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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0043] of the specification, the use of the terms Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, which are trade names or marks used in commerce1, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because in line 9, the phrase "a distal end of the end cap defining a shaft with an spiked tip" should be amended to read "a distal end of the end cap defining a shaft with a spiked tip". The use of “an” before a consonant is considered to be grammatically incorrect.
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Claim 1 is objected because, according to the specification, the phrase a “second internal cavity” in line 15 is located within the circumferential wall surface of the disinfection cap. Claim 1 does not establish this structural relationship; however, it was explicitly defined for the first internal cavity [located within the wall surface of the guide housing]; therefore, for clarification purposes the claim should be amended to explicitly disclose that the “second internal cavity” is located within the circumferential wall surface of the disinfection cap which is structurally connected to the guide housing to facilitate the alignment of the first internal cavity and the second internal cavity. Same clarification requirement applies to independent claim 15.
Claim 1 is objected because the phrase “the open distal end” in line 20 of claim 1 should be “the distal open end” to be consistent with the language introduced in lines 12-13 of claim 1.
Claims 4-8, 12, 14, 17-21, 25, and 27, do not conform to U.S. patent practice with respect to claim construction. The claims in question appear to lack a connecting term to connect the introduction of the claim and the body of the claim. For example, in claim 4, after the introduction [“The device of claim 3”] a term such as “wherein” should be utilized to connect the introduction of the claim [preamble] and the body of the claim [“the selectively engageable locking mechanism comprising a twist connector”]. The same discrepancy appears to apply to claims 5-8, 12, 14, 17-21, 25, and 27.
Claim 6 is objected because in the second line of this claim, between the second word “profile” and the word “comprises”, there is a period “.” which erroneously concludes the claim. Moreover, the claim is objected because, if the claim is going to disclose numerical references to the drawings/specification, these numbers must be enclosed within parenthesis [see MPEP 608.01(m)].
Claims 8 and 9 are objected because of the inconsistency in claim 8 with “the tubular stem portion” in line 2 and “the tubular stem” in line 4, and “the tubular stem” in line 1 of claim 9.
Claim 15 is objected because “the open distal end” in line 17 should be “the distal open end” to be consistent with the language introduced in lines 11-12 of claim 15.
Claim 23 is missing from the list of claims filed on 6/28/2023. This is a formal matter that must be corrected. If claim 23 was cancelled, it should be disclosed with the other claims and indicated as "[Cancelled]" or if this problem is simply a mistake in the numbering of the claims, the subsequent claims should be renumbered.
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 1-14 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 1 recites the limitation "second through aperture" in line 3. There is a lack of proper antecedent basis for this limitation in the claim because the phrase is missing article “a” before the phrase “second through aperture”. Appropriate correction is required.
Claim 1 recites the limitation “the end cap shaft” in line 18 and “the shaft of the end cap” in line 12. The claim introduces the word “shaft” in line 9 with the phrase "a distal end of the end cap defining a shaft with [a] spiked tip". Both, the phrase “the end cap shaft” [line 18] and the phrase “the shaft of the end cap” [line 12] lack proper antecedent basis because it is the distal end of the end cap that defines the shaft, not just the end cap. The lack of uniformity in referring to the “shaft” creates ambiguity because it is not clear whether "the end cap shaft" in line 18 is the same as the two previously mentioned "shaft" in lines 9 and 12. Appropriate correction is required.
Claim 1 recites the limitation "a connector" in the phrase “disinfection of the patient connector when the disinfection cap is coupled to a connector" in line 25. The use of the term “connector” alone is unclear because the claim previously introduced "a patient connector" in line 1, “a first Luer connector” in line 7, and “a second Luer connector” in line 13. Accordingly, it is unclear whether the term “connector” alone refers to the previously disclosed "patient connector", “first or second Luer connector” or a different, unnamed connector. Appropriate correction is required.
Claim 1 discloses the phrase “the second cavity” in lines 16 and 17. This phrase lacks antecedent basis and should be amended to read “the second internal cavity”.
The examiner of record reminds Applicant that changes to the terminology in claim 1 will affect claims 2 to 14 with respect to antecedent basis; therefore, a complete review of claims 1-14 is required to properly comply with section 112(b), antecedent basis requirements.
Claims 15-22 and 24-27 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 15 recites the limitation "second through aperture" in line 3. There is a lack of proper antecedent basis for this limitation in the claim because the phrase is missing article “a” before the phrase “second through aperture”. Appropriate correction is required.
Claim 15 recites the limitation “the end cap shaft” in line 16 and “the shaft of the end cap” in line 11. The claim introduces the word “shaft” in line 8 with the phrase "a distal end of the end cap defining a shaft with [a] spiked tip". Both, the phrase “the end cap shaft” [line 16] and the phrase “the shaft of the end cap” [line 11] lack proper antecedent basis because it is the distal end of the end cap that defines the shaft, not just the end cap. The lack of uniformity in referring to the “shaft” creates ambiguity because it is not clear whether "the end cap shaft" in line 16 is the same as the two previously mentioned "shaft" in lines 8 and 11. Appropriate correction is required.
