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 . This is the first office action in response to the above identified patent application filed on 01/05/2024. Claims 24-48 are currently pending and being examined.
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 lock to prevent unauthorised or accidental release of the securement device, wherein the lock comprises a push to release lock in the cap (Independent Claim 24) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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.
Claims 24-34 and 41-47 are 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 original specification mentions the lock as "optionally" "If desired", refer to page 5 lines 6-9; page 16 lines 6-12. Also, the specification states, "Suitable lock mechanisms are to be found in the child-proof locks of medicine bottle or the like", page 16 lines 11-12. However, no details are provided for the claimed lock recited in independent claim 24 nor it is shown at all in the drawings. It appears that the lock recited in independent claim 24 is merely an idea for future development since neither the drawings nor the specification elaborate on the actual physical structure of the claimed lock. Appropriate correction is required (i.e., cancel claims 24-34 and 41-47).
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 24-47 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.
In independent claim 24 line 8, the recitation “an article” is presumed to be – the tubular article -- for proper clarity and antecedent basis. Appropriate correctio is required.
In independent claim 24 line 3, the recitation “a surface” is presumed to be – the surface -- for proper clarity and antecedent basis. Appropriate correctio is required.
Claims 25-34 depend from Claim 24 and are rejected accordingly.
In independent claim 35 lines 8 and 13, the recitation “an article” is presumed to be – the tubular article -- for proper clarity and antecedent basis. Appropriate correctio is required.
In independent claim 35 line 3, the recitation “a surface” is presumed to be – the surface -- for proper clarity and antecedent basis. Appropriate correctio is required.
Claims 36-40 depend from Claim 24 and are rejected accordingly.
In dependent claims 41-44 line 3, the recitation “an article” is presumed to be – the tubular article -- for proper clarity and antecedent basis. Appropriate correctio is required.
Claims 45 and 46 depend from Claim 24 and are rejected accordingly.
In dependent claim 47 line 3, the recitation “a medical article” is presumed to be – the tubular article -- for proper clarity and antecedent basis. Appropriate correctio is required.
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 35-39 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,896,784. Although the claims at issue are not identical, they are not patentably distinct from each other because the referencing US Patent fully encompass the subject matter of the instant application claims and therefor anticipate the claims of the instant application. Since the claims of the instant application are anticipated by the claims of the referencing US Patent, the claims of the instant application are not patentably distinct from the referencing US Patent.
Claim 48 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of U.S. Patent No. 11,896,784. Although the claims at issue are not identical, they are not patentably distinct from each other because the referencing US Patent fully encompass the subject matter of the instant application claims and therefor anticipate the claims of the instant application. Since the claims of the instant application are anticipated by the claims of the referencing US Patent, the claims of the instant application are not patentably distinct from the referencing US Patent.
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.
Claims 24-26, 28-30, 41, 42 and 45-47 are rejected under 35 U.S.C. 102a1 as being anticipated by Ciccone et al. (US 9,480,821).
In regards to Independent Claim 24, and with particular reference to Figures 1-8, 14-16, 18-20 , Ciccone discloses a securement device (20) for attaching a tubular medical article (8) to a surface (patient’s skin; col. 1 lines 17-20, col. 7 lines 19) comprising:
an anchor pad (12) attachable to the surface (patient’s skin; col. 1 lines 17-20, col. 7 lines 19);
a base (22) on the anchor pad for receiving the article;
a cap (24) mountable on the base (22) at a mounting (42; figure 5) defined between the base and the cap, the cap being rotatable (rotatable about an imaginary line through the mounting 42; refer to figures 18-20) on the base between an article receiving position (base 22 open to receive the article 8; figure 14-15) and an article gripping position (cap rotated to the close position to clamp the article; figure 16) and comprising a slot (each of the grooves 36 formed on the cap 24 for receiving the article; refer to figures 7, 8, 16) for receiving the article (8) in the article receiving position (refer to figures 14-15) and gripping the article in the article gripping position (refer to figure 16); and
a lock (88; figure 4) to prevent unauthorised or accidental release of the securement device (20), wherein the lock comprises a push to release lock in the cap (figure 4; element 98 has to be pushed down to release the lock; col. 21 lines 24-25).
Regarding dependent Claim 25, Ciccone discloses wherein the push to release lock 88 in the cap (24) is configured for release by pushing down on the cap (figures 4, 20; element 98 has to be pushed down to release the lock; col. 21 lines 24-25) before rotation to release the cap from the base (before rotation of the cap to the position in figure 18).
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Regarding dependent Claim 26, Ciccone discloses wherein the slot comprises first and second oppositely disposed slot portions in a sidewall of the cap, wherein each of the slot portions comprise an upright slot element and a substantially horizontal slot element contiguous with the upright slot element in the sidewall, and wherein the upright slot elements are connected by a transverse slot element, as shown in marked-up figures above.
