DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed 5/10/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 13/829,254 does not appear to correspond to US 9,669,165. It appears that the correct application number is 13/829,251. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 7, 8, 11 and 18 are objected to because of the following informalities:
Regarding claim 1, line 12, the limitation “surf ace” appears to be amended to recite “surface” in order to remove unnecessary spacing.
Regarding claim 7, last line “o-ring” appears to be amended to recite “front o-ring” for the purpose of referring the same limitation consistently in the entire claim.
Regarding claim 8, lines 2 and 3, the recitation “the o-ring” appears to be amended to recite “the front o-ring” in order to refer to the same limitation consistently in the entire claim.
Regarding claim 11, the recitation “it” appears to be replaced with the intended feature being referred in order to clearly indicate the referenced feature.
Regarding claim 18, line 2, the recitation “a gas-tight seal” appears to be amended to recite “the gas-tight seal” in order to refer to “a gas-tight seal” recited in claim 17, line 9.
Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 2 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 2 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 3 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 3 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 4 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 4 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 5 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 6 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 6 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 7 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 7 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 8 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 8 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 9 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 9 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 10 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 10 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 11 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 11 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 12 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 12 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 13 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 13 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 14 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 14 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 15 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 15 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim 16 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 16 of prior U.S. Patent No. 10,195,350. This is a statutory double patenting rejection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 17, 18 and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bisegna et al. (US 2007/0219508 A1).
Regarding claim 17, Bisegna teaches a syringe 100 (figure 1F) for use in a drug infusion system 200, the syringe 100 comprising:
a barrel (barrel of element 100) having a front end (see “F” in figure 1F below), a rear end (see “R” in figure 1F below), and a cylindrical wall (wall of element 100) defining an outer surface (outer surface of element 100) and an inner surface (inner surface of element 100), the rear end (“R” in figure 1F below is construed to be open in order to element 220 extend) being open, and the front end (see “F” in figure 1F below) including an orifice (see “O” in figure 1F below);
a plunger 50 within the barrel, the plunger 50 including a front end (end comprising element 54) and defining an external seal surface (surface of element 50 covered by element 30); and
an overmolded seal 20 constructed of one of a thermoplastic rubber and a thermoplastic elastomer (paragraph 0050, lines 4-14) covering the front end (end comprising element 54) of the plunger and the external seal surface, the overmolded seal covering the front end of the plunger to define a contact surface (surface of element 40) over the front end of the plunger, and a radially-extending wiper (see “W” in figure 1F below) that creates a gas-tight seal (surface of “W” in figure 1F below touching the interior surface of element 100 would create a gas-tight seal) between the inner surface of the barrel and the plunger 50,
wherein a product chamber (hollow portion inside element 100) is defined between the inner surface of the barrel (inner surface of element 100), the radial wiper (see “W” in figure 1F below) of the overmolded seal, and the contact surface (surface of element 40),
wherein the product chamber (hollow portion inside element 100) is adapted to contain a product (paragraph 0054, lines 1-3, “fluid”) to be dispensed by the syringe 100,
wherein actuation of the plunger 50 within the barrel decreases the volume of the product chamber to dispense the product through the orifice (element 50 could be actuated to dispense the product), and
wherein the radial wiper (see “W” in figure 1F below, since “W” in figure 1F is made of the claimed material, the “W” in figure 1F is capable to maintain gas tight seal through a claimed temperature range) is sized to maintain the gas tight seal through a temperature range of -25° C. to 40o C.
PNG
media_image1.png
757
590
media_image1.png
Greyscale
Regarding claim 18, Bisegna teaches the overmolded seal 20 is molded over the front end of the plunger 50 to ensure a gas-tight seal between the overmolded seal 20 and the external seal surface of the plunger 50.
