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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 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.
Claims 1-4, 10-12, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goransson (US 2010/0057010).
Regarding claim 1, Goransson discloses:
A trocar fixation assembly (Fig. 1) comprising a fixation device (4, 5) and a medical dressing (2), wherein said fixation device (4, 5) comprises an annular member (4) defining a channel (3) for receiving a trocar (1; Fig. 2); said annular member (4) being disposed about a longitudinal center line, wherein said fixation device (4, 5) is configured to be movable between a first configuration (Fig. 1), which allows for a trocar (1) to be moved along said longitudinal center line of said annular member (4), and a second configuration (Fig. 3), which allows for a trocar (1) to be fixed in a locked position (¶0036), wherein in said second configuration (Fig. 3), the cross-sectional area of at least one portion of said channel (3) is smaller than the cross-sectional area of said at least one portion of said channel (3) in said first configuration (Fig. 1) (the opening 3 shrinks in diameter from the first configuration to the second configuration).
Regarding claim 2, Goransson discloses:
The trocar fixation assembly according to claim 1, wherein said second configuration (Fig. 3) is a relaxed configuration (¶0034) and wherein said first configuration (Fig. 1) is a retracted configuration (¶0034 – a user has to put pressure on tabs 6 to open the device. When that pressure is removed, the device springs back into a closed position).
Regarding claim 3, Goransson discloses:
The trocar fixation assembly according to claim 1, wherein said fixation device (4, 5) comprises locking means (6) configured to move said fixation device between said first and second configurations (¶0034).
Regarding claim 4, Goransson discloses:
The trocar fixation assembly according to claim 3, wherein said locking means (6) comprises a spring member (¶0034).
Regarding claim 10, Goransson discloses:
The trocar fixation assembly according to claim 1, wherein said medical dressing (2) comprises a centrally disposed aperture (cutout of the dressing 2) configured to encircle said annular member (4).
Regarding claim 11, Goransson discloses:
The trocar fixation assembly according to claim 1, wherein said medical dressing (2) extends uninterrupted around said annular member (4) (the dressing 2 can be interpreted as uninterrupted along the sheet; the insertion slot 7 still allows the dressing 2 to extend around the annular member 4).
Regarding claim 12, Goransson discloses:
The trocar fixation assembly according to claim 1, wherein said medical dressing (2) comprises a backing layer and an adhesive skin contact layer (¶0037 – it would be understood to a person of ordinary skill in the art that the dressing would have a backing layer to cover the adhesive layer before use of the device).
Regarding claim 16, Goransson discloses:
A trocar system (Fig. 2) comprising a trocar fixation assembly (Fig. 1) according to claim 1 and a trocar (1).
Regarding claim 17, Goransson discloses:
A trocar system according to claim 16, wherein said trocar (1) comprises a cannula, wherein said cannula (see Fig. 2) comprises an interior surface and an exterior surface, wherein said exterior surface of said cannula is smooth (Fig. 2).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Goransson in view of Worthley (US 2004/0220505).
Regarding claim 13, Goransson discloses the trocar fixation assembly according to claim 12 but is silent regarding “said adhesive skin contact layer comprises a silicone based adhesive.” However, Worthley teaches a medical dressing (Fig. 2; Abstract), thus being in the same field of endeavor, that teaches the adhesive layer for such a dressing can be silicone adhesive, among other options (¶0050). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the adhesive of Goransson to be a silicone adhesive as taught by Worthley in order to provide sufficient structure to adhere a dressing to skin.
Regarding claim 14, Goransson discloses the trocar fixation assembly according to claim 12 but is silent regarding “an absorbent pad between said backing layer and said adhesive skin contact layer.” However, Worthley teaches a medical dressing (Fig. 2; Abstract), thus being in the same field of endeavor, that comprises multiple layers including a backing (16), an adhesive layer (52) and an absorbent layer (46) in the form of a polyurethane foam (¶0051). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the dressing of Goransson to incorporate an absorbent layer between the backing layer and the adhesive layer as taught by Worthley in order to provide sufficient structure to prevent the adhesive from being damaged prior to use.
Regarding claim 15, Goransson in view of Worthley discloses that the absorbent pad, modified in view of Worthley in the rejection of claim 14, comprises a polyurethane foam (Worthley; ¶0051).
Allowable Subject Matter
Claims 5-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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, Bhisma Mehta can be reached at (571)272-3383. 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.
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
Prosecution Insights