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 .
Drawings
The drawings are objected to because all of the lead lines, reference numerals and structural outlines in figs. 1-24 are faded/dotted. Every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined. Additionally, the weight of all lines must be heavy enough to permit adequate reproduction. See 37 C.F.R. 1.84(l).
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.
Specification
The disclosure is objected to because of the following informalities: the specification includes section headings which are bolded. Section headings are required to be in all upper case font with no underline or bold text. See MPEP 37 C.F.R. 1.154(c).
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 3, the term “the mouth” is suggested to be changed to --a mouth-- in order to clarify the claim.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the limitation “the open portion corresponding in position to the mouth of a human body” (claim 1, lines 2-3) appears to positively claiming human body parts. Applicant is suggested to use --for--, --adapted to--, --configured to-- or --whereby-- clause in order to avoid positively claiming the human body parts.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 1-7 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the limitation “wherein a relative position between the first tube retaining portion and the open can be changed” (lines 16-17) is unclear and confusing as to what is being claimed, the limitation “the open” lacks proper antecedent basis, it is unclear if “the open” is referring to “an open portion” being claimed in claim 1, line 2 or not.
Regarding claim 3, the limitation “a main body third tube retaining portion” (line 2) is unclear if a main body second tube retaining portion is being claimed or not, to claim a third without a second makes it unclear if there is a second.
Regarding claim 3, the limitation “the main body further includes a main body first tube retaining portion and/or a main body third tube retaining portion, and the main body first tube retaining portion and the main body third tube retaining portion are located on the first side” (lines 1-4) is unclear as to how to determine the metes and bounds of the limitation, specifically, the usage of the limitation “a main body first tube retaining portion and/or a main body third tube retaining portion” allows for the major body third tube retaining portion to be optional, however, the limitation “the main body first tube retaining portion and the main body third tube retaining portion are located on the first side” requires both the main body first tube retaining portion and the main body third tube retaining portion are located on the first side, therefore, the claim is indefinite because both a broad limitation and a narrow limitation exist in the same claim.
Regarding claim 4, the limitation “two third protruding posts…a third enlarged end” (lines 4-5) is unclear if there are second protruding post and second enlarged end being claimed.
Regarding claim 5, the limitation “a main body second tube retaining portion and/or a main body fourth tube retaining portion” (lines 1-2) is unclear if there is a main body first tube retaining portion and a main body third tube retaining portion being claimed or not. It is noted that claim 5 is not dependent on claims 3-4.
Regarding claim 5, the limitation “the main body further includes a main body second tube retaining portion and/or a main body fourth tube retaining portion, and the main body second tube retaining portion and the main body fourth tube retaining portion are located on the second side” (lines 1-4) is unclear as to how to determine the metes and bounds of the limitation, specifically, the usage of the limitation “a main body second tube retaining portion and/or a main body fourth tube retaining portion” allows for the major body fourth tube retaining portion to be optional, however, the limitation “the main body second tube retaining portion and the main body fourth tube retaining portion are located on the second side” requires both the main body second tube retaining portion and the main body fourth tube retaining portion are located on the second side, therefore, the claim is indefinite because both a broad limitation and a narrow limitation exist in the same claim.
Regarding claim 6, the limitation “two second protruding posts…second enlarged end…two fourth protruding posts….a fourth enlarged end” (lines 2 and 4-5) is unclear if there are first protruding post, first enlarged end, third protruding post and third enlarged end being claimed or not. It is noted that claims 5-6 are not dependent on claims 3-4.
Regarding claim 7, the limitation “the around bite portion” (line 6) lacks proper antecedent basis. Furthermore, it is unclear if the around bite portion is the same as or different from “a bite portion” being claimed in claim 7, line 5.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Islava (6,067,985) in view of Bond (2012/0168571).
