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 .
Claim Objections
Claims 10 and 16-17 are objected to because of the following informalities:
Claim 10 line 3 “the edges” is suggested to read “the width-directional opposite edges” for better antecedent basis.
Claim 16 line 3 “a state of wrapping the instrument” is suggested to read “the state of wrapping the instrument” for better antecedent basis.
Claim 17 line 3 “a state of wrapping the instrument” is suggested to read “the state of wrapping the instrument” for better antecedent basis.
Appropriate correction is required.
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” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “an adhesive, which serves as a means for coupling opposite ends of the body” in claim 14; and “at least one insertion hole, into which the protrusion is coupled, is formed in the other end of the body as a means for coupling opposite ends of the body” in claim 15.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claims 2 and 15-17 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 2 recites “the biodegradable substance” in lines 1-2 and is unclear how the body can be made of the biodegradable substance (as introduced in claim 1) if the body is made of a biodegradable substance OR a non-absorbent substance. The claim never further defines a biodegradable substance has to be chosen for the body. For the purposes of examination, the Office will assume the biodegradable substance is chosen, however Applicant must clarify this language.
Claim 15 recites “the protrusion” in line 3 and is unclear if only one protrusion of the at least one protrusion is to be coupled with the at least one insertion hole, or each of the at least one protrusion is to be coupled with the at least one insertion hole. For the purposes of examination, the Office will interpret the claim to mean the latter.
Claim 16 recites “assuming that a length of the apparatus” in lines 1-2 and is unclear what is meant by the term “assuming.” It is unclear as to how to assume the length of the apparatus, for the length is what the length is. The term “assuming” also makes it unclear as to whether or not the length of the apparatus is or is not in fact “L.” therefore, the limitation is rendered indefinite. For the purposes of examination, the Office will interpret the claim to mean “wherein a length of the apparatus.”
Claim 16 recites the limitation "each protrusion" in line 10. There is insufficient antecedent basis for this limitation in the claim. It is unclear if claim 16 is meant to be dependent off of claim 15 where the at least one protrusion is introduced, or if a protrusion is meant to be introduced earlier in claim 16. For the purposes of examination, the Office will interpret claim 16 to mean the latter.
Claim 17 recites “assuming that a width of the apparatus” in lines 1-2 and is unclear what is meant by the term “assuming.” It is unclear as to how to assume the width of the apparatus, for the width is what the width is. The term “assuming” also makes it unclear as to whether or not the width of the apparatus is or is not in fact “W.” therefore, the limitation is rendered indefinite. For the purposes of examination, the Office will interpret the claim to mean “wherein a width of the apparatus.”
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 1-6 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soo et al. (KR101649351), hereinafter known as “Soo.”
With regards to claim 1, Soo discloses (Figures 1-5) an apparatus (figure 2 – mesh band; paragraph 1) for fixing an instrument installed in an intestinal canal in a state of wrapping the instrument outside the intestinal canal (see figure 2 – mesh is attached to the outside of the intestinal canal) in order to protect an anastomosis region after resection of a tubular internal organ, the apparatus comprising:
a band-shaped body (figure 2 – mesh) band having a predetermined thickness and width (paragraph 17), wherein
the body is made of a biodegradable (absorbent) substance (paragraph 23) or a non-absorbent substance that has no foreign body reaction in a human body (paragraphs 19 and 22), and has low elongation in a longitudinal direction of the body (paragraph 29).
With regards to claim 2, Soo discloses wherein the biodegradable substance comprises at least one of pteroylglutamic acid (PGA), poly lactic acid (PLA), polylactic-co-glycolic acid (PLGA), or palladium oxide (PDO) (paragraph 23).
With regards to claim 3, Soo discloses wherein the body has an elongation of less than 10% in the longitudinal direction of the body (paragraphs 29 and 56 – tensile change rate of 0.5%, 7.2%, and 5.6% are shown);
With regards to claim 4, Soo discloses wherein the body is configured in a structure in which yarn made of a biodegradable (absorbent) substance is woven in a mesh form (paragraphs 34-44).
With regards to claim 5, Soo discloses wherein weaving in the mesh form is performed using warp and weft, each of which has a size of USP 1 to USP 7 (yarn thickness) (paragraphs 34-44 – USP 3 to USP 4 is used).
With regards to claim 6, Soo discloses wherein width-directional opposite edges of the body of the apparatus are finished in a flexible form so as not to damage an outer surface of the intestinal canal when coming into contact with the outer surface of the intestinal canal (paragraphs 22 and 24).
