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 with traverse of Group I (claims 1-4 and 6-8) in the reply filed on 6 April 2026 is acknowledged. The traversal is on the ground(s) that there is not a search burden and that it would not involve the consideration of a reasonable number of claims. This is not found persuasive because the claims are drawn toward distinct inventions that require different fields of search and different search terms and strategies to conduct a comprehensive search. Groups II and IV are drawn toward a separate and distinct subcombination that does not require the presence of the elements of Group I. Group III is drawn toward an apparatus for performing the method of Group I. As detailed in the previous action, the method does not require the presence of the claimed apparatus. With regards to the number of claims, it is the scope of the subject matter disclosed which is the issue that results in a search burden. The number of claims is not necessarily germane to this matter.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-2 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peroni et al. (US 2002/0124535 A1) hereinafter referred to as Peroni.
Regarding claim 1, Peroni discloses a method (figs. 2 and 4) of foil (15, 16, 17) packaging components for a drug delivery device (11; paragraph 0068 – “a medication-specific hopper which is adapted to receive a bulk product such as tablets, caplets, capsules, ampoules, vials, ovules, or ready-to-use syringes”), the method comprising:
introducing (paragraphs 0076-0078) a first sheet of foil (15) and a second sheet of foil (16) into a welding assembly (130), the welding assembly including a first welding bar (131) and a second welding bar (132);
welding (paragraphs 0076-0078, 0096; fig. 2) the first sheet of foil and the second sheet of foil together at a first subsection of the first and second sheets of foil to define a first welded subsection, wherein welding the first and second sheets of foil together at the first subsection includes clamping the first welding bar and the second welding bar at the first subsection (fig. 4; repeated welds 18 and 19);
providing (14; paragraph 0072) a component for a drug delivery device (11; paragraph 0068) between the first sheet of foil and the second sheet of foil above the first welded subsection (figs. 2 and 4);
unclamping (paragraph 0077 – “The jaws are able to move in and out in the supports 133, 134 in a horizontal direction and in phase with each other”) the first welding bar and the second welding bar from the first welded subsection;
moving (140, 141, 142; paragraphs 0082, 0094, 0096) the first sheet of foil and the second sheet of foil downward in the welding assembly; and
welding (figs. 2 and 4; paragraphs 0076-0078, 0094, 0096) the first sheet of foil and the second sheet of foil together at a second subsection of the first and second sheets of foil to define a second welded subsection, the second welded subsection being offset a predefined distance from the first welded subsection, wherein, after welding the first and second sheets of foil together at the first and second subsections, the first welded subsection is on one side of the component and the second welded subsection is on an opposite side of the component such that the component is surrounded by the first and second sheets of foil.
Regarding claim 2, Peroni discloses repeating (figs. 2 and 4 show the process repeated) the steps of providing (14; paragraph 0072) the component for the drug delivery device (11; paragraph 0068) between the first sheet of foil (15) and the second sheet of foil (16), unclamping (paragraph 0077) the first and second welding bars (131, 132), moving (140, 141, 142; paragraphs 0082, 0094, 0096) the first and second sheets of foil downward in the welding assembly, and welding (figs. 2 and 4; paragraphs 0076-0078, 0094, 0096) the first and second sheets of foil together until each of the components for the drug delivery device is individually packaged in foil.
Regarding claim 6, Peroni discloses wherein the predefined distance between the first subsection and the second subsection is adjustable based on at least a dimension of the component for the drug delivery device (paragraph 0099).
Regarding claim 7, Peroni discloses wherein moving (140, 141, 142; paragraphs 0082, 0094, 0096) the first and second sheets of foil (15, 16) downward further comprises: clamping the first and second sheets of foil between a first jaw (141) and a second jaw (142) of a transporting assembly (140) at the first welded subsection; moving the first and second jaws of the transporting assembly downward; and unclamping the first and second jaws (paragraphs 0082, 0094, 0096).
Regarding claim 8, Peroni discloses wherein the first and second welding bars (131, 132) of the welding assembly (130) are moveable along an x-axis (paragraph 0077 – “The jaws are able to move in and out in the supports 133, 134 in a horizontal direction and in phase with each other”), and wherein the first and second jaws (141, 142) of the transporting assembly are moveable along the x-axis and a y-axis (paragraph 0082 – “The members 140 comprise a pair of opposing clamps 141, 142 on either side of the tube 17 that are adapted to move in and out in phase with each other and in phase with longitudinal 121, 122 and transverse 131, 132 sealing jaws, in horizontal direction for clamping the tube 17, and then in a vertical direction for pulling it in the direction W.”).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peroni (US 2002/0124535 A1) in view of Maloney (US Patent 4,631,905).
Regarding claim 3, Peroni discloses wherein introducing the first sheet of foil (15) and the second sheet of foil (16) into the welding assembly (130) comprises introducing the first sheet of foil along a first set of rollers (111) and the second sheet of foil (112) along a second set of rollers (112) into the welding assembly, but fails to disclose a first and second roll of foil.
However, Maloney (fig. 15) teaches wherein introducing the first sheet of foil (213) and the second sheet of foil (214) into the welding assembly (210) comprises introducing a first roll of foil (217) along a first set of rollers (24, 221) and a second roll of foil (219) along a second set of rollers (224, 221) into the welding assembly.
Given the teachings of Maloney, it would have been obvious to one of ordinary skill in the art before the time of effective filing to modify the invention of Peroni to have the first and second roll of foil and set of rollers of Maloney. Peroni already discloses moving sheets of foil along rollers. Maloney further teaches that having the sheet supplied by a roll and having the sheet moved along by rollers was well-known in the art. Doing so provides an easily accessible supply of film over an extended period of time and would help to properly direct the sheet as needed through the welding station among other stations.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peroni (US 2002/0124535 A1) in view of Finkelstein et al. (US 2002/0281146 A1) hereinafter referred to as Finkelstein.
Regarding claim 4, Peroni discloses wherein the drug delivery device includes a ready-to-use syringe (paragraph 0068), but fails to disclose wherein the drug delivery device includes an autoinjector, and wherein the component for the drug delivery device includes at least one of a compression spring or a power spring.
However, Finkelstein teaches a drug delivery device includes an autoinjector (10), and wherein the component for the drug delivery device includes at least one of a compression spring (50; paragraph 0133) or a power spring.
Given the teachings of Finkelstein, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the drug delivery device of Peroni be an autoinjector as in Finkelstein. Personi is already concerned with packaging a ready-to-use syringe. An autoinjector is a specific type of ready-to-use syringe which was well-known in the art and provides the benefit of being able to be consistently fired into tissue with a desired amount of penetrating strength as might be needed to properly administer the drug.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited. The art not relied upon generally pertains to vertical product filling and sealing film methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW M TECCO whose telephone number is (571)270-3694. The examiner can normally be reached M-F 11a-7p.
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/ANDREW M TECCO/ Primary Examiner, Art Unit 3731
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