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 .
Election/Restrictions
Applicant's election with traverse of claims 1-16 in the reply filed on 04/23/2026 is acknowledged. The traversal is on the grounds that the process for preparing a glass syringe barrel of non-elected Group II would not impose a serious burden on the . This is not found persuasive because there would need to be different search queries to find both how a glass syringe barrel is to look and a process for molding a glass syringe. Although both Groups discuss glass syringe barrels, there exist different areas of search for manufacturing and making syringes, and details of syringes. Particularly, the process as claimed in claim 17 is so broad that it may produce any glass syringe, and not specifically the glass syringe as claimed in claim 1. Therefore, the arguments are not convincing.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/26/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because in FIG. 5, the right extending arrow for d2, the outer diameter of the flange region, does not extend to the correct boundary line. Instead the right extending arrow extends one boundary line short, sharing the boundary line with d”, which is the distance between P’1 and P”1.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Paragraphs [0011] and [0045] recite the function “f(xmax)”. It is confusing to the examiner if this function is supposed to be the same as “f’(xmax)”, “f(x)max”, or an entirely new function. The examiner suggest correcting the function or including the new function in the drawings. For the purposes of examination, the examiner will interpret the function to be the same as “f(x)max”.
Paragraph [00121] states “…a position x (with f’(x) = 0 at point P2), The glass syringe barrel…”. The comma after the paratheses should be corrected to be a period, in order to properly begin the next sentence.
Paragraph [00121] states “…point P3 being located vertically above point P1(=thickness of the flange region at its deepest point).”. For clarity purposes of what the information within the parentheses is referring to, the examiner suggest modifying the sentence to state “point P3 being located vertically above point P1, P1 equaling the thickness of the flange region at its deepest point.
Paragraph [00122] states “FIG. 4 shows in a further a cross-sectional enlarged view…”’ To fix grammatical errors, the beginning of the sentence should be restructured to state “FIG. 4 shows in a further cross-sectional enlarged view…”.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: A majority of the information included under the heading “SUMMARY” beginning on page 2 of the specification is improperly included within a Summary section, as per MPEP § 608.01(d). Particularly, preferred embodiments of the invention belong within a “DETAILED DESCRIPTION OF THE INVENTION” section, as per MPEP § 608.01(g). The examiner suggest reviewing the content included in both the “SUMMARY” section beginning on page 2 of the specification and the “DETAILED DESCRIPTION” section beginning on page 28 of the specification, and appropriately rearranging the content of the sections to align with that set forth in the MPEP. For quick reference, brief synopses of both sections have been included in this office action below.
Appropriate correction is required.
BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses.
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). Further, it is confusing to the examiner when at some points the reference characters are put in parentheses, but then later uses do not put the reference character in parentheses.
These reference characters include:
fo – claim 1 lines 19, 24, and 25, claim 5 line 3, claim 6 line 2.
f’o – claim 1 lines 21 and 30, claim 9 line 2.
x – claim 1 lines 24 and 30, claim 10 line 6.
P1 – claim 1 line 24, claim 4 lines 1 and 3.
P0 - claim 1 line 25.
L1 - claim 1 line 26.
P2 – claim 1 line 30.
D1 – claim 4 line 1.
P3 – claim 4 line 2.
D2 – claim 4 line 3.
d’ – claim 5 lines 1 and 4.
x’max – claim 5 lines 1 and 3.
x”max – claim 5 lines 2 and 3.
d” – claim 6 line 1, claim 7 line 1.
P’1 – claim 6 line 1, claim 10 line 2.
P”1 – claim 6 line 2, claim 10 lines 3 and 6.
xmax – claim 9 line 2.
α – claim 9 lines 2.
L2 – claim 10 lines 2 and 8.
L3 – claim 10 lines 5 and 8.
β – claim 10 line 8.
Claim 4 is objected to because of the following informalities: In the first line of claim 4, the claim states "D1". Based on other mentions of this distance reference character, the "1" should be correct as a subscript, so as to read "D1". Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The claim states “an angle β of less than 3 degree.”. Since 3 is plural, proper grammar suggest that “degree” should be “degrees”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The claim states “wherein at least one of the following conditions is fulfilled”. The use of “at least one” is broad in the sense that “at least” is an unspecified sum. The examiner suggest adding specificity to the claim language to avoid such a broad interpretation of the claim. Appropriate correction is required. For the purposes of examination, the examiner will interpret “at least one” to mean one or more.
Claim 16 is objected to because of the following informalities: The claim appears to be missing a period after the word “glass” to end the sentence. 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.
