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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 11/13/2023 and 10/22/2024, have been considered by the examiner.
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 1-13 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] The term “loose” in claim 1 is a relative term which renders the claim indefinite. The term “loose” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the degree of connectivity between the plurality of caps, as well as the degree of connectivity between the caps and the elongate sleeve, is rendered indefinite. For purposes of examination, it is interpreted that any degree of connectivity between the structures meets the limitations of claim.
[Claim 5] The claim recites the limitation of “the hanging hold” in the 2nd and 3rd lines of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this is a typographical error which misspells the previously recited “hanging hole,” or if a new structure is intended to be introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation refers to the previously recited “hanging hole.”
[Claim 7] The claim recites the limitation of “wherein the antiseptic cap units are not engaged with the elongate sleeve.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the phrase “not engaged” is intended to be interpreted. Given the limitations of claim 1, it is unclear how the antiseptic cap units and the elongate sleeve would not be “engaged” with one another. For purposes of examination, it is interpreted that the antiseptic cap units and the elongate sleeve do not comprise a permanent attachment between the two structures.
[Claim 8] The claim recites the limitation of “the elongate portion” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation is intended to refer to the previously recited “elongate sleeve,” or if an additional structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the elongate portion” refers to the previously recited “elongate sleeve.”
[Claim 8] The term “sufficiently low” in claim 8 is a relative term which renders the claim indefinite. The term “sufficiently low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the permissible degree of a coefficient of friction is rendered indefinite. For purposes of examination, it is interpreted that any value of a coefficient of friction which allows movement of the antiseptic cap units meets the limitations of the claim.
[Claim 13] The claim recites the limitation of “the width of the opening” in the 1st and 2nd lines of the claim. There is a lack of antecedent basis for the term “the width.” For purposes of examination, it is interpreted the limitation recites “a width of the opening.”
[Claims 2-13] The claims are rejected based upon their dependency from independent claim 1.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blum (USPN 3,411,665).
[Claim 1] Blum teaches a medical antiseptic cap delivery system (figure 1, item 10), comprising:
an elongate sleeve (figure 1, item 22) containing a plurality of sealed antiseptic cap units (figure 1, items 12/14/16/42),
each of the plurality of sealed antiseptic cap units (figure 1, items 12/14/16/42) comprising an antiseptic cap (figure 1, item 12), an antiseptic material (figure 1, item 42) positioned within the antiseptic cap (figure 1, item 12), and a sealing lid (figure 12, items 14/16) (Blum provides an example of possible 20 containers 12; given that a “plurality” only requires 2 items, the structure taught by Blum contains a “plurality” wherein the base 14 of one structure could be considered to be the “sealing lid” of the container below it) (column 2, lines 53-71; column 3, lines 1-47);
the elongate sleeve (figure 1, item 22) comprising an inner cavity with an interior width that corresponds to an outer width of the plurality of antiseptic cap units (figure 1, items 12/14/16/42) (figure 1), such that the antiseptic cap units (figure 1, items 12/14/16/42) can be inserted or loaded into a proximal opening of the elongate sleeve (figure 1, item 22) and moved through the elongate sleeve (figure 1, item 22) in a single loose column (see 112b interpretation above) (figure 1), the antiseptic cap units (figure 1, items 12/14/16/42) not being connected directly to each other (figures 1 and 2; column 3, lines 64-75; column 4, lines 1-24); and
a dispensing region (figure 2, item 46) comprising a distal constriction (figure 2, item 44) in the elongate sleeve (figure 1, item 22), the dispensing region (figure 2, item 46) configured to maintain a distal antiseptic cap unit (figure 1, items 12/14/16/42) in the delivery system (figure 1, item 10) until the distal antiseptic cap unit (figure 1, items 12/14/16/42) is removed by a user by pulling the antiseptic cap unit (figure 1, items 12/14/16/42) through the dispensing region (figure 2, item 46) (figures 1 and 2; column 3, lines 64-75; column 4, lines 1-24).
Claim Rejections - 35 USC § 103
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 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (PGPub 2013/0138085), in view of Langdon (USPN 3,460,742).
[Claims 1-3] Tennican teaches a medical antiseptic cap delivery system (figure 7b), comprising:
an elongate sleeve (figure 7b, item 702), made of flexible/transparent plastic sheets (paragraph [0035]), containing a plurality of sealed antiseptic cap units (figure 6a, item 600; paragraph [0030]),
each of the plurality of sealed antiseptic cap units (figure 6a, item 600) comprising an antiseptic cap (figure 6a, item 602), an antiseptic material (figure 6a, item 606) positioned within the antiseptic cap (figure 6a, item 602), and a sealing lid (figure 6a, item 604) (figure 6a; paragraph [0030]);
the elongate sleeve (figure 7b, item 702) comprising an inner cavity with an interior width that corresponds to an outer width of the plurality of antiseptic cap units (figure 6a, item 600) (figure 7b), such that the antiseptic cap units (figure 6a, item 600) can be inserted or loaded into a proximal opening of the elongate sleeve (figure 7b, item 702) and moved through the elongate sleeve (figure 7b, item 702) in a single loose column (see 112b interpretation above) (figure 7b; paragraph [0035]), the antiseptic cap units (figure 6a, item 600) not being connected directly to each other (figures 7a/7b; paragraphs [0034], [0035]).
Tennican does not specifically disclose a dispensing region comprising a distal constriction in the elongate sleeve.
