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 .
Response to Amendment
The amendment filed on March 20, 2026 was considered by the examiner. Claims 1-15 are pending in the application. Also, the response filed on March 20, 2026 is not in conformance with the Office’s rules and regulations regarding claim amendments. In particular, Applicant has removed “i.” and “ii.” from claim 2, and “a.”, “b.”, “c.”, and “d.” from claim 9, as submitted on December 21, 2023, with no indication of this claim amendment, or new markings to indicate this claim amendment. In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making claim amendments.
Claim Objections
Claims 1, 4, 9, and 13 are objected to because of the following informalities:
in claim 1, line 7: “poly-terephthalate” should be “poly-terephthalate; and”;
in claim 4, line 1: “the” should be inserted before “at least one”;
in claim 5, line 2: “Shore 70” should be “Shore A 70”;
in claim 9, line 14: “poly-terephthalate.” should be “poly-terephthalate; and”; and
in claim 13, line 1: “the” should be inserted before “at least one”.
Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The specification ¶[0004] contains a hyperlink that should be removed.
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.
Claims 1-15 are 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 1 recites “wherein the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511” in lines 8-9. The specification of the present application details that the “biodegradable polymer/plastic showed a 13.12% biodegration over 90 days” (see specification ¶[0066]-[0067]). The recitation as presently recited in claim 1 is broader than the disclosure given in the specification, such that, the recitation as recited in claim 1 is considered new matter. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 2 recites “wherein the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511” in lines 8-9. The specification of the present application details that the “biodegradable polymer/plastic showed a 13.12% biodegration over 90 days” (see specification ¶[0066]-[0067]). The recitation as presently recited in claim 2 is broader than the disclosure given in the specification, such that, the recitation as recited in claim 2 is considered new matter. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 3-8 are rejected by virtue of their dependence from claim 2.
Claim 9 recites “wherein the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511” in lines 14-16. The specification of the present application details that the “biodegradable polymer/plastic showed a 13.12% biodegration over 90 days” (see specification ¶[0066]-[0067]). The recitation as presently recited in claim 2 is broader than the disclosure given in the specification, such that, the recitation as recited in claim 2 is considered new matter. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 10-15 are rejected by virtue of their dependence from claim 9.
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 1-15 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 1 recites the limitation “the material composition” in line 8. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “the inflatable bladder” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 1 contains the trademark/trade name ASTM in line 9. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a standard and, accordingly, the identification/description is indefinite.
Claim 2 contains the trademark/trade name ASTM in line 9. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a standard and, accordingly, the identification/description is indefinite.
Claims 3-8 are rejected by virtue of their dependence from claim 2.
Claim 6 recites “the inflatable bladder has a Shore D 60 to Shore D 70 hardness” in lines 1-2; however, that level of hardness appears to be too much for an inflatable bladder. It appears as if the recitation should read “the at least one connector”; see the present specification ¶[0014], the connectors have a hardness between Shore D 45 to Shore D 80. Amending the recitation to “the at least one connector has a Shore D 60 to Shore D 70 hardness” would overcome the present recitation. The claim is being read as such for the purposes of examination.
Claim 8 recites “is reusable” in line 2, but it is not clear what structure (i.e., the cuff or the sleeve) is intended to be reusable. From the specification, it appears as if the cuff is reusable. Amending the claim as such would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claims 3-8 are rejected by virtue of their dependence from claim 2.
Claim 9 recites “the additive is added to each of the materials in a-c” in line 12, which is not clear. It is not clear the relationship between “the additive” in line 12 has to the recitations of “an additive” in lines 2, 5, and 8. The indefinite article “a” suggests that they are different, but the similar phraseology and definite article “the” used in line 12 suggest that they are related/the same. Furthermore, “the materials in a-c” lacks antecedent basis. Furthermore, “a-c” is not referencing any element in the claim as amended. These inconsistencies render claim 9 indefinite. The relationship between the recitations of “additive” should be made clear. To what “the additive” of line 12 is being added should be clearly stated.
