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 .
Claims 1-2 and 11-21 are pending in the application. Claims 3-10 have been canceled. Preliminary amendment filed 03 December 2024.
Priority
This application is a continuation of 17/929,906 filed 09/06/2022, now US Patent No. 12063949, which is a continuation of 16/062,598 filed 06/14/2018, now US Patent No. 11432578, which is a 371 of PCT/IB2016/057675 filed 12/15/2016. This application claims foreign priority to EP 15200067.5 filed 12/15/2015, and to EP 16154144.6 filed 02/03/2016 under 35 U.S.C. 119(a)-(d). The certified copy of the priority documents have been filed in application # 16/062,598.
The parent application EP 15200067.5 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-21 of this application.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites notations for the human milk oligosaccharide components. Applicant is requested to recite the expansion for the said notations followed by the notations in parentheses for clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 11-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are drawn to a mixture of human milk oligosaccharides, namely, LNnT, LNT, 2’-FL, 3’-SL, 6’-SL and either DFL or 3-FL. This judicial exception is not integrated into a practical application, and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The test regarding Patent Subject Matter Eligibility comprises the questions:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For claims 1-2 and 11-21, the answer is “Yes” because the claim is to a composition of matter.
(2a) Prong one: Does the claim recite or involve a judicial exception? The answer is “Yes” because the composition is drawn to a combination of compounds that are products of nature. The compounds are found in human breast milk (Urashima et al, 2011, Nutrition and Diet Research Progress: Milk Oligosaccharides, New York, Nova Science Publishers, Inc., pages 1-92; see Table 1 at page 4 and Table 4 at page 14; document cited in IDS filed 08/19/2024). Applicant also admits in the specification that the instant invention is drawn to mixture of HMO’s (at page 2).
(2a) Prong two: Is the judicial exception integrated into a practical application? The answer is “no” because there is nothing required besides the compounds, per se, that integrate the judicial exceptions into a practical application.
(2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.” Beyond the actual judicial exceptions, there are no additional elements that amount to significantly more.
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.
Claims 1-2 and 11-21 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The recitation of the phrase “synthetic mixture”, in light of the guidance in the instant specification, renders the instant claims indefinite due to the ambiguous nature of the guidance. Specifically, the instant specification states: (page 5, lines 9-14)
PNG
media_image1.png
200
840
media_image1.png
Greyscale
This guidance is unclear because on one hand it specifies that the “synthetic mixture” is artificially prepared but on the other hand states that the “synthetic mixture” may be identical to a naturally occurring composition. The claim will be interpreted to encompass compositions that are artificially prepared or naturally occurring compositions.
Claims 15-21, which depend from claims 1 and 17, recite ‘wherein the mixture comprises’. Parent claim 1 recites ‘consisting essentially of’. Claims 15-21 are broadening the parent claim. It is not clear what else is included in claim 15-21.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Schroven et al (WO 2013/185780 A1; document cited in IDS filed 08/19/2024).
Schroven et al teaches an HMO composition consisting essentially of LNnT, LNT, 2’-FL, 3’-SL, 6’-SL (page 15, Example 5; part of the limitations of the instant claims-five of the six components). According to Schroven the HMO mixture can also have DFL as a component (page 18; claim 11 of Schroven; the sixth component recited in the instant claims). The said components can be combined to make a nutritional and a pharmaceutical composition wherein lactose can be an optional component too (page 10, lines 14-37; components as in instant claims 1-2 and 11-21).
Even though Schroven et al does not teach a mixture of HMO’s having the percentages of components as in instant claims 2 and 11-21, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to make the claimed compositions in view of the teachings of Schroven.
Therefore, one of ordinary skill in the art would have reasonably expected that DFL, would have same or substantially similar beneficial effects, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214, and if the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species. In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904, as noted in MPEP 2144.
It is well within the skill level of the artisan to adjust the percentages of the components to arrive at the compositions recited in instant claims 2 and 11-21 based on the composition taught by Schroven as starting point.
It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). One of skill in the art would want to adjust the amounts of the ingredients in the instant compositions in order to obtain mixtures that have optimal beneficial effects.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, the claimed HMOs and lactose are known in the art to be used as components in a composition. Thus, it is obvious to arrive at the claimed composition having the claimed percentages in view of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
One of ordinary skill in the art would be motivated to make the claimed compositions consisting essentially of the components recited in the instant claims since they are all components of human milk and are of interest due to their important functions in human development (Schroven). The artisan would also choose to substitute 3-FL in the composition in Example 5 of Schroven with DFL to arrive at the instant composition since DFL is a component that is closer to the core structures LNT and LNnT identified in HMO’s (Schroven-page 1-Background of Invention).
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 11-21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,432,578 (‘578), and as being unpatentable over claims 1-20 of U.S. Patent No. 12,063,949 (‘949 in view of Schroven et al (WO 2013/185780 A1; document cited in IDS filed 08/19/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a synthetic mixture of human milk oligosaccharides consisting essentially of LNnT, 2’-FL, 3’-FL, 6’-SL, either DFL or 3-FL and optionally lactose. Claim 11 is drawn to the mixture consisting essentially of LNnT, 2’-FL, 3’-FL, 6’-SL and DFL. Claims 2 and 11-14 recite percentages for the components. Claims 15-21 are drawn to the mixtures comprising sufficient amounts of the components.
Claims 1-7 of ‘578 is drawn to a method of treating a viral infection using an HMO composition that also consists essentially of the same oligosaccharides and percentages as instantly claimed. Claims 1-20 of ‘949 are drawn to a method of increasing the abundance of Bifidobacterium or barnesiella using an HMO composition that also consists essentially of the same oligosaccharides and percentages as instantly claimed.
The teachings of the secondary reference are set forth above.
Claims 1-7 and 1-20 of ‘578 and ‘949 differ from the instant claims in that the instant claims are drawn to a composition consisting essentially of the recited HMOs and their percentages, whereas the claims of the patents use the same composition in a method. However, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to arrive at the composition as claimed form the teachings of the patents.
In the instant case both patents teach an HMO composition consisting essentially of the HMOs and their percentages applicant claims. Although the claims of the patents use the same composition in a method, one of ordinary skill in the art would readily recognize that the composition taught by the patents can be made since it is made and used in the prior art. The use of known HMOs in compositions taught in the prior art is not seen to render the instantly claimed composition unobvious over the art. Once the composition has been shown to be old, the burden is on the applicant to present reason or authority for believing that the instant composition is different and the non-obviousness of making it. The artisan would make the claimed compositions, which are also taught by the cited patents, since they are all components of human milk and are of interest due to their important functions in human development (Schroven). The artisan would also choose to substitute 3-FL in the composition in Example 5 of Schroven with DFL to arrive at the instant composition since DFL is a component that is closer to the core structures LNT and LNnT identified in HMO’s (Schroven-page 1-Background of Invention).
Conclusion
1. Pending claims 1-2 and 11-21 are rejected.
2. Claims 3-10 have been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
