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 Pursuant to MPEP § 821.04(a), the restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim.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 Accordingly, the restriction requirement between Species A and B is withdrawn. However, claim 18, directed to Species C is withdrawn from consideration because claim 18 does not require all the limitations of an allowable claim.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) 1 is/are objected to because of the following informalities:
In claim 1, the term “and” at the end of line 2 should be removed for grammatical correctness.
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) 7 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 7, line 3 recites “the first rolled configuration”. Claim 7 is directly dependent on claim 6 and indirectly dependent on claim 1. However, neither claim 1 or claim 6 introduces “a first rolled configuration” and therefore there is insufficient antecedent basis for this limitation in claim 7. It is unclear if the Applicant has intended to introduce a new “first rolled configuration” or refer to the “first rolled configuration” of claim 2. For the sake of Examination, it is being interpreted that “the first rolled configuration” of claim 7 is intended to refer to claim 2. Therefore, Applicant is suggested to amend claim 6 to depend on claim 2 to overcome rejection of claim 7.
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, 6, 7, 8 and 9 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Perot et al (US 20130256166 A1, herein Perot).
Regarding claim 1, Perot discloses a syringe and syringe package system (drug delivery device 1 in Fig. 1 which is interpreted as a syringe in a package system) comprising:
a syringe barrel (tubular barrel 4 in Fig. 3) having an open proximal end and a distal end (having open distal and proximal ends [0067]);
a syringe stopper (plunger 20 in Fig. 6) placed in the open proximal end of the syringe barrel (the proximal end being sized and shaped to receive a plunger 20 [0067]); and
a shape-changeable package (package 3 in Fig. 1, which is seen to split into web of material/plunger rod 8 and tray 9 in Fig. 3, and interpreted as shape changeable), the syringe barrel and the syringe stopper contained within the shape-changeable package (tubular barrel 4 and plunger 20 is seen contained within package 3 in Fig. 6), wherein the shape-changeable package comprises a web of material (package 3 is interpreted to comprise web of material 8) having a distal end (the tear-off line 7 runs only on one side of the web of material 8 and it has a proximal end 7a and a distal end 7b [0074]; it is interpreted that the location on plunger rod 8 near 7b is the distal end of web of material 8) , a proximal end (the tear-off line 7 runs only on one side of the web of material 8 and it has a proximal end 7a and a distal end 7b [0074]; it is interpreted that the location on web of material 8 near 7a is the proximal end of web of material 8), a first edge (junction outline 22 near first longitudinal portion 11 in Fig. 4) extending from the distal end of the web of material to the proximal end of the web of material (junction outline 22 is seen extending from distal end to proximal end in Fig. 4) and a second edge (junction outline 22 near second longitudinal portion 12 in Fig. 4) extending from the distal end of the web of material to the proximal end of the web of material (junction outline 22 is seen extending from distal end to proximal end in Fig. 4) and opposite the first edge (first longitudinal portion 11 and 12 are located opposite to each other and therefore the two junction outlines is interpreted to be opposite to each other in Fig. 4), the web of material sized and arranged to contain the syringe barrel and the syringe stopper (web of material 8 contains barrel 4 and plunger 20 in Fig. 6) and configured to be converted to a plunger rod (web of material 8 is converted to a plunger rod in Fig. 5) that engages the syringe stopper (the plunger rod 8 is provided at its distal end with attaching means, under the form of a projecting screw 13 on the example shown, for attaching said distal end to the plunger 20 present in the tubular barrel 4 [0080]) and is translatable within the open proximal end of the syringe barrel (plunger rod 8 is inserted into proximal end of barrel 4 in Fig. 5); and
a radial projection (see radial projection in annotated Fig. 7 below) configured to releasably engage the first edge (radial projection is seen in engagement with junction outline 22 in annotated Fig. 7; since web of material 8 can separate from tray 9 when line 7 is torn, it is interpreted that the radial projection is in releasable engagement with junction outline 22).
PNG
media_image1.png
407
478
media_image1.png
Greyscale
Annotated Fig. 7 of Perot
Regarding claim 6, Perot disclosed all limitations of claim 1. Perot further discloses the first edge comprising a crease (see crease in annotated Fig. 7 above) and the radial projection extending outwardly configured to lock with the crease (crease of line 7 engages with radial projection in annotated Fig. 7 above)
Regarding claim 7, Perot disclosed all limitations of claim 6. Perot further discloses wherein when the radial projection is locked with the crease, the shape-changeable package is in the first rolled configuration (package 3 is seen in a rolled form in annotated Fig. 7 when crease is in engagement with radial projection).
Regarding claim 8, Perot disclosed all limitations of claim 6. Perot further discloses further comprising a flange (flange 16 in Fig. 6) extending from the proximal end of the web of material (flange 16 extends from proximal end of web of material 8 in Fig. 6), the flange providing a thumb press for the plunger rod (flange 16 is interpreted as providing thumb press when plunger rod 8 is pushed into barrel 4 in Fig. 5).
