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 of group I, claims 1-18 in the reply filed on 04/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/24/2026.
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.
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(s) 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 limitation(s) is/are: feature configured to accommodate in claim 3. For examination purposes, the claim limitation is being interpreted based on [0021] of the specification as cutouts or contours and structural equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/these limitation(s) 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 § 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.
Claims 1-3, 8-11, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peartree et al. (US 20030187472 A1).
Regarding claim 1 Peartree disclose (fig. 20-24) a medical device comprising: a first handle 194 coupled to a first sheath 191 (see fig. 24 and [0121]);
a second handle (proximal portion of 146) coupled to a second sheath (distal portion of 146, see fig. 23-24), wherein at least a portion of the first sheath 191 is disposed within a lumen of the second sheath (see fig. 23-24 and [0123]); and
a patch 182 (see fig. 24 and [0122]);
wherein, in a first configuration (configuration when the patch is rolled and within 146, see [0123]), the first handle and the second handle are separated by a first distance ([0123] and fig. 22 disclose 191 is attached before the roll is inserted into the sheath, thus when it is positioned in the sheath it is separated by a first distance), and the patch is disposed between a distal portion of the first sheath and a distal portion of the second sheath (see fig. 22-23 and [0123]); and
wherein, in a second configuration (configuration when the patch is delivered from 146, as shown in fig. 23-24), the first handle and the second handle are contacting one another or are separated by a second distance (see fig. 24), wherein the second distance is smaller than the first distance ([0123] discloses that the roll, which is connected to 191, is moved through the sheath and to the other side; this movement will cause 194 to be closer to 146 than when within the sheath), and wherein a distalmost end of the second sheath is proximal of a proximal end of the patch (see fig. 23-24).
Regarding claim 2 Peartree further disclose (fig. 20-24) the first handle 194 comprises a proximal opening (see fig. 20 and [0121]) configured to receive a distal portion of a handle of an endoscope. The language “configured to receive a distal portion of a handle of an endoscope” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Peartree meets the structural limitations of the claim, and the proximal opening of the first handle is capable of receiving a distal portion of a handle of an endoscope as it is an opening that receives a syringe.
Regarding claim 3 Peartree further disclose (fig. 20-24) the first handle 194 comprises a feature (opening; see fig. 20 and [0121]) configured to accommodate a feature of an endoscope. The language “configured to accommodate a feature of an endoscope” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Peartree meets the structural limitations of the claim, and the proximal opening of the first handle is capable of accommodating a feature of an endoscope as it is an opening that receives a syringe.
Regarding claim 8 Peartree further disclose (fig. 20-24) a distal portion of the first sheath 191 includes a balloon 186 coupled to an external surface of the first sheath (see fig. 20, 24, and [0121]).
Regarding claim 9 Peartree further disclose (fig. 20-24) in the first configuration, the balloon is disposed between the first sheath 191 and the patch 182 (see fig. 22, the roll is positioned within 146 in the first configuration).
Regarding claim 10 Peartree further disclose (fig. 20-24) in a third configuration (configuration of fig, 24), the balloon 186 is inflated and the patch 182 is disposed on the inflated balloon (see fig. 24 and [0123]).
Regarding claim 11 Peartree further disclose (fig. 20-24) in a fourth configuration, the balloon 186 and the patch 182 are separated (configuration when the balloon is withdrawn, see [0123]).
Regarding claim 16 Peartree disclose (fig. 20-24) a medical device comprising: a first sheath 191 (see fig. 24 and [0121]);
a second sheath (distal portion of 146, see fig. 23-24), wherein the first sheath 191 is disposed within a lumen of the second sheath (see fig. 23-24 and [0123]); and
a balloon 186 (see fig. 20 and [0121]);
a patch 182 (see fig. 24 and [0122]);
wherein, in at least one configuration of the medical device (configuration when the patch is rolled and within 146, see [0123]), at least a portion of the patch 182 is disposed between the second sheath (distal portion of 146) and at least a portion of the balloon 186, and at least a portion of the balloon 186 is disposed between at least a portion of the patch 182 and the first sheath 191 (see fig. 22-23, the roll is positioned within 146 in the first configuration).
Regarding claim 18 Peartree further disclose (fig. 20-24) the at least one configuration is a first configuration and wherein, in a second configuration (configuration of fig. 24), the second sheath is retracted relative to the first sheath and the balloon is inflated (see fig. 24 and [0123]).
The language “the second sheath is retracted relative to the first sheath” constitutes intended use/ functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Peartree meets the structural limitations of the claim, and the second sheath is capable of being retracted relative to the first sheath as the second sheath is moveable relative to the first sheath.
Claims 1, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tovey et al. (US 5,370,650).
