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 .
This action is in response to the amendment and RCE filed on 12/23/2025. Claims 1-3, 6, 13-15, 17, and 20-31 are pending. Claims 1, 2, 6, and 13 are independent. Claims 4, 5, 7-12, 16, 18, and 19 are canceled. Claims 27-31 have been newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 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.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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 27 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 27 recites the limitation “wherein the first external adjustment force is applied onto a first portion of the implantable medical device by the deformable body and the second external adjustment force is applied to a second portion of the implantable medical device by the deformable body, wherein the second portion is that is angularly offset about a circumference of the implantable medical device by about 90 degrees relative to the first portion” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on the first external adjustment force being applied onto a first portion of the implantable medical device by the deformable body. Figure 2A and 2C shows the two external adjustment forces F1 and F2. However, the disclosure does not describe that both F1 and F2 are applied by the deformable body although F2 can be considered as applied by the deformable body / cross-sectional adjustment mechanism 220. However, original disclosure is silent on the first external adjustment force F1 being applied onto a first portion of the implantable medical device by the deformable body.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is 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 27 recites “wherein the first external adjustment force is applied onto a first portion of the implantable medical device by the deformable body and the second external adjustment force is applied to a second portion of the implantable medical device by the deformable body, wherein the second portion is that is angularly offset about a circumference of the implantable medical device by about 90 degrees relative to the first portion” which include method steps. However, claim 2 is an apparatus claim. Claim 27 is indefinite because it positively claiming a method step in an apparatus claim. See MPEP 2173.05(p) II.
Furthermore, claim 2 recites that the first external adjustment force is applied on the deformable body and the second external adjustment force is applied on the deformable body while claim 27 recites that the first external adjustment force is applied by the deformable body and the second external adjustment force is applied by the deformable body. Therefore, claim 27 contradicts with the limitations recited in claim 2.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112 issue(s) stated above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, 20-27, 30, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeCampli (US Pat. No.: 5,797,879).
Regarding claims 1 and 24-26, DeCampli discloses [claim 1] a system (20, Figs. 1-5 ) comprising: an implantable medical device (graft 21, Fig. 1) defining a lumen (lumen of 21, Figs. 1-4); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, and 23, Fig. 1) including a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device, the cross-sectional adjustment mechanism configured to actuate the implantable medical device between a first dimension (the dimensioned when the graft is compressed, Fig. 3) and a second dimension (the dimension when the graft is circular-shaped) that is larger than a first dimension to adjust an amount of fluid flow through the lumen when an orthogonally transcutaneously applied external adjustment force is applied to deformable body (Figs. 1-5 and also see Fig. 12 and Col. 5, line 46 – Col. 9, line 21. Fig. 12 is used solely for the purpose of showing to the applicant that the external adjustment force applied to deformable body is an orthogonally transcutaneously applied external adjustment force. The force is applied through the end of tube/lumen 25 which is orthogonally connected 23 as shown in Figs. 1 and 12; see Figures below. Based on https://www.merriam-webster.com, the term “transcutaneous” is defined as “passing, entering, or made by penetration through the skin.”. It is a common practice to use needle for transcutaneously delivering substance into the body tissue beneath the skin.); and [claim 24] wherein the cross-sectional adjustment mechanism is fully capable to lessen thrombus formation or stenosis in response to transitioning of the implantable medical device between the first dimension and the second dimension (the cross-sectional adjustment mechanism is fully capable to lessen thrombus formation or stenosis in response to transitioning of the implantable medical device between the first dimension and the second dimension by changing the blood flow through the vessel); [claim 25] wherein the deformable body is a ring (the deformable body of 22 and 23 forms a ring, Fig. 2) coupled to a surface of the implantable medical device (Fig. 1); [claim 26] wherein the deformable body is a stent structure (the deformable body formed by 22 and 23 as shown in Fig. 2 is a tubular structure which can be served as a stent structure and the deformable body is overlaying a portion of the implantable medical device) overlaying a portion of the implantable medical device (Fig. 2).
