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 with traverse of Species B, claims 1-7, 10-16 and 18-20, in the reply filed on 2/18/2026 is acknowledged. The traversal is on the ground(s) that nothing in the application as-filed states or implies that the different asserted species are not capable of being used together. This is not found persuasive because the coupler 502 of Species A, Fig. 5, is a toolless magnetized male feature that couples with an opposing magnetized female feature ([0073]; claims 8-9), the coupler of Species B, Figs. 6A-6D, is an elastic sleeve 604 with an outer surface affixed to an imaging shaft ([0079]; claims 2-6), and the coupled of Species C, Fig. 7, is an elastic sleeve with an inner surface affixed to an imaging shaft ([0085]). It is clear that an elastic sleeve cannot be both affixed to an outer surface and of an imaging device with its outer surface and its inner surface. Only one at a time can be true. Therefore, Species B and C are mutually exclusive. Similarly, a coupler cannot be both an elastic sleeve and a toolless magnetized male feature. Accordingly, Species A, B, and C are mutually exclusive. Further, applicant has provided no evidence in the specification i.e., no figures or recitations that these different embodiments are usable together.
Applicant further argues there is no objective evidence of record that the asserted species have different search classifications, as asserted, or would use different search terminology. This argument is not found persuasive. The elected claims 1-7 and 10-20 require the following text search for different limitations in which none of the following terms/concepts (or their reasonable synonyms) would be searched for the non-elected claims 8-9: “elastic”, “sleeve”, “expand”, “gripped”, “tapered”, “hydrophilic”, “imaging window”. Claims 8-9 require searches for words along the lines of: “toolless”, “magnetization”, “complementary coupling feature”, “polarity”, “attracted” which are not required by Species B or C claimed. Claim 17 requires searches for “affixed” and “lumen” which are not required by Species A or B. Therefore, this clearly demonstrates the existence of a serious burden of search. Moreover, petitioner’s arguments regarding art found in one search area can be applied to all the groups of claims may have been overly simplified. It must be noted that eh search for the claimed species are totally different. It is additionally pointed out that contrary to what petitioner suggested, the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive. The searches of the different species are indeed different and burdensome.
Claims 8-9 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/18/2026. It is noted applicant states claims 1-8 and 10-20 are readable on the elected species. The examiner respectfully disagrees and finds claim 8 to read on Species A, Fig. 5 due to the at least one coupler including a toolless coupling feature which is described with respect to Fig. 5 in paragraph [0072]. The examiner further finds claim 17 to read on Species C, Fig. 7 due to the elongated shaft assembly passing through and affixed to the sleeve lumen of the elastic sleeve. Accordingly, claims 8-9 and 17have been withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 recites “an interventional medical device” in line 5 which should read “the interventional medical device”. Appropriate correction is required.
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.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20 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 19 recites the limitation “an elongate shaft assembly” in lines 2 and 6. It is unclear if the elongate shaft assembly of line 6 is intended to be the same or in addition to that of line 2. For the purposes of examination, the two are interpreted as the same elongate shaft assembly.
Claim 20 recites the limitation “an elastic sleeve, attached to the elongate shaft assembly”. Claim 20 depends from claim 19 which recites “coupling means for receiving an interventional medical device for coupling into alignment with an elongate shaft assembly”. According to the 112(f) interpretation the “coupling means” is the elastic sleeve which stabilizes or secures an interventional device or the instrument inserted therethrough ([0080]). Therefore, it is unclear if the elastic sleeve is the same coupling means of claim 19 or in addition thereto. For the purposes of examination, the two are interpreted as the same elastic sleeve. Similarly, claim 20 recites “an introducer sheath” and claim 19 recites “means for deploying the interventional medical device”. According to the 112(f) interpretation the “means for deploying” is the introducer sheath. Therefore, it is unclear if the introducer sheath is the same means for of claim 19 or in addition thereto. For the purposes of examination, the two are interpreted as the same introducer sheath.
