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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the angle between the retractor surface portion and the distal end axis of claims 1 - 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Examiner’s Note
Claims 7 recites the term “and/or”. This is determined to be definite since the claim covers the follow defined options:
The retractor head is configured to form an acute angle with the foil.
The attachment structure is configured to form an acute angle with the foil.
Both the retractor head and attachment structure are configured to form an acute angle with the foil.
Claims 8 - 12 also recites the term “and/or” with respect to the retractor head and attachment structure. These instances are also determined to be definite because the three options are clearly conveyed.
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: “attachment structure” in claim 7 and “resilient member” in claims 18 and 20.
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.
Regarding the attachment structure, paragraph [0060] discloses a blade-shaped member having a slot and a tab. Therefore, for purposes of examination the structure determined sufficient to perform the function of releasably attaching to a foil is a blade-shaped member having a slot and a tab or functional equivalents thereof.
Regarding the resilient member, paragraph [0065] discloses a resilient material such as a polymer or metals such as shape metal s (e.g. nitinol). Therefore, for purposes of examination the structure determined sufficient to perform the function of extending between a closed and open configured is a resilient material such as polymers or shape metals.
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 § 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(s) 5, 7 – 20, 25, 27 and 28 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 5 depends from claim 1 which requires an acute angle. However, claim 5 goes on to require a parallel angle. Because acute angles are greater than 0 degrees and less than 90 degrees and a parallel angle is a 0-degree angle, the angle cannot be both acute and parallel. For purposes of examination, the angle of claim 5, is assumed to be substantially parallel.
Claim 7 recites “an attachment structure…configured to releasably attach a foil to the retractor head” and further states that the foil forms an acute angle with respect to the distal end axis. It is unclear if the foil is meant to be part of the claimed invention, or only functionally recited. For purposes of examination the foil is assumed to be part of the claimed invention.
Claim 11, similar to claim 5 above, claims a parallel angle. However, claim 11 is dependent upon claim 7 which recites “an acute angle”. Because the angle cannot be both parallel and acute, for purposes of examination claim 11 will be read as “substantially parallel”.
Claim 25 recited “the foil”, however there is a lack of antecedent basis for the foil. Claim 25 depends from independent claim 24 which does not recite the foil. Claim 24 incorporates claim 1 which also does not recite the foil. For purposes of examination clam 25 will be read as “wherein the surgical retractor comprises a foil, using the surgical retractor including the foil in the deliver configuration”.
Claim 27 is recited to be dependent upon claim 23, however claim 27 is directed towards the method and not the surgical retractor. Therefore, for purposes of examination claim 27 is assumed to depend from claim 24.
Claim 28 recites “the foil” which lacks antecedent basis. In addition, it is unclear if the foil is meant to be part of the claimed retractor. For purposes of examination claim 28 will be read as “positioning the retractor head and a foil in the heart chamber”.
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 - 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiltebrandt et al. (US 5,113,846).
Regarding claim 1, Hiltebrandt discloses a surgical retractor (Abstract), comprising:
a handle (ref. 4) having a distal end portion defining a distal end axis (see remarked Fig. 3 below); and
a retractor head (see remarked Fig. 3 below, ref. 8) including a retractor surface portion on the distal end portion of the handle (Fig. 3, refs. 9, 11), wherein the retractor surface portion forms an acute angle that is substantially less than 90 with respect to the distal end axis (see remarked Fig. 3 below).
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Regarding claim 2, Hiltebrandt discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 30 with respect to the distal end axis (Fig. 1).
Regarding claim 3, Hiltebrandt discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 15 with respect to the distal end axis (Fig. 1).
Regarding claim 4, Hiltebrandt discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 50 with respect to the distal end axis (Figs. 1 – 2).
Regarding claim 5, Hiltebrandt discloses the surgical retractor of claim 1, wherein the retractor surface portion is parallel to the distal end axis (Fig. 1).
