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
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/03/2026.
Applicant’s election without traverse of Claims 1-14, Group I in the reply filed on 09/03/2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 5: “a filling spout defining an first channel and an second channel” should read “a filling spout defining a first channel and a second channel”. 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 1-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “a catch” in claim 1, line 5 is indefinite since the term “a catch” is not defined in the specification nor referenced to in the drawings of the instant application. It is unclear what structure/component of the apparatus of the instant application is the catch. For the purposes of examination, a “catch” is interpreted to be a component/structure that “catches and fastens, such as a latch”, as defined by Dictionary.com (see attached PTO-892).
The term “incapable” in claim 14 is a relative term which renders the claim indefinite. The term “incapable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not understood to what extent a component or structure would be “incapable” of performing the sealing of a first channel. It is unclear how a component/structure can be assessed quantitatively to be “incapable” of performing the sealing or not. For the purposes of examination, the diaphragm is interpreted to be incapable of sealing the first channel when punctured through by the spike.
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.
Claim(s) 1-5, 8-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Branderburger et al. (Publication No. US 2008/0009783 A1), hereby referred to as “Branderburger ‘783”, in view of Brandenburger et al. (Publication No. US 2011/0022024 A1), hereby referred to as “Brandenburger ‘024”.
Regarding claim 1, Branderburger ‘783 teaches an apparatus for enteral feeding (Abstract), the apparatus comprising:
a receptacle filled with a sterile enteral nutrition solution (film bag 22 filled with feed solution – inherent that feed solution should be sterile for patient consumption; Paragraph 0036-0037; Figure 7), the receptacle comprising an opening (film bag 22 has opening located where the base part 5 is welded to the upper and lower film sheets of the bag; Paragraph 0031; Figure 7);
a connector fixed to the opening of the receptacle (connector A is inserted to bag 22; Paragraph 0037; Figure 7), the connector comprising:
a filling spout defining an first channel and an second channel (passage 2 having a first channel/portion of passage 2 above the pinching-off part 4 and a second channel/portion of passage 2 where pinching-off part 4 is located; annotated Figure 1 below; Paragraph 0029 and 0031);
a catch (outer teeth 21; annotated Figure 1 below; Paragraph 0035); and
a septum that seals the first channel (self-sealing membrane 11 seals the first channel; annotated Figure 1 below; Paragraph 0033); and
a closure (closure part 3; Paragraph 0028; Figure 2) comprising:
a base that is latched to the catch (base 6 with inner teeth 20 of closure part 3 is latched to the outer teeth 21; annotated Figure 1 below; Paragraph 0035); and
a removable portion that covers the septum and that is removably connected to the base (top part 8 covers the self-sealing membrane 11 and is removably connected to the base 6 with inner teeth 20 of the closure part; annotated Figure 1; Figure 3; Paragraph 0032), wherein: the septum is self-sealing (septum 11 is self-sealing; Paragraph 0033; annotated Figure 1 below). Branderburger ‘783 does not teach a diaphragm connected to the filling spout at a hinge within the first channel, the filling spout, the catch, and the diaphragm are integral, the diaphragm allows fluid communication between the first channel and the second channel,
a bottom of the septum is spaced a distance from the hinge such that, when the septum is pierced by a spike and the spike is subsequently remove self-sealing of the septum is not impaired by the diaphragm.
However, Brandenburger ‘024 teaches a diaphragm connected to the filling spout at a hinge within the first channel (injected membrane 6’ within the first channel – obvious that hinge is formed where the opening of the pierced section is made and a part of the diaphragm will move inwards when the spike is inserted through the diaphragm; Figure 3; Paragraph 0035),
a bottom of the septum is spaced a distance from the hinge such that, when the septum is pierced by a spike and the spike is subsequently remove self-sealing of the septum is not impaired by the diaphragm (bottom of septum 10’ spaced a distance from the hinge of membrane 6’ so that the piercing of septum 10’ does not impact the membrane 6’, i.e. tip of spike penetrates through septum 10’ but not membrane 6’; Figure 3).
Branderburger ‘783 and Brandenburger ‘024 are both considered to be analogous to the claimed invention because they are in the same field of fluid containers with pierceable connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branderburger ‘783 to incorporate the teachings of Brandenburger ‘024 and have the frangible diaphragm of Brandenburger ‘024 within the first channel of Branderburger ‘783 and the sterilization of the apparatus before use, as taught by Brandenburger ‘024. This prevents the septum to come into direct contact with the solution (Brandenburger ‘024; Paragraph 0020) and ensures that the apparatus is sterile prior to use (Brandenburger ‘024; Paragraph 0034). The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches the filling spout, the catch, and the diaphragm are integral (membrane is a one-piece component of the tubular connection piece, as taught by Brandenburger ‘024 in Paragraph 0020, where the filling spout and the catch of Branderburger ‘783 are integral with the tubular connection piece; Figure 2 of Branderburger ‘783; see combination above), the diaphragm allows fluid communication between the first channel and the second channel (Brandenburger ‘024; membrane 6’ allows for fluid communication between the first and second channel of Branderburger ‘783 when penetrated; Paragraph 0035 and 0037; Figure 3; see combination above).
