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 of Species D1 and A2 in the reply filed on 3/3/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
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.
Claims 1-5, 8-10, 12, 16-19, 21-23, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Margolin (US 2015/0246102 From IDS) and further in view of Davis et al. (US 2016/0317393).
Regarding claim 1 Margolin discloses a method of preparing a nutritional composition, the method comprising: connecting a hydrolysis device with a first and second end to a flow device and wherein the hydrolysis device contains lipase within a chamber of the hydrolysis device; wherein the nutritional composition includes triglycerides;(See Margolin [0122]-[0127] and [0151] wherein a hydrolysis device with immobilized lipase has first and second ends, i.e.top and bottom mesh sides) and flowing the nutritional solution through the hydrolysis device which result in a hydrolyzed nutritional composition in which at least some of the triglycerides are hydrolyzed into free fatty acids and monoglycerides. (See Margolin [0002] and [0005] wherein the lipase converts triglycerides into free fatty acids and monoglycerides upon contact with a nutritional composition.)
Margolin discloses that the hydrolysis device may be placed in a flow line such that it is used during transfer of fluids between containers and/or to a patient (See [0122] and [0134])and that the container for holding the lipase and formula may be a syringe.(See Margolin [0124]) and that treatment may occur upon additional and removal from a container. (See Margolin [0139]
While Margolin discloses the use of syringes and that the hydrolysis device may be connected to “any other structure to facilitate transfer of fluid to another container or to assist in feeding” it does not specifically disclose the specific operation of a syringe.
Davis discloses a syringe used to transfer fluids and assist in feeding wherein a nutritional composition, i.e. fluid with nutrients, is drawn into a port of a syringe in a first direction and expelled form the port of a syringe in a second direction opposite the first direction by operation of a syringe plunger such that a nutritional formula is transferred a user via a feeding tube. (See Davis Abstract [0003],[0043])
It would have been obvious to one of ordinary skill in the art at the time of invention to place the hydrolysis device of Margolin connected with the syringe barrel of Davis and operate the syringe as described by Davis to perform fluid transfer and feeding because doing so allows the effective supplementation of nutritional fluid to a patient and accurate dosing of said fluids as would be desirable in the method of Margolin.
In regards to pulling and pushing of the syringe plunger and movement of fluid in first and second directions it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and moving material therein in a first direction and expelling material from the syringe requires pushing the plunger and moving fluid from the syringe in a second direction.
Regarding claim 2 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the nutritional composition flows through the hydrolysis device in the first direction for a time duration ranging from about 1 second to about 5 minutes.(See Margolin [0012] wherein the nutritional composition is exposed to the lipase, i.e. flows through the hydrolysis device in a first direction for various times including at least 5 minutes and/or no more than 5 minutes.)
It would have been obvious to one of ordinary skill in the art at the time of invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. In re Malagari, 182 USPQ 549.
Regarding claim 3 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the nutritional composition is one of an enteral formula, an infant formula, or milk. (See [0009] and [0083] wherein the composition is an enteral formula.)
Regarding claim 4 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the lipase contained within the hydrolysis device is immobilized. (See Margolin [0016] wherein the lipase is immobilized.)
Regarding claim 5 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising delivering the hydrolyzed nutritional composition to a subject. (See Margolin [0013] and Claim 98 wherein the hydrolyzed nutritional composition is delivered via a feeding tube.)
Regarding claim 8 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising connecting a feeding tube to the second end of the hydrolysis device prior to expelling the nutritional composition from the syringe. (See Margolin [0013] and Claim 98 wherein the hydrolyzed nutritional composition is delivered via a feeding tube and thus the second end of the syringe and hydrolysis device must be connected to the feeding tube prior to expelling.)
Regarding claim 9 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising delivering the hydrolyzed nutritional composition to a subject via the feeding tube. (See Margolin [0013] and Claim 98 wherein the hydrolyzed nutritional composition is delivered via a feeding tube.)
Regarding claim 10 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein expelling the nutritional composition from the syringe comprises using a syringe pump.(See Davis [0043] wherein the materials are delivered by using a syringe pump which moves the plunger.)