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Regarding claims 2, 20-23, and 27, DeCampli discloses [claim 2] a medical system (20, Figs. 1-5) configured to be transcutaneously, cross-sectionally adjusted, the system comprising: an implantable medical device (graft 21, Fig. 1) defining a lumen (lumen of 21, Figs. 1-4); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, 22’, and 23, Fig. 1; alternatively the combination of 24, 25, 22, 23, 90, and 200, Fig. 11 and 12) include a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device, the cross-sectional adjustment mechanism fully capable to selectively actuate the implantable medical device from a first dimension to a second dimension that is larger than the first dimension by applying a first external adjustment force (a suction force to withdraw the fluid, Col. 5, lines 52-54; alternatively, the force of the expansion of 200 in the orthogonal direction to the injection force; further alternatively, an external compression force can be applied to the deformable body. Applicant should be noted that the first external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The first external adjustment force is recited in a functional limitation) on the deformable body in a first radial direction (outward direction) and from the second dimension back to the first dimension by applying a second external adjustment force (injection force to inject the fluid, Col. 5, lines 52-54. Applicant should be noted that the second external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The second external adjustment force is recited in a functional limitation) on the deformable body in a second radial direction (inward direction) that is orthogonal to from the first radial direction (Figs. 1-5 and Col. 5, line 46 – Col. 9, line 21, the cross-sectional adjustment mechanism is fully capable to selectively actuate the implantable medical device from a first dimension to a second dimension that is larger than the first dimension by applying an external adjustment force on the cross-sectional adjustment mechanism in a first radial direction while deflating the balloon or overcoming the pressure from the balloon and from the second dimension to the first dimension by applying an external adjustment force on the cross-sectional adjustment mechanism in a second radial dimension that is different from the first radial direction via the force of the injection fluid); [claim 20] wherein the external adjustment force applied in the first radial direction is fully capable to cause the deformable body to flip outwardly (the external adjustment force applied in the first radial direction is fully capable to cause the adjustment mechanism to flip outwardly); [claim 21] wherein the external adjustment force applied in the second radial direction causes the deformable to flip inwardly (Fig. 3 or 3A); [claim 22] wherein the cross-sectional adjustment mechanism is positioned along an inner surface of the lumen (Figs. 1-5, the adjustment mechanism is positioned along/over/parallel to the length of both an inner surface and an outer surface of the lumen); and [claim 23] wherein at least one of the first and second external adjustment forces are a squeezing force (the cross-sectional adjustment mechanism fully capable to perform the claimed functions such that the at least one of the first and second external adjustment forces are a squeezing force).; [claim 27] wherein the system is fully capable such to have the first external adjustment force applied onto a first portion of the implantable medical device by the deformable body and the second external adjustment force applied to a second portion of the implantable medical device by the deformable body, wherein the second portion is that is angularly offset about a circumference of the implantable medical device by about 90 degrees relative to the first portion (the system is fully capable such to have the first external adjustment force applied onto a first portion of the implantable medical device by the deformable body and the second external adjustment force applied to a second portion of the implantable medical device by the deformable body, wherein the second portion is that is angularly offset about a circumference of the implantable medical device by about 90 degrees relative to the first portion by external forces applied perpendicular to each other (Applicant should be noted that the first external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The first external adjustment force is recited in a functional limitation. Also, the second external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The second external adjustment force is recited in a functional limitation. A functional limitation or a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim).
Regarding claims 6, 30 and 31, DeCampli discloses [claim 6] a system (20, Figs. 11 and 12) comprising: an implantable medical device (graft 21, Fig. 11) defining a lumen (lumen of 21, Figs. 11 and 12); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, 23, and 90, Fig. 11 and 12) having a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device (Figs. 11 and 12), the deformable body configured to transition from an original dimension (original large dimension, Fig. 11) to a reduced dimension upon a transcutaneous application of an orthogonally external adjustment force (see Figures above. Also, the term “transcutaneous” is defined as “passing, entering, or made by penetration through the skin.” It is a common practice to use needle for transcutaneous delivery of a substance into the body tissue beneath the skin.) and to maintain the reduced dimension upon removal of the external adjustment force (Col. 5, lines 52-54 and Col. 13, line 66 – Col. 14, line 11); [claim 30] wherein the lumen of the implantable medical device is smaller in the reduced dimension compared to the original dimension (Fig. 12); [claim 31] wherein a length of the deformable body is less than a length of the implantable medical device (Fig.11, a length of the deformable body is less than a length of the implantable medical device along the longitudinal axis of the deformable body or the longitudinal axis of the implantable medical device)
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeCampli (US Pat. No.: 5,797,879) as applied to claim 2 above, and further in view of Abarca et al. (US Pub. No.: 2010/0318175)
Regarding claim 3, DeCampli discloses all the limitations of the claim 2 as taught above. DeCampli discloses that the cross-sectional adjustment mechanism includes an elastic member (22’, Fig. 3A) fully capable to move between the first dimension and the second dimension in response to the external adjustment force (Col. 6, lines 45 – 62). However, DeCampli does not disclose that the elastic member is formed of a shape memory material.
Abarca teaches, in the same field of endeavor (vascular medical device), a cross-sectional adjustment mechanism comprising an elastic member (150, Figs. 1-4) formed of a shape memory material (Paras. [0035]-[0038], [0056], and [0057]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the elastic member of DeCampli to be formed of shape memory material as taught by Abarca in order to obtain the advantage of having the ability to transition to a remembered configuration in response to an externa stimulus that is applied in a non-invasive manner (Abarca, Para. [0057]).
