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 amendment filed on 5/5/26. As directed by the amendment: claims 12 and 18-22 have been amended, claims 1-11, 14, and 16 have been cancelled, and new claim 23 has been added. Thus, claims 12, 13, 15, and 17-23 are presently pending in this application.
The amendments to the claims are sufficient to overcome the claim objections and the rejections under 35 U.S.C. 112(b) as presented in the prior action.
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 23 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. The language “of the pre-filled type” is new matter which lacks written description.
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 23 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.
Regarding claim 23, the language “of the pre-filled type” is indefinite since it is not clear how to determine the scope of “type” that would be encompassed by the claim language.
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, 13, 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), Carney et al. (US 10098816), and Roussie (US 7845687).
Regarding claim 12, 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 have a substantially trapezoidal or rectangular section 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).
Carney et al. further 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)).
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 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 planar 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).
Response to Arguments
Applicant's arguments filed 5/5/26 have been fully considered but they are not persuasive.
Regarding applicant’s arguments on pg. 7-10 of the Remarks directed to particular shape(s) illustrated in Carney’s fig. 8 and the effects associated therewith, Examiner respectfully disagrees that Carney et al. is limited to specifically those particulars. Specifically, as previously cited, Carney et al. envisions that the number, size, shape, and orientation of the protrusions will all be recognized by one having ordinary skill in the art as parameters to be adjusted for to achieve a desired frictional profile (col. 10, ln. 47 – col. 11, ln. 2), the profile argued on pg. 7-9 of Applicant’s Remarks being one example.
Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., various functionalities associated with the claimed shape(s) as described on pg. 9-10 of the Remarks) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Roussie is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the disclosure of Roussie is directed to configurations for screw threads of tubular connectors, which is considered analogous to the screw threaded connector of the present application.
Regarding applicant’s additional arguments on pg. 11 of the Remarks directed to Roussie, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In particular, Examiner notes that Roussie is relied upon for the teaching that the claimed shape is known for use in thread crests, in combination with Carney’s earlier discussed teaching regarding the obviousness of adjusting the shape of the crest.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/
Primary Examiner, Art Unit 3783
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