Regarding claim 6, Hiltebrandt discloses the surgical retractor of claim 1, wherein the retractor surface portion is configured at an angle sufficiently close to parallel with respect to the distal end axis (Fig. 1) to facilitate insertion of the distal end portion of the handle into a heart chamber of a patient, optionally a left atrium or right atrium of the patient, from a side of the patient in a medial direction aligned with the distal end axis of the handle (this is considered an intended use limitation in which the retractor surface portion is close to parallel with the distal end axis and thus is fully capable of being used in such a manner due to its small profile in the configuration).
Claim(s) 1, 7 – 13, 19, 20 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jadhav et al. (US 2019/0388080).
Regarding claim 1, Jadhav discloses a surgical retractor (Abstract), comprising:
a handle (Fig. 7, refs. 14, 16, 24) having a distal end portion defining a distal end axis (Fig. 7, “7A”); and
a retractor head including a retractor surface portion on the distal end portion of the handle (the retractor surface portion is considered to be the top outer surface of ref. 24, see remarked Fig. 7 below which shows the retractor surface portion shaded in), wherein the retractor surface portion forms an acute angle that is substantially less than 90 with respect to the distal end axis (paragraph [0043] discloses that ref. 24 can pivot relative to refs. 14, 16 via pivot pin, ref. 28, thus able to form a plurality of acute angles, see Figs. 7C – 7B).
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Regarding claim 7, Jadhav discloses the surgical retractor of claim 1, further comprising an attachment structure (Fig. 7, ref. 36, 38) on the distal end portion of the handle configured to releasably attach a foil (ref. 26) to the retractor head (paragraph [0046]), wherein the retractor head and/or the attachment structure are configured such that a surface portion of the foil, when attached to the retractor head, forms an acute angle that is substantially less than 90 with respect to the distal end axis (as shown in remarked Fig. 7 above, the foil forms a curved surface that has portions which are acutely angled with respect to the distal end axis).
Regarding claim 8, Jadhav discloses the surgical retractor of claim 7, wherein the retractor head and/or the attachment structure are configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 30 with respect to the distal end axis (paragraph [0045] discloses that the foil ref. 26 can be rolled or folded to held into opening ref 22, thus during insertion and deployment configurations there will be a surface portion of the foil that makes an angle of less than 30 degrees).
Regarding claim 9, Jadhav discloses the surgical retractor of claim 7, wherein the retractor head and/or the attachment structure are configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 15 with respect to the distal end axis (paragraph [0045] discloses that the foil ref. 26 can be rolled or folded to held into opening ref 22, thus during insertion and deployment configurations there will be a surface portion of the foil that makes an angle of less than 15 degrees).
Regarding claim 10, Jadhav discloses the surgical retractor of claim 7, wherein the retractor head and/or the attachment structure are configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 5 with respect to the distal end axis (paragraph [0045] discloses that the foil ref. 26 can be rolled or folded to held into opening ref 22, thus during insertion and deployment configurations there will be a surface portion of the foil that makes an angle of less than 5 degrees).
Regarding claim 11, Jadhav discloses the surgical retractor of claim 7, wherein the retractor head and/or the attachment structure are configured such that a surface portion of the foil, when attached to the retractor head, is parallel to the distal end axis (the top portion of the foil is substantially parallel to the distal end axis when viewed in Fig. 7).
Regarding claim 12, Jadhav discloses the surgical retractor of claim 7, wherein the retractor head and/or attachment structure are configured such that the surface portion of the foil, when attached to the retractor head, is at an angle sufficiently close to parallel with respect to the distal end axis to facilitate insertion of the distal end portion of the handle and the foil into a heart chamber of a patient, optionally a left atrium or right atrium of the patient, from a side of the patient in a medial direction aligned with the distal end axis of the handle (when the foil is folded into the opening ref. 22, a portion will be substantially parallel and thus would be fully capable of being used in the manner described above).
Regarding claim 13, Jadhav discloses the surgical retractor of claim 7, wherein the attachment structure comprises a tab (ref. 38).
Regarding claim 19, Jadhav discloses the surgical retractor of claim 7, further comprising a foil (ref. 26) attached to the distal end portion of the handle by the attachment structure (Figs. 3, 7).