Claims1-16 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 1 recites the limitation "f'(xmax)" in the thirty-first line of the claim. There is insufficient antecedent basis for this limitation in the claim. Although the limitation does not have “the” in front of it, there has been no prior introduction in the claim regarding the limitation.
Claim 10 recites the limitation "the deepest point P'1" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the deepest point P"1" in the third and sixth lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-16 are included in the rejection for depending either directly or indirectly upon a rejected claim.
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.
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.
Claims 1-12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Oberhänsli et al. (United States Patent Application Publication No. US 2021/0085877 A1; herein, Oberhänsli).
Regarding claim 1, Oberhänsli discloses a glass syringe barrel (glass syringe barrel 100), comprising:
a bottom end through which a liquid can be ejected (top end 102);
a top end into which a plunger stopper can be pushed (bottom end 103); and
a longitudinal axis defined through the bottom and top ends (FIG. 6B, FIG. 8, [0107], longitudinal axis Lbarrel);
wherein the glass syringe barrel, in a direction from the bottom end to the top end, includes:
a cone region (FIG. 2, cone region 105) having a first end that corresponds to the bottom end (FIG. 2, first end of the cone region 106) and a second end (FIG. 2, second end of the cone region 107);
a shoulder region (FIG. 2, shoulder region 111) having a third end adjacent to the second end (FIG. 2, first end of the shoulder region 112) and a fourth end (FIG. 2, second end of the shoulder region 113);
a body region (body region 114) with a first outer diameter (diameter of body region d2) having a fifth end that is adjacent to the fourth end (FIG. 2, first end of the body region 115) and a sixth end (Annotated on FIG. 1 below); and
a flange region (Annotated on FIG. 1 below) having, at least in parts, a circular shape (FIG. 6B), the flange region having a seventh end that is adjacent to the sixth end (Annotated on FIG. 1 below) and an eighth end that corresponds to the top end (second end of the body region 116), wherein the flange region has a second outer diameter (Annotated on FIG. 1 below), the second outer diameter being larger than the first outer diameter (See annotated FIG. 1, the distance between the outer ends of the flanges is larger than the distance between one side of the body region to the other).
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In the enlarged view of a part of the flange region of FIG. 1 below (Figure 1A) , Oberhänsli teaches a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). The enlarged view of a part of the flange region shows the flange region has a first outer contour at the seventh end (Annotated on Figure 1A below) and a second outer contour at the eighth end (Annotated on Figure 1A below); wherein for any cut surface that includes the longitudinal axis and is obtainable by cutting the glass syringe barrel in a plane at which a shape of the flange region is circular: fo is a straight line that runs perpendicular to the longitudinal axis (Annotated on Figure 1A below) and touches the first outer contour at a deepest point (Annotated on Figure 1A below), f'o is a straight line that runs perpendicular to the longitudinal axis (Annotated on Figure 1A below) and touches the second outer contour at a highest point (Annotated on Figure 1A below).
However, Oberhänsli does not explicitly disclose f(x) defines an absolute value of a vertical distance between any point of the first outer contour and the straight line fo at a position x, with f(x) = 0 at point P1, wherein x is a horizontal distance between any given point on the straight line fo and point Po at which the straight line fo crosses a line L1 that runs parallel to the longitudinal axis and that touches an outer surface of the body region, and a maximum value for the term f(x) in a range from x = Po to x = P1 is f(x)max determined at position xmax; wherein f'(x) defines an absolute value of the vertical distance between any point of the second outer contour and the straight line f'o at a position x, with f(x) = 0 at point P2, and wherein the following condition is fulfilled: f'(xmax)/f(x)max > 1.
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 flange region of Oberhänsli to specify functions, such as f(x) and f’(x), and distances, such as x and xmax, in order to meet the ratio of f'(xmax)/f(x)max > 1 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.2d1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the flange region of Oberhänsli would not operate differently with the claimed functions, distances, and ratio and since the first outer contour is supposed to have a more defined curvature that the second outer contour the flange region would function appropriately having the specified claimed functions, distances, and ratio. Oberhänsli also teaches the flange region as a finger flange ([0059], [0066], [0082], [0113]), which is shaped in a way that a plunger stopper can be pushed ([0066]) without opposition, and known in the art to provide support against mechanical strength created when pushing on the plunger. Further, it appears that the applicant places no criticality on the ratio claimed, indicating the condition of the ratio needs to be fulfilled by the design, but offers other preferable ratio options ([0009], [0042], [0098]). The same goes for the function and distance values, as those are determined by how the contour is shaped, there is no criticality mentioned regarding the curvature and shape of the contour.
