DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 embodiment represented in claim 1 must be shown or the feature(s) canceled from the claim(s). Claim 1, which claims an access opening in the top panel, does not align with any of the drawings, as the embodiments with the top access opening (figs. 9, 10, and 12) do not have the claimed adhesive strip and semicircular mitten arrangement. 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 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 1 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 1, the claim recites the limitation “the semicircular mitten” in line 15. There is insufficient antecedent basis for this limitation in the claim.
The claim further recites the limitation “substantially” in line 19. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” 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.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Andrews et al. US 5,437,621 in view of Stephens US 5,604,933 further in view of Bellamy et al. US 2011/0245744 A1.
Regarding claim 1, Andrews discloses a sterile catheterization sleeve 60 for use during a surgical procedure (fig. 4 and col. 1, lines 11-15, the invention is a medical dressing; medical dressings are typically sterile and are capable of being used during a surgical procedure and catheterization), comprising:
a rectangular sheet that includes opposite proximal and distal edges and opposite first and second side edges that connect the opposite proximal and distal edges (please see annotated fig. A below, which shows the four claimed edges, which form the perimeter of a generally rectangularly-shaped sheet; please note that while the embodiment with glove fingers is being annotated in fig. A, the actual embodiment being used for this rejection is the mitten embodiment in fig. 4; the drawings do not include a view of the mitten embodiment opened up like that of the annotated figure, which is why this view is being provided to show specific features that would pertain to the mitten embodiment as well, as they are structured the same except for the gloved fingers, as described in col. 6, line 66-col. 7, line 2), wherein the rectangular sheet includes a bottom panel 30b/70 and a top panel 30a connected to the bottom panel 30b/70 along a fold line (annotated fig. A, the top panel being closure flap 30a, and the bottom panel being the central palm portion 70 and the closure flap 30b; the closure flap 30b can be considered part of the bottom panel particularly when the glove is open as in fig. A);
a first adhesive strip 64b formed along a first portion of the second side edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B below shows the first adhesive strip 64b, which is along the center portion of the second side edge);
a second adhesive strip 64a formed along the distal edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B show the second adhesive strip 64a formed along the distal/top edge);
wherein the top panel 30a of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel 30b/70 (annotated fig. B), wherein the bottom panel 30b/70 is secured to the top panel 30a by the second adhesive strip 64a (annotated fig. B and col. 7, lines 10-14, the adhesive strip 64a on the closure flap 30b of the bottom panel is connected with fastener 66 on the top panel/closure flap 30a) and the top panel 30a is secured to the semicircular mitten 70 by the first adhesive strip 64b (annotated fig. A and col. 7, lines 10-14, the top closure flap 30a is fastened with adhesive strip 64b to connect the flap 30a with flap 30b, which is connected to the semicircular mitten 70; thus, the top panel 30a is secured to the semicircular mitten 70 via the adhesive strip 64b), wherein the second adhesive strip 64a adjacent the distal edge is secured to areas of the bottom panel 30b/70 adjacent the distal edge (annotated fig. A shows the second adhesive strip being near the distal edge and on flap 30b of the bottom panel 30b/70, and the first adhesive strip 64b being secured to areas of the bottom panel 30b/70 substantially adjacent the first side edge (annotated fig. B, the first adhesive strip 64b is secured to flap 30b of the bottom panel 30b/70 and is adjacent/near the first side edge when the glove is closed and the top panel 30a is brought into connection with the flap 30b).
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Andrews is silent on an access opening formed in the top panel between the proximal and distal edges of the rectangular sheet, and between the first and second side edges of the rectangular sheet, wherein the access opening is completely surrounded by the rectangular sheet.
However, Stephens teaches an analogous medical glove 12 (fig. 7 and col. 1, lines 7-11) comprising an access opening 40 formed in the top panel between the proximal and distal edges of the analogous sheet, and between the first and second side edges of the analogous sheet, wherein the access opening 40 is completely surrounded by the sheet (fig. 7 and col. 4, lines 35-40, the opening 40 is formed in the part of the glove that overlies the back of the hand, similar to Andrews’ top panel; the opening 40 is surrounded by the sheet forming the glove such that it is situated between the proximal, distal, and side edges (essentially the entire perimeter) of the glove when viewed from the top).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the top panel of the catheterization sleeve of Andrews with an access opening formed in the top panel between the proximal and distal edges of the rectangular sheet, and between the first and second side edges of the rectangular sheet, wherein the access opening is completely surrounded by the rectangular sheet, as taught by Stephens, to allow for inspection, inject, etc. (col. 4, lines 35-40), without having to expose a greater part of the hand and risk contamination or injury.