Claim 9 recites the limitation “the material composition” in lines 15-16. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 contains the trademark/trade name ASTM in line 16. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a standard and, accordingly, the identification/description is indefinite.
Claims 10-15 are rejected by virtue of their dependence from claim 9.
Claim 10 recites “the non-biodegradable polymer in a-c” in line 1. It is not clear the relationship between “the non-biodegradable polymer” in claim 10 has to the recitations of “a non-biodegradable polymer” in claim 9, lines 2, 5, and 8. The indefinite article “a” suggests that they are different, but the similar phraseology and definite article “the” used in claim 10 suggest that they are related/the same. Furthermore, “a-c” is not referencing any element in claim 9 as amended. These inconsistencies render claim 10 indefinite. The relationship between the recitations of “non-biodegradable polymer” should be made clear.
Claim 11 recites “further comprising: an antimicrobial additive” in lines 1-2; however, it is not clear what further comprises the antimicrobial additive. One of a-c or combinations thereof? This causes claim 11 to be indefinite.
Claim 12 is rejected by virtue of its dependence from claim 11.
Claim 15 recites “is reusable” in line 2, but it is not clear what structure (i.e., the cuff or the sleeve) is intended to be reusable. From the specification, it appears as if the cuff is reusable. Amending the claim as such would overcome the present rejection. The claim is being read as such for the purposes of examination.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 102 and 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 2, 4, and 7-8 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Vivenzio et al. (US Patent Application Publication 2010/0298724 – cited in prior action), hereinafter Vivenzio.
Regarding Claim 2, Vivenzio teaches a blood pressure cuff that may be entirely made from a biodegradable material (see abstract and Figs. 1-8). Vivenzio teaches a blood pressure cuff (see abstract and Figs. 1-8) comprising:
an inflatable bladder (¶[0041]-[0043] the cuff 20 may include a bladder 60 disposed within a sleeve 30, ¶[0048] the cuff 100 with the sleeve 102 with the sealed inflatable compartment 114 in place of the removable bladder, ¶[0052]-[0053] and ¶[0056] the cuff 150 with inflatable cuff interior, the cuff 150 may only be used a certain number of times, which could be one or several; Figs. 1-8); and
at least one connector (¶[0043] the socket 64, ¶[0049] the socket 110, ¶[0053] the socket 158; Figs. 1-8),
wherein the inflatable bladder and the at least one connector are made from a material (¶[0015]-[0016], ¶[0023], ¶[0041], ¶[0048], ¶[0052], and ¶[0058] the cuff and/or the sleeve may be formed of the same biodegradable material, the socket is included in the structure of the cuff) comprised of:
i. a non-biodegradable polymer selected from a group consisting of polyamide, polyester, polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane and combinations thereof (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable); and
ii. a biodegradable additive (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable),
wherein the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511 (as Vivenzio teaches the composition of the material, Vivenzio teaches such a claimed property, and the property would be inherent to the composition of Vivenzio, see MPEP 2112.01 (I) and (II)).
Regarding Claim 4, Vivenzio teaches the device of claim 2 as stated above. Vivenzio further teaches the inflatable bladder and at least one connector are made of the same material (¶[0015]-[0016], ¶[0023], ¶[0041], ¶[0048], ¶[0052], and ¶[0058] the cuff and/or the sleeve may be formed of the same biodegradable material, the socket is included in the structure of the cuff).
Regarding Claim 7, Vivenzio teaches the device of claim 2 as stated above. Vivenzio further teaches the blood pressure cuff is a single-use disposable blood pressure cuff (¶[0052]-[0053] and ¶[0056] the cuff 150 with inflatable cuff interior, the cuff 150 may only be used a certain number of times, which could be one or several; Fig. 8).
Regarding Claim 8, Vivenzio teaches the device of claim 2 as stated above. Vivenzio further teaches the blood pressure cuff further includes a sleeve and is reusable (¶[0041]-[0043] the cuff 20 may include a bladder 60 disposed within a sleeve 30, the cuff is reusable and the sleeve is disposable; Figs. 1-3).