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) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerbi et al. (US 2007/0249939 A1).
Regarding claim 1, Gerbi discloses an imaging catheter apparatus (delivery system 10; Figs. 1A-1B) comprising: an elongate shaft assembly (shaft 16) having a tube (as shaft 16 is a tube; Fig. 1B) defining an internal tubular passage (axial passage 22; [0033]; Fig. 7) with a hermetically sealed distal end (due at least to the viewing surface 42 and compliant layer disposed between the viewing windows 36, 42 of the ultrasound insert 28 and the shaft 16, wherein the inner cavity 22 may be filled with a fluid; thus, the distal end of the shaft 16 is hermetically sealed or the fluid would leak out of the shaft; [0036]), the elongate shaft assembly (16) configured to carry an imaging transducer (ultrasound imaging insert 28, which carries transducer 12) such that the imaging transducer is locatable and translatable within the internal tubular passage of the elongate shaft assembly of the imaging catheter apparatus (as ultrasound imaging insert 28 is removably and replaceably disposed within the axial passage 22 of the shaft 16 i.e., translatable therein; [0033]; and/or the shaft 16 provides for axial and/or rotational orientation of the insert 28; [0036]; [0044]); and at least one coupler (needle guide 44), attached to the elongate shaft assembly (16; Fig. 1B), the at least one coupler (44) configured to permit an end user to at least one of couple or attach at least one of a guidewire or an interventional medical device (ablation/infusion needle 14) to the elongate shaft assembly via the at least one coupler (Fig. 1B).
Regarding claim 7, Gerbi discloses wherein the elongate shaft (16) includes one of an intravascular ultrasound (IVUS) transducer, an optical coherence tomography (OCT) transducer, or other imaging modality transducer (as the imaging transducer 12 is an ultrasound transducer; [0034]).
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) 2-4, 6, 10, 12-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerbi et al. (US 2007/0249939 A1) in view of Owens et al. (US 2019/0350648 A1).
Regarding claim 2, Gerbi discloses wherein the at least one coupler (44) includes a sleeve (Fig. 1B), included in or attached to the elongate shaft assembly (Fig. 1B), the sleeve including a sleeve lumen (lumen of 44), but fails to disclose the sleeve being elastic and the sleeve lumen including an inner diameter configured to expand.
However, Owens teaches an imaging catheter apparatus (imaging component 100; Fig. 1A) comprising: an elongate shaft assembly (imaging shaft 103) that is configured to carry an imaging transducer (imaging transducer 107); at least one coupler (tube 115; Figs. 1B, 2B), attached to the elongate shaft assembly (Figs. 1B, 2B), the at least one coupler configured to permit an end user to at least one of couple or attach at least one of a guidewire an interventional medical device (first and/or second instrument) to the elongate shaft assembly via the at least one coupler (Fig. 2B), wherein the at least one coupler includes an elastic sleeve (tube 115 made of a material comprising elasticity; [0095]) attached to the elongated shaft assembly of the imaging catheter apparatus, the elastic sleeve including a sleeve lumen (Fig. 1B), the sleeve lumen including an inner diameter configured to expand (as the tube 115 has sufficient elasticity in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube; therefore, gripping around the instrument; [0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve of Gerbi to be elastic such that it expands to grip the interventional medical device as taught by Owens in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube.
Regarding claim 3, modified Gerbi discloses wherein the inner diameter of the sleeve lumen (sleeve 44 of Gerbi modified by elastic sleeve 115 of Owens) is configured to expand upon receiving an introducer sheath (as a second tube may be removably inserted into the first tube 115 to aid in the insertion of the one or more plurality of instruments; [0094] of Owens), the introducer sheath configured to receive the interventional medical device ([0094] of Owens), the introducer sheath configured to be removeable such that the interventional medical device remains within and is gripped by the sleeve lumen of the elastic sleeve (because the second tube is manually inserted into the first tube 115, it is also capable of being manually removed from the first tube 115; [0094] of Owens).
Regarding claim 4, modified Gerbi fails to disclose wherein at least one of a distal end portion or a proximal end portion of the elastic sleeve is tapered to present a smaller cross-sectional profile than at a center region of the elastic sleeve.
However, Owens teaches that the cavity (105) of the shaft (103) may include a cross-sectional area that narrows in diameter to allow greater flexibility of the distal end of the shaft (i.e. a smaller cross-sectional profile at the distal end of the shaft; [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elastic sleeve of modified Gerbi to have a tapered distal end portion to present a smaller cross-sectional profile than at a center region of the elastic sleeve in light of the teachings of Owens in order to allow the distal end of the elastic sleeve to have greater flexibility when it is extended out past the cavity of the elongate shaft assembly.
Regarding claim 6, modified Gerbi discloses wherein the elastic sleeve (modified 44 of Gerbi) includes an imaging window (transparent viewing surface 42) that more easily passes imaging energy than another portion of the elastic sleeve (wherein the transparent viewing surface 42 more easily passes imaging energy than the side walls of the sleeve 44).
Regarding claim 10, Gerbi discloses an imaging catheter apparatus (delivery system 10; Figs. 1A-1B) comprising: an elongate shaft assembly (shaft 16) having a tube (as shaft 16 is a tube; Fig. 1B) defining an internal tubular passage (axial passage 22; [0033]; Fig. 7) with a hermetically sealed distal end (due at least to the viewing surface 42 and compliant layer disposed between the viewing windows 36, 42 of the ultrasound insert 28 and the shaft 16, wherein the inner cavity 22 may be filled with a fluid; thus, the distal end of the shaft 16 is hermetically sealed or the fluid would leak out of the shaft; [0036]), the elongate shaft assembly (16) configured to carry an imaging transducer (ultrasound imaging insert 28, which carries transducer 12) such that the imaging transducer is locatable and translatable within the internal tubular passage of the elongate shaft assembly of the imaging catheter apparatus (as ultrasound imaging insert 28 is removably and replaceably disposed within the axial passage 22 of the shaft 16 i.e., translatable therein; [0033]; and/or the shaft 16 provides for axial and/or rotational orientation of the insert 28; [0036]; [0044]); and at least one coupler (needle guide 44), attached to the elongate shaft assembly (16; Fig. 1B), the at least one coupler (44) configured to permit an end user to at least one of couple or attach at least one of a guidewire or an interventional medical device (ablation/infusion needle 14) to the elongate shaft assembly via the at least one coupler (Fig. 1B), wherein the at least one coupler (44) includes a sleeve (Fig. 1B), included in or attached to the elongate shaft assembly (Fig. 1B), the sleeve including a sleeve lumen (lumen of 44) extending longitudinally through the sleeve.
Gerbi fails to disclose the sleeve being elastic and the sleeve lumen including an inner diameter that is expandable.
However, Owens teaches an imaging catheter apparatus (imaging component 100; Fig. 1A) comprising: an elongate shaft assembly (imaging shaft 103) that is configured to carry an imaging transducer (imaging transducer 107); at least one coupler (tube 115; Figs. 1B, 2B), attached to the elongate shaft assembly (Figs. 1B, 2B), the at least one coupler configured to permit an end user to at least one of couple or attach at least one of a guidewire an interventional medical device (first and/or second instrument) to the elongate shaft assembly via the at least one coupler (Fig. 2B), wherein the at least one coupler includes an elastic sleeve (tube 115 made of a material comprising elasticity; [0095]) attached to the elongated shaft assembly of the imaging catheter apparatus, the elastic sleeve including a sleeve lumen (Fig. 1B), the sleeve lumen including an inner diameter configured to expand (as the tube 115 has sufficient elasticity in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube; therefore, gripping around the instrument; [0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve of Gerbi to be elastic such that it expands to grip the interventional medical device as taught by Owens in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube.
Regarding claim 12, modified Gerbi fails to disclose wherein at least one of a distal end portion or a proximal end portion of the elastic sleeve is tapered to present a smaller cross-sectional profile than at a center region of the elastic sleeve.
However, Owens teaches that the cavity (105) of the shaft (103) may include a cross-sectional area that narrows in diameter to allow greater flexibility of the distal end of the shaft (i.e. a smaller cross-sectional profile at the distal end of the shaft; [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elastic sleeve of modified Gerbi to have a tapered distal end portion to present a smaller cross-sectional profile than at a center region of the elastic sleeve in light of the teachings of Owens in order to allow the distal end of the elastic sleeve to have greater flexibility when it is extended out past the cavity of the elongate shaft assembly.
Regarding claims 13-14, modified Gerbi discloses using the elastic sleeve (44 of Gerbi modified), wherein the elastic sleeve defines a longitudinal sleeve lumen (lumen through modified 44) extending longitudinally through the elastic sleeve (Fig. 1B), wherein the sleeve lumen is sized and shaped to slidably receive one or more of a plurality of instruments (Fig. 1B), the sleeve lumen having an inner diameter from about 0.5 mm to about 2 mm and/or about 1 mm to about 3 mm ([0041]). All of these diameters are sized and shaped to allow insertion and free passage of a 0.35 mm outer diameter guidewire therethrough and include a “resting” inner diameter of about 0.5 mm.
Regarding claim 15, modified Gerbi wherein the sleeve (44 of Gerbi modified) can have a length in a range from about 20 cm to about 40 cm ([0041]), which lies within the claimed range of 0.3 cm and 50 cm.
Regarding claim 16, modified Gerbi wherein a distal end of the elastic sleeve (44 of modified Gerbi) is proximally offset from a distal end of the elongate shaft (16; as the shaft includes distal deflectable tip 26 and the sleeve 44 is proximal to portion 26; Fig. 1B), but fails to explicitly disclose the offset being at least 1 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the offset of modified Gerbi to be at least 1 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the elastic sleeve of Owens would not operate differently with the claimed offset since the elastic sleeve is intended to be proximal of the distal end of the elongate shaft assembly to allow the distal most portion to pivot in order to image tissue and the device would function appropriately having the claimed offset. Further, Applicant places no criticality on the range claimed, indicating the offset is “at least” 1 mm without a limiting upper range.
Regarding claims 19-20, Gerbi discloses an imaging catheter apparatus (delivery system 10; Figs. 1A-1B) comprising: an elongate shaft assembly (shaft 16) having a tube (as shaft 16 is a tube; Fig. 1B), for carrying an imaging transducer (ultrasound imaging insert 28, which carries transducer 12), the elongate shaft assembly (16) having a tube (16) defining an internal tubular passage (axial passage 22; [0033]; Fig. 7) with a hermetically sealed distal end (due at least to the viewing surface 42 and compliant layer disposed between the viewing windows 36, 42 of the ultrasound insert 28 and the shaft 16, wherein the inner cavity 22 may be filled with a fluid; thus, the distal end of the shaft 16 is hermetically sealed or the fluid would leak out of the shaft; [0036]); at least one coupler/sleeve (needle guide 44) for receiving an interventional medical device (needle 14) for coupling into alignment with the elongate shaft assembly (Fig. 1B); the interventional medical device for performing a medical procedure at a target location using information obtained from an image of the target location obtained using the imaging transducer ([0044]-[0045]).
Gerbi fails to disclose a coupling means (interpreted under 112(f) as an elastic sleeve and equivalents thereof; [0080]) for receiving an interventional medical device for coupling into alignment with an elongate shaft assembly; and means for deploying (interpreted under 112(f) as an introducer sheath and equivalents thereof; [0081]) the interventional medical device, the means for deploying comprising an introducer sheath insertable into the coupling means comprising an elastic sleeve, attached to the elongate shaft assembly, to expand an inner diameter of a sleeve lumen of the elastic sleeve.
