DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed before March 16, 2013 is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 07/07/26 have been entered in the case. Claims 1-3, 5-6 are pending for examination and claim 4 is cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 is as failing to comply with the written description requirement. The claim 2 requires that a width (w3) of the housing along a portion of the opposing concave regions is smaller than a width (w1) of the housing along at least a portion of the first overmolded gripping region and a width (at region 130 or region 132) of the housing . Conversely, Fig. 4 shows that w1 is less than w3; w1 is greater than w130 or 132.
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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 1-3 & 5-6 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.
The limitation “a second overmolded gripping region” is vague. It is unclear whether the second overmolded gripping region refers to region 130, region 132, or both regions 130 and 132. If the second overmolded gripping region is considered to be either region 130 or region 132, claim 2 would be rejected under 35 U.S.C. 112, first paragraph. The width of the housing at the second gripping region (130 or 132) is less than w1, w2, and w3.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gamlin et al. (WO 2011/057065) in view of Jacobs et al. (US 2007/0197976) and Polzin et al. (US 2003/0172498).
Regarding claim 1, Gamlin discloses a housing 18 for a drug-delivery device, comprising: a first gripping region 14 formed on a proximal terminal end of the housing; a second gripping region 36; and opposing concave regions 18 abutting the first and second gripping regions 14 & 36, wherein the housing encloses a cavity for accommodating a container 50.
Gamlin does not disclose that the first and second gripping regions are first and second overmolded gripping regions
Jacobs discloses a housing for drug delivery device comprising: a first overmolded griping region formed on a proximal terminal end 97 of the housing, para [0036].
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the device of Gamlin to include the overmodled gripping region on the proximal terminal end of the housing as taught by Jacobs. One of ordinary skill in the art would have been motivated to make this modification to provide a soft-touch surface, to enable a user to securely grip the terminal end with reduced physical effort, and to provide shock absorption in the event that the device is dropped.
Gamlin (or Gamlin in view of Jacobs) does not disclose the limitation that second gripping region comprise an overmolded composition.
Polzin discloses an apparatus comprising: a housing 10, a gripping regions 20 include(s) an overmolded composition on both opposite sides of the housing at gripping regions. It is noted that the gripping region 20 is equivalent to the claimed limitation of the second overmold gripping region."
Since Gamlin and Polzin both concern the same field of endeavor—specifically, gripping regions—and both devices feature a cylindrical shape, the purpose disclosed by Polzin would have been recognized in the pertinent art of Gamlin.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Gamlin (or Gamlin in view of Jacobs) to include an overmolded composition on both opposite sides of the housing at gripping regions, as taught by Polzin, in order to provide a soft-touch surface, to enable a user to securely grip the terminal end with reduced physical effort, and to provide shock absorption in the event that the device is dropped
Regarding claim 2, Gamlin in view of Jacobs and Polzin discloses all the claimed subject matter as required. Gamlin discloses that a width w3 of the housing along a portion of the opposing concave regions is smaller than a width w1 of the housing along at least a portion of the first overmolded gripping region and a width W of the housing at the second overmolded gripping region.
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Regarding claim 3, Gamlin in view of Jacobs and Polzin discloses all the claimed subject matter as required. Gamlin discloses that wherein the opposing concave regions 18 of the housing lack a gripping surface.
Regarding claim 5, Gamlin in view of Jacobs and Polzin discloses all the claimed subject matter as required. Gamlin discloses that wherein the second overmolded gripping region 36 of the housing has a tapered tubular structure.
Regarding claim 6, Gamlin in view of Jacobs and Polzin discloses all the claimed subject matter as required. Gamlin discloses that an injection device 20 comprising: the housing of claim 1; and a substance liquid in the container 50. A person skilled in the art would recognize that container 50 can contain an antibody for the intended purpose of treating a specific condition.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
