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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
The specification defines the “titling angle” as element “a” in at least paragraphs 0008, 0027, 0043, 0057, and 0059. The drawings define this same angle as “α” in figure 6. This discrepancy may cause confusion as to the angle being identified and it is suggested that one of the two element symbols be changed to match the other for clarity purposes.
The specification defines the “distance between the bottom side of the removal device and the upper end of the receptacles” as element “DH” in at least paragraphs 0017 and 0062. The drawings define this same distance as “ΔH” in figure 9. This discrepancy may cause confusion as to the distance being identified and it is suggested that one of the two element symbols be changed to match the other for clarity purposes.
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.
Claim Objections
Claims 1, 7, and 9 are objected to because of the following informalities:
Claim 1 recites the limitation “using a heat” on line 3. The wording of this phrase is confusing. It is suggested to change the limitation to “using heat” or “using a heating source” or similar.
Claim 1 recites the limitation “l1-l1' is at least 10 to 10% of the total length l1” on the final line 49. It seems the limitation has a typo and is intended to be “l1-l1' is at least 10 to 90% of the total length l1” as seen in line 48 above it. If this is the intended meaning, appropriate correction is required.
Claim 7 recites the limitation “range from 10 to < 11 mm” on line 2. It seems the “<” is a typo based on the other similarly worded claims. If so, appropriate correction is required.
Claim 9 recites the limitation “wherein the elong length” on line 2. It seems that the presence of the word “elong” is a typo based on the wording of similar claims. If so, appropriate correction is required.
Claim Interpretation
Claim 13 recites the limitation of “a poka-yoke feature” on line 6. The idea of a poka-yoke feature has meaning within the art as any feature that helps prevent a user from making a mistake. As used in the claim itself, the specifics of the feature used “to ensure that only the holding structure and further holding structure adapted to accommodate formed cartridges having a same range for the outer diameter d1 can be stacked on top of one another” provides the structural description that defines the poka-yoke feature. Claim 2 recites the limitation “a regular arrangement” on lines 1-2. The meaning behind “regular arrangement” in the provided context could have a different meaning to different persons having ordinary skill in the art. Thus, for purposes of proper claim interpretation, this limitation is interpreted as “an arrangement with hexagonal symmetry” as described in the specification.
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.
Claim 14 and 15 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 14 recites the limitation “a plurality of the formed cartridges” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim. While claim 1 introduces “a plurality of sterilized cartridges”, claim 14 is an independent claim and thus no such introduction is accomplished thus rendering the claim indefinite.
Claim 15, which is dependent on claim 14, is likewise indefinite for the reason listed above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Yamada (WO 2019189423) . The references below for Yamada are taken from the provided machine translation cited in the IDS filed on 4/21/2025. Paragraph numbers were added for clarity and the updated copy of the reference is provided with this office action.
Regarding claim 14, as best understood based on the 35 U.S.C. 112(b) issue identified above, Yamada teaches
A holding structure adapted and arranged for holding a plurality of the formed cartridges (Paragraph 0001, The present invention relates to a syringe storage container and a syringe package for storing a large number of syringes),
each cartridge having an elongated cylindrical body in the form of a tube (Figure 2, syringe body 20; Paragraph 0041, the syringe 12 includes a syringe body 20; Paragraph 0039, The syringe body 20 includes a barrel portion 24 that can be filled with a chemical solution; Because the body can be filled it is implied that is it hollow)
having an inner diameter d2 (Figure 8A, see syringe body 20; It is implied that an inner diameter exists),
an outer diameter d1 (Figure 8A, see syringe body 20; It is implied that an outer diameter exists),
and a longitudinal axis Lcartridge and a total length l1 (Figure 8A, see syringe body 20; It is implied that a total length along a longitudinal axis exists),
wherein the elongated cylindrical body comprises a bottom region with a circular opening (Figure 2, cylindrical trunk body 30; Paragraph 0041, The trunk portion 24 includes a cylindrical trunk body 30),
the bottom region comprising a bulbous thickening of material forming the tubular elongated cylindrical body (Figure 8A, proximal flange 32; Paragraph 0041, The trunk portion 24 includes a cylindrical trunk body 30 that extends in the axial direction, and a proximal flange 32 that is provided at the proximal end of the trunk body 30)
and having an inner diameter d4 (Figure 8A, see proximal flange 32; it is implied that an inner diameter exists)
