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 .
Priority
The application is a National Stage entry of PCT/EP2023/055803 filed 7 March 2023 and claims priority to EP22305266.3 (9 March 2022). Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). A Certified Copy has been received.
Formal Matters
Claims 1-15 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 November 2024 has been considered by the examiner. A signed copy is attached.
Specification - Objection
The abstract of the disclosure is objected to because it exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“A mechanism” (in claim 1, line 14) is recited generically.
“A mechanism” is taught in the specification as “comprising a sliding assembly along the shaft” (p. 2 of 10, line 32) that is “operable by moving a second sliding ring” (p. 3 of 10, line 6) and exemplified by element 14 (p. 6 of 10, line 14).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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 1-15 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. Claim 1, line 3 recites “an inner channel” (previously annotated as 8). Claim 1, line 5 also recites “an inner channel” (previously annotated as 11), then refers to “the” inner channel” in lines 6 and 7. However, now that the annotations referencing elements 8 and 11 have been cancelled from the claim, it is unclear which “an inner channel” the “the inner channel” is referring to.Claims 2-15 are rejected as depending from a rejected claim.
In order to promote compact prosecution, the examiner will broadly interpret “an inner channel” (previously annotated as 8) as “an inner channel of the shaft” and “an inner channel (previously annotated as 11) as “an inner channel of the rib”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Erbey et al., US 20210370019 (2 December 2021, benefit to 28 May 2020).
Regarding independent claim 1, Erbey teaches a hemostatic device (FIGs 41A-C, catheter 512; ¶414) comprising:
a hollow shaft (FIGs 41A-C, catheter tube 526) extending from a first end to a second end (FIGs 41A-C), the hollow shaft (526) comprising an inner channel (FIGs 41A-C, 524) configured to be fluidically connected to a vacuum source (¶¶264, 414);
a plurality of hollow ribs (522), a first end of each hollow rib being fixed to the first end (FIGs 41A-C) of the hollow shaft (526), each hollow rib (522) comprising an inner channel (FIGs 41A-C) fluidically connected (¶414) to the inner channel (¶414) of the hollow shaft (526) and a plurality of holes (FIGs 41A-C; ports 534; ¶414) leading to the inner channel (FIGs 41A-C, shown by arrows 532) of the respective hollow rib (522).
a membrane (FIGs 41A-C, protected surface area 1000, 1001, ¶¶400-401; ¶517-518) extending between the hollow ribs (522; ¶518) and configured to be placed so as to face, at least partially (outwardly facing, inwardly facing, ¶402), a bleeding area (FIGs 41A-C, 1000, 1001; ¶400) of a natural body cavity (¶414), the plurality of holes (534; ¶414) of each hollow rib (522) being arranged so as to face the bleeding area (¶¶402, 414) to induce a negative pressure (¶264) in the natural body cavity (¶414) when a negative pressure is applied by the vacuum source (pump assembly 710, ¶520; ¶264),
the induced negative pressure (¶264) being configured so that the wall of the natural cavity (¶414) is attracted (¶¶264, 414) to the hollow ribs (522; ¶414); and
a mechanism (FIGs 41A-C, expandable cage 530; ¶414) configured to move the hollow ribs (522) relative to the hollow shaft (526) between a retracted position allowing insertion and extraction of the hemostatic device into the natural cavity (¶414) and an expanded position wherein the membrane (FIGs 41A-C, 1000, 1001; ¶279) and the hollow ribs (522) substantially fit the natural cavity (¶414).
In view of the multiple recitations of “an inner channel” that previously referred to different designated structural components prior to the cancellation of the annotations from the claims (see rejection set forth above), the examiner broadly interprets “an inner channel” (previously annotated as 8) as “an inner channel of the shaft” and an inner channel associated with the shaft (previously annotated as 11) as an inner channel associated with the rib, as broadly read in context, in order to promote compact prosecution.
The recitations of “hemostatic” in the preamble is an intended use of the device. It is well understood in patent law that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ2d at 480-81 (CCPA 1951) (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim).
Regarding the functional arrangement “so as to face the bleeding area” (claim 1, line 10), Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. See also, MPEP 2114.
Regarding claim 2, Erbey teaches the hemostatic device according to claim 1, as set forth above, wherein the membrane (FIGs 41A-C, protected surface areas 1000, 1001; ¶¶279, 518) covers the hollow ribs (522) and comprises membrane holes (¶500) placed so as to face (¶402) the holes of the hollow ribs (¶¶295, 400, 500).
Regarding claim 12, Erbey teaches the hemostatic device according to claim 1, as set forth above, wherein the holes in each hollow rib are arranged in a constant pattern (FIGs 41A-C; ¶395).
Regarding claim 13, Erbey teaches the hemostatic device according to claim 1, as set forth above, comprising at least three hollow ribs, the hollow ribs being spaced from each other by a same angle (FIGs 41A-C; ¶395).
Regarding claim 14, Erbey teaches the hemostatic device according to claim 1, as set forth above, wherein the hollow shaft (526) is made of a rigid biocompatible polymer (¶288) and the hollow ribs are made of a flexible biocompatible polymer (¶¶288, 414).
Regarding claim 15, Erbey teaches the hemostatic device according to claim 1, as set forth above, wherein the membrane (cover of cage, ¶¶517-518) is made of a waterproof fabric or of an elastomer (¶518).
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 3, 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Erbey et al., US 20210370019 (2 December 2021, benefit to 28 May 2020).
Regarding claim 3, Erbey teaches the hemostatic device according to claim 1, as set forth above.
In the base embodiment 512 (FIG 41), Erbey does not teach wherein the mechanism (FIGs 41A-C, expandable cage 530; ¶414) comprises a sliding assembly slidable along the hollow shaft the sliding assembly comprising a first sliding ring connected to a plurality of connecting rods each connecting rod being connected to a respective hollow rib so that, when the first sliding ring is slid towards the first end of the hollow shaft, the connecting rods make the hollow ribs move to the expanded position.
In the base embodiment 512 (FIG 41), Erbey teaches that cage 530, which comprises hollow ribs 522, is configured to transition from a contracted state to a deployed state (¶414), but does not teach any particular mechanism by which they expand.
However, Erbey teaches a different embodment at ¶511 (FIGs 1L and 1M). Erbey teaches a mechanism comprising a sliding assembly (FIGs 1L, 1M; slidable ring 24a/28a; ¶511) slidable along the hollow shaft (32a) the sliding assembly comprising a first sliding ring 24a connected to a plurality of connecting rods (tines, ¶511) so that, so that, when the first sliding ring 24a is slid towards the first end of the support, the connecting rods and supports move to the expanded position (¶511).
In the embodiment at ¶511, Erbey does not each connecting rod being connected to a respective hollow rib. However, Erbey teaches sheaths 20a, 22a extend between a slidable ring or collar 24a and a stationary or mounted ring or collar 28a and that sheaths 20a, 22a can also be connected by one or more rigid members, such as supports 32a. Erbey teaches that the supports 32a are positioned to provide support for the proximal sheath 20a and to prevent the distal end 30a from collapsing when it is in the deployed position. In this embodiment, Erbey provides the structure and function that demonstrates how cage 530 comprising hollow ribs 522 may be configured to transition from a contracted state to a deployed state (¶414), by using the sliding rings/collars as recited in the embodiment at ¶511 and as shown in FIGs 1L and 1M.
One of ordinary skill in the art would reasonably know and understand that the expansion mechanism in embodiment 512 may incorporate a respective hollow rib as a support, as indicated in the embodiment at ¶511 because ¶414 expressly teaches that the cage 530, which comprises hollow ribs 522, is configured to transition from a contracted state to a deployed state. One of ordinary skill in the art would also look to Erbey’s cage deployment solutions within the same reference, given the teaching of a base catheter device comprising a cage for medical treatment using negative pressure. The configuration of the slidable structure comprising rings/collars at embodiment ¶511 can be incorporated alongside Erbey’s base catheter device and expandable cage 530 using known assembly methods, including the ones taught at ¶511, without redesigning the base catheter or expandable cage. Because Erbey addresses multiple engineering problems in the same reference, using different embodiments, and the proposed modification are mechanically compatible and implemented by routine engineering practices (adding slidable rings/collars to flexible or rigid supports comprising hollow ribs 522, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 8, Erbey teaches the hemostatic device according to claim 3, as set forth above, wherein the hollow shaft (526) comprises a first stop (FIGs 1L, 1M, mounted ring 28a ¶511) configured to stop a sliding of the sliding assembly towards the first end of the hollow shaft (catheter proximal end, ¶511).
Regarding claim 9, Erbey teaches the hemostatic device according to claim 3, as set forth above, wherein the hollow shaft (526) comprises a second stop (FIGs 1L, 1M, mounted ring 28a ¶511) configured to reversibly stop a sliding of the sliding assembly towards the second end of the hollow shaft when the hollow ribs are in a maximum expanded position (¶511).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lubock, US 20050240074 (27 October 2005) teaches vacuum devices and method for treating tissue adjacent a body cavity.
Lubock, US 2004021048 (28 October 2004) teaches tissue irradiation devices.
Broderick et al., US 20170281231 (10 May 2017) teaches a medical device for insertion in uterus to aid in contracting uterus.
Rioux et al., US 20200246069 (6 August 2020) teaches minimally invasive articulating assembly having ablation capabilities.
Balasubramaniam, US 20210068865 (11 March 2021) teaches apparatuses and method for improving recovery from minimally invasive surgery.
Ott et al., US 20220354507 (11 October 2022) teaches a hemostatic device.
Urvoy, US 20250177003 (5 June 2025) teaches a hemostatic device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771