, a predetermined number of tablets can be readily filled/loaded in a stable manner in a flat state and the occurrence of the tablet from being moved to a standing state can readily prevented as taught by Yagyu (Para. 0012, 0103-0105).
Regarding Claim 16, Cima, as modified, discloses the plurality of drug tablets are aligned in a channel (holes 211 of disk 21 of Yagyu) of a holder (21 of Yagyu).
Regarding Claim 17, Cima, as modified, discloses the aligning comprises placing an end of the channel (of 211 of Yagyu) in communication with the opening (see Figure 18 of Yagyu which shows opening of “m” being matched with the channel 211) .
Regarding Claim 18, Cima, as modified, discloses the drug tablets (“t” of Yagyu) have planar end faces and the aligning comprises positioning the tablets (“t”) end-to-end such that the planar end faces are in contact with planar end faces of adjacent drug tablets (“t”) in the channel (211 of Yagyu; see Figure 18 and Para. 0103-0105 of Yagyu).
Regarding Claim 19, Cima, as modified, discloses the holder (21 of Yagyu) comprises a base portion (disk body 22) and a cover portion (forming member 23) that define the channel (211; see Figure 19A-19B of Yagyu).
Regarding Claim 22, Cima, as modified, discloses several features of the claimed invention but does not readily disclose the plurality of drug tablets comprises from 10 to 100 drug tablets. It is further noted that Billeter teaches an embodiment (Figure 3) that includes eight depicted tables. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have utilized 10 to 100 tablets, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations. See MPEP 2144.05(II)(A).
Regarding Claim 23, Cima, as modified, discloses several features of the claimed invention but does not readily disclose the pushing comprises manual use of a push rod. However it would have been obvious to one having ordinary skill in the art at the time the invention was effectively to have manually pushed the tablets, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations.
Regarding Claim 25, Cima, as modified, discloses the sealing comprises filling the openings with an adhesive and/or with a spacer (30 via 35; Para. 0068, 0078, 0144; and via the wire 20 and epoxy 22 which assist in retaining the wire 20 in place; Para. 0114; note in order to retain the wire 16 within the lumen 18 thereof, the wire must be sealed therein via the end wire 20/epoxy 22 or some other sealing manner).
Regarding Claim 26, Cima, as modified, discloses the body comprises an elastomeric dual lumen tube (12, 14 shown in Figure 1).
Regarding Claim 27, Cima, as modified, discloses the dual lumen tube is made of silicone (see Para. 0073; “silicone sheath” 18; Para. 0113).
Regarding Claim 28, Cima, as modified, discloses the retention frame comprises a nitinol wire (Para. 0012, 0112).
Regarding Claim 29, Cima, as modified, discloses the plurality of drug tablets are mini-tablets (“t” of Yagyu can be clearly viewed as mini tablets as such fit within a capsule).
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Cima (US PGPUB 2009/0149833-cited in IDS), in view of Billeter (US Patent 4,731,054-cited in IDS) and Yagyu (US PGPUB 2009/0241482), as applied to Claim 15, and in further view of Pollard (US Patent 6,631,826).
Regarding Claim 24, Cima, as modified, discloses several features of the claimed invention but does not readily disclose the pushing comprises application of pressurized gas or vacuum.
Attention is brought to Pollard which outlines a tablet dispensing device (10; Figure 1) which utilizes an application of pressurized gas (from 24; Figure 3B) to push tablets (A) from at outlet (22; Col 6, lines 24-48).
Utilizing pressurized gas/vacuum systems to convey tablet type articles to a destination has been known in the art. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized a pressurized gas pushing system as taught by Pollard in the method of Cima as such would allow for singulating and pushing in a fast and reliable manner as taught by Pollard (Col 1, lines 51-53).
Alternatively, Claims 15-19, 22, 23, and 25-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Cima (US PGPUB 2009/0149833-cited in IDS), in view of Whitehead (US Patent 4,863,455) and in further view of Yagyu (US PGPUB 2009/0241482).
Alternatively regarding Claim 15, Cima discloses a method for assembling a drug delivery device (10; Figure 1) comprising several claimed limitations (see previous 103 rejection).
However, Cima fails to explicitly disclose the drug rod being a plurality of drug tablets and does not disclose aligning a plurality of drug tablets, adjacent to an opening of an elongated drug reservoir lumen of a body of the drug delivery device.
