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 .
Benefit
The application filed 24 February 2025 claims benefit of US Provisional 63/557,219 (23 February 2024).
Formal Matters
Claims 1-21 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 February 2025 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
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.
Drawings – Objections
The drawings are objected to under 37 CFR 1.83(a). Pressure pad 250 is recited in claims 17 and 20 and disclosed in numbered “sentences” 28 and 29 of the Specification (p. 7). However, pressure pad 250 is not shown in the Drawings. The drawings must show every feature of the invention specified in the claims. Therefore, the pressure pad 250 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference Figure “FIG. 8” has been used to designate four separate different images in the Drawings. Each of these images should be separately labeled (e.g. FIGs 8a, 8b, 8c, 8d) and the specification amended accordingly, without including new matter.
Similarly, reference Figure “FIG. 11” has been used to designate two separate photographs in the Drawings. A sub label (a) and (b) appears under each of the photographs. These images appear to have been prepared for or alternatively excerpted from a research paper. Each of these distinct images are required to be separately labeled as a Figure (e.g. FIG 11A, FIG 11B).
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. 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 - Objections
The disclosure is objected to because of the following informalities: the numbering of “sentences” on pages 3-9 and the numbered list of references on pages 17-19 of the Specification are not in compliance with MPEP 608.01 and 37 CFR 1.52(b)(6). Beginning on page 3 and continuing to page 9 the Specification contains textual material in the “Summary of the Invention” section that may be confused with the numbered claims, as there are multiple “sentences” that are numbered in a manner similar to claims. Beginning on page 4, the numbered designations are referred to as “sentences 1 – 2”, “sentences 1 – 3”, etc. However, neither the numbering nor the designation as numbered “sentences” is permitted under MPEP 608.01, which provides for numbered paragraphs at the time the application is filed, where the numbers are enclosed in square brackets, including leading zeros (see MPEP 608.01 and 37 CFR 1.52(b)(6) and MPEP 608.01). However, MPEP 608.01 expressly states that text elements and lists should not be independently numbered. This broadly includes the numbered list of “sentences” which could easily be confused with claims. The numbered “list of references” also falls into this express admonition against numbering in the Specification.
Additionally, on p. 20 of the Specification, a list of “Figure Reference Numbers” are provided. Rather than referencing Figures, as the title suggests, the list is drawn to reference characters. Accordingly, it is suggested that the title of the list be changed to “List of Reference Characters” in order to avoid confusion with the Figures. The examiner also recognizes that the reference characters are also shown in the Figures and throughout the Specification and the Claims.
In the Brief Description of the Drawings, the reference to FIG. 8 does not contain information about the four distinct photographs labeled in the drawings as “FIG. 8”. Each of these images should be separately identified and labeled (e.g. FIGs 8a, 8b, 8c, 8d) without including new matter.
Similarly, the Brief Description of the Drawings references “FIG. 11”, which has been used to designate two separate photographs in the Drawings, each of which contain a sub-label (a) and (b), with accompanying text, under each of the photographs. These images appear to have been prepared for or alternatively excerpted from a research paper. However, each of these images are required to be separately indicated as distinct Figures in the Brief Description of the Drawings (e.g. FIG 11A, FIG 11B).
The text of the Specification is objected to for containing end note reference numbers within the text. While there is no singular specific MPEP citation against the use of foot notes or end notes in the Specification, the end-noting in the Application is directed to a list of references appearing at the end of the Specification (pp 17-19) and the link to the references renders the Specification unclear and confusing (MPEP 608.01) because the relevance of those references to the text of the Specification is not entirely clear.
Appropriate correction is required.
Advisory Notice
Applicant is advised that although a list of references may appear in the Specification, the examiner has not considered those references unless or until they appear in an Information Disclosure Statement (IDS) that is properly filed under MPEP 609. See also, MPEP 2173.05(s).
Applicant is advised that although reference numbers in the claims are properly formatted (being enclosed in parentheses), as stated in MPEP 608.01(m), the presence or absence of reference characters in the claims generally does not affect the legal scope of the claim. The examiner will broadly consider the reference numbers insofar as they are consistent with the specification and the drawings, but they are not otherwise limiting as to the legal scope of the claims, which the examiner will interpret under the Broadest Reasonable Interpretation standard, and as set forth above, under the Claim Interpretation heading.
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.
Claims 1, 3, 4, 6-8, 10, 12, 14-18, 20, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buckman et al., US 20050165445 (28 July 2005).
Regarding independent claim 1, Buckman teaches a trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) for non-tourniquetable (¶¶100, 102) hemorrhage control (FIG 20, peripheral hemostasis system 320; ¶97) of a patient having an entry wound in a shoulder bundle, groin, femoral, abdominal, back, or chest region (¶102) said trauma belt (1) comprising
a rigid top arm (70) (FIG 20, upper shell 314; ¶97)
a rigid bottom arm (80) (FIG 20, lower shell 312; ¶97) and
a stem (40) (FIG 20 hinge 306; ¶97) connecting the top arm (70) (FIG 20, upper shell 314; ¶97)
and the bottom arm (80) (FIG 20, lower shell 312; ¶97),
a pad (100) (FIG 20, pad 310; ¶97) connected to the interior surface (20) (FIG 20)
of the top arm (70) (FIG 20, upper shell 314; ¶97),
wherein the stem (40) (FIG 20 hinge 306; ¶97) is configured to provide constricting force between the top arm (70) (FIG 20, upper shell 314; ¶97) and bottom arm (80) (FIG 20, lower shell 312; ¶97) to provide pressure of the pad (100) (FIG 20, pad 310; ¶97) against the entry wound.
Regarding claim 3, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, wherein the pad (100) (FIG 20, pad 310; ¶97) is detachable from the trauma belt (1) (removable, ¶74).
Regarding claim 4, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, wherein the pad (100) (FIG 20, pad 310; ¶97) has a compression plate (110) (fluid impermeable barrier 204, ¶¶97-98) and a pressure pad (120) (dam 206, ¶¶97-98).
Note that the reference defines element 206 as a dam and element 208 as a strap in ¶95, but then inadvertently refers to strap 206 and dam 206 in ¶96, also referring to dam 206 in ¶98. It is readily apparent from the four paragraphs (¶¶95-98) that the reference to “strap 206” is a typographical error.
Regarding claim 6, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, wherein the trauma belt (1) is formed using additive manufacturing, as set forth above, for the reasons set forth above.
Claim 6 is a product-by-process claim. Patentability of a product-by-process claims is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it (In re Thorpe 227 USPQ 964 (Fed. Cir. 1985)). In the present case, the final product does not appear to be distinguished by any particular features or characteristics over the product of the prior art as a result of the process by which it is made. Thus, the claimed product is not patentable over the product of the prior art absent any distinct difference in the products themselves (see MPEP § 2113).
Regarding claim 7, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 6, as set forth above, for the reasons set forth above.
Claim 7 is dependent on product-by-process claim 6. The thickness of the exterior wall is a step in additive manufacturing and as such, is part of the process limitations of the claim.
Patentability of a product-by-process claims is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it (In re Thorpe 227 USPQ 964 (Fed. Cir. 1985)). In the present case, the final product does not appear to be distinguished by any particular features or characteristics over the product of the prior art as a result of the process by which it is made. Thus, the claimed product is not patentable over the product of the prior art absent any distinct difference in the products themselves (see MPEP § 2113).
Regarding claim 8, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 6, as set forth above, for the reasons set forth above.
Claim 8 is dependent on product-by-process claim 6. The “internal infill percentage” of claim 8 is a step in additive manufacturing and as such, is part of the process limitations of the claim.
Patentability of a product-by-process claims is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it (In re Thorpe 227 USPQ 964 (Fed. Cir. 1985)). In the present case, the final product does not appear to be distinguished by any particular features or characteristics over the product of the prior art as a result of the process by which it is made. Thus, the claimed product is not patentable over the product of the prior art absent any distinct difference in the products themselves (see MPEP § 2113).
Regarding claim 10, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, as set forth above, for the reasons set forth above. wherein the thickness of the compression plate (110) is 0.1-1 inch (1/8 to 1/4 inch”, ¶73 [converts to 0.125 inch to 0.25 inch]).
Regarding claim 12, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, wherein the pad (100) (FIG 20, pad 310; ¶97) further comprises one or more components selected from the group consisting of a quick clot, an anticoagulant, an anesthetic, and an antimicrobial (¶102).
Regarding independent claim 14, Buckman teaches a stretchable trauma belt (200) (FIGs 11, Hemostatic packing device 10; ¶¶72-74) for non-tourniquetable (¶¶100, 102) hemorrhage control of a patient having an entry wound in a shoulder bundle, groin, femoral, abdominal, back, or chest region (¶102), said trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) comprising
a stretchable belt (210) (FIG 11, straps 38, ¶74),
a pad (230) (FIG 11, absorbent region 52; ¶74)
adhered to the stretchable belt (210) (FIG 11, straps 38, ¶74),
a fastener (220) (FIG 11, Velcro® 62; ¶74)
configured to fasten two or more opposite edges of the stretchable belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) to form a closed loop to provide a constricting force and pressure of the pad (230) (FIG 11, absorbent region 52; ¶74) against the entry wound (¶74).
Regarding claim 15, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 14, as set forth above, for the reasons set forth above, comprising a plurality of pads (230) (“over the entire surface applied to the patient” ¶74).
Regarding claim 16, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 14, as set forth above, for the reasons set forth above, wherein the pad (230) (FIG 11, absorbent region 52; ¶74) is detachable (“removable”, ¶74) from the stretchable belt (210) (FIG 11, straps 38, ¶74),.
Regarding claim 17, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 14, as set forth above, for the reasons set forth above, wherein the pad (230) (FIG 11, absorbent region 52; ¶74) comprises a compression plate (240) (FIG 11, gasket 54; ¶73) and a pressure pad (250) (“gauze or absorbent region 52 further comprising gasket 54 or a plurality of gaskets 54”, ¶72), wherein the compression plate has a top side adhered (adhesive, ¶74) to the pressure pad and a bottom side adhered to the stretchable belt (FIG 11, ¶74).
Regarding claim 18, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 17, as set forth above, for the reasons set forth above, wherein the compression plate (240) is rigid or semi-rigid (FIG 11, gasket 54; ¶73).
Regarding claim 20, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 19, as set forth above, for the reasons set forth above, wherein each of the plurality of pads (230) (FIG 11, absorbent region 52; ¶74) comprises an elongate, rigid compression plate (240) (FIG 11, gasket 54; ¶73) and a pressure pad (250) (“gauze or absorbent region 52 further comprising gasket 54 or a plurality of gaskets 54”, ¶72).
Regarding claim 21, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 20, as set forth above, for the reasons set forth above, wherein the stretchable belt (210) (FIG 11, straps 38, ¶74) is made of a material selected from the group consisting of high-strength textile, elastomeric sheet, and polymer film (Coban®, ¶74).
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.
Claims 2, 5, 9, 11, 13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Buckman et al., US 20050165445 (28 July 2005).
Regarding claim 2, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, as set forth above, for the reasons set forth above.
Buckman’s Embodiment of FIG 20 does not teach wherein a second pad (100) is connected to an interior surface (50) of the bottom arm (80) to press against an exit wound.
However, in the Embodiment of FIG 20, Buckman teaches “pad 310 is affixed to the interior aspect of the lower shell member 312” (¶98).
Buckman also teaches the Embodiment of FIG 12, comprising a plurality of pads (230) (FIG 12, absorbent region 52,¶76).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss. Buckman’s Embodiment in FIG 11 (¶¶72-75) teaches the hemostatic packing device 10 in the form of a wound dressing, PHS, or bandage (¶72). Buckman’s Embodiment in FIG 12 (¶76) teaches the hemostatic packing device 10 in the form of a wound dressing or bandage as shown in FIG 11 further comprising a plurality of dams or gaskets that aid in hemodynamic control (¶76). One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case.
Regarding claim 5, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 4, as set forth above, for the reasons set forth above.
In the Embodiment of FIG 20, Buckman does not expressly teach wherein the pressure pad (120) is a block type (120a), or has curved edges (120b), or is trapezoidal shaped (120c) or is hemispherical shaped (120d).
However, Buckman teaches the Embodiment of FIG 11, where gauze or absorbent region 52 is further comprised of a plurality of dams or gaskets 54 running or weaving in a honeycomb, rectangular, diamond, or other appropriate pattern throughout and within the gauze or absorbent region 52 of the bandage 50 (¶76). Gasket 54 or dam is also taught as being “configured with a skin contact surface that has a cross-section that includes, but is not limited to, triangular, rounded, trapezoidal, rectangular, rounded triangular” (¶73).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss. Buckman’s embodiment in FIG 20 (¶¶97-100) teaches peripheral hemostatic device system 320 (¶97) comprising an upper and a lower arm/shell member which wraps circumferentially around the affected region. In the Embodiment of FIG 20, Buckman teaches wherein the pad (100) (FIG 20, pad 310; ¶97) has a compression plate (110) (fluid impermeable barrier 204, ¶¶97-98) and a pressure pad (120) (dam 206, ¶¶97-98).
Buckman’s Embodiment in FIG 11 (¶¶72-75) teaches the hemostatic device 10 for non-tourniquetable (¶¶100, 102) hemorrhage control of a patient having an entry wound in a shoulder bundle, groin, femoral, abdominal, back, or chest region (¶102), said trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) comprising a stretchable belt (210) (FIG 11, straps 38, ¶74), a pad (230) (FIG 11, absorbent region 52; ¶74) adhered to the stretchable belt (210) (FIG 11, straps 38, ¶74), a fastener (220) (FIG 11, Velcro® 62; ¶74) configured to fasten two or more opposite edges of the stretchable belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) to form a closed loop to provide a constricting force and pressure of the pad (230) (FIG 11, absorbent region 52; ¶74) against the entry wound (¶74). While Buckman’s Embodiment at FIG 11 primarily focuses on an entry wound, Buckman’s Embodiment at FIG 20 focuses on an entry and exit wound where there is more significant tissue loss (FIG 20) and where bone 316, and blood vessels 218 are involved (¶97). One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case.
One of skill in the art would clearly recognize, based on the express teachings of Buckman, in its various embodiments, that the structure of the hemostatic device can be optimized depending on the end effect desired for the use case. One of ordinary skill in the art would have had a reasonable expectation of success to determine type of optimization based on the type of wound. Modifications to the hemostasis devices can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential injuries involved in particular anatomical regions and the types or categories of anticipated wounds. As such, modifying the hemostatic devices for anatomy and use cases would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 9, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, as set forth above, for the reasons set forth above.
Buckman teaches wherein the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) is configured to have sufficient tension to ensure that the pad (100) (FIG 20, pad 310; ¶97) pressure inward towards the wound.
Buckman does not teach the inward pressure of the pad of the Embodiment of FIG 20. However, Buckman teaches an Embodiment at FIG 11 comprising a pad with a dam as gasket 54 that exerts pressure with enough force to prevent the escape of blood under arterial pressures, which can range from 80mm Hg to over 200mg Hg (FIG 11,¶73).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss. Buckman’s Embodiment in FIG 11 (¶¶72-75) teaches the hemostatic device 10 in the form of a wound dressing, PHS, or bandage (¶72). Buckman expressly teaches that gasket 54 aids in hemodynamic control as it presses into the tissue surrounding the wound to ensure a strong resistance to hemorrhage or leakage of blood beyond the dam (¶73). One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case.
One of skill in the art would clearly recognize, based on the express teachings of Buckman, in its various embodiments, that the structure of the hemostatic device can be optimized depending on the end effect desired for the use case. One of ordinary skill in the art would have had a reasonable expectation of success to determine type of optimization based on the type of wound. Modifications to the hemostasis devices can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential injuries involved in particular anatomical regions and the types or categories of anticipated wounds. As such, modifying the hemostatic devices for anatomy and use cases would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 11, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, as set forth above, for the reasons set forth above.
In the Embodiment of FIG 20, Buckman does not expressly teach an area of the pad (100) (FIG 20, pad 310; ¶97) in the horizontal plane is 4-36 square inches.
In the Embodiment of FIG 18, Buckman teaches in the horizontal plane is 4-36 square inches (¶93). In the Embodiment of FIG 18, Buckman teaches in the horizontal plane is 4-36 square inches (¶93). Buckman’s Embodiment in FIG 18 teaches multiple examples of horizontal dimensions of the region covering the wound in a range of “0.25 inches to 10 inches or more in diameter” with specific examples of 16 square inches (4 x 4) and 25 square inches (5 x 5) (¶93).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss.
Buckman’s Embodiment in FIG 20 (¶¶97-100) teaches peripheral hemostatic device system 320 (¶97) comprising an upper and a lower arm/shell member which wraps circumferentially around the affected region. In the Embodiment of FIG 20, Buckman teaches wherein the pad (100) (FIG 20, pad 310; ¶97) has a compression plate (110) (fluid impermeable barrier 204, ¶¶97-98) and a pressure pad (120) (dam 206, ¶¶97-98).
Buckman’s Embodiment in FIG 18 teaches multiple examples of horizontal dimensions of the region covering the wound in a range of “0.25 inches to 10 inches or more in diameter” with specific examples of 16 square inches (4 x 4) and 25 square inches (5 x 5) (¶93). One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case.