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Regarding claim 1, Islava discloses a retaining device for medical equipment (entire device in figs. 1-5), comprising: a main body (130, 114, 134, 112, 180, figs. 1-5, col 3, line 47 to col 5, line 18), including a solid portion (the solid portion is formed by 114, 130, 131 and 134, see fig. 2), an open portion (portion formed between 112 and 114 that is opened, see the annotated-Islava fig. 2 above) and a coupling unit (140 and portion of 128 that interface with 130 and 131, figs. 3-4, see col 4, lines 10-27), the open portion corresponding in position to the mouth of a human body (see the annotated-Islava figs. 1-2 above), the coupling unit being disposed on the solid portion (see figs. 1-5), two sides of the main body being defined as a first side and a second side relative to a longitudinal centerline (see the annotated-Islava figs. 1-2 above), respectively; a strap (111 and 180, see the annotated-Islava figs. 1-2 above, col 5, lines 1-13), coupled to the main body (see the annotated-Islava figs. 1-2 above); and a retaining seat (126, 128, 150, 148, 144, 146, 160, 153, 155, see figs. 1-5), coupled to the solid portion through the coupling unit (see figs. 1-5), the retaining seat including a first tube retaining portion (153 or 153 and portion on 146 that contacts tube 24, see figs. 1-5 and the annotated-Islava fig. 2 above), the first tube retaining portion corresponding in position to the open portion (see figs. 1-2), wherein the retaining seat further including a bite block holder (portion of 155 holding bite block 166, see col 4, lines 41-59), the first tube retaining portion and the bite block holder being arranged along a transverse direction (see the annotated-Islava figs. 1-2 and 5 above, col 3, line 47 to col 5, line 18, specifically, see col 4, lines 28-59), but fails to disclose that the coupling unit including a movable cap and a protruding shaft, the retaining seat having a through hole, the retaining seat being sleeved on the protruding shaft via the through hole, the movable cap being coupled to the protruding shaft to form an unlocking position and a locking position, when in the unlocking position, the retaining seat being detachable to be reverse or rotatable relative to the main body, wherein in a relative position between the first tube retaining portion and the open portion can be changed by detaching and reversing the retaining seat or rotating the retaining seat.
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However, Bond teaches a retaining seat (105, 165, 135, 70, 75, figs. 1-6, paragraphs 0026-0037), detachably or rotatably coupled to a solid portion (solid portion of 20, figs. 1-6, paragraphs 0026-0037, 150 and 20/115 forms a removable connection) through a coupling unit (125, 115, 150, 155, figs. 1-6, paragraphs 0036-0037), the coupling unit including a movable cap (155 and 150, see figs. 1-6, paragraphs 0036-0037) and a protruding shaft (115 and 125, figs. 1-6, paragraphs 0034-0037), the retaining seat having a through hole, the retaining seat being sleeved on the protruding shaft via the through hole, the movable cap being coupled to the protruding shaft to form an unlocking position and a locking position, when in the unlocking position, the retaining seat being detachable to be reverse or rotatable relative to the main body, wherein in a relative position between the first tube retaining portion and the open portion can be changed by detaching and reversing the retaining seat or rotating the retaining seat (see the annotated-Bond fig. 6 above, see paragraphs 0026-0037 and figs. 1-6, Bond discloses in paragraphs 0034-0037 that the cap 150 is a locking cap that forms a clamping mechanism that can be releasably secure the tube grasping mechanism 30 to the body portion 20 and can be a removable connection, therefore, when unlocked, the retaining seat being detachable to be reverse or alternatively can be rotatable relative to the main body).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling unit of Islava to be the coupling unit having a shaft and a movable cap as taught by Bond for the purpose of providing an alternative coupling connection that would allow the retaining seat to slide across the solid portion in order to adjust the position of the retaining seat or to provide a coupling unit that is removable, which would provide ease of repair, replacement and cleaning of parts (see paragraphs 0034-0037 of Bond).
Regarding claim 2, the modified Islava discloses that the coupling unit is located at a position where the longitudinal centerline passes, and the first tube retaining portion deviates from the longitudinal centerline (see the annotated-Bond fig. 6 above and the annotated-Islava figs. 1, 2 and 5 above, after the modification with Bond, where the longitudinal centerline passes the coupling unit would deviates from the first tube retaining portion).
