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 of Species I in the reply filed on 12/16/2025 is acknowledged. Applicant only stated Di Florio does not read over the claimed invention, but did not explain how the claimed invention contributes over Di Florio. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they fail to comply with the following PCT Rule 11 sections.
New corrected drawings in compliance with PCT Rules 11.2 and 11.3(a) are required in this application because the line and text quality, particularly in Figures 7-8, makes it difficult to determine the structure of the claimed invention and prevents satisfactory reproduction characteristics.
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.
Claim Objections
Claims 2-5, 7-12, 14 & 16 are objected to because of the following informalities.
Claim 2 should read --The assembly according to claim 1, wherein the cannula comprises a first tubular portion, a second tubular portion, and a fitting protruding perpendicularly at the second tubular portion, the first tubular portion having a smaller diameter than a diameter of the second tubular portion, so that a shoulder is placed at a junction of the first tubular portion and the second tubular portion.—
Claim 3 should read --The assembly according to claim 2, wherein the first tubular portion comprises a plurality of through holes which put an interior of the cannula in communication with an interior of the elastomeric pump, allowing filling and emptying of the cannula.—
Claim 5 should read --The assembly according to claim 2, wherein the fitting originates from the second tubular portion of the cannula and extends perpendicular therefrom, ending with an open end configured to be coupled to an infusion line.—
Claim 7 should read --The assembly according to claim 2, wherein each of the first and second half-shells are formed by a first shell portion and a second shell portion of smaller width than a width of the first shell portion, and each of the first and second half-shells comprise an inner surface, an outer surface, and an edge which connects the first shell portion and the second shell portion, said first shell portion being configured to accommodate the elastomeric pump, while said second shell portion is configured to house a set comprising the open end of the elastomeric pump, the second tubular portion of the cannula with the fitting, and the filling valve.—
Claim 8 should read --The assembly according to claim 7, wherein the edge of the first half-shell comprises a groove and the edge of the second half-shell comprises a ridge, the groove and the ridge configured to be sealingly coupled to each other.—
Claim 12 should read --The assembly according to claim 7, wherein the first and second half-shells comprise feet for vertically supporting the assembly and/or the first half-shell comprises feet for horizontally supporting the assembly and/or the outer surface of the second half-shell comprises a flat portion for an application of adhesive labels.—
Claim 14 should read --The assembly according to claim 2, wherein the fitting originates from the second tubular portion of the cannula and extends perpendicular therefrom, ending with an open end, flared in shape, configured to be coupled to an infusion line.--
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 1-5 & 7-16 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.
As to Claim 1, the term “the sealed coupling”, in Line 6, lacks antecedent basis. Additionally, it is not clear if the use of the term is an attempt to defined new structure, or if the term is attempting to add structure to how the first and second half-shells are coupled together, rendering the claim indefinite. For the purpose of examination, the term will be interpreted as a generic structure which allows for the half-shells to be coupled together.
As to Claim 9, the phrase “the inner surface of the half-shells”, in Lines 1-2, should read -- the inner surface of each the first and second half-shells.
The limitation “of a shape and size to accommodate a semi-cylindrical portion of the set comprising the elastomeric pump and the second tubular portion of the cannula”, in Lines 4-6, is indefinite. It is not clear which structure has the claimed shape and size, since multiple structures were claimed prior to the limitation.
Additionally, the claimed “set” in Claim 9 is missing structure from the claimed set in Claim 7. As such, it is not clear if the set in Claim 9 is the same set as the set in Claim 7, or if the respective sets are different sets. For the purpose of examination, the respective sets will be interpreted as the same set, and the limitation will be interpreted as the semicircular recess is of a shape and size to accommodate a semi-cylindrical portion of the set; where the structure claimed after the term “the set” is deleted, since it is superfluous language.
The phrase “the groove placed on the edge of the first half-shell”, in Lines 6-7, lacks antecedent basis. Additionally, since the term is written in a manner which is commonly used to indicate the term has been previously defined or claimed, it is not clear if Applicant intended for Claim 9 to be dependent on Claim 7, as written, or on Claim 8, which positively claims a groove placed on the edge of the first half-shell. For the purpose of examination, the claim will be interpreted as being dependent on Claim 8.
The phrase “the edge of the first rib”, in Line 7, lacks antecedent basis. Additionally, it is not clear if the claimed edge is also part of the edge first claimed in Claim 7, or if the edge in Claim 9 is a separate edge.
The phrase “the ridge of the respective edge”, in Line 8, is indefinite. It is not clear which ridge is being referred to, since multiple ridges were previously defined. Additionally, it is not clear which edge is being referred to since multiple edges were previously defined.
The phrase “the edge of the recess”, in Lines 8-9, lacks antecedent basis.
Lastly, the claim as a whole is grammatically confusing. Examiner suggests numbering each of the repetitive structure names, i.e., first edge, second edge, third edge, first ridge, second ridge, etc.
As to Claim 10, the limitation “the inner surface of the second shell portion or of only the first shell portion comprises a second rib comprising a respective recess of a shape and size to accommodate a semi-cylindrical portion of the set comprising the second tubular portion of the cannula and the filling valve” is indefinite.
It is not clear how to interpret the phrase “of only”. The phrase is grammatically confusing when combined with the rest of the limitation, since it is not clear what structure is “of only”.
Additionally, the claimed “set” in Claim 10 is missing structure from the claimed set in Claim 7. As such, it is not clear if the set in Claim 10 is the same set as the set in Claim 7, or if the respective sets are different sets. For the purpose of examination, the respective sets will be interpreted as the same set, and the limitation will be interpreted as a semi-cylindrical portion of the set; where the structure claimed after the term “the set” is deleted, since it is superfluous language.
As to Claim 15, the limitation “the elastomeric pump is made of a thermoplastic elastomer and is free of polyvinyl chloride, and is made of a hydrogenated polystyrene block copolymer with polyolefins” is indefinite. It is not clear if the thermoplastic elastomer and the hydrogenated polystyrene block copolymer with polyolefins are the same material, or if the hydrogenated polystyrene block copolymer with polyolefins is the claimed thermoplastic elastomer. For the purpose of examination, the limitation will be interpreted as though the thermoplastic elastomer is a hydrogenated polystyrene block copolymer with polyolefins.
As to Claim 16, the limitation “the inner surface of the first half-shell comprises a seat for a hygroscopic filter and a hook for suspending the assembly and/or a seat for a strap” is indefinite. The limitation reads as though the hook and the seat are part of the claimed inner surface. However instant application Figure 2A –which embodies the elected species—shows hook 27 on the outer surface of first half-shell 3a. Additionally, instant application Figure 2A –which embodies the elected species—shows seat 28 on the outer surface of first half-shell 3a. As such, it is not clear if the limitation was written as intended, or if the claimed hook and seat should be on the outer surface of the first half-shell.
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.
Claims 1-3 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tsukada (U.S. Patent 5,211,632), in view of Chatlynne (U.S. PGPub 2007/0156103).
As to Claim 1, Tsukada teaches a medical solution infusion device assembly (Figure 9(B)), comprising an infusion device (the infusion device shown in Figure 1) and a housing (81/82; Column 8, Lines 13-24) containing (as shown in Figure 9(B)) the infusion device (the infusion device shown in Figure 1), the infusion device (the infusion device shown in Figure 1) comprising an elastomeric pump (2) having a closed end (the left end of 2, as viewed in Figure 4(A)) and an open end (the right end of 2, as viewed in Figure 4(A)), a cannula (1) and a filling valve (5/51) configured to fill (Column 5, Lines 19-29) the elastomeric pump (2) with a medical solution (the “solution of medicine” described in Column 5, Lines 19-29).
Tsukada is silent on the structure of the housing, so does not teach the housing of the infusion device comprises a first half-shell and a second half-shell, configured to be sealingly coupled to each other and to the infusion device, the sealed coupling with the infusion device being arranged in a position adjacent to the open end of the elastomeric pump.
Chatlynne describes an infusion device with an elastomeric pump (4/20), and teaches the housing (12) of the infusion device (at least 20/26/34/40/46) comprises a first half-shell (18) and a second half-shell (16), configured to be sealingly coupled to each other (via the mating features described in Paragraph 0033) and to (via rib 51) the infusion device (at least 20/26/34/40/46), the sealed coupling (the mating features described in Paragraph 0033) with the infusion device (at least 20/26/34/40/46) being arranged in a position (as shown in Figure 2) adjacent to (one of ordinary skill in the art would conclude the mating features described in Paragraph 0033 are broadly adjacent to the left end of elastomeric pump 4/20 shown in Figure 2) the open end (the left end of 4/20, as viewed in Figure 2) of the elastomeric pump (4/20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the housing, as taught by Chatlynne, in place of the housing, as taught by Tsukada, "so that the elastomeric bladder 4 may be placed within the interior space defined by the housing prior to the assembly of the first and second [half-shells] of the housing (Paragraph 0033).”
