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 of the following reasons:
The “flexible sleeve” should have a reference number. The flexible sleeve seems to be shown, and supported by the specification, but does not comprise a reference number
The drawings are unclear. The photographs are not of sufficient quality, 37 CFR 1.84(b)(1) states: Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. For example, photographs or photomicrographs of: electrophoresis gels, blots (e.g., immunological, western, Southern, and northern), auto- radiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and unstained), animals, plants, in vivo imaging, thin layer chromatography plates, crystalline structures, and, in a design patent application, ornamental effects, are acceptable. If the subject matter of the application admits of illustration by a drawing, the examiner may require a drawing in place of the photograph. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent.
37 CFR 1.84(b)(l) states: Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning. 37 CFR 1.84(b)(M) states: The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color.
The photographs, lines, and shading are not clean, well defined, and the drawings seem to have reduced legibility. Therefore the drawings objections are applicable
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.
Figure 4 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. It would seem that retractors as shown in figure 4 are prior art, as disclosed in paragraph 94 of the specification of the application. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 Objections
Of note: The claims should be amended to concisely and clearly recite the limitations where terminology/limitations are consistent, clear, and concise. Examples are found below:
Claim 1 is objected to because of the following informalities: Terminology should be consistent. In order to avoid any antecedent issues, the “retractors” in line 5 should be “ the first adjustable wound retractor and the second first adjustable wound retractor”. The limitation “the first retraction ring” of line 8 should be “the first interior retraction ring”. The limitation “the second retraction ring” of line 11 should be “the second exterior retraction rings. The limitation “ the second retraction rings” of lines 17-18 and 18 should be “the second retraction rings of each of the adjustable first wound retractor and the adjustable second retractor”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: for concise and clarity purposes the use of “which” in lines 21 and 22 should be deleted and replaced with “where the” or “wherein the”, or similar phrases. Appropriate correction is required.
Claim 1, 14 are objected to because of the following informalities: The term “and/or” should be deleted and replaced with a phrase (such as “at least one of”) that can clearly claim the scope of the claim. Appropriate correction is required.
Claims 2, 3, 12, 13, are objected to because of the following informalities: In order to be concise for clarity purposes, the phrase “the transfer bag of the transfer bag device” can be amended to read “the transfer bag . Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the umbilical cord” should be deleted and replaced “an umbilical cord of the preterm” or a similar phrase. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In order to avoid any antecedent issues, the terms “the laparotomy site” and “the hysterotomy site” of lines 2, 3-4 should be deleted and replaced “a laparotomy site of the pregnant mammal” and “a laparotomy site of the pregnant mammal” or a similar phrase(s). Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the hysterotomy site” of lines 2 should be deleted and replaced “a hysterotomy site”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: for concise and clarity purposes the use of “which” in lines 2 and 3 should be deleted and replaced with “where the” or “wherein the”, or similar phrases. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the hysterotomy site” of line 4 and “the preterm” in line 14 should be deleted and replaced “a hysterotomy site” and “a preterm” respectively. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: for concise and clarity purposes the use of “which” in lines 19 and 20 should be deleted and replaced with “where the” or “wherein the”, or similar phrases. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the laparotomy site” of line 3 should be deleted and replaced “a laparotomy site”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: claim 16 uses inconsistent antecedent usage. Claim 16 states in the preamble “… a preterm from a natural womb of a pregnant mammal to an artificial womb” as well as stating “providing the kit-of parts of claim 14” in line 3. However line 4 states “a pregnant mammal”, line 6 and “the laparotomy site”, “the hysterotomy site”, and “the preterm” in lines 6, 8, 18 respectively. The claim should be consistent with antecedent usage with respect to using “the/said” and “a/an” with respect to terms in the preamble and/or previously stated in the claim and/or in claim 14. Of Note: the limitations above are examples. The claim should be amended to be consistent, for clarity purposes, with respect to antecedent usage. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the laparotomy site” of line 4 should be deleted and replaced “a laparotomy site”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: for concise and clarity purposes the use of “which” in line 19 should be deleted and replaced with “where the” or “wherein the”, or similar phrases. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: In order to avoid any antecedent issues, the term “the hysterotomy site” of line 10 should be deleted and replaced “a hysterotomy site”. Appropriate correction is required.
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 1-19 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.
Regarding claims 1, 3, 8, 10, 11, 13, 14, 16, 17, 19, the phrases "such as" “in particular”, and “i.e.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The limitation can be deleted to positively recite the limitations following the phrase. See MPEP § 2173.05(d).
The term “loosely” in claim 4 is a relative term which renders the claim indefinite. The term “loosely” 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. The extent of what is loose and what would not be loose is not known and supported by the specification, Therefore the term is indefinite.
Claim 6 contains the trademark/trade name “SurgiSleeve” and copyright “Alexis”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe retractors and, accordingly, the identification/description is indefinite. It is recommended claim 6 be canceled.
Claim 9 states “…configured to receive a respective second retraction ring” in lines 4-5. However claim 9 is dependent off of claim 1 which also claims a second exterior retraction ring / the second retraction ring. It would be unclear if claim 9 is trying to claim other second retraction rings or the second retraction rings of claim 1. It would be suggested that the limitation is amended to read “configured to receive the second exterior retraction ring of the adjustable first wound retractor and the adjustable second wound retractor respectively”.
Claim 10 is indefinite based on the inventive entity is unclear. Claim 10 seems to be directed to “a transfer bag device comprising a transfer bag” and “the transfer device bag is provided with at least one integrate glove”. However claim 10 states “…secured to a transfer device base of claim 9”. Claim 9 is dependent off claim 1 which already claims a transfer bag and a glove. Further it is unclear what “transfer device base” is being referenced. Since the term of claim states “a transfer device base” and not “ the transfer device base”, it would seem that a new transfer device is being claimed in claim 10 and not the “transfer device base” of claim 9. However, it is unclear then why claim 10 would reference claim 9. It is unclear if the inventive entity of claim 10 is just a transfer bag which is capable of being used with a generic transfer device base, a device comprising a transfer bag and a transfer device base, a second transfer bag being used with the device of claim 9/1, or some other inventive entity. Claim 10 does seem to try to positively recite claim 9, but the specific scope of the inventive entity is unclear. Since what is trying to be positively claimed in claim 10 is unclear, the claim is considered to be indefinite. Of note, dependent claims 11-13 of claim 10 will comprise similar issues with respect to claim 10, the inventive entity, and/or what is trying to be newly positively claimed.
The term “loosely” in claim 18 is a relative term which renders the claim indefinite. The term “loosely” 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. The extent of what is loose and what would not be loose is not known and supported by the specification, Therefore the term is indefinite.
Claim Rejections - 35 USC § 102
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 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2017/0055973 to Albrecht.
As to claim 8, Albrecht discloses adjustable wound retractor adapted to dilate a surgical wound incision (paragraph 6, 66), such as a wound incision at the hysterotomy site, to a desired diameter, comprising a flexible sleeve (204, figure 3b, paragraph 67) disposed in a cylindrical form between a first retraction ring (206) and a second retraction ring (202), wherein: the first retraction ring having a diameter greater than the desired diameter of the wound incision and being adapted to be disposed interior of the wound incision (figure 3c, paragraph 67, 58-62); and the second retraction ring having an annular axis and a diameter greater than the desired diameter of the wound incision and being adapted to be disposed exterior of the wound incision (figure 3c, paragraph 67, 58-62), wherein the second retraction ring is rollable over itself and around the annular axis to provide the flexible sleeve with a radial retraction force sufficient to stretch the incision to the desired diameter (figure 2, 3a-c, paragraph 67, 58-62), wherein the diameter of the first retraction ring is smaller than the diameter of the second retraction ring (figure 3c). Albrecht discloses the device of figure 1 can have two rings and sleeve, where the outer sleeve can be rolled which expand the diameter of the sleeve. The rings can be of any shape/size. Figure 3a-c teaches an embodiment with a smaller inner ring and a bigger outer ring with a sleeve attached therebetween. The device of figure 3a-c can have the ring rollable about itself, similar to the device of figure 1-2, to achieve the force as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,524,644 to Crook, U.S. Patent 5,813,409 to Leahy, U.S. Patent 6,033,428 to Sardella, U.S. Patent 6,382,211 to Crook, U.S. 6,485,467 to Crook, U.S. Patent Publication 2004/0049099 to Ewers, U.S. Patent Publication 2004/0154624 to Bonadio, U.S. Patent Publication 2013/0158563 to Adams, U.S. Patent Publication 2016/0262794 to Wachli, and U.S. Patent Publication 2023/0363792 to Delbressine all disclose similar devices and/or methods pertinent to the scope of the claims
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771