and an outer diameter d3 (Figure 8A, see proximal flange 32; it is implied that an outer diameter exists);
and having a top region (Figure 8A, tip nozzle 26; Paragraph 0042, a tip opening 36 for filling the body portion 24 with a chemical solution is formed at the tip of the tip nozzle 26)
comprising a shoulder (Figure 8A, see tip nozzle 26; It can be seen in the figure that a shoulder exists),
a neck (Figure 8A, see tip nozzle 26; It can be seen in the figure that a neck exists),
and a collar (Figure 8A, see tip nozzle 26; It can be seen in the figure that a collar exists);
the holding structure comprising (Figure 8A, holding member 44c):
a base plate (Figure 8A, flat plate portion 70; Paragraph 0088, The holding member 44c includes a flat plate portion 70 and a large number of holding portions 72 c provided on the flat plate portion 70);
a plurality of receptacles arranged on top of the base plate (Figure 8A, holding portions 72c; Paragraph 0088, The holding portion 72c includes a support bottom portion 80a including a support surface 79a that supports the base end surface 13 of the syringe 12),
each receptacle having a longitudinal axis Lreceptable running in a longitudinal direction through a center of the receptacle (Figure 8A, see holding portions 72c; A longitudinal axis is implied)
and comprising an upper end where the formed cartridge is inserted (Figure 8A, see holding portions 72c),
a bottom end where the receptacle is connected to the base plate (Figure 8A, see holding portions 72c and syringe body 20; Paragraph 0088, The holding portion 72c includes a support bottom portion 80a including a support surface 79a that supports the base end surface 13 of the syringe 12),
a circumferentially formed side wall extending in a longitudinal direction from the upper end to the bottom end (Figure 8A, see cylindrical peripheral wall portion 82c and syringe body 20),
and a positioning means located in a center of the bottom end of the receptacle (Figure 10A, see insertion portion 100b and holding portions 72d; Paragraph 0120, the syringe storage container and the syringe package according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention; It is implied that different embodiment features can be combined);
each receptacle being adapted and arranged to accommodate one of the formed cartridges such that wherein
at least a part of the elongated body having a length l1' is inserted into the receptacle (Figure 8A, see holding portion 72c, cylindrical peripheral wall portion 82c, and syringe body 20; It is implied that an insertion portion exists below the wall)
and a remaining part of the elongated cylindrical body having a length l1-l1' protrudes out of the receptacle (Figure 8A, see holding portion 72c, cylindrical peripheral wall portion 82c, and syringe body 20; It is implied that a non-inserted portion exists above the wall);
the positioning means being a protrusion protruding into the circular opening at the bottom region of the formed cartridge (Figure 10A, see insertion portion 100b and body portion 24; Paragraph 0090, an insertion protrusion 100a that is inserted into the body portion 24 from the proximal end opening 28 thereof),
thereby ensuring that the formed cartridge is tilted by an angle a of not more than 10 degrees, the angle a being formed between the longitudinal axis Lreceptacle and the longitudinal axis Lcartridge of the formed cartridge accommodated in the receptacle (Figure 10A, see insertion protrusion 100b and syringe body 20; Paragraph 0093, an insertion protrusion 100a inserted into the body portion 24 from the end opening 28. Thereby, the base end part of the trunk drum 24 of many syringes 12 can be supported more stably by the support surface 79a and the insertion protrusion 100a; It is implied by the figure that the angle between the syringe and the holding portion is zero degrees which is less than 10 degrees);
l1' is at least 10 to 90% of the total length l1 (See figure 3, wall portion 82a, figure 7A, wall portion 82b, and figure 8A, see wall portion 82c; It is implied that the wall portion can be of different sizes and lengths based on the figures. Adjustment of the wall portion lengths would in turn adjust the indicated values);
l1-l1' is at least 10 to 90 % of the total length l1 (See figure 3, wall portion 82a, figure 7A, wall portion 82b, and figure 8A, see wall portion 82c; It is implied that the wall portion can be of different sizes and lengths based on the figures. Adjustment of the wall portion lengths would in turn adjust the indicated values).
Below are two annotated pictures of figure 8A of Yamada. These pictures are provided to help with demonstrating the teachings of Yamada as it applies to the claimed limitations. Of note this is only an example of the potential relationships between the recited limitations and Yamada.
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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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yamada (WO 2019189423). The references below for Yamada are taken from the provided machine translation cited in the IDS filed on 4/21/2025. Paragraph numbers were added for clarity and the updated copy of the reference is provided with this office action.
Regarding claim 15, Yamada fully teaches for claim 14 as seen section “Claim Rejections - 35 USC § 102” above.
Yamada fails to fully teach transporting cartridges from a process station in which the cartridges are formed to a process station in which the formed cartridges are sterilized via the holding structure as recited in claim 14. While Yamada does teach the use of a syringe package for transport (Paragraph 0038; the syringe package 10A according to the first embodiment of the present invention is used when a large number of syringes 12 are transported and stored) and that the syringes can be sterilized within the package (Paragraph 0067, The sealing member 16 is preferably permeable to gas for sterilization and impermeable to fine particles such as bacteria and viruses), it does not fully teach wherein this transportation is done from one location in which the cartridges are formed to another where they are sterilized.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to devise a method to transport a syringe package from one location, such as a location where the syringes were formed, to another, such as a location where they are sterilized. A person having ordinary skill in the art would understand that a syringe package, as taught by Yamada, would potentially need to be transported, as taught by Yamada, from one location to another to accomplish a step of sterilization, as taught by Yamada.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wittland et al. (US 20070186510), hereinafter Wittland, in view of Yamada (WO 2019189423). The references below for Yamada are taken from the provided machine translation cited in the IDS filed on 4/21/2025. Paragraph numbers were added for clarity and the updated copy of the reference is provided with this office action.
Regarding claim 1, the limitations are split into essentially two categories: limitations related to the method for producing a plurality of sterilized cartridges and limitations related to specifics of the cartridges and holding structure used in the described method.
Regarding the method limitations, Wittland teaches
a method for producing a plurality of sterilized cartridges (Paragraph 0021, a method sequence is shown which illustrates the production of prefillable syringes right through to their being packaged in a form of an array of syringes in a closed and sterilized container),
the method comprising the steps of:
a) forming the cartridges using a heat (Paragraph 0022, Step a concerns the production of a syringe body as such directly from forming of plastic or glass by a suitable device which is known per se and is not described in detail; A person having ordinary skill in the art would know that one of the glass forming methods known per se is through heat application),
b) inserting the plurality of formed cartridges into a holding structure adapted and arranged for holding the plurality of the formed cartridges (Paragraph 0023, In step a1, the syringe bodies that have been produced in this way are packaged),
c) transporting the holding structure from a first location to a further location (Paragraph 0023 and 0024, In step a1, the syringe bodies that have been produced in this way are packaged. The packaging operation can be carried out under controlled clean-room conditions... Alternatively, the syringe bodies are produced and also packaged in a production area in which the degree of cleanliness is not controlled. In step b1, the syringe bodies that have been packaged as described above are unpacked under controlled clean-room conditions; Because step a1 can be performed in an uncontrolled area but step b1 is done under clean-room conditions, it is implied that a transfer step must take place between step a1 and b1);
d) removing the formed containers from the holding structure at the further location (Paragraph 0024, In step b1, the syringe bodies that have been packaged as described above are unpacked);
e) sterilizing the formed containers (Paragraph 0025, In a further step b, the inner surface of the syringe body is cleaned, for example with cleaned or sterile air, or with ionized air, likewise under controlled conditions as in step b1; This cleaning step constitutes sterilization of the syringes).
Regarding the remaining limitations, Wittland fails to fully teach specifics of the cartridges or the holding structure.
However, Yamada fully teaches each of the remaining limitations of the claim as described above for claim 14 in section “Claim Rejections - 35 USC § 102”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wittland regarding a method for producing sterilized syringes and the teachings of Yamada regarding the specifics of a syringe and a holding structure for said syringes. One would have been motivated to combine the teachings as the method taught by Wittland teaches the need for a holding structure for syringes and Yamada teaches a holding structure that could be used and provides additional benefits that would be beneficial to the method of Wittland (Yamada paragraphs 0003-0004, the central portion in the axial direction of each barrel portion of a large number of syringes is held by the holding portion, the base end portion of the barrel portion may be wobbled. The present invention has been made in view of such problems, and a syringe storage container and a syringe that can stably support the base end portions of the barrels of a large number of syringes with the tip nozzle facing upward).
A person having ordinary skill in the art would have had the capability to combine this method and product and would have recognized that the combination would yield predictable results. Furthermore, each element in the combined context would perform the same function they did separately.
A person having ordinary skill in the art would be motivated to incorporate the teachings of Yamada to Wittland because they are in the same field of endeavor directed to the same technology (syringe production), which would prompt its use based on design improvements that are predictable and recognized by one having ordinary skill in the art.
Regarding claim 2, Wittland in view of Yamada fully teaches for claim 1 as seen above.
Wittland fails to fully teach wherein the receptacles are arranged in a regular arrangement and wherein the side wall is formed as a common partition between each two directly adjacent receptacles of the plurality of receptacles.