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Annotated Figure 1
Regarding claim 2, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not expressly teach wherein the distance is between 3 mm and 20 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the septum and the diaphragm to be separated by between 3 millimeters and 20 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the septum and diaphragm would not operate differently with the claimed distance since the septum and diaphragm are constructed with similar components and structure (see disclosed above) and is intended to prevent fluid from escaping after withdrawal of spike (Branderburger ‘783; Paragraph 0013) and to prevent the septum from getting in contact with the solution (Brandenburger ‘024; Paragraph 0020). Further, applicant places no criticality on the range claimed, indicating simply that the distance is within the claimed ranges (specification; page 15, line 36 to page 16, line 11).
Regarding claim 3, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 2. The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not expressly teach wherein the distance is between 5 mm and 10 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the septum and the diaphragm to be separated by between 5 millimeters and 10 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the septum and diaphragm would not operate differently with the claimed distance since the septum and diaphragm are constructed with similar components and structure (see disclosed above) and is intended to prevent fluid from escaping after withdrawal of spike (Branderburger ‘783; Paragraph 0013) and to prevent the septum from getting in contact with the solution (Brandenburger ‘024; Paragraph 0020). Further, applicant places no criticality on the range claimed, indicating simply that the distance is within the claimed ranges (specification; page 15, line 36 to page 16, line 11).
Regarding claim 4, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 3. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein the diaphragm supports the spike when the septum is pierced by the spike (second membrane prevents fluid to come into contact with self-sealing membrane and retains the spike in place when the spike pierces through the septum; Brandenburger ‘024; Paragraph 0020-0021).
Regarding claim 5, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein the first channel and the diaphragm are sterile (Brandenburger ‘024; the integral piece of the tubular connection piece comprising the diaphragm and the first channel are welded to the infusion bag and sterilized before use; Paragraph 0034).
Regarding claim 8, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not teach wherein the hinge is level with the catch.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the hinge to be level with the catch, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, with the common function of removably connecting the filling spout with the closure, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Regarding claim 9, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein the first channel is narrower than the second channel (Branderburger ‘783; second channel is wider than the first channel; annotated Figure 1 above).
Regarding claim 10, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. Branderburger ‘783 further teaches wherein the removable portion is fixed to the base and is configured to break-off of the base at a break-off point (top part 8 is fixed to base 6 and is configured to break off the base 6 at break-off point 7; Paragraph 0032; Figure 1).
Regarding claim 11, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. Branderburger ‘783 further teaches wherein the removable portion is configured to twist-off of the base (top part 8 is configured to twist off base part 6; Figure 1; Paragraph 0034-0035).
Regarding claim 14, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein the diaphragm is incapable of sealing the first channel (diaphragm of Brandenburger ‘024 used to hold spike in place after insertion of spike and puncture through diaphragm; Brandenburger ‘024, Paragraph 0020-0021).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Branderburger et al. (Publication No. US 2008/0009783 A1) in view of Brandenburger et al. (Publication No. US 2011/0022024 A1), as applied to claim 1 above, and further in view of Niedospial, Jr. (Patent No. US 6,039,718 A).
Regarding claim 6, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not teach wherein the diaphragm has a thickness between 0.05 mm and 0.5 mm.
However, Niedospial, Jr. teaches wherein said diaphragm has a thickness that is between 0.001 millimeters and 1.0 millimeters (Column 2, lines 52-62; Claim 7).
Branderburger ‘783 in view of Brandenburger ‘024 and Niedospial, Jr. are both considered to be analogous to the claimed invention because they are in the same field of fluid container connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branderburger ‘783 in view of Brandenburger ‘024 to incorporate the teachings of Niedospial, Jr. and have the diaphragm of Branderburger ‘783 in view of Brandenburger ‘024 to have the thickness, as taught by Niedospial, Jr. This would allow for luer connectors, syringes, and needle cannula to pass through the membrane (Niedospial, Jr., Column 2, lines 53-62).
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 thickness of between 0.001 millimeters and 1.0 millimeters to between 0.05 millimeters and 0.5 millimeters as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 7, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein: the diaphragm supports the spike when the septum is pierced by the spike (second membrane prevents fluid to come into contact with self-sealing membrane and retains the spike in place when the spike pierces through the septum; Brandenburger ‘024; Paragraph 0020-0021), the first channel and the diaphragm are sterile (Brandenburger ‘024; the integral piece of the tubular connection piece comprising the diaphragm and the first channel are welded to the infusion bag and sterilized before use; Paragraph 0034). The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not expressly teach the distance is between 5 mm and 10 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the septum and the diaphragm to be separated by between 3 millimeters and 20 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the septum and diaphragm would not operate differently with the claimed distance since the septum and diaphragm are constructed with similar components and structure (see disclosed above) and is intended to prevent fluid from escaping after withdrawal of spike (Branderburger ‘783; Paragraph 0013) and to prevent the septum from getting in contact with the solution (Brandenburger ‘024; Paragraph 0020). Further, applicant places no criticality on the range claimed, indicating simply that the distance is within the claimed ranges (specification; page 15, line 36 to page 16, line 11).
