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 .
Claims 1-7 are pending, and claims 1-7 have been considered on the merits.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 discloses “a recombinant human granulocyte colony stimulating factor injection rhG-CSF”. It would be more appropriate as “a recombinant human granulocyte colony stimulating factor (rhG-CSF)” instead. Appropriate correction is required.
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 1-7 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Applicant is advised to rewrite the claims.
Claim 1 discloses the term “whole blood hematopoietic stem cells”. It is not clear what this term intends to point out. Does the term “whole blood” mean the source of the cells, or the hematopoietic stem cells being in a whole blood, i.e. without purification of hematopoietic stem cells from the whole blood? Clarification is required.
Claim 1 discloses a step of “performing a matching of dogs”. It is not clear what this phrase intends to point out. The step 1 discloses various steps therein including immunizing, testing, and matching. However, the steps are not clear how the matching is carried out. Clarification is required.
Claim 1, step 1, disclose “a blood type of specific pathogen free (SPF) dogs is a negative blood”. It is not clear what this phrase intends to point out. How is this phrase related to matching of dogs.
Claim 1 discloses the term “specific” in “specific pathogen free”. It is not clear what this term intends to point out. The term “specific” is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 discloses “using an indirect ELISA method for testing”. It is not clear what testing the ELISA method is for. The claim further discloses the wherein clause directed to the antibody titer, however, it is not clear what the antibody is. While it appears the antibody is referring to the immunizing step, however, the claim is not clear what the limitation points out. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973).
Claim 1, step 1, discloses the antibody titer of each of the SPF dogs reaches over 29. It is not clear which antibody this limitation is referring to. Furthermore, the number of antibody is not disclosed with any unit, and thus, it is not clear what the claimed titer is. Is it per ml of blood, or per any unit? Clarification is required. For search purpose, the limitation is interpreted as the dogs having sufficient number of antibody titer after the immunization with the pentavaccine.
Claim 1 discloses “matching the SPF dogs with diseased dogs” in step 1. It is not clear what this phrase intends to point out. How are the immunized SPF dogs matched to any diseased dogs? Is it referring to blood typing? The method steps in the step 1 are not clearly stated how the matching is carried out. Clarification is required.
Claim 1, step 2 discloses “performing a physical examination of the SPF dogs”, and then discloses “regularly collecting a venous blood of the SPF dogs for a hematology…” It is not clear if the “performing a physical examination” and the hematology and serum testing are two different steps, or the hematology and serum biochemical testing is referring to the physical examination. Clarification is required.
The step 2 of claim 1 appears to disclose contradicting limitation. The step 2 discloses a venous blood collecting, i.e. blood sampling, is carried out regularly before a blood sample of the SPF dogs. Clarification is required.
Claim 1, step 2 discloses “each index of the hematology and serum biochemical testing”. It is not clear what indices are included or excluded from the index of the hematological test and serum biochemical testing.
Claim 3 discloses that the SPF dogs comprise the listed dogs. The term “comprise” is inclusive and thus, the limitation is interpreted as the SPF dogs are all of the listed dogs. It does not appear the claim requires all of the listed dogs in the claimed method. Clarification is required. Applicant is advised to use the phrase “the SPF dogs are selected from the group consisting of …”
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gareau et al. (2022, Vet. Comp. Oncol.) in view of Baranidharan et al. (2018, Hematology & Transfusion International Journal), Wardrop et al. (2016, J. Vet. Int. Med.), Veterinary Medical Center (2016, downloaded from web.archive.org/web/20160206123213/http://cvm.msu.edu/hospital/services/blood-donor-program/become-a-canine-donor), Grant (2021, IWCT; downloaded from web.archive.org/web/20211114185302/https://iwct-uk.org/blog/the-5-in-1-vaccine/), Yang et al. (2020, J Vet Sci.), Okamoto et al. (2023, Evidence-Based Complementary and Alternative Medicine; published on 1/13/2023), Puotinen (2019, Whole Dog Journal) and as evidenced by Neupogen (2013, Amgen) and Diamond (2026, downloaded from www.pawlicy.com/blog/greyhound-growth-and-weight-chart/#weight-chart)
Gareau et al. teach a method of allogeneic peripheral blood hematopoietic stem cell transplantation for the treatment of dogs with lymphoma (see entire document). Gareau et al. teach DLA genotyping and donor preparation (p.863), and DLA-matched donor dogs underwent routine general health screening which included physical examination, CBC, serum chemistries and vector-borne disease screening (p.864).
Regarding the blood type being a negative blood (claim 1) or the dogs being greyhounds, Beagle, Dobermans, boxers, German shepherd (claim 3), Gareau et al. do not particularly teach the limitation.
However, it is well known in the art that blood donor dogs are typically universal donors that should be negative for DEA 1 and DEA 7, thus, negative blood type, and the most frequently studied breeds were German shepherd, Golden Retriever, Greyhound, Doberman, and Rottweiler according to Baranidharan et al. (p.47). This teaching would also meet the limitation of claim 3.
Regarding specific pathogen free (SPF) dogs, Gareau et al. teach that the donor dogs underwent vector-borne disease screening (p.864), however, they do not particularly teach specific pathogen free (SPF) dogs. However, it is well known in the art that the vector-borne disease screening taught by Gareau et al. would select pathogen-free donors, and furthermore, Wardrop et al. teach canine blood donor screening for blood-borne pathogens for minimize pathogen transmission (p.1).
Therefore, it would have been obvious to a person skilled in the art to screen the donor dogs for blood pathogen, i.e. specific pathogen, and utilize donor dogs that are specific pathogen free for the allogeneic HSC transplantation of Gareau et al. with a reasonable expectation of success.