Regarding claim 9, Perot disclosed all limitations of claim 8. Perot further discloses further comprising lugs (see projecting screw 13 as lugs in Fig. 4) extending radially outwardly from the distal end of the web of material (projecting screw 13 is interpreted as projecting out radially and located near distal end of web of material 8) and configured to engage the syringe stopper (projecting screw 13, for attaching said distal end of plunger rod 8 to the plunger 20 [0080]) and the syringe stopper comprising threads configured to engage the lugs (plunger 20 being provided with a threaded recess matching the thread of the screw 13 [0080]).
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) 10, 12, 19 and 20 is/are rejected under 35 U.S.C 103 as being unpatentable over Perot et al (US 20130256166 A1, herein Perot), and further in view of Fernandes et al. (US 20120277544 A1, herein Fernandes).
Regarding claim 10, Perot disclosed all limitations of claim 9. Perot however failed to explicitly disclose wherein the web of material comprises a biodegradable material.
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].
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 Perot to include wherein the web of material comprises a biodegradable material as taught by Fernandes since such a modification enables the device of Perot to have material forming the device to biodegrade and be absorbed by the body [Fernandes, 0012].
Regarding claim 12, Perot as modified by Fernandes disclosed all limitations of claim 10. However, Perot failed to explicitly disclose wherein the biodegradable material is soluble in a solvent.
However, Fernandes teaches biodegradable polymers may include natural polymers and polymers derived thereof. Some of these materials may degrade either by enzymatic hydrolysis or exposure to water in vivo, by surface or bulk erosion [0070].
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 Perot to include wherein the biodegradable material is soluble in a solvent as taught by Fernandes since such a modification enables the device of Perot to have material forming the device to biodegrade and be absorbed by the body [Fernandes, 0012]
Regarding claim 19, Perot discloses a syringe and syringe package system (drug delivery device 1 in Fig. 1 which is interpreted as a syringe in a package system) comprising:
a syringe barrel (tubular barrel 4 in Fig. 3) having an open proximal end and a distal end (having open distal and proximal ends [0067]);
a syringe stopper (plunger 20 in Fig. 6) placed in the open proximal end of the syringe barrel (the proximal end being sized and shaped to receive a plunger 20 [0067]);
a shape-changeable package (package 3 in Fig. 1, which is seen to split into web of material/plunger rod 8 and tray 9 in Fig. 3, and is interpreted as shape changeable), the syringe barrel and the syringe stopper contained within the shape-changeable package (tubular barrel 4 and plunger 20 is seen contained within package 3 in Fig. 6), wherein the shape-changeable package comprises a rolled web of material (package 3 is interpreted to comprise web of material 8; the web of material 8 is seen partially rolled in package 3 and can assume rolled configuration as seen in Fig. 5) having a distal end (the tear-off line 7 runs only on one side of the web of material 8 and it has a proximal end 7a and a distal end 7b [0074]; it is interpreted that the location on web of material 8 near 7b is the distal end of web of material 8), a proximal end (the tear-off line 7 runs only on one side of the web of material 8 and it has a proximal end 7a and a distal end 7b [0074]; it is interpreted that the location on web of material 8 near 7a is the proximal end of web of material 8), a first edge (junction outline 22 near first longitudinal portion 11 in Fig. 4) extending from the distal end of the rolled web of material to the proximal end of the rolled web of material (junction outline 22 is seen extending from distal end to proximal end in Fig. 4) and a second edge (junction outline 22 near second longitudinal portion 12 in Fig. 4) extending from the distal end of the rolled web of material to the proximal end of the rolled web of material (junction outline 22 is seen extending from distal end to proximal end in Fig. 4) and opposite the first edge (first longitudinal portion 11 and 12 are located opposite to each other and therefore the two junction outlines is interpreted to be opposite to each other in Fig. 4), the rolled web of material sized and arranged to contain the syringe barrel and the syringe stopper (web of material 8 contains barrel 4 and plunger 20 in Fig. 6) and configured to be converted to a plunger rod (web of material 8 is converted to a plunger rod in Fig. 5) that engages the syringe stopper (the plunger rod 8 is provided at its distal end with attaching means, under the form of a projecting screw 13 on the example shown, for attaching said distal end to the plunger 20 present in the tubular barrel 4 [0080]) and is translatable within the open proximal end of the syringe barrel (plunger rod 8 is inserted into proximal end of barrel 4 in Fig. 5); and
a radial projection (see radial projection in annotated Fig. 7 above) configured to releasably engage the first edge (radial projection is seen in engagement with junction outline 22 in annotated Fig. 7; since web of material 8 can separate from tray 9 when line 7 is torn, it is interpreted that the radial projection is in releasable engagement with junction outline 22).
