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 .
Response to Amendments and Arguements
The Examiner acknowledges the amendments. The previous drawing objections and 112 rejections are withdrawn. The 103 rejections are maintained and made final.
Applicant argues the amendments overcome the 103 rejections. The Examiner respectfully disagrees. Applicant relies on the limitation “a first connecting link having a first end secured to the first end of the center link and connecting the first end of the center link to the first grip member; a second connecting link having a first end secured to the second end of the center link and connecting the second end of the center link to the second grip member”. A definition of secured to is “Firmly fixed or fastened”. Since the linkage system of Kroseder is continuously tightly pressed by springs, it is of the Examiner’s opinion that they are firmly fixed to each other.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,883,362. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant application
US 11,883,362
1. An assembly fixture device for attaching a vial adapter to a vial, the device comprising:
a vial adapter grip assembly comprising an adapter grip member configured to engage and hold the vial adapter, the vial adapter grip assembly movable from a first position to a second position; and
a vial grip assembly, the vial grip assembly comprising:
first and second grip members that are movable relative to each other and configured to engage and hold the vial;
a center link having a first end, a second end opposite the first end, and a central pivot positioned between the first end and the second end;
a first connecting link connecting the first end of the center link to the first grip member;
a second connecting link connecting the second end of the center link to the second grip member; and
a biasing member that biases the first grip member toward the second grip member to provide a vial engagement force.
1. An assembly fixture device for attaching a vial adapter to a vial, the device comprising:
a base having a first side and a second side positioned opposite the first side;
a support member secured to the base, the support member having a first end and a second end positioned opposite the first end;
a handle connected to the support member, the handle is movable between a first position and a second position;
a vial adapter grip assembly connected to the handle, the vial adapter grip assembly comprising an adapter grip member configured to engage and hold the vial adapter, the vial adapter grip assembly having a first position when the handle is in the first position and a second position when the handle is in the second position; and
a vial grip assembly connected to the base, the vial grip assembly comprising:
first and second grip members that are movable relative to each other and configured to engage and hold the vial;
a center link having a first end, a second end opposite the first end, and a central pivot positioned between the first end and the second end;
a first connecting link connecting the first end of the center link to the first grip member;
a second connecting link connecting the second end of the center link to the second grip member; and
a biasing member that biases the first grip member toward the second grip member to provide a vial engagement force.
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 1-4, 6-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US 924,360) in view of Kroseder (us 5,893,700).
Regarding claim 1, Kirkegaard discloses an assembly fixture device for attaching a vial adapter to a vial, the device comprising:
a vial adapter grip assembly (Items 20, 30 and 40) comprising an adapter grip member configured to engage and hold the vial adapter, the vial adapter grip assembly movable from a first position to a second position (Page 2 lines 77-98); and
a vial grip assembly (at least Items 60-66), the vial grip assembly comprising:
Kirkegaard fails to disclose a vial grip assembly comprising first and second grip members that are movable relative to each other and configured to engage and hold the vial; a center link having a first end, a second end opposite the first end, and a central pivot positioned between the first end and the second end; a first connecting link having a first end secured to the first end of the center link and connecting the first end of the center link to the first grip member; a second connecting link having a first end secured to the second end of the center link and connecting the second end of the center link to the second grip member; and a biasing member that biases the first grip member toward the second grip member to provide a vial engagement force.
Kroseder teaches a vial grip assembly, the vial grip assembly comprising:
first and second grip members (Items 5a and 4a) that are movable relative to each other and configured to engage and hold the vial; a center link (Items 8) having a first end, a second end opposite the first end, and a central pivot positioned between the first end and the second end (Figures 1 and 1a); a first connecting link (Item 5b) having a first end secured to the first end of the center link and connecting the first end of the center link to the first grip member; a second connecting link (Items 4b) having a first end secured to the second end of the center link and connecting the second end of the center link to the second grip member; and a biasing member (Item 9) that biases the first grip member toward the second grip member to provide a vial engagement force. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the foot pressed vial grip assembly of Kirkegaard with the vial grip assembly of Kroseder. Both grip assemblies are known to grip a vial /bottle/ cylindrical container. Thus a simple substitution would lead to the predictable result of the container being properly gripped. Kroseder discusses in Column 1 Lines 7-42 how their design can be cheaply made by plastic and the spring elements extend the life of the gripper by preventing elastic deformation in the gripper members.
Regarding claim 2, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1, wherein movement of the first connecting link in a first direction results in movement of the second connecting link in a second direction opposite from the first direction (Kroseder Figure 1).
Regarding claim 3, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1, wherein the first and second connecting links are each rotatable relative to the center link (Kroseder Figure 1).
Regarding claim 4, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1, further comprising a base, wherein the vial grip assembly is attached to the base (as modified, the vial grip assembly would be located on the lower portion of Kirkegaard; similarly Items 16 and 17 of Kroseder can be considered a base).
Regarding claim 6 Kirkegaard in view of Kroseder disclose the assembly fixture device claim 4, wherein the base defines a first guide channel and a second guide channel, wherein at least a portion of the first grip member extends through the first guide channel, and wherein at least a portion of the second grip member extends through the second guide channel (Kroseder, Item 18 extends through Items 16 and 17).
Regarding claim 7, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 4, further comprising: a support member (Kirkegaard Item 11) secured to the base (Item 10); and a handle (Item 15) connected to the support member, wherein the handle is configured to move the vial adapter grip assembly from the first position to the second position.
