DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 9/28/2026. Currently, claims 1-3, 6, 7 and 9-23 are pending in the application. Claims 4, 5 and 8 are cancelled by Applicant.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/28/2026 has been entered.
Response to Arguments
Applicant’s amendment to claim 1 is sufficient to overcome the previous rejection of claims 1-3, 6, 7 and 9-23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant’s amendment to claim 9 is sufficient to overcome the previous rejection of claim 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant’s amendment to claim 21 is sufficient to overcome the previous rejection of claim 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 22 is sufficient to overcome the previous rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant’s arguments that Smith does not teach that the distal opening lies in a distal plane that is non-perpendicular to the longitudinal axis (as recited in claim 6) have been fully considered and are persuasive. However, upon further consideration and in view of Applicant’s amendment, a new ground(s) of rejection is made in view of Chen et al. (US 2015/0164552 A1).
Applicant's remaining arguments filed 9/28/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Applicant’s original disclosure provides support for claim 23 limitation “a leading distal insertion angle is defined by a projection of a distal plane containing the distal opening and a plane perpendicular to a lateral axis of the guard portion,” the examiner respectfully disagrees. The examiner appreciates Applicant’s thorough explanation. The examiner understands that the recited leading distal insertion angle is in reference to the angle formed by bottom line 7032 and top line 7032, with the bottom line 7032 corresponding to a projection of the distal plane. However, Applicant failed to identify a teaching in Applicant’s original disclosure that indicates the top line 7032 being a projection of a plane perpendicular to the lateral axis, as claimed. Applicant’s figures (see Figure 189A, for instance) do not clearly illustrate the top line 7032 being perpendicular to a lateral axis of the guard portion (as claimed) and therefore, do not reasonably convey that Applicant contemplated this feature at the time the application was filed. Further, this feature is not taught in Applicant’s original specification. Claim 23, therefore, remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as detailed below.
In response to Applicant’s argument does not teach that the side section and distal end of the guard portion form a wedge-shaped configuration because Smith teaches the configuration being rectangular, the examiner respectfully disagrees. The rectangular configuration of Smith can be considered wedge-shape inasmuch as it includes a pointed edge that widens progressively away from said pointed edge, similar to the shape of a wedge.
Applicant's additional arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 recites “the distal opening lies in a distal plane that is non-perpendicular to the longitudinal axis,” which is a claim limitation lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim 9 recites “the handle portion is angled relative to the reinforcing portion. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 recites “a leading distal insertion angle is defined by a projection of a distal plane containing the distal opening and a plane perpendicular to a lateral axis of the guard portion.” No support is provided for this claim limitation in Applicant’s specification as originally filed. As shown in at least Applicant’s Figure 188, the leading distal insertion angle is defined by a projection of a distal plane containing the distal opening and the lateral axis of the guard portion.
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) 1-3, 7, 9-16 and 18-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2012/0245429 A1).
In regards to claim 1, Smith teaches in Figures 1-7, [0025] and [0027]
a guard portion (housing 110, tube 130) formed of cut-resistant material (the housing 110 and tube 130 are taught in Figures 1-7 to be made of physical material(a) having a thickness, thus having a degree of resistance to cutting) and having a generally tubular shape (as shown in Figures 1-7, housing 110 has a tubular structure with lumen 116 extending therethrough; [0025] teaches “housing 110 may also define a lumen 116 extending longitudinally therethrough”) having an inner surface (interior surface of housing 110) and an outer surface (exterior surface of housing 110) defining a thickness therebetween (as shown in Figure 1); the guard portion (housing 110, tube 130) defining a lumen (lumen 116) extending along a longitudinal axis ([0025] teaches “housing 110 may also define a lumen 116 extending longitudinally therethrough”) between (extending between, as shown in Figure 1) a proximal opening (opening of lumen 116 positioned in proximal end 112; see Figure 1) at a proximal end (proximal end 112) and a distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1) at a distal end (distal end 114); and