Regarding claim 12 Margolin discloses a method of preparing a nutritional composition, the method comprising: connecting a hydrolysis device with a first and second end to a flow device and wherein the hydrolysis device contains lipase within a chamber of the hydrolysis device; wherein the nutritional composition includes triglycerides;(See Margolin [0122]-[0127] and [0151] wherein a hydrolysis device with immobilized lipase has first and second ends, i.e.top and bottom mesh sides) and flowing the nutritional solution through the hydrolysis device which result in a hydrolyzed nutritional composition in which at least some of the triglycerides are hydrolyzed into free fatty acids and monoglycerides. (See Margolin [0002] and [0005] wherein the lipase converts triglycerides into free fatty acids and monoglycerides upon contact with a nutritional composition.)
Margolin discloses that the hydrolysis device may be placed in a flow line such that it is used during transfer of fluids between containers and/or to a patient (See [0122] and [0134])and that the container for holding the lipase and formula may be a syringe barrel.(See Margolin [0124]) and that treatment may occur upon additional and removal from a container. (See Margolin [0139]
While Margolin discloses the use of syringes and that the hydrolysis device may be connected to a port of “any other structure to facilitate transfer of fluid to another container or to assist in feeding” it does not specifically disclose the specific operation of a syringe.
Davis discloses a syringe used to transfer fluids and assist in feeding wherein a nutritional composition, i.e. fluid with nutrients, is drawn into a port of a syringe in a first direction and expelled form the port of a syringe in a second direction opposite the first direction by operation of a syringe plunger such that a nutritional formula is transferred a user via a feeding tube. (See Davis Abstract [0003],[0043])
It would have been obvious to one of ordinary skill in the art at the time of invention to place the hydrolysis device of Margolin connected with the syringe barrel of Davis and operate the syringe as described by Davis to perform fluid transfer and feeding because doing so allows the effective supplementation of nutritional fluid to a patient and accurate dosing of said fluids as would be desirable in the method of Margolin.
In regards to pulling and pushing of the syringe plunger and movement of fluid in first and second directions it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and moving material therein in a first direction and expelling material from the syringe requires pushing the plunger and moving fluid from the syringe in a second direction.
Regarding claim 16 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising connecting a feeding tube to the second end of the hydrolysis device prior to pushing the plunger of the syringe to expel the nutritional composition out of the syringe. (See Margolin [0013] and Claim 98 and Davis [0043] wherein the nutritional composition is delivered via a feeding tube and thus the second end of the syringe and hydrolysis device must be connected to the feeding tube prior to expelling, i.e. by pushing the plunger.)
In regards to pulling and pushing of the syringe plunger and it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and expelling material from the syringe requires pushing the plunger.
Regarding claim 17 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein pushing the plunger of the syringe to expel the nutritional composition comprises using a syringe pump. (See Davis [0043] wherein the materials are delivered by using a syringe pump which moves the plunger.)
In regards to pulling and pushing of the syringe plunger and it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and expelling material from the syringe requires pushing the plunger.
Regarding claim 18 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the nutritional composition is one of an enteral formula, an infant formula, or milk. (See [0009] and [0083] wherein the composition is an enteral formula.)
Regarding claim 19 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the nutritional composition flows through the hydrolysis device for the first time for a time duration ranging from about 1 second to about 5 minutes. (See Margolin [0012] wherein the nutritional composition is exposed to the lipase, i.e. flows through the hydrolysis device in a first direction for various times including at least 5 minutes and/or no more than 5 minutes.)
It would have been obvious to one of ordinary skill in the art at the time of invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. In re Malagari, 182 USPQ 549.
Regarding claim 21 Margolin discloses a method of preparing a nutritional composition, the method comprising: connecting a hydrolysis device with a first and second end to a flow device and wherein the hydrolysis device contains lipase within a chamber of the hydrolysis device; wherein the nutritional composition includes triglycerides;(See Margolin [0122]-[0127] and [0151] wherein a hydrolysis device with immobilized lipase has first and second ends, i.e.top and bottom mesh sides) and flowing the nutritional solution through the hydrolysis device which result in a hydrolyzed nutritional composition in which at least some of the triglycerides are hydrolyzed into free fatty acids and monoglycerides. (See Margolin [0002] and [0005] wherein the lipase converts triglycerides into free fatty acids and monoglycerides upon contact with a nutritional composition.)
