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 .
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses. Specifically reference character (α).
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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.
Claims 1-4 and 7-11 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.
The term “about” in claims 1 and 8 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the limitation that the ridge height is “about ¼ of the neck height” has rendered the claims indefinite. The claims have been examined below as best the Examiner can understand. However, further correction and clarification is required.
The term “substantially” in claims 1 and 8 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the limitation that the maximum width of the ridge “substantially corresponds to the ridge height” has rendered the claims indefinite. The claims have been examined below as best the Examiner can understand. However, further correction and clarification is required.
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.
Claim(s) 1, 7, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wimmer (US 3653528) in view of Albrecht et al. (US 4227617) (hereinafter Albrecht).
Regarding Claims 1 and 11
Wimmer teaches a bottle (below – Fig. 2) for a container for parenterally administrable pharmaceutical products, the bottle (10) comprising a neck (10a), having a neck height, and ending superiorly in an access mouth defined by a radially protruding ridge (10b), having a ridge height and a maximum width; wherein the ridge height is about 1/4 of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, as can be seen in the figure below (Col. 2, Ln. 5-11). Wimmer teaches the ridge is provided with a rounded outer edge, as can be seen in the expanded view of Fig. 2 below.
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Wimmer does not teach the ridge is provided with an upper bevel having an inclination angle between 25° and 35°, or more specifically, an inclination angle of 30°; or the rounded profile having a radius of 0.5mm.
Albrecht teaches a bottle (below – Fig. 4) for a container for parenterally administrable pharmaceutical products, the bottle comprising a neck (42) having a neck height, and ending superiorly in an access mouth defined by a radially protruding ridge (shown below) having a ridge height and a maximum width; wherein the ridge height is about of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, wherein the ridge is provided with an upper bevel (shown at 53) having an inclination angle (α) between 25° and 35°, and wherein the ridge is provided with a lower recess having a rounded profile having a radius of 0.5mm (Col. 4, Ln. 61 – Col. 6, Ln 11).
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Wimmer and Albrecht are analogous inventions in the field of containers for parenterally administrable pharmaceutical products. It would have been obvious to one skilled in the art at the time of filing to modify the ridge of Wimmer with the teachings of the upper bevel of Albrecht as the upper bevel allows for an increased sealing surface between the sealing element and the ridge. [See MPEP 2143(I)(B)].
Regarding the specifics of the upper bevel, at the time of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art for the upper bevel to have an inclination angle between 25° and 35°, or more specifically, an inclination angle of 30°. Applicant has not disclosed that the upper bevel having an inclination angle between 25° and 35°, or more specifically, an inclination angle of 30° provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of the upper bevel having an inclination angle between 25° and 35°, or more specifically, an inclination angle of 30° does not provide patentable distinction over the prior art of record.
Further, it would have been an obvious matter of design choice to a person of ordinary skill in the art, at the time of filing, to have the rounded profile having a radius of 0.5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A). Applicant has not disclosed that the rounded profile having a radius of 0.5mm provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of the rounded profile having a radius of 0.5mm does not provide patentable distinction over the prior art of record.
Regarding Claim 7
Wimmer in view of Albrecht (hereinafter “modified Wimmer”) teaches all the limitations of claim 1 as shown above. Wimmer appears to teach a bottle made of a transparent material (based on the cross-hatching) however, does not specifically teach the bottle is made of glass.
At the time of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the bottle made from glass, as glass is an exceptionally well-known material for transparent medicament flasks. As such, the claim of the bottle being made from glass does not provide patentable distinction over the prior art of record.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over modified Wimmer as applied to claim 1 above, and further in view of Sudo et al. (US 7934613) (hereinafter Sudo).
Regarding Claim 2
Modified Wimmer teaches all the limitations of claim 1 as shown above. Modified Wimmer does not teach the neck has an inner diameter between 7mm and 7.5mm.
Sudo teaches a bottle (below – Fig. 1A-3 and 2C) for a container capable of being used for parenterally administrable pharmaceutical products, the bottle comprising a neck (2), having a neck height (shown below), and ending superiorly in an access mouth defined by a radially protruding ridge (shown below), having a ridge height and a maximum width; wherein the ridge height is about ¼ of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, as can be seen in the figures below (Abstract and Col. 11, Ln. 50-62). Sudo further teaches the neck has an inner diameter of 7mm (Col. 11, Ln. 59-60).