a batten (elongate member 140) configured to stiffen and reinforce ([0025] teaches “an elongate member 140 insertable into tube 130;” [0027] teaches “elongate member 140 is made of a semi-rigid material” and “when inserted, elongate member 140 provides additional rigidity to tube 130;” when inserted into tube 130, the semi-rigid elongate member 140 provides structural support to increase the rigidity of the tube 130 and stiffen and reinforce the structure thereof) a side section (tube 130; Figure 1 teaches the tube 130 being positioned on the lateral outer surface 118 of housing 110) of the guard portion (housing 110, tube 130) to facilitate insertion of the surgical shield (surgical device 100) into ([0025] teaches “an elongate member 140 insertable into tube 130;” the elongate member 140 is capable of being inserted into tube 130 before insertion of the surgical device 100 into tissue T such that the elongate member 140 provides a semi-rigid handle to stabilize movement of the surgical device during insertion) the orifice ([0027] teaches “distal end 114 of housing 110 to be secured against an inner surface of tissue ‘T’”); the batten (elongate member 140) having a reinforcing portion (portion of elongate member 140 positioned within tube 130 in use; see Figure 5; [0025] teaches “an elongate member 140 insertable into tube 130”) connected to a handle portion (portion of elongate member 140 external to tube 130 in use; shown in Figure 5; can be considered a “handle” inasmuch as it is capable of being manually grasped); the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) being connected to (as shown in Figure 1; [0025] teaches “an elongate member 140 insertable into tube 130”) the side section (tube 130) of guard portion (housing 110, tube 130) and extending along (as shown in Figure 7) the longitudinal axis of ([0027] teaches “elongate member 140 is made of a semi-rigid material and may be inserted through longitudinal portion 132”) such that, in a side cross-sectional view (as shown in Figure 1), the side section (tube 130) and distal end (distal end 114) of the guard portion (housing 110, tube 130) form a wedge-shaped configuration (the angle formed by the intersection between the tube 130 and distal end 114) that increases in size in a proximal direction (as shown in Figure 1, the angle formed by the intersection between the tube 130 and distal end 114 initiates at a vertex and widens in directions extending proximally to opening 136 and the left extend of the distal end 114); the handle portion (portion of elongate member 140 external to tube 130 in use) being located at (as shown in Figures 5 and 7) the proximal end (proximal end 112) of the guard portion (housing 110, tube 130) and extending away from (Figures 5 and 7 teach the portion of elongate member 140 external to tube 130 in use extending laterally away from the proximal end 112) the proximal end (proximal end 112) of the guard portion (housing 110, tube 130).
In regards to claim 2, Smith teaches the apparatus of claim 1. Smith teaches in Figures 1 and 7, [0027] and [0029] that the guard portion (housing 110, tube 130) comprises a bead ([0029] teaches “elongate member 140 now circumnavigates distal end 114 of housing 110 thereby creating a ring similar to ring 122”) having an enlarged thickness (inasmuch as the distal ring 122 is shown in Figure 7 to flare outward and project laterally, increasing the width/thickness of surgical device 100) around (as shown in Figure 7) the distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1).
In regards to claim 3, Smith teaches the apparatus of claims 1 and 2. Smith teaches in Figures 1 and 7, [0027] and [0029] that the enlarged thickness (inasmuch as the distal ring 122 is shown in Figure 7 to flare outward and project laterally, increasing the width/thickness of surgical device 100) is non-uniform around (inasmuch as the distal ring 122 is shown in Figure 7 to flare outwardly and thus, forms a gradually increasing width/thickness of surgical device 100) the distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1) such that, in a plane containing the distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1), the thickness of the bead ([0029] teaches “elongate member 140 now circumnavigates distal end 114 of housing 110 thereby creating a ring similar to ring 122”) is more prominent (prominence of the thickness of the bead in a plane containing the opening of lumen 116 varies depending upon the point of view of the observer) along a top of the guard portion (housing 110, tube 130) relative to a bottom of the guard portion (housing 110, tube 130).
In regards to claim 7, Smith teaches the apparatus of claim 1. Smith teaches in Figures 1-7 that the proximal opening (opening of lumen 116 positioned in proximal end 112; see Figure 1) lies in a proximal plane (the opening of lumen 116 positioned in distal end 114 lies in a substantially horizontal proximal plane, as shown in Figure 1) that is angled (substantially perpendicularly) with respect to the longitudinal axis (vertical axis) to create a flange (formed by the pointed corner where the housing 110 and proximal end 112 intersect) at the proximal end (proximal end 112).