With regards to claim 14, Soo discloses wherein an adhesive, which serves as a means for coupling opposite ends of the body, is applied to at least one end of the body (paragraph 24 – “one of the main points of the biodegradable mesh band is that there should be no necrosis due to adhesion with the large intestine or intestinal cutting due to the elasticity of the fabric” – it is interpreted that an adhesive is applied to at least one end of the body so that the mesh band may form adhesion with the large intestine).
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.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Jose et al. (US PGPub 2016/0095599), hereinafter known as “Jose.”
With regards to claim 7, Soo discloses the apparatus as claimed in claim 6. Soo is silent wherein round concave and convex portions are formed at the width-directional opposite edges of the body.
However, in a similar field of endeavor of anastomosis devices, Jose teaches (Figures 6-7) wherein round concave and convex portions are formed at the width-directional opposite edges of the body (see annotated figure 6 below; paragraphs 53-54).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Soo to include the round concave and convex portions are formed at the width-directional opposite edges of the body as taught by Jose for the purpose of providing a helical threaded first and second tubular sheath/band in order for circumferential alignment so that the first tubular sheath can be fastened around the second tubular sheath, thereby locking the position of the vessels and implant (paragraph 54 of Jose).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Greenhalgh (US PGPub 2002/0052649), and as evidenced by Omico Plastics (see NPL attached).
With regards to claims 8-9, Soo discloses the apparatus as claimed in claim 6. Soo is silent wherein the width-directional opposite edges of the body are configured in a form in which the width-directional opposite edges are woven at lower density than a central portion of the body (claim 8); and wherein predetermined portions of the width-directional opposite edges of the body are made of fabric having higher softness than fabric of the central portion of the body (claim 9).
However, in a similar field of endeavor of wrapping the instrument, Greenhalgh teaches (Figures 1-2) wherein the width-directional opposite edges 22 of the body are configured in a form in which the width-directional opposite edges 22 are woven at lower density than a central portion of the body (paragraph 28); and wherein predetermined portions of the width-directional opposite edges of the body are made of fabric having higher softness than fabric of the central portion of the body (paragraph 28 – material used is polyethylene). Further, as evidenced by Omico Plastics, low density polyethylene is softer and flexible, translating to a higher softness of material. On the other hand, high density polyethylene is rigid and offer higher strength and resistance to heat, therefore having a lower softness (see “Differences in Physical Characteristics”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Soo to include wherein the width-directional opposite edges of the body are configured in a form in which the width-directional opposite edges are woven at lower density than a central portion of the body; and wherein predetermined portions of the width-directional opposite edges of the body are made of fabric having higher softness than fabric of the central portion of the body as taught by Greenhalgh for the purpose of promoting higher permeability at the edges and maintaining hemostatic integrity in the center (paragraph 28 of Greenhalgh).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Celermajer et al. (US PGPub 2019/0307459) hereinafter known as "Celermajer."
With regards to claim 10, Soo discloses the apparatus as claimed in claim 6. Soo is silent wherein a shock-absorbing substance is applied to the width-directional opposite edges of the body in order to alleviate sharpness or stiffness of the edges.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to alleviate sharpness or stiffness of the edges, Celermajer teaches (Figure 15) wherein a shock-absorbing substance is applied to the width-directional opposite edges of the body in order to alleviate sharpness or stiffness of the edges (paragraph 71).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Soo to include the shock-absorbing substance taught by Celermajer for the purpose of cushioning and protecting the surface within the patient's anatomy (paragraph 71 of Celermajer).
Claim 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Ducharme (US PGPub 2008/0287965).
With regards to claim 11-12, Soo discloses the apparatus as claimed in claim 1. Soo further discloses a case in which suture is performed in a state in which the apparatus is applied to the intestinal canal of the human body (paragraph 17). Soo is silent wherein a predetermined portion of the body comprises an X-ray contrast medium enabling accurate confirmation of a position of the apparatus using X-ray equipment (claim 11); and wherein the X-ray contrast medium comprises a solid substance that is distinguishable by an X-ray (claim 12).
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to accurately confirm of a position of the apparatus, Ducharme teaches (Figures 3A-5) wherein a predetermined portion of the body 45 comprises an X-ray contrast medium 45 enabling accurate confirmation of a position of the apparatus using X-ray equipment (paragraphs 22 and 26); and wherein the X-ray contrast medium comprises a solid substance that is distinguishable by an X-ray (paragraphs 22 and 26).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Soo to include wherein a predetermined portion of the body comprises an X-ray contrast medium enabling accurate confirmation of a position of the apparatus using X-ray equipment as taught by Ducharme for the purpose of ensuring safe use of operation via non-invasively observing and monitoring the band within the patient’s body at predetermined intervals of time or randomly throughout a patient’s course of treatment (paragraph 26 of Ducharme).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Lawrence-Brown (US Patent 8,163,005).