Regarding claim 20, Bisegna teaches wherein a rear end (see “RE” in figure 1C below) of the plunger 50 includes an integrally-formed molded ring (see “RG” in figure 1C below) having a maximum outer diameter (outer diameter of element “RG” in figure 1C below) that is slightly less than an inner diameter of the barrel (see figure 1F where element 50 is having a diameter slightly less than an inner diameter of the barrel) such that the integrally-formed molded ring (see “RG” in figure 1C below) fits within the barrel with close tolerances, and wherein the radially-extending wiper (see “W” in figure 1F above) and the integrally-formed molded ring resist tipping of the plunger within the barrel (“W” in figure 1F above and “RG” in figure 1C below are capable to resist tipping of the plunger within the barrel).
PNG
media_image2.png
402
266
media_image2.png
Greyscale
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.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bisegna et al. (US 2007/0219508 A1) in view of Chong et al. (US 2009/0326458 A1) and further in view of Niedospial, Jr. (US 2003/0097096 A1).
Regarding claim 19, Bisegna discloses the claimed invention substantially as claimed, as set forth above in claim 17. Bisegna discloses a second seal see “S” in figure 1F above) but is silent regarding the plunger includes a rear circumferential seal gland axially spaced to the rear of the overmolded seal, the syringe further comprising a rear o-ring made of a diene rubber compound, wherein the rear o-ring is positioned in the rear seal gland, and wherein the rear o-ring creates a gas-tight seal between the inner surface of the barrel and the plunger.
However, Chong teaches a design of a plunger (figures 10A, 14A, 15A) in different embodiments with different number of sealing elements comprising the plunger 622 (figure 15A) includes a rear circumferential seal gland 625 (closest to element 626) spaced to the rear of the seal 624 (closest to element 622), the syringe 600 comprising a rear o-ring 624 (closest to element 626), wherein the rear o-ring 624 is positioned in the rear seal gland 625, and wherein the rear o-ring 624 (is capable to create gas-tight seal) creates a gas-tight seal between the inner surface of the barrel 610 and the plunger 620 for the purpose of using a well-known alternative form of improving, maintaining or adding seal contact between the plunger and the barrel (paragraph 0138, figure 15A).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the plunger of Bisegna to incorporate the plunger includes a rear circumferential seal gland axially spaced to the rear of the seal (overmolded), the syringe further comprising a rear o-ring, wherein the rear o-ring is positioned in the rear seal gland, and wherein the rear o-ring creates a gas-tight seal between the inner surface of the barrel and the plunger for the purpose of using a well-known alternative form of improving, maintaining or adding seal contact between the plunger and the barrel (paragraph 0138, figure 15A).
While Chong discloses in paragraph 0138 that element 624 could be made of a rubber, Chong (and therefore Bisegna/Chong) fails to explicitly recite o-ring made of a diene rubber compound.
However, Niedospial, Jr. teaches a design of a syringe wherein a plunger ring is made of a diene rubbber compound (paragraphs 0151-0156) for the purpose of using a well-known material to perform gas tight sealing within the syringe (paragraph 0148).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the material of the o-ring of Bisegna/Chong to incorporate o-ring made of diene rubber compound as taught by Niedospial, Jr. for the purpose of using a well-known material to perform gas tight sealing within the syringe (paragraph 0148).
Allowable Subject Matter
Claims 1-16 are would be allowable if these claims overcome the double patenting rejection as set forth in the current Office Action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Alheidt (US 2005/0154353 A1) in view of Hoffmann et al. (US 2009/0166978 A1) discloses a syringe comprising a barrel having a tapered front end, a rear end, and a cylindrical wall defining an outer surface and an inner surface, a plunger within the barrel, the plunger including a continuous contact surface tat a front end of the plunger, a front o-ring positioned in the front seal gland, wherein the front o-ring is sized to maintain the gas tight seal through a temperature change within a temperature range of -25oC to 40oC but is silent regarding a rear seal gland extending circumferentially around the plunger between the front seal gland and the rear end of the plunger, the tapered outer surface increasing in diameter from a surface of the rear seal gland to the rear end of the plunger in combination with other claimed limitations of claim 1.
Claims 2-16 being dependent on claim 1 are also indicated allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alder et al. (US 2009/0312716 A1): discloses a design of a plunger having a protrusion in the rear end to assist the plunger to remain in central portion of the syringe barrel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights