DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 08/01/25 have been entered in the case. Claims 21, 23-25, 28-35 are pending for examination and claims 1-20, 22, 26 are cancelled.
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 35 is 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.
The claim 25 requires that: a syringe, a needle shield…, a cap…, a needle shield remover according to any of claims 21, 23-25 & 28-34. However, the limitation “a needle shield remover” according to any of claims 21, 23-25 & 28-34 that already includes the limitations: a syringe, a needle shield, a cap… Therefore, it does not make any sense that there are more than one syringe, more than one cap, more than one needle shield remover in the an automatic injection device.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 24-25, 28-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Olson (US 7,771,397) in view of Szwarc (US 4,964,866).
Regarding claim 21, Olson discloses a needle shield remover (including elements 28 & 31) comprising:
a tubular member 31 having a distal end 24, a proximal end (opposite to the distal end 24) and a plurality of outer diameters (e.g., outer threads 24 & 34) for enclosing a needle shield 38 & 40 coupled to a syringe 44, the needle shield 38 & 40 having a distal portion and a proximal end having an aperture to receive a needle; and
one or more shield engagement mechanisms 36 provided at the proximal end of the tubular member configured for engagement with the needle shield 38 (at region 46, Fig. 2);
a cap engagement mechanism (including elements 22, 28, 30 & 32) being formed with the distal end 24 of the tubular member 31, the cap engagement mechanism 22, 28, 30 & 32 configured for engagement with a cap 10 for covering an end of the tubular member;
in order to perform an action such as: wherein, when the needle shield remover is pulled away from the syringe, a user must use some forces to apply on the shield engagement mechanism 36. In other words, the one or more shield engagement mechanisms 36 exert force against the needle shield 38 (at region 46) to remove the needle shield from the syringe.
with regarding the limitation “integrally”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the cap engagement mechanism being “integrally formed” with the distal end of the tubular member, since it has been held that constructing a formerly integral structure or separate structure in various elements involves only routine skill in the art.
PNG
media_image1.png
536
960
media_image1.png
Greyscale
Olson does not disclose that the one or more shield engagement mechanism are configured to be positioned within a gap located in between a proximal engage of the needle shield and the syringe.
Szwarc discloses a needle shield remover comprising: a tubular member 52; one or more shield engagement mechanisms 57 (or/and including element 47) provided at a proximal end of the tubular member 52 configured for engagement with a needle shield 41, the one or more shield engagement mechanisms are configured to be positioned within a gap A located between a proximal edge of the needle shield and the syringe 27, see marked-up Fig. 4 below.
PNG
media_image2.png
278
679
media_image2.png
Greyscale
Since Olson and Szwarc are both from the same field of endeavor, the purpose disclosed by Szwarc would have been recognized in the pertinent art of Olson.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the shield engagement mechanism of the device of Olson with providing one or more shield engagement mechanisms being provided at a proximal end of the tubular member, as taught by Szwarc, in order to enhance a securing of an engagement in between the tubular member and the needle shield.
PNG
media_image3.png
705
842
media_image3.png
Greyscale
Regarding claim 24, Olson in view of Scwarc discloses all claimed subject matter as requreid in the claimed invention. Olson further discloses that wherein the cap 10 comprises an aperture 20 and a flanged portion (an L-shaped portion, see the marked-up Fig. 2 below) provided in the aperture 20, and wherein the cap engagement mechanism 30/32 is configured to fit within the aperture 20 in the cap and wherein the flanged portion of the cap is accommodated in a gap under the cap engagement mechanism. Note: the ledge 28 inserts in the gap, or contacts at the gap, see the marked-up Fig. 2 below).
PNG
media_image4.png
466
856
media_image4.png
Greyscale
Regarding claim 25, Olson in view of Scwarc discloses all claimed subject matter as required in the claimed invention. With broadest interpretation, the tubular member 31 in Olson includes an aperture (an interior space of the tubular member 31) and the one or more shield engagement mechanism(s) is/are provided in the aperture (the interior space). In addition, Scwarc (or Olsen in view of Scwarc) further discloses that wherein the tubular member comprises one aperture at proximal end of the tubular 52 as shown in Fig. 4 in Scwarc; wherein the inwardly flange 57 (equivalent to the claimed of the shield engagement mechanism located at the aperture at the proximal end of the tubular 52).
Regarding claim 28, Olson in view of Scwarc discloses all claimed subject matter as required in the claimed invention. Olson discloses that wherein the needle shield comprises a soft inner portion 40 and a rigid outer portion 38.
Regarding claim 29, Olson in view of Scwarc discloses all claimed subject matter as required in the claimed invention. Olson discloses that wherein the needle shield remover 31 is configured for engagement with the needle shield 38/40 coupled to the syringe 44 before the syringe 44 is inserted into a housing of an automatic injection device.
Note: the limitation, i.e., a needle shield remover “is configured for engagement with the needle shield coupled to the syringe before the syringe is inserted into a housing of an automatic injection device” is a method of using or packaging/assembly step into the device claim. The limitation above is equivalent to the product-by-process limitation and has not been given weight in determining the patentability of the device claim. See MEPE §2113. Therefore, this limitation above is considered as a functional limitation and only requires to perform of function. In this case, a person skilled in the art would recognize that the syringe 44 can be made as an autoinjector and therefore the syringe 44 is capable of inserting into a housing of the autoinjector. In other words, the needle shield remover in Olsen is capable of coupling to the syringe 44 before the syringe 44 is inserted into a housing of an automatic injection device (for example: the standard syringe can be made or inserted into the automatic injection device, as evidence in Cowe).
Evidence: Cowe (US 2012/0220954) discloses an auto injector comprising: a needle shield remover 166; a needle shield 122 & 168, see Fig. 9. Therefore, a person skilled in the art would recognize that the needle shield remover in Olsen can be used (or capable of using) in the automatic injection device of Cowe.
Because the limitation 29 is a functional limitation, the examiner provides evidence in Cowe that: it is well-known in the art that the syringe 44 Olsen can be assembled as auto-injector, as shown in Cowe.
For example: the syringe 44 in Olsen is similar or equivalent to a syringe 14 in Cowe. Therefore, a person skilled in the art would recognize that the syringe 44 in Olsen can be assembled or made as auto-injector.
Claims 21, 23-25, 28-31, 33-35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 5,928,205) in view of Olson (US 7,771,397).
Regarding claim 21, Marshall discloses a needle shield remover 4 comprising:
a tubular member 4 having a distal end, a proximal end and a plurality of outer diameters (e.g. diameter at portion 4 is different with diameter at portion 9) for enclosing a needle shield 7 coupled to a syringe 2; the needle shield 7 having a distal portion 7 and a proximal end 8 having an aperture (located at a proximal end 8) to receive a needle 1;
one or more shield engagement mechanisms 6 (in Fig. 1-2) provided at the proximal end (near element 11 in Fig. 1) of the tubular member configured for engagement with the needle shield 7, the one or more shield engagement mechanisms 6 are configured to be positioned within a gap (see marked-up Fig. 1 below) located between a proximal edge of the needle shield 7 and the syringe 2 (at a nose 13 of the syringe); and
wherein, when the needle shield remover 4 is pulled away from the syringe, the one or more shield engagement mechanisms 6 exert force against the proximal edge of the needle shield to remove the needle shield from the syringe. Note: in order to perform an action such as: wherein, when the needle shield remover is pulled away from the syringe, a person skilled in the art would recognize that a user must use some forces to apply on the shield engagement mechanism 6 exert force against the needle shield 7 (as seen in Fig. 1) to remove the needle shield from the syringe.
PNG
media_image5.png
320
658
media_image5.png
Greyscale
Note: with regarding to the limitation “a gap located between the needle shield and the syringe”, the Figs. 11-12 in the current application show that a gap is located in between a proximal end of the needle shield 612 and at a shoulder of the syringe. Similarly, Marshall discloses that the gap (as shown in marked-up Fig. 1) is located in between a proximal end of the needle shield 7 and at a shoulder 16 of the syringe 15.
Marshall does not disclose that a cap engagement mechanism integrally formed with the distal end of the tubular member, the cap engagement mechanism configured for engagement with a removable distal cap for covering the distal end of the tubular member. Note: the limitation “… configured for engagement with a removable distal cap for covering the distal end of the tubular member” is a functional limitation and only requires performing a function.
In this case, Olson discloses a needle shield remover 10 comprising: a tubular member 31; a needle shield 40; a cap engagement mechanism (including elements 28, 30 & 32) integrally formed with a distal end of the tubular member 31; the cap engagement configured for engagement with a removable distal cap 10 for covering the distal end of the tubular member 31.
PNG
media_image6.png
433
330
media_image6.png
Greyscale
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Marshall with including a cap engagement mechanism being integrally formed with the distal end of the tubular member and the cap engagement mechanism being engaged with a removable distal cap, as taught by Olson, in order to enhance of protection an injection needle in sterile condition.
As mentioned above, the limitation “… configured for engagement with a removable distal cap for covering the distal end of the tubular member” is a functional limitation and only requires to performing a function. In this case, the cap engagement mechanism (as modified by Olson) is configured for engagement with a removable distal cap for covering the distal end of the tubular member, as required in the claimed invention.
Regarding claims 23, 30-31, 33-34, Marshall in view of Olson discloses all claimed subject matter as required in the claimed invention. Marshall further discloses that one or more slots (slots/grooves in L-shaped, see marked up figure below) radially disposed on exterior surface of the tubular member extending substantially parallel to a longitudinal axis L thereof; wherein the slots are disposed on the proximal portion of the tubular member 4; wherein the one or more slots includes two slots separated from each other by about 180 degrees. As for claim 34, the one or more longitudinal extending grooves engage a syringe sleeve 16 to maintain the needle shield remover in an axial orientation relative to the syringe held by the syringe sleeve.
PNG
media_image7.png
401
362
media_image7.png
Greyscale
Regarding claim 24, Marshall in view of Olson discloses all claimed subject matter as required in the claimed invention. Olson (or Marshall in view of Olson) discloses that the cap 10 comprises an aperture 20 and a flange portion (an inwardly-flange in L-shaped of the cap 10 that located adjacent to element 26/28 in Fig. 2, also see the marked-up figure below) provided in the aperture, and wherein the cap engagement mechanism (e.g. elements 30, 32 and part of element 28) is configured to fit within the aperture in the cap and wherein flange portion of the cap is accommodated in a gap under the cap engagement mechanism.
PNG
media_image8.png
369
362
media_image8.png
Greyscale
Regarding claim 25, Marshall in view of Olson discloses all claimed subject matter as required in the claimed invention. Marshall (or Marshall in view of Olson) discloses that the tubular member comprises an aperture 6, and wherein the shield engagement mechanisms is/are provided in the aperture.
Regarding claim 28, Marshall in view of Olson discloses all claimed subject matter as required in the claimed invention. Marshall discloses that the needle shield comprises either soft inner portion (rubber) or a rigid outer portion (plastic sheath 7), col. 3, line 5. Olson discloses a needle shield remover 31 comprises: a needle shield 31 comprises: a soft inner portion 40 and a rigid outer portion 38 to enhance of protection an injection needle.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Marshall in view Olson with including a soft inner portion and a rigid outer portion in the needle shield, as taught by Olson, in order to enhance of protection an injection needle.
