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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following limitations must be shown or the feature(s) canceled from the claim(s), no new matter should be entered:
---Claim 17. A method for providing a fluid connector system, the method comprising: providing a first valve assembly comprising a housing and a compressible valve, the housing having a first end, a second end, a cavity that extends through the second end of the housing toward the first end of the housing, and a post that extends within the cavity toward the second end of the housing, and the compressible valve within the cavity; and providing a second valve assembly couplable to the first valve assembly such that the compressible valve of the first valve assembly is engaged against a second end of a valve plug of the first valve assembly, and a distal end portion of the post is positioned within a slit of the valve plug and extends entirely through the valve plug such that the first valve assembly is fluidically coupled with the second valve assembly.
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Applicant’s main invention can be best seen in at least Figs. 4-5 (see FIG. A above). These figures show a fluid connector system 100 having a first valve assembly 110 with a compressible valve 114 and a post 120 and a second valve assembly 210 with a valve plug 214, when the couplers/valve-assemblies are connected together, the compressible valve of the first valve assembly is compressed rearwards, the post of the first valve assembly pierces through a slit of the compressible valve and then a slit on the valve plug of the second valve assembly which allows for fluid communication between the two couplers/valve-assemblies. Due to a possible claim drafting error, claim 17 requires that the first valve assembly (110) includes both a compressible valve (114) and a valve plug (214?) “such that the compressible valve of the first valve assembly is engaged against a second end of a valve plug of the first valve assembly”. As best understood by the Office, the first valve assembly 110 only has a compressible valve 114 and the valve plug 214 belongs to the second valve assembly 210. As such, the way the claim is written appears as the applicant is attempting to claim a non-illustrated embodiment.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-8 and 10-16 are objected to because of the following informalities:
---Claims 2-8 and 10-16 L1 (13 instances) recite the limitation of “The valve plug of Claim”. However, notice that intervening claim 1 is primary directed to “A fluid connector system” rather than just a valve plug.
As such, this limitation in claims 2-8 and 10-16 L1 (13 instances) should be amended as follows:
“ The fluid connector system of Claim ”.
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 17-20 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 17 recites the following:
17. A method for providing a fluid connector system, the method comprising: providing a first valve assembly comprising a housing and a compressible valve, the housing having a first end, a second end, a cavity that extends through the second end of the housing toward the first end of the housing, and a post that extends within the cavity toward the second end of the housing, and the compressible valve within the cavity; and providing a second valve assembly couplable to the first valve assembly such that the compressible valve of the first valve assembly is engaged against a second end of a valve plug of the first valve assembly, and a distal end portion of the post is positioned within a slit of the valve plug and extends entirely through the valve plug such that the first valve assembly is fluidically coupled with the second valve assembly.
As it was noted in the Drawings section above, due to a possible claim drafting error, claim 17 appears to requires that the first valve assembly (110) includes both a compressible valve (114) and a valve plug (214?) “such that the compressible valve of the first valve assembly is engaged against a second end of a valve plug of the first valve assembly”. As best understood by the Office, the first valve assembly 110 only has a compressible valve 114 and the valve plug 214 belongs to the second valve assembly 210. This makes it unclear and indefinite if the applicant is attempting to claim a non-illustrated embodiment where the first valve assembly 110 includes both a compressible valve (114) and a valve plug (214?) or a claim drafting error occurred. Based on the disclosure, the Office will assume that a claim drafting error occurred and the applicant meant to claim “and providing a second valve assembly (210) couplable to the first valve assembly (110) such that the compressible valve (114) of the first valve assembly is engaged against a second end of a valve plug (214) of the second valve assembly”. The Office suggests that the claim is amended to clarify this issue.
---Claim(s) 18-20, being dependent on any of the preceding claim(s) above, inherit the same deficiencies as the parent/intervening claim(s) and as such is/are rejected in the same manner, see the rejection(s) above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Coambs US-20080197626.
Regarding claims 17-20, as best understood by the Office, in making and/or using the device of Coambs US-20080197626, Coambs US-20080197626 teaches in Figs. 1-14 (see at least Figs. 2-3) the limitations of:
---Claim 17. A method for providing a fluid connector system (coupling device 8), the method comprising: providing a first valve assembly (male part 12) comprising a housing (body 13) and a compressible valve (tubular sheath 19 with pre-slitted diaphragm 28), the housing having a first end, a second end, a cavity (chamber 26) that extends through the second end of the housing toward the first end of the housing, and a post (cannula 24) that extends within the cavity toward the second end of the housing, and the compressible valve within the cavity; and providing a second valve assembly (female part 10) couplable to the first valve assembly such that the compressible valve of the first valve assembly is engaged against a second end of a valve plug (pre-slitted diaphragm 18) of the first valve assembly (assumed to be a claim drafting error and should be read as “a valve plug of the second valve assembly”), and a distal end portion of the post is positioned within a slit of the valve plug and extends entirely through the valve plug such that the first valve assembly is fluidically coupled with the second valve assembly (see Figs. 2-3, notice that the device of Coambs comprises similar structure and function as applicant’s invention as compared to at least Figs. 4-5 of the application).