Regarding claim 8-11, Kirkegaard in view of Kroseder disclose the device of claim 1. Kirkegaard in view of Kroseder fails to explicitly disclose wherein the vial engagement force is about constant when a distance between the first and second grip members is less than 40 mm, from 2.50-2.75 N when the distance between the first and second grip members is 14 mm and from 3.00-3.25 N when the distance between the first and second grip members is 55 mm. Column 3 Line 56-Column 4 Line 9 of Kroseder discusses how the springs and arms exert a force as the arms compress the container but fails to discuss the size or the force necessary. Kroseder does not assign values to the vial engagement force or the clamping distance, but discloses the concept of gripping to a constant value. Thus, the claimed dimensions are recognized as result effective variable, i.e. a variable in which achieves a recognized result as set forth above. Therefore since the general conditions of the claim (e.g. having the claimed structure as recited above) is disclosed by Kirkegaard in view of Kroseder it is not inventive to discover the optimum workable range by routine experimentation, and it would have been obvious to one of ordinary skill in the art at the time when the invention was filed to provide the vial engagement force is about constant when a distance between the first and second grip members is less than 40 mm, from 2.50-2.75 N when the distance between the first and second grip members is 14 mm and from 3.00-3.25 N when the distance between the first and second grip members is 55 mm. Further in the instant application Paragraphs (Paragraphs [0005-9 and 0045]) Applicant has not disclosed any criticality for the claimed limitations. Specifically, in Paragraphs [005-0009] Applicant uses the term “may” which would lead one of ordinary skill in the art to question if these values are needed to reach the functional/performance limitations of the claims.
Regarding claim 12, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1, wherein the first and second grip members each comprise a cam surface (Kroseder Figure 1a, “recess”) and vial receiving surface (Item 6), the cam surfaces of the first and second grip members are configured to engage the vial and move the first and second grip members away from each other, and the vial receiving surfaces of the first and second grip members are configured to engage the vial.
Regarding claim 13, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 12, wherein the cam surfaces are each angled and together form a V-shape when the first and second grip members are positioned adjacent to each other (Kroesder Figure 1).
Regarding claim 14, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 12. Kirkegaard fails to explicitly disclose wherein the vial receiving surface of the first and second grip members each comprise a V-shaped surface. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the recess of Kroseder from curved to be v shaped. Such a modification is viewed as a change in shape, which has been held to be of routine by one skilled in the art (see MPEP 2144.04). The shape of the recess would depend on the shape of the vial, the center rotational member, the material in which they were made of and the forces experiences therein. When looking to the instant application, there is no criticality discussed for the claimed limitation.
Regarding claim 19, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1, wherein the vial adapter grip assembly further comprises a press member having an engagement surface configured to engage the vial adapter (Kirkegaard Item 43).
Regarding claim 20, Kirkegaard in view of Kroseder disclose the method of attaching a vial adapter to a vial using the device of claim 1, comprising: coupling the vial adapter to the adapter grip member of the vial adapter grip assembly; positioning the vial between the first and second grip members of the vial grip assembly; and moving the vial adapter grip assembly from the first position to the second position to attach the vial adapter to the vial (Kirkegaard Page 2 Lines 50-130).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkegaard (US 924,360) in view of Kroseder (us 5,893,700) in view of Holstein (US 4,232,499)
Regarding claim 15, Kirkegaard in view of Kroseder disclose the assembly fixture device of claim 1. Kirkegaard fails to explicitly disclose wherein the adapter grip member includes first and second adapter arms configured to deflect radially outward when engaged by the vial adapter.
Holstein teaches an assembly fixture wherein the adapter grip member includes first and second adapter arms configured to deflect radially outward when engaged by the vial adapter (Items 52a/b Column 4 Line 17-Column 8 line 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kirkegaard to use the adapter grip member of Holstein. Holstein discusses how there are many types and styles of vial adapters, and how his adapter grip members can easily be replaced for different sizes (Column 1 Line 65-Column 2 Line 2).
Regarding claim 16, Kirkegaard in view of Kroseder in view of Holstein disclose the assembly fixture device of claim 15. Kirkegaard fails to explicitly disclose wherein the first and second adapter arms each define a semi- cylindrical surface.
Holstein teaches a frustoconical gripping surface, which is capable of gripping a cylindrical surface. Holstein teaches that the gripping surfaces can easily be replaced for different sizes and shapes (Column 13 Lines 1-4). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the gripping surfaces to be cylindrical. Such a modification is viewed as a change in shape, which has been held to be of routine by one skilled in the art (see MPEP 2144.04). Further in the instant application, there is no criticality discussed by the spherical shape. Applicant states in paragraph 44 of the instant application “although other suitable shapes and configurations may be utilized.”
Regarding claim 17, Kirkegaard in view of Kroseder in view of Holstein disclose the assembly fixture device of claim 15, wherein the adapter grip member defines an elongated slot positioned between the first and second adapter arms (Holstein Figure1 between items 52a and 52b).
Regarding claim 18, Kirkegaard in view of Kroseder in view of Holstein disclose the assembly fixture device of claim 15, wherein the first and second adapter arms each include a cam surface, and wherein the cam surface is configured to engage a vial adapter and bias the first and second adapter arms radially outward to engage and hold a vial adapter (Holstein Items 100 and 110).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. When looking to the prior art and Kroseder, the spring attaches between the center member and the pair of arms. There would be no reasoning to modify how the spring of Kroseder. Since there are no known references that in combination with all other limitations in the independent claim, claim 5 is determined to be novel and non-obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOM R RODGERS whose telephone number is (313)446-4849. The examiner can normally be reached Monday thru Friday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Posigian can be reached at (313) 446-6546. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOM RODGERS/Primary Examiner, Art Unit 3723
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