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Figure 1A: An enlarged view of a part of the flange region of FIG. 1
Regarding claim 2 and 3, Oberhänsli discloses in Figure 1A above a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). Figure 1A, which is of a similar shape to that in the instant application, has been annotated with various points and lines that play a role in calculating f’(xmax) and f(x)max.
However, Oberhänsli does not explicitly disclose f’(xmax) is in a range from 0.15 to 0.7mm and f(x)max is in a range from 0.01 to 0.65mm.
There is no evidence that establishes changing the length of f’(xmax) and f(x)max would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, the applicant has not disclosed that the claimed ranges solve any stated problem, indicating that the ranges are within that claimed amounts, but offering other preferable ranges ([0010], [0011], [0044], [0045]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to have f’(xmax) is in a range from 0.15 to 0.7mm and f(x)max is in a range from 0.01 to 0.65mm as an obvious matter of design choice within the skill of the art in order to create the proper curvature of the first and second outer contours.
Regarding claim 4, Oberhänsli discloses in Figure 1B below a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). Figure 1B, which is of a similar shape to that in the instant application, has been annotated with various points and lines.
However, Oberhänsli does not explicitly disclose D1 is a distance between the point P1 on the first outer contour and a point P3 on the second outer contour, wherein the point P3 is located vertically above point P1 and D2 is a distance between a point of the first outer contour and the outer contour at position xmax and wherein the following condition is fulfilled: D1/D2< 1.6.
There is no evidence that establishes changing the length of D1 and D2 would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed ratio solves any stated problem, indicating that the ratio needs to be fulfilled by the design, but offers other preferable ratio options ([0012], [0041]) and therefore there appears to be no criticality placed on the ratio as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to have distances separating points on the first and second contours that meet the condition D1/D2< 1.6 as an obvious matter of design choice within the skill of the art in order that the flange meet a certain thickness.
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Figure 1B: An enlarged view of a part of the flange region of FIG. 1
Regarding claims 5, 6, and 7, Oberhänsli discloses in Figure 1C below a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). Figure 1C, which is of a similar shape to that in the instant application, has been annotated with various distances between the opposing flanges.
However, Oberhänsli does not explicitly disclose d' is a distance between point x'max on a left side of the flange region and point x"max on a right side of the flange region on the straight line fo, x'max and x"max corresponding to points at which the function f(x) reaches a maximum value on the left side and the right side, wherein d' is in a range from 12.5 to 15 mm, d" is a distance between point P'1 on a left side of the flange region and point P"1 on a right side of the flange region on the straight line fo, wherein d"/d2 is in a range from 0.8 to 0.95, and d" is in a range from 8 to 20 mm and the second outer diameter is in a range from 12 to 22 mm.
There is no evidence that establishes changing the length of d’, d”, or the second outer diameter would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed ranges solve any stated problem, indicating that the ranges are within the claimed amounts, but offers other preferable range options ([0015], [0016], [0017], [0049], [0050], [0051]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to have distances separating points at opposing sides of the flange region as an obvious matter of design choice within the skill of the art in order that the glass syringe barrel meet a specific width to fit within a nest box.
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Figure 1C: An enlarged view of the flange region of FIG. 1
Regarding claim 9, Oberhänsli discloses in Figure 1D below a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). Figure 1D, which is of a similar shape to that in the instant application, has been annotated with various points and lines.
However, Oberhänsli does not explicitly disclose a tangent that touches the second outer contour at position xmax includes an angle α with the straight line f'o and wherein the angle α is in a range from 10 to 28 degrees.
There is no evidence that establishes changing the angle of a tangent would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed range solves any stated problem, indicating that the range is within the claimed amounts, but offers other preferable range options ([0018], [0052]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to have an angle of a tangent touching the second outer contour between 10 to 28 degrees as an obvious matter of design choice within the skill of the art in order to properly curve the upper side of the flange.
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Figure 1D: An enlarged view of a part of the flange region of FIG. 1
Regarding claim 10, Oberhänsli discloses in Figure 1E a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). Figure 1E, which is of a similar shape to that in the instant application, has been annotated with various points and lines.
However, Oberhänsli does not explicitly disclose L2 is a straight line that touches the deepest point P'1 of the first outer contour on the left side of the flange region and the deepest point P"1 of the first outer contour on the right side of the flange region; L3 is a straight line that touches the first outer contour on the left side of the flange region at a position x at which f(x) reaches the maximum value f(x)max and the deepest point P"1 of the first outer contour on the right side of the flange region; and the straight lines L2 and L3 enclose an angle β of less than 3 degrees.