Regarding dependent Claim 28, Ciccone discloses wherein the base (22) defines a channel (in figure 8, the channel between two adjacent post 74) for receiving the article (8, refer to figures 8, 15).
Regarding dependent Claim 29, Ciccone discloses wherein the base (22) comprises a substantially (substantially interpreted as being largely but not wholly that which is claimed) cylindrical base (22).
Regarding dependent Claim 30, Ciccone discloses wherein the base (22) defines a channel (in figure 8, the channel between two adjacent post 74) for receiving the article (8, refer to figures 8, 15) and wherein the slot comprises an article receiving portion complementary with the channel for receiving the article in the article receiving position, as shown in figures 2-3, 14-16, the channel formed on the base is complementary to the channel formed on the cap , which together receive the article 8.
Regarding dependent Claim 41, Ciccone discloses wherein the securement device 20 comprises a secondary fixing clasp (as shown in figure 16, the secondary channel formed on the base is complementary to the secondary channel formed on the cap, which together receive an additional article) for clasping an article (one of the branches 114 forming the article 8, refer to figure 16) in place.
Regarding dependent Claim 42, Ciccone discloses wherein the securement device (20) comprises a secondary fixing clasp (as shown in figure 16, the secondary channel formed on the base is complementary to the secondary channel formed on the cap, which together receive an additional article) for clasping an article (one of the branches 114 forming the article 8, refer to figure 16) in place, wherein the secondary fixing clasp is mounted on the anchor pad (12; refer to figures 3 and 14).
Regarding dependent Claim 45, Ciccone discloses wherein the anchor pad (12) comprises an adhesive (adhesive surface 16; figure 1) for adhering the securement device (20) to the surface (patient’s skin; col. 1 lines 17-20, col. 7 lines 19).
Regarding dependent Claim 46, Ciccone discloses wherein the anchor pad (12) comprises an adhesive (adhesive surface 16; figure 1) for adhering the securement device (20) to the surface (patient’s skin; col. 1 lines 17-20, col. 7 lines 19), wherein the anchor pad (12) comprises a release film on the adhesive (16 in figure 1).
Regarding dependent Claim 47, Ciccone discloses wherein the securement device (20) comprises a securement device for attaching a medical article (catheter 8) to a patient (patient’s skin; col. 1 lines 17-20, col. 7 lines 19).
Claims 35-39 are rejected under 35 U.S.C. 102a1 as being anticipated by Delage (FR 305118 A1).
In regards to Independent Claim 35, and with reference to Figures 1-6, Delage discloses a securement device (1) for attaching a tubular article (21) to a surface (skin of a patient; figure 6) comprising:
an anchor pad (4) attachable to a surface (skin of a patient; figure 6);
a base (5) on the anchor pad (4) for receiving the article (21); and
a cap (3) mountable on the base (5) at a mounting (10+17 in figure 3) defined between the base (5) and the cap (3), the cap (3) being rotatable on the base (5) between an article receiving position (as shown in figure 4) and an article gripping position (as shown in figure 5) and comprising a slot (slot between adjacent elements 15 on the cap 3; refer to figures 1-5) for receiving the article (21) in the article receiving position (figure 4) and gripping the article (21) in the article gripping position (figure 5);
wherein the mounting (10+17) comprises a screw mounting (cap 3 is screwed to base 5 via the engagement of elements 10 and 17; figure 3) to impart a downward compressive force (screwing cap 3 to base 5 imparts a downward force to clamp the article 21; refer to figures 3-5) on the article (21) in the article gripping position (as shown in figure 5).
Regarding dependent Claim 36, Delage discloses wherein the screw mounting comprises a thread (10) on the base (5), refer to figure 3.
Regarding dependent Claim 37, Delage discloses wherein the screw mounting comprises a thread (10) on the base (5), wherein the thread (10) comprises first and second oppositely disposed substantially helical threads (as shown in figure 3) on the base (5).
Regarding dependent Claim 38, Delage discloses wherein the screw mounting comprises a thread (10) on the base (5), wherein the thread (10) comprises a groove-like thread (refer to figure 3).
Regarding dependent Claim 39, Delage discloses wherein the screw mounting comprises a thread (10) on the base (5), wherein the screw mounting comprises at least one lug (170) on the cap (3) insertable in the thread (10), refer to figure 3.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following reference(s) are also relevant for at least claims 24 and 35.
Molina et al. (US 2021/0106789). Particularly refer to figures 1 and 6; lock or screw mounting 156.
The following reference(s) are also relevant for at least claim 24.
Bierman (US 6,361,523). Particularly refer to figures 14 and 15; lock 86a.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741
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