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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 9/26/2024 and 2/5/2025 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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 no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soutorine et al. (US 2018/0344321).
Soutorine discloses (see Figs. 1-2C and 3E) a surgical clip comprising the following claim limitations:
(claim 1) A vascular clip (100) for controlling blood flow ([0003]; [0033]), comprising: a deformable central portion (101); a first pressing portion (i.e., “upper” jaw 102 in Fig. 1) connected to one end of the deformable central portion (101) (as shown in Fig. 1); and a second pressing portion (i.e., “lower” jaw 102 in Fig. 1) connected to the other end of the deformable central portion (101) so as to face the first pressing portion with a blood vessel (153) interposed therebetween (as shown in Figs. 1-2C), wherein the deformable central portion (101) is formed of a first shape memory polymer that presses the first pressing portion and the second pressing portion in a direction close to each other by shape recovery at body temperature so as to compress the blood vessel (153) (as shown in Figs. 2A-2C; see Abstract and claim 1; [0039]; [0068]-[0069]);
(claim 11) wherein the deformable central portion (101) has a deformation-promoting groove recessed inward from a space between the first pressing portion and the second pressing portion (at 101e cut-out grooves, as expressly shown in Figs. 3E); and
(claim 12) wherein each of the first pressing portion and the second pressing portion has a blood vessel-contact surface formed to be convex toward the blood vessel (as shown in Fig. 1, undulating teeth on each jaw 102 comprise tissue-engaging surfaces at the respective convex upper surfaces of each respective tooth).
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) 2-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Soutorine as applied to claim 1 above, and further in view of Fry (US 2002/0072759).
Soutorine, as applied above, discloses a surgical clip comprising all the limitations of the claim except for wherein each of the first pressing portion and the second pressing portion comprises: a main body connected to the deformable central portion and configured to contact and compress the blood vessel; and a core disposed inside the main body and formed of a second/third shape memory polymer, wherein the cores of the first pressing portion and the second pressing portion cause the main bodies to spread apart/recover their shape away from each other by shape recovery at a reaction temperature higher than the body temperature so as to release the compression of the blood vessel, and further comprising a heat source disposed in each of the first pressing portion and the second pressing portion and configured to heat the core to the reaction temperature in response to an external stimulus applied from outside the body.
However, Fry teaches (see Figs. 2A-2B) a similar surgical clip wherein each of the first pressing portion (i.e., upper clip arm in Figs. 2A-2B) and the second pressing portion (i.e., lower clip arm in Figs. 2A-2B) comprises: a main body (i.e., outer/exterior shape memory material to clamp, as depicted in Fig. 2A) connected to the deformable central portion (i.e., i.e., central hinge connecting both clip arms in Figs. 2A-2B) and configured to (i.e., capable of) contact and compress the blood vessel (as expressly shown in Fig. 2A; see Abstract; [0028]-[0029]); and a core (i.e., inner/interior shape memory material to open, as depicted in Fig. 2A) disposed inside the main body and formed of a second/third shape memory polymer (as expressly shown in Figs. 2A-2B), wherein the cores of the first pressing portion and the second pressing portion cause the main bodies to spread apart/recover their shape away from each other by shape recovery at a reaction temperature higher than the body temperature so as to release the compression of the blood vessel ([0029]-[0031]; [0036]; use of either of a higher or a lower temperature expressly taught for unclamping/opening clip arms), and further comprising a heat source disposed in each of the first pressing portion and the second pressing portion and configured to (i.e., capable of) heat the core to the reaction temperature in response to an external stimulus applied from outside the body ([0004]; [0017]; [0025]; [0028]-[0029]; [0031]; [0036]; the material comprising each of the clamp arms is expressly heated to unclamp/open the clamp arms via heated fluid, electrical current, and the like) in order to beneficially allow for the clamp/clip to be easily placed around a vessel in an inactive form after which the patient’s body temperature causes the material to assume its predetermined memory shape and clamp the artery or other vessel ([0024]; [0029]-[0031]; [0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Soutorine to have each of the first pressing portion and the second pressing portion comprising a main body connected to the deformable central portion and configured to contact and compress the blood vessel; and a core disposed inside the main body and formed of a second/third shape memory polymer, wherein the cores of the first pressing portion and the second pressing portion cause the main bodies to spread apart/recover their shape away from each other by shape recovery at a reaction temperature higher than the body temperature so as to release the compression of the blood vessel, and further comprising a heat source disposed in each of the first pressing portion and the second pressing portion and configured to heat the core to the reaction temperature in response to an external stimulus applied from outside the body in order to beneficially allow for the clamp/clip to be easily placed around a vessel in an inactive form after which the patient’s body temperature causes the material to assume its predetermined memory shape and clamp the artery or other vessel, as taught by Fry.
Regarding claim 7, Soutorine in view of Fry teaches the claimed invention except for the first and second pressing portions having a lower shape recovery rate than that of the deformable central portion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first and second pressing portions comprise a lower shape recovery rate than that of the deformable central portion, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Soutorine in view of Fry as applied to claim 2 above, and further in view of Zhang et al. (CN 113288320) (copy and translation provided herein).
Soutorine in view of Fry, as applied above, teaches a surgical clip comprising all the limitations of the claim except for a heat source disposed in each of the first pressing portion and the second pressing portion and configured to heat the core to the reaction temperature in response to at least one of a magnetic field, an electromagnetic wave, and a radio frequency applied from outside the body, wherein the heat source is composed of either nanoparticles dispersed inside the core and configured to generate heat by the magnetic field or the electromagnetic wave, or a polymer with which an outer surface of the core is coated and which is configured to generate heat by the electromagnetic wave, and wherein the heat source is a micro-heater placed on an outer surface of the core and configured to generate heat by the radio frequency.
