DETAILED ACTION
In Applicant’s RCE filed 10/21/24, Applicant requested entry of the Response filed 9/20/24 in which Applicant amended claims 1 and 17. Currently, claims 1-18 are pending (claims 10-16 and 18 were previously withdrawn).
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 on 10/21/24, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/20/24 has been entered.
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 use the word “means,” and, therefore, are 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: “an attachment means” in claims 2 and 17; and a mechanical means in claim 5. Specifically, these limitations recite a generic placeholder (“means”) coupled with functional language (“attachment” or “mechanical”) without giving sufficient structure, material or acts for achieving this function. Thus, for claims 2 and 17, the phrase “attachment means” will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is being interpreted to cover the corresponding structure described in the specification (adhesive – para [0015;0050]; magnetic flange or magnets – para [0016;0050]; mechanical means (para [0017;0050])) as performing the claimed function, and equivalents thereof. For claim 5, the phrase “mechanical means” will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is being interpreted to cover the corresponding structure described in the specification (“any mechanical means known in the art suited for attaching and or coupling medical bags/drapes to support structures” – para [0050]) 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 § 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 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.
Claims 1-2 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Marinchak (US 2014/0338676) in view of Eizenfeld et al (WO 2004/016299 A2) and further in view of Perkins (US 5496259).
With respect to claim 1, Marinchak discloses a contamination prevention bag assembly for covering an instrument (sterile drape 2 to cover medical equipment – abstract; figs 1-18) deployable from a system (medical equipment system shown i.e. in figs 17-18) having a deployment port for deploying the instrument (arm 13 is responsible for deployment of an attached instrument 6), the instrument being deployable from a non-deployed position to a deployed position through the deployment port externally distal from the deployment port (the arm 13 is interpreted as being capable of moving the instrument 6 back and forth between a non-deployed, storage position and an expanded, deployed position where the instrument is positioned for use), the bag assembly comprising:
a bag (drape 2 having sidewalls that form a bag to cover equipment 6; para [0056]; figs 1-3, 17 and 18) comprising:
an inner and an outer bag surface (inherent physical characteristics – inner surface faces and is adjacent to the covered equipment during use and the outer surface faces outwardly);
a deployment port attaching end configured to be attached to a mating portion (cinch 36 at the opening 14 at the distal end 16 which is configured to attach to the arm 13 of the equipment as shown in figs 17-18); and
a distal deployment end having a distal mating feature configured to receive a distal portion of the instrument (coupling 8 at a proximal end of drape 2 which can be coupled directly to the equipment via adapter 10 – para [0057]; fig 18), wherein the bag is folded in a non-deployed state (fig 8 shows the rolled up drape folded – para [0021]).
Marinchak also discloses that the bag is unfolded when the instrument is moved from the non-deployed position to the deployed position (as shown in figures 17-18 of Marinchak, the drape is coupled directly to a piece of equipment and then unfolded when deployed to cover the equipment for use. Thus, when the equipment is moved from a non-deployed to a deployed position during use in order to perform a procedure, the drape will be unfolded as shown in fig 18 to cover the equipment).
Marinchak does not, however, disclose that the system has a deployment port for deploying the instrument wherein the instrument is deployable to a deployed position through the deployment port and wherein the bag assembly is configured such that the deployment port attaching end is configured to be attached to a mating portion of the deployment port and deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port, such that the bag is then passively extended over said portion of the instrument.
Eizenfeld, however, teaches a system (dispenser 24) having a deployment port (entrance port 36) for deploying an instrument (pg 7 lines 20-23), the instrument being deployable from a non-deployed position to a deployed position through the deployment port externally distal from the deployment port (the endoscope is inserted through the entrance port 34 into the dispenser 24 during deployment into the patient’s body – see pg 7 line 20 – pg 8 line 8; as shown in figs 1-3, the endoscope is in a non-deployed position prior to insertion into dispenser 24 and then, for deployment into the patient’s body for a procedure, the distal end of the endoscope is first inserted from an external location into and through port 36 into the dispenser 24), and a bag assembly for covering the instrument (sleeve assembly 20 for covering endoscope 22) and having a deployment port attaching end configured to be attached to a mating portion of the deployment port (the proximal end of the sleeve is held at entrance port 36 by anchor 34 – see pg 7 lines 18-20) wherein the bag assembly is configured such that deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port (distal end of endoscope 22 is inserted into and through port 36 and moves away from port 36 through dispenser 24 during deployment), such that the bag is then passively extended over said portion of the instrument (sleeve 26 unfolds as the endoscope 22 is passed through the sleeve and then inserted into the patient’s body; pg 8 lines 21-23).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the bag of Marinchak with a system which has a deployment port for deploying the instrument wherein the instrument is deployable to a deployed position through the deployment port and wherein the bag assembly is configured such that the deployment port attaching end is configured to be attached to a mating portion of the deployment port and deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port, such that the bag is then passively extended over said portion of the instrument, as taught by Eizenfeld, so that the bag is deployed over the instrument as the instrument is inserted into a patient’s body rather than in a separate preliminary operation (see Eizenfeld pg 2 lines 8-10) thereby improving efficiency and reducing prep time for a procedure.