As to Claim 2, Tsukuda, as modified, teaches all the limitations of Claim 1, and continues to teach the cannula (Tsukada 1) comprises a first tubular portion (Tsukada 3), a second tubular portion (Tsukada 4), and a fitting (Tsukada 6) protruding perpendicularly at (as shown in Tsukada Figure 1) the second tubular portion (Tsukada 4), the first tubular portion (Tsukada 3) having a smaller (one of ordinary skill in the art would conclude the Tsukada first tubular portion diameter --see Tsukada Figure 1 below-- is smaller than the Tsukada second tubular portion diameter --see Tsukada Figure 1 below--, as shown in Tsukada Figure 1) diameter (see Tsukada Figure 1 below) than a diameter (see Tsukada Figure 1 below) of the second tubular portion (Tsukada 4), so that a shoulder (see Tsukada Figure 1 below) is placed at a junction (see Tsukada Figure 1 below) of the two portions (Tsukada 3/4).
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Tsukada Figure 1, Modified by Examiner
As to Claim 3, Tsukada, as modified, teaches all the limitations of Claims 1-2, and continues to teach the first tubular portion (Tsukada 3) comprises a plurality of through holes (Tsukada 31; Tsukada Column 5, Lines 47-53) which put an interior (Tsukada 11) of the cannula (Tsukada 1) in communication with (Tsukada Column 5, Lines 54-55) the interior (the internal volume of Tsukada elastomeric pump 2, as shown in Tsukada Figures 4(A)/4(B)) of an elastomeric pump (Tsukada 2), allowing filling and emptying of (as shown in Tsukada Figures 4(A)/4(B)) the cannula (Tsukada 1).
As to Claim 5, Tsukada, as modified, teaches all the limitations of Claims 1-2, and continues to teach the fitting (Tsukada 6) originates from (as shown in Tsukada Figure 1) the second tubular portion (Tsukada 4) of the cannula (Tsukada 1) and extends perpendicular thereto (as shown in Tsukada Figure 1), ending with (as shown in Tsukada Figure 1) an open end (see Tsukada Figure 1 in the Claim 2 rejection above) configured to be coupled to (via Tsukada 6; Tsukada Column 7, Lines 23-29) an infusion line (Tsukada 8).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tsukada, in view of Chatlynne, further in view of Heston (U.S. PGPub 2006/0229558).
As to Claim 4, Tsukada, as modified, teaches all the limitations of Claims 1-2, but does not teach the first tubular portion comprises a protruding ring.
Heston describes an infusion device with an elastomeric pump (160), and teaches the first tubular portion (700) comprises a protruding ring (the ring protruding at the bottom of groove 740, as viewed in Figure 7).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include a groove, as taught by Heston, in the first tubular portion, as taught by Tsukada, as modified, to fluidly seal the elastomeric pump onto the first tubular portion (Paragraph 0026).
Claims 13 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsukada, in view of Chatlynne, further in view of Di Florio (EP3248633A1), as evidenced by Maris (U.S. PGPub 2007/0232747).
As to Claim 13, Tsukuda, as modified, teaches all the limitations of Claim 1, but is silent on the material used to make elastomeric pump (Tsukada 2), so does not explicitly teach the elastomeric pump is made of a thermoplastic elastomer and is free of polyvinyl chloride.
Di Florio describes an infusion device with an elastomeric pump (5), and teaches the elastomeric pump (5) is made of a thermoplastic elastomer (Paragraph 0022).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric pump, as taught by Tsukuda, as modified, from a thermoplastic elastomer, as taught by Di Florio, so the elastomeric pump has “a high elasticity and shape memory, has the property of not increasing the diameter over a certain inner pressure of the fluid, but of increasing the longitudinal extension thereof (Paragraph 0024).”
Di Florio continues to teach the thermoplastic elastomer should be a polystyrene block copolymer hydrogenated with polyolefins (Paragraph 0023), but is silent on if the material is free of polyvinyl chloride.