Margolin discloses that the hydrolysis device may be placed in a flow line such that it is used during transfer of fluids between containers and/or to a patient (See [0122] and [0134])and that the container for holding the lipase and formula may be a syringe.(See Margolin [0124]) and that treatment may occur upon additional and removal from a container. (See Margolin [0139]
While Margolin discloses the use of syringes and that the hydrolysis device may be connected to “any other structure to facilitate transfer of fluid to another container or to assist in feeding” it does not specifically disclose the specific operation of a syringe.
Davis discloses a syringe used to transfer fluids and assist in feeding wherein a nutritional composition, i.e. fluid with nutrients, is drawn into a port of a syringe in a first direction and expelled form the port of a syringe in a second direction opposite the first direction by operation of a syringe plunger such that a nutritional formula is transferred a user via a feeding tube. (See Davis Abstract [0003],[0043])
It would have been obvious to one of ordinary skill in the art at the time of invention to place the hydrolysis device of Margolin connected with the syringe barrel of Davis and operate the syringe as described by Davis to perform fluid transfer and feeding because doing so allows the effective supplementation of nutritional fluid to a patient and accurate dosing of said fluids as would be desirable in the method of Margolin.
In regards to pulling and pushing of the syringe plunger and movement of fluid in first and second directions it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and moving material therein in a first direction and expelling material from the syringe requires pushing the plunger and moving fluid from the syringe in a second direction.
Margolin also discloses wherein the nutritional composition flows through the hydrolysis device the first time for a time duration ranging from about one second to about five minutes.(See Margolin [0012] wherein the nutritional composition is exposed to the lipase, i.e. flows through the hydrolysis device in a first direction for various times including at least 5 minutes and/or no more than 5 minutes.)
It would have been obvious to one of ordinary skill in the art at the time of invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. In re Malagari, 182 USPQ 549.
Regarding claim 22 modified Margolin discloses all the claim limitations as set forth above as well as the method the nutritional composition is one of an enteral formula, an infant formula, or milk. (See [0009] and [0083] wherein the composition is an enteral formula.)
Regarding claim 23 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the lipase contained within the hydrolysis device is immobilized. (See Margolin [0016] wherein the lipase is immobilized.)
Regarding claim 27 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising connecting a feeding tube to the second end of the hydrolysis device prior to using the syringe pump to expel the nutritional composition out of the syringe. (See Margolin [0013] and Claim 98 wherein the hydrolyzed nutritional composition is delivered via a feeding tube and thus the second end of the syringe and hydrolysis device must be connected to the feeding tube prior to expelling.)
Regarding claim 28 modified Margolin discloses all the claim limitations as set forth above as well as the method further comprising delivering the hydrolyzed nutritional composition to a subject via the feeding tube. (See Margolin [0013] and Claim 98 wherein the hydrolyzed nutritional composition is delivered via a feeding tube.)
Claims 6-7, 13-15, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Margolin (US 2015/0246102 From IDS) in view of Davis et al. (US 2016/0317393) as applied to claims above, and further in view of Yale et al. (US 5,820,621).
Regarding claims 6-7 modified Margolin does not specifically disclose connection of an enteral straw to fill the syringe such that the material flows through the straw into the hydrolysis in the first direction
Yale discloses that straws are attached to the end of a syringe when filling syringes in order to allow piercing of filling vessels while maintaining sterility and removal of the straw prior to expelling the material from the syringe to a patient. (See Yale Abstract and Col. 1 Line 40-Col. 2 Line 18)
It would have been obvious to one of ordinary skill in the art at the time of filling to attach a straw to a syringe before filling the syringe and remove it prior to dispensing the contents thereof as described by Yale in the method of modified Margolin because straws are known in the art to be used in syringe filling systems to allow sanitary filling of a syringe and allow connection to other systems for delivery as would be desirable in the method of modified Margolin.
Regarding claims 13-15 modified Margolin does not specifically disclose connection of an enteral straw to fill the syringe such that the material flows through the straw into the hydrolysis in the first direction
Yale discloses that straws are attached to the end of a syringes prior to filling syringes in order to allow piercing of filling vessels while maintaining sterility and removal of the straw prior to expelling the material from the syringe to a patient. (See Yale Abstract and Col. 1 Line 40-Col. 2 Line 18)
It would have been obvious to one of ordinary skill in the art at the time of filling to attach a straw to a syringe before filling the syringe and remove it prior to dispensing the contents thereof as described by Yale in the method of modified Margolin because straws are known in the art to be used in syringe filling systems to allow sanitary filling of a syringe and allow connection to other systems for delivery as would be desirable in the method of modified Margolin.