Regarding claim 3, the modified Islava discloses that the main body further includes a main body first tube retaining portion and/or a main body third tube retaining portion, and the main body first tube retaining portion and the main body third tube retaining portion are located on the first side (see the annotated-Islava fig. 2 above, see the portions formed by 190, which forms a main body first tube retaining portion and a main body third tube retaining portion, see col 5, lines 14-18 of Islava).
Regarding claim 5, the modified Islava discloses that the main body further includes a main body second tube retaining portion and/or a main body fourth tube retaining portion, and the main body second tube retaining portion and the main body fourth tube retaining portion are located on the second side (see the annotated-Islava fig. 2 above, see the portions formed by 190, which forms a main body second tube retaining portion and a main body fourth tube retaining portion, see col 5, lines 14-18 of Islava, it is noted that claim 5 is not dependent on claims 3-4, therefore, for claim 5, the sides has be redefined).
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Regarding claim 7, the modified Islava discloses that the retaining seat further includes a first face, the bite block holder includes an opening (opening of 155 accommodating bite block 166 of Islava, see col 4, lines 40-59 of Islava), the movable cap (155 and 150, see figs. 1-6, paragraphs 0036-0037 of Bond) has an inner end face and a collar protruding from the inner end face (see the annotated-Bond fig. 1 and fig. 6 above), when in the locking position, the first face, the collar and the inner end face jointly define a first holding groove (since the movable cap can be unscrew from the bolt 115/125, one can unscrew 150, place a thin sheet of paper or metal between 150 and 135, then tightened the cap 150, which would define a holding groove, see paragraphs 0034-0037 of Bond); the retaining device further comprises a bite block (166 of Islava, see col 4, lines 40-59 of Islava), the bite block includes a bite portion (portion of bite block 166 being bitten by the patient and the portion that connects the bite portion to 172, see col 4, lines 40-59 of Islava) and a holding portion (172, fig. 5, col 4, lines 50-59 of Islava) surrounding the around bite portion (see figs. 1-5 of Islava, the holding portion 172 surrounding the around bite portion, the around bite portion is the portion adjacent to 172 that is around the bite portion), the holding portion has a thickness corresponding to a groove width of the first holding groove (after the modification with Bond, due to the size of the movable cap and shaft 115 of Bond, the groove can be made/defined to correspond to a thickness of 172, the thickness of 172 can be defined as a very small portion of 172 of Islava), the holding portion has a notch, and the notch corresponds in shape to a part of a periphery of the movable cap (see figs. 4-5 of Islava, the holding portion 172 is larger than 167 and forms a notch at the corner that rest on the bite block holder of 155, furthermore, the notch corresponds in shape to a part of a periphery of the movable cap 150 of Bond, because each one has a flat surface, therefore, their flat surface correspond to one another, alternatively, when the bite block 166 of Islava is removed and the cap 150 of Bond is removed, the corner of 150 of Bond can come into contact with the notch of Islava).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Islava (6,067,985) in view of Bond (2012/0168571) as applied to claim 3 above, and further in view of Payton (4,742,824).
Regarding claim 4, the modified Islava discloses that the main body first tube retaining portion includes two first protruding posts and the main body third tube retaining portion (see col 5, lines 14-18 of Islava and the annotated-Islava fig. 2 above), but fails to disclose that the two first protruding posts each having a first enlarged end, and a space between the two first enlarged ends is less than a spacing between the two first protruding posts, and the two third protruding posts each having a third enlarged end, and a spacing between the two third enlarged ends is less than a spacing between the two third protruding posts.