Marinchak also does not disclose that the distal mating feature provided at the distal deployment end additionally comprises a receptacle, such that the distal portion of the instrument is mated to the receptacle, and wherein the receptacle is configured such that a probe having a probe attachment portion can be attached to the distal portion of the instrument through the receptacle.
Perkins, however, teaches a sterile protective sheath and drape system that includes a bag (sterile drape 44) comprising: an inner and an outer bag surface (surfaces facing towards the covered instrument and away from the instrument as shown in figs 3-4); a distal deployment end having a distal mating feature configured to receive a distal portion of an instrument (end of body 48 of drape 44 at ring/hub member 46), wherein the bag is folded in a non-deployed state (shown in fig 2), wherein the distal mating feature provided at the distal deployment end (ring/hub 46) additionally comprises a receptacle (mechanism 36), such that the distal portion of the instrument is mated to the receptacle (handle 16 is attached to insertion tube 12 at the area where mechanism 36 is provided; see figs 1-4), and wherein the receptacle is configured such that a probe (insertion tube 12) having a probe attachment portion (portion attached to handle 16) can be attached to the distal portion of the instrument through the receptacle (as shown in figures 2-4 the insertion tube is attached to the handle 16 through the opening provided interiorly of mechanism 36). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Marinchak in view of Eizenfeld so that that the distal mating feature provided at the distal deployment end additionally comprises a receptacle, such that the distal portion of the instrument is mated to the receptacle, and wherein the receptacle is configured such that a probe having a probe attachment portion can be attached to the distal portion of the instrument through the receptacle, as taught by Perkins, in order to protect the instrument and minimize the risk of exposure to contamination without impairing functionality of the attached probe.
With respect to claim 2, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 1) and Marinchak also discloses an attachment means disposed on the deployment port attaching end of the bag (cinch 36) so that the deployment port attaching end is configured to be removably attached to the mating portion of the deployment port (the cinch is tightened to attach to a portion of the arm and is not permanently attached to the arm and, therefore, is removable).
With respect to claim 5, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 2) and Marinchak also discloses that the attachment means includes a mechanical means for removably attaching the deployment port attaching end of the bag to the mating portion of the deployment port (cinch 36 is interpreted as being a mechanical attachment means for connecting to a portion of the arm).
With respect to claim 6, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 2) and Marinchak also discloses contamination prevention packaging hermetically sealing at least the outer bag surface in a non-deployed state, wherein the bag is packaged and stored in a folded state (drape 2 is packaged in a container 42 in a collapsed configuration – para [0064-0065]; the container is interpreted as being hermetically sealed in order to maintain sterility of the packaged drape).
With respect to claim 7, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 2) and Marinchak also discloses that the contamination prevention packaging (container 42) includes at least one removable attachment portion covering the deployment port attaching end of the non- deployed drape assembly, and wherein the at least removable portion is configured to be removed before attaching the attachment means to the mating portion of the deployment port (parts 45 and 47 formed with a hinged section 61 separating the parts with supports 50 extending between the parts and being removable to permit the container to open to permit release of drape 2 – para [0065]; figs 14-16).
With respect to claim 8, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 6) and Marinchak also discloses that the contamination prevention packaging (container 42) includes at least one removable inner liner covering the deployment port attaching end of the non- deployed drape assembly (container top 55 which is applied over parts 45 and 47 and thus covers the enclosed drape including the deployment port attaching end; see para [0066]), and wherein the at least one removable inner liner portion (55) is configured to be removed before attaching the distal portion of the instrument to the distal mating feature configured to receive the distal portion of the instrument (the container top 55 along with the parts 45/47 of the container are removed to permit the container to open to permit release of drape 2 – para [0065]; figs 14-16).
With respect to claim 9, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 6) and Marinchak also discloses that the contamination prevention packaging(container 42) includes at least one removable portion covering at least a distal side and a length side of the bag assembly defined by folded edges formed by the folded bag in the non-deployed state, which when removed, uncovers the distal deployment end of the bag assembly and the folded edges of the bag (parts 45 and 47 formed with a hinged section 61 separating the parts with supports 50 extending between the parts and being removable to permit the container to open to permit release of drape 2 – para [0065]; figs 14-16).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marinchak (US 2014/0338676) in view of Eizenfeld et al (WO 2004/016299 A2) and Perkins (US 5496259) and further in view of Livesey (US 2015/0342685).