One of skill in the art would clearly recognize, based on the express teachings of Buckman, in its various embodiments, that the structure of the hemostatic device can be optimized depending on the end effect desired for the use case. One of ordinary skill in the art would have had a reasonable expectation of success to determine type of optimization based on the type of wound. Modifications to the hemostasis devices can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential injuries involved in particular anatomical regions and the types or categories of anticipated wounds. As such, modifying the hemostatic devices for anatomy and use cases would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Regarding claim 13, Buckman teaches the trauma belt (1) (Abstract, Title, Apparatus for Hemostasis) of claim 1, as set forth above, for the reasons set forth above.
In the Embodiment of FIG 20, Buckman does not expressly teach wherein a distance between a lower surface of the pad (100) (FIG 20, pad 310; ¶97) attached to the top arm (70) (FIG 20, upper shell 314; ¶97) and an upper surface of the bottom arm (80) (FIG 20, lower shell 312; ¶97), is from about 6 inches to about 24 inches.
In the Embodiment of FIG 18, Buckman teaches in the horizontal plane is 4-36 square inches (¶93). Buckman’s embodiment in FIG 18 teaches multiple examples of horizontal dimensions of the region covering the wound in a range of “0.25 inches to 10 inches or more in diameter” with specific examples of 16 square inches (4 x 4) and 25 square inches (5 x 5) (¶93).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss.
Buckman’s Embodiment in FIG 20 (¶¶97-100) teaches peripheral hemostatic device system 320 (¶97) comprising an upper and a lower arm/shell member which wraps circumferentially around the affected region. In the Embodiment of FIG 20, Buckman teaches wherein the pad (100) (FIG 20, pad 310; ¶97) has a compression plate (110) (fluid impermeable barrier 204, ¶¶97-98) and a pressure pad (120) (dam 206, ¶¶97-98).
One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case. One of skill in the art would clearly recognize, based on the express teachings of Buckman, in its various embodiments, that the structure of the hemostatic device can be optimized depending on the end effect desired for the use case. One of ordinary skill in the art would have had a reasonable expectation of success to determine type of optimization based on the type of wound. Modifications to the hemostasis devices can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential injuries involved in particular anatomical regions and the types or categories of anticipated wounds. As such, modifying the hemostatic devices for anatomy and use cases would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Additionally, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Regarding claim 15, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 14, as set forth above, for the reasons set forth above, comprising a plurality of pads (230) (“over the entire surface applied to the patient” ¶74).
Buckman also teaches the Embodiment of FIG 12, comprising a plurality of pads (230) (FIG 12, ¶76).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings and suggestions of the multiple embodiments of Buckman given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Buckman provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings and suggestions with a reasonable expectation of success.
Buckman teaches different embodiments each solving known problems in the art, including hemostasis devices for patients who have received skin-penetrating wounds (Abstract). One of ordinary skill in the art would be motivated to select among the various embodiments of Buckman depending on the type of wound and the likelihood of blood loss. Buckman’s Embodiment in FIG 11 (¶¶72-75) teaches the hemostatic packing device 10 in the form of a wound dressing, PHS, or bandage (¶72). Buckman’s Embodiment in FIG 12 (¶76) teaches the hemostatic packing device 10 in the form of a wound dressing or bandage as shown in FIG 11 further comprising a plurality of dams or gaskets that aid in hemodynamic control (¶76). One would have a reasonable expectation of success in selecting from the finite embodiments taught by Buckman that are best suited for the particular end-use case.
Regarding claim 19, Buckman teaches the stretchable trauma belt (200) (FIG 11, Hemostatic packing device 10; ¶¶72-74) of claim 15, as set forth above, for the reasons set forth above.
Buckman teaches wherein each of the plurality of pads (230) (FIG 11, absorbent region 52; ¶74) are arranged side by side along the stretchable belt such that their longitudinal edges are adjacent to each other (FIG 12, ¶76).
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Kosiorek, US 20190216469 (18 July 2019) teaches junctional hemorrhage control plate apparatus systems and methods.
Dou, US 20180250016 (6 September 2018) teaches bilateral femoral artery hemostasis device by compression.
Saunders et al., US 20130296921 (7 November 2013) teaches a junctional tourniquet.
Harmon et al., US 20170049459 (23 February 2017) teaches hemorrhage control devices.
Besser et a., US 20230338193 (26 October 2023, benefit to 5 December 2022) teaches a first aid device.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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