Regarding claim 20, Jadhav discloses the surgical retractor of claim 19, wherein the foil comprises a resilient member configured to extend between a closed or reduced diameter delivery configuration and an increased diameter open configuration (paragraph [0045]).
Regarding claim 23, Jadhav discloses the surgical retractor of claim 1, wherein: the distal end portion of the handle is linear (Fig. 7); and the linear distal end portion of the handle has a length that is sufficiently long that the linear distal end portion can extend outside of the patient after the distal end portion and the retractor head are inserted into the patient's heart chamber (this is considered an intended use or functional limitation in which the linear handle is fully capable of functioning in such a manner due to its substantially straight configuration).
Claim(s) 24 - 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrison et al. (US 5, 613,937).
Regarding claim 24, Garrison discloses a method for providing surgical access to a heart chamber of a patient (Abstract), optionally a right atrium or a left atrium, by the retractor of claim 1 (claim 1 is reproduced below in italics),
a handle (Fig. 15, ref. 166) having a distal end portion defining a distal end axis (see remarked Fig. 15 below); and
a retractor head (see remarked Fig. 15 below) including a retractor surface portion on the distal end portion of the handle (ref. 192), wherein the retractor surface portion forms an acute angle that is substantially less than 90 with respect to the distal end axis (see remarked Fig. 3 below),
comprising inserting the retractor head into the heart chamber of the patient from a side of the patient at least substantially in a medial direction aligned (e.g., colinear) with the distal end axis of the distal end portion of the handle (Fig. 2 and 5, shows a medial direction for accessing the heart chamber with the retractor ref. 40, note that “a side” may be any side of the body).
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Regarding claim 25, Garrison discloses the method of claim 24, using the surgical retractor including the foil in the delivery configuration (the foil is considered to be one of ref. 192).
Regarding claim 26, Garrison discloses the method of claim 25, further comprising causing the foil to open to an operative position in the heart chamber and retract tissue in the heart (the foil/rake arms 192 “they may be expanded by pulling thumb ring 186 relative to finger rings 174”).
Regarding claim 27, Garrison discloses the method of claim 23, wherein inserting the retractor head includes moving the distal end portion of the handle in a direction parallel to the distal end axis (because the retractor is substantially linear and elongated along the distal end axis, see Fig. 15, any movement of the distal end portion would be parallel to the distal end axis).
Regarding claim 28, Garrison discloses the method of claim 27, wherein inserting the retractor head includes inserting a linear portion of the handle including the distal end portion into the patient and positioning the retractor head and optionally the foil in the heart chamber while the linear portion of the handle extends outside of the side of the patient (Fig. 9).
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.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jadhav et al. (US 2019/0288080) in view of Mirza et al. (US 2019/0029497 A1).
Regarding claim 21, Jadhav discloses the surgical retractor of claim 1, except for further comprising a light or imaging device on the distal end portion of the handle.
Mirza teaches a medical device for use in heart surgical procedures (paragraph [0050]) comprising a handle (ref. 110, Fig. 1), wherein the handle comprises a light (paragraph [0098], ref. 170) or imaging device (paragraph [0090], ref. 130). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Jadhav to include the light and camera, as taught by Mirza, for the purpose of sufficient resolution for imaging with sufficient clarity in order to observe performance of the surgical procedure (Mirza, paragraph [0091]).
Regarding claim 22, Jadhav in view of Mirza discloses the surgical retractor of claim 21, wherein the light or imaging device define an optical axis that extends at a non-zero acute angle with respect to the distal end axis (Mirza, paragraph [0094] discloses a movable camera, thus having a plurality of optical axes that would be non-zero acute angles).
Allowable Subject Matter
Claims 14 - 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 14 - 18 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a surgical retractor comprising a first blade and the attachment structure comprises a second blade adjacent to the first blade, wherein the first and second blades define a slot to releasably receive the foil.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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/TESSA M MATTHEWS/ Examiner, Art Unit 3773