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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Fig. 1 directed to a system for treating a tissue site comprising a tissue interface having a fluid flow path; a pouch at least partially encapsulating the tissue interface; at least one saturation meter disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path; and a negative-pressure source configured to be fluidly coupled to the tissue interface to draw fluid along the fluid flow path (readable on claims 8-12 and 15);
Figs. 2-4 directed to a dressing for treating a tissue site, the dressing comprising: a tissue interface having a serpentine fluid flow path having at least one bend; an encapsulating film at least partially encapsulating the tissue interface; and at least one indicator comprising a film having an ultra-low index coating disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path (readable on claims 1-5 and 16-18); and
Figs. 5-8 comprising dressing for treating a tissue site, the dressing comprising: a tissue interface having a fluid flow path; an encapsulating film at least partially encapsulating the tissue interface; and at least one indicator disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path; wherein the indicator comprises a plurality of microfluidic channels disposed at an angle to the fluid flow path, configured to draw fluid into each microfluidic channel of the plurality of microfluidic channels; and the at least one location comprises a first end of each channel of the plurality of microfluidic channels disposed at an interface between the tissue interface and the tissue site and a second end of each channel of the plurality of microfluidic channels disposed between the tissue interface and the encapsulating film (readable on claims 1, 6-7, 16 and 19-20).
Upon election of Species I Applicants are required to elect from the following subspecies:
A: Figs 2-4, drawn to at least one indicator comprising a film having an ultra-low index coating disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path; and
B: Figs. 5-8, drawn to an indicator comprises a plurality of microfluidic channels disposed at an angle to the fluid flow path, configured to draw fluid into each microfluidic channel of the plurality of microfluidic channels.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, there are no generic claims.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Species I-III lack unity of invention because even though the inventions of these groups require the technical feature of a tissue interface having a fluid flow path, a partially encapsulated tissue interface and at least one indicator disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of U.S. Patent Application Publication No. 2020/0289726 (“Locke et al.”). Locke et al. discloses a dressing (104) for treating a tissue site (abstract and para. [0029]) comprising a tissue interface (114, see para. [0029])) having a fluid flow path (see para. [0039] which discusses that in some embodiments, the tissue interface 114 may be a manifold which may include any substance or structure providing a plurality of pathways adapted to collect or distribute fluid across a tissue site under pressure), a partially encapsulated tissue interface (cover 116 partially encapsulates tissue interface 114, see Fig. 2) and at least one indicator (pressure indicator 124) disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path (see para. [0072] which discusses the pressure indicator can provide a fluid path around or through the tissue interface).
During a telephone conversation with Christopher Cauble on December 8, 2025 a provisional election was made without traverse to prosecute the invention of Species I and subspecies A, claims 8-12 and 15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-7, 13, 14 and 13-20 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statements filed November 22, 2024 have been received and made of record. Note the acknowledged PTO-1449 form enclosed herewith.
Drawings
The drawings are objected to because Fig. 4 includes reference character “115” indicating that the drawing is directed to a pouch; however [0099] indicates Fig.4 is a cross-sectional view of dressing “110”.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “400” in Fig. 4.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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
Regarding claims 8-12 and 15, Applicant’s recitation of “a pouch at least partially encapsulating the tissue interface” is indefinite in that the specification in para. [0028] recites “pouch 115 is representative of a container, canister, or other storage component…”, yet the claim recites a different use for the pouch. Applicant is advised rectify the difference between the disclosure of the pouch and the use of the pouch in the claim. For the purpose of compact prosecution, the term pouch will be interpreted as a film.
Regarding claim 10, the recitation of “an ultra-low index coating” is indefinite in that it is unclear what coating Applicant is claiming. Applicant is advised to recite --an ultra-low index coating of refraction--.
Claims 9, 11, 12 and 15 are necessarily rejected by virtue of their dependence on claim 9 for indirectly containing the same indefinite language.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application No. 20200289726 (“Locke et al.”)