First, attention is brought to Whitehead which teaches a drug delivery device (Figures 1, 3) which includes either a single drug core (3; Figure 1) or a core embodied as a plurality of tablets (A, B; Col 4, lines 29-41).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the drug rod of Cima to be embodied as tablets as taught by Whitehead. By utilizing tablets instead of a drug rod, the drug delivery device will be capable of delivering different drugs within the same device as taught by Whitehead (Col 4, lines 29-41).
Second, attention is brought to the teachings of Yagyu which outlines a method for filling a drug delivery device (in the form of a capsule) wherein a plurality of drug tablets (t; Figures 18-19) are aligned (within holes 211 of disk 21) adjacent to an opening of a lumen (m) of a body of the drug delivery device (capsule) and loaded into the lumen (m; Para. 0089-0091 and 0096-0097).
Aligning tablets prior to loading into a corresponding receptacle is known in the art as outlined by Yagyu. It would have been obvious to one of ordinary skill in the art at the time was effectively filed to have loaded the tablets (of Whitehead) incorporated into Cima in the aligned manner as taught by Yagyu. By loading the tablets in this manner, a predetermined number of tablets can be readily filled/loaded in a stable manner in a flat state and the occurrence of the tablet from being moved to a standing state can readily prevented as taught by Yagyu (Para. 0012, 0103-0105).
Regarding Claims 16-19, 22, 23, and 25-29 see the previous 103 rejection.
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Cima (US PGPUB 2009/0149833-cited in IDS), in view of Whitehead (US Patent 4,863,455) and Yagyu (US PGPUB 2009/0241482), as applied to Claim 15, and in further view of Pollard (US Patent 6,631,826).
Regarding Claim 24, Cima, as modified, discloses several features of the claimed invention but does not readily disclose the pushing comprises application of pressurized gas or vacuum.
Attention is brought to Pollard which outlines a tablet dispensing device (10; Figure 1) which utilizes an application of pressurized gas (from 24; Figure 3B) to push tablets (A) from at outlet (22; Col 6, lines 24-48).
Utilizing pressurized gas/vacuum systems to convey tablet type articles to a destination has been known in the art. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized a pressurized gas pushing system as taught by Pollard in the method of Cima as such would allow for singulating and pushing in a fast and reliable manner as taught by Pollard (Col 1, lines 51-53).
Allowable Subject Matter
Claim 30 is allowed.
Claims 20 and 21 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 20, Cima, as modified, discloses the elongated drug reservoir lumen (30, 12) is defined by elastic body (elastomeric tube 30; Para. 0068) but does not readily disclose a pressurized gas is used to expand the elastic body while the plurality of drug tablets are pushed into the opening of the elongated drug reservoir lumen.
While other references such as Pollard (US Patent 6,631,826) disclose gas system for conveying tablets, such gas supply is not intended to expanding an elastic body such as that of Cima and further references such as Smaw (US Patent 4,018,031) teach using gas to expand a packaging while pushing articles therein (see Figures 19-23), however, this system is intended for packaging paper products within a packaging such as a bag and it would not have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the invention of Cima to include such a gas expansion system of Smaw without the use of improper hindsight and further, it is not readily clear that such a system of Smaw would be capable of expanding such elastic lumens of Cima without further structural modifications.
Regarding Claim 30, the claim recites similar limitations to that of Claim 20 and therefore is viewed as allowable for same reasonings.
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. See “Notice of References Cited”.
-Lucke (US Patent 4,183,194), Blattner (US PGPUB 2011/0262603), Petersen (US Patent 4,203,269), disclose pressurized gas systems for expanding a packaging and pushing systems for pushing articles into expanded packaging.
Karwacki Jr. (US PGPUB 2009/0272758), Williams (US Patent 6,971,541), Saito (US Patent 6,443,326), Hoogers (US Patent 7,284,934), Faller (US Patent 4,627,225) disclose gas/vacuum pushing systems for tablets.
Magruder (US Patent 5,174,999), Wong (US Patent 5,391,381), Grislain (US Patent 5,433,958), Holmes (US Patent 8,734,430), and Leech (US PGPUB 2011/0287081) and Whitehead (US PGPUB 2009/0148485) disclose a drug delivery system with tablets therein.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 5/26/2026
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