However, Zhang teaches (see Figs. 2a-2c) a similar surgical clip having a heat source disposed in each of the first pressing portion and the second pressing portion (1, Fig. 4) and configured to (i.e., capable of) heat the core (4, Fig. 4) to the reaction temperature in response to at least one of a magnetic field, an electromagnetic wave, and a radio frequency applied from outside the body ([0014]; [0031]; [0039]-[0040]; heat generating from external electromagnetic wave such as light expressly taught), wherein the heat source is composed of either nanoparticles dispersed inside the core and configured to generate heat by the magnetic field or the electromagnetic wave, or a polymer with which an outer surface of the core is coated and which is configured to generate heat by the electromagnetic wave ([0015]; [0040]; photo-responsive polymer coating of polydopamine expressly taught) in order to beneficially provide light-driven clip actuation using optical fibers and other means to achieve remote excitation, which can avoid the discomfort caused by high-temperature heating, and remote excitation is particularly beneficial for minimally invasive interventional treatment ([0039]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Soutorine in view of Fry to have a heat source disposed in each of the first pressing portion and the second pressing portion and configured to heat the core to the reaction temperature in response to at least one of a magnetic field, an electromagnetic wave, and a radio frequency applied from outside the body, wherein the heat source is composed of either nanoparticles dispersed inside the core and configured to generate heat by the magnetic field or the electromagnetic wave, or a polymer with which an outer surface of the core is coated and which is configured to generate heat by the electromagnetic wave in order to beneficially provide light-driven clip actuation using optical fibers and other means to achieve remote excitation, which can avoid the discomfort caused by high-temperature heating, and remote excitation is particularly beneficial for minimally invasive interventional treatment, as taught by Zhang.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Soutorine in view of Fry and Zhang as applied to claim 4 above, and further in view of Asvadi et al. (US 2010/0234779).
Soutorine in view of Fry and Zhang, as applied above, teaches a surgical clip comprising all the limitations of the claim except for wherein the heat source is a micro-heater placed on an outer surface of the core and configured to generate heat by the radio frequency.
However, Asvadi teaches (see Fig. 8C) a similar heat-activated shape memory device (1) comprising a heat source is a micro-heater (3) placed on an outer surface of the core (4) and configured to (i.e., capable of) generate heat by the radio frequency ([0026]; [0041]; [0052]; actuating shape memory material via radio frequency heating expressly disclosed). Accordingly, Asvadi teaches that it is known that an integral heating element actuated via radio frequency and a photoreactive coating actuated by an electromagnetic wave (i.e., light) are elements that are functional equivalents for providing heat actuation to shape memory material components. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the integral heating element actuated via radio frequency taught by Asvadi for the photoreactive coating actuated by an electromagnetic wave of Soutorine in view of Fry and Zhang because both elements were known equivalents for providing heat actuation to shape memory material components within the medical arts. The substitution would have resulted in the predictable results of providing heat actuation to shape memory material components of the device of Soutorine in view of Fry and Zhang.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Soutorine as applied to claim 1 above, and further in view of Moon et al. (WO 2021/071129) (copy and translation provided herein).
Soutorine, as applied above, discloses a surgical clip comprising all the limitations of the claim except for each pressing portion comprising a support connected to the deformable central portion; and a degradable layer disposed on an outer surface of the support and configured to contact and compress the blood vessel, wherein the degradable layer biodegrades after a predetermined period of time to release the compression of the blood vessel; wherein the support biodegrades slower than the degradable layer; and wherein the degradable layer has a porous or mesh structure.
However, Moon teaches (see Figs. 1 and 9) a similar surgical clip having each pressing portion comprising a support (see 11/12, Fig. 1; 310a, Fig. 9; i.e., inner metal clip arm) connected to the deformable central portion (13, Fig. 1); and a degradable layer (310b, Fig. 9; i.e., outer biodegradable polymer layer) disposed on an outer surface of the support (as shown in Fig. 9; [0059]) and configured to (i.,e., capable of) contact and compress the blood vessel (as shown in exemplary Fig. 2), wherein the degradable layer (310b) biodegrades after a predetermined period of time to release the compression of the blood vessel ([0059]); wherein the support (310a) biodegrades slower than the degradable layer (310b) ([0021]; outer biodegradable layer expressly degrades first/quicker than the inner metal layer); and wherein the degradable layer (310b) has a porous or mesh structure ([0014]; [0045]; multiple conventional porous materials such as polyphosphoester expressly taught) in order to beneficially allow for the calculation of a more accurate decomposition speed while preserving the gripping ability of the clamp arm surface ([0007]; [0011]; [0014]-[0015]; [0021]; [0059]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Soutorine to have each pressing portion comprising a support connected to the deformable central portion; and a degradable layer disposed on an outer surface of the support and configured to contact and compress the blood vessel, wherein the degradable layer biodegrades after a predetermined period of time to release the compression of the blood vessel; wherein the support biodegrades slower than the degradable layer; and wherein the degradable layer has a porous or mesh structure in order to beneficially allow for the calculation of a more accurate decomposition speed while preserving the gripping ability of the clamp arm surface, as taught by Moon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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