Andrews in view of Stephens is silent on a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively.
However, Bellamy teaches an analogous hand covering 600 (fig. 6A and [0070]) comprising an analogous adhesive strip 637 comprising a removable release liner 636 that covers the adhesive strip 637, the release liner 636 being configured to be removed from the adhesive strip 637 (fig. 6A and [0070], release liner 636 can be peeled from adhesive layer 637 to expose the adhesive).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the first and second adhesive strips of Andrews in view of Stephens with a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively, as taught by Bellamy, to protect the underlying adhesive until ready for use.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,937,894 B2 in view of Andrews et al. US 5,437,621 further in view of Bellamy et al. US 2011/0245744 A1.
Regarding claim 1, the conflicting patent claims a sterile catheterization sleeve for use during a surgical procedure, comprising: a rectangular sheet that includes opposite proximal and distal edges and opposite first and second side edges that connect the opposite proximal and distal edges, wherein the rectangular sheet includes a bottom panel and a top panel connected to the bottom panel along a fold line; an access opening formed in the top panel between the proximal and distal edges of the rectangular sheet, and between the first and second side edges of the rectangular sheet, wherein the access opening is completely surrounded by the rectangular sheet; a first adhesive strip; a second adhesive strip; wherein the bottom panel is secured to the top panel by the second adhesive strip.
The conflicting patent is silent on the first adhesive strip formed along a first portion of the second side edge of the rectangular sheet; a removable first release liner that covers the first adhesive strip; the second adhesive strip formed along the distal edge of the rectangular sheet; and a removable second release liner that covers the second adhesive strip, wherein the top panel of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel, and the top panel is secured to the semicircular mitten by the first adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively, wherein the second adhesive strip adjacent the distal edge is secured to areas of the bottom panel adjacent the distal edge, and the first adhesive strip is secured to areas of the bottom panel substantially adjacent the first side edge.
However, Andrews teaches a sterile catheterization sleeve 60 for use during a surgical procedure (fig. 4 and col. 1, lines 11-15, the invention is a medical dressing; medical dressings are typically sterile and are capable of being used during a surgical procedure and catheterization), comprising: a first adhesive strip 64b formed along a first portion of the second side edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B shows the first adhesive strip 64b, which is along the center portion of the second side edge); a second adhesive strip 64a formed along the distal edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B show the second adhesive strip 64a formed along the distal/top edge); wherein the top panel 30a of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel 30b/70 (annotated fig. B), and the top panel 30a is secured to the semicircular mitten 70 by the first adhesive strip 64b (annotated fig. A and col. 7, lines 10-14, the top closure flap 30a is fastened with adhesive strip 64b to connect the flap 30a with flap 30b, which is connected to the semicircular mitten 70; thus, the top panel 30a is secured to the semicircular mitten 70 via the adhesive strip 64b), wherein the second adhesive strip 64a adjacent the distal edge is secured to areas of the bottom panel 30b/70 adjacent the distal edge (annotated fig. A shows the second adhesive strip being near the distal edge and on flap 30b of the bottom panel 30b/70, and the first adhesive strip 64b being secured to areas of the bottom panel 30b/70 substantially adjacent the first side edge (annotated fig. B, the first adhesive strip 64b is secured to flap 30b of the bottom panel 30b/70 and is adjacent/near the first side edge when the glove is closed and the top panel 30a is brought into connection with the flap 30b).
Therefore, 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 sleeve of the conflicting Patent with the first adhesive strip formed along a first portion of the second side edge of the rectangular sheet; the second adhesive strip formed along the distal edge of the rectangular sheet; wherein the top panel of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel, and the top panel is secured to the semicircular mitten by the first adhesive strip, wherein the second adhesive strip adjacent the distal edge is secured to areas of the bottom panel adjacent the distal edge, and the first adhesive strip is secured to areas of the bottom panel substantially adjacent the first side edge, as taught by Andrews, as this configuration allows the top and bottom panels of the sleeve to fasten securely around the hand when worn.
The conflicting Patent in view of Andrews is silent on a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively.