However, Payton teaches a plurality of retaining portions (24, 22 and 44, see figs. 1-5) comprising a main body first tube retaining portion includes two first protruding posts (24, figs. 1-5) each having a first enlarged end (26 of 24, see figs. 1-5), and a spacing between the two first enlarged ends is less than a spacing between the two first protruding posts (see fig. 5); wherein the main body third tube retaining portion includes two third protruding posts (22, figs. 1-5) each having a third enlarged end (26 of 22, see figs. 1-5), and a spacing between the two third enlarged ends is less than a spacing between the two third protruding posts (fig. 5 and col 3, lines 1-68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body first tube retaining portion and the main body third tube retaining portion of the modified Islava to be the plurality of retaining portions as taught by Payton for the purpose of providing safety to the patient by preventing accidental dislodgement of the nasogastric tube of the modified Islava (see col 1, lines 56-63 of Payton).
After the modification, both of the 24 of Payton forms the main body first tube retaining portion and both of the 22 of Payton forms the main body third tube retaining portion.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Islava (6,067,985) in view of Bond (2012/0168571) as applied to claim 5 above, and further in view of Payton (4,742,824).
Regarding claim 6, the modified Islava discloses that the main body second tube retaining portion includes two first protruding posts and the main body fourth tube retaining portion (see col 5, lines 14-18 of Islava and the annotated-Islava fig. 2 above), but fails to disclose that the two second protruding posts each having a second enlarged end, and a space between the two second enlarged ends is less than a spacing between the two second protruding posts, and the two fourth protruding posts each having a fourth enlarged end, and a spacing between the two fourth enlarged ends is less than a spacing between the two fourth protruding posts.
However, Payton teaches a plurality of retaining portions (24, 22 and 44, see figs. 1-5) comprising a main body first tube retaining portion includes two first protruding posts (24, figs. 1-5) each having a first enlarged end (26 of 24, see figs. 1-5), and a spacing between the two first enlarged ends is less than a spacing between the two first protruding posts (see fig. 5); wherein the main body third tube retaining portion includes two third protruding posts (22, figs. 1-5) each having a third enlarged end (26 of 22, see figs. 1-5), and a spacing between the two third enlarged ends is less than a spacing between the two third protruding posts (fig. 5 and col 3, lines 1-68).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body second tube retaining portion and the main body fourth tube retaining portion of the modified Islava to be the plurality of retaining portions as taught by Payton for the purpose of providing safety to the patient by preventing accidental dislodgement of the nasogastric tube of the modified Islava (see col 1, lines 56-63 of Payton).
After the modification, both of the 24 of Payton forms the main body second tube retaining portion and both of the 22 of Payton forms the main body fourth tube retaining portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim (KR 20140103546) is cited to show a rotatable tube stabilizer.
Xu (CN 202154931) is cited to show a tube stabilizer.
Feng (CN 211536145) is cited to show a tube stabilizer comprising a pivoting tube holder.
Zhang (CN 110585028) is cited to show a tube holder.
Zhang (CN 107929903) is cited to show a tube holder having a hinge.
Fu (CN 113769236) is cited to show a tube holder.
Liu (CN 107233648) is cited to show a tube holder.
Li (CN 214970652) is cited to show a tube holder.
Molden (2016/0339194) is cited to show a tube holder comprising a lock state and an unlock state.
Battaglia (5,345,931) is cited to show an endotracheal tube holder.
Eross (3,946,742) is cited to show an endotracheal tube holder.
Fabro (5,934,276) is cited to show a tube holder comprising a pivot point.
Beattie (5,806,516) is cited to show an endotracheal tube stabilizer.
Rogers (5,653,232) is cited to show an endotracheal tube positioned comprising a hinge.
Levine (8,726,903) is cited to show a respiratory facemask with sliding endotracheal tube holder.
Johnson (2022/0023608) is cited to show a medical tube securement device comprising a rotatable hinge.
Visconti (2014/0261463) is cited to show a tube holding device with a bite block.
Brar (2021/0187229) is cited to show a tube holding device with a bite block.
Gaiser (2002/0151871) is cited to show a tube stabilizer.
Levine (2011/0126839) is cited to show a tube holder.
Rudy (6,634,359) is cited to show a tube holding device having a rotatable hinge.
Bates (5,437,273) is cited to show a tube holder.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TU A VO/ Primary Examiner, Art Unit 3785