In regards to claim 9, Smith teaches the apparatus of claim 1. Smith teaches in Figure 7 that the batten (elongate member 140) is L-shaped (Figure 7 teaches the elongate member 140 having an angled structure resembling the shape of a capital letter “L”) such that the handle portion (portion of elongate member 140 external to tube 130 in use; shown in Figure 5; can be considered a “handle” inasmuch as it is capable of being manually grasped) is angled relative to the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use; see Figure 5; [0025] teaches “an elongate member 140 insertable into tube 130”); the handle portion (portion of elongate member 140 external to tube 130 in use; shown in Figure 5; can be considered a “handle” inasmuch as it is capable of being manually grasped) being substantially straight (as shown in Figure 7) and extending radially away from the longitudinal axis (Figure 7 teaches the portion of elongate member 140 external to tube 130 in use extending laterally away from the vertical axis of the device).
In regards to claim 10, Smith teaches the apparatus of claim 1. Smith teaches in Figures 1 and 7 that the lumen (lumen 116) has an elongate (inasmuch as it has a length) cross-section (shown in Figures 1 and 7) taken in a plane perpendicular to the longitudinal axis (vertical axis) at the proximal end (proximal end 112) and an elongate (inasmuch as it has a length) cross-section (shown in Figures 1 and 7) taken in a plane perpendicular to the longitudinal axis (vertical axis) at the distal end (distal end 114).
In regards to claim 11, Smith teaches the apparatus of claims 1 and 10. Smith teaches in Figures 1 and 7 the lumen (lumen 116) has a circular cross-section between (as shown in Figures 1 and 7) the distal end (distal end 114) and proximal end (proximal end 112).
In regards to claim 12, Smith teaches the apparatus of claim 1. Smith teaches in [0025] and Figures 1 and 7 a bead (ring 122; shown in Figure 7 to have a cross-section resembling the shape of a bead) around (as shown in Figure 7; [0027] teaches “a ring 122 circumnavigating proximal end 112”) the proximal opening (opening of lumen 116 positioned in proximal end 112; see Figure 1).
In regards to claim 13, Smith teaches the apparatus of claim 1. Smith teaches in Figures 5 and 7 that the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) is curved so as to conform to (as shown in Figures 5 and 7, the portion of elongate member 140 positioned within tube 130 follows the curvature of the interior and exterior surfaces of housing 110) the shape of the inner (interior surface of housing 110) and outer (exterior surface of housing 110) surfaces of the guard portion (housing 110, tube 130).
In regards to claim 14, Smith teaches the apparatus of claim 1. Smith teaches in Figure 5 that the outer surface (exterior surface of housing 110) of the guard portion (housing 110, tube 130) is curved concave along (as shown in Figure 5) the longitudinal axis (vertical axis) and the inner surface (interior surface of housing 110) of the guard portion (housing 110, tube 130) is conformingly curved convex (as shown in Figure 5).
In regards to claim 15, Smith teaches the apparatus of claims 1 and 14. Smith teaches in Figure 5 that the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) is curved so as to have an outer surface (exterior, outward-facing surface) that is concave along a length (as shown in Figure 5) of the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) and is convex along a width (as shown in Figure 5) of the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use).
In regards to claim 16, Smith teaches the apparatus of claims 1 and 14. Smith teaches in Figure 5 that the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) is curved so as to have an inner surface (interior surface) that is convex along a length (as shown in Figure 5) of the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use) and is concave along a width (as shown in Figure 5) of the reinforcing portion (portion of elongate member 140 positioned within tube 130 in use).
In regards to claim 18, Smith teaches the apparatus of claim 1. Smith teaches in [0025] and [0027] that the guard portion (housing 110, tube 130) is made of flexible material ([0025] teaches “housing 110 may be made of a bio-compatible material which is flexible or collapsible and designed to allow for flexibility or collapsibility during insertion”) and the batten (elongate member 140) is more rigid relative to ([0027] teaches “elongate member 140 is made of a semi-rigid material”) the guard portion (housing 110, tube 130).
