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 Amendment
This office action is responsive to the preliminary amendment filed on 8/14/23. As directed by the amendment: no claims have been amended, claims 1-11 have been cancelled, and new claims 12-22 have been added. Thus, claims 12-22 are presently pending in this application.
Claim Objections
Claims 12 and 18-20 are objected to because of the following informalities: the claims include random parentheses that should be removed. Appropriate correction is required.
Claims 14 is objected to because of the following informalities: this claim includes a reference numeral in parentheses that appears to be inconsistent with the formatting of the other concurrent claims. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “is plane” is grammatically incorrect. 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 12-22 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.
Regarding claim 12, the phrase “and in that” in line 10 is grammatically unclear, and thus unclearly links the subsequent limitation to the remainder of the claim.
Regarding claim 14, it is unclear how a “set” of elements, the plain meaning of set requiring a group of multiple elements, can encompass an embodiment where one element is present, which is included by reciting “at least one” element. Clarity is further eroded since “raised elements” were previously recited in parent independent claim 12; it is unclear if this “at least one raised element” is one of the “raised elements” from claim 12, and additionally, unclear if this limitation is properly further limiting “raised elements” from claim 12.
Regarding claim 22, it is unclear what is meant by reciting “a syringe…and a pre-filled syringe”. For the purposes of examination, the claim will be interpreted as reciting a single syringe.
Remaining claims are rejected due to dependency on a claim rejected above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Parent claim 13 recites “sets” of raised elements, but claim 14 goes on to define a set as comprising “at least one” raised element. The plain meaning of “set” in claim 13 requires a group of more than one element. Therefore, claim 14 appears to both fail to further limit claim 13 and fail to incorporate all the limitations of claim 13, by including within its broadest interpretation a single raised element within a set. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 12-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucuk (US 20190344017) in view of Maritan et al. (EP 2862587) and Carney et al. (US 10098816).
Regarding claim 12, as best understood, Kucuk discloses a cap 1 for a syringe 30 with Luer-lock connector (connector portion of 30 illustrated in fig. 3), comprising: - a main body provided with a first handle portion 50 and a second coupling portion 40 having an external threading 42 for coupling with a corresponding internal threading 32 of the Luer-lock connector of the syringe (see fig. 3), an axial cavity 14 having an aperture at the second coupling portion being formed in the main body (opening in 40 into which 33 is illustrated extending in fig. 3); and – an elastomeric (par. 0110) sealing element 20 housed in the axial cavity of the main body (see fig. 3), wherein the elastomeric sealing element has a surface facing the aperture of the axial cavity and designed to abut against an open free end of a tip of the syringe for air-tightly closing the open free end (par. 0108; see fig. 3; inner surfaces of sealing portion 21 which interact with 33 and 34); except for specifically disclosing that the elastomeric sealing element is a rubber, and wherein raised elements are formed at respective crests of threads of the external threading of the second coupling portion and in that the raised elements are dimensioned so as to frictionally couple with a bottom of corresponding threads of the internal threading of the Luer-lock connector.
However, Maritan et al. teaches forming the elastomeric sealing member of a similar syringe cap as a rubber, in that it is made of one of various types of rubber (par. 0053). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elastomeric sealing element of Kucuk to specifically be a rubber, as taught by Maritan et al., since rubber meets the requirement of having elastomeric properties required by Kucuk, and is taught by Maritan et al. to be appropriate for use in the same type of device as Kucuk.
Furthermore, Carney et al. teaches forming raised elements 102a/102b at respective crests of threads of the external threading of a coupling portion (see fig. 8) that are dimensioned so as to frictionally couple with a bottom of corresponding threads of the internal threading of corresponding connecting threads (col. 10, ln. 47 – col. 11, ln. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the threads 42 of Kucuk to include raised elements as taught by Carney et al. for the purpose of increasing friction between the mating elements during connection to provide effective feedback to the user that a connection is being made (col. 10, ln. 47 – col. 11, ln. 2).
Regarding claim 13, Carney et al. further teaches the raised elements comprise at least two sets of raised elements provided in a diametrically opposite position on the external threading (col. 10, ln. 37-46).
Regarding claim 14, as best understood, Carney et al. further teaches each set of raised elements comprises at least one raised element (see fig. 8; col. 10, ln. 37-46).
Regarding claim 15, Carney et al. further teaches the raised elements of each set of raised elements are aligned therebetween along the external threading of the second coupling portion (see fig. 8; col. 10, ln. 37-46).
Regarding claim 17, Carney et al. further teaches the raised elements are recessed or aligned with respect to an edge of the external threading of the second coupling portion (aligned; see fig. 8).
Regarding claim 18, Kucuk in view of Maritan et al. teaches the surface of the elastomeric sealing element 20, modified with Maritan et al. to be a rubber, facing the aperture of the axial cavity is plane or convex with convexity facing the aperture of the axial cavity (convexity formed by interior of 21 and 24 which faces 33 and 34, see fig. 3; additionally, the bottom surface of interior of 21 and 24 also forms a plane, see fig. 3).
Regarding claim 19, Kucuk in view of Maritan et al. teaches the axial cavity comprises a side surface (inwardly facing side of cavity 14) and a rigid bottom surface (see annotated fig. 3 below), against which a surface of the elastomeric sealing element 20 (modified by Maritan et al. to be a rubber) opposite to the surface facing the aperture of the axial cavity abuts (see annotated fig. 3 below).
Regarding claim 20, Kucuk in view of Maritan et al. teaches the elastomeric sealing element 20, modified by Maritan et al. to be a rubber, further comprises at least one longitudinal groove 25 formed in a side surface thereof (see fig. 3).
Regarding claim 21, Kucuk discloses the second coupling portion has a conical mouth at a free end thereof (mouth formed by 21; see fig. 3).
Regarding claim 22, as best understood, Kucuk, as modified by Maritan et al. and Carney et al., teaches a pre-filled syringe (par. 0019) with Luer-lock connector (par. 0018; fig. 3), and comprising a cap according to claim 12 (see rejection of claim 12 above).
Claim(s) 16 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucuk in view of Maritan et al. and Carney et al., and further in view of Roussie (US 7845687).
Regarding claim 16, Carney et al. teaches the raised elements as claimed, except for the raised elements specifically having a substantially trapezoidal or rectangular section. However, Carney et al. teaches that one of ordinary skill in the art will appreciate that the number, size, shape, and orientation of the protrusions can be chosen to provide a desired amount of friction (col. 10, ln. 47 – col. 11, ln. 2). Furthermore, Roussie teaches providing a trapezoidal protrusion from a thread (see protrusion defined by surfaces 12 and 21 in fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize any known shape of protrusion for the protrusions taught by Carney et al., such as a trapezoidal protrusion as taught by Roussie, for the purpose of adapting the friction to desired characteristics as envisioned by Carney et al. Additionally, based on the disclosure of Carney et al. in col. 10, ln. 47 – col. 11, ln. 2, such a modification of shape would be considered a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Feith et al. (US 6152913) discloses adding raised protrusions 238 to threads to create a “crush thread” (see fig. 17a). See attached notice of references cited for additional references.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783