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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/26 has been entered.
Response to Amendment
Applicant amended claims 1 and 22, and added claim 24. Claims 1-14 and 16-24 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Applicant’s Remarks, filed 03/09/26, with respect to the rejections of claims 1-7, 9, 14, 16, 18, and 20-22 under 35 U.S.C. 102(a)(1) as being anticipated by Norton have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Applicant’s arguments, see pages 8-9, with respect to the rejections of claim 8 under 35 U.S.C. 103 as being unpatentable over Norton in view of Haber and of claims 10-13 as being unpatentable over Norton in view of Gaillot have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-7, 14, 16, 18, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neftel et al. (US 6,280,430 B1).
Regarding claim 1, Neftel discloses a vial adapter (Figs. 1-5, feat. 40; Col. 3, line 33 – Col. 4, line 46), comprising two chamber parts in axial extension of each other (52, 54), wherein a first chamber part (Figs. 4a and 5, feat. 54) is configured for slidably receiving at least a part of a vial crown (14, 18), and a second chamber part (52) is configured for slidably receiving at least a part of a vial body (12), wherein the second chamber part (52) comprises one or more ribs extending radially inward of a chamber wall (Fig. 4b, feat. 53; Col. 4, lines 35-46), wherein the one or more ribs have a longitudinal direction, and wherein the longitudinal direction is axially oriented (Col. 4, lines 35-46). Regarding claim 2, Neftel further discloses that the second chamber part comprises or consists of a coherent cylindrical chamber wall (Figs. 3-5, feat. 52). Regarding claim 3, Neftel further discloses that the first chamber part (54) comprises one or more radially inwardly extending ribs, which are axially oriented (Figs. 3-5, feat. 58; Col. 3, line 48 – Col. 4, line 23). Regarding claim 4, Neftel further discloses that the axially oriented ribs are configured as vial crown retainers (Fig. 4a, feats. 14, 18, and 58; Col. 3, line 60 – Col. 4, line 23) and/or vial body retainers. Regarding claim 5, Neftel further discloses that the axially oriented ribs (58) are configured to be elastic compressive outwardly towards the chamber wall (Col. 4, lines 24-29: ribs 58 are resilient). Regarding claim 6, Neftel further discloses that the axially oriented ribs (58) comprises a planar or annular shaped section, as seen in cross-sectional view, for engaging with the vial crown and/or vial body (Figs. 3-5, feat 58). Regarding claim 7, Neftel further discloses that the axially oriented ribs (58) have a cross sectional shape selected from the group of: isosceles trapezoidal, trilateral trapezoidal, rectangular, or squared (Figs. 3-5, feat 58). Regarding claim 14, Neftel further discloses that the vial adapter (40) comprises a piercing member for piercing or puncturing a septum of a cap of the received vial crown (Figs. 2 and 6a-c, feat. 45). Regarding claim 16, Neftel further discloses that the vial adapter comprises a top wall (60) located near a proximal end of the adapter and opposite to a chamber opening (Fig. 2; the opening of part 52) for receiving at least the part of the vial crown (14, 18), wherein the chamber opening is located at a distal end of the adapter (Fig. 2; the opening of part 52), and wherein a length between the top wall and the chamber opening defines a chamber length (Fig. 2). Regarding claim 18, Neftel further discloses that the axially oriented ribs are configured as wedges (Fig. 4a, feat. 58).
Regarding claim 22, Neftel discloses a vial adapter (Figs. 1-5, feat. 40; Col. 3, line 33 – Col. 4, line 46), comprising two chamber parts in axial extension of each other (52, 54), wherein a first chamber part (Figs. 4a and 5, feat. 54) is configured for slidably receiving at least a part of a vial crown (14, 18), and a second chamber part (52) is configured for slidably receiving at least a part of a vial body (12), wherein the vial adapter is configured to receive the vial up to a fully inserted position (Fig. 4a), wherein the first chamber part comprises one or more ribs extending radially inwardly of a chamber wall (Figs. 3-5, feat. 58; Col. 3, line 65 – Col. 4, line 29), wherein the one or more ribs have a longitudinal direction, wherein the longitudinal direction is axially oriented (Figs. 3 and 5, feat. 58), and wherein the one or more ribs are configured to abut the vial crown when the vial is in the fully inserted position to restrict radial movement of the vial relative to the vial adapter (Fig. 4a, feats. 14, 18, and 58; Col. 3, line 65 – Col. 4, line 29).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Neftel in view of Haber et al. (US 5,647,845 A).
Regarding claim 8, Neftel discloses the vial adapter of claim 1, but does not disclose that the axially oriented ribs extend inwardly with a radial angle of below 90 degrees.
Haber teaches an intravenous infusion system (Fig. 1, feat. 1; Col. 3, lines 53-65) comprising a vial adapter (Figs. 1-5, feat. 20) for a vial (100; Col. 5, lines 33-67). The vial adapter comprises a cylindrical wall (Figs. 2-5, feat. 26) with a plurality of ribs extending inwardly with a radial angle less than 90 degrees (Figs. 3-5, feat. 28; Col. 5, lines 33-67). The ribs (Figs. 3-5, feat. 28) are angled to flex and compress towards the outer wall upon insertion of a vial in order to be able to accept vials with any diameter (Col. 5, lines 33-67). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the adapter disclosed by Neftel so that the axially oriented ribs extend inwardly with a radial angle of below 90 degrees in order to accept vials with any diameter as taught by Haber.
Claims 9-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Neftel in view of Gaillot et al. (US 2013/0303994 A1).
Regarding claims 9-13, Neftel discloses the vial adapter of claim 1, but does not disclose that the one or more radially inwardly extending ribs are circumferentially oriented ribs extending along at least a part of the circumference of the chamber wall, with respect to claim 9, that the at least one circumferentially oriented rib is configured for snap fitting over the vial crown, with respect to claim 10, that the at least one circumferentially oriented rib is placed at the distal end of the first chamber part, with respect to claim 11, that the vial at least one circumferentially oriented rib is adjacent to at least one circumferentially oriented slit, with respect to claim 12, or that the at least one circumferentially oriented slit is connected to at least one partially axially oriented slit, optionally wherein the at least one circumferentially orient slit is connected to two or more axially oriented slits, with respect to claim 13.
Gaillot teaches a vial adapter (Figs. 1-3, feat. 1; ¶0039-0043) comprising snap-fit features (28; ¶0043) comprising resilient deformable legs (30) with inwardly protruding ribs, which are also oriented to be extending along the circumference of the adapter (Fig. 2, feat. 32). The ribs (Figs. 2-3, feat. 32) of the snap-fit features (28) lock over the shoulder, or crown, (Fig. 3, feat. 42) of the vial which advantageously hinder the removal of the vial from the vial adapter (¶0016 and 0043). Gaillot further teaches that the circumferential rib (Fig. 3, feat. 42) cooperate with the shoulder of the vial (42), which is at the bottom of the crown, and therefore at the distal end of the first chamber part or proximal end of the second chamber part (¶0043). Gaillot further teaches that the snap-fit feature (Figs. 1-2, feat. 28), which includes the circumferentially oriented rib (Fig. 2, feat. 32), is surrounded by one circumferentially oriented slit and two axially oriented slits connected to it. Modifying the radially inwardly extending ribs in the second chamber part of Neftel to also be partly circumferentially oriented and snap-fitting features like those taught by Gaillot would advantageously hinder the removal of the vial from the vial adapter as taught by Gaillot. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vial adapter disclosed by Neftel so that the one or more radially inwardly extending ribs are circumferentially oriented ribs extending along at least a part of the circumference of the chamber wall, with respect to claim 9, so that the at least one circumferentially oriented rib is configured for snap fitting over the vial crown, with respect to claim 10, so that the at least one circumferentially oriented rib is placed at the distal end of the first chamber part, with respect to claim 11, so that the vial at least one circumferentially oriented rib is adjacent to at least one circumferentially oriented slit, with respect to claim 12, and so that the at least one circumferentially oriented slit is connected to at least one partially axially oriented slit, optionally wherein the at least one circumferentially oriented slit is connected to two or more axially oriented slits, with respect to claim 13, in order to hinder the removal of the vial from the vial adapter as taught by Gaillot.
Regarding claim 19, Neftel in view of Gaillot suggests the vial adapter of claim 9. Neftel further discloses that the vial adapter comprises a top wall (60) located near a proximal end of the adapter and opposite to a chamber opening (Fig. 2; the opening of part 52) for receiving at least the part of the vial crown (14, 18), wherein the chamber opening is located at a distal end of the adapter (Fig. 2; the opening of part 52), and wherein a length between the top wall and the chamber opening defines a chamber length (Fig. 2). Neftel in view of Gaillot is silent with respect to the circumferentially oriented ribs being located between 15-30% from the top wall relative to the chamber length as claimed. However, where the only difference between the prior art and the claims is 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 is not patentably distinct from the prior art device. Please see MPEP §2144.04(IV)(A) with respect to Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, the circumferentially oriented ribs of claims 9 and 19 are the radially inwardly extending ribs of claim 1, and serve to slidably receive a part of the vial body, as recited in claim 1. Therefore, because the ribs of Neftel in view of Gaillot also receive a part of the vial body, they do not function differently, and a device in which the circumferentially oriented ribs being located between 15-30% from the top wall relative to the chamber length is not patentably distinct from the device suggested by Neftel in view of Gaillot.
Claims 17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Neftel in view of Fangrow (US 2009/0216212 A1).
Regarding claim 17, Neftel discloses the vial adapter of claim 14, and further discloses that the vial adapter comprises a top wall (60) located near a proximal end of the adapter and opposite to a chamber opening (Fig. 2; the opening of part 52) for receiving at least the part of the vial crown (14, 18), wherein the chamber opening is located at a distal end of the adapter (Fig. 2; the opening of part 52), and wherein a length between the top wall and the chamber opening defines a chamber length (Fig. 2). Neftel does not disclose that a distal tip of the piercing member is located between 25%-50% from the top wall relative to the chamber length. Regarding claim 23, Neftel further does not disclose that the distal tip of the piercing member is located between 30-45% from the top wall relative to the chamber length.
Fangrow teaches a vial adapter (Figs. 1 and 6-7, feat. 10; ¶0061) comprising a penetrating portion (14; ¶0061 and 0064-0068) homologous to the piercing member of Neftel, and one or more tabs which aid in securing the adapter to the vial (20; ¶0061 and 0077-0080). The tabs define an upper portion (Figs. 6-7, feat. 20b; ¶0078-0079) which receives the cap or crown of a vial (Fig. 2A, feat. 26; ¶0063), thereby being homologous to the first chamber of Neftel, and a lower portion (Figs. 6-7, feat. 20c; ¶0078-0080) which receives the body of a vial (Fig. 2A, feat. 22), thereby being homologous to the second chamber of Neftel. Fangrow teaches that the penetrating portion may extend a length of between 12 mm and 27 mm into the upper and lower portions (¶0067), and the total length of the upper and lower portions may be between 28 mm and 47.5 mm (¶0079-0080). This allows the adapter to be used with a variety of vial sizes (¶0010 and 0066-0068). Therefore, Fangrow teaches that the penetrating portion may extend between 25.2% and 96.4% of the total length of the upper and lower portions. This overlaps the claimed range of 25-50%, with respect to claim 17, and the claimed range of 30-45%, with respect to claim 23, and therefore a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vial adapter disclosed by Neftel so that a distal tip of the piercing member is located between 25-50% from the top wall relative to the chamber length, with respect to claim 17, or so that the distal tip of the piercing member is located between 30-45% from the top wall relative to the chamber length, with respect to claim 23, so that the adapter may be used with a variety of vial sizes as taught by Fangrow.
Claims 20-21 is rejected under 35 U.S.C. 103 as being unpatentable over Neftel in view of Sharp (US 2006/0287639 A1).
Regarding claim 20, Neftel discloses the vial adapter of claim 14, but does not disclose that the piercing member comprises a cylindrical section and a conic shaped tip section.
Sharp teaches a safety fluid transfer cannula (Figs. 1-4 and 9, feats. 14 and 30; ¶0029-0033 and 0046) for transferring fluid from a vial (20; ¶0030) which may comprise a cylindrical cannula body (30; ¶0031-0033; 30d; ¶0046) and a conic shaped section (32, 32d). Sharp teaches that such a cannula body advantageously does not core the septum of the vial or produce unwanted particles during insertion (¶0029). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vial adapter disclosed by Neftel so that the piercing member comprises a cylindrical section and a conic shaped tip section in order to avoid coring the septum of the vial or produce unwanted particles during insertion as taught by Sharp.
Regarding claim 21, Neftel discloses a vial adapter (Figs. 1-5, feat. 40; Col. 3, line 33 – Col. 4, line 46), comprising two chamber parts in axial extension of each other (52, 54), wherein a first chamber part (Figs. 4a and 5, feat. 54) is configured for slidably receiving at least a part of a vial crown (14, 18), and a second chamber part (52) is configured for slidably receiving at least a part of a vial body (12), wherein the first chamber part (54)and/or the second chamber part (52) comprises one or more ribs extending radially inward of a chamber wall (Fig. 4a-b, feats. 53 and 58; Col. 4, lines 35-46; Col. 3, line 48 – Col. 4, line 23), wherein the vial adapter (40) comprises a piercing member for piercing or puncturing a septum of a cap of the received vial crown (Figs. 2 and 6a-c, feat. 45).
Neftel does not disclose that the piercing member comprises a cylindrical section in continuity with a conic shaped tip section.
Sharp teaches a safety fluid transfer cannula (Figs. 1-4 and 9, feats. 14 and 30; ¶0029-0033 and 0046) for transferring fluid from a vial (20; ¶0030) which may comprise a cylindrical cannula body (30; ¶0031-0033; 30d; ¶0046) and a conic shaped section (32, 32d). Sharp teaches that such a cannula body advantageously does not core the septum of the vial or produce unwanted particles during insertion (¶0029). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vial adapter disclosed by Neftel so that the piercing member comprises a cylindrical section in continuity with a conic shaped tip section in order to avoid coring the septum of the vial or produce unwanted particles during insertion as taught by Sharp.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Neftel in view of Sharp and in further view of Fangrow.
Regarding claim 24, Neftel in view of Sharp suggests the vial adapter of claim 21. Neftel further discloses that the vial adapter comprises a top wall (60) located near a proximal end of the adapter and opposite to a chamber opening (Fig. 2; the opening of part 52) for receiving at least the part of the vial crown (14, 18), wherein the chamber opening is located at a distal end of the adapter (Fig. 2; the opening of part 52), and wherein a length between the top wall and the chamber opening defines a chamber length (Fig. 2). Neftel in view of Sharp do not disclose that a distal tip of the piercing member is located between 25%-50% from the top wall relative to the chamber length.
As discussed above, Fangrow teaches a vial adapter (Figs. 1 and 6-7, feat. 10; ¶0061) comprising a penetrating portion (14; ¶0061 and 0064-0068) homologous to the piercing member of Neftel, and one or more tabs which aid in securing the adapter to the vial (20; ¶0061 and 0077-0080). The tabs define an upper portion (Figs. 6-7, feat. 20b; ¶0078-0079) which receives the cap or crown of a vial (Fig. 2A, feat. 26; ¶0063), thereby being homologous to the first chamber of Neftel, and a lower portion (Figs. 6-7, feat. 20c; ¶0078-0080) which receives the body of a vial (Fig. 2A, feat. 22), thereby being homologous to the second chamber of Neftel. Fangrow teaches that the penetrating portion may extend a length of between 12 mm and 27 mm into the upper and lower portions (¶0067), and the total length of the upper and lower portions may be between 28 mm and 47.5 mm (¶0079-0080). This allows the adapter to be used with a variety of vial sizes (¶0010 and 0066-0068). Therefore, Fangrow teaches that the penetrating portion may extend between 25.2% and 96.4% of the total length of the upper and lower portions. This overlaps the claimed range of 25-50% and therefore a prima facie case of obviousness exists for the claimed ranges. Please see MPEP §2144.05(I). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vial adapter disclosed by Neftel so that a distal tip of the piercing member is located between 25-50% from the top wall relative to the chamber length, with respect to claim 17 so that the adapter may be used with a variety of vial sizes as taught by Fangrow.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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