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.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1, 9-10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Vivenzio as applied to claim 2 above, and in view of Citron et al. (US Patent Application Publication 2023/0081428 – cited in prior action), hereinafter Citron.
Regarding Claim 1, Vivenzio teaches a blood pressure cuff that may be entirely made from a biodegradable material (see abstract and Figs. 1-8). Vivenzio teaches a blood pressure cuff (see abstract and Figs. 1-8) comprising:
an inflatable bladder (¶[0041]-[0043] the cuff 20 may include a bladder 60 disposed within a sleeve 30, ¶[0048] the cuff 100 with the sleeve 102 with the sealed inflatable compartment 114 in place of the removable bladder, ¶[0052]-[0053] and ¶[0056] the cuff 150 with inflatable cuff interior, the cuff 150 may only be used a certain number of times, which could be one or several; Figs. 1-8) comprised of:
a non-biodegradable polymer selected from a group consisting of polyamide, polyester, polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane and combinations thereof (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable);
and an additive (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable).
The modified Vivenzio details two commercial additives that may be utilized to make the material biodegradable (see ¶[0041]), but not specifically what the additives comprise.
Citron teaches a composition comprising an additive including a biodegradable polymer, a biodegradation catalyst, and a polymer carrier (see abstract),
in which the additives are added to a target polymer, such as polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), or combinations thereof (see ¶[0033]),
in which the biodegradable polymer in the additive may include polylactic acid (PLA), polyhydroxyalkanoates (PHA), polybutylene adipate terephthalate (PBAT), or combinations thereof (see ¶[0030]),
the biodegradation catalyst may include an inorganic compound, such as calcium phosphate and/or an organic compound, such as bone meal, or combinations thereof (see ¶[0029]), and
the polymer carrier is the same as or compatible with the target polymer, such as polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), or combinations thereof (see ¶[0035]),
in which the polymer additive is added to the target polymer in an amount sufficient to promote biodegradation of the target polymer in the natural environment, such as 0.25% by weight to approximately 25% by weight of the weight of the target polymer; preferably, approximately 0.5% by weight to approximately 2% by weight of the target polymer (see ¶[0033]), and
the polymer additive comprises the following weight components: polymer carrier 0% to approximately 75%; preferably, approximately 40% to approximately 55%; biodegradable polymer approximately 25% to approximately 97%; preferably, approximately 40% to approximately 55%; and biodegradation catalyst approximately 0.05% to approximately 10%; preferably, approximately 1% to approximately 3% (see ¶[0036]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the additive composition of Citron as the additive in the modified Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires a biodegradable additive and Citron teaches one such additive. Here, the present application indicates that polyethylene terephthalate is a poly-terephthalate (see present specification ¶[0020]).
The modified Vivenzio teaches that the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511 (as the modified Vivenzio teaches the composition of the material, the modified Vivenzio teaches such a claimed property, and the property would be inherent to the composition of the modified Vivenzio, see MPEP 2112.01 (I) and (II)).
Regarding Claim 9, Vivenzio teaches a blood pressure cuff that may be entirely made from a biodegradable material (see abstract and Figs. 1-8). Vivenzio teaches a blood pressure cuff (see abstract and Figs. 1-8) comprising:
a. an inflatable bladder (¶[0041]-[0043] the cuff 20 may include a bladder 60 disposed within a sleeve 30, ¶[0048] the cuff 100 with the sleeve 102 with the sealed inflatable compartment 114 in place of the removable bladder, ¶[0052]-[0053] and ¶[0056] the cuff 150 with inflatable cuff interior, the cuff 150 may only be used a certain number of times, which could be one or several; Figs. 1-8) de of a non-biodegradable polymer and an additive, wherein the non-biodegradable polymer is selected from polyamide, polyester, polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane and combinations thereof (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable);
b. at least one connector (¶[0043] the socket 64, ¶[0049] the socket 110, ¶[0053] the socket 158; Figs. 1-8) made of a non-biodegradable polymer and an additive, wherein the non-biodegradable polymer is selected from a group consisting of nylon, polyester, polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane and combinations thereof (¶[0015]-[0016], ¶[0023], ¶[0041], ¶[0048], ¶[0052], and ¶[0058] the cuff and/or the sleeve may be formed of the same biodegradable material, the socket is included in the structure of the, ¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable);
c. tubing (¶[0002] the tubing to connect the pump to the cuff, ¶[0051] the pneumatic means 138; Fig. 7); and
d. wherein the additive is added to each of the materials in a-b (¶[0041], ¶[0048], and ¶[0058] the cuff may be made from polyethylene or polypropylene treated with an additive to make the material biodegradable).