There is no evidence that establishes changing the position of the lines and points, as well as the angle of a tangent would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed range solves any stated problem, indicating that the range is within the claimed amounts, but offers other preferable range options ([0019], [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to position lines that touch points on the flanges to enclose an angle of a tangent being less than 3 degrees as an obvious matter of design choice within the skill of the art in order to equally align the opposing flanges.
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Figure 1E: An enlarged view of the flange region of FIG. 1
Regarding claims 8 and 11, Oberhänsli discloses in FIG. 1 above a flange formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). FIG. 1, which is of a similar shape to that in the instant application, has been annotated with various points and lines.
However, Oberhänsli does not explicitly disclose the first outer diameter is in a range from 6 to 20 mm and the second outer diameter minus the first outer diameter in a range from 5 to 8 mm.
There is no evidence that establishes changing the diameters of the flange and body would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed range solves any stated problem, indicating that the range is within the claimed amounts, but offers other preferable range options ([0020]-[0021], [0054]-[0055], [0078]-[0090]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the widths of the body region and flange region of Oberhänsli so that the second outer diameter minus the first outer diameter in a range from 5 to 8 mm as an obvious matter of design choice within the skill of the art in order that the flange remains somewhat compact in reference to the body for fitting into a nest box.
Regarding claim 12, Oberhänsli discloses the flange region, in a plane that is perpendicular to the longitudinal axis, has the shape of a circle or the shape of a circle where two opposite sections of the circle have been removed (FIG. 1, visual analysis of a part of the flange region shows a relative circular shape, with a section of the circle being removed in order for the flange region to flow into the body region seamlessly).
Regarding claim 15, Oberhänsli discloses a syringe (FIG. 1, all components) comprising: the glass syringe barrel of claim 1 (glass syringe barrel 100); and a plunger stopper pushed into the top end (plunger stopper 104).
Regarding claim 16, Oberhänsli discloses a pharmaceutical composition in the glass syringe barrel ([0060], [0070], “a pharmaceutical composition that is contained in the glass syringe can be squeezed out of the glass syringe barrel”).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Oberhänsli as applied to claim 1 above, and further in view of Kochansky et al. (United States Patent No. Des. 354,351; herein, Kochansky).
Regarding claims 13 and 14, Oberhänsli discloses a glass syringe barrel of claim 1 (glass syringe barrel 100). Oberhänsli does not disclose a nest box comprising: a plurality of the glass syringe barrels of claim 1, wherein at least one of the following conditions is fulfilled: a relative standard deviation of a flange thickness is less than 6%; and a relative standard deviation of a length of the glass syringe barrels is less than 12%, and wherein both conditions are fulfilled.
However, Kochansky teaches a nest box (FIG. 1, syringe organizer tray), comprising: a plurality of the glass syringe barrels (FIG. 7, syringes organized within the syringe organizer tray). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glass syringe disclosed by Oberhänsli to be a plurality of syringes stored within a nest box as taught by Kochansky in order that the syringe be stored in an organized manner.
Oberhänsli discloses in FIG. 1 a flange region and glass syringe barrel both showing an undisclosed thickness and length. The flange is formed through heating the tube with a flame while rotating around its major axis, to a temperature above its glass transition temperature. While heated, the end of the tube can be molded by molding tools to form the flange ([0059]). However, Oberhänsli in view of Kochansky still does not explicitly disclose wherein at least one of the following conditions is fulfilled: a relative standard deviation of a flange thickness is less than 6%; and a relative standard deviation of a length of the glass syringe barrels is less than 12%, and wherein both conditions are fulfilled.
There is no evidence that establishes changing the thickness of the flange or length of the glass syringe barrel would result in a difference in function of the Oberhänsli device. Further, a person having ordinary skill in the art, being faced with modifying the flange region or body region of Oberhänsli, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed range. Lastly, the applicant has not disclosed that the claimed ranges solve any stated problem, indicating that the range is within the claimed amounts, but offers other preferable range options ([0074]-[0075], [0077]-[0078], [0084]-[0085]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange region of Oberhänsli to fulfill one of both of a relative standard deviation of a flange thickness is less than 6% and a relative standard deviation of a length of the glass syringe barrels is less than 12% as an obvious matter of design choice within the skill of the art in order to effectively reproduce the size of each syringe.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Langsdorf et al. (United States Patent Application Publication No. US 2021/0002016 A1) is considered relevant prior art with regards to a glass container having a fanged neck and top region, having distance and points labeled on a part of the top region.
Gronemeyer et al. (United States Patent No. US 3,708,083 A) is considered relevant prior art with regards to a glass container having shaped resilient sealing rings.
Burroughs (United States Patent No. US 3,684,119 A) is considered relevant prior art with regards to glass container having a rounded top rim or bead.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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