Maris describes a polystyrene block copolymer hydrogenated with polyolefins (Abstract), and describes the polystyrene block copolymer hydrogenated with polyolefins as being free of polyvinyl chloride. Maris makes no mention of using chloride and only mentions the use of monovinyl. As such, one of ordinary skill in the art would conclude polystyrene block copolymer hydrogenated with polyolefins does not have polyvinyl chloride.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric pump, as taught by Tsukuda, as modified, from polystyrene block copolymer hydrogenated with polyolefins does not have polyvinyl chloride, as taught by Maris, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
As to Claim 15, Tsukuda, as modified, teaches all the limitations of Claim 1, but is silent on the material used to make elastomeric pump (Tsukada 2), so does not explicitly teach the elastomeric pump is made of a thermoplastic elastomer and is free of polyvinyl chloride, and is made of a hydrogenated polystyrene block copolymer with polyolefins.
Di Florio describes an infusion device with an elastomeric pump (5), and teaches the elastomeric pump (5) is made of a thermoplastic elastomer (Paragraph 0022), which is a hydrogenated polystyrene block copolymer with polyolefins (Paragraph 0023).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric pump, as taught by Tsukuda, as modified, from a thermoplastic elastomer, as taught by Di Florio, so the elastomeric pump has “a high elasticity and shape memory, has the property of not increasing the diameter over a certain inner pressure of the fluid, but of increasing the longitudinal extension thereof (Paragraph 0024).”
Di Florio is silent on if the material is free of polyvinyl chloride.
Maris describes a polystyrene block copolymer hydrogenated with polyolefins (Abstract), and describes the polystyrene block copolymer hydrogenated with polyolefins as being free of polyvinyl chloride. Maris makes no mention of using chloride and only mentions the use of monovinyl. As such, one of ordinary skill in the art would conclude polystyrene block copolymer hydrogenated with polyolefins does not have polyvinyl chloride.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the elastomeric pump, as taught by Tsukuda, as modified, from polystyrene block copolymer hydrogenated with polyolefins does not have polyvinyl chloride, as taught by Maris, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tsukada, in view of Chatlynne, further in view of Naidu (U.S. PGPub 2019/0105464).
As to Claim 14, Tsukada, as modified, teaches all the limitations of Claims 1-2, and continues to teach the fitting (Tsukada 6) originates from (as shown in Tsukada Figure 1) the second tubular portion (Tsukada 4) of the cannula (Tsukada 1) and extends perpendicular thereto (as shown in Tsukada Figure 1), ending with (as shown in Tsukada Figure 1) an open end (see Tsukada Figure 1 in the Claim 2 rejection above) configured to be coupled to (via Tsukada 6; Tsukada Column 7, Lines 23-29) an infusion line (Tsukada 8).
Tsukada, as modified, does not teach the open end is flared in shape.
Naidu describes an infusion device with a fitting, the fitting (14) having an open end (the end connected to tube 16 in Figure 3A) flared in shape (as shown in Figure 3A).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to flare, as taught by Naidu, the open end, as taught by Tsukada, as modified, to allow easier connections.
Allowable Subject Matter
Claims 7-12 & 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claim 7, the prior art of record teaches an infusion device assembly with an infusion device and a housing; the infusion device comprised of an elastomeric pump, a cannula and a filling valve; the housing comprise of first and second half shells coupled to each other; the cannula comprised of first and second tubular portions, and a fitting; the first and second tubular portions forming a shoulder at a junction of the first and second tubular portions; each of the first and second half-shells are formed by a first shell portion and a second shell portion, each of the first and second half-shells comprise an inner surface, an outer surface and an edge; said first shell portion configured to accommodate the elastomeric pump; said second shell portion configured to house a set comprising the open end of the elastomeric pump, and the second tubular portion of the cannula with the fitting. The prior art does not teach “said second shell portion is configured to house a set comprising…the filling valve”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 7. The closest art of record is Tsukada, in view of Chatlynne (cited above). However, neither of Tsukada or Chatlynne describe the filling valve within the second shell portion. When viewing Tsukada Figure 9(B) and Chatlynne Figure 2, one of ordinary skill in the art would conclude the filling valve must be located outside of the second shell portion. It would not be obvious to one of ordinary skill in the art to modify Tsukada, as modified, without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 7, is neither anticipated nor made obvious by the prior art of record.
Claims 8-12 & 16 depend on Claim 7, so would also be found allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chi (2014/0228758) and Yamada (2006/0150725) describe similar infusion device assemblies.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783