Perot however failed to explicitly disclose that the rolled web of material comprises a material that 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].
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 Perot to include the rolled web of material comprises a material that is biodegradable as taught by Fernandes since such a modification enables the device of Perot to have material forming the device to biodegrade and be absorbed by the body [Fernandes, 0012].
Regarding claim 20, Perot as modified by Fernandes disclosed all limitations of claim 19. However, Perot failed to explicitly disclose wherein the rolled web of 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 Perot to include wherein the biodegradable material comprises zein as taught by Fernandes since such a modification enables the device of Perot to degrade either by enzymatic hydrolysis or exposure to water, by surface or bulk erosion [Fernandes, 0070].
Allowable Subject Matter
Claim(s) 2, 3, 11, 13, 14, 15, 16 and 17 would be allowable if rewritten to overcome the objection of claim 1 set forth in this Office action from which they depend from 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 2 and 11 could not be found nor was suggested in the prior art of record.
Claim 2 requires the package to be collapsible from a first rolled to a second rolled configuration. Perot discloses the first rolled configuration (package 3 is seen in a rolled form in annotated Fig. 7 when crease is in engagement with radial projection) but fails to explicitly disclose a second rolled configuration since only the web of material 8 is rolled into a new configuration. Because web of material 8 and tray 9 together make up the packaging 3 of Perot, claim 2 requires both the web of material 8 and tray 9 to be collapsible from the first rolled to the second rolled configuration, and therefore Perot fails to meet this requirement.
Claim 3 depend, directly or indirectly, on claim 2 and therefore incorporate all the limitations of claim 2. Because claim 2 includes limitations not taught or suggested by the prior art of record, claim 3 likewise contain allowable subject matter.
Claim 11 requires the radial projection to comprise a first elongate projection extending radially inwardly adjacent to the second edge. Perot discloses the radial projections as projecting outwardly and therefore fails to meet the requirement of claim 11.
Claim 13, 14, 15, 16 and 17 depend, directly or indirectly, on claim 11 and therefore incorporate all the limitations of claim 11. Because claim 11 includes limitations not taught or suggested by the prior art of record, claims 13-17 likewise contain allowable subject matter.
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.”
Response to Amendment
Applicant has amended claims 6, 7, 13 and 20 which were previously objected to. Examiner accordingly withdraws the objection of claims 6, 7, 13 and 20. Claim 4 is canceled which was previously objected to.
Applicant has amended claims 8, 9, 11, 12, 13 and 15 which were previously rejected under the U.S.C § 112(b) rejection. Examiner accordingly withdraws the 112(b) rejections of claims 8, 9, 11, 12, 13 and 15. Claims 4 and 5 is canceled which was previously rejected under the U.S.C § 112(b) rejection. Examiner accordingly also withdraws the 112(b) rejections of claims 6, 8-17 which were previously rejected due to their dependency on claim 4. However, amended claim 7 has been issued 112(b) rejection as set forth above.
Response to Arguments
Applicant’s argument filed on 04/28/2026 have been fully considered but they are not found persuasive.
Applicant has argued that Keeney does not disclose, teach or suggest the syringe and syringe package system of amended claim 1. However Perot fully reads on the limitations of claim 1 as per the 102 rejection of claim 1 as set forth above.
Applicant has argued that Keeney, Fernandes or their combination discloses, teach or suggest the syringe and syringe package system of claim 19 and 20. Applicant argued that Keeney failed to explicitly disclose, teach or suggest a radial projection configured to releasably engage the first edge of the rolled web of biodegradable material. Applicant further argued that Fernandes failed to disclose, teach or suggest the syringe and syringe package system of claims 19 and 20.
However Perot disclosed the radial projection as required by claim 19 as seen in annotated Fig. 7 above. Fernandes teaches the biodegradable material of claim 19 and 20, and Perot in combination with Fernandes disclosed all limitations of claim 19 as per the 103 rejection of claim 19 set forth above.
Conclusion
16. Any inquiry concerning this communication or earlier communications from the
examiner should be directed to MAHMOOD FAROOQ whose telephone number is
(571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p
EST. Examiner interviews are available via telephone, in-person, and video
conferencing using a USPTO supplied web-based collaboration tool. To schedule an
interview, applicant is encouraged to use the USPTO Automated Interview Request
(AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number
for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be
obtained from Patent Center. Unpublished application information in Patent Center is
available to registered users. To file and manage patent submissions in Patent Center,
visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-
center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For
additional questions, contact the Electronic Business Center (EBC) at 866-217-9197
(toll-free). If you would like assistance from a USPTO Customer Service
Representative, call 800-786-9199 (IN USA OR CANADA) or
571-272-1000.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights