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/Restrictions
Applicant’s election without traverse of Group I, claims 1-17, in the reply filed on 9/1/2026 is acknowledged. Claims 18-20 are withdrawn.
Effective Filing Date
The instant application, filed 8/8/2024, is a continuation of PCT/US2023/013505, filed 2/21/2023, which claims priority to U.S. Provisional Application 63/268,322, filed 2/22/2022. Claims 9-17 are directed to subject matter that was introduced for the first time in PCT/US2023/013505, filed 2/21/2023. The earlier provisional application did not provide support for the features of a reservoir being external to the housing. This is instead shown in Fig. 10 in PCT/US2023/013505. The earliest disclosure for the subject matter of claims 9-17 and thus the effective filing date for the subject matter of is 2/21/2023. Claims 1-8 are given the earlier benefit of an effective filing date of 2/22/2022.
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.
Claim 7 is 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 7 recites the limitation "a second channel" in line 2. There is insufficient antecedent basis for this limitation in the claim. The term “second” would imply the presence of a first channel. However, no such first channel has been defined in claim 7 nor its parent claims. Instead, a first channel is introduced in claim 4, from which claim 7 is not dependent upon. Therefore, it is unclear how many channels are required by claim 7.
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(s) 1, 2, 4, 5, 9-14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnault et al (US 2009/0182405).
Arnault et al discloses the following limitations:
Claim 1. A delivery apparatus (Figs. 17-20) comprising:
a handle (404);
a shaft (416) extending within and distally from the handle and having a main lumen (424) (Figs. 17, 20A; [0132]); and
a reservoir (440) fluidly coupled to the main lumen, wherein the reservoir is filled with fluid and has an adjustable fluid volume (the reservoir is a syringe with a plunger, which adjusts the fluid reservoir volume when the plunger moves downward), and wherein the reservoir is configured to passively supply fluid to the main lumen based on a fluid pressure in the main lumen (Applicant discloses the invention involves fluid passively flowing into the main lumen due to a vacuum or negative pressure in the main lumen, and not due to a user actively pushing fluid from the reservoir (see [0157] of the application publication). This negative pressure can pull the plunger of a syringe barrel further into the barrel, causing fluid to exit the reservoir ([0153]-[0156]). Therefore, since the device of Arnault et al is a syringe with a plunger coupled to a main lumen, the presence of a negative pressure would similarly cause the fluid to be pulled downward into the main lumen passively. Applicant’s direction is MPEP 2112.01, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the device of Arnault et al is capable of passively supplying to the main lumen based on a fluid pressure in the main lumen since there is no structure in the device of Arnault et al that would prevent the fluid from entering the main lumen when there is enough of a pressure differential in the main lumen.
Claim 2. The delivery apparatus of claim 1, wherein the handle further comprises a flush port (438) coupled to a housing (442) of the handle, and wherein the flush port is fluidly coupled to the reservoir ([0132]; Figs. 17, 20A).
Claim 4. The delivery apparatus of claim 1, wherein the main lumen is fluidly coupled to the reservoir by a first channel (438) (Fig. 20A) disposed within the handle, and wherein the reservoir comprises a movable wall (plunger of syringe 440 in Fig. 17) that is configured to conform to the adjustable fluid volume and move inward (seen by arrows in Fig. 17) as fluid within the reservoir is transferred to the main lumen via the first channel and the fluid volume decreases.
Claim 5. Under an alternative interpretation of the reservoir, Arnault et al discloses a delivery apparatus (Figs. 17-20) comprising:
a handle (404);
a shaft (416) extending within and distally from the handle and having a main lumen (424) (Figs. 17, 20A; [0132]); and
a reservoir (438) (wherein the broadest reasonable definition of the term includes a chamber inside a tool that holds fluid, as seen in Fig. 20A, reference number 438 is a chamber inside housing 442 of handle 404 that can hold fluid as fluid is delivered into the main lumen) fluidly coupled to the main lumen, wherein the reservoir is filled with fluid and has an adjustable fluid volume (the reservoir is filled with fluid when fluid enters therein from syringe 440, and the amount of fluid will decrease when fluid is emptied from the syringe and therefore is considered an adjustable volume), and wherein the reservoir is configured to passively supply fluid to the main lumen based on a fluid pressure in the main lumen (Applicant discloses the invention substantially as claimed above, may involve fluid passively flowing into the main lumen due to a vacuum or negative pressure in the main lumen, and not due to a user actively pushing fluid from the reservoir (see [0157] of the application publication). This negative pressure can pull the plunger of a syringe barrel further into the barrel, causing fluid to exit the reservoir ([0153]-[0156]). Therefore, since the device of Arnault et al is a syringe with a plunger coupled to a main lumen, the presence of a negative pressure would similarly cause the fluid to be pulled downward into the main lumen passively. Applicant’s direction is MPEP 2112.01, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the device of Arnault et al is capable of passively supplying to the main lumen based on a fluid pressure in the main lumen since there is no structure in the device of Arnault et al that would prevent the fluid from entering the main lumen when there is enough of a pressure differential in the main lumen), wherein the handle comprises a housing (442) and the reservoir (438) is disposed internal to the housing (Fig. 20A).
Claim 9. The delivery apparatus of claim 1, wherein the handle comprises a housing (436) and the reservoir (440) is disposed external to the housing (Fig. 17; [0132]).
Claim 10. The delivery apparatus of claim 9, wherein the reservoir is fluidly coupled to a flush port (438) that is coupled to the housing (Fig. 20A), and wherein the flush port is fluidly coupled to the main lumen by a flush lumen (see annotated figure below) that extends through an adaptor spine (442) of the handle.
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Claim 11. The delivery apparatus of claim 9, wherein the reservoir comprises a barrel (syringe 440) and a movable wall (plunger of syringe seen in Fig. 17) disposed within the barrel, the barrel and the movable wall defining an internal cavity (inside of syringe) which contains the fluid therein, and wherein the movable wall is capable of moving inward (see arrows in Fig. 17) as fluid within the reservoir is transferred to the main lumen and the fluid volume decreases responsive to the fluid pressure in the main lumen being negative.
Claim 12. A guide sheath (Figs. 17-20) comprising:
a handle comprising:
a housing (436); and
a flush port (438) coupled to the housing;
a reservoir (440) fluidly coupled to the flush port and disposed external to the housing, wherein the reservoir is filled with fluid and has an adjustable volume (the reservoir is a syringe with a plunger, which adjusts the fluid reservoir volume when the plunger moves downward) (Fig. 17; [0132]); and
a shaft (416) extending within and distally from the handle (Figs. 17, 20A) and having a main lumen (424) that extends within the housing, wherein the main lumen is fluidly coupled to the reservoir by the flush port ([0132]), and wherein the reservoir is configured to passively supply fluid to the main lumen based on a fluid pressure in the main lumen (Applicant discloses the invention substantially as claimed above, involves fluid passively flowing into the main lumen due to a vacuum or negative pressure in the main lumen, and not due to a user actively pushing fluid from the reservoir (see [0157] of the application publication). This negative pressure can pull the plunger of a syringe barrel further into the barrel, causing fluid to exit the reservoir ([0153]-[0156]). Therefore, since the device of Arnault et al is a syringe with a plunger coupled to a main lumen, the presence of a negative pressure would similarly cause the fluid to be pulled downward into the main lumen passively. Applicant’s direction is MPEP 2112.01, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the device of Arnault et al is capable of passively supplying to the main lumen based on a fluid pressure in the main lumen since there is no structure in the device of Arnault et al that would prevent the fluid from entering the main lumen when there is enough of a pressure differential in the main lumen.
Claim 13. The guide sheath of claim 12, wherein the handle further comprises a seal housing assembly (442) including one or more fluid seals (444) (Fig. 20; [0132]).
Claim 14. The guide sheath of claim 13, wherein the shaft (416) extends through the seal housing assembly (Fig. 20A).
Claim 16. The guide sheath of claim 12, wherein the reservoir comprises a barrel (barrel of syringe 440) and a movable wall (plunger of syringe 440 seen in Fig. 17) disposed within the barrel, the barrel and the movable wall defining an internal cavity which contains the fluid therein (Fig. 17; [0132]).
Claim 17. The guide sheath of claim 16, wherein the movable wall is capable of moving inward (arrows in Fig. 17), toward the flush port, as fluid is pulled passively from the reservoir into the main lumen and the volume of fluid in the reservoir decreases responsive to a negative pressure in the main lumen.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnault et al in view of Lostetter et al (US 2017/0281382).
Claim 3. Arnault et al discloses the invention substantially as claimed above, but fails to disclose the handle further comprises a seal housing assembly including one or more fluid seals, and wherein the flush port is disposed distal and adjacent to the seal housing assembly.
However, in a similar field of endeavor of delivery apparatuses for implantable medical devices, Lostetter et al teaches a delivery apparatus comprising a handle assembly (Fig. 3 profile is graspable by hand) having a seal housing assembly (46) including one or more fluid seals (60), wherein the flush port (48) is disposed distal and adjacent to the seal housing assembly (Fig. 3), the seal (60) forms a seal about a guidewire of a lumen of an inner shaft (26) (akin to the shaft 416 of Arnault et al having a main lumen 424 for accommodating a guidewire). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Arnault et al with the handle further comprising a seal housing assembly including one or more fluid seals, and wherein the flush port is disposed distal and adjacent to the seal housing assembly to provide a hemostatic seal around any element that is inserted into the main lumen of the shaft ([0036]).
Claims 13 and 15. Under an alternative interpretation of Arnault et al for claim 13, Arnault et al discloses the invention substantially as claimed above, but fails to disclose the handle further comprises a seal housing assembly including one or more fluid seals, wherein the flush port is coupled to the housing distal to the seal housing assembly.
However, in a similar field of endeavor of delivery apparatuses for implantable medical devices, Lostetter et al teaches a delivery apparatus comprising a handle assembly (Fig. 3 profile is graspable by hand) having a seal housing assembly (46) including one or more fluid seals (60), wherein the flush port (48) is disposed distal and adjacent to the seal housing assembly (Fig. 3), the seal (60) forms a seal about a guidewire of a lumen of an inner shaft (26) (akin to the shaft 416 of Arnault et al having a main lumen 424 for accommodating a guidewire). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Arnault et al with the handle further comprising a seal housing assembly including one or more fluid seals, and wherein the flush port is disposed distal and adjacent to the seal housing assembly to provide a hemostatic seal around any element that is inserted into the main lumen of the shaft ([0036]).
Allowable Subject Matter
Claims 6 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record, Arnault et al, discloses the invention substantially as claimed above.
In regard to claim 6, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed delivery apparatus comprising, inter alia,
a wall of the reservoir comprises a flexible material, and wherein the reservoir is configured to compress as its fluid volume reduces. Instead, the wall of the cited reservoir in Arnault et al is a hard surface of handle portion 442.
In regard to claim 8, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed delivery apparatus comprising, inter alia,
the reservoir is annular and extends axially along a portion of the handle, and wherein the reservoir is disposed radially outward of the shaft, relative to a central longitudinal axis of the delivery apparatus.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Malhi et al (US 2013/0267891) explicitly discloses fluid (saline) that is passively drawn into a main lumen (32) of a shaft by negative pressure created in the vessel lumen ([0068]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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