With respect to claim 3, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 2) but does not disclose that the attachment means includes adhesive pre-applied to the deployment port attaching end for attaching the bag to the mating portion of the deployment port.
Livesey, however, teaches use of an adhesive material for attaching a drape to an instrument (adhesive 30 on drape 10; para [0024]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used adhesive as taught by Livesey on the drape of Marinchak in view of Eizenfeld and further in view of Perkins instead of the cinch 36 for attaching the drape to an instrument in order to more securely attach the drape to an instrument and hold the drape in a specific location on the instrument by preventing the drape from sliding during use.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marinchak (US 2014/0338676) in view of Eizenfeld et al (WO 2004/016299 A2) and Perkins (US 5496259) and further in view of Devengenzo et al (US 2017/0086934).
With respect to claim 4, Marinchak in view of Eizenfeld and further in view of Perkins discloses the invention as claimed (see rejection of claim 2) but does not disclose that the attachment means includes a magnetic flange affixed to the deployment port attaching end that magnetically attaches to the mating portion of the deployment port.
Devengenzo teaches a surgical system which includes an attachment device feature to connect a surgical drape wherein the attachment device may be a metal member, such as, for example, a ferrous metal member, or a magnet (para [0047]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have replaced the cinch 36 on the drape of Marinchak in view of Eizenfeld and further in view of Perkins with a magnetic attachment device as taught by Devengenzo in order to more securely attach the drape to an instrument and hold the drape in a specific location on the instrument due to attraction between the magnets at the attachment which prevent the drape from sliding during use.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hicks (US 5198894) in view of Marinchak (US 2014/0338676) and further in view of Eizenfeld et al (WO 2004/016299 A2) and Perkins (US 5496259).
With respect to claim 17, Hicks discloses a contamination prevention bag assembly for covering an instrument (drape for covering a camera attached to an endoscope shown in figs 1-3) the bag assembly consisting of:
a bag (drape 22) consisting of:
an inner and an outer bag surface (inherent physical characteristics; inner surface faces the camera during use while the outer surface is the exposed outer surface);
wherein the bag is folded in a non-deployed state (fig 1; col 2 lines 33-34),
wherein the bag is unfolded when the instrument is moved from the non-
deployed position to the deployed position (fig 2; col 2 lines 35-38).
Hicks does not, however, disclose that the bag consists of a deployment port attaching end with an attachment means disposed on the deployment port attaching end and a distal deployment end having a distal mating feature configured to receive a distal portion of the instrument; and contamination prevention packaging hermetically sealing at least the outer bag surface in a non-deployed state.
Marinchak teaches a contamination prevention bag assembly for covering an instrument (sterile drape 2 to cover medical equipment – abstract; figs 1-18) deployable from a system (medical equipment system shown i.e. in figs 17-18) having a deployment port for deploying the instrument (arm 13 is responsible for deployment of an attached instrument 6), the instrument being deployable from a non-deployed position to a deployed position through the deployment port externally distal from the deployment port (the arm 13 is interpreted as being capable of moving the instrument 6 back and forth between a non-deployed, storage position and an expanded, deployed position where the instrument is positioned for use), wherein the assembly is configured to be “deployed over equipment in a non-sterile field thereby freeing up people in the sterile field who would otherwise typically deploy the drape…[and] may be deployed while other parts of the procedure are performed since a person not working in the sterile field may deploy the drape of the present invention…[leading] to shorter procedure times and, therefore, reduced cost and increased efficiency” (para [0005]), the bag assembly comprising:
a bag (drape 2 having sidewalls that form a bag to cover equipment 6; para [0056]; figs 1-3, 17 and 18) comprising:
an inner and an outer bag surface (inherent physical characteristics – inner surface faces and is adjacent to the covered equipment during use and the outer surface faces outwardly);
a deployment port attaching end configured to be attached to a mating portion (cinch 36 at the opening 14 at the distal end 16 which is configured to attach to the arm 13 of the equipment as shown in figs 17-18r); and
a distal deployment end having a distal mating feature configured to receive a distal portion of the instrument (coupling 8 at a proximal end of drape 2 which can be coupled directly to the equipment via adapter 10 – para [0057]), wherein the bag is folded in a non-deployed state (fig 8 shows the rolled up drape folded – para [0021]),
wherein the bag is unfolded when the instrument is moved from the non-
deployed position to the deployed position (shown in figs 17-18).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape 22 of Hicks to include a deployment port attaching end with an attachment means disposed on the deployment port attaching end so that the deployment port attaching end is configured to be removably attached to a mating portion; and a distal deployment end having a distal mating feature configured to receive a distal portion of the instrument and a receptacle such that a probe having a probe attachment portion can be attached to the distal portion of the instrument through the receptacle; and contamination prevention packaging hermetically sealing at least the outer bag surface in a non-deployed state, as taught by Marinchak, in order to provide shorter procedure times and, therefore, reduced cost and increased efficiency (Marinchak para [0005]).
Hicks in view of Marinchak does not, however, disclose that the system has a deployment port for deploying the instrument wherein the instrument is deployable to a deployed position through the deployment port and wherein the bag assembly is configured such that the deployment port attaching end is configured to be attached to a mating portion of the deployment port and deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port, such that the bag is then passively extended over said portion of the instrument.
Eizenfeld, however, teaches a system (dispenser 24) having a deployment port (entrance port 36) for deploying an instrument (pg 7 lines 20-23), the instrument being deployable from a non-deployed position to a deployed position through the deployment port externally distal from the deployment port (the endoscope is inserted through the entrance port 34 into the dispenser 24 during deployment into the patient’s body – see pg 7 line 20 – pg 8 line 8; as shown in figs 1-3, the endoscope is in a non-deployed position prior to insertion into dispenser 24 and then, for deployment into the patient’s body for a procedure, the distal end of the endoscope is first inserted from an external location into and through port 36 into the dispenser 24), and a bag assembly for covering the instrument (sleeve assembly 20 for covering endoscope 22) and having a deployment port attaching end configured to be attached to a mating portion of the deployment port (the proximal end of the sleeve is held at entrance port 36 by anchor 34 – see pg 7 lines 18-20) wherein the bag assembly is configured such that deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port (distal end of endoscope 22 is inserted into and through port 36 and moves away from port 36 through dispenser 24 during deployment), such that the bag is then passively extended over said portion of the instrument (sleeve 26 unfolds as the endoscope 22 is passed through the sleeve and then inserted into the patient’s body; pg 8 lines 21-23).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used the bag of Hicks in view of Marinchak with a system which has a deployment port for deploying the instrument wherein the instrument is deployable to a deployed position through the deployment port and wherein the bag assembly is configured such that the deployment port attaching end is configured to be attached to a mating portion of the deployment port and deployment of the distal portion of the instrument in a direction away from the deployment port causes a portion of the instrument proximal to the distal portion to move through the deployment port, such that the bag is then passively extended over said portion of the instrument, as taught by Eizenfeld, so that the bag is deployed over the instrument as the instrument is inserted into a patient’s body rather than in a separate preliminary operation (see Eizenfeld pg 2 lines 8-10) thereby improving efficiency and reducing prep time for a procedure.
Hicks in view of Marinchak also does not disclose that the distal mating feature provided at the distal deployment end additionally comprises a receptacle, such that the distal portion of the instrument is mated to the receptacle, and wherein the receptacle is configured such that a probe having a probe attachment portion can be attached to the distal portion of the instrument through the receptacle.
Perkins, however, teaches a sterile protective sheath and drape system that includes a bag (sterile drape 44) comprising: an inner and an outer bag surface (surfaces facing towards the covered instrument and away from the instrument as shown in figs 3-4); a distal deployment end having a distal mating feature configured to receive a distal portion of an instrument (end of body 48 of drape 44 at ring/hub member 46), wherein the bag is folded in a non-deployed state (shown in fig 2), wherein the distal mating feature provided at the distal deployment end (ring/hub 46) additionally comprises a receptacle (mechanism 36), such that the distal portion of the instrument is mated to the receptacle (handle 16 is attached to insertion tube 12 at the area where mechanism 36 is provided; see figs 1-4), and wherein the receptacle is configured such that a probe (insertion tube 12) having a probe attachment portion (portion attached to handle 16) can be attached to the distal portion of the instrument through the receptacle (as shown in figures 2-4 the insertion tube is attached to the handle 16 through the opening provided interiorly of mechanism 36). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Hicks in view of Marinchak and further in view of Eizenfeld so that that the distal mating feature provided at the distal deployment end additionally comprises a receptacle, such that the distal portion of the instrument is mated to the receptacle, and wherein the receptacle is configured such that a probe having a probe attachment portion can be attached to the distal portion of the instrument through the receptacle, as taught by Perkins, in order to protect the instrument and minimize the risk of exposure to contamination without impairing functionality of the attached probe.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 9/20/24 have been fully considered as follows:
Regarding the claim interpretation under 35 USC 112(f), in the absence of any amendments to remove the “means plus function” language from the claims or arguments against this interpretation, the Office has maintained the interpretation as noted above.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 9-12 have been fully considered but are rendered moot in view of the new grounds of rejection presented above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786