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Modified Wimmer and Sudo are analogous inventions in the field of medical bottles having stoppers for use with syringes. At the time the of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the inner diameter of the neck being between 7mm and 7.5mm, 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. Applicant has not disclosed that the inner diameter of the neck being between 7mm and 7.5mm provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of the inner diameter of the neck being between 7mm and 7.5mm does not provide patentable distinction over the prior art of record. See MPEP 2144.05(II)(A).
Regarding Claim 3
Modified Wimmer teaches all the limitations of claim 1 as shown above. Modified Wimmer does not teach the neck has an inner diameter between 7mm and 7.5mm.
Sudo teaches a bottle (Fig. 1A-3 and 2C) for a container capable of being used for parenterally administrable pharmaceutical products, the bottle comprising a neck (2), having a neck height (shown above), and ending superiorly in an access mouth defined by a radially protruding ridge (shown above), having a ridge height and a maximum width; wherein the ridge height is about ¼ of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, as can be seen in the figures above (Abstract and Col. 11, Ln. 50-62). Sudo further teaches the neck has a maximum outer diameter defined by the ridge, as can be seen above. Sudo does not specifically teach said maximum outer diameter is between 11mm and 12mm. Based on what is shown in the figures, it appears as though Sudo teaches the maximum diameter of the ridge is roughly 12.6mm (Col. 12, Ln. 4-5).
Modified Wimmer and Sudo are analogous inventions in the field of medical bottles having stoppers for use with syringes. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have a maximum outer diameter of the ridge being between 11mm and 12mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, Applicant has not disclosed that a maximum outer diameter of the ridge being between 11mm and 12mm provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of a maximum outer diameter of the ridge being between 11mm and 12mm does not provide patentable distinction over the prior art of record. See MPEP 2144.04(IV)(A).
Regarding Claim 4
Modified Wimmer teaches all the limitations of claim 1 as shown above. Modified Wimmer does not teach the neck has an inner diameter between 7mm and 7.5mm.
Sudo teaches a bottle (Fig. 1A-3 and 2C) for a container capable of being used for parenterally administrable pharmaceutical products, the bottle comprising a neck (2), having a neck height (shown above), and ending superiorly in an access mouth defined by a radially protruding ridge (shown above), having a ridge height and a maximum width; wherein the ridge height is about ¼ of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, as can be seen in the figures above (Abstract and Col. 11, Ln. 50-62). Sudo further teaches the neck has a maximum outer diameter defined by the ridge, as can be seen above. Sudo does not specifically teach said maximum outer diameter is between 11mm and 12mm. Based on what is shown in the figures, and the given diameter for the inside of the neck and the estimated diameter of the ridge, it appears as though Sudo teaches the ridge having a maximum width of roughly 2.8mm [(12.6mm-7mm)/2)] (Col. 11, Ln. 59-60 and Col. 12, Ln. 4-5).
Modified Wimmer and Sudo are analogous inventions in the field of medical bottles having stoppers for use with syringes. It would have been an obvious matter of design choice to a person of ordinary skill in the art, at the time of filing, to have maximum width of the ridge being less than 2.5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, Applicant has not disclosed that a maximum width of the ridge being less than 2.5mm provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of a maximum width of the ridge being less than 2.5mm does not provide patentable distinction over the prior art of record. See MPEP 2144.04(IV)(A).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mutterle (US 10843913) in view of Albrecht et al. (US 4227617) (hereinafter Albrecht).
Regarding Claim 8
Mutterle teaches a container (below – Fig. 5, 6 and Fig. 7, f-4) for parenterally administrable pharmaceutical products, the container comprising: a bottle (1) comprising a neck having a neck height, and ending superiorly in an access mouth defined by a radially protruding ridge having a ridge height and a maximum width, wherein the ridge height is about ½ of the neck height, and the maximum width of the ridge substantially corresponds to the ridge height (see Fig. 6); and a plastic closing device comprising: an inner cage (100) provided with a central opening (101’) and ending in a lower edge at which at least one hook-like ridge (120) is provided for permanent snap engagement with the neck of the bottle below the ridge (at 4c); an outer cap (300) snap-engaged below the lower edge of the inner cage through at least one internally extending relief (320), and provided with tearable weakenings (323) to allow removal of the outer cap by tearing; and a rubber sealing element (200) housed inside the inner cage so that, once the outer cap has been removed, a pierceable portion of said rubber sealing element is accessible from outside through the central opening of the inner cage (Col. 3, Ln. 58 – Col. 4, Ln. 20 and Col. 6, Ln. 30-60).