However, Yamada teaches
wherein the receptacles are arranged in a regular arrangement (Figure 8B, see arrangement of holding portions 72c)
and wherein the side wall is formed as a common partition between each two directly adjacent receptacles of the plurality of receptacles (Figure 8A, see adjacent holding portions 72c and peripheral wall portion 82c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wittland regarding a method for producing sterilized syringes and the teachings of Yamada regarding the specifics of a syringe and a holding structure for said syringes for the reasons indicated above. The additional teaching of Yamada mentioned here would simply be another limitation applied to the holding structure and it would have been obvious to include to improve the system further.
Regarding claim 3, Wittland in view of Yamada fully teaches for claim 1 as seen above.
Wittland fails to fully teach wherein the plurality of formed cartridges is accommodated in the receptacles of the holding structure in such a way that the remaining parts of the elongated body 11-11' protruding out of the receptacles do not come into contact with each other during transport in process step c.
However, Yamada teaches
wherein the plurality of formed cartridges is accommodated in the receptacles of the holding structure in such a way that the remaining parts of the elongated body 11-11' protruding out of the receptacles do not come into contact with each other during transport in process step c (Figures 8A and 10A, see adjacent syringe bodies 20; It is implied by the figure that the syringe bodies are not in contact with each other and thus will remain as such during transport).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wittland regarding a method for producing sterilized syringes and the teachings of Yamada regarding the specifics of a syringe and a holding structure for said syringes for the reasons indicated above. The additional teaching of Yamada mentioned here would simply be another limitation applied to the holding structure and it would have been obvious to include to improve the system further.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wittland (US 20070186510) in view of Yamada (WO 2019189423) as applied to claim 1 above, and further in view of Grayson (NPL).
Regarding claim 4, Wittland further teaches
wherein the cartridges formed in process step a. are glass cartridges (Paragraph 0022, Step a concerns the production of a syringe body as such directly from forming of plastic or glass by a suitable device which is known per se and is not described in detail).
Wittland fails to full teach wherein forming with heat comprises a process step, at least a part of the glass being heated to a temperature above the glass transition temperature in the process step.
However, Wittland does teach that the glass is formed using a device which is known per se. The process of raising glass to a high temperature above the glass transition temperature for form the glass is well known in the art (see at least Grayson, The glass transition temperature can be practically considered as the temperature where the liquid converts to a solid on cooling or conversely of which the solid begins to behave as a viscoelastic solid on heating … Glass is worked and formed at very high temperatures, where its viscosity is low). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known method of glass forming by heating above the glass transition temperature to form the glass syringes of Wittland.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wittland (US 20070186510) in view of Yamada (WO 2019189423) as applied to claim 1 above, and further in view of Komann et al. (US 20200156824), hereinafter Komann 2020.
Regarding claim 5, Wittland nor Yamada fully teach wherein each receptacle further comprises guides projecting radially into the receptacle and adapted and arranged to contact a part of the outer surface of the elongated cylindrical body of one of the formed cartridges accommodated in the receptacle.
However, Komann 2020 teaches
wherein each receptacle further comprises guides projecting radially into the receptacle (Figure 1D, guide ribs 18; Paragraph 0029, guide ribs 18 extending in the longitudinal direction of the receptacle 5 can be provided on the side wall 10)
and adapted and arranged to contact a part of the outer surface of the elongated cylindrical body of one of the formed cartridges accommodated in the receptacle (Figure 1D, see guide ribs 18 and containers (Carpoules) 60; Paragraph 0029, The maximum width w1 of an interior formed by the guide ribs 18 is slightly greater than a maximum breadth or a maximum external diameter of the containers (not shown) that are to be received, such that the containers, during their insertion perpendicularly from above into the receptacles 5, slide without friction, or with minimal friction, into the receptacles 5 and in doing so are guided to a centered position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add guide ribs, as taught by Komann 2020, to holding portions as taught by Yamada. One would have been motivated to combine these teachings as a means to improve the system of Yamada by guiding the syringes to a centered position in the holding portion (Komann 2020 paragraph 0029, The maximum width w1 of an interior formed by the guide ribs 18 is slightly greater than a maximum breadth or a maximum external diameter of the containers (not shown) that are to be received, such that the containers, during their insertion perpendicularly from above into the receptacles 5, slide without friction, or with minimal friction, into the receptacles 5 and in doing so are guided to a centered position).
A person having ordinary skill in the art would have had the capability to combine these systems and would have recognized that the combination would yield predictable results. Furthermore, each element in the combined context would perform the same function they did separately.
A person having ordinary skill in the art would be motivated to incorporate the teachings of Komann 2020 and Yamada to Wittland because they are in the same field of endeavor directed to the same technology (syringe production), which would prompt its use based on design improvements that are predictable and recognized by one having ordinary skill in the art.