---Claim 18. The method of Claim 17, further comprising providing the compressible valve in a first position wherein the compressible valve obstructs a fluid passage through the post (see Fig. 2).
---Claim 19. The method of Claim 18, wherein the compressible valve comprises a second position (see Fig. 3), when the first valve assembly is coupled to the second valve assembly, wherein the compressible valve is compressed along the post (see Fig. 3).
---Claim 20. The method of Claim 17, wherein, when the first valve assembly is coupled to the second valve assembly, the valve plug is positioned between the distal end portion of the post and the compressible valve (see Figs. 2-3, notice that the device of Coambs comprises similar structure and function as applicant’s invention as compared to at least Figs. 4-5 of the application).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent Wine US-12208231.
Although the claims at issue are not identical, they are not patentably distinct from each other because the device of the claims of the patent either explicitly or implicitly anticipates all the limitations of the present application and/or any missing structure or detail would be obvious over the devices of the patent themselves and/or the cited prior art. Notice that at least claims 1-16 of the application generally mirrors the limitations found in claims 1-19 of the patent with the patent claiming in greater details the elements of the claimed invention of the application. Following the rationale in In re Goodman cited in the preceding paragraph, where the applicant has once been granted a patent containing a claim for the specific or narrower invention, the applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Note that since the claims of the application are anticipated by the claims of the patent and since anticipation is the epitome of obviousness, then the claims of the application are obvious over the claims of the patent. Additionally, any missing structure or detail is either
implicitly met by the devices of the patent and/or would be obvious over the devices of the patent themselves and/or the cited prior art. Notice that in the case of claims 17-20 of the application, these claims are presented as method claims whereas the claims of the patent are device claims. However, these method claims essentially recites “providing X, wherein X comprises Y…, providing Z, etc.” and one of ordinary skill in the art can recognize that in making and/or using a device that comprises structures “X, Y and Z”, the method steps of “providing X, Y and Z” are implicitly met. Furthermore, any missing structure or detail would be obvious over the cited prior art with at least: Coambs US-20080197626 teaching a valved coupling assembly comprising a first/male coupling having a post/cannula and a compressible valve with a pre-cut slit and a second/female coupling with a valve plug with a pre-cut slit such that when the couplings are coupled, the compressible valve is compressed rearwards and the post pierces through the slits of the compressible valve and the valve plug to allow fluid flow between the two coupler and when the couplers are uncoupled, the resiliency of the valve plug and compressible valve seals the fluid communication providing a dry-disconnect quick coupling feature that is especially useful in medical fluid communication applications and has similar overall structure and function as applicant’s main invention; and Hokanson US-8343113, Lee US-7857285, Yeh US-20170080203, Thompson US-5814024 and Raybuck US-7040598 teaching of various examples of medical couplers including at least one valved coupler having a resilient slitted valve plug with specific structure similar to applicant’s main invention (such as having the recess, the ridge, the floor, the apex, the concave surface, etc.) that allows for the efficient fluid transfers between couplings when the couplers are coupled and providing dry-disconnect when the couplers are uncoupled in a similar manner as applicant’s invention.
Conclusion
The prior/relevant art made of record and is considered pertinent to applicant's disclosure is as follows:
---References A (relevant but not “prior” art): Wine US-12208231.
---References B (Slitted connectors): Ueda US-11491084, Kakinoki US-11273297, Rogier US-11235136, Yoshioka US-11135417, Guala US-10918851, Rogier US-10751523, Sanders US-10744315, Nelson US-10179231, Hatton US-9580214, Tachizaki US-9579495, Tachizaki US-8974425, Bonnal US-8910919, Hokanson US-8343113, Guala US-8133209, Newton US-7914502, Lee US-7857285, Thorne US-7841581, Raybuck US-7040598, Vaillancourt US-7004934, Hishikawa US-6808161, Leinsing US-6802490, Leinsing US-6706022, Erskine US-5820614, Thompson US-5814024, Zinger US-5807348, Yeh US-20170080203, Coambs US-20070066965, Leinsing US-20030209681, Yeh US-10195415 and Coambs US-20080197626.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID COLON-MORALES, whose telephone number 571-270-1741 and fax number is 571-270-2741. If the applicant has authorized internet communications via the filling of form PTO/SB/439, the examiner can be reached via email at david.colon-morales@uspto.gov , email communication is not permitted if the applicant has not filed an authorization for internet communication (see MPEP 502.03 for more details on internet communications). The examiner can normally be reached on Monday-Friday (7:30AM-3:30PM EST).
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/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753