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 2, 20 are objected to because of the following informalities:
claim 2, line 5 contains a typo – “he” instead of “the”.
Claim 20 includes a period after the 2nd line, this should be a semicolon.
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.
Claim 19 is 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 19 recites the limitation "the priming cap" in line 2. The step of providing “a priming cap” is recited in claim 18, however claim 19 depends from claim 17 which does not include such a recitation. Therefore, there is insufficient antecedent basis for this limitation in the claim.
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) 1-7, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bengtsson et al (US 2021/0128817).
Regarding claim 1, Bengtsson discloses a fluid transfer device, comprising: a first housing 15 comprising a fixedly attached delivery needle 20 (page 5, para. 0068; fig. 2); a second housing 50 longitudinally translatable along a portion of the first housing between a protected position (fig. 2, 6a) and an injected position (fig. 6c); a biasing mechanism 19 biasing the second housing toward the protected position (fig. 2; page 5, para. 0072); and a plug 39 attached to a distal end of the second housing (fig. 2; page 5, para. 0068), wherein the second housing encapsulates a tip of the delivery needle when the second housing is in the protected position (fig. 2; page 5, para. 0068), the tip penetrates the plug as the second housing translates between the protected position and the injected position, and the tip is exposed when the second housing is in the injected position (figs. 6b, 6c).
Regarding claim 2, Bengtsson discloses a fluid transfer device, comprising: a first housing 15 comprising a fixedly attached delivery needle 20 (fig. 2; page 5, para. 0068); and a second housing 50 comprising a plug 39 at a distal end (fig. 2; page 5, para. 0068) and being longitudinally translatable along a portion of the first housing between a protected position (fig. 2, 6a) and an injected position (fig. 6c), wherein the second housing is biased toward the protected position (page 5, para. 0071), and he needle penetrates the plug as the second housing translates between the protected position and the injected position (figs. 6a-c).
Regarding claim 3, Bengtsson discloses a biasing mechanism 19 biasing the second housing toward the protected position (fig. 2; page 5, para. 0071).
Regarding claim 4, Bengtsson discloses that the biasing mechanism is a spring 19 (page 5, para. 0072).
Regarding claim 5, Bengtsson discloses that the second housing encapsulates a tip of the delivery needle when the second housing is in the protected position (fig. 2; page 5, para. 0068).
Regarding claim 6, Bentsson discloses that the plug 39 encapsulates and seals the tip when the second housing is in the protected position (fig. 2; page 5, para. 0068).
Regarding claim 7, Bengtsson discloses that a tip of the delivery needle is exposed when the second housing is in the injected position (fig. 6c).
Regarding claim 17, Bengtsson discloses a method of providing a hypodermic fluid transfer device, comprising: providing a first housing 115 comprising a fixedly attached delivery needle 20 (fig. 2; page 5, para. 0068); and providing a second housing 50 comprising a plug 39 at a distal end (fig. 2; page 5, para. 0068), the second housing being longitudinally translatable along a portion of the first housing between a protected position (fig. 2, 6a) and an injection position (fig. 6c), wherein the second housing is biased toward the protected position (page 5, para. 0071), and the needle penetrates the plug 39 as the second housing translates between the protected position and the injected position (fig. 6a-c).
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.
Claim(s) 12-15 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson.
Claim 12 calls for the first housing to further comprises a longitudinal rail having a shelf on a distal end; and the second housing to further comprises a slot configured to receive the longitudinal rail. Bengtsson teaches the first housing having a slot to receive a longitudinal rail having a shelf on the second housing (fig. 6a; page 5, para. 0077). The rail and shelf taught by Bengtsson are on the reverse of the first housing and second housing as compared to the claimed invention. It has been held that a mere reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)). Therefore, 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 rail and slot taught by Bengtsson to be on the reverse of the first housing and second housing because doing so would have been an obvious modification including reversal of parts.
Regarding claim 13, Bengtsson discloses two longitudinal rails and the second housing comprises two slots, each configured to receive one longitudinal rail (fig. 7a).
Claim 14 calls for the plug to be one of spherical, ovoid, and a prism having a flat contact surface. Bengtsson teaches that the plug has a disk shape (fig. 7a). Applicant has not provided any particular reason for the claimed shape of the plug, nor would the plug perform different than the prior art device having the claimed shape, particularly a prism having a flat contact surface (the shape of the plug being rectangular instead of round thereby forming a rectangular prism). Therefore, the claimed device is not patentably distinct form the prior art. (MPEP 2144.04(IV)(B).
Regarding claim 15, Bengtsson discloses that the plug comprises an angled flat contact surface (fig. 7a).
Allowable Subject Matter
Claims 8-11, 16, 18-20 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.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter of the indicated claims could not be found and was not suggested by the prior art of record, in combination with the features of the invention, substantially as claimed.
Regarding claim 8, the prior art fails to teach or fairly suggest a priming cap removably attached to the first housing, the priming cap having a cap housing and a cap plug, the cap housing and the cap plug creating a sealed interior, wherein the cap plug is in contact with the plug, in combination with the features of the invention, substantially as claimed.
Claims 9, 10 are allowable at least for their dependence on claim 8.
Regarding claim 11, Bengtsson teaches a drug vial on the proximal end of the needle, opposite the plug and therefore not contacting the plug. There is no reason to modify the device of Bengtsson to include the vial on the opposite end as it would fundamentally change the operation of the device.
Regarding claim 16, the prior art fails to teach or fairly suggest the plug further comprising an exposed portion and an enclosed portion, and the exposed portion and the enclosed portion comprise different materials, in combination with the features of the invention, substantially as claimed.
Regarding claims 18 and 19, the prior art fails to teach or fairly suggest the priming cap in combination with the features of the invention, substantially as claimed, as discussed above.
Regarding claim 20, Bengtsson teaches a drug vial on the proximal end of the needle, opposite the plug and therefore not contacting the plug. There is no reason to modify the device of Bengtsson to include the vial on the opposite end as it would fundamentally change the operation of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783