In regards to claim 19, Smith teaches the apparatus of claim 1. Smith teaches in Figure 1 that the guard portion (housing 110, tube 130) includes a depending flange portion (free end of tube 130) at (Figure 1 teaches the free end of tube 130 being positioned on the proximal end 112) the proximal end (proximal end 112).
In regards to claim 20, Smith teaches the apparatus of claim 1. Smith teaches in Figure 5 that the guard portion (housing 110, tube 130) is substantially hourglass shaped (Figure 5 teaches the housing 110 being shaped like an hourglass).
In regards to claim 21, Smith teaches the apparatus of claim 1. Smith teaches in Figures 1 and 7 that the surgical shield (surgical device 100), when positioned in the insertion direction, is configured to move in a pendulum manner about a proximal end (free end) of the handle portion (portion of elongate member 140 external to tube 130 in use) so as to create an arc-shaped pathway of insertion (as shown in Figures 1 and 7, the surgical device 100 is structured such that a user is capable of manually grasping the free end of the portion of elongate member 140 external to tube 130 in use and moving the surgical device in a pendulum manner to create an arc-shaped pathway of insertion).
In regards to claim 22, Smith teaches the apparatus of claim 1. Smith teaches in Figure 1 the wedge-shaped configuration (the angle formed by the intersection between the tube 130 and distal end 114) serves as a leading end (the angle formed by the intersection between the tube 130 and distal end 114 is capable of being used as the first, leading point of entry of the surgical device 100 during insertion) having an acute angle (contained therein and defined by the outward curve of the bottom end of the tube 130 after insertion into tissue “T,” as shown in Figure 7) to further facilitate tissue retraction during insertion (see angle defined in the annotated copy of Figure 7 provided below; the outward curve of the bottom end of the tube 130 after insertion into tissue “T” is capable of gripping the tissue “T” (as shown in Figure 7) in order to secure the tissue “T” in the retracted position).
In regards to claim 23, Smith teaches the apparatus of claim 1. Smith teaches in Figure 7 that a leading distal insertion angle (as defined in the annotated copy of Figure 7 provided below) is defined by (defined between, as shown in Figure 7) a projection of a distal plane (horizonal plane at the opening of lumen 116 positioned in distal end 114) containing the distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1) and a plane (vertical plane, as defined in the annotated copy of Figure 7 provided below) perpendicular to a lateral axis (horizontal axis) of the guard portion (housing 110, tube 130).
PNG
media_image1.png
438
775
media_image1.png
Greyscale
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0245429 A1) in view of Chen et al. (US 2015/0164552 A1).
In regards to claim 6, Smith teaches the apparatus of claim 1. Smith teaches in Figures 1-7 and [0027] that the distal opening (opening of lumen 116 positioned in distal end 114; see Figure 1) lies in a distal plane (the opening of lumen 116 positioned in distal end 114 lies in a substantially horizontal distal plane, as shown in Figure 1) that is angled (substantially perpendicularly) with respect to the longitudinal axis (vertical axis) to facilitate insertion of the distal end (distal end 114) of the surgical shield (surgical device 100) into the orifice of ([0027] teaches “distal end 114 of housing 110 to be secured against an inner surface of tissue “T’”) the patient.
Smith does not teach that the angle is non-perpendicular.
However, Chen et al. teaches in Figures 1 and 3 and [0054] an analogous device wherein the angle (angle BB) is non-perpendicular (as shown in Figures 1 and 3; [0054] teaches “the distal opening 62 may lie in a plane forming an angle forming an angle BB with the bottom of the sheath, with BB ranging from 95 to 125 or 100 to 115 degrees”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the angle of Smith to be non-perpendicular as taught by Chen et al. because this element is known to provide a narrower leading end that can enter tissue more easily in use, as Chen et al. teaches in Figures 1 and 3.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0245429 A1).
In regards to claim 17, Smith teaches the apparatus of claim 1. Smith does not teach that the reinforcing portion and the handle portion of the batten have a width of one inch.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the reinforcing portion and the handle portion of the batten have a width of one inch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the width of the reinforcing portion and the handle portion of the batten could be modified necessary to accommodate the size if a particular surgical incision and/or to most comfortably accommodate the manual grasp of a particular user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
FORESTIERE (US 2,406,600 A)
Hjelle et al. (US 2007/0270882 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM 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, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 9/30/2026