Allowable Subject Matter
Claims 13-15, 17, 28, and 29 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6, 20-27, 30, and 31 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on page 8 of the remarks, DeCampli discloses [claim 1] a system (20, Figs. 1-5 ) comprising: an implantable medical device (graft 21, Fig. 1) defining a lumen (lumen of 21, Figs. 1-4); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, and 23, Fig. 1) including a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device, the cross-sectional adjustment mechanism configured to actuate the implantable medical device between a first dimension (the dimensioned when the graft is compressed, Fig. 3) and a second dimension (the dimension when the graft is circular-shaped) that is larger than a first dimension to adjust an amount of fluid flow through the lumen when an orthogonally transcutaneously applied external adjustment force is applied to deformable body (Figs. 1-5 and also see Fig. 12 and Col. 5, line 46 – Col. 9, line 21. Fig. 12 is used solely for the purpose of showing to the applicant that the external adjustment force applied to deformable body is an orthogonally transcutaneously applied external adjustment force. The force is applied through the end of tube/lumen 25 which is orthogonally connected 23 as shown in Figs. 1 and 12; see Figures below. Based on https://www.merriam-webster.com, the term “transcutaneous” is defined as “passing, entering, or made by penetration through the skin.”. It is a common practice to use needle for transcutaneously delivering substance into the body tissue beneath the skin. It is a common practice to use needle for transcutaneously delivering substance into the body tissue beneath the skin.). The term “transcutaneously” does not mean without puncturing of the skin of the patient.
In response to the argument(s) on page 9 of the remarks, DeCampli discloses [claim 2] a medical system (20, Figs. 1-5) configured to be transcutaneously, cross-sectionally adjusted, the system comprising: an implantable medical device (graft 21, Fig. 1) defining a lumen (lumen of 21, Figs. 1-4); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, 22’, and 23, Fig. 1; alternatively the combination of 24, 25, 22, 23, 90, and 200, Fig. 11 and 12) include a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device, the cross-sectional adjustment mechanism fully capable to selectively actuate the implantable medical device from a first dimension to a second dimension that is larger than the first dimension by applying a first external adjustment force (a suction force to withdraw the fluid, Col. 5, lines 52-54; alternatively, the force of the expansion of 200 in the orthogonal direction to the injection force; further alternatively, an external compression force can be applied to the deformable body. Applicant should be noted that the first external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The first external adjustment force is recited in a functional limitation) on the deformable body in a first radial direction (outward direction) and from the second dimension back to the first dimension by applying a second external adjustment force (injection force to inject the fluid, Col. 5, lines 52-54. Applicant should be noted that the second external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The second external adjustment force is recited in a functional limitation) on the deformable body in a second radial direction (inward direction) that is orthogonal to from the first radial direction (Figs. 1-5 and Col. 5, line 46 – Col. 9, line 21, the cross-sectional adjustment mechanism is fully capable to selectively actuate the implantable medical device from a first dimension to a second dimension that is larger than the first dimension by applying an external adjustment force on the cross-sectional adjustment mechanism in a first radial direction while deflating the balloon or overcoming the pressure from the balloon and from the second dimension to the first dimension by applying an external adjustment force on the cross-sectional adjustment mechanism in a second radial dimension that is different from the first radial direction via the force of the injection fluid). Applicant should be noted that the first external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The first external adjustment force is recited in a functional limitation. Also, the second external adjustment force is not positively claimed, such that it is not claimed as part of the medical system. The second external adjustment force is recited in a functional limitation. A functional limitation or a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to the argument(s) on page 10 of the remarks, DeCampli discloses [claim 6] a system (20, Figs. 11 and 12) comprising: an implantable medical device (graft 21, Fig. 11) defining a lumen (lumen of 21, Figs. 11 and 12); and a cross-sectional adjustment mechanism (combination of 24, 25, 22, 23, and 90, Fig. 11 and 12) having a deformable body (body of the combination of 23 and 22, Fig. 3A) coupled to the implantable medical device (Figs. 11 and 12), the deformable body configured to transition from an original dimension (original large dimension, Fig. 11) to a reduced dimension upon a transcutaneous application of an orthogonally external adjustment force (see Figures above, The term “transcutaneous” is defined as “passing, entering, or made by penetration through the skin”. It is a common practice to use needle for transcutaneous delivery of a substance into the body tissue beneath the skin.) and to maintain the reduced dimension upon removal of the external adjustment force (Col. 5, lines 52-54 and Col. 13, line 66 – Col. 14, line 11). Again, the term “transcutaneously” means through the skin. It is a common practice to use needle for transcutaneously delivering substance into the body tissue beneath the skin.). The term “transcutaneously” does not mean without puncturing of the skin of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cull (US Pub. No.: 2013/0303959) discloses a system comprising an implantable medical device; and cross-section adjustment mechanism including a deformable body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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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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/JING RUI OU/ Primary Examiner, Art Unit 3771
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