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
Claim 6 is objected to because of the following informalities: claims should not utilize the letter “x” as both a variable and a multiplication symbol (claim 6 for example). Appropriate correction is required.
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 4-8 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.
Claim 4 recites the limitation "the outer surface of the curved glass heel". There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the outer surface of the glass tube". There is insufficient antecedent basis for this limitation in the claim.
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.
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langsdorf (EP 3,590,896A1).
In re claims 1, 2, and 3, with reference to Figs. 1 and 3c, Langsdorf discloses: A glass container (100, fig. 1, paragraphs 0001, 0094, comprising: i) a glass tube (paragraph 0001) with a first end, a further end, an outer diameter (dc, fig. 1) and a glass thickness (dw, Fig. 1); ii) a glass bottom (paragraph 0001, Fig. 1) closing the glass tube at the first end and comprising an inner surface directed to an inside of the glass container and an outer surface directed to an outside of the glass container (Fig. 1); and iii) a curved glass heel (at 105, see Fig. 1) extending from an outer end of the glass bottom to the first end of the glass tube; wherein the glass container is characterized by a longitudinal axis (L.sub.tube) that passes through a center of the glass bottom (Fig. 1); wherein for any cut surface of the glass container that is obtainable by cutting the glass container in a plane that includes the longitudinal axis L.sub.tube (see Fig. 1) a minimum thickness (db,min, fig. 3c, paragraph 0025) and a maximum thickness (paragraphs 0024-25 discloses there must be a max thickness) of the glass bottom determined at any position having a distance d.sub.1/4 or less to longitudinal axis L.sub.tube and a thickness (s.sub.d1/4) is the thickness of the glass bottom determined at a position having the distance d.sub.1/4 to the longitudinal axis L.sub.tube (there will be a max and min thickness within that range, paragraphs 0024-25), the distance to the longitudinal axis L.sub.tube in each case being determined in a direction that is perpendicular to the longitudinal axis L.sub.tube and thicknesses s.sub.min, s.sub.max and s.sub.d1/4 being determined in a direction that is parallel to longitudinal axis L.sub.tube (paragraph 0025); wherein the glass container has an overflow capacity of more than 9 ml, wherein the overflow capacity is a maximum volume of liquid that the glass container can hold if filled to the point of overflowing (paragraphs 0095-0103).
Langsdorf fails to disclose wherein the following condition is fulfilled: wherein s.sub.max/s.sub.min is less than 1.8; s.sub.1×s.sub.d1/4 is in a range from 1.1 to 17 mm.sup.2, or the overflow capacity is not more than 20 ml and sixsa1/4 is in a range from 1.1 to 6 mm2;II) the overflow capacity is more than 20 ml and less than 50 ml and sixs1/4 is in a range from 1.4 to 9 mm2;III) the overflow capacity is at least 50 ml and less than 100 ml and sixsa1/4 in a range from 2.3 to 13 mm2; or IV) the overflow capacity is at least 100 ml and sixsa1/4 is in a range from 3 to 17 mm2, and I) the overflow capacity is not more than 20 ml and s1/4 is in a range from 1.8 to 2.7 mm;II) the overflow capacity is more than 20 ml and not more than 50 ml and s1/4 is in a range from 2.1 to 4 mm;III) the overflow capacity is more than 50 ml and not more than 100 ml and s1/4 in a range from 3 to 5 mm; or IV) the overflow capacity is more than 100 ml and s1/4 is in a range from 3 to 5.5 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed range since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results. Langsdorf does not expressly disclose that: smax/sminis less than 1.8 or that s1xsd1/4 is in a range from 1.1 to 6 mm2, or sd1/4 is in a range from 1.8 to 2.7 mm.
With respect to the limitation that smax/smin is less than 1.8, this is a range that could be found through routine experimentation. Smax/Smin is a result effective variable that a person of ordinary skill in the art would have been motivated to optimize via routine experimentation. Langsdorf discloses that the thickness of the bottom varies along the bottom (0024,0025) and is most thin at the center (10024,0025). The claimed ratio (1.8 = 9/5) is saying that the max thickness is no more than 1.8 times the min thickness. Too large or too small of a ratio would use a non-optimal amount of glass to manufacture the bottom.
