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 .
Claim Objections
Claims 44, 47-48, 50, and 63 are objected to because of the following informalities:
Claim 44 should be corrected to “[[is]] are performed” (line 2).
Claim 47 should be corrected to “prior to the overmolding of the elastomer component” (line 3).
Claim 48 should be corrected to “after the overmolding of the elastomer component” (lines 1-2)
Claim 50 should be corrected to “after the overmolding of the interfacing polymer components” (lines 1-2)
Claim 63 should be corrected to “[[the]] an interfacing portion” (line 5)
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 55, 57, 60-61, 63, 65, and 68-69 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.
Claim 55 recites the limitation “the attaching” in line 1. There ambiguous insufficient antecedent basis for this limitation in the claim. It is unclear whether the attaching means (1) “attaching a plurality of linkers to the plurality of interfacing polymer components” (claim 52 lines 1-2), (2) “attaching a plurality of carrier polymer-agent components to the plurality of linkers” (claim 54 lines 2-3), or (3) both. For the purpose of examination, either of these interpretations would read on the claim.
Claim 57 is rejected under 35 U.S.C. 112(b) as being dependent from claim 55.
Claim 60 recites the limitation “the attaching” in line 1. There ambiguous insufficient antecedent basis for this limitation in the claim. It is unclear whether the attaching means (1) “attaching a plurality of linkers to the plurality of interfacing polymer components” (claim 52 lines 1-2), (2) “attaching a plurality of carrier polymer-agent components to the plurality of linkers” (claim 54 lines 2-3), or (3) both. For the purpose of examination, either of these interpretations would read on the claim.
Claim 61 is rejected under 35 U.S.C. 112(b) as being dependent from claim 60.
Claim 63 recites the limitation “the attaching” in line 1. There ambiguous insufficient antecedent basis for this limitation in the claim. It is unclear whether the attaching means (1) “attaching a plurality of linkers to the plurality of interfacing polymer components” (claim 52 lines 1-2), (2) “attaching a plurality of interfacing polymer-(carrier polymer-agent) components to the plurality of linkers” (claim 62 lines 2-3), or (3) both. For the purpose of examination, either of these interpretations would read on the claim.
Claim 65 is rejected under 35 U.S.C. 112(b) as being dependent from claim 63.
Claim 68 recites the limitation “the attaching” in line 1. There ambiguous insufficient antecedent basis for this limitation in the claim. It is unclear whether the attaching means (1) “attaching a plurality of linkers to the plurality of interfacing polymer components” (claim 52 lines 1-2), (2) “attaching a plurality of interfacing polymer-(carrier polymer-agent) components to the plurality of linkers” (claim 62 lines 2-3), or (3) both. For the purpose of examination, either of these interpretations would read on the claim.
Claim 69 is rejected under 35 U.S.C. 112(b) as being dependent from claim 68.
Appropriate correction or clarification is required.
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.
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.
Claims 43-44, 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Ejima (US 20040266315 A1).
Regarding claim 43, Ejima teaches a method [of making a gastric residence system assembly] comprising: a) overmolding an elastomer component (a molten material (thermoplastic elastomer of 30 in hardness) over a first portion (upstream portions of elbows or knees, i.e., close to a torso) of a plurality of at least three intercomponent anchors (portions corresponding to two arms and two legs of the semi-finished product 32) (figs. 16, 17; [0087-0088]: to form a torso portion); and b) overmolding a plurality of interfacing polymer components (a molten material (thermoplastic elastomer of 30 in hardness) over a second portion of each intercomponent anchor (downstream portions of elbows or knees, i.e., distant from a torso), wherein each interfacing polymer component is overmolded over a corresponding one of the at least three intercomponent anchors (figs. 16, 17; [0087-0088]: to form downstream portions of two elbows and two knees). Here, although the method is not intended to make a gastric residence system assembly, the claim does not require any further steps that are specifically related to a gastric residence system assembly. Moreover, it would have been obvious to one of ordinary skill in the art to apply the generally known molding process of overmolding an elastic resin component over two different portions of an insert which interconnects two different sections of a molded article so as to make a molded article with an interconnecting insert are integrated thereto, for example, a gastric residence system assembly.
Regarding claim 44, Ejima teaches the method of claim 43, wherein the overmolding of the elastomer component and the overmolding of the interfacing polymer components is performed by injection molding (figs. 16, 17; [0087-0088]: a resin material is injected to spaces 34 of a mold 33).
Regarding claim 47, Ejima teaches the method of claim 43, wherein the plurality of intercomponent anchors are connected by a first scaffold (mold 33), where the first scaffold maintains the anchors in a desired position prior to overmolding the elastomer component (figs. 16, 17; [0087-0088]: the thus-obtained semi-finished product 32 is securely placed in a further mold 33).
Regarding claim 48, Ejima teaches the method of claim 47, further comprising removing the first scaffold after overmolding the elastomer component (fig. 17; [0088]: when the mold 33 is opened after cooling thereof, a finished product is obtained; here, it is implied that the mold 33 is removed after the overmolding is completed).
Regarding claim 49, Ejima teaches the method of claim 43, wherein the overmolded plurality of interfacing polymer components are connected by a second scaffold formed during the overmolding of the interfacing polymer components, where the second scaffold maintains the interfacing polymer components in a desired position (figs. 16, 17; [0087-0088]: the thus-obtained semi-finished product 32 is securely placed in a further mold 33).
Regarding claim 50, Ejima teaches the method of claim 49, further comprising removing the second scaffold after overmolding the interfacing polymer components (fig. 17; [0088]: when the mold 33 is opened after cooling thereof, a finished product is obtained; here, it is implied that the mold 33 is removed after the overmolding is completed).
Allowable Subject Matter
Claims 45, 51-54, and 62 are 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.
Claims 55, 57, 60-61, 63, 65, and 68-69 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yamanouchi Pharmaceutical Co. (AU6199090 A; hereinafter, Yamanouchi) teaches a method of making a gastric residence system assembly comprising: a) overmolding an elastomer component (A) over a first portion of a plurality of at least three intercomponent anchor (B) (figs. 5-6, pages. 30-31: Example 8; pages 49-50: explanation of figs. 5, 6), and a plurality of intercomponent anchor (C) having a first portion and a second portion are overmolded over an elastomer component (A) and a plurality of interfacing polymer components (B) in an embodiment of fig. 6 (fig. 6, pages 49-50).
Bellinger (US 20170106099 A1) teaches residence structures and related methods (abstract). Of note, this reference is not qualified for prior art under 35 U.S.C. 102(a)(2) as the 35 U.S.C. 102(b)(2) exception applies.
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/INJA SONG/Examiner, Art Unit 1744
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