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Mutterle does not teach the ridge height is about ¼ of the neck height; and the ridge is provided with an upper bevel having an inclination angle (α) between 25° and 35°, and wherein the ridge is provided with a lower recess having a rounded profile having a radius of 0.5mm.
It would have been an obvious matter of design choice to a person of ordinary skill in the art, at the time of filing, to have the ridge height being about ¼ of the neck height, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Further, Applicant has not disclosed that the ridge height being about ¼ of the neck height provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of the ridge height being about ¼ of the neck height does not provide patentable distinction over the prior art of record. See MPEP 2144.04(IV)(A).
Albrecht teaches a container (Fig. 4) for parenterally administrable pharmaceutical products, the container comprising: a bottle comprising a neck (42) having a neck height, and ending superiorly in an access mouth defined by a radially protruding ridge (shown below) having a ridge height and a maximum width, wherein the ridge height is about ¼ of the neck height and the maximum width of the ridge substantially corresponds to the ridge height, wherein the ridge is provided with an upper bevel having an inclination angle, and wherein the ridge is provided with a lower recess having a rounded profile; an inner cage (30) provided with a central opening (33) and ending in a lower edge at which at least one hook-like ridge (52) is provided for permanent snap engagement with the neck of the bottle below the ridge; an outer cap (12); and a rubber sealing element (40) housed inside the inner cage so that, once the outer cap has been removed, a pierceable portion (48) of said rubber sealing element is accessible from outside through the central opening of the inner cage (Col. 4, Ln. 61 – Col. 6, Ln 11).
Modified Mutterle and Albrecht are analogous inventions in the field of containers for parenterally administrable pharmaceutical products. It would have been obvious to one skilled in the art at the time of filing to modify the ridge of modified Mutterle with the teachings of the upper bevel of Albrecht as the upper bevel allows for an increased sealing surface between the sealing element and the ridge. Regarding the lower recess having a rounded profile, it would have been obvious at the time of filing to modify the ridge of modified Mutterle with the teachings of the rounded profile of Albrecht to achieve the predictable result of the at least one hook-like ridge having permanent snap engagement with the neck of the bottle below the ridge [See MPEP 2143(I)(B)].
Regarding the specifics of the upper bevel, at the time of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art for the upper bevel to have an inclination angle between 25° and 35°. Further, it would have been an obvious matter of design choice to a person of ordinary skill in the art, at the time of filing, to have the rounded profile having a radius of 0.5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A). Applicant has not disclosed that the upper bevel having an inclination angle between 25° and 35°, or the rounded profile having a radius of 0.5mm provides an advantage, is used for a particular purpose or solves a stated problem. As such, the claim of that the upper bevel having an inclination angle between 25° and 35°, and the rounded profile having a radius of 0.5mm does not provide patentable distinction over the prior art of record.
Regarding Claim 9
Modified Mutterle in view of Albrecht teaches all the limitations of claim 8 as stated above. Mutterle further teaches an outer diameter of the closing device is smaller than, or at most corresponds to, an outer diameter of the bottle, as can be seen in the figures above.
Regarding Claim 10
Modified Mutterle in view of Albrecht teaches all the limitations of claim 8 as stated above. Mutterle further teaches the bottle and the closing device define a cylindrical shape as a whole, as can be seen in Fig. 7, f-4 above.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 8 have been considered but are moot because the new ground of rejection does not rely on any reference as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Further, regarding the arguments surrounding the upper bevel and lower rounded profile of the container, the Applicant appears to argue their benefits with regards to the method of making vs. the physical structure of the container. As the claims are drawn to the physical structure and not a method of making the container, these arguments appear to be moot.
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 JENNIFER CASTRIOTTA whose telephone number is (571)270-5279. The examiner can normally be reached Monday - Friday 9am-5pm.
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/JENNIFER CASTRIOTTA/Examiner, Art Unit 3733
/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 28 August 2025