The modified combination of Branderburger ‘783 in view of Brandenburger ’024 does not teach the diaphragm has a thickness between 0.05 mm and 0.5 mm.
However, Niedospial, Jr. teaches wherein said diaphragm has a thickness that is between 0.001 millimeters and 1.0 millimeters (Column 2, lines 52-62; Claim 7).
Branderburger ‘783 in view of Brandenburger ‘024 and Niedospial, Jr. are both considered to be analogous to the claimed invention because they are in the same field of fluid container connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branderburger ‘783 in view of Brandenburger ‘024 to incorporate the teachings of Niedospial, Jr. and have the diaphragm of Branderburger ‘783 in view of Brandenburger ‘024 to have the thickness, as taught by Niedospial, Jr. This would allow for luer connectors, syringes, and needle cannula to pass through the membrane (Niedospial, Jr., Column 2, lines 53-62).
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 thickness of between 0.001 millimeters and 1.0 millimeters to between 0.05 millimeters and 0.5 millimeters as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Branderburger et al. (Publication No. US 2008/0009783 A1) in view of Brandenburger et al. (Publication No. US 2011/0022024 A1), as applied to claim 1 above, and further in view of Hess, III et al. (Patent No. US 6,050,451 A).
Regarding claim 12, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 further teaches wherein: the connector comprises a welding portion that extends into the receptacle (Branderburger ‘783; the base parts 5 that extend on both sides with passage 2 of connecting part extending into the base parts 5 – base parts are welded to film sheets 23 and 24; Paragraph 0031 and 0037; Figure 1), the filling spout extends into the receptacle at an edge region of the receptacle (Branderburger ‘783; base parts 5 are located in the edge region of pouch 22; Figure 7; Paragraph 0047). The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not teach the welding portion comprises a first spacer wing, a second spacer wing, and spacer ribs that cooperate to prevent the receptacle from blocking the second channel of the filling spout, the spacer ribs are offset from each other, and the spacer ribs are connected to the filling spout.
However, Hall, III teaches the welding portion comprises a first spacer wing, a second spacer wing (base 50 of fitment 20 that is welded to pouch has wings formed by extension of boat-shaped base 50 at lateral ends 74 and 76; Figure 9; Column 7, lines 13-58), and spacer ribs (ribs 78 that are spaced apart and parallel to each other; Figure 9; Column 7, lines 13-58), the spacer ribs are offset from each other, and the spacer ribs are connected to the filling spout (spacer ribs are offset/spaced from each other along direction of extension of passage 84; Figure 9; Column 7, lines 13-58).
Since the prior art of Branderburger ‘783 and Hall, III both teaches a welded portion of the connector with spacer wings and is analogous to the claimed invention in the field of fluid containers with pierceable connectors, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the welded wings of Branderburger ‘783 with the welded spacer wings and spacer ribs of Hall, III, as it is merely the selection of functionally equivalent welded wings, with the same function of welding/sealing the connector into the bag/container, recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another, substituting the welded wings of Branderburger ‘783 with the welded spacer wings and spacer ribs of Hall, III, is obvious when predictable results are achieved, with the results of welding/sealing the connector into the bag/container to prevent detachment of the two components. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). It is obvious that the welding portion with similar structure of spacer wings and spacer ribs of Branderburger ‘783 in view of Brandenburger ‘024 and Hall, III is fully capable of cooperating to prevent the receptacle from blocking the second channel of the filling spout.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Branderburger et al. (Publication No. US 2008/0009783 A1) in view of Brandenburger et al. (Publication No. US 2011/0022024 A1), as applied to claim 1 above, and further in view of Segovia, Jr. et al. (Patent No. US 6,612,428 B1)
Regarding claim 13, Branderburger ‘783 in view of Brandenburger ‘024 teaches the apparatus of claim 1. The combination of Branderburger ‘783 in view of Brandenburger ‘024 does not teach wherein the catch is a circumferential groove.
However, Segovia, Jr. teaches wherein the catch is a circumferential groove (circumferential groove 16; Figure 3; Column 2, lines 55-65).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the connection reversed between the filling spout and the closure and to have the filling spout has the protrusion and the closure has the groove, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, with the common function of removably connecting the filling spout with the closure, In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI.C.).
Furthermore, Branderburger ‘783 in view of Brandenburger ‘024 and Segovia, Jr. are both considered to be analogous to the claimed invention because they are in the same field of fluid container connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branderburger ‘783 in view of Brandenburger ‘024 to incorporate the teachings of Segovia, Jr. and have the circumferential groove of Segovia, Jr. be the catch of Branderburger ‘783 in view of Brandenburger ‘024 with the receiving protrusion of Segovia, Jr. on the closure of Branderburger ‘783 in view of Brandenburger ‘024. This would allow for a variety of caps to fit into the bag in a snap-lock manner (Segovia, Jr.; Column 2, lines 15-27 and Column 2, lines 55-65).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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