Claim 15 recites the limitation “the respective first and second cavities” in line 13. This phrase lacks antecedent basis. Claim 15 positively discloses “a first internal cavity” but not “a first cavity”. With respect to the “second internal cavity”, claim 15 does not disclose “a second cavity” or “a second internal cavity in the body of the claim. As it was explained in the claim objections, according to the specification, the phrase a “second internal cavity” is located within the circumferential wall surface of the disinfection cap. Claim 15 does not establish this structural relationship; however, it was explicitly define for the first internal cavity [located within the wall surface of the guide housing]; therefore, for clarification purposes, claim 15 should also be amended to explicitly disclose that the “second internal cavity” is located within the circumferential wall surface of the disinfection cap which is structurally connected to the guide housing to facilitate the alignment of the first internal cavity and the second internal cavity.
Claim 15 recites the phrase “the flushing syringe” in line 32. Claim 15 introduces the phrase “a pre-filled flush syringe” in line 22. However, the phrase “the flushing syringe” lacks proper antecedent basis.
In Claim 26, it appears that “a compressible disinfection pad” in line 2 of claim 26 refers to “the disinfection pad” in claim 25 (and in claim 15) (and based on the specification) – this means that “comprising a compressible disinfection pad” in claim 26 should be “the disinfection pad further comprising a compressible disinfection pad” or some other similar language that make it clear that the compressible disinfection pad recited in claim 26 is not a separate or additional disinfection pad from the one recited in claims 15 and 25.
The examiner of record reminds Applicant that changes to the terminology in claim 15 will affect claims 16-22 and 24-27 with respect to antecedent basis; therefore, a complete review of claims 15-22 and 24-27 is required to properly comply with section 112(b), antecedent basis requirements.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. The claims are allowable over the prior art of record for the reasons given below. Independent claims 1 and 15 are directed to a device and system for disinfecting and flushing an intravenous patient connector. While these claims currently stand rejected under 35 U.S.C. § 112(b) for issues of clarity and indefiniteness [lack of antecedent basis] as detailed in the corresponding rejection, the subject matter they define is deemed patentable over the prior art of record under 35 U.S.C. § 102 and § 103.
None of the prior art of record, either individually or in any reasonable combination, teach or suggest the novel combination of features recited in independent claims 1 and 15. The primary reasons for allowance are based on the unique structural and functional integration of the claimed device, which provides a novel two-in-one solution for both disinfecting and flushing a patient connector. The closest prior art found is Ryan et al. (US 2005/0151105A1; hereinafter “Ryan”). This publication shows in figure 2, a needle-free intravenous injection port assembly (100) comprising a spike body (102) provided with a hollow spike (104), a female luer connector component (106), a flexible and resilient boot valve (108), an H-guide centering member (110), and a resilient septum (112). However, Ryan does not disclose or suggest, in combination, the following limitations:
an end cap captured within and translatable within the first internal cavity [of the guide housing], a proximal end of the end cap defining an inlet and a first Luer connector adapted for engagement, through the first through aperture, with a corresponding Luer tip of a flush syringe, a distal end of the end cap defining a shaft with an spiked tip, the shaft defining an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap;
a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector adapted for engagement with a corresponding Luer connector of a patient connector; the first internal cavity and a second internal cavity being aligned with each other so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity;
an elastomeric sleeve captured within the second internal cavity, the sleeve having a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap; and
a disinfection pad captured within the second internal cavity, intermediate the elastomeric sleeve and the distal open end of the disinfection cap, the pad defining a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining a distal end surface adapted for disinfection of the patient connector when the disinfection cap is coupled to a connector.
In relation to claim 15, Ryan does not disclose or suggest, in combination, the following limitations:
an end cap captured within and translatable within the first internal cavity [of the guide housing], a proximal end of the end cap defining an inlet and a first Luer connector, a distal end of the end cap defining a shaft with a spiked tip, the shaft defining an outlet and an internal lumen in fluid communication with the inlet and the outlet of the end cap;
a disinfection cap having an internal, second, circumferential wall surface, a proximal end wall defining a third through aperture for receipt of the shaft of the end cap, and a distal open end, the second circumferential wall surface defining a second Luer connector; the respective first and second cavities being aligned with each so that the spiked tip of the end cap is translatable within the third through aperture into the second cavity;
an elastomeric sleeve captured within the second internal cavity, the sleeve having a proximal surface that is pierced by the spiked tip when the end cap shaft is translated through the third through aperture, and a distal surface facing the open distal end of the disinfection cap; and
a disinfection pad captured within the second internal cavity, intermediate the elastomeric sleeve and the distal open end of the disinfection cap, the pad defining a fourth aperture for exposure of the distal surface of the elastomeric sleeve to the distal open end of the disinfection cap, the disinfection pad defining a distal end surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
1 To determine the official status of the terms in question, use the USPTO Trademark Search at: https://tmsearch.uspto.gov/search/search-information