Regarding claim 8, Locke et al. disclose a system (100, see Fig. 1 and para. [0029]) for treating a tissue site (see the abstract), the system comprising: a tissue interface (interface layer 308, see para. [0055]) having a fluid flow path (see Fig. 3 and para. [0057] which discloses apertures 316 are configured to transfer fluid through the interface layer 308); a pouch (interpreted as a film; cover 116, see para. [0045] which discloses the cover is a film) at least partially encapsulating the tissue interface (see Fig. 2, which shows cover 116 at least partially encapsulates the tissue interface by being positioned on top of the tissue interface); at least one saturation meter (pressure indicator 124, see para. [0068], see also para. [0073] which discloses the pressure indicator 124 may indicate an impediment to pressure delivery, such as saturation of the dressing, see also para. [0072]; thus the pressure indicator indicates saturation of the dressing, i.e., saturation meter) disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path (see Fig. 2); and a negative-pressure source (pressure source 102, see para. [0051]) configured to be fluidly coupled to the tissue interface to draw fluid along the fluid flow path (as can be seen from flow diagram in Fig. 1), fluidly coupled to the tissue interface to draw fluid along the fluid flow path (see para. [0036], which discloses the pressure distributed to the tissue interface, see also para. [0039] and para. [0071]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. in view of WO 2021/084444 (“Cavanaugh et al.”)
Regarding claim 9, Locke et al. discloses the system of claim 8, except wherein the fluid flow path comprises a serpentine flow path having at least one bend; and the at least one location comprises the at least one bend. However, Cavanaugh et al. it the disclosure of an analogous tissue treatment system (100) teaches it is known to treat a tissue site in need of therapy with a treatment system (100, see Figs 1 and 3), comprising a serpentine manifold with at least one bend in order to provide a tortuous fluid path from the inlet to the outlet that can increase or maximize fluid absorption by the absorbent layers.
In view Cavanaugh et al., it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have included a manifold having a serpentine flow path having at least one bend in order to provide a tortuous fluid path from the inlet to the outlet that can increase or maximize fluid absorption by the absorbent layers.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. in view of U.S. Patent No. 8,552,083 (“Taranekar et al.”)
Regarding claim 10, modified Locke et al. discloses the system of claim 8, wherein the saturation meter comprises a film (1100, see para. [0068]) defining a portion of the fluid flow path, the film having a low index coating (the film is polarized; polarized film is inherently coated with a low refractive index coating).
Locke et al. fails to disclose an ultra-low refractive index coating. However, Taranekar et al., in its analogous disclosure of ultra-low refractive index coatings teaches it is known to provide ultra-low index refractive coatings in order to inherently dramatically cut reflections to increase light transmission for clearer images and to enable broader anti-reflection across colors/angles.
In view of Taranekar et al., it would have been obvious to one having ordinary skill in the art to provide the indicator of Locke et al. with a polarized film having an ultra-low refractive index coating in order dramatically cut reflections to increase light transmission for clearer images underneath the film.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cavanaugh et al. in view of Locke et al.
Regarding claim 8, Cavanaugh et al. discloses a flexible fluid storage pouch with absorbent that substantially discloses Applicants’ claimed invention. More specifically, Cavanaugh et al. discloses a system (100, see Figs. 1 and 3) comprising: a tissue interface (a first layer 300, see para. [0067]) having a fluid flow path (through inlet 320, see para. [0071] and first fluid conductor 205, see para. [0065] and through inlet 320 to manifold 310, see Fig. 3); a pouch (interpreted as a film; second layer 305 is a film, see para. [0067]) at least partially encapsulating the tissue interface (see therapy system 100 in Fig. 1 and para. [0033], see also Fig. 3) and a negative-pressure source (negative-pressure source 105, see para. [0033]) configured to be fluidly coupled to the tissue interface to draw fluid along the fluid flow path, see Fig. 5 and para. [0065] which discloses the first fluid conductor 205 may be coupled to the negative pressure source 105 to remove fluids from the tissue site).
Cavanaugh et al. fails to disclose at least one saturation meter disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path. However, Locke et al. in the disclosure of an analogous therapy system teaches it is known to provide a therapy system with at least one saturation meter (pressure indicator 124, see para. [0068], see also para. [0073] which discloses the pressure indicator 124 may indicate an impediment to pressure delivery, such as saturation of the dressing, see also para. [0072]) in order to indicate saturation of the dressing.