In regards to pulling and pushing of the syringe and it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and moving material therein in a first direction and expelling material from the syringe requires pushing the plunger and moving fluid from the syringe in a second direction. Furthermore it is noted that when the straw is connected to the syringe it is also fluidically connected to the second end of the hydrolysis device within the syringe.
Regarding claims 24-26 modified Margolin does not specifically disclose connection of an enteral straw to fill the syringe such that the material flows through the straw into the hydrolysis in the first direction
Yale discloses that straws are attached to the end of a syringes prior to filling syringes in order to allow piercing of filling vessels while maintaining sterility and removal of the straw prior to expelling the material from the syringe to a patient. (See Yale Abstract and Col. 1 Line 40-Col. 2 Line 18)
It would have been obvious to one of ordinary skill in the art at the time of filling to attach a straw to a syringe before filling the syringe and remove it prior to dispensing the contents thereof as described by Yale in the method of modified Margolin because straws are known in the art to be used in syringe filling systems to allow sanitary filling of a syringe and allow connection to other systems for delivery as would be desirable in the method of modified Margolin.
In regards to pulling and pushing of the syringe and it is noted that one of ordinary skill in the art would be well appraised of the operation of syringes and that filling a syringe requires pulling the plunger and moving material therein in a first direction and expelling material from the syringe requires pushing the plunger and moving fluid from the syringe in a second direction. Furthermore it is noted that when the straw is connected to the syringe it is also fluidically connected to the second end of the hydrolysis device within the syringe.
Claims 11, 20 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Margolin (US 2015/0246102 From IDS) in view of Davis et al. (US 2016/0317393) as applied to claims above, and further in view of Garcia-Rodenas et al. (US 2014/0286908).
Regarding claim 11 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the composition comprises long chain polyunsaturated fatty acids is delivered to a patient diagnosed with various conditions that require enteral feeding but does not specifically disclose necrotizing enterocolitis.
Garcia-Rodenas et al. discloses a method of delivering a nutritional composition comprising long-chain polyunsaturated fatty acids to a patient with necrotizing enterocolitis for treatment/recovery thereof. (See Garcia-Rodenas Abstract and [0011])
It would have been obvious to deliver the nutritional formula having long chain polyunsaturated fatty acids in the method of modified Margolin to a patient diagnosed with necrotizing enterocolitis as described by Garcia-Rodenas because doing so is known in the art to be beneficial for said patient as would be desirable in the method of modified Margolin.
Regarding claim 20 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the composition comprises long chain polyunsaturated fatty acids is delivered to a patient diagnosed with various conditions that require enteral feeding but does not specifically disclose necrotizing enterocolitis.
Garcia-Rodenas et al. discloses a method of delivering a nutritional composition comprising long-chain polyunsaturated fatty acids to a patient with necrotizing enterocolitis for treatment/recovery thereof. (See Garcia-Rodenas Abstract and [0011])
It would have been obvious to deliver the nutritional formula having long chain polyunsaturated fatty acids in the method of modified Margolin to a patient diagnosed with necrotizing enterocolitis as described by Garcia-Rodenas because doing so is known in the art to be beneficial for said patient as would be desirable in the method of modified Margolin.
Regarding claim 29 modified Margolin discloses all the claim limitations as set forth above as well as the method wherein the composition comprises long chain polyunsaturated fatty acids is delivered to a patient diagnosed with various conditions that require enteral feeding but does not specifically disclose necrotizing enterocolitis.
Garcia-Rodenas et al. discloses a method of delivering a nutritional composition comprising long-chain polyunsaturated fatty acids to a patient with necrotizing enterocolitis for treatment/recovery thereof. (See Garcia-Rodenas Abstract and [0011])
It would have been obvious to deliver the nutritional formula having long chain polyunsaturated fatty acids in the method of modified Margolin to a patient diagnosed with necrotizing enterocolitis as described by Garcia-Rodenas because doing so is known in the art to be beneficial for said patient as would be desirable in the method of modified Margolin.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 21-22 of copending Application No. 19/260/039. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. 19/260/039 include all the limitations of claims 1-29 and are generally more specific.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gjerde (US 2024/0060861) discloses a syringe having attached thereto device with immobilized enzymes for treatment of a fluid therewith.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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