With regards to claim 13, Soo discloses the apparatus as claimed in claim 1. Soo is silent to a scale enabling an operator to accurately calculate a length of the apparatus when performing an operation using the apparatus or a mark distinguishable by color is formed at a predetermined portion of the body.
However, in the field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to accurately calculate a length of the apparatus, Lawrence-Brown teaches (Figures 1-2) wherein a mark 4/7 distinguishable by color is formed at a predetermined portion of the body 1, wherein the mark 4/7 distinguishable by color enables an operator to accurately calculate a length of the apparatus when performing an operation using the apparatus (Col 4 lines 12-28 – distinguishable by color since the markings/radiopaque markers must comprise of some color to be able to be identified).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Soo to include the mark distinguishable by color as taught by Lawrence-Brown for the purpose of enabling the physician when placing the band to know the diameter of the band and hence where it is placed (Col 4 lines 17-22).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Soo in view of Dudai (US PGPub 2009/0306465).
With regards to claim 15, Soo discloses the apparatus as claimed in claim 1. Soo discloses wherein the body has a first end and a second end; and a coupling mechanism that is a suture coupling mechanism of the band (paragraphs 24-25). Soo is silent to a coupling mechanism wherein at least one protrusion is formed on one end of the body and at least one insertion hole, into which the protrusion is coupled, is formed in the other end of the body as a means for coupling opposite ends of the body.
However, in the field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to couple the band with a protrusion and insertion hole, Dudai teaches (Figures 1-3B) wherein at least one protrusion 16 is formed on one end of the body 14 and at least one insertion hole 18, into which the protrusion 16 is coupled, is formed in the other end of the body 14 as a means for coupling opposite ends of the body 14 (figures 3A-3B; paragraph 38).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the suture coupling mechanism of Soo for the protrusions and the insertion holes as taught by Dudai for the purpose of selectively adjusting the apparatus to be fixed in the body at variable lengths.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Soo.
With regards to claim 16, the band of Soo discloses wherein a length of the apparatus for fixing the instrument in a state of wrapping the instrument outside the intestinal canal is "L" since the band of Soo discloses a certain length in order to be wrapped around the intestinal canal. The band of Soo further discloses the structure of the band so that there should be no necrosis due to adhesion with the large intestine or intestinal cutting due to the elasticity of the fabric (paragraph 24 of Soo).
The band of Soo is silent to a mathematical expression to calculate “L”:
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where D indicates a diameter of a portion of the instrument at which the apparatus is mounted, T indicates the thickness of an intestinal wall of the intestinal canal, and H indicates a height of each protrusion of the instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have calculated “L” using the mathematical expression above in order to not create a large band length that will cause damage to surrounding cells and tissue; as the band is closed, the length of the band must be large enough to fit around the diameter of the instrument and full thickness of the tissue which it surrounds (2 sides multiplied by pi in the case of a rounded instrument); and further the band must be small enough so that it does not slide off, therefore it must be smaller than the diameter of the instrument, the height of the protrusions it sits between, and full thickness of the tissue plus the which it surrounds (2 sides multiplied by pi in the case of a rounded instrument). Regardless, the instrument is only functionally recited; and the claim is to the apparatus, hence the band of Soo needs only to be capable of fixing an instrument installed in the intestinal canal, in which the band of Soo is capable of (see figure 2). The band of Soo reads on the claims as being able to perform the same overall function.
With regards to claim 17, the band of Soo discloses wherein a width of the apparatus for fixing the instrument in a state of wrapping the instrument outside the intestinal canal is "WB" since the band of Soo discloses a certain width in order to be wrapped around the intestinal canal. The band of Soo further discloses the structure of the band so that there should be no necrosis due to adhesion with the large intestine or intestinal cutting due to the elasticity of the fabric (paragraph 24 of Soo).
The band of Soo/Lawrence-Brown is silent to a mathematical expression to calculate “WB”:
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where W indicates a distance between protrusions of the instrument and T indicates a thickness of an intestinal wall of the intestinal canal.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have calculated “WB” using the mathematical expression above in order to not create a large band width that will cause damage to surrounding cells and tissue; the width of the band must necessarily be less than the distance between the protrusions of the instrument supporting the intestinal canal, less the tissue thickness on each side (i.e. 2 respective protrusion sides) in order to allow for the band to not cut into the tissue of the intestinal canal as desired by Soo. Regardless, the instrument is only functionally recited; and the claim is to the apparatus, hence the band of Soo needs only to be capable of fixing an instrument installed in the intestinal canal, in which the band of Soo is capable of (see figure 2). The band of Soo reads on the claims as being able to perform the same overall function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/31/2025
/SARAH A LONG/Primary Examiner, Art Unit 3771