However, Bellamy teaches an analogous hand covering 600 (fig. 6A and [0070]) comprising an analogous adhesive strip 637 comprising a removable release liner 636 that covers the adhesive strip 637, the release liner 636 being configured to be removed from the adhesive strip 637 (fig. 6A and [0070], release liner 636 can be peeled from adhesive layer 637 to expose the adhesive).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the first and second adhesive strips of the conflicting Patent in view of Andrews with a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively, as taught by Bellamy, to protect the underlying adhesive until ready for use.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,304,773 B2 in view of Andrews et al. US 5,437,621 further in view of Bellamy et al. US 2011/0245744 A1.
Regarding claim 1, the conflicting patent claims a sterile catheterization sleeve for use during a surgical procedure, comprising: a rectangular sheet that includes opposite proximal and distal edges and opposite first and second side edges that connect the opposite proximal and distal edges, wherein the rectangular sheet includes a bottom panel and a top panel connected to the bottom panel along a fold line; an access opening formed in the top panel between the proximal and distal edges of the rectangular sheet, and between the first and second side edges of the rectangular sheet, wherein the access opening is completely surrounded by the rectangular sheet; a first adhesive strip; a second adhesive strip; wherein the bottom panel is secured to the top panel by the second adhesive strip, and the top panel is secured to the semicircular mitten by the first adhesive strip.
The conflicting patent is silent on the first adhesive strip formed along a first portion of the second side edge of the rectangular sheet; a removable first release liner that covers the first adhesive strip; the second adhesive strip formed along the distal edge of the rectangular sheet; and a removable second release liner that covers the second adhesive strip, wherein the top panel of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively, wherein the second adhesive strip adjacent the distal edge is secured to areas of the bottom panel adjacent the distal edge, and the first adhesive strip is secured to areas of the bottom panel substantially adjacent the first side edge.
However, Andrews teaches a sterile catheterization sleeve 60 for use during a surgical procedure (fig. 4 and col. 1, lines 11-15, the invention is a medical dressing; medical dressings are typically sterile and are capable of being used during a surgical procedure and catheterization), comprising: a first adhesive strip 64b formed along a first portion of the second side edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B shows the first adhesive strip 64b, which is along the center portion of the second side edge); a second adhesive strip 64a formed along the distal edge of the rectangular sheet (col. 7, lines 9-19; annotated figs. A and B show the second adhesive strip 64a formed along the distal/top edge); wherein the top panel 30a of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel 30b/70 (annotated fig. B), wherein the second adhesive strip 64a adjacent the distal edge is secured to areas of the bottom panel 30b/70 adjacent the distal edge (annotated fig. A shows the second adhesive strip being near the distal edge and on flap 30b of the bottom panel 30b/70, and the first adhesive strip 64b being secured to areas of the bottom panel 30b/70 substantially adjacent the first side edge (annotated fig. B, the first adhesive strip 64b is secured to flap 30b of the bottom panel 30b/70 and is adjacent/near the first side edge when the glove is closed and the top panel 30a is brought into connection with the flap 30b).
Therefore, 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 sleeve of the conflicting Patent with the first adhesive strip formed along a first portion of the second side edge of the rectangular sheet; the second adhesive strip formed along the distal edge of the rectangular sheet; wherein the top panel of the rectangular sheet is configured to be folded along the fold line into a closed configuration with the bottom panel, wherein the second adhesive strip adjacent the distal edge is secured to areas of the bottom panel adjacent the distal edge, and the first adhesive strip is secured to areas of the bottom panel substantially adjacent the first side edge, as taught by Andrews, as this configuration allows the top and bottom panels of the sleeve to fasten securely around the hand when worn.
The conflicting Patent in view of Andrews is silent on a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively.
However, Bellamy teaches an analogous hand covering 600 (fig. 6A and [0070]) comprising an analogous adhesive strip 637 comprising a removable release liner 636 that covers the adhesive strip 637, the release liner 636 being configured to be removed from the adhesive strip 637 (fig. 6A and [0070], release liner 636 can be peeled from adhesive layer 637 to expose the adhesive).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the first and second adhesive strips of the conflicting Patent in view of Andrews with a removable first release liner that covers the first adhesive strip; a removable second release liner that covers the second adhesive strip, the first and second release liners are configured to be removed from the first and second adhesive strips, respectively, as taught by Bellamy, to protect the underlying adhesive until ready for use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786