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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 14, 2025, has been entered.
Acknowledgments
In the reply, filed on November 14, 2025, Applicant amended claims 1-2, 4, 6-9, 11-12, 14-15, 17-18, and 22-24.
Applicant cancelled claims 3 and 19-21.
Applicant added new claims 25-28.
In the final rejection of May 23, 2025, Examiner rejected claims 12, 14-15, 17-18, and 24 under 35 U.S.C. 112(a). Applicant amended claim 12. Rejection is withdrawn.
Currently, claims 1-2, 4, 6-9, 11-12, 14-15, 17-18, and 22-28 are under examination.
Claim Objections
Claims 1, 12, 17, and 26 are objected to because of the following informalities:
In regards to claim 1, line 12, “use” should be changed to “the use”.
In regards to claim 12, line 3, “the steps” should be changed to “steps”.
In regards to claim 12, line 4, “a blood collection and delivery device” should be changed to “the blood collection and delivery device”.
In regards to claim 12, line 16, “a kink” should be changed to “the kink”.
In regards to claim 12, line 17, “blood flow” should be changed to “the blood flow”.
In regards to claim 17, lines 1-2, “a length” should be changed to “the length”.
In regards to claim 26, line 2, “its length” should be changed to “the length”.
Appropriate correction is required.
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 1-2, 4, 6-9, 11-12, 14-15, 17-18, and 22-28 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.
In regards to claim 1, lines 1-2 recite: “A blood collection and delivery device for use in transfusion medicine”; however, such is new matter not described in the Specification. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 2-3 recite: “the device comprising medical tubing for blood collection and administration”; however, such is new matter not described in the Specification. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 5-6 recite: a non-bendable sleeve for removal of kinks “that may form in the medical device during use of the device”; however, such is new matter not described in the Specification. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 11-15 recite: wherein sliding of the non-bendable sleeve along the medical tubing in a direction that is perpendicular to a kink “formed in the medical tubing during use of the device” removes the kink and restores “blood flow within the medical tubing”; however, such is new matter not described in the Specification. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 2, lines 1-7 recite: wherein the non-bendable sleeve comprises a material selected from the group consisting of “polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), polycarbonate (PC), acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon),polyvinylidene fluoride (PVDF), polyether ether ketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA),polyimide (PI), acetal, and polyetherimide (PEI)”; however, such is new matter not described in the Specification.
In regards to claim 4, lines 1-2 recite: wherein the device “further comprises a tubing clamp”; however, such is new matter not described in the Specification.
In regards to claim 12, lines 1-2 recite: A method of restoring “blood flow in a blood collection and delivery device for use in transfusion medicine”; however, such is new matter not described in the Specification. Claims 14-15, 17-18, 24, and 27-28 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 4-5 recite: “providing a blood collection and delivery device comprising i. medical tubing for blood collection and administration”; however, such is new matter not described in the Specification. Claims 14-15, 17-18, 24, and 27-28 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 7-8 recite: a non-bendable sleeve for removal of a kink “that may form in the medical tubing during use of the device”; however, such is new matter not described in the Specification. Claims 14-15, 17-18, 24, and 27-28 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 15-16 recite: sliding the non-bendable sleeve along the medical tubing in a direction that is perpendicular to a kink “formed in the medical tubing”; however, such is new matter not described in the Specification. Claims 14-15, 17-18, 24, and 27-28 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 17-18 recite: wherein the sliding removes the kink and restores “blood flow within the medical tubing”; however, such is new matter not described in the Specification. Claims 14-15, 17-18, 24, and 27-28 are rejected by virtue of being dependent upon claim 12.
In regards to claim 14, lines 1-7 recite: wherein the non-bendable sleeve comprises a material selected from the group consisting of “polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), polycarbonate (PC), acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyether ether ketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA),polyimide (PI), acetal, and polyetherimide (PEI)”; however, such is new matter not described in the Specification.
In regards to claim 23, lines 1-7 recite: wherein the non-bendable sleeve comprises “two or more materials selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), polycarbonate (PC), acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyether ether ketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA), polyimide (PI), acetal, and polyetherimide (PEI)”; however, such is new matter not described in the Specification.
In regards to claim 24, lines 1-7 recite: wherein the non-bendable sleeve comprises “two or more materials selected from the group consisting of polyethylene (PE),polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC),polycarbonate (PC), acrylic, nylon, acrylonitrile-butadiene-styrene (ABS),polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyether ether ketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxy alkanes (PFA), polyimide (PI), acetal, and polyetherimide (PEI)”; however, such is new matter not described in the Specification.
In regards to claim 25, line 1 recites: wherein the device “further comprises a blood bag”; however, such is new matter not described in the Specification.
In regards to claim 27, lines 1-3 recite: wherein the sliding restores “the blood flow within the medical tubing by at least 80% compared to a blood flow within the medical tubing prior to removal of the kinks”; however, such is new matter not described in the Specification.
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 1-2, 4, 6-9, 11, 22-23, and 25-27 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.
In regards to claim 1, lines 5-6 recite “the medical device”. There is insufficient antecedent basis for this limitation in the claim. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 6 and 13 recite “the device”. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 1, lines 6 and 13 reciting “the device”. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 12 and 14 recite “a kink”/“the kink”. Claim 1, line 5 previously recites “kinks”. It is unclear whether the two terms refer to the same component or to different components. Claims 2, 4, 6-9, 11, 22-23, and 25-26 are rejected by virtue of being dependent upon claim 1.
In regards to claim 2, line 1 recites “The device”. Claim 2 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 2, line 1 reciting “The device”.
In regards to claim 4, line 1 recites “The device”. Claim 4 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 4, line 1 reciting “The device”.
In regards to claim 4, line 1 recites “the device”. Claim 4 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 4, line 1 reciting “the device”.
In regards to claim 6, line 1 recites “The device”. Claim 6 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 6, line 1 reciting “The device”.
In regards to claim 6, line 3 recites “the kinked medical tubing”. There is insufficient antecedent basis for this limitation in the claim.
In regards to claim 7, line 1 recites “The device”. Claim 7 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 7, line 1 reciting “The device”.
In regards to claim 8, line 1 recites “The device”. Claim 8 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 8, line 1 reciting “The device”.
In regards to claim 9, line 1 recites “The device”. Claim 9 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 9, line 1 reciting “The device”.
In regards to claim 11, line 1 recites “The device”. Claim 11 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 11, line 1 reciting “The device”.
In regards to claim 22, line 1 recites “The device”. Claim 22 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 22, line 1 reciting “The device”.
In regards to claim 23, line 1 recites “The device”. Claim 23 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 23, line 1 reciting “The device”.
In regards to claim 25, line 1 recites “The device”. Claim 25 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 25, line 1 reciting “The device”.
In regards to claim 25, line 1 recites “the device”. Claim 25 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 25, line 1 reciting “the device”.
In regards to claim 26, line 1 recites “the device”. Claim 26 depends upon claim 1. Claim 1, line 1 previously recites “A blood collection and delivery device” and lines 5-6 previously recite “the medical device”. It is unclear which term is being referred to by claim 26, line 1 reciting “the device”.
In regards to claim 27, line 3 recites “the kinks”. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4, 6-9, 11-12, 14-15, 17-18, and 22-28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783