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 .
Election/Restrictions
Applicant’s election with traverse of Species B in the reply filed on Dec 12, 2025 is acknowledged.
Applicant does not present any arguments to the restriction of Species C from Species A and B, but argues that no burden would exist to examine the claims of both Species A and Species B because each of Species A and B requires a projection. This argument is moot in view of the below indication of claim 5 as being allowable. Pursuant to MPEP § 821.04(a), the restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Claim 5 reads on both Species A and B with claims 6-10 reading only on Species A and claims 11-17 reading only on Species B; since claim 5 is allowable, claims 6-10 and 11-17 require all the limitations of an allowable claim. Accordingly, the restriction requirement between Species A and B is withdrawn. However, claim 18, directed to Species C is withdrawn from consideration because claim 18 does not require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Claim Objections
Claim(s) 4, 6, 7, 13 and 20 is/are objected to because of the following informalities:
In claim 4, line 2-3, “the web of a material” should be corrected to “the web of material” for claim language consistency.
In claim 6, line 2, “the radial projection extending outwardly” should be corrected to “the radial projection” for claim language consistency.
In claim 7, the term “is” should be inserted before the phrase “in the first rolled configuration” on lines 2-3 to be grammatically correct.
In claim 13, the term “the” should be inserted before the phrase “second edge” on line 2 to be grammatically correct.
In claim 20, lines 1-2, “the biodegradable material” should be corrected to “a rolled web of biodegradable material” for claim language consistency.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4, 8, 9, 11, 12,13 and 15 is/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 4, line 2-3 recites “the distal end” and “the proximal end”. Claim 4 is indirectly dependent on claim 1, however both claim 1 and 4 introduces “a distal end” and “a proximal end”. It is unclear if the Applicant intended for claim 4 to refer to the “distal end” and “proximal end” of claim 1 or 4. The antecedent basis for “the distal end” and “the proximal end” is therefore ambiguous. For the sake of examination, the term “the distal end” and “the proximal end” in this claim is being interpreted as “the distal end of the web of material” and “the proximal end of the web of material” respectively. Therefore, The Applicant is suggested to amend claim 4 to overcome rejection.
Claims 5-17 is also rejected by virtue of their dependency on claim 4.
Claim 8, line 2 recites “the proximal end”. Claim 4 is indirectly dependent on claim 1 and 4, however both claim 1 and 4 introduces “a proximal end”. It is unclear if the Applicant intended for claim 8 to refer to the “proximal end” of claim 1 or 4. The antecedent basis for “the proximal end” is therefore ambiguous. For the sake of examination, the phrase “the proximal end” in this claim is being interpreted as “the proximal end of the web of material”. Therefore, The Applicant is suggested to amend claim 8 to overcome rejection.
Claim 9, line 2 recites “the distal end”. Claim 9 is indirectly dependent on both claim 1 and 4, however both claim 1 and 4 introduces “a distal end”. It is unclear if the Applicant intended for claim 9 to refer to the “distal end” of claim 1 or 4. The antecedent basis for “the distal end” is therefore ambiguous. For the sake of examination, the term “the distal end” in this claim is being interpreted as “the distal end of the web of material”. Therefore, The Applicant is suggested to amend claim 9 to overcome rejection.
Claim 12, line 4 recites “biodegradable material”. Claim 12 is dependent on claim 11, however claim 11 does not recite “biodegradable material, and therefore there is insufficient antecedent basis for this limitation in the claim. For the sake of examination, claim 12 is being interpreted as being dependent on claim 10 and the term “the” is inserted before the phrase “biodegradable material”. Applicant is therefore suggested to amend claim 12 to overcome rejection.
Claim 13, line 4 recites “the first are positioned”. The claim is indefinite because it contains an incomplete phrase that renders the scope unclear. The Examiner is unsure what “the first” corresponds to, and therefore the scope of the claim cannot be reasonably determined. For the sake of examination, the phrase “the first are positioned” in this claim is being interpreted as “the second elongate projection is positioned”. Therefore, Applicant is suggested to amend claim 13 to overcome rejection.
Claim 11, line 6 recites “a first rolled configuration”. Claim 11 is indirectly dependent on claim 2, however claim 1 also recites “a first rolled configuration”. It is unclear if the Applicant intended to a new first configuration or intended to refer to the first configuration of claim 2. For the sake of examination “a first rolled configuration” in this claim is being interpreted as being referred to the first configuration of claim 2. Applicant is therefore suggested to amend claim 11 to recite “the first rolled configuration” to overcome rejection.