However, Langdon teaches a delivery system (figure 1, item 11) for sterile medical articles (figure 1; abstract) comprising a transparent plastic elongate sleeve (figure 1, item 12; abstract) having a dispensing region (figure 1, item 18) comprising a distal constriction (figure 1, near item 22) in the elongate sleeve (figure 1, item 12), the dispensing region (figure 1, item 18) configured to maintain the medical article in the delivery system (figure 1, item 11) until the article is removed by a user by pulling the article through the dispensing region (figure 1, item 18) (figure 4; column 4, lines 1-19).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the elongate sleeve of Tennican, to have utilized a dispensing region, as taught by Langdon, in order to provide increased functionality and ease of use, by allowing for a means by which sterile antiseptic caps might be easily removed from the elongate sleeve while maintaining sterility (Langdon; column 4, lines 1-19).
[Claim 4] Tennican and Langdon teach the limitations of claim 3, upon which claim 4 depends. In addition, Langdon discloses the dispensing region (figure 1, item 18) comprises an opening (figure 4, opening between items 13 and 14) configured to temporarily resiliently or flexibly increase in size to permit an individual one of the antiseptic cap units to pass through the constriction (figure 4; column 4, lines 1-19).
Claims 5-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (PGPub 2013/0138085), in view of Langdon (USPN 3,460,742), in further view of Solomon et al. (PGPub 2016/0144118).
[Claim 5] Tennican and Langdon teach the limitations of claim 4, upon which claim 5 depends. Tennican and Langdon do not specifically disclose a hanging hole utilized in the system.
However, Solomon teaches a medical antiseptic cap delivery system (figure 14) comprising an elongate sleeve (figure 14, item 50) having a plurality of sealed antiseptic cap units (figure 14, item 43), wherein the system comprises a hanging hole (figure 14, item 57) positioned on a proximal side of the antiseptic cap delivery system (figure 14), the hanging hole (see 112b interpretation above) (figure 14, item 57) being sized and configured to allow the delivery system (figure 14) to be hung on an IV pole such that the delivery system (figure 14) is oriented generally vertically during use (figure 14; paragraph [0063]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the elongate sleeve of Tennican and Langdon, to have utilized a hanging hole, as taught by Soloman, in order to provide increased functionality and ease of use, by allowing for a means by which the delivery system might be located such that accessibility is maximized (Soloman; paragraph [0063]).
[Claim 6] Tennican, Langdon, and Soloman, teach the limitations of claim 5, upon which claim 6 depends. In addition, Langdon discloses the dispensing region (figure 1, item 18) comprises a sealing portion (figure 4, item 22) positioned on a distal side of the sleeve (figure 1, item 12) that is configured to be torn away by a user before accessing the dispensing region (figure 1, item 18) (figure 4; column 4, lines 1-19).
[Claim 7] Tennican, Langdon, and Soloman, teach the limitations of claim 6, upon which claim 7 depends. Tennican further discloses the antiseptic cap units (figure 6a, item 602) are not engaged with the elongate sleeve (figure 7b, item 702) (see 112b interpretation above) (figure 7b; paragraphs [0034], [0035]).
[Claim 8] Tennican, Langdon, and Soloman, teach the limitations of claim 7, upon which claim 8 depends. In addition, Tennican teaches an interior wall of the elongate sleeve (see 112b interpretation above) (figure 7b, item 702) has a coefficient of friction that is sufficiently low (see 112b interpretation above) to permit consistent migration of the antiseptic cap units (figure 6a, item 602) through the delivery system (figure 7b) during use (figure 7b; paragraphs [0034], [0035]).
[Claim 11] Tennican, Langdon, and Soloman, teach the limitations of claim 8, upon which claim 11 depends. Tennican further discloses the delivery system (figure 7b) is configured to permit withdrawal of only one antiseptic cap unit (figure 6a, item 602) at a time (figure 7b; paragraphs [0034], [0035]).
[Claims 12 and 13] Tennican, Langdon, and Soloman, teach the limitations of claim 11, upon which claims 12 and 13 depend. Langdon also discloses a width of the constriction (figure 1, near item 22) is smaller than a width of the sleeve (figure 1, item 12) (figure 4) (the examiner notes that “a width” has not been defined; as such, “a width” does not necessarily mean a “total width” or imply any particular orientation in space for measurement; given this, the “constriction” and “sleeve” taught by Langdon meet the limitations of the claim); wherein a width (see 112b interpretation above) of the opening (figure 4, opening between items 13 and 14) in the dispensing region (figure 1, item 18) is smaller than a width of the antiseptic cap units (again, the examiner notes “a width” has not been defined; additionally, as the opening taught by Langdon is dynamic, there exists “a width” which is smaller than “a width” of the antiseptic cap units).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (PGPub 2013/0138085), in view of Langdon (USPN 3,460,742), in view of Solomon et al. (PGPub 2016/0144118), in further view of Gardner et al. (PGPub 2013/0197485).
[Claims 9 and 10] Tennican, Langdon, and Soloman, teach the limitations of claim 8, upon which claims 9 and 10 depend. Tennican, Langdon, and Solomon, do not specifically disclose each antiseptic cap unit includes an antiseptic cap holder.
However, Gardner teaches an antiseptic cap unit (figure 1, item 10) comprising an antiseptic cap (figure 1, item 30), an antiseptic material (“antiseptic fluid”) (paragraph [0048]) positioned within the antiseptic cap (figure 1, item 30), and a sealing lid (figure 2, item 66; paragraph [0053]); wherein each antiseptic cap unit (figure 1, item 10) includes an antiseptic cap holder (figure 1, item 28) (figure 1; paragraph [0045]); and wherein the sealing lid (figure 2, item 66) is applied to the antiseptic cap holder (figure 1, item 28) (figure 2; paragraph [0053]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the antiseptic cap unit of Tennican, Langdon, and Solomon, to have utilized an antiseptic cap holder, as taught by Gardner, in order to provide increased functionality, safety, and control, by providing for an additional level of sterility maintenance prior to use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/12/2026