Regarding claim 29, the limitation, i.e., the needle shield remover, “is configured for engagement with the needle shield coupled to the syringe before the syringe is inserted into a housing of an automatic injection device” is a functional limitation and only requires performing of function. In this case, a person skilled in the art would recognize that the injection device is adapted to be an automatic injection device with including the needle shield remover as required in the claimed invention. Therefore, the needle shield remover in Marshall in view of Olson is capable of engagement with the needle shield 7 coupled to the syringe 12 & 2 is inserted into a housing 3 of the automatic injection device (a whole unit in Fig. 1). Note: as mentioned above, a person skilled in the art would recognize that the injection device in Marshall can be provided as an automatic injection device, as for intended use purpose.
Regarding claim 35, the claim is being rejected using the same analysis as noted the above with regarding to the claim 21. Marshall (or Marshall in view of Olson) discloses that a syringe; a needle shield 7 coupled to a distal end of the syringe; a cap 10 (as modified by Olson) for covering the needle shield; and a needle shield remover, as discussed in the claim 21 above.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 5,928,205) in view of Olson (US 7,771,397) and further in view of Brunel (US 6,033,387).
Regarding claim 32, Marshall in view of Olson discloses all the claimed subject matter as required in the claimed invention except for the limitation that the one or more slots allow the tubular member to flex radially outwardly during engagement to the needle shield.
Brunel discloses a tubular member 101 (in Figs. 1-11) or 109 (in Figs. 12a-13b) comprising: one or more slot 102 radially (at 104) disposed on an exterior surface of the tubular member extending substantially parallel to a longitudinal axis L; wherein the one or more slots 102 allow the tubular member to flex radially outwardly during engagement to an outer component 109.
Alternatively, Brunel discloses a tubular member 109 (in Figs. 12a-13b) comprising: one or more slot 124 radially (at 123) disposed on an exterior surface of the tubular member extending substantially parallel to a longitudinal axis L; wherein the one or more slots 124 allow the tubular member to flex radially outwardly during engagement to an outer component 109.
Since Marshall in view of Olson and Brunel are both from the same field of endeavor (i.e., engaging to another component), the purpose disclosed by Brunel would have been recognized in the pertinent art of Olson.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Marshall in view Olson with providing/including slot being located on the tubular member, as taught by Brunel, in order to create a flexibility of the tubular member during inserting or engaging into an outer component, i.e., the cap member.
Claim 35 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Olson (US 7,771,397) in view of Szwarc (US 4,964,866) & Cowe (US 2012/0220954).
Regarding claim 35, Olson discloses that an injection device, comprising:
a syringe 44, a needle shield 38 & 40 coupled to a distal end of the syringe 44;
a cap 10 for covering the needle shield; and
Olson in view of Szwarc discloses a needle shield remover 28 & 31 according to the claims 21, 23-25 and 27-34 (e.g., in this case, a needle shield remover 28 & 31 according to the claims 21 above, please see the rejection in claim 21 above).
Olson in view of Szwarc does not mention that the injection device in Fig. 2 is as automatic injection device.
Cowe discloses that an automatic injection device comprising: a syringe 112, a needle shield 122 & 168 coupled to a distal end of the syringe 112;
a cap 166 for covering the needle shield.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to provide the injection device of Olson in view of Szwarc with an automatic injection device, as taught by Cowe, for the benefits of friendly user with consequent savings in manufacturing and assembly cost, and a lower environmental impact.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 23-25, 32-35 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-27, 32-35 of U.S. Patent Nos. 9,339,610. Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patent.
Regarding claim 21, it is to be found in claims 1, 15 of the US’610
Regarding claim 23, it is to be found in claim 13 of the US’610
Regarding claim 24, it is to be found in claim 2 of the US’610
Regarding claim 25, it is to be found in claim 3 of the US’610
Regarding claim 32, it is to be found in claim 13 of the US’610
Regarding claim 33, it is to be found in claim 14 of the US’610
Regarding claim 34, it is to be found in claim 23 of the US’610
Regarding claim 35, it is to be found in claim 15 of the US’610
Response to Arguments
Applicant's arguments filed 08/01/25 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 21, 23-25, 28-35 have been considered but are moot because the new ground of rejection being applied in the office action. Please see above for more details.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783