Claim 13, line 5-6 recites “the first rolled configuration”. Claim 13 is directly dependent on claim 11 and indirectly dependent on claim 2. If claim 11 is intended to introduce a new “first rolled configuration” in addition to that of claim 2, then claim 13 is subject to being rejected with the phrase “the first rolled configuration” lacking proper antecedent basis. However, if the “first rolled configuration” of claim 11 is intended to refer to configuration as that of claim 2 as interpreted by the Examiner for the sake of examination), then no rejection of claim 13 would be necessary. Applicant is therefore suggested to amend claim 13 to overcome objection.
Claim 15, line 2 recites “the proximal end”. Claim 15 is indirectly dependent on claim 1 and 4, however both claim 1 and 4 introduces “a proximal end”. It is unclear if the Applicant intended for claim 15 to refer to the “proximal end” of claim 1 or 4. The antecedent basis for “the proximal end” is therefore ambiguous. For the sake of examination, the phrase “the proximal end” in this claim is being interpreted as “the proximal end of the web of material”. Therefore, The Applicant is suggested to amend claim 15 to overcome rejection.
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, 3 and 4 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Keeney et al (US 20190118213 A1, herein Keeney).
Regarding claim 1, Keeney disclosed that a syringe and syringe package system (application syringe 100 in Fig 1) comprising
a syringe barrel (barrel 110 in Fig. 2, which is an assembly view of Fig. 1) having an open proximal end (see Fig. 4, which is a section view of Fig. 2, wherein the back end 114 corresponds to the proximal end of barrel 110 located away from the distal end of fluid channel 117) and a distal end (see Fig. 4, which is a section view of Fig. 2, wherein the front end 112 corresponds to the distal end of barrel 110 located near to the distal end of fluid channel 117);
a syringe stopper (plunger 120 in Fig. 1) placed in the open proximal end of the syringe barrel (plunger 120 placed in from back end 114 in Fig. 1);
and a shape-changeable package (plunger shaft 130 in Fig. 2), the syringe barrel and the syringe stopper contained within the shape-changeable package (barrel 110 contained within plunger shaft 130 in Fig. 2; plunger 120 contained within barrel 110 which is contained within plunger shaft 130, not shown in Fig. 2, see Fig. 4, which is a section view of Fig. 2) wherein the shape-changeable package comprises a web of material sized and arranged to contain the syringe barrel and the syringe stopper (The resilient material of the plunger shaft causes it to hug the exterior of the barrel [0010]) and configured to be converted to a plunger rod that engages the syringe stopper and is translatable within the open proximal end of the syringe barrel (the two edges of the longitudinal slit may spring back towards each other when the plunger shaft is removed from the barrel of the applicator syringe. In this way, the plunger shaft may be inserted through an opening in the back end of the barrel and placed into operational contact with the back side of the plunger [0010]).
Regarding claim 2, Keeney disclosed all limitations of claim 1. Keeney further disclosed wherein the shape-changeable package is configured to be collapsible from a first rolled configuration (the two edges of the longitudinal slit may be spread apart, thereby opening the plunger shaft so that it can be secured about the exterior of the barrel [0010]) having a first diameter (initial diameter of plunger shaft 130 in Fig. 2 to hug the exterior of barrel) to a second rolled configuration having a second diameter smaller than the first diameter (diameter of plunger shaft 130 in Fig. 5 smaller than the diameter of plunger shaft in Fig. 2) .
Regarding claim 3, Keeney disclosed all limitations of claim 2. Keeney further disclosed wherein the first diameter is sized and arranged to contain the syringe barrel (initial diameter of plunger shaft 130 in Fig. 2 to hug the exterior of barrel) and the second diameter is sized to fit within the syringe stopper and the syringe barrel (diameter of plunger shaft 130 in Fig. 5 smaller than the diameter of plunger shaft in Fig. 2).
Regarding claim 4, Keeney disclosed all limitations of claim 3. Keeney further disclosed wherein the web of a material comprising a distal end (not shown, see annotated Fig. 5 below which is a assembly of Fig.1), a proximal end (not shown, see annotated Fig. 5 below which is a assembly of Fig.1), a first edge extending from the distal end to the proximal end (not shown, see annotated Fig. 5 below which is a assembly of Fig.1) and a second edge extending from the distal end to the proximal end and opposite the first edge (not shown, see annotated Fig. 5 below which is a assembly of Fig.1).
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Annotated Fig. 5 from Keeney
Claim Rejections - 35 USC § 103
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.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C 103 as being unpatentable over Keeney et al (US 20190118213 A1, herein Keeney), and further in view of Fernandes et al. (US 20120277544 A1, herein Fernandes).
Regarding claim 19, Keeney discloses that a syringe and syringe package system (application syringe 100 in Fig 1) comprising:
a syringe barrel (barrel 110 in Fig. 2, which is an assembly view of Fig. 1) having an open proximal end (see Fig. 4, which is a section view of Fig. 2, wherein the back end 114 corresponds to the proximal end of barrel 110 located away from the distal end of fluid channel 117) and a distal end (see Fig. 4, which is a section view of Fig. 2, wherein the front end 112 corresponds to the distal end of barrel 110 located near to the distal end of fluid channel 117);
a syringe stopper (plunger 120 in Fig. 1) placed in the open proximal end of the syringe barrel (plunger 120 placed in from back end 114 in Fig. 1);
and a shape-changeable package (plunger shaft 130 in Fig. 2), the syringe barrel and the syringe stopper contained within the shape-changeable package (barrel 110 contained within plunger shaft 130 in Fig. 2; plunger 120 contained within barrel 110 which is contained within plunger shaft 130, not shown in Fig. 2, see Fig. 4, which is a section view of Fig. 2) wherein the shape-changeable package sized and arranged to contain the syringe barrel and the syringe stopper (The resilient material of the plunger shaft causes it to hug the exterior of the barrel [0010]) and configured to be converted to a plunger rod that engages the syringe stopper and is translatable within the open proximal end of the syringe barrel (the two edges of the longitudinal slit may spring back towards each other when the plunger shaft is removed from the barrel of the applicator syringe. In this way, the plunger shaft may be inserted through an opening in the back end of the barrel and placed into operational contact with the back side of the plunger [0010]). Keeney discloses that the shape-changeable package comprises a rolled web of material, but does not explicitly disclose that this material is biodegradable.
However, Fernandes teaches the insertion guide provides a pathway or conduit for a stimulation lead, a catheter, medical device, or other therapeutic device to a desired location. The insertion guide is further made of biodegradable material [0012], demonstrating that biodegradable material was known and suitable for use in medical device components.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the application syringe of Keeney with Fernandes to include the shape-changeable package comprises a rolled web of biodegradable material since such a modification may reduce environmental impact associated with single-use medical devices such as syringes. Material selection for medical device components is a routine design consideration, and the substitution of a known material for another yields predictable results (see MPEP 2143.I.B).
Regarding claim 20, Keeney as modified by Fernandes disclosed all limitations of claim 19. Keeney further disclosed all limitations of claim 19. However, Keeney failed to explicitly disclose wherein the biodegradable material comprises zein.
However, Fernandes teaches that biodegradable polymers may include natural polymers and polymers derived thereof such as albumin, alginate, casein, chitin, chitosan, collagen, dextran, elastin, proteoglycans, gelatin and other hydrophilic proteins, glutin, zein and other prolamines and hydrophobic proteins [0070].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the application syringe of Keeney with Fernandes to include wherein the biodegradable material comprises zein since such a modification would enable the device of Keeney to degrade either by enzymatic hydrolysis or exposure to water, by surface or bulk erosion [0070]. Material selection for medical device components is a routine design consideration, and the substitution of a known material for another yields predictable results (see MPEP 2143.I.B).
Allowable Subject Matter
Claim(s) 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject
matter:
The subject matter of dependent claims 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 could not be found nor was suggested in the prior art of record.
Claim 5 requires a radial projection to engage with the first edge. Keeney discloses the first edge (see annotated Fig. 5 below which is an assembly of Fig.1) but fails to explicitly disclose a radial projection to engage with the first edge. Koopman (US 20060229568 A1, herein Koopman) also reads on the invention of claims 1-4, but also does not disclose the subject matter of dependent claim 5.
Claims 6-17 depend, directly or indirectly, on claim 5 and therefore incorporate all the limitations of claim 5. Because claim 5 includes limitations not taught or suggested by the prior art of record, claims 6-17 likewise contain allowable subject matter. Koopman teaches the flange required by claim 8 and 15 and Fernandes et al. teaches the biodegradable material required by claims 10, 12, 16 and 17. However because claims 6-17 are directly and indirectly dependent on claim 5, they inherit the limitations of claim 5 which are not taught or suggested by prior art of record.
Any comments considered necessary by applicant must be submitted no later
than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on
Statement of Reasons for Allowance.”
Conclusion
16. Any inquiry concerning this communication or earlier communications from the
examiner should be directed to MAHMOOD FAROOQ whose telephone number is
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for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783