In view of Locke et al. it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of Cavanaugh et al. with at least one saturation meter in the form of a pressure indicator in order to indicate saturation of the dressing.
Regarding claim 9, modified Cavanaugh et al. discloses the system of claim 8, wherein: the fluid flow path comprises a serpentine flow path having at least one bend (see the Abstract which discloses the serpentine shape of manifold 310 which provides a fluid path from the inlet to the outlet that can increase or maximize fluid absorption); and the at least one location comprises the at least one bend (see Fig. 3, which shows bends in the manifold 310).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cavanaugh et al. in view of Locke et al., as applied to claim 8 above, and in further view of U.S. Patent Application Publication No. 2009/0227969 (“Jaeb et al.”).
Regarding claim 15, modified Cavanaugh et al. discloses the system of claim 8, except that the system further comprises a manifold disposed between the tissue interface and the tissue site, the manifold configured to direct fluid flow from the tissue site to the tissue interface. However, Jaeb et al. discloses a reduced pressure treatment system (100, see Fig. 2) comprising a manifold layer in the form of tissue interface (220, see para. [0047]) constructed from open cell, reticulated polyurethane foam which wicks fluid away from the tissue site while continuing to provide negative pressure to the wound site (para. [0047]). The interface layer further promotes granulation at the tissue site. For example, any or all of the surfaces of the interface layer (220) may have a jagged profile that causes microstrains and stresses at the tissue site that increase new tissue growth (see para. [0049]).
In view of modified Jaeb et al., it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of Cavanaugh et al. with a manifold layer positioned between the tissue interface and the tissue site in order to promote tissue granulation at the wound site for increasing new tissue growth.
Claim(s) 8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cavanaugh et al. in view of RU 2507516 C2 (“Pehjtel”), as evidenced by the Refractive Index Database.
Regarding claims 8 and 10-12, Cavanaugh et al. discloses a system for treating a tissue site, that substantially discloses Applicant’s claimed invention. More specifically, Cavanaugh et al. discloses a system (100, see Fig. 2) comprising: a tissue interface (a first layer 300, see para. [0067]) having a fluid flow path (through inlet 320, see para. [0071] and first fluid conductor 205, see para. [0065]); a pouch (interpreted as a film; second layer 305 is a film, see para. [0067] at least partially encapsulating the tissue interface (see Fig. 3); (therapy system 100, see para. [0033]) and a negative-pressure source (negative-pressure source 105, see para. [0033]) configured to be fluidly coupled to the tissue interface to draw fluid along the fluid flow path, see Fig. 5 and para. [0065] which discloses the first fluid conductor 205 may be coupled to the negative pressure source 105 to remove fluids from the tissue site).
Cavanaugh et al. fails to disclose at least one saturation meter disposed adjacent to the tissue interface proximate to at least one location along the fluid flow path. However, Pehjtel in its disclosure of an analogous indicator system, based on etching of metals, teaches it is known to provide a coating of aluminum, having an ultra-low refractive index, as evidenced by the Refractive Index Database, on a film, which coating when activated by a liquid is destroyed and the film is transitions to transparent from opaque (see the abstract).
In view of Pehjtel, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of Cavanaugh et al., with a saturation meter in the form of a humidity indicator, by coating second layer (305) with a thin layer of aluminum that can be destroyed when activated with a liquid, such as water, to transition the cover from opaque to transparent in order to indicate when the dressing is saturated, thereby transitioning between opacity and transparency in the presence of liquid.
Regarding claim 10, modified Cavanaugh et al. discloses the system of claim 8, wherein the saturation meter comprises a film defining a portion of the fluid flow path, the film having an ultra-low index coating (note the rejection of claim 8 above).
Regarding claim 11, modified Cavanaugh et al. discloses the system of claim 10, wherein the ultra-low index coating is configured to transition between opacity and transparency in a presence of liquid (note the rejection of claim 8 above).
Regarding claim 12, modified Cavanaugh et al. discloses the system of claim 11, wherein the ultra-low index coating is configured to transition from opaque to transparent in the presence of liquid (note the rejection of claim 8 above).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786