Regarding the immunizing step of the SPF dogs with a conventional pentavaccine in step 1 (claim 1), while Gareau et al. do not particularly teach the limitation, it is known in the art that the donor dogs required to have up-to-date on vaccines according to Veterinary Medical Center (p.1). As it is extremely well known in the art that immunizing dogs with conventional penta vaccines for dogs (see Grant), it would have been obvious to a person skilled in the art to have the donor dogs vaccinated with the penta vaccine to have the donor dogs for the purpose of allogeneic HSCT of Gareau et al.
Regarding the determining the antibody titer using indirect ELISA method, Yang et al. teach an indirect ELISA for the detection of canine adenovirus type 2 antibodies (see entire document). It would have been obvious to a person skilled in the art to determine if the vaccination in the donor dogs is sufficient to prevent any transmission of pathogens by using the indirect ELISA taught by Yang et al. with a reasonable expectation of success. One skilled in the art would determine the antibody titer sufficient enough to reduce pathogens in the donor dogs, and select the dogs as pathogen free dogs for allogeneic HSCT of Gareau et al. with a reasonable expectation of success.
Regarding step 2 of claim 1, as Gareau et al. teach the physical examination, CBC (hematology) and serum biochemistries (p.864, 1st col.), it would have been obvious to a person skilled in the art that the donor dogs would have normal range for all the test for the method of Gareau et al. Regarding the regularly collecting a venous blood, while the cited references do not teach the limitation, however, it would have been obvious to a person skilled in the art to regularly repeat the CBC and serum biochemistries prior to the collection of donor blood for the transplantation with a reasonable expectation of success.
Regarding step 3, claim 1, directed to injecting a mobilization agent every day before the blood collection, Gareau et al. teach that donor dogs were mobilized using filgrastim for 5 days, or plerixafor in addition to filgrastim, 10 h before apheresis (i.e. blood collection) (p.864, 1st col.).
Regarding step 3, claim 1 directed to feeding the dogs a royal jelly before the collection, Gareau et al. do not teach the limitation.
Okamoto et al. teach that royal jelly increases hematopoietic stem cells in peripheral blood when a human subject is received the royal jelly (see entire document).
It would have been obvious to a person skilled in the art to try royal jelly for the donor dog in order to increase the hematopoietic stem cells to produce sufficient number of HSCs in HSCT transplantation for the method of Gareau et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the human study suggests a potential benefit in increasing HSCs in a human subject, the similar effect of royal jelly would be expected in the absence of evidence to the contrary. As royal jelly is recognized as a food supplement in dogs according to Puotinen (see, p.8), even if the same effect as in human might not be present in dogs, however, it is generally beneficial for the health of the dogs, and thus, the feeding of royal jelly to the donor dogs for the method of HSCT taught by Gareau et al. would be obvious.
Regarding claim 2 directed to a complete sterile closed room, it is well known in the art that the sterile closed room is utilized to prevent any microbial contamination, and one skilled in the art would recognize that the process of obtaining HSCs from the donor dogs for HSCT taught by Gareau et al. would be performed in a sterile closed room as it is desired and beneficial to prevent any contamination. As the mobilization of HSCT and testing takes several days to process according to the teachings discussed above, it would have been obvious to a person skilled in the art to use a closed sterile room to keep the donor dogs from infection or contamination for a successfully harvesting of HSCs during the procedure which takes at least 5 days (see Gareau et al. p.864, 2.3.1).
Regarding claim 3, the weight of donor dogs and the ages, Gareau et al. teach that the donor dogs are 24-108 months in their age (Table 1), and thus, the range overlaps with the claimed 2-4 years old. However, they do not teach the weight of the donor dogs. However, it would have been obvious to a person skilled in the art that the weight of the donor dogs would overlap with the claimed range as the suitable donor dogs such as Greyhound as the average weight of Greyhound at 2 years and up is 60-70 lb. (Diamond, p.1), which is overlapping with 20-40 kg of claim 3.
Regarding claim 4 directed to the mobilization agent being rhG-CSF, Gareau et al. teach the use of filgrastim for mobilizing the HSC, and filgrastim is a recombinant human G-CSF known as Neupogen® from Amgen (see p.1 description).
Regarding claim 5 directed to the mobilization agent being subcutaneously injected at 150 mg/kg per day, Gareau et al. do not teach the claimed amount of 150 mg/kg per day. However, it would have been obvious to a person skilled in the art to modify the concentration of filgrastim in order to mobilize the HSCs in the donor dogs by routine experimentations. In the absence of any criticality of the concentration of the mobilization agent utilized to mobilize the HSCs, one skilled in the art would adjust the concentration of the mobilization agent as needed because the concentration is recognized as a result-effective parameter that can be readily modified.
Regarding claim 6 directed to the first time collection being performed on a fifth day of the subcutaneous injection of the mobilization agent, Gareau et al. teach a step of mobilizing donor dogs for 5 days, and ~10 h before apheresis (p.864). This teaching could be interpreted as the apheresis (collection of blood) would be carried out either the day 5 or day 6 of the starting point of mobilization. Thus, it would have been obvious to a person skilled in the art to carry out the blood collection at day 5 after the mobilization with a reasonable expectation of success. This is because a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP2144.05(I)), particularly in the absence of evidence to the contrary. Thus, modification of the blood collection timing is routinely optimizable and one skilled in the art would be able to choose the first collection time being at day 5 after mobilization.
Regarding claim 7 directed to the second time of collection being performed if the first time collection being not enough, this limitation is interpreted the same as claim 6 as the wherein clause of the claim is directed to a contingent process. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP2111.04(II)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631