Therefore, before the claimed invention was effectively filed, it would have been obvious to a person of ordinary skill in the art to have modified the bottom of Langsford glass bottle to include the recited range, because it is an optimal or workable range that could be found through routine experimentation. Further, the applicant has not disclosed any criticality and/or unexpected results to the claimed range. The disclosure does not establish any type of nexus between the claimed range and a supposed benefit.
Further, the would be a reasonable expectation of success in modifying the container because it would only involve changing relative thicknesses which would be well within in the skill of a designer. With respect to the limitation that s1xsd1/4 is in a range from 1.1 to 6 mm2 or sd1/4 is in a range from 1.8 to 2.7 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have s1xsd1/4 is in a range from 1.1 to 6 mm2 or sd1/4 is in a range from 1.8 to 2.7 mm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results
In re claim 4: Langsdorf discloses wherein for any cut surface of the glass container that is obtainable by cutting the glass container in a plane that includes the longitudinal axis Ltube the curved glass heel is defined by an outer radius (ro, fig 4), an inner radius (ri, fig 5) and a thickness of the glass (dh, fig 5) determined at a position at which a tangent line that includes an angle of 45° with the longitudinal axis Ltube touches the outer surface of the curved glass heel, the thickness dh being determined in a direction perpendicular to the tangent line (0104,0105). Langsford does not disclose s1 x ri x sh x sd1/4 is in a range from 0.8 to 7.5 mm4 for a glass container having an overflow capacity of not more than 20 ml. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed range since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claim 5: Langsford discloses lines and a point as claimed (see fig 1), but does not disclose wherein: (s1 x ri x sh x sd1/4)/b is in a range from .4 to 2.5mm3 for a glass container having an overflow capacity of not more than 20ml.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed range since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claims 6 and 7: Langsdorf discloses the lines and point, as recited in the claim (see fig 1), but does not disclose wherein the distance of point P3 to the longitudinal axis Ltube is X, wherein the following condition is fulfilled :X > 0.7/.76 X d1/2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed range since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claim 8: Langsdorf, as applied above, does not disclose wherein the following condition is fulfilled: IA) (s1xrixshx sd1/4)/q is in a range from 0.6 to 1.5mm3 for a glass container having an overflow capacity of not more than 20ml.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed range since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claims 9-12, 15, and 16: Langsdorf does not disclose the recited ranges/values. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed ranges/values since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claim 13: Langsdorf discloses that the following condition is fulfilled: ri+sh-ro>0mm. See in re claims 4 and 5 wherein dh equates to sh.
In re claim 14: Langsdorf does not disclose wherein ri + sh - ro> 0.5 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Langsdorf to have the claimed ranges/values since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Langsdorf. would not operate differently with the claimed range and since the device is a glass bottle that could hold material with any number of different wall thicknesses and dimensions. Further, it appears that applicant places no criticality on the range claimed or disclosed any unexpected results.
In re claim 17: Langsdorf discloses wherein the glass tube is a cylindrical glass tube and the glass bottom is a circular glass bottom (see fig 3).
In re claim 18: Langsdorf discloses wherein the glass container comprises a glass of a type selected from the group consisting of a borosilicate glass, an aluminosilicate glass, soda lime glass and fused silica (paragraph 0089).
In re claim 19: Langsdorf discloses wherein an interior volume of the glass container comprises a pharmaceutical composition (paragraphs 0002,0087,0089).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langsdorf as applied to claim 19 above, and further in view of US PG Pub No. 2022/0168185 (Redkar, of record).
Regarding claim 20: Langsdorf does not disclose that the pharmaceutical composition comprises a sugar, a salt, or a mixture thereof.
Redkar discloses a very similar glass container (10035, fig 1) for containing an mRNA-vaccine (10058).
Further, is taking Official Notice that it is known in the art that mRNA vaccines include sugar and salts.
Before the claimed invention was effectively filed, it would have been obvious to a person of ordinary skill in the art to have made the pharmaceutical composition of Langsdorf an mRNA-vaccine, as taught by Redkar, because a glass container is an effective means of transporting MRNA-vaccines and because it would be desirable to transport the vaccines so that they could be given to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW T KIRSCH whose telephone number is (571)270-5723. The examiner can normally be reached Mon-Fri, 9a-5p EST.
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/ANDREW T KIRSCH/ Primary Examiner, Art Unit 3733
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