However, Owens teaches an imaging catheter apparatus (imaging component 100; Fig. 1A) comprising: an elongate shaft assembly (imaging shaft 103) that is configured to carry an imaging transducer (imaging transducer 107); at least one coupler (tube 115; Figs. 1B, 2B), attached to the elongate shaft assembly (Figs. 1B, 2B), the at least one coupler configured to permit an end user to at least one of couple or attach at least one of a guidewire an interventional medical device (first and/or second instrument) to the elongate shaft assembly via the at least one coupler (Fig. 2B), wherein the at least one coupler includes an elastic sleeve (tube 115 made of a material comprising elasticity; [0095]) attached to the elongated shaft assembly of the imaging catheter apparatus, the elastic sleeve including a sleeve lumen (Fig. 1B), the sleeve lumen including an inner diameter configured to expand (as the tube 115 has sufficient elasticity in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube; therefore, gripping around the instrument; [0095]). Owens discloses wherein the inner diameter of the sleeve is configured to expand upon receiving an introducer sheath (as a second tube may be removably inserted into the first tube 115 to aid in the insertion of the one or more plurality of instruments; [0094]), the introducer sheath configured to receive the interventional medical device for the purpose of aiding in the insertion of one or more of a plurality of instruments ([0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupler/sleeve of Gerbi to be elastic such that it expands to grip the interventional medical device as taught by Owens in order to adapt to an instrument of a size somewhat larger than the perimeter of the tube.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupler/sleeve of modified Gerbi to include the second tube/introducer sheath as taught by Owens in order to aid in the insertion of one or more of the plurality of instruments.
4. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerbi et al. (US 2007/0249939 A1) in view of Owens et al. (US 2019/0350648 A1), as applied to claim 2 above, and further in view of in view of McCaffrey et al. (US 2020/0129196 A1).
Regarding claim 5, modified Gerbi fails to explicitly disclose an inner surface of the elastic sleeve includes a hydrophilic coating.
However, McCaffrey teaches the interior surface of a delivery sheath (130) may include lubricating coating, such as a hydrophilic coating, to help slidably advance a distal portion (96) of a medical device (94) within the inner lumen of the delivery sheath (130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner surface of the elastic sleeve of modified Gerbi to be a hydrophilic coating as taught by McCaffrey as a hydrophilic coating is a type of lubricant which would help slidably advance medical instruments therethrough.
Allowable Subject Matter
Claims 11 and 18 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 Gerbi et al. (US 2007/0249939 A1), Owens et al. (US 2019/0350648 A1) and Mann et al. (US 2005/0136385 A1) fails to disclose the limitations of claim 11. For example, a peel-away introducer sheath, sized and shaped to be inserted into the sleeve lumen while expanding the inner diameter of the sleeve lumen, the peel-away introducer sheath configured to receive the interventional medical device, the peel-away introducer sheath configured to be removeable such that an interventional medical device remains within and is gripped by the sleeve lumen.
Gerbi is silent to any additional sleeves being inserted into guide 44 and peel-away sheaths.
Owens discloses a second tube may be inserted into the elastic sleeve (first tube 115), the second tube having a different inner lumen geometry than the first, thereby aiding in the insertion of one or more of a plurality of instruments ([0094]), but fails to disclose the second tube being a peel-away introducer sheath stretching or expanding the elastic sleeve or first tube.
Mann teaches peel-away sheaths are well known in the art ([0121]), but the peel-away sheath (67) is not inserted into an elastic sleeve to expand the elastic sleeve and hold another medical device therein. It would not have been obvious to insert a peel-away sheath introducer into the elastic sleeve of Owens to expand or stretch the sleeve lumen without additional teachings in the art because the stretched or expanded elastic sleeve would hinder peeling away the peel-away sheath introducer therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771