Claims 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wittland (US 20070186510) in view of Yamada (WO 2019189423) as applied to claim 1 above, and in further view of Krisdiyanto et al. (NPL), hereinafter Krisdiyanto.
Regarding claims 6 through 12, each claim gives specific limitations regarding dimensions ranges related to the cartridges and the cartridge receptacles. These ranges vary from claim to claim but across the claims:
Outer diameter d1 is in the range from 8 to 28 mm
Length l1 is in the range from 31 to 80 mm
Length l1' is in the range from 20 to 30mm
Wittland nor Yamada teach specific dimensions for their respective systems. However, it would have been obvious to a person having ordinary skill in the art to design a holding member as taught by Yamada to work with syringes of the sizes recited in the claims as the recited dimensions encompass sizing characteristics of syringes typical within the art (see at least figure 1 of Krisdiyanto). A person having ordinary skill in the art would have been motivated to adjust the dimensions of a holding member and of syringes as taught by Yamada to the dimensions recited to accommodate syringes of varying sizes common within the art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Wittland regarding a method for producing sterilized syringes and the teachings of Yamada regarding the specifics of a syringe and a holding structure for said syringes for the reasons indicated above. The additional teaching of Yamada mentioned here would simply be another limitation applied to the holding structure and it would have been obvious to include to adapt the system to common components known in the art.
Furthermore, for each of these claims, 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. Thus, in addition to the obvious argument above, the limitations in the claims would not make the system patently distinct from the prior art as taught by Wittland in view of Yamada. For more information, see MPEP 2144.04(IV)(A).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wittland (US 20070186510) in view of Yamada (WO 2019189423) as applied to claim 1 above, and further in view of Komann et al. (US 20240025611), hereinafter Komann 2024.
Regarding claim 13, Wittland nor Yamada fully teach wherein in process step c the holding structure and a further holding structure are stacked on top of one another and are transported from a first location to a further location, each of the holding structure and the further holding structure accommodating the formed cartridges, wherein each of the holding structure and the further holding structure of the stack is adapted to hold cartridges having the same outer diameter d1 and comprises a poka-yoke feature to ensure that only the holding structure and further holding structure adapted to accommodate formed cartridges having a same range for the outer diameter d1 can be stacked on top of one another.
However, Komann 2024 teaches
wherein each of the holding structure and the further holding structure of the stack is adapted to hold cartridges having the same outer diameter d1 and comprises a poka-yoke feature to ensure that only the holding structure and further holding structure adapted to accommodate formed cartridges having a same range for the outer diameter d1 can be stacked on top of one another (Claim 8, wherein the closed, smooth curve—with the at least one local maximum and the at least one local minimum—forms a stacking feature configured for facilitating a space-saving stacking of a plurality of the holding structure vertically relative to one another; Claim 9, wherein the stacking feature is configured for facilitating the space-saving stacking because an undesired jamming of the upper edge of the peripherally formed side walls is avoided).
While Komann 2024 does not directly teach of a method of stacking said holding structures during transportation from one location to another, a person having ordinary skill in the art would be motivated to stack holding structures, as taught by Komann 2024, during transportation as a means to save space, as taught by Komann 2024, and as a means to decrease production time as is known in the art.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a stacking feature to a holding structure, as taught by Komann 2024, to the holding member of Yamada as a means to save space (Komann 2024 Claim 8, wherein the closed, smooth curve—with the at least one local maximum and the at least one local minimum—forms a stacking feature configured for facilitating a space-saving stacking of a plurality of the holding structure vertically relative to one another) and would also be motivated to stack multiple holding packages during steps a1 and b1 of Wittland as a means of saving space, as taught by Komann 2024, and as a means of decreasing production time as is known in the art.
A person having ordinary skill in the art would have had the capability to combine these methods and products and would have recognized that the combination would yield predictable results. Furthermore, each element in the combined context would perform the same function they did separately.
A person having ordinary skill in the art would be motivated to incorporate the teachings of Komann 2024 and Yamada to Wittland because they are in the same field of endeavor directed to the same technology (syringe production), which would prompt its use based on design improvements that are predictable and recognized by one having ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure [See PTO-892 Notice of References Cited] because the prior art references contain subject matter that related to one or more the of the Applicant’s claim limitations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN THOMAS KOSKY whose telephone number is (571)270-7277. The examiner can normally be reached Monday - Friday (8:00 am - 4:30 pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacob S Scott can be reached at (571) 270-3415. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.T.K./Examiner, Art Unit 3655
/JACOB S. SCOTT/Supervisory Patent Examiner, Art Unit 3655
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