Vivenzio describes that a hose/pneumatic means is utilized to inflate the cuff/bladder, but does not specifically describe what material is utilized to make the hose.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the same material as the bladder and connector in making the hose because (1) it is the application of a known technique to a known device ready for improvements to yield predictable results; and/or (2) the hose requires a material and Vivenzio teaches one such material; and/or (3) the biodegradable material of Vivenzio is ecologically friendly and at a low cost, especially since it is the same material as the other parts, as a different material would not need to be made/sourced (see Vivenzio ¶[0001], ¶[0021], and ¶[0023]).
The modified Vivenzio details two commercial additives that may be utilized to make the material biodegradable (see ¶[0041]), but not specifically what the additives comprise.
Citron teaches a composition comprising an additive including a biodegradable polymer, a biodegradation catalyst, and a polymer carrier (see abstract),
in which the additives are added to a target polymer, such as polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), or combinations thereof (see ¶[0033]),
in which the biodegradable polymer in the additive may include polylactic acid (PLA), polyhydroxyalkanoates (PHA), polybutylene adipate terephthalate (PBAT), or combinations thereof (see ¶[0030]),
the biodegradation catalyst may include an inorganic compound, such as calcium phosphate and/or an organic compound, such as bone meal, or combinations thereof (see ¶[0029]), and
the polymer carrier is the same as or compatible with the target polymer, such as polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), or combinations thereof (see ¶[0035]),
in which the polymer additive is added to the target polymer in an amount sufficient to promote biodegradation of the target polymer in the natural environment, such as 0.25% by weight to approximately 25% by weight of the weight of the target polymer; preferably, approximately 0.5% by weight to approximately 2% by weight of the target polymer (see ¶[0033]), and
the polymer additive comprises the following weight components: polymer carrier 0% to approximately 75%; preferably, approximately 40% to approximately 55%; biodegradable polymer approximately 25% to approximately 97%; preferably, approximately 40% to approximately 55%; and biodegradation catalyst approximately 0.05% to approximately 10%; preferably, approximately 1% to approximately 3% (see ¶[0036]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the additive composition of Citron as the additive in the modified Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires a biodegradable additive and Citron teaches one such additive. Here, the present application indicates that polyethylene terephthalate is a poly-terephthalate (see present specification ¶[0020]).
The modified Vivenzio teaches that the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511 (as the modified Vivenzio teaches the composition of the material, the modified Vivenzio teaches such a claimed property, and the property would be inherent to the composition of the modified Vivenzio, see MPEP 2112.01 (I) and (II)).
Regarding Claim 10, Vivenzio in view of Citron teaches the device of claim 9 as stated above. The modified Vivenzio further teaches wherein the non-biodegradable polymer in a-c is present in a concentration from 90-99.9 wt. %, the additive is present in a concentration from 0.1-10 wt. % (see Citron ¶[0033], the polymer additive is added to the target polymer in an amount sufficient to promote biodegradation of the target polymer in the natural environment, such as 0.25% by weight to approximately 25% by weight of the weight of the target polymer; preferably, approximately 0.5% by weight to approximately 2% by weight of the target polymer) and
the additive has 30-70 wt. % of the first polymer and 30-70% of the second polymer (see Citron ¶[0036], the polymer additive comprises the following weight components: polymer carrier 0% to approximately 75%; preferably, approximately 40% to approximately 55%; biodegradable polymer approximately 25% to approximately 97%; preferably, approximately 40% to approximately 55%; and biodegradation catalyst approximately 0.05% to approximately 10%; preferably, approximately 1% to approximately 3%).
Here, the ranges of the modified Vivenzio suggest the ranges of the present claim because the claimed ranges overlap with the ranges of the modified Vivenzio. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 14, Vivenzio in view of Citron teaches the device of claim 9 as stated above. Vivenzio further teaches the blood pressure cuff is a single-use disposable blood pressure cuff (¶[0052]-[0053] and ¶[0056] the cuff 150 with inflatable cuff interior, the cuff 150 may only be used a certain number of times, which could be one or several; Fig. 8).
Regarding Claim 15, Vivenzio in view of Citron teaches the device of claim 9 as stated above. Vivenzio further teaches the blood pressure cuff further includes a sleeve and is reusable (¶[0041]-[0043] the cuff 20 may include a bladder 60 disposed within a sleeve 30, the cuff is reusable and the sleeve is disposable; Figs. 1-3).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Vivenzio as applied to claim 2 above, and in view of McCarthy et al. (US Patent Application Publication 2017/0367863 – cited in prior action), hereinafter McCarthy.
Regarding Claim 3, Vivenzio teaches the device of claim 2 as stated above. Vivenzio does not specifically teach the hardness of the inflatable bladder or of the at least one connector.
McCarthy teaches devices and methods for treating obesity involving a balloon system (see abstract and ¶[0022]; Figs. 6A-6B), in which a valve for inflation has a hardness of Shore A 50 or greater, and a retaining structure for the valve that has a hardness of Shore D 40 to Shore D 70 or more, and may be made from a non-metallic polymeric material (see ¶[0104] and ¶[0107]; Figs. 6A-6B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the valve and retaining structure of McCarthy as the socket in Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires a socket and McCarthy teaches one such socket; and/or (3) the harder housing of the valve ensures that the components are sealed properly during inflation (see McCarthy ¶[0104]).
Here, the socket of the modified Vivenzio now includes a structure with hardness of Shore D 40 to Shore D 70 (i.e., the retaining structure for the valve), which would be a different hardness than the flexible material used in the cuff configured to be wrapped around a user’s arm (see Vivenzio Figs. 4, 7, and 10). For example, Hapco inc. (“Hardness Comparison Chart”, Hapco inc., accessed on 01/23/2026, accessed at https://hapcoincorporated.com/resources/hardness-chart/) teaches that an inner tube has a hardness of about Shore A 40, while Shore D 40 to Shore D 70 corresponds to a textbook cover, golf ball, shopping cart wheel, and wooden ruler (see pg. 2). Therefore, the inflatable bladder and the at least one connector in the modified Vivenzio would have differing hardnesses, as a hardness of Shore D 40 to Shore D 70 would not be capable to wrap around an arm of a user.
Regarding Claim 6, Vivenzio teaches the device of claim 2 as stated above. Vivenzio does not specifically teach the hardness of the at least one connector (see above 35 U.S.C. § 112 rejection/interpretation).
McCarthy teaches devices and methods for treating obesity involving a balloon system (see abstract and ¶[0022]; Figs. 6A-6B), in which a valve for inflation has a hardness of Shore A 50 or greater, and a retaining structure for the valve that has a hardness of Shore D 40 to Shore D 70 or more, and may be made from a non-metallic polymeric material (see ¶[0104] and ¶[0107]; Figs. 6A-6B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the valve and retaining structure of McCarthy as the socket in Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires a socket and McCarthy teaches one such socket; and/or (3) the harder housing of the valve ensures that the components are sealed properly during inflation (see McCarthy ¶[0104]).
Here, the socket of the modified Vivenzio now includes a structure with hardness of Shore D 40 to Shore D 70 (i.e., the retaining structure for the valve. Therefore, the range of the modified Vivenzio suggests the range of the present claim because Shore D 60 to Shore D 70 falls within the range of Shore D 40 to Shore D 70. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vivenzio as applied to claim 2 above, and in view of Nishikawa et al. (US Patent Application Publication 2019/0261871 – cited in prior action), hereinafter Nishikawa.
Regarding Claim 5, Vivenzio teaches the device of claim 2 as stated above. Vivenzio does not specifically teach the hardness of the inflatable bladder.
Nishikawa teaches a bag-shaped structure excellent in creep resistance and vascular compressibility (see abstract and Figs. 5-6), in which the sheet layers forming the bag-shaped structure have layers, in which the outer layers have a hardness of Shore A 70 or higher and the middle layer has a hardness of Shore A 65 or lower (see ¶[0015]-[0018] and ¶[0054]-[0055]; Figs. 4-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the hardness and structure of the bag-shaped structure of Nishikawa with the inflatable bladder in Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires an inflatable bladder and Nishikawa teaches one such bladder; and/or (3) the hardness configuration of Nishikawa used in a cuff of a blood pressure monitor is excellent in creep resistance and vascular compressibility (see Nishikawa abstract and ¶[0073]).
Here, the inflatable bladder of the modified Vivenzio now includes a structure with hardness of Shore A 70 or higher and Shore A 65 or lower. Therefore, the range of the modified Vivenzio suggests the range of the present claim because Shore A 50 to Shore A 70 overlaps with the range of Shore A 70 or higher and Shore A 65 or lower. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vivenzio in view of Citron as applied to claim 9 above, and in view of Deselle et al. (US Patent Application Publication 2015/0351851 – cited in prior action), hereinafter Deselle.
Regarding Claim 11, Vivenzio in view of Citron teaches the device of claim 9 as stated above. The modified Vivenzio does not specifically teach further comprising: an antimicrobial additive.
Deselle teaches an economical blood pressure cuff shield that acts as a hygienic barrier between patients and blood pressure cuffs during measurements (see abstract and Figs. 1-3), in which the shield may comprise polypropylene, polyethylene, paper, or polylactic acid (PLA) (see ¶[0060]) and the antimicrobial agent may include ionic silver, ionic copper (see ¶[0052]-[0055]), and isothiazones (see ¶[0058]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the antimicrobial agent of Deselle with the sleeve in the modified Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the antimicrobial agent would help to reduce the risk of pathogen spread to the blood pressure cuff or from patient to patient (see Deselle ¶[0001], ¶[0028]-[0029], and ¶[0063]-[0064]).
Regarding Claim 12, Vivenzio in view of Citron and Deselle teaches the device of claim 11 as stated above. The modified Vivenzio further teaches the antimicrobial is selected from isothiazolinone treatments, zinc pyrithione, thiabendazole, and silver (see Deselle ¶[0052]-[0055], the antimicrobial agent may include ionic silver, ionic copper, and see ¶[0058], isothiazones).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vivenzio in view of Citron as applied to claim 9 above, and in view of McCarthy.
Regarding Claim 13, Vivenzio in view of Citron teaches the device of claim 9 as stated above. The modified Vivenzio does not specifically teach the hardness of the inflatable bladder or of the at least one connector.
McCarthy teaches devices and methods for treating obesity involving a balloon system (see abstract and ¶[0022]; Figs. 6A-6B), in which a valve for inflation has a hardness of Shore A 50 or greater, and a retaining structure for the valve that has a hardness of Shore D 40 to Shore D 70 or more, and may be made from a non-metallic polymeric material (see ¶[0104] and ¶[0107]; Figs. 6A-6B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the valve and retaining structure of McCarthy as the socket in the modified Vivenzio because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Vivenzio requires a socket and McCarthy teaches one such socket; and/or (3) the harder housing of the valve ensures that the components are sealed properly during inflation (see McCarthy ¶[0104]).
Here, the socket of the modified Vivenzio now includes a structure with hardness of Shore D 40 to Shore D 70 (i.e., the retaining structure for the valve), which would be a different hardness than the flexible material used in the cuff configured to be wrapped around a user’s arm (see Vivenzio Figs. 4, 7, and 10). For example, Hapco inc. (“Hardness Comparison Chart”, Hapco inc., accessed on 01/23/2026, accessed at https://hapcoincorporated.com/resources/hardness-chart/) teaches that an inner tube has a hardness of about Shore A 40, while Shore D 40 to Shore D 70 corresponds to a textbook cover, golf ball, shopping cart wheel, and wooden ruler (see pg. 2). Therefore, the inflatable bladder and the at least one connector in the modified Vivenzio would have differing hardnesses, as a hardness of Shore D 40 to Shore D 70 would not be capable to wrap around an arm of a user.
Response to Arguments
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 7, filed March 20, 2026, with respect to the rejections of claims 6 and 8-15 under 35 U.S.C. § 112(b) have been fully considered and are NOT persuasive. The Applicant has not addressed the rejections by amendment or by argument. Therefore, the rejections are maintained. The new grounds of rejection under 35 U.S.C. § 112 were necessitated by Applicant’s amendment filed on March 20, 2026.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 7-11, filed March 20, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. § 102 and § 103 have been fully considered and are NOT persuasive. Applicant first argues that, with regard to claim 2, Vivenzio does not teach the claim as presently amended, including the recitation that “the material composition exhibits at least 10% anaerobic biodegradation within 90 days when tested according to ASTM D5511”. The examiner respectfully disagrees. As stated above, as Vivenzio teaches the composition of the material, Vivenzio teaches such a claimed property, and the property would be inherent to the composition of Vivenzio, see MPEP 2112.01 (I) and (II). Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, with regard to claims 1 and 9, similar to the above claim 2 arguments, Vivenzio in view of Citron does not teach every element of amended claims 1 and 9. This argument is not persuasive as explained above. The Applicant also argues that the combination of Vivenzio in view of Citron is a hindsight reconstruction, and not a proper obvious analysis. The examiner respectfully disagrees. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that, with respect to the McCarthy reference, the components recited in McCarthy are not those recited in the present claims, and that McCarthy does not disclose a cuff bladder or connector pair having the claimed hardness relationship, and the rejection relies on improper component-to-component mapping. The examiner respectfully disagrees. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the rejections to claims 3 and 6 rely on a combination of Vivenzio in view of McCarthy, and claim 13 relies on a combination of Vivenzio in view of Citron and McCarthy, that in combination, teach the elements of those respective claims. Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that, with respect to the Nishikawa reference, the hardness discussion pertains to different layers of that bag-shaped structure (i.e., in Nishikawa) and Nishikawa does not disclose an inflatable bladder of a blood pressure cuff having the presently claimed Shore A hardness range as a unitary claim limitation, and it does not teach Applicant’s claimed biodegradable additive formulation or ASTM D5511 performance. The examiner respectfully disagrees. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the rejection to claim 5 relies on a combination of Vivenzio in view of Nishikawa, that in combination, teach the elements of claim 5. Therefore, Applicant’s arguments are not persuasive.
Next, the Applicant argues that, with respect to the Deselle reference, that while Deselle may disclose antimicrobial agents for the separate shield of Deselle, Deselle does not that Applicant’s claimed blood pressure cuff materials further comprise an antimicrobial additive, and that a separate barrier or sleeve with antimicrobial properties is not the same as incorporating an antimicrobial additive into the claimed cuff components. The examiner respectfully disagrees. First, the present claim 11 as written is not clear as to which component, if any, an antimicrobial additive may be incorporated therewithin. See above 35 U.S.C. § 112(b). Nevertheless, and secondly, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the rejection to claims 11-12 relies on a combination of Vivenzio in view of Citron and Deselle, that in combination, teach the elements of claims 11-12. Therefore, Applicant’s arguments are not persuasive.
Applicant’s arguments directed towards the dependent claims are not persuasive for commensurate reasons for the independent claims as argued above. Therefore, Applicant’s arguments are not persuasive and the rejections to claims 1-15 under 35 U.S.C. § 102 and § 103 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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