Regarding claim 1 Tovey discloses (fig. 1-3) a medical device comprising:
a first handle 11 coupled to a first sheath 19 (see col. 4 ln. 26-39);
a second handle 23 coupled to a second sheath 12, wherein at least a portion of the first sheath is disposed within a lumen of the second sheath 12 (see fig. 2-3 and col. 4 ln. 26-52); and
a patch 20 (see fig. and col. 5 ln. 30-38);
wherein, in a first configuration (configuration of fig. 2), the first handle 11 and the second handle 23 are separated by a first distance (see fig. 2), and the patch 20 is disposed between a distal portion of the first sheath 19 and a distal portion of the second sheath 12 (see fig. 2); and
wherein, in a second configuration (configuration of fig, 3), the first handle 11 and the second handle 23 are contacting one another or are separated by a second distance, wherein the second distance is smaller than the first distance (see fig. 3 and col. 4 ln. 26-52), and wherein a distalmost end of the second sheath 12 is proximal of a proximal end of the patch 20 (see fig. 3).
Regarding claim 4 Tovey further discloses (fig. 1-3) the patch 20 comprises at least one pull line 14 (see fig. 3 and col. 5 ln. 30-38).
Regarding claim 6 Tovey further discloses (fig. 1-3) each of the at least one pull lines 14 terminates in two free ends extending from a same edge of the patch 20 (see fig. 3).
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.
Claims 4, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Peartree in view of Bates (US 20110152897 A1).
Regarding claims 4, 5, and 17, Peartree discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 16. Peartree is silent regarding the patch comprises at least one pull line; the at least one pull line is arranged within a perimeter of the patch and conforming to a shape of the perimeter of the patch.
However Bates, in the same field of endeavor, teaches (fig. 1) a patch 30 comprising at least one pull line 32; the at least one pull line 32 is arranged within a perimeter of the patch 30 and conforming to a shape of the perimeter of the patch 30 (see fig. 1 and [0026]-[0027]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Peartree to have the patch comprises at least one pull line; the at least one pull line is arranged within a perimeter of the patch and conforming to a shape of the perimeter of the patch as taught by Bates, for the purpose of being able to retrieve the patch from inside the body (see Bates [0027]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tovey in view of Levin et al. (US 20110054500 A1).
Regarding claim 7, Tovey discloses the claimed invention substantially as claimed, as set forth above for claim 1. Tovey is silent regarding the first handle comprises an actuator configured to move at least one pull line in a proximal direction.
However Levin, in the same filed of endeavor, teaches a first handle 102 that comprises an actuator 1001 configured to move at least one pull line 112 in a proximal direction (see [0256]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Peartree to have the first handle comprises an actuator configured to move at least one pull line in a proximal direction as taught by Levin, for the purpose of being able actuate clips to attach the device to tissue (see Levin [0213]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Peartree in view of Levy (US 20120065674 A1).
Regarding claim 12, Peartree discloses the claimed invention substantially as claimed, as set forth above for claim 1. Peartree is silent regarding the patch includes an adhesive on a side of the patch facing away from the first sheath.
However Levy, in the same filed of endeavor, teaches (fig. 1A) a patch 18 includes an adhesive 20 on a side of the patch facing away from a first sheath 14 (see fig. 1A and [0031]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Peartree to have the patch includes an adhesive on a side of the patch facing away from the first sheath as taught by Levy, for the purpose of being able to attach the patch to the tissue for a more secure delivery (see Levy [0032]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Peartree in view of Smith et al. (US 20200038005 A1).
Regarding claim 13, Peartree discloses the claimed invention substantially as claimed, as set forth above for claim 1. Peartree is silent regarding the patch is exposed to a liquid via a fluid channel.
However Smith, in the same filed of endeavor, teaches (fig. 3A-3D) a patch 820 is exposed to a liquid via a fluid channel (see [0049]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Peartree to have the patch is exposed to a liquid via a fluid channel as taught by Smith, for the purpose of being able to further expand the patch upon contact with fluid (see Levy [0032]).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Peartree in view of Kieturakis et al. (US 5,730,756)
Regarding claims 14 and 15, Peartree discloses the claimed invention substantially as claimed, as set forth above for claims 2 and 1. Peartree is silent regarding the medical device is removably coupled to the endoscope by means of one or more fasteners, adhesives, or a friction fit; the first sheath comprises a lumen to receive a shaft of an endoscope.
However Kieturakis, in the same filed of endeavor, teaches (fig. 75-82) a first sheath 851 on which a balloon 855 is attached, wherein the first sheath 851 comprises a lumen to receive a shaft 870 of an endoscope (see col. 37 ln. 36 – col. 38 ln. 16); the first sheath 851 has a first handle 652; the medical device is removably coupled to the endoscope 870 by a friction fit (formed by seal 854, see fig. 82 and col. 38 ln. 53-62).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Peartree to have the first sheath comprises a lumen to receive a shaft of an endoscope and to have the medical device removably coupled to the endoscope by a friction fit as taught by Kieturakis, for the purpose of being able to visualize images of the distal end of the device to improve treatment routing and placement (see Kieturakis col. 37 ln. 36 – col. 38 ln. 16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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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